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What changed in Nanobiotix S.A.'s 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of Nanobiotix S.A.'s 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+770 added−894 removedSource: 20-F (2026-03-31) vs 20-F (2025-04-02)

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

770 paragraphs added · 894 removed · 591 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

148 edited+20 added−126 removed301 unchanged
Biggest changeRisks Related to the Discovery, Development and Commercialization of Our Product Candidates (see “Risks Factors — Risks Related to the Discovery, Development and Commercialization of Our Product Candidates” for additional details): • Our product candidate development programs are in various phases of development, including in early stages of development, and may be unsuccessful. • Initial, interim and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. • We may encounter substantial delays in clinical trials of our lead product candidate NBTXR3 1 , including the timing of the interim analysis (the timing of which is dependent on both the requisite number of events having been observed and the last patient having been recruited) or final analysis of Study Nanoray-312 given it is an event driven trial, and a function of amongst other factors, patient enrollment rate, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. • Even if we or Janssen, our strategic development and commercialization licensee, successfully complete clinical trials of our lead product candidate NBTXR3, NBTXR3 may not be successfully commercialized for other reasons. • Any issues that arise in the highly complex manufacturing process for our product candidates could have an adverse effect on its technology transfer to our licensee, our business, financial position or prospects. • Difficulty enrolling patients could delay timelines of interim or final analysis we announce or publish from time to time or prevent clinical studies of NBTXR3. • If our product candidates do not achieve projected development milestones and commercialization in the announced or expected timeframes, further development or commercialization of our product candidates may be delayed, and our business may be harmed. 1 Any references to “NBTXR3” or “JNJ-1900” should be understood as referring to the licensed product under the Janssen Agreement.
Biggest changeRisks Related to the Discovery, Development and Commercialization of Our Product Candidates (see “Risks Factors — Risks Related to the Discovery, Development and Commercialization of Our Product Candidates” for additional details): • The lead product candidate JNJ-1900 (NBTXR3 1 ) is in various phases of development and may be unsuccessful. • Initial, interim and preliminary data from clinical trials relating to JNJ-1900 (NBTXR3 that we or our licensee, Janssen, announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. • Our licensee, Janssen, may encounter substantial delays in clinical trials of the lead product candidate JNJ-1900 (NBTXR3), including the timing of any planned analyses or reporting in respect of Study Nanoray-312 given it is an event driven trial, and a function of amongst other factors, patient enrollment rate, or Study Nanoray-312 may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. • Even if we or our licensee Janssen, successfully complete clinical trials of the lead product candidate JNJ-1900 (NBTXR3), JNJ-1900 (NBTXR3) may not be successfully commercialized for other reasons. • Any issues that arise in the highly complex manufacturing process for JNJ-1900 (NBTXR3) could have an adverse effect on its technology transfer to our licensee, our business, financial position or prospects. • Difficulty enrolling patients could delay timelines of any planned analyses or reporting by us or our licensee Janssen, in respect of studies of JNJ-1900 (NBTXR3) or prevent clinical studies of JNJ-1900 (NBTXR3). 1 Any references to “NBTXR3” or “JNJ-1900” should be understood as referring to the licensed product under the Janssen Agreement.
Securities law, we are exempt from a number of rules under the U.S. securities laws and we follow certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance standards.
Securities law, we are exempt from a number of rules under the U.S. securities laws and we follow certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance standards.
Thus, as at the date of the Annual Report, any investment: by any non-European Union or non-European Economic Area’s investor that will result in the relevant investor (a) holding, directly or indirectly, acting alone or in concert with others, at least a 10% threshold of voting rights of the Company or (b) acquiring all or part of a business line of the Company where the Company is developing research and development activity listed by the French Ministry of Economy as 41 Table of Contents included in the critical technologies, is subject to the prior authorization of the French Ministry of Economy, which authorization may be conditioned on certain undertakings.
Thus, as at the date of the Annual Report, any investment: by any non-European Union or non-European Economic Area’s investor that will result in the relevant investor (a) holding, directly or indirectly, acting alone or in concert with others, 35 Table of Contents at least a 10% threshold of voting rights of the Company or (b) acquiring all or part of a business line of the Company where the Company is developing research and development activity listed by the French Ministry of Economy as included in the critical technologies, is subject to the prior authorization of the French Ministry of Economy, which authorization may be conditioned on certain undertakings.
Accordingly, despite expending significant resources in pursuit of their development, our product candidates may never achieve commercial success, and any time, effort and financial resources we expend on development programs that we pursue may adversely affect our ability to develop and commercialize our product candidates.
Despite expending significant resources in pursuit of their development, our product candidates may never achieve commercial success, and any time, effort and financial resources we expend on development programs that we pursue may adversely affect our ability to develop and commercialize our product candidates.
Any such financings may not be accessible on acceptable terms, if at all. 13 Table of Contents We are limited in our ability to raise additional share capital, which may make it difficult for us to fund our operations Under French law, our extraordinary general shareholders’ meeting may decide to increase our share capital at a majority vote of at least two-thirds of the shareholders present, represented by proxy.
Any such financings may not be accessible on acceptable terms, if at all. 14 Table of Contents We are limited in our ability to raise additional share capital, which may make it difficult for us to fund our operations Under French law, our extraordinary general shareholders’ meeting may decide to increase our share capital at a majority vote of at least two-thirds of the shareholders present, represented by proxy.
In addition, in the future, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial production and sale of any of our product candidates, including NBTXR3 that receive regulatory approval, which could adversely affect our business.
In addition, in the future, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial production and sale of any of our product candidates, including JNJ-1900 (NBTXR3) that receive regulatory approval, which could adversely affect our business.
We cannot guarantee that any of our patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third party patent and pending application in the European countries, Japan, United States and abroad that is relevant to or necessary for the commercialization of our product candidates, including NBTXR3, in any jurisdiction.
We cannot guarantee that any of our patent searches or analyses, including but not limited to the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third party patent and pending application in the European countries, Japan, United States and abroad that is relevant to or necessary for the commercialization of our product candidates, including JNJ-1900 (NBTXR3), in any jurisdiction.
Any issues that arise in the highly complex manufacturing process for our product candidates could have an adverse effect on our business, financial position or prospects. 16 Table of Contents Our nanotechnology-based products undergo a complex, highly regulated manufacturing process. The process is subject to strict controls and procedures to ensure minimal batch-to-batch variability.
Any issues that arise in the highly complex manufacturing process for our product candidates could have an adverse effect on our business, financial position or prospects. 17 Table of Contents Our nanotechnology-based products undergo a complex, highly regulated manufacturing process. The process is subject to strict controls and procedures to ensure minimal batch-to-batch variability.
The approval process varies among countries and may limit our or our strategic licensees’ ability to develop, manufacture, promote and sell our product candidates including NBTXR3 internationally. Failure to obtain marketing authorization approval or certification in international jurisdictions would prevent the product candidates from being marketed outside of the jurisdictions in which regulatory approvals have been received.
The approval process varies among countries and may limit our or our strategic licensees’ ability to develop, manufacture, promote and sell our product candidates including JNJ-1900 (NBTXR3) internationally. Failure to obtain marketing authorization approval or certification in international jurisdictions would prevent the product candidates from being marketed outside of the jurisdictions in which regulatory approvals have been received.
All entities involved in the preparation of products for clinical studies or commercial sale, including our existing contract manufacturers for our product candidates, including NBTXR3 as well as our in-house manufacturing facility in Villejuif, France, and Janssen, which has assumed certain manufacturing rights with respect to NANORAY-312,are subject to extensive regulations.
All entities involved in the preparation of products for clinical studies or commercial sale, including our existing contract manufacturers for our product candidates, including JNJ-1900 (NBTXR3) as well as our in-house manufacturing facility in Villejuif, France, and Janssen, which has assumed certain manufacturing rights with respect to NANORAY-312,are subject to extensive regulations.
You should consider our business and prospects in light of the risks and difficulties we face as a company focused on developing products in the field of physics-based therapeutic approaches and advancing clinical trials. The near and medium term prospects for our lead product candidate NBTXR3 depend heavily on Janssen’s successful clinical development and commercialization of NBTXR3.
You should consider our business and prospects in light of the risks and difficulties we face as a company focused on developing products in the field of physics-based therapeutic approaches and advancing clinical trials. The near and medium term prospects for our lead product candidate JNJ-1900 (NBTXR3) depend heavily on Janssen’s successful clinical development and commercialization of JNJ-1900 (NBTXR3).
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research and development programs of our product candidates, or the commercialization of any product candidate other than NBTXR3 for which the rights of development and commercialization have been granted to Janssen.
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research and development programs of our product candidates, or the commercialization of any product candidate other than JNJ-1900 (NBTXR3) for which the rights of development and commercialization have been granted to Janssen.
The manufacturing process for any products that we, or our licensee Janssen with regard to NBTXR3, may develop is subject to FDA, and any other regulatory authority approval or notified body for the jurisdictions in which we or our strategic development and commercialization partners will seek marketing approval for commercialization as well as ongoing compliance requirements.
The manufacturing process for any products that we, or our licensee Janssen with regard to JNJ-1900 (NBTXR3), may develop is subject to FDA, and any other regulatory authority approval or notified body for the jurisdictions in which we or our strategic development and commercialization partners will seek marketing approval for commercialization as well as ongoing compliance requirements.
We are a clinical-stage biotechnology company pioneering disruptive, physics-based therapeutic approaches focused on developing first-in-class product candidates that use its proprietary nanotechnology to transform cancer treatment by increasing the efficacy of radiotherapy. Investment in biotech development is a highly speculative endeavor.
We are a late-stage clinical development company pioneering disruptive, physics-based therapeutic approaches focused on developing first-in-class product candidates that use its proprietary nanotechnology to transform cancer treatment by increasing the efficacy of radiotherapy. Investment in biotech development is a highly speculative endeavor.
Patient enrollment is affected by a variety of factors, including: • severity of the disease under investigation; • incidence and prevalence of the disease under investigation; • design of the clinical trial protocol; • size and nature of the patient population; • eligibility criteria for the trial in question; • perceived risks and benefits of the product candidate under trial, including relative to other available therapies; • proximity and availability of clinical trial sites for prospective patients; • availability of competing therapies and clinical trials; • patient referral practices of physicians; • our ability to monitor patients adequately during and after treatment, and • ability of the clinical sites to have sufficient resources and avoid any backlogs.
Patient enrollment is affected by a variety of factors, including: • severity of the disease under investigation; • incidence and prevalence of the disease under investigation; • design of the clinical trial protocol; 18 Table of Contents • size and nature of the patient population; • eligibility criteria for the trial in question; • perceived risks and benefits of the product candidate under trial, including relative to other available therapies; • proximity and availability of clinical trial sites for prospective patients; • availability of competing therapies and clinical trials; • patient referral practices of physicians; • our ability to monitor patients adequately during and after treatment, and • ability of the clinical sites to have sufficient resources and avoid any backlogs.
Even after obtaining approval or certification in a jurisdiction for the product candidates we develop, including NBTXR3, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, and submission of safety and other post-market information.
Even after obtaining approval or certification in a jurisdiction for the product candidates we develop, including JNJ-1900 (NBTXR3), they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, and submission of safety and other post-market information.
We expect to continue to incur significant expense related to the development and manufacturing of nanotechnology product candidates such as NBTXR3 and conducting clinical studies. Additionally, we may encounter unforeseen difficulties, complications, development delays and other unknown factors that require additional expense. As a result of these expenditures, we expect to continue to incur significant losses in the near term.
We expect to continue to incur significant expense related to the development and manufacturing of nanotechnology product candidates and conducting clinical studies. Additionally, we may encounter unforeseen difficulties, complications, development delays and other unknown factors that require additional expense. As a result of these expenditures, we expect to continue to incur significant losses in the near term.
However, we cannot assure you that we will not be classified as a PFIC for the taxable year ending December 31, 2025 or any future taxable year, which may result in adverse U.S. federal income tax consequences to U.S. holders. • As a foreign private issuer under U.S.
However, we cannot assure you that we will not be classified as a PFIC for the taxable year ending December 31, 2026 or any future taxable year, which may result in adverse U.S. federal income tax consequences to U.S. holders. • As a foreign private issuer under U.S.
Side effects of, or manufacturing defects in, products that we develop could result in the deterioration of a patient’s condition, injury or even death. For example, our liability could be sought by patients participating in the clinical trials for our product candidates, including NBTXR3, as a result of unexpected side effects resulting from the administration of these product candidates.
Side effects of, or manufacturing defects in, products that we develop could result in the deterioration of a patient’s condition, injury or even death. For example, our liability could be sought by patients participating in the clinical trials for our product candidates, as a result of unexpected side effects resulting from the administration of these product candidates.
The approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain approval or certification for product candidates, our business will be substantially harmed. We, or Janssen as licensee of NBTXR3, must obtain approval or certification to market and sell our product candidates, including NBTXR3.
The approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain approval or certification for product candidates, our business will be substantially harmed. We, or Janssen as licensee of JNJ-1900 (NBTXR3), must obtain approval or certification to market and sell our product candidates, including JNJ-1900 (NBTXR3).
We maintain product liability insurance coverage for damages caused by our product candidates including NBTXR3, including clinical trial insurance coverage, with coverage limits that we believe are customary for similarly situated companies in our industry. This coverage may be insufficient to reimburse us for any expenses or losses we may suffer.
We maintain product liability insurance coverage for damages caused by our product candidates including JNJ-1900 (NBTXR3), including clinical trial insurance coverage, with coverage limits that we believe are customary for similarly situated companies in our industry. This coverage may be insufficient to reimburse us for any expenses or losses we may suffer.
For example, in the U.S., we must obtain FDA approval for each product candidate in each specific indication that we - or Janssen as licensee of NBTXR3 - intend to commercialize, and in the EU, we or Janssen, as applicable, must obtain for a medicinal product approval from the European Commission (EC), based on the opinion of the EMA.
For example, in the U.S., we must obtain FDA approval for each product candidate in each specific indication that we - or Janssen as licensee of JNJ-1900 (NBTXR3) - intend to commercialize, and in the EU, we or Janssen, as applicable, must obtain for a medicinal product approval from the European Commission (EC), based on the opinion of the EMA.
In addition, even if we or our strategic licensees were able to obtain approval or certification, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.
In addition, even if we or our strategic licensees were able to obtain approval or certification, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to 27 Table of Contents charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.
Because NBTXR3 represents a new approach to treatment, it may have a higher cost than conventional therapies and may require long-term follow-up evaluations, which may increase the risk that coverage and/or reimbursement rates may be inadequate for us to achieve profitability.
Because JNJ-1900 (NBTXR3) represents a new approach to treatment, it may have a higher cost than conventional therapies and may require long-term follow-up evaluations, which may increase the risk that coverage and/or reimbursement rates may be inadequate for us to achieve profitability.
We have not submitted any NDA, Marketing Authorisation Application request and it is possible that none of our existing product candidates including NBTXR3 or any product candidates we may seek to develop in the future will ever obtain such regulatory approval.
We have not submitted any NDA, Marketing Authorisation Application request and it is possible that none of our existing product candidates including JNJ-1900 (NBTXR3) or any product candidates we may seek to develop in the future will ever obtain such regulatory approval.
This approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval or certification to market the product candidates we develop, including NBTXR3, which would significantly harm our business, results of operations and prospects.
This approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval or certification to market the product candidates we develop, including JNJ-1900 (NBTXR3), which would significantly harm our business, results of operations and prospects.
Because our programs may involve additional product candidates or improved formulations of existing product candidates, including NBTXR3, 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 depend in part on our ability to acquire, in-license or use such intellectual property and proprietary rights.
The Company has not yet established a source of revenues sufficient to cover its operating costs, and as such, has financed its growth through successive capital increases, collaboration and license agreements, loans and receipt of research tax credit available in France.
The Company has not yet established a source of revenues sufficient to cover its operating costs, and as such, has financed its growth through successive capital increases, collaboration and license agreements, loans and royalty financing, and receipt of research tax credit available in France.
Furthermore, third parties may petition courts for declarations of invalidity or unenforceability with respect to our patents or individual claims. If successful, such claims could narrow the scope of protection afforded our product candidates, including NBTXR3, and future products, if any.
Furthermore, third parties may petition courts for declarations of invalidity or unenforceability with respect to our patents or individual claims. If successful, such claims could narrow the scope of protection afforded our product candidates, including JNJ-1900 (NBTXR3), and future products, if any.
However, we cannot assure you that we will not be classified as a PFIC for the taxable year ending December 31, 2025 or any future taxable year, which may result in adverse U.S. federal income tax consequences to U.S. holders.
However, we cannot assure you that we will not be classified as a PFIC for the taxable year ending December 31, 2026 or any future taxable year, which may result in adverse U.S. federal income tax consequences to U.S. holders.
The FDA or other regulatory authorities may delay, limit or deny approval or certification 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 29 Table of Contents 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 authorities may delay, limit or deny approval or certification 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.
Accordingly, Janssen’s prioritization of, and commitment of resources to, the development and commercialization of NBTXR3, Janssen’s effective design and execution of clinical studies, and Janssen’s delivery of timely, quality data and other information with respect to such studies will be critical to our overall operating and financial performance.
Accordingly, Janssen’s prioritization of, and commitment of resources to, the development and commercialization of JNJ-1900 (NBTXR3), Janssen’s effective design and execution of clinical studies, and Janssen’s delivery of timely, quality data and other information with respect to such studies will be critical to our overall operating and financial performance.
It is possible that we could be classified as a PFIC for the taxable year ending December 31, 2025 or future taxable years due to changes in the composition of our assets or income, as well as changes to the market value of our assets.
It is possible that we could be classified as a PFIC for the taxable year ending December 31, 2026 or future taxable years due to changes in the composition of our assets or income, as well as changes to the market value of our assets.
Additional factors that may influence whether NBTXR3 is accepted in the market, include: • the clinical indications for which NBTXR3 is approved; • the potential and perceived advantages and risks of NBTXR3 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 a product candidate, such as JNJ-1900 (NBTXR3) is accepted in the market, include: • the clinical indications for which a product candidate or JNJ-1900 (NBTXR3) is approved; • the potential and perceived advantages and risks of a product candidate or JNJ-1900 (NBTXR3) 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.
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; and • 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 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; and • 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.
We or those evaluating NBTXR3 pursuant to licenses from us may not be able to identify, recruit and enroll a sufficient number of patients or patients with required or desired characteristics to achieve the objectives of the study.
We or those evaluating JNJ-1900 (NBTXR3) pursuant to licenses from us may not be able to identify, recruit and enroll a sufficient number of patients or patients with required or desired characteristics to achieve the objectives of the study.
Further, we face the risk of significant disruptions in the development and commercialization of NBTXR3 should Janssen terminate the Janssen Agreement or the Asia Licensing Agreement, which it is permitted to do upon prior notice without cause.
Further, we face the risk of significant disruptions in the development and commercialization of JNJ-1900 (NBTXR3) should Janssen terminate the Janssen Agreement or the Asia Licensing Agreement, which it is permitted to do upon prior notice without cause.
If we identify any new material weakness in the future, any such newly identified material weakness could limit our ability to prevent or detect a misstatement of our accounts or disclosures that could result in a material misstatement of our annual or interim financial statements.
However, if we identify any material weakness in the future, any such newly identified material weakness could limit our ability to prevent or detect a misstatement of our accounts or disclosures that could result in a material misstatement of our annual or interim financial statements.
Furthermore, even if not challenged, our patents and patent applications may not adequately protect our product candidates, including NBTXR3 or technology or prevent others from designing their products or technology to avoid being covered by our patent claims.
Furthermore, even if not challenged, our patents and patent applications may not adequately protect our product candidates, including JNJ-1900 (NBTXR3) or technology or prevent others from designing their products or technology to avoid being covered by our patent claims.
Certain of these changes could impose limitations on the prices we will be able to charge for our products and any approved product candidates or the amounts of reimbursement available for these products from governmental and 32 Table of Contents private third-party payers, may increase the tax obligations on pharmaceutical companies or may facilitate the introduction of generic competition with respect to our products.
Certain of these changes could impose limitations on the prices we will be able to charge for our products and any approved product candidates or the amounts of reimbursement available for these products from governmental and private third-party payers, may increase the tax obligations on pharmaceutical companies or may facilitate the introduction of generic competition with respect to our products.
We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We devote most of our financial resources to research and development relating to our NBTXR3, including the advancement of our clinical trials.
We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We devote most of our financial resources to research and development, including the advancement of our clinical trials.
Cyberattacks could include, but are not limited to, the deployment of harmful malware (including as a result of advanced persistent threat intrusions), denial-of-service (such as credential stuffing), credential harvesting, social engineering attacks (including through phishing attacks), viruses, ransomware, supply chain attacks, personnel misconduct or error and other similar threats.
Cyberattacks could include, but are not limited to, the deployment of harmful malware (including as a result of advanced persistent threat intrusions), denial-of-service (such as credential stuffing), credential harvesting, social engineering attacks (including through phishing attacks), viruses, ransomware, supply 25 Table of Contents chain attacks, personnel misconduct or error and other similar threats.
U.S. federal and state governments have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, waivers from Medicaid drug rebate law requirements, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.
U.S. federal and state governments have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, waivers from Medicaid drug rebate law requirements, restrictions on reimbursement and requirements for substitution of generic products for branded 29 Table of Contents prescription drugs.
Based on our determination made on June 30, 2024 (the last business day of our most recently completed semester), we qualify as a foreign private issuer. The next determination as to foreign private issuer status will be made on June 30, 2025.
Based on our determination made on June 30, 2025 (the last business day of our most recently completed semester), we qualify as a foreign private issuer. The next determination as to foreign private issuer status will be made on June 30, 2026.
In addition, the legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, , and the requirements for patentability differ, in varying degrees, from country to country, and the laws of some foreign countries do not protect intellectual property rights, including trade secrets, to the same 37 Table of Contents extent as federal and state laws of the United States.
In addition, the legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, , and the requirements for patentability differ, in varying degrees, from country to country, and the laws of some foreign countries do not protect intellectual property rights, including trade secrets, to the same extent as federal and state laws of the United States.
Product candidates in later stages of clinical trials such as NBTXR3 may still fail to show the desired safety and efficacy profile despite having successfully progressed through initial clinical trials.
Product candidates in later stages of clinical trials such as JNJ-1900 (NBTXR3) may still fail to show the desired safety and efficacy profile despite having successfully progressed through initial clinical trials.
Because of the significance of our collaboration with Janssen and the contemplated scope of Janssen’s involvement in the development and commercialization of NBTXR3, such risks are particularly acute with respect to our reliance on Janssen for the worldwide development and commercialization of NBTXR3.
Because of the significance of our collaboration with Janssen and the contemplated scope of Janssen’s involvement in the development and commercialization of JNJ-1900 (NBTXR3), such risks are particularly acute with respect to our reliance on Janssen for the worldwide development and commercialization of JNJ-1900 (NBTXR3).
Grounds for a validity challenge include alleged failures to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for unenforceability assertions include allegations that someone 39 Table of Contents connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.
Grounds for a validity challenge include alleged failures to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for unenforceability assertions include allegations that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.
Moreover, because of the novel nature of NBTXR3, potential patients and their doctors may be less likely to enroll in our clinical trials relative to clinical trials for more conventional therapies.
Moreover, because of the novel nature of JNJ-1900 (NBTXR3), potential patients and their doctors may be less likely to enroll in our clinical trials relative to clinical trials for more conventional therapies.
Although the matter is not free from doubt, we do not believe that we were a PFIC for U.S. federal income tax purposes for the taxable year ended December 31, 2024.
Although the matter is not free from doubt, we do not believe that we were a PFIC for U.S. federal income tax purposes for the taxable year ended December 31, 2025.
Data privacy regulations could adversely affect our business, results of operations and financial condition. 27 Table of Contents We are subject to data privacy and protection laws and regulations that impose requirements relating to the collection, transmission, storage and use of personally-identifying information, including comprehensive regulatory systems in the U.S. and EU.
Data privacy regulations could adversely affect our business, results of operations and financial condition. We are subject to data privacy and protection laws and regulations that impose requirements relating to the collection, transmission, storage and use of personally-identifying information, including comprehensive regulatory systems in the U.S. and EU.
If we or our strategic licensees fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals or certifications, the target market will be reduced and the ability to realize the full market 31 Table of Contents potential of the subject product candidates will be harmed and our business may be adversely affected.
If we or our strategic licensees fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals or certifications, the target market will be reduced and the ability to realize the full market potential of the subject product candidates will be harmed and our business may be adversely affected.
Approvals by any regulatory agency may not be indicative of what any other regulatory agency may require for approval or what such regulatory agencies may require for approval in connection with our product candidates, in particular NBTXR3.
Approvals by any regulatory agency may not be indicative of what any other regulatory agency may require for approval or what such regulatory agencies may require for approval in connection with our product candidates, in particular JNJ-1900 (NBTXR3).
The timing of clinical studies depends, in part, on the speed of recruitment of patients to participate in testing such product candidates such as NBTXR3 as well as completion of required follow-up periods.
The timing of clinical studies depends, in part, on the speed of recruitment of patients to participate in testing such product candidates such as JNJ-1900 (NBTXR3) as well as completion of required follow-up periods.
If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected. We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected. 32 Table of Contents We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
Even if we or our strategic licensees successfully complete clinical trials for NBTXR3, NBTXR3 may not be commercialized for other reasons, including: • failing to receive regulatory approvals required to market them as drug or medical device; • being subject to proprietary rights held by others; • failing to comply with GMP requirements; • being difficult or expensive to manufacture on a commercial scale; • having adverse side effects that make their use less desirable; • being inferior to existing approved drugs or therapies; • failing to compete effectively with existing or new products or treatments commercialized by competitors; or • failing to show long-term benefits sufficient to offset associated risks.
Even if we or our strategic licensees successfully complete clinical trials for JNJ-1900 (NBTXR3), JNJ-1900 (NBTXR3) may not be commercialized for other reasons, including: • failing to receive regulatory approvals required to market them ; • being subject to proprietary rights held by others; • failing to comply with GMP requirements; • being difficult or expensive to manufacture on a commercial scale; • having adverse side effects that make their use less desirable; • being inferior to existing approved drugs or therapies; • failing to compete effectively with existing or new products or treatments commercialized by competitors; or • failing to show long-term benefits sufficient to offset associated risks.
Following the assignment, Janssen will also have the development and commercialization rights provided for under the Asia Licensing Agreement with respect to product candidate NBTXR3 in the Asia Licensing Territory.
Following the assignment, Janssen will also have the development and commercialization rights provided for under the Asia Licensing Agreement with respect to product candidate JNJ-1900 (NBTXR3) in the Asia Licensing Territory.
Adverse differences between initial, preliminary or interim data and final data could significantly harm our business prospects. We may encounter substantial delays in our clinical trials, including clinical studies of NBTXR3, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
Adverse differences between initial, preliminary or interim data and final data could significantly harm our business prospects. Clinical studies, including clinical studies of JNJ-1900 (NBTXR3) may encounter substantial delays in our clinical trials, including clinical studies of JNJ-1900 (NBTXR3), or may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
Accordingly, rights under any of our or our 36 Table of Contents licensors’ patents may not provide us with sufficient protection against competitive products or processes and any loss, denial or reduction in scope of any such patents and patent applications may have a material adverse effect on our business.
Accordingly, rights under any of our or our licensors’ patents may not provide us with sufficient protection against competitive products or processes and any loss, denial or reduction in scope of any such patents and patent applications may have a material adverse effect on our business.
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, as the case may be, EMA, or any other regulatory authority regarding the scope or design of clinical trials; • inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support initiation of clinical studies; • 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 (IRBs), or other reviewing entities at clinical sites selected for participation in our clinical trials; • delays in study NANORAY-312 trial, including the timing of the interim analysis (the timing of which is dependent on both the requisite number of events having been observed and the last patient having been recruited) or final analysis of Study NANORAY-312 given it is an event driven trial, and a function of amongst other factors, patient enrollment rate; 15 Table of Contents • the identification of flaws in the design of a clinical trial; • changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; • recommendations from independent data monitoring committees to modify or discontinue ongoing studies due to unforeseen safety issues or lack of effectiveness; • 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, including as a result of manufacturing issues at our in-house manufacturing facilities or at the facilities of our external partners; • lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including, specifically with respect to NANORAY-312 any material impact caused by or resulting from the transfer of sponsorship to Janssen, size of patient population, sites selection, nature of trial protocol, the availability of approved 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 IRB approval at each clinical study site; • the placing of a clinical hold on our or our strategic licensees’ clinical trials; • 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 and unexpected safety issues, including related side effects experienced by patients in clinical trials; • failure of our or our strategic development third-party contractors to meet their contractual obligations in a timely manner; or • lack of, or failure to, demonstrate efficacy of our products candidate.
In addition, a number of events, including any of the following, could delay clinical trials, negatively impact the ability to obtain regulatory approval for, and to market and sell, a particular product candidate, or result in suspension or termination of a clinical trial: • conditions imposed by the FDA, or, as the case may be, EMA, or any other regulatory authority regarding the scope or design of clinical trials; • inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support initiation of clinical studies; 16 Table of Contents • 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 (IRBs), or other reviewing entities at clinical sites selected for participation in our clinical trials; • delays in study NANORAY-312 trial, including the timing of any planned analyses or reporting in respect of Study NANORAY-312 given it is an event driven trial, and a function of amongst other factors, patient enrollment rate; • the identification of flaws in the design of a clinical trial; • changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; • recommendations from independent data monitoring committees to modify or discontinue ongoing studies due to unforeseen safety issues or lack of effectiveness; • 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, including as a result of manufacturing issues at our in-house manufacturing facilities or at the facilities of our external partners; • lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including, specifically with respect to NANORAY-312 any material impact caused by or resulting from the transfer of sponsorship to JJEI, size of patient population, sites selection, nature of trial protocol, the availability of approved 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 IRB approval at each clinical study site; • the placing of a clinical hold on our or our strategic licensees’ clinical trials; • 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; • serious and unexpected safety issues, including related side effects experienced by patients in clinical trials; • failure of our or our strategic development third-party contractors to meet their contractual obligations in a timely manner; or • lack of, or failure to, demonstrate efficacy of our products candidate.
Risks Related to Our Business We are a clinical-stage biotechnology company pioneering disruptive, physics-based therapeutic approaches, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
Risks Related to Our Business We are a late-stage clinical development company pioneering disruptive, physics-based therapeutic approaches, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
Compliance with environmental laws and regulations may be expensive and may impair our research and development efforts. If we fail to comply with these requirements, we could incur delays, substantial costs, including civil or criminal fines and penalties, clean-up costs or capital expenditures for control equipment or operational changes necessary to achieve and maintain compliance.
Compliance with 24 Table of Contents environmental laws and regulations may be expensive and may impair our research and development efforts. If we fail to comply with these requirements, we could incur delays, substantial costs, including civil or criminal fines and penalties, clean-up costs or capital expenditures for control equipment or operational changes necessary to achieve and maintain compliance.
Our future profitability, if any, depends, in part, on the ability of Janssen, our strategic licensee on NBTXR3, to penetrate global markets, where we and Janssen would be subject to additional regulatory burdens and other risks and uncertainties.
Our future profitability, if any, depends, in part, on the ability of Janssen, our strategic licensee for JNJ-1900 (NBTXR3), to penetrate global markets, where we and Janssen would be subject to additional regulatory burdens and other risks and uncertainties.
Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our product candidates or competitive products. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Such proceedings could result in revocation or amendment of our 34 Table of Contents patents in such a way that they no longer cover our product candidates or competitive products. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
The market price and demand for our ADSs may also fluctuate substantially, regardless of our actual operating performance, which may limit or prevent holders from readily selling 46 Table of Contents their ADSs and may otherwise negatively affect the liquidity of our capital shares.
The market price and demand for our ADSs may also fluctuate substantially, regardless of our actual operating performance, which may limit or prevent holders from readily selling their ADSs and may otherwise negatively affect the liquidity of our capital shares.
This means that holders of our ADSs may not be 45 Table of Contents able to exercise their right to vote, and there may be nothing such holders can do if the ordinary shares underlying such ADSs are not voted as requested.
This means that holders of our ADSs may not be able to exercise their right to vote, and there may be nothing such holders can do if the ordinary shares underlying such ADSs are not voted as requested.
In addition, our ongoing efforts to comply with evolving laws and regulations in the U.S., EU and elsewhere may be costly and require ongoing modifications to our policies, procedures and systems. Because our consolidated financial statements rely on estimates and assumptions, actual results may vary significantly from estimates that we make.
In addition, our ongoing efforts to comply with evolving laws and regulations in the U.S., EU and elsewhere may be costly and require ongoing modifications to our policies, procedures and systems. 26 Table of Contents Because our consolidated financial statements rely on estimates and assumptions, actual results may vary significantly from estimates that we make.
Litigation may be necessary to resolve an ownership dispute, and if we are not successful, we may be precluded from using certain intellectual property and associated products and technology, or may lose our rights in that intellectual property. Either outcome could have a material adverse effect on our business.
Litigation may be necessary to resolve an ownership dispute, and if we are not successful, we may be precluded from using certain intellectual property and associated 33 Table of Contents products and technology, or may lose our rights in that intellectual property. Either outcome could have a material adverse effect on our business.
We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows. 43 Table of Contents Although not free from doubt, we do not believe we were a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes for the taxable year ended December 31, 2024.
We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows. Although not free from doubt, we do not believe we were a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes for the taxable year ended December 31, 2025.
If we, our licensee Janssen, or our CMOs, are unable to reliably produce NBTXR3 or products to specifications acceptable to the FDA, or other regulatory authorities, we may not obtain or maintain the approvals we need to further develop, conduct clinical trials for, and commercialize such products in the relevant territories.
If we, our licensee Janssen, with regard to JNJ-1900 (NBTXR3), or our CMOs, are unable to reliably produce or products to specifications acceptable to the FDA, or other regulatory authorities, we may not obtain or maintain the approvals we need to further develop, conduct clinical trials for, and commercialize such products in the relevant territories.
Furthermore, our proprietary information may be independently developed or lawfully reverse-engineered by others in a manner that could prevent legal recourse by us. We cannot guarantee that our trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to our trade secrets.
Furthermore, our proprietary 31 Table of Contents information may be independently developed or lawfully reverse-engineered by others in a manner that could prevent legal recourse by us. We cannot guarantee that our trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to our trade secrets.
We have concentrated our research, development and manufacturing efforts on our nanotechnology-based product candidate NBTXR3, and our future success depends on the successful development of this therapeutic approach using a physical mode of action.
Historically, we have concentrated our research, development and manufacturing efforts on our nanotechnology-based product candidate JNJ-1900 (NBTXR3), and our future success depends on the successful development of this therapeutic approach using a physical mode of action.
In July 2023, we entered into a global exclusive licensing, development, and commercialization agreement with Janssen (the “Janssen Agreement”), for the investigational, potential first-in-class radioenhancer NBTXR3, on a worldwide basis excluding (at that time) the Asia Licensing Territory (as defined below).
In July 2023, we entered into a global exclusive licensing, development, and commercialization agreement with Janssen (the “Janssen Agreement”), for the investigational, potential first-in-class nanoradioenhancer JNJ-1900 (NBTXR3), on a worldwide basis excluding (at that time) the Asia Licensing Territory (as defined below).
In December 2023, our strategic licensing agreement with Lian Oncology Limited (“LianBio”), under which LianBio had exclusive development and commercialization rights with respect to certain product candidates, including NBTXR3 within the Asia Licensing Territory (the “Asia Licensing Agreement”), was assigned to Janssen.
In December 2023, our strategic licensing agreement with Lian Oncology Limited (“LianBio”), under which LianBio had exclusive development and commercialization rights with respect to certain product candidates, including JNJ-1900 (NBTXR3) within the Asia Licensing Territory (the “Asia Licensing Agreement”), was novated to Janssen.
Third parties on whom we rely to conduct, supervise and monitor clinical studies may not perform satisfactorily. We and our strategic licensees rely on medical institutions, clinical investigators, CROs and contract laboratories to carry out, or otherwise assist with, clinical trials or to perform data collection and analysis.
Third parties on whom we rely to conduct, supervise and monitor clinical studies may not perform satisfactorily. 22 Table of Contents We and our strategic licensees rely on medical institutions, clinical investigators, CROs and contract laboratories to carry out, or otherwise assist with, clinical trials or to perform data collection and analysis.
The occurrence of any of the foregoing would also require additional financial and management resources. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.
The occurrence of any of the foregoing would also require additional financial and management resources. We cannot assure you that the measures we have taken through the date of this Annual Report, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.
If patients are unable or unwilling to participate in such studies, the timeline for recruiting patients, conducting studies and obtaining 17 Table of Contents regulatory approval of potential products may be delayed.
If patients are unable or unwilling to participate in such studies, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed.
However, our ADS holders in the United States will not be entitled to exercise or sell such rights unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available.
However, our ADS holders in the United States will not be entitled to exercise or sell such rights unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration 39 Table of Contents requirements is available.
Although we are a late-stage clinical development company, the safety, specificity and clinical benefits of NBTXR3 has not yet been fully demonstrated in all indications, and we cannot assure you that the results of current and future clinical trials will demonstrate the value and efficacy of our platform.
Although we are a late-stage clinical development company, the safety, specificity and clinical benefits of JNJ-1900 (NBTXR3) has not yet been fully demonstrated in all indications, and we cannot 15 Table of Contents assure you that the results of current and future clinical trials will demonstrate the value and efficacy of our platform.
We will only be able to protect our product candidates from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them.
We will only be able to protect our product candidates from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively 30 Table of Contents protected trade secrets, cover them.

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Biggest changeThe dose expansion part of the trial has the following treatment cohorts: 63 Table of Contents • LRR or R/M HNSCC and that is resistant to a prior anti-PD-1/L1 therapy with at least one lesion located in either the head and neck region, soft tissues, lungs or liver amenable for intratumoral injection and irradiation. • LRR or R/M HNSCC naïve to anti-PD-1/L1 therapy and eligible for an anti-PD-1 therapy with at least one lesion located in either the head and neck region, soft tissues, lungs or liver amenable for intratumoral injection and irradiation. • Lung or liver or soft tissue metastases from any primary tumor that are resistant to a prior anti-PD-1/L1 therapy and eligible for anti-PD-1 therapy with at least one lesion located in either soft tissue, lungs or liver that could be injected intratumorally and irradiated.
Biggest changeThe dose escalation part of the trial included three populations of patients naive or resistant to anti-PD1: • Patients with locoregional recurrent (LRR) or recurrent or metastatic (R/M) HNSCC amenable to irradiation of the head and neck field (“HNSCC Cohort”), • Lung metastases from any primary cancer eligible for anti-PD-1 therapy (“Lung Cohort”), or • Liver metastases from any primary cancer eligible for anti-PD-1 therapy (“Liver Cohort”). 55 Table of Contents The dose expansion part of the trial has the following treatment cohorts: • LRR or R/M HNSCC and that is resistant to a prior anti-PD-1/L1 therapy with at least one lesion located in either the head and neck region, soft tissues, lungs or liver amenable for intratumoral injection and irradiation. • LRR or R/M HNSCC naïve to anti-PD-1/L1 therapy and eligible for an anti-PD-1 therapy with at least one lesion located in either the head and neck region, soft tissues, lungs or liver amenable for intratumoral injection and irradiation. • Lung or liver or soft tissue metastases from any primary tumor that are resistant to a prior anti-PD-1/L1 therapy and eligible for anti-PD-1 therapy with at least one lesion located in either soft tissue, lungs or liver that could be injected intratumorally and irradiated.
NBTXR3 (JNJ-1900) nanoparticles Amplifying the Effect of Radiation Cell Damage and Immune Response At the cellular level, preclinical studies have revealed various types of damage that are amplified with nanoparticles, such as an increase in double-stranded DNA breaks (DSBs), leading to an increase in micronuclei formation (free DNA found in the cytoplasm of cells), as well as Lysosomal Membrane Permeabilization, observed only in the presence of nanoparticles.
JNJ-1900 (NBTXR3) nanoparticles Amplifying the Effect of Radiation Cell Damage and Immune Response At the cellular level, preclinical studies have revealed various types of damage that are amplified with nanoparticles, such as an increase in double-stranded DNA breaks (DSBs), leading to an increase in micronuclei formation (free DNA found in the cytoplasm of cells), as well as Lysosomal Membrane Permeabilization, observed only in the presence of nanoparticles.
Phase 1 Trial - MD Anderson (“ Study 2020-0123 ”) - NCT04505267 This trial is an open-label, two-cohort, prospective Phase 1 study of reirradiation in patients with inoperable locoregional recurrent NSCLC. Patients generally only receive a single course of radiotherapy due to toxicity limitations associated with subsequent courses of radiotherapy.
Phase 1 NSCLC Trial (“ Study 2020-0123 ”) - MD Anderson - NCT04505267 This trial is an open-label, two-cohort, prospective Phase 1 study of reirradiation in patients with inoperable locoregional recurrent NSCLC. Patients generally only receive a single course of radiotherapy due to toxicity limitations associated with subsequent courses of radiotherapy.
The patient population includes adults (age ≥ 18 years) with BRPC or LAPC that are radiographically non-metastatic at screening, having received between two to six months of chemotherapy prior to trial enrollment and that have not previously received radiation therapy or surgery for pancreatic cancer. In December 2024, Nanobiotix announced the completion of the Phase 1 study.
The patient population includes adults (age ≥ 18 years) with BRPC or LAPC that are radiographically non-metastatic at screening, having received between two to six months of chemotherapy prior to trial enrollment and have not previously received radiation therapy or surgery for pancreatic cancer. In December 2024, Nanobiotix announced the completion of the Phase 1 study.
Any product candidates that we or they develop and commercialize may compete with existing therapies, as well as new therapies that may become available in the future, including therapies with a mode of action similar to that of NBTXR3 (JNJ-1900).
Any product candidates that we or they develop and commercialize may compete with existing therapies, as well as new therapies that may become available in the future, including therapies with a mode of action similar to that of JNJ-1900 (NBTXR3).
Future collaborations and mergers and acquisitions may result in further resource concentration among a smaller number of competitors. These competitors also compete with us in recruiting and retaining qualified research and development and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Future collaborations and mergers and acquisitions may result in further resource concentration among a smaller number of competitors. These competitors also compete with us in recruiting and retaining qualified research and development and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as acquiring technologies complementary to, or necessary for, our programs.
Nanobiotix has obtained a CE-mark as a Medical Device from the notified body GMED dated 02 Apr 2019 for the indication “Preoperative treatment of patients with locally advanced soft tissue sarcoma of the extremity, girdles and trunk wall, who have indication for radiation therapy” , however the product has not been marketed in any country worldwide.
Nanobiotix obtained a CE-mark as a Medical Device from the notified body GMED dated 02 Apr 2019 for the indication “Preoperative treatment of patients with locally advanced soft tissue sarcoma of the extremity, girdles and trunk wall, who have indication for radiation therapy”, however the product has not been marketed in any country worldwide.
In fact, published scientific data shows that only 15%-20% of non-small cell lung cancer patients and 13%-22% of head and neck squamous cell carcinoma patients respond to immune checkpoint inhibitors 18 . Recently, significant interest has been focused on the possibility of achieving better outcomes across cancers using various I-O treatments in combination or alone.
In fact, published scientific data shows that only 15%-20% of non-small cell lung cancer patients and 13%-22% of head and neck squamous cell carcinoma patients respond to immune checkpoint inhibitors 13 . Recently, significant interest has been focused on the possibility of achieving better outcomes across cancers using various I-O treatments in combination or alone.
Our contracts with these contract manufacturing organizations generally provide that the manufacturing partner may not transfer its rights or sub-contract any of the services covered. The manufacturing partners are required to perform their obligations in accordance with international professional standards, including the Good Manufacturing Practices guidelines issued by the International Council for Harmonization.
Our contracts with these contract manufacturing organizations generally provide that the manufacturing partner may not transfer its rights or sub-contract any of the services covered. The manufacturing partners are required to perform their obligations in accordance with international professional standards, including the Good Manufacturing Practices (GMP) guidelines issued by the International Council for Harmonization.
We own over 300 trademark registrations and applications related to our products, product candidates, processes and technology worldwide. Trademark registrations are generally granted for a period of ten years and are renewable. We anticipate we will apply for additional patents and trademark registrations in the future as we develop new products, product candidates, processes and technologies.
We own over 300 trademark registrations and applications related to our products, product candidates, processes, and technology worldwide. Trademark registrations are generally granted for a period of ten years and are renewable. We anticipate that we will apply for additional patents and trademark registrations in the future as we develop new products, product candidates, processes, and technologies.
The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases or conditions and to determine dosage tolerance, optimal dosage and dosing schedule. • Phase 3 .
The product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases or conditions and to determine dosage tolerance, optimal dosage and dosing schedule. • Phase 3 .
Restrictions under applicable US federal and state and foreign healthcare laws and regulations include, but are not limited to, the following: • the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing compensation, including any kickback, bribe or rebate, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, 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; • U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which can be enforced by individuals through civil whistleblower or qui tam actions, which prohibit individuals or entities from, among other things, 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; • HIPAA, which created additional federal criminal statutes which prohibit, among other things, executing or attempting to execute 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, and their implementing regulations, which impose certain requirements on covered entities, including certain healthcare providers, health plans and healthcare clearing-houses, and their business associates, individuals and entities that perform functions or activities that involve individually identifiable health information on behalf of covered entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; • US federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the Affordable Care Act (ACA), that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, 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; and • analogous state or foreign laws and regulations, 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 the 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 federal government, state and local laws that require the registration of pharmaceutical sales representatives, 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, thus complicating compliance efforts. 88 Table of Contents Ensuring business arrangements with third parties comply with applicable healthcare laws and regulations is costly.
Restrictions under applicable US federal and state and foreign healthcare laws and regulations include, but are not limited to, the following: • the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing compensation, including any kickback, bribe or rebate, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, 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; • U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which can be enforced by individuals through civil whistleblower or qui tam actions, which prohibit individuals or entities from, among other things, 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; • HIPAA, which created additional federal criminal statutes which prohibit, among other things, executing or attempting to execute 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, and their implementing regulations, which impose certain requirements on covered entities, including certain healthcare providers, health plans and healthcare clearing-houses, and their business associates, individuals and entities that perform functions or activities that involve individually identifiable health information on behalf of covered entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; • US federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the Affordable Care Act (ACA), that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, 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; and • analogous state or foreign laws and regulations, 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 the 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 federal government, state and local laws that require the registration of pharmaceutical sales representatives, 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, thus complicating compliance efforts.
Study 102 Escalation Part In the escalation part of the study, the administered dosage of NBTXR3, calculated as percentage (%) of tumor volume was escalated (5%, 10%, 15% and 22%), with 19 patients in total receiving an injection of NBTXR3, followed by intensity-modulated radiation therapy (70 Gy in total, or 2 Gy per day, five days a week for seven weeks), in accordance with standard medical practice, commencing one to five days after NBTXR3 injection.
Study 102 Escalation Part In the escalation part of the study, the administered dosage of JNJ-1900 (NBTXR3), calculated as percentage (%) of tumor volume was escalated (5%, 10%, 15% and 22%), with 19 patients in total receiving an injection of JNJ-1900 (NBTXR3), followed by intensity-modulated radiation therapy (70 Gy in total, or 2 Gy per day, five days a week for seven weeks), in accordance with standard medical practice, commencing one to five days after NBTXR3 injection.
In our Phase 2/3 locally advanced STS clinical trial, based on immunohistochemistry analyses, we observed that RT-activated NBTXR3 increased the density of CD8+ T cell lymphocytes and also decreased FOXP3+ (Treg) (regulatory T cells that work to suppress the immune response) compared to radiotherapy alone in the tumors, while macrophage number remained relatively constant.
In our Phase 2/3 locally advanced STS clinical trial, based on immunohistochemistry analyses, we observed that RT-activated JNJ-1900 (NBTXR3) increased the density of CD8+ T cell lymphocytes and also decreased FOXP3+ (Treg) (regulatory T cells that work to suppress the immune response) compared to radiotherapy alone in the tumors, while macrophage number remained relatively constant.
Anti-PD-1 therapy was scheduled for all patients to begin after radiotherapy. Thus, in these data, there is differentiation between responses in “injected lesions” versus “overall response” with the latter being a measure of response from a patient’s total disease burden (i.e., lesions injected with NBTXR3 and irradiated and those neither injected with NBTXR3 nor irradiated).
Anti-PD-1 therapy was scheduled for all patients to begin after radiotherapy. Thus, in these data, there is differentiation between responses in “injected lesions” versus “overall response” with the latter being a measure of response from a patient’s total disease burden (i.e., lesions injected with JNJ-1900 (NBTXR3) and irradiated and those neither injected with JNJ-1900 (NBTXR3) nor irradiated).
Post-Approval Requirements Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not consistent with the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific and educational activities, and requirements for promotional activities involving the Internet.
Post-Approval Requirements 80 Table of Contents Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not consistent with the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific and educational activities, and requirements for promotional activities involving the Internet.
In March 2021, researchers from our collaborative partner MD Anderson shared preclinical data at the American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine. This study examined RT-activated NBTXR3 in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1 resistant mouse model.
In March 2021, researchers from our collaborative partner MD Anderson shared preclinical data at the American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine. This study examined RT-activated JNJ-1900 (NBTXR3) in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1 resistant mouse model.
NBTXR3 (JNJ-1900) At an average size of approximately 50 nanometers in diameter, our nanoparticles are directly injected into a malignant tumor prior to standard radiotherapy and can be internalized into the cell through endocytosis to function as radioenhancers. They have an inorganic core of crystallized hafnium oxide, which has a high electron density.
JNJ-1900 (NBTXR3) At an average size of approximately 50 nanometers in diameter, our nanoparticles are directly injected into a malignant tumor prior to standard radiotherapy and can be internalized into the cell through endocytosis to function as nanoradioenhancers. They have an inorganic core of crystallized hafnium oxide, which has a high electron density.
Study 1100, a multi-cohort Phase 1 trial of RT-activated NBTXR3 followed by an anti-PD-1 checkpoint inhibitor in patients with R/M HNSCC or with lung, liver, or soft tissue metastases from other solid tumors eligible for anti-PD-1 therapy is ongoing. In this study, patients failing a prior treatment with checkpoint inhibitors continue that treatment with additional therapy of RT-NBTXR3.
Study 1100, a multi-cohort Phase 1 trial of RT-activated JNJ-1900 (NBTXR3) followed by an anti-PD-1 checkpoint inhibitor in patients with R/M HNSCC or with lung, liver, or soft tissue metastases from other solid tumors eligible for anti-PD-1 therapy is ongoing. In this study, patients failing a prior treatment with checkpoint inhibitors continue that treatment with additional therapy of RT-JNJ-1900 (NBTXR3).
In our preclinical studies and our early clinical data, treatment using radiation-activated nanoparticles has also been observed to trigger destruction of metastatic lesions 11 . Based on these observations, we believe that our nanoparticles may prime the body’s immune response, rendering tumors more prone to recognition by a patient’s immune system.
In our preclinical studies and our early clinical data, treatment using radiation-activated nanoparticles has also been observed to trigger destruction of metastatic lesions 5 . Based on these observations, we believe that our nanoparticles may prime the body’s immune response, rendering tumors more prone to recognition by a patient’s immune system.
This research collaboration is distinct from our clinical trial collaboration with MD Anderson and is intended to enable us to generate preclinical data using NBTXR3 activated by radiotherapy plus anti-PD-1 nivolumab (murine version of Opdivo) or other immune checkpoint inhibitors, such as anti-CTLA-4, anti-TIGIT and anti-LAG3.
This research collaboration is distinct from our clinical trial collaboration with MD Anderson and is intended to enable us to generate preclinical data using JNJ-1900 (NBTXR3) activated by radiotherapy plus anti-PD-1 nivolumab (murine version of Opdivo) or other immune checkpoint inhibitors, such as anti-CTLA-4, anti-TIGIT and anti-LAG3.
Elderly patients with locally advanced tumors who receive radiation only also generally have limited OS expectancy (median of 12 months following diagnosis 14 ) and typically experience poor quality of life, as they have limited therapeutic options and a high unmet medical need and are largely underrepresented in existing clinical trials.
Elderly patients with locally advanced tumors who receive radiation only also generally have limited OS expectancy (median of 12 months following diagnosis 6 ) and typically experience poor quality of life, as they have limited therapeutic options and a high unmet medical need and are largely underrepresented in existing clinical trials.
In all lesions, data showed an overall response rate of 79.5% (35/44) with a complete response rate of 52.3% (23/44). Importantly, the median duration of response in NBTXR3-injected lesions was not reached by the end of the study, compared to a median duration of response of 12.4 months in all lesions, suggesting durable antitumor activity from RT-activated NBTXR3.
In all lesions, data showed an overall response rate of 79.5% (35/44) with a complete response rate of 52.3% (23/44). Importantly, the median duration of response in JNJ-1900 (NBTXR3)-injected lesions was not reached by the end of the study, compared to a median duration of response of 12.4 months in all lesions, suggesting durable antitumor activity from RT-activated JNJ-1900 (NBTXR3).
The trial’s main objective is to determine the safety profile and recommended Phase 2 dose of RT-activated NBTXR3 in combination with an anti-PD-1. Secondary endpoints include efficacy evaluation. The dose expansion trial is ongoing and we intend to enroll a total of approximately 145 evaluable patients in the United States.
The trial’s main objective is to determine the safety profile and recommended Phase 2 dose of RT-activated JNJ-1900 (NBTXR3) in combination with an anti-PD-1. Secondary endpoints include efficacy evaluation. The dose expansion trial is ongoing and we intend to enroll a total of approximately 145 evaluable patients in the United States.
However, SBRT dosage is limited due to potential toxicity to surrounding tissues and the need to preserve liver function. Our clinical trial described below evaluated NBTXR3 in patients with liver cancers in need of an alternative treatment, when standard care protocols either could not be used or did not exist.
However, SBRT dosage is limited due to potential toxicity to surrounding tissues and the need to preserve liver function. Our clinical trial described below evaluated JNJ-1900 (NBTXR3) in patients with liver cancers in need of an alternative treatment, when standard care protocols either could not be used or did not exist.
PharmaEngine is entitled to receive from the Company a low-single digit percentage tiered royalty based on net sales of NBTXR3 in the Asia-Pacific region for a 10-year period commencing on the corresponding first date of sales in the region. As of December 31, 2024, such triggering events have not occurred.
PharmaEngine is entitled to receive from the Company a low-single digit percentage tiered royalty based on net sales of NBTXR3 in the Asia-Pacific region for a 10-year period commencing on the corresponding first date of sales in the region. As of December 31, 2025, such triggering events have not occurred.
Our approximately 1,195 square meter manufacturing facility is located in the Villejuif BioPark, a scientific research and innovation center just outside of Paris, France. The lease for the facility, which began on July 1, 2017 and was renewed in 2021, has a term of 8 years, ending June 30, 2030.
Our approximately 1,195 square meter manufacturing facility is located in the Villejuif BioPark, a scientific research and innovation center just outside of Paris, France. The lease for the facility, which began on July 1, 2017 and was renewed in 2021, has a term of 9 years, ending June 30, 2030.
In December 2018 Nanobiotix entered into a collaboration with MD Anderson as part of which five clinical trials are currently being conducted in the United States to evaluate RT-activated NBTXR3, either alone or in combination with immuno-therapies or chemotherapies, across several cancer types.
Nanobiotix entered into a collaboration with MD Anderson in December 2018 as part of which five clinical trials are currently being conducted in the United States to evaluate RT-activated JNJ-1900 (NBTXR3), either alone or in combination with immuno-therapies or chemotherapies, across several cancer types.
In the All treated population, mPFS (11.4 months) and mOS (18.1 months) were prolonged compared with historical data (PFS ~9 months; OS ~12 months 17 ) despite the negative prognostic factors (aged ≥ 70, ACCI ≥ 4, oropharyngeal cancer with negative HPV-16 status, and oral cavity tumor) observed in this population.
In the All treated population, mPFS (11.4 months) and mOS (18.1 months) were prolonged compared with historical data (PFS ~9 months; OS ~12 months 10 ) despite the negative prognostic factors (aged ≥ 70, ACCI ≥ 4, oropharyngeal cancer with negative HPV-16 status, and oral cavity tumor) observed in this population.
Nevertheless, many of these patients still die from the progression of their cancer because, among other reasons, they are not able to receive a high enough radiation dose to completely destroy their tumor without resulting in an unacceptable level of damage to surrounding healthy tissues.
In addition, many of these patients still die from the progression of their cancer because, among other reasons, they are not able to receive a high enough radiation dose to completely destroy their tumor without resulting in an unacceptable level of damage to surrounding healthy tissues.
Five patients discontinued IMRT due to TEAEs of which one, sepsis, was possibly related to RT and NBTXR3. 10 deaths occurred within 180 days of enrollment, of which 1 death (sepsis) was possibly related to RT and NBTXR3. 80% of these patients (8/10) entered the study with a high burden of comorbidity (ACCI ≥ 4).
Five patients discontinued IMRT due to TEAEs of which one, sepsis, was possibly related to RT and JNJ-1900 (NBTXR3). 10 deaths occurred within 180 days of enrollment, of which 1 death (sepsis) was possibly related to RT and JNJ-1900 (NBTXR3). 80% of these patients (8/10) entered the study with a high burden of comorbidity (ACCI ≥ 4).
Response was measured in the NBTXR3-injected lesion alone (“injected lesion”) as per RECIST 1.1, and in the NBTXR3-injected and non-injected lesions together (“all lesions”). In the injected lesions, data showed an overall response rate (ORR) of 81.8% (36/44) with a complete response rate (CRR) of 63.6% (28/44).
Response was measured in the JNJ-1900 (NBTXR3)-injected lesion alone (“injected lesion”) as per RECIST 1.1, and in the JNJ-1900 (NBTXR3)-injected and non-injected lesions together (“all lesions”). In the injected lesions, data showed an overall response rate (ORR) of 81.8% (36/44) with a complete response rate (CRR) of 63.6% (28/44).
In support of the rationale for neoadjuvant therapy, a retrospective analysis demonstrated a near doubling in OS in pancreatic ductal adenocarcinoma (PDAC) patients who underwent surgery, which was attributed, at least in part, to the increased proportion of borderline resectable pancreatic cancer (BRPC) patients who became eligible for surgery as a result of neoadjuvant intervention.
In support of the rationale for neoadjuvant therapy, a retrospective analysis demonstrated a near doubling in OS in pancreatic ductal adenocarcinoma (PDAC) patients who underwent surgery, which was in part attributed to the increased proportion of borderline resectable pancreatic cancer (BRPC) patients who became eligible for surgery as a result of neoadjuvant intervention.
In addition, in the subgroup of patients with a higher histology grade (i.e., a more aggressive disease), which represented the majority of patients in the trial, pathological complete response was achieved in four times as many patients in the NBTXR3 arm (17.1%) compared to patients in the control arm (3.9%).
In addition, in the subgroup of patients with a higher histology grade (i.e., a more aggressive disease), which represented the majority of patients in the trial, pathological complete response was achieved in four times as many patients in the JNJ-1900 (NBTXR3) arm (17.1%) compared to patients in the control arm (3.9%).
Exploitation of NBTXR3 and Products Containing NBTXR3 Within the Janssen Agreement Territory, Janssen has the sole and exclusive right to develop, manufacture, commercialize and otherwise exploit NBTXR3 and products containing NBTXR3 as an active ingredient, except that (a) the Company may conduct its ongoing studies, including its ongoing pivotal head and neck study, ongoing 74 Table of Contents studies pursuant to the MD Anderson Agreement, and other ongoing studies that commenced prior to the date of the Janssen Agreement, as well as certain new proof-of-concept or pivotal studies; and (b) the Company may manufacture NBTXR3 or the NBTXR3 active pharmaceutical ingredient in the Janssen Agreement Territory, as described below.
Exploitation of NBTXR3 and Products Containing NBTXR3 Within the Janssen Agreement Territory, Janssen has the sole and exclusive right to develop, manufacture, commercialize and otherwise exploit NBTXR3 and products containing NBTXR3 as an active ingredient, except that (a) the Company may conduct its ongoing studies, including its ongoing pivotal head and neck study, ongoing studies pursuant to the MD Anderson Agreement, and other ongoing studies that commenced prior to the date of the Janssen Agreement, as well as certain new proof-of-concept or pivotal studies; and (b) the Company may manufacture NBTXR3 or the NBTXR3 active pharmaceutical ingredient in the Janssen Agreement Territory, as described below.
Based on its proprietary, physics-based properties and its administration via intratumoral injection, we believe that NBTXR3 could improve local control alone or in combination with other treatment modalities in any indication where radiotherapy is a part of the treatment regimen.
Based on its proprietary, physics-based properties and its administration via intratumoral injection, we believe that JNJ-1900 (NBTXR3) could improve local control alone or in combination with other treatment modalities in any indication where radiotherapy is a part of the treatment regimen.
Preclinical studies have also demonstrated an increase in the expression of certain biological elements or biological pathways, known to be involved in the anti-tumor immune response, such as biomarkers of Immunogenic Cell Death (ICD), an increase in the immunopeptidome, and activation of the cGAS-STING pathway 10 .
Preclinical studies have also demonstrated an increase in the expression of certain biological elements or biological pathways, known to be involved in the anti-tumor immune response, such as biomarkers of Immunogenic Cell Death (ICD), an increase in the immunopeptidome, and activation of the cGAS-STING pathway 4 .
Two types of liver cancer are hepatocellular carcinoma (HCC), the most common type of liver cancer, and secondary liver cancer, or liver metastasis, which occurs when cancer from another part of the body spreads to the liver. Surgical resection is often not an option for patients with either HCC or liver metastasis.
The two most common types of liver cancer are hepatocellular carcinoma (HCC), the most common primary liver cancer, and liver metastasis (secondary liver cancer), which occurs when cancer from another part of the body spreads to the liver. Surgical resection is often not an option for patients with either HCC or liver metastasis.
In November 2017, we opened a facility to expand our manufacturing capabilities, increase production capacity of NBTXR3 for our clinical trial needs. This facility is located in the Villejuif BioPark, a scientific research and innovation center just outside of Paris, France.
In November 2017, we opened a facility to expand our manufacturing capabilities and increase production capacity of JNJ-1900 (NBTXR3) for our clinical trial needs. This facility is located in the Villejuif BioPark, a scientific research and innovation center just outside of Paris, France.
Overall Survival was also planned to be analyzed. In each patient, the primary tumor was injected with NBTXR3, while involved lymph nodes were not injected. The NBTXR3-injected lesions and the non-injected lesions were treated with the same dose of intensity-modulated radiation therapy (IMRT).
Overall Survival was also planned to be analyzed. In each patient, the primary tumor was injected with JNJ-1900 (NBTXR3), while involved lymph nodes were not injected. The JNJ-1900 (NBTXR3)-injected lesions and the non-injected lesions were treated with the same dose of intensity-modulated radiation therapy (IMRT).
In the study, patients could have cancer lesions located in different parts of the body. Specific lesions were selected for NBTXR3 injection and radiotherapy. Lesions that were not injected with NBTXR3 were not intended to be treated with radiotherapy unless they were located in the field of radiotherapy due to proximity to the injected lesion.
In the study, patients could have cancer lesions located in different parts of the body. Specific lesions were selected for JNJ-1900 (NBTXR3) injection and radiotherapy. Lesions that were not injected with JNJ-1900 (NBTXR3) were not intended to be treated with radiotherapy unless they were located in the field of radiotherapy due to proximity to the injected lesion.
The secondary endpoints of both parts were to evaluate the safety and tolerability of NBTXR3, to evaluate the overall response rate and the complete response rate (based on RECIST 1.1) of injected (target) and non-injected lesions (non-target), to evaluate the local progression and PFS, assess the feasibility of local administration by intratumoral injection of NBTXR3.
The secondary endpoints of both parts were to evaluate the safety and tolerability of JNJ-1900 (NBTXR3), to evaluate the overall response rate and the complete response rate (based on RECIST 1.1) of injected (target) and non-injected lesions (non-target), to evaluate the local progression and PFS, assess the feasibility of local administration by intratumoral injection of JNJ-1900 (NBTXR3).
Safety results All 56 patients treated received at least 90% of the planned injected volume of NBTXR3 and 89% completed IMRT. Grade ≥ 3 treatment-emergent adverse events (TEAEs) related to NBTXR3 or the injection procedure represented 1.3% of all TEAEs.
Safety results All 56 patients treated received at least 90% of the planned injected volume of JNJ-1900 (NBTXR3) and 89% completed IMRT. Grade ≥ 3 treatment-emergent adverse events (TEAEs) related to JNJ-1900 (NBTXR3) or the injection procedure represented 1.3% of all TEAEs.
In the study, all patients will receive standard of care chemoradiation followed by consolidation anti-PD-L1 therapy (durvalumab) and in the experimental arm, patients will receive NBTXR3 in addition. The study will enroll up to 130 patients. The first patient was dosed in January 2025.
In the study, all patients will receive standard of care chemoradiation followed by consolidation anti-PD-L1 therapy (durvalumab) and in the experimental arm, patients will receive JNJ-1900 (NBTXR3) in addition. The study will enroll up to 130 patients. The first patient was dosed in January 2025.
Together, these data suggest that RT-activated NBTXR3 could be able to modulate the anti-tumor immune response and transform the tumor into an in situ vaccine, which prompted the initial development of our I-O program.
Together, these data suggest that RT-activated JNJ-1900 (NBTXR3) could be able to modulate the anti-tumor immune response and transform the tumor into an in situ vaccine, which prompted the initial development of our I-O program.
Approximately 60% of all cancer patients undergo radiotherapy at some point during their course of treatment 21 . Current research in radiotherapy focuses primarily on (1) methods to increase sensitivity of tumors to radiation and (2) methods to protect healthy tissues from radiation.
Approximately 60% of all cancer patients undergo radiotherapy at some point during their course of treatment 15 . Current research in radiotherapy focuses primarily on (1) methods to increase sensitivity of tumors to radiation and (2) methods to protect healthy tissues from radiation.
Pursuant to the Janssen AAA, all agreements entered into by the Company and each vendor related to the support or implementation of the NANORAY-312 clinical trial and listed in the Janssen AAA were assigned to JJDC as of the Effective Date, including all rights, title and interest.
Pursuant to the Janssen AAA, all agreements entered into by the Company and each vendor related to the support or implementation of the NANORAY-312 clinical trial and listed in the Janssen AAA were assigned to JJEI as of the Effective Date, including all rights, title and interest.
Janssen has undertaken to conduct and ensure that all of its affiliates, sublicensees and subcontractors conduct their business under the Asia Licensing Agreement in accordance with applicable laws and to the extent applicable with respect to certain development activities, FDA and EU medical device requirements.
Janssen has undertaken to conduct and ensure that all of its affiliates, sublicensees and subcontractors conduct their business under the Asia Licensing Agreement in accordance with applicable laws and to the extent applicable with respect to certain development activities, FDA and EU requirements.
Janssen, or its affiliates and/or sublicensees, is solely responsible for all communications, filings with, as well as approvals sought from regulatory authorities to obtain all marketing authorizations in relation to NBTXR3 in the Asia Licensing Territory. 78 Table of Contents As consideration for entering into the Asia Licensing Agreement, the Company received a non-refundable upfront payment from LianBio of $20.0 million in June 2021.
Janssen, or its affiliates and/or sublicensees, is solely responsible for all communications, filings with, as well as approvals sought from regulatory authorities to obtain all marketing authorizations in relation to NBTXR3 in the Asia Licensing Territory. As consideration for entering into the Asia Licensing Agreement, the Company received a non-refundable upfront payment from LianBio of $20.0 million in June 2021.
These results suggest that RT-activated NBTXR3 could modulate the immunogenicity of the cancer cells. We also observed RT-activated NBTXR3 in vivo generate an abscopal effect, which is a reduction of metastatic burden outside the irradiated area.
These results suggest that RT-activated JNJ-1900 (NBTXR3) could modulate the immunogenicity of the cancer cells. We also observed RT-activated JNJ-1900 (NBTXR3) in vivo generate an abscopal effect, which is a reduction of metastatic burden outside the irradiated area.
This abscopal effect depends on the increase of CD8+ T cell lymphocyte infiltrates (T lymphocytes that work to kill malignant tumor cells) in both treated and untreated tumors, induced by RT-activated NBTXR3.
This abscopal effect depends on the increase of CD8+ T cell lymphocyte infiltrates (T lymphocytes that work to kill malignant tumor cells) in both treated and untreated tumors, induced by RT-activated JNJ-1900 (NBTXR3).
Janssen Agreement Under the Janssen Agreement, the Company granted Janssen an exclusive royalty-bearing license for the development, manufacturing, commercialization and other exploitation of the investigational, potential first-in-class radioenhancer NBTXR3 and any product that contains NBTXR3 as an active ingredient.
Janssen Agreement Under the Janssen Agreement, the Company granted Janssen an exclusive royalty-bearing license for the development, manufacturing, commercialization and other exploitation of the investigational, potential first-in-class nanoradioenhancer NBTXR3 and any product that contains NBTXR3 as an active ingredient.
Results from the Phase 1 part of Study 103 showed feasibility of injection at each of the five tested dose levels (10%, 15%, 22%, 33% and 42%) with no leakage to surrounding healthy tissues. One SAE of bile duct stenosis was deemed to be related to NBTXR3 and no dose-limiting toxicities were observed. The RP2D was been set at 42%.
Results from the Phase 1 part of Study 103 showed feasibility of injection at each of the five tested dose levels (10%, 15%, 22%, 33%, and 42%) with no leakage to surrounding healthy tissues. One SAE of bile duct stenosis was deemed to be related to JNJ-1900 (NBTXR3) and no dose-limiting toxicities were observed. The RP2D was set at 42%.
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.
The primary endpoints of dose expansion were to confirm that the recommended dose is safe and to obtain preliminary evidence of efficacy by observing the objective response rate and complete response rate of the NBTXR3-injected lesion by imaging according to RECIST 1.1.
The primary endpoints of dose expansion were to confirm that the recommended dose is safe and to obtain preliminary evidence of efficacy by observing the objective response rate and complete response rate of the JNJ-1900 (NBTXR3)-injected lesion by imaging according to RECIST 1.1.
There is no assurance that NBTXR3 will demonstrate efficacy in future trials. Preliminary efficacy and safety results showed that NBTXR3 was well tolerated and the recommended dose was established as equivalent to 22% of tumor volume.
There is no assurance that NBTXR3 will demonstrate efficacy in future trials. Preliminary efficacy and safety results showed that JNJ-1900 (NBTXR3) was well tolerated and the recommended dose was established as equivalent to 22% of tumor volume.
The data showed that the Combo therapy (RT-activated NBTXR3 + anti-PD-1 + anti-LAG3 + anti-TIGIT) significantly promoted the proliferative activity of CD8+ T cells, improved local and distal tumor control, and increased survival rate.
The data showed that the Combo therapy (RT-activated JNJ-1900 (NBTXR3) + anti-PD-1 + anti-LAG3 + anti-TIGIT) significantly promoted the proliferative activity of CD8+ T cells, improved local and distal tumor control, and increased survival rate.
Phase 1 Trial - MD Anderson (“ Study 2019-1001 ”) This MD Anderson led trial is an open-label, single-arm, prospective Phase 1 study examining the use of RT-activated NBTXR3 in LAPC and BRPC patients after receiving chemotherapy. It consisted of two parts: (i) dose-escalation to determine the RP2D and (ii) expansion at RP2D.
Phase 1 Trial - MD Anderson (“ Study 2019-1001 ”) - NCT04484909 This MD Anderson led trial is an open-label, single-arm, prospective Phase 1 study examining the use of RT-activated JNJ-1900 (NBTXR3) in LAPC and BRPC patients after receiving chemotherapy. It consisted of two parts: (i) dose-escalation to determine the RP2D and (ii) expansion at RP2D.
The main characteristics of the population at study entry were: advanced age (61% aged ≥ 70) and a high burden of comorbidity as measured by the age-adjusted Charlson Comorbidity Index (ACCI) as 67% had ACCI scores of ≥4 15 .
The main characteristics of the population at study entry were: advanced age (61% aged ≥ 70) and a high burden of comorbidity as measured by the age-adjusted Charlson Comorbidity Index (ACCI) as 67% had ACCI scores of ≥ 4 8 .
Pursuant to the Janssen Agreement and the Asia Licensing Agreement, following its assignment to Janssen from LianBio, Janssen has worldwide development and commercialization rights with respect to NBTXR3. The Janssen Agreement and the Asia Licensing Agreement streamline the global alliance for co-development and registration of the radioenhancer with Nanobiotix.
Pursuant to the Janssen Agreement and the Asia Licensing Agreement, following its assignment to Janssen from LianBio, Janssen has worldwide development and commercialization rights with respect to NBTXR3. The Janssen Agreement and the Asia Licensing Agreement streamline the global alliance for co-development and registration of the nanoradioenhancer with Nanobiotix.
Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall benefit/risk ratio of the product and provide an adequate basis for product approval. 83 Table of Contents Generally, two adequate and well-controlled Phase 3 clinical trials are required.
Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall benefit/risk ratio of the product and provide an adequate basis for product approval. Generally, two adequate and well-controlled Phase 3 clinical trials are required.
The following graphic depicts shrinkage of the tumor in a patient in the trial over time following treatment. The tumor continued to shrink after the end of treatment, with the patient achieving a complete response at seven months. 57 Table of Contents N.B.: Early-stage results, including anecdotal reports of patient responses, are not necessarily predictive of later-stage clinical outcomes.
The following graphic depicts shrinkage of the tumor in a patient in the trial over time following treatment. The tumor continued to shrink after the end of treatment, with the patient achieving a complete response at seven months. N.B.: Early-stage results, including anecdotal reports of patient responses, are not necessarily predictive of later-stage clinical outcomes.
The protocol, schedule, monitoring, termination and replacement of each trial will be determined by mutual agreement between MD Anderson and the Company. 80 Table of Contents MD Anderson has made a number of representations for the benefit of the Company and has granted the Company audit and information rights in connection with these clinical trials, in particular with respect to pharmacovigilance.
The protocol, schedule, monitoring, termination and replacement of each trial will be determined by mutual agreement between MD Anderson and the Company. MD Anderson has made a number of representations for the benefit of the Company and has granted the Company audit and information rights in connection with these clinical trials, in particular with respect to pharmacovigilance.
We have also partnered with The University of Texas MD Anderson Cancer Center in Houston, Texas, to conduct immunotherapeutic preclinical research in lung cancer, combining NBTXR3 and immune checkpoint inhibitors.
We have also partnered with The University of Texas MD Anderson Cancer Center in Houston, Texas, to conduct immunotherapeutic preclinical research in lung cancer, combining JNJ-1900 (NBTXR3) and immune checkpoint inhibitors.
These free electrons dissipate their energy in multiple interactions with surrounding molecules, producing free radicals for example. These highly reactive free radicals have the capacity to break the covalent bonds of the molecules they interact with, including DNA, RNA, and proteins, causing damage in the cell in multiple ways, and ultimately help lead to cell death.
These free electrons dissipate their energy in multiple interactions with surrounding molecules, producing free radicals for example. These highly reactive free radicals have the capacity to break the covalent bonds of the molecules they interact with, including DNA, RNA, and proteins, causing damage in the cell in multiple ways, and ultimately leading to cell death.
We believe that the Curadigm technology could have broad implications across the healthcare system by increasing the efficacy of therapeutics at their current dose or lowering the necessary dose in order to decrease toxicity and cost, thus allowing for novel therapeutic approaches.
We believe that the Curadigm technology could have broad implications across the healthcare system by increasing the efficacy of therapeutics at their current dose or lowering the necessary dose in order to decrease toxicity and cost, while preserving the same efficacy, thus allowing for novel therapeutic approaches.
The three product candidates differ in the composition of the nanoparticle coating or formulation, which have been developed for three different modes of administration to cover most oncology applications. The most advanced product candidate in the NanoXray portfolio, and our current focus for development and commercialization, is injectable NBTXR3.
The three product candidates differ in the composition of the nanoparticle coating or 67 Table of Contents formulation, which have been developed for three different modes of administration to cover most oncology applications. The most advanced product candidate in the NanoXray portfolio, and our current focus for development and commercialization, is injectable NBTXR3.
After the FDA evaluates the application, manufacturing process and manufacturing facilities, it may issue: 85 Table of Contents – an approval letter authorizing commercial marketing of the drug with specific prescribing information for specific indications. – a Complete Response (CR) action Letter indicating that the review cycle of the application is complete and the application is not ready for approval.
After the FDA evaluates the application, manufacturing process and manufacturing facilities, it may issue: – an approval letter authorizing commercial marketing of the drug with specific prescribing information for specific indications. – a Complete Response (CR) action Letter indicating that the review cycle of the application is complete and the application is not ready for approval.
Primarily, these capital expenditures will be made in France, where our research and development facilities are currently located. 47 Table of Contents The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov . We also maintain a website at http://www.nanobiotix.com/en/ .
Primarily, these capital expenditures will be made in France, where our research and development facilities are currently located. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov . We also maintain a website at http://www.nanobiotix.com/en/ .
These efforts are at an earlier stage than NBTXR3 and we believe have great potential to bring substantial benefits to the problems they are designed to address.
These efforts are at an earlier stage than JNJ-1900 (NBTXR3) and we believe have great potential to bring substantial benefits to the problems they are designed to address.
Phase 1 (“ Study 102 ”) Dose-Escalation/Dose-Expansion Trial - (NCT01946867) We conducted a Phase 1, dose escalation and dose expansion clinical trial of NBTXR3 activated by intensity-modulated radiation therapy in patients with locally advanced head and neck cancer (LA-HNSCC) (patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx) who are ineligible for cisplatin or intolerant to cetuximab.
Phase 1 LA-HNSCC Dose-Escalation / Dose-Expansion Trial - (“ Study 102 ”) - Nanobiotix - (NCT01946867) Nanobiotix conducted a Phase 1, dose escalation and dose expansion clinical trial of JNJ-1900 (NBTXR3) activated by intensity-modulated radiation therapy in patients with locally advanced head and neck cancer (LA-HNSCC) (patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx) who are ineligible for cisplatin or intolerant to cetuximab.
For additional registrational trials, the Company and Janssen have agreed to provide each other with rights to access all clinical safety data and to provide an opportunity to license any right of reference to efficacy data, subject to certain cost-sharing and/or enrollment undertakings.
For additional registrational trials, the Company and Janssen have agreed to provide each other 72 Table of Contents with rights to access all clinical safety data and to provide an opportunity to license any right of reference to efficacy data, subject to certain cost-sharing and/or enrollment undertakings.
The secondary endpoints were to evaluate the safety profile of RT-activated NBTXR3 and compare the rate of tumor surgery with R0 margins (meaning no remaining cancer cells could be seen microscopically within a widely accepted margin after resection), the percentage of tumor necrosis/infarction, limb amputation rates and tumor response as measured by RECIST 1.1.
The secondary endpoints were to evaluate the safety profile of radiotherapy-activated JNJ-1900 (NBTXR3) and compare the rate of tumor surgery with R0 margins (meaning no remaining cancer cells could be seen microscopically within a widely accepted margin after resection), the percentage of tumor necrosis/infarction, limb amputation rates and tumor response as measured by RECIST 1.1.
ITEM 4. INFORMATION ON THE COMPANY A. History and Development of the Company Our legal and commercial name is Nanobiotix S.A. We were incorporated as a société anonyme under the laws of the French Republic on March 4, 2003 for a period of 99 years.
ITEM 4. INFORMATION ON THE COMPANY 40 Table of Contents A. History and Development of the Company Our legal and commercial name is Nanobiotix S.A. We were incorporated as a société anonyme under the laws of the French Republic on March 4, 2003 for a period of 99 years.
Amendment No. 1 to the Janssen Agreemen t The amendment to the Janssen Agreement (“Amendment n°1 to the Janssen Agreement”) executed by and between Nanobiotix and Janssen on March 17, 2025 removes Nanobiotix’s funding obligation for NANORAY-312 and releases Janssen from select future potential milestone payments.
Amendment No. 1 to the Janssen Agreemen t The amendment to the Janssen Agreement (“Amendment n°1 to the Janssen Agreement”) executed by and between Nanobiotix and Janssen on March 17, 2025 removes Nanobiotix’s funding obligation for NANORAY-312 and releases Janssen from a portion of select future potential milestone payments.
In the case of a clinical hold, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose a clinical hold on a drug candidate at any time before or during clinical trials due to safety concerns or noncompliance.
In the 77 Table of Contents case of a clinical hold, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose a clinical hold on a drug candidate at any time before or during clinical trials due to safety concerns or noncompliance.
The FDA may also determine that a risk evaluation and mitigation strategy (REMS) is necessary to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS, and the FDA will not approve the NDA without an approved REMS.
The FDA may also determine that a risk evaluation and mitigation strategy (REMS) is necessary to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS, and the 79 Table of Contents FDA will not approve the NDA without an approved REMS.
In December 2023, the exclusive rights to develop and commercialize NBTXR3 in the Asia Licensing Territory were assigned by LianBio to Janssen, in accordance with the terms of the Asia Licensing Agreement.
In December 2023, the exclusive rights to develop and commercialize NBTXR3 in the Asia Licensing Territory were novated by LianBio to Janssen, in accordance with the terms of the Asia Licensing Agreement.
Subject to applicable bankruptcy law, either party may also terminate the Asia Licensing Agreement in the connection with the occurrence of certain insolvency or bankruptcy events with respect to the other party. Janssen may terminate the Asia Licensing Agreement following a change in control of the Company, subject to a specified notice period.
Subject to applicable bankruptcy law, either party may also terminate the Asia Licensing Agreement in the connection with the occurrence of certain insolvency or bankruptcy events with respect to the other party. Janssen may terminate the Asia Licensing Agreement following a change in control of the Company, subject to a specified 73 Table of Contents notice period.
The Company is also required to make an additional one-time milestone payment upon (i) a first regulatory approval obtained from the FDA for NBTXR3 and (ii) the enrollment of a certain number of patients in the United States.
The Company is also required to make an additional one-time milestone payment upon (i) a first regulatory approval obtained from the FDA for 74 Table of Contents NBTXR3 and (ii) the enrollment of a certain number of patients in the United States.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

92 edited+50 added−39 removed69 unchanged
Biggest changeThe components of our revenues and other income are set forth in the table below: For the year ended December 31, (in thousands of euros) 2024 2023 2022 Services (17,534) 29,750 — Other sales 5,924 308 — Total revenues (11,609) 30,058 — Research tax credit 3,300 3,939 4,091 Subsidies 89 229 135 Other 1,029 1,981 550 Total other income 4,419 6,150 4,776 Total revenues and other income (7,191) 36,207 4,776 Total Revenues In 2024, negative revenue was recognized according to the application of IFRS15 mainly due to: (i) negative €17.5 million net Services Revenue composed of: • negative €23.4 million impact related to Janssen contract modification, recorded as per IFRS 15.
Biggest changeFor further details, refer to Note 16 – Revenues and other income to the financial statements included elsewhere in this Annual Report) The components of our revenues and other income are set forth in the table below: For the year ended December 31, (in thousands of euros) 2025 2024 2023 Services 22,682 (17,534) 29,750 Other sales 6,961 5,924 308 Total revenues 29,643 (11,609) 30,058 Research tax credit 2,817 3,300 3,939 Subsidies 78 89 229 Other 55 1,029 1,981 Total other income 2,950 4,419 6,150 Total revenues and other income 32,593 (7,191) 36,207 95 Total Revenues As of December 31, 2025, the total revenues reached €29.6 million, composed of: (i) the line ‘Services’ amounting to €22.7 million, mainly includes: • a one-off positive revenue impact amounting to €21.8 million directly attributable to the contract modification impact occurred during the first half of 2025 that counterbalances the negative revenue impact recognized in fiscal year 2024: the amendments signed during the last quarter of 2024 had significantly reduced the transaction price of the license agreement as the R&D service performance obligation was replaced with a funding obligation for the Company towards Janssen, while the amendment letter executed in March 2025 did not impact the scope of the Company's performance obligations but increased the remaining transaction price of the Global License Agreement with Janssen. • other ‘Services’ revenue linked to technology transfer and technical assistance recharge to Janssen BV for €0.9 million.
Other Income Our other income consists mainly of refundable research tax credits as well as income from collaboration and supply services in the framework of the Clinical Supply Agreement signed in May 2022 and of the Global Trial Clinical Agreement ‘GTCA’ signed in June 2023 with LianBio, and grants and subsidies from government agencies.
Other Income Our other income mainly consists of refundable research tax credits as well as income from collaboration and supply services in the framework of the Clinical Supply Agreement signed in May 2022 and of the Global Trial Clinical Agreement ‘GTCA’ signed in June 2023 with LianBio, and grants and subsidies from government agencies.
For the year ended December 31, 2023, the €30.1 million of total Revenues mainly includes (i) ‘Services’ revenue linked to the assignment of the license to Janssen and the rendered R&D services in proportion of the completion of the ongoing studies, totaling €29.6 million; (ii) ‘Services’ revenue linked to technology transfer and technical assistance recharge for €0.1 million; (iii) and €0.3 million of ‘Other Sales’ related to product clinical supplies to Janssen.
For the year ended December 31, 2023, the €30.1 million of total Revenues mainly includes (i) ‘Services’ revenue linked to the assignment of the license to Janssen and the rendered R&D services in proportion of the completion of the ongoing studies, totaling €29.6 million; (ii) ‘Services’ revenue linked to technology transfer and technical assistance recharge for €0.1 million; (iii) and €0.3 million of ‘Other Sales’ related to clinical product supplies to Janssen.
This variation is mainly due to one-off fees paid in 2023 to a financial adviser for €1.4 million and the €0.5 million legal fees related to the signature of the license agreement with Janssen. • an increase of €0.2 million or 1.8% in payroll costs mainly driven by the recruitment of additional positions.
This variation is mainly due to one-off fees paid in 2023 to a financial adviser for €1.4 million and legal fees of €0.5 million related to the signature of the license agreement with Janssen. • an increase of €0.2 million or 1.8% in payroll costs mainly driven by the recruitment of additional positions.
Our present and future funding requirements will depend on many factors, including, among other things: • the size, progress, timing and completion of our clinical trials; • the monitoring of capital allocation and incurred costs; • the number of potential new product candidates we identify and decide to develop, including through the development of our Curadigm and Oocuity platforms; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties; • the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates; • selling and marketing activities undertaken in connection with the anticipated commercialization of NBTXR3 and any other current or future product candidates and costs involved in the creation of an effective sales and marketing organization; and • the amount of revenue, if any, we may derive either directly or in the form of milestones or royalty payments from our existing or future partnership or collaboration agreements.
Our present and future funding requirements will depend on many factors, including, among other things: • the size, progress, timing and completion of our clinical trials; • the monitoring of capital allocation and incurred costs; • the number of potential new product candidates we identify and decide to develop, including through the development of our Curadigm and Oocuity platforms; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties; 104 • the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates; • selling and marketing activities undertaken in connection with the anticipated commercialization of NBTXR3 and any other current or future product candidates and costs involved in the creation of an effective sales and marketing organization; and • the amount of revenue, if any, we may derive either directly or in the form of milestones or royalty payments from our existing or future partnership or collaboration agreements.
In the event that we elect to prepay a tranche of the EIB loan, EIB requires prepayment of the EIB loan in connection with an event of default or other prepayment event under the Finance Contract, or a change of control event occurs following the maturity of the EIB loan, EIB is entitled to request payment of an amount equal to the highest of (i) the 106 net present value of all future royalties, as determined by an independent expert, (ii) the amount required for EIB to realize an internal rate of return of 20% on the EIB loan, and (iii) €35.0 million.
In the event that we elect to prepay a tranche of the EIB loan, EIB requires prepayment of the EIB loan in connection with an event of default or other prepayment event under the Finance Contract, or a change of control event occurs following the maturity of the EIB loan, EIB is entitled to request payment of an amount equal to the highest of (i) the net present value of all future royalties, as determined by an independent expert, (ii) the amount required for EIB to realize an internal rate of return of 20% on the EIB loan, and (iii) €35.0 million.
This decrease in loss is primarily attributable to a significantly higher foreign exchange net gain of €5,1 million, the one-off recognition of the derivatives classification related to JJDC capital increase that lead to a €4.2 fair value loss in 2023 not recurring in 2024, and the 104 €1.4 million higher interest income in 2024 as compared to 2023, while the overall interest cost has remained stable when comparing 2024 to 2023.
This decrease in loss is primarily attributable to a significantly higher foreign exchange net gain of €5,1 million, the one-off recognition of the derivatives classification related to JJDC capital increase that lead to a €4.2 fair value loss in 2023 not recurring in 2024, and the €1.4 million higher interest income in 2024 as compared to 2023, while the overall interest cost has remained stable when comparing 2024 to 2023.
We also continue to incur expenses associated with being a public company in France and the United States, including costs related to audit, legal, tax, regulatory, internal control advisors 100 further to the Sarbanes-Oxley Act of 2002, services associated with maintaining compliance with Nasdaq listing and SEC requirements, director and officer insurance premiums, and investor relations costs.
We also continue to incur expenses associated with being a public company in France and the United States, including costs related to audit, legal, tax, regulatory, internal control advisors further to the Sarbanes-Oxley Act of 2002, services associated with maintaining compliance with Nasdaq listing and SEC requirements, director and officer insurance premiums, and investor relations costs.
The net cash flows used in operating activities for the year ended December 31, 2024 increased by €7.1 million compared to the net cash used in operating activities in 2023, primarily due to the decrease of cash collection on operating revenue amounting to €24,1 million received from Janssen linked to first milestone achievement, clinical products and services income, as compared to €27.5 million received in 2023, and to the decrease of cash collection received from LianBio amounting to €0.6 million in 2024 as compared to €1.7 million in 2023 further to the supply and collaboration agreements, leading to a lower cash collection totalling €4.5 million (See Note 4.1- Global License Agreement with Janssen Pharmaceutica NV (the Janssen Agreement) , and Note 4.2. - Asia Licensing Agreement (former LianBio contract), strategic partnership with Janssen, and other notes on Janssen and LianBio license agreements included in our Consolidated financial statements elsewhere in this Annual Report).
The net cash flows used in operating activities for the year ended December 31, 2024 increased by €7.1 million compared to the net cash used in operating activities in 2023, primarily due to the decrease of cash collection on operating revenue amounting to €24,1 million received from Janssen linked to first milestone achievement, clinical products and services income, as compared to €27.5 million received in 2023, and to the decrease of cash collection received from LianBio amounting to €0.6 million in 2024 as compared to €1.7 million in 2023 further to the supply and collaboration agreements, leading to a lower cash collection totaling €4.5 million (See Note 4.1- Global License Agreement with Janssen Pharmaceutica NV (the Janssen Agreement) , and Note 4.2. - Asia Licensing Agreement (former LianBio contract), strategic partnership with Janssen, and other notes on Janssen and LianBio license agreements included in our Consolidated financial statements elsewhere in this Annual Report).
The agreements signed with Janssen BV during the fourth quarter of 2024 (see Note 4.1 - Global License Agreement with Janssen Pharmaceutica NV ), resulted in a contract modification replacing a performance obligation (providing R&D services) by an obligation to refund the NANORAY-312 remaining due study costs to Janssen BV.
The agreements signed with Janssen during the fourth quarter of 2024 (see Note 4.1 - Global License Agreement with Janssen Pharmaceutica NV ), resulted in a contract modification replacing a performance obligation (providing R&D services) by an obligation to refund the NANORAY-312 remaining due study costs to Janssen.
See Note 13 - Financial liabilities and Note 19- Net financial income (loss) to our Consolidated financial statements included elsewhere in this Annual Report for further details. B. Liquidity and Capital Resources Introduction Since our inception, we have consistently generated negative operating cash flows.
See Note 13 - Financial liabilities and Note 19- Net financial income (loss) to our Consolidated financial statements included elsewhere in this Annual Report for further details. 98 B. Liquidity and Capital Resources Introduction Since our inception, we have consistently generated negative operating cash flows.
This agreement consists of two parts: • A conditional advance of €500 thousand, of which €350 thousand was disbursed at the agreement's inception in June 2020, and the remaining €150 thousand was released in January 2023 following the 107 successful completion of a project related to nanomedicine therapy in October 2022.
This agreement consists of two parts: • A conditional advance of €500 thousand, of which €350 thousand was disbursed at the agreement's inception in June 2020, and the remaining €150 thousand was released in January 2023 following the successful completion of a project related to nanomedicine therapy in October 2022.
Prior to repayment at maturity (or earlier prepayment), interest on the first tranche shall accrue at the rate of 6% annually, with such PIK interest being capitalized and added to the outstanding principal. Interest on the second tranche is payable semi-annually in arrears at a 5% fixed rate.
Prior to repayment at maturity (or earlier prepayment), interest on the first tranche shall accrue at the rate of 6% annually, with such PIK interest being capitalized and added to the outstanding principal. Interest on the second 99 tranche is payable semi-annually in arrears at a 5% fixed rate.
The Company has benefited from the research tax credit since its creation. 99 Operating Expenses Our operating expenses are primarily incurred for research and development and selling, general and administrative purposes, for the most part in France. Research and Development Expenses Research and development activities are central to our business.
The Company has benefited from the research tax credit since its creation. Operating Expenses Our operating expenses are primarily incurred for research and development and selling, general and administrative purposes, for the most part in France. Research and Development Expenses Research and development activities are central to our business.
Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this Annual Report, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements.” Financial Overview The following selected statement of consolidated operations data for the years ended December 31, 2024, 2023, and 2022 and the selected statement of consolidated financial position data as of December 31, 2024 and 2023 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this Annual Report, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward-Looking Statements.” Financial Overview The following selected statement of consolidated operations data for the years ended December 31, 2025, 2024, and 2023 and the selected statement of consolidated financial position data as of December 31, 2025 and 2024 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report.
Business Overview,” “Item 5A - Operating Results” and “Item 5B - 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.
Business Overview,” “Item 5A - Operating Results” and “Item 5B - 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.
The net cash flows used in financing activities significantly decreased by €51.9 million between 2024 and 2023 which is mainly due to the net proceeds from capital increases occurred only in 2023 further to JJDC, Inc capital injections and global offerings from specified investors, totalling €57.4 million net inflows, offset by a one-off payment related to accrued PIK interest paid to EIB in 2023 for €5.4 million.
The net cash flows used in financing activities significantly decreased by €51.9 million between 2024 and 2023 which is mainly due to the net proceeds from capital increases occurred only in 2023 further to JJDC, Inc capital injections and global offerings from specified investors, totaling €57.4 million net inflows, offset by a one-off payment related to accrued PIK interest paid to EIB in 2023 for €5.4 million.
These expenses include: • sub-contracting, collaboration and consultant expenses that primarily consist of the cost of third-party contractors, such as contract research organizations that conduct our non-clinical studies and clinical trials; • employee-related costs for employees in research and development functions; • expenses relating to preclinical studies and clinical trials for NBTXR3; • manufacturing costs for production of NBTXR3 to support clinical development; • certain intellectual property expenses; • expenses relating to regulatory affairs; and • expenses relating to the implementation of our quality assurance system.
These expenses include: • sub-contracting, collaboration and consultant expenses that primarily consist of the cost of third-party contractors, such as contract research organizations that conduct our non-clinical studies and clinical trials; • employee-related costs for employees in research and development functions; • expenses relating to preclinical studies and clinical trials for JNJ-1900 (NBTXR3); • manufacturing costs for production of JNJ-1900 (NBTXR3) to support clinical development; • certain intellectual property expenses; • expenses relating to regulatory affairs; and • expenses relating to the implementation of our quality assurance system.
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 and planned preclinical 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 patent applications and maintaining and enforcing patents and other intellectual property rights and defending against claims or infringements raised by third parties; and • the ability to market, commercialize and achieve market acceptance for NBTXR3 or any other product candidate that we may develop in the future.
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 and planned preclinical 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 patent applications and maintaining and enforcing patents and other intellectual property rights and defending against claims or infringements raised by third parties; and 93 • the ability to market, commercialize and achieve market acceptance for JNJ-1900 (NBTXR3) or any other product candidate that we may develop in the future.
We cannot determine with certainty the duration and completion costs of the current or planned future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval, including through licensing agreements as it is the case for NBTXR3.
We cannot determine with certainty the duration and completion costs of the current or planned future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates that obtain regulatory approval, including through licensing agreements as it is the case for JNJ-1900 (NBTXR3).
EIB may require us to prepay all outstanding amounts under the EIB loan in connection with certain events, including a substantial reduction in the anticipated cost of our NBTXR3 development program such as the total prior amount of the loan represents more than a certain percentage of the reduced cost, a prepayment of certain non-EIB financing, certain change of control events, Dr.
EIB may require us to prepay all outstanding amounts under the EIB loan in connection with certain events, including a substantial reduction in the anticipated cost of our JNJ-1900 (NBTXR3) development program such as the total prior amount of the loan represents more than a certain percentage of the reduced cost, a prepayment of certain non-EIB financing, certain change of control events, Dr.
Net Financial Income (Loss) Net financial income (loss) comprises primarily of interest cost which consists of both fixed and variable rate interest costs related to the Company’s financial debts, IFRS 9 debt valuation impact, financial income received from the short-term deposits, foreign exchange gains and losses and the interest costs on leases related to the application of IFRS 16.
Net Financial Income (Loss) Net financial income (loss) comprises primarily of interest cost which consists of both fixed and variable rate interest costs related to our financial debts, IFRS 9 debt valuation impact, financial income received from the short-term deposits, foreign exchange gains and losses and the interest costs on leases related to the application of IFRS 16.
Historically, we have financed our operations and growth through: • the issuance and sale of ordinary shares, primarily including €12.1 million in net proceeds from our initial public offering on the Euronext market in Paris in October 2012, €28.1 million in net proceeds from a private placement capital increase in April 2019, €18.8 million in net proceeds from a private placement capital increase in July 2020, $113.3 million (€93.5 million as of December 10, 2020) in net proceeds from our global offering, including our U.S. initial public offering, in December 2020, and €57.4 million in net proceeds from our global equity offering and JJDC’s two-tranche equity investment between September and December 2023 (See Note 1 - Company information and Note 10 - Share Capital to our Consolidated financial statements included elsewhere in this Annual Report). • loans, conditional advances and grants awarded by governmental entities, including: ◦ our EIB finance contract and royalties agreement granted by the EIB in July 2018 and amended in October 2022, from which we drew (i) the initial tranche of €16.0 million (repayable in a single installment at maturity, except for a payment-in-kind (“PIK”) interest capitalized paid in October 2023) upon satisfying the requisite documentary criteria in October 2018 and (ii) the second tranche of €14.0 million (repayable in semi-annual installments of principal and interest after a two year grace period) in March 2019 upon achieving the requisite performance criteria (the positive evaluation of the Phase 3 clinical benefit/risk ratio of NBTXR3 for the treatment of STS by the French notified body covering medical devices, GMED, and the successful identification of the recommended NBTXR3 dosage in our locally advanced head and neck cancer clinical trial). ◦ a €2.1 million repayable advance received from Bpifrance in 2013 through France’s Strategic Industrial Innovation program, an interest-free innovation loan of €2.0 million from Bpifrance received in September 2016 and a non-dilutive €1.0 million financing agreement granted in June 2020 as part of Bpifrance’s Deep Tech program in order to support Curadigm’s Nanoprimer technology. ◦ an aggregate of €10 million in state guaranteed loans (“Prêt garanti par l’Etat” or “PGE”) pursuant to a €5 million PGE agreement with HSBC France (the “HSBC PGE Loan”) in June 2020 and a €5 million PGE agreement with Bpifrance in July 2020 (the “Bpifrance PGE Loan”).
Historically, we have financed our operations and growth through: • the issuance and sale of ordinary shares, primarily including €12.1 million in net proceeds from our initial public offering on the Euronext market in Paris in October 2012, €28.1 million in net proceeds from a private placement capital increase in April 2019, €18.8 million in net proceeds from a private placement capital increase in July 2020, $113.3 million (€93.5 million as of December 10, 2020) in net proceeds from our global offering, including our U.S. initial public offering, in December 2020, and €57.4 million in net proceeds from our global equity offering and JJDC’s two-tranche equity investment between September and December 2023 (See Note 1 - Company information and Note 10 - Share Capital to our Consolidated financial statements included elsewhere in this Annual Report). • loans, conditional advances and grants awarded by governmental entities, including: ◦ our EIB finance contract and royalties agreement granted by the EIB in July 2018 and amended in October 2022 and November 2025, from which we drew (i) the initial tranche of €16.0 million (repayable in a single installment at maturity, except for a payment-in-kind (“PIK”) interest capitalized paid in October 2023) upon satisfying the requisite documentary criteria in October 2018 and (ii) the second tranche of €14.0 million (repayable in semi-annual installments of principal and interest after a two year grace period) in March 2019 upon achieving the requisite performance criteria (the positive evaluation of the Phase 3 clinical benefit/risk ratio of JNJ-1900 (NBTXR3) for the treatment of STS by the French notified body covering medical devices, GMED, and the successful identification of the recommended JNJ-1900 (NBTXR3) dosage in our locally advanced head and neck cancer clinical trial). ◦ a €2.1 million repayable advance received from Bpifrance in 2013 through France’s Strategic Industrial Innovation program, an interest-free innovation loan of €2.0 million from Bpifrance received in September 2016 and a non-dilutive €1.0 million financing agreement granted in June 2020 as part of Bpifrance’s Deep Tech program in order to support Curadigm’s Nanoprimer technology. ◦ an aggregate of €10 million in state guaranteed loans (“Prêt garanti par l’Etat” or “PGE”) pursuant to a €5 million PGE agreement with HSBC France (the “HSBC PGE Loan”) in June 2020 and a €5 million PGE agreement with Bpifrance in July 2020 (the “Bpifrance PGE Loan”). • a royalty financing agreement entered on October 30, 2025 with HCRx group including an initial $50 million gross installment.
However, we expect our operating expenses will continue to be significant in the foreseeable future as we continue to conduct our clinical trials: • advance our ongoing clinical trial of NBTXR3 with Study 1100; • initiate, conduct, or fund additional clinical trials of NBTXR3, including those with MD Anderson; • continue the research and development of other product candidates or other applications of NBTXR3, including the advancement of our Curadigm and Oocuity platforms; • maintain our manufacturing capabilities to support the launch of additional products; • maintain, expand and protect our intellectual property portfolio; and • add operational, financial and management information systems and personnel, including personnel to support our product development and current and future collaborations.
However, we expect our operating expenses will continue to be significant in the foreseeable future as we continue to conduct our clinical trials and to initiate future developments: • advance our ongoing clinical trial of JNJ-1900 (NBTXR3) with Study 1100; • initiate, conduct, or fund additional clinical trials of JNJ-1900 (NBTXR3), including those with MD Anderson; • continue the research and development of other product candidates , including the advancement of our Curadigm and Oocuity platforms; • maintain our manufacturing capabilities to support the launch of additional products; • maintain, expand and protect our intellectual property portfolio; and • add operational, financial and management information systems and personnel, including personnel to support our products development and current and future collaborations.
Laurent Levy ceasing to be our principal executive officer or ceasing to hold a specified number of shares, or certain dispositions of assets related to our NBTXR3 development program, in each case, subject to the payment of a customary prepayment fee.
Laurent Levy ceasing to be our principal executive officer or ceasing to hold a specified number of shares, or certain dispositions of assets related to our JNJ-1900 (NBTXR3) development program, in each case, subject to the payment of a customary prepayment fee.
A change in the outcome of any of these variables with respect to the development of NBTXR3 or any other product candidate that we develop could mean a significant change in the costs and timing associated with the development of NBTXR3 or such other product candidates.
A change in the outcome of any of these variables with respect to the development of JNJ-1900 (NBTXR3) or any other product candidate that we develop could mean a significant change in the costs and timing associated with the development of JNJ-1900 (NBTXR3) or such other product candidates.
Under the finance contract as amended, the final repayment date for the outstanding principal under the two drawn tranches is fixed on the earliest of (i) June 30, 2029 and (ii) the third royalty payment date (being June 30 of the third financial year starting after commercialization of NBTRX3, defined as the first Financial Year in which the Group first achieves net sales in excess of EUR 5,000,000 (the “Commercialization”)) for the first tranche and the second royalty payment date (being June 30 of the second financial year starting after Commercialization) for the second tranche.
Under the finance contract as amended, the final repayment date for the outstanding principal under the two drawn tranches is fixed on the earliest of (i) June 30, 2029 and (ii) the third royalty payment date (being June 30 of the third financial year starting after commercialization of JNJ-1900 (NBTXR3), defined as the first Financial Year in which the Group first achieves net sales in excess of EUR 5,000,000 (the “Commercialization”)) for the first tranche and the second royalty payment date (being June 30 of the second financial year starting after Commercialization) for the second tranche.
Pursuant to the amendment to the Janssen Agreement signed as of March 17, 2025, we anticipate that our expenses will remain stable or decrease modestly, in the near future, due to a reduced financial obligation for the NANORAY-312 study.
Pursuant to the amendment to the Janssen Agreement signed as of March 17, 2025, we anticipate that our expenses will remain stable in the near future, due to a reduced financial obligation for the NANORAY-312 study.
Trend information 111 For a discussion of trends, see “Item 4B.
Trend information For a discussion of trends, see “Item 4B.
This resulted in a negative transaction price that had to be recognized in its entirety as of December 31, 2024, irrespective of the actual percentage of completion of the performance obligation. • partially offset by Janssen Agreement R&D Revenue recognised overtime for €4.0 million and by Services Revenue linked to technology transfer and technical assistance recharge to Janssen BV for €1.8 million (ii) €5.9 million of ‘Other Sales’ related to products clinical supplies to Janssen BV in 2024, compared to €0.3 million in 2023.
This resulted in a negative transaction price that had to be recognized in its entirety as of December 31, 2024, irrespective of the actual percentage of completion of the performance obligation. • partially offset by Janssen Agreement R&D Revenue recognised overtime for €4.0 million and by Services Revenue linked to technology transfer and technical assistance recharge to Janssen for €1.8 million (ii) €5.9 million of ‘Other Sales’ related to clinical products supplies to Janssen for the year ended December 31, 2024..
We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described in Note 3.2. to our audited consolidated financial statements as of December 31, 2023 and 2024 and for each of the three years ended December 31, 2022, 2023 and 2024. 112
We believe that the most significant management judgments and assumptions in the preparation of our financial statements are described in Note 3.2. to our audited consolidated financial statements as of December 31, 2024 and 2025 and for each of the three years ended December 31, 2023, 2024 and 2025. 105
Further to the application of IFRS15 revenue recognition standards application, a negative €19.3 million net revenue impact has been recorded as a contract modification, resulting from non-cash accounting entries, thus without any impact on the Company’s cash position.
Further to the application of IFRS15 revenue recognition standards application, a one-time negative impact amounting to €19.3 million has been recorded as a contract modification, resulting from non-cash accounting entries, thus without any impact on the Company’s cash position.
Accordingly, pursuant to IAS 38 (see note 5 - Intangible assets for details), the Company has recognized all of its research and development costs incurred as an expense in 2024 and prior periods. In the years ended December 31, 2024, 2023 and 2022, we incurred expenses of €40.5 million, €38.4 million and €32.6 million, respectively, on research and development. D.
Accordingly, pursuant to IAS 38 (see note 5 - Intangible assets for details), the Company has recognized all of its research and development costs incurred as an expense in 2024 and prior periods. In the years ended December 31, 2025, 2024 and 2023, we incurred expenses of €23.1 million, €40.5 million and €38.4 million, respectively, on research and development. D.
Since our inception, we have recorded operating losses every year, due primarily to research and development expenses incurred in connection with our efforts to advance our development program for NBTXR3. Our net losses were €68.1 million, €39.7million and €57.0 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Since our inception, we have recorded operating losses every year, due primarily to research and development expenses incurred in connection with our efforts to advance our development program for JNJ-1900 (NBTXR3). Our net losses were €24.0 million, €68.1 million and €39.7million for the years ended December 31, 2025, 2024, and 2023, respectively.
Operating Capital Requirements We expect our future cash operating expenses will remain stable or decrease modestly in the near future, further to the latest license agreement amendment executed as of March 17, 2025 (see Note 25 - Subsequent Events to the financial statements included elsewhere in this Annual Report).
Operating Capital Requirements We expect our future cash operating expenses will remain stable or decrease modestly in the near future, further to the latest license agreement amendment executed as of March 17, 2025 (see Note 1 - Company Information to the financial statements included elsewhere in this Annual Report).
Subsidies include the Bpifrance Deep Tech Grant received by Curadigm SAS, €89 thousand for the year ended December 31, 2024, €229 thousand for the year ended December 31, 2023 and €135 thousand for the year ended December 31, 2022.
Subsidies include the Bpifrance Deep Tech Grant received by Curadigm SAS, €78 thousand for the year ended December 31, 2025, €89 thousand for the year ended December 31, 2024 and €229 thousand for the year ended December 31, 2023.
Historical Changes in Cash Flows The table below summarizes our cash inflows and outflows for the years ended December 31, 2024, 2023 and 2022: For the year ended December 31, (in thousands of euros) 2024 2023 2022 Net cash flows from (used in) operating activities (19,551) (12,476) (37,103) Net cash flows from (used in) investing activities (955) (349) 138 Net cash flows from (used in) financing activities (5,135) 46,771 (5,651) Effect of exchange rates changes on cash 94 (51) 83 Net increase (decrease) in cash and cash equivalents (25,547) 33,895 (42,533) Cash Flows from / used in operating activities Our net cash flows used in operating activities was an outflow of €19.6 million for the year ended December 31, 2024 as compared to an outflow of €12.5 million for the year ended December 31, 2023.
Historical Changes in Cash Flows The table below summarizes our cash inflows and outflows for the years ended December 31, 2025, 2024 and 2023: 102 For the year ended December 31, (in thousands of euros) 2025 2024 2023 Net cash flows from (used in) operating activities (33,422) (19,551) (12,476) Net cash flows from (used in) investing activities (578) (955) (349) Net cash flows from (used in) financing activities 37,416 (5,135) 46,771 Effect of exchange rates changes on cash (402) 94 (51) Net increase (decrease) in cash and cash equivalents 3,014 (25,547) 33,895 Cash Flows from / used in operating activities The net cash flows used in operating activities was an outflow of €33.4 million for the year ended December 31, 2025 as compared to an outflow of €19.6 million for the year ended December 31, 2024.
The research tax credit decreased from €3.9 million to €3.3 million between 2023 and 2024, mainly due to the exclusion of eligible expenses of a contract research organizations related to the 312 study, further to the failure to obtain the CIR eligibility accreditation. The research tax credit was stable between 2022 and 2023.
The research tax credit decreased from €3.9 million to €3.3 million between 2023 and 2024, mainly due to the exclusion of eligible expenses of a contract research organization related to the 312 study, further to the unavailability of CIR eligibility accreditation.
The audited consolidated financial statements have been prepared in accordance with IFRS Accounting Standards, as issued by the International Accounting Standards Board (“IASB”), as well as interpretations issued by the IFRS Interpretations Committee (“IFRS-IC”) and the Standard Interpretations Committee (the “SIC”), which application is mandatory as of January 1, 2024.
We operate in a single operating segment for accounting purposes. The audited consolidated financial statements have been prepared in accordance with IFRS Accounting Standards, as issued by the International Accounting Standards Board (“IASB”), as well as interpretations issued by the IFRS Interpretations Committee (“IFRS-IC”) and the Standard Interpretations Committee (the “SIC”), which application is mandatory as of January 1, 2025.
The total amount of expenses incurred with respect to research and development activities increased by €5.8 million, or 17.6%, from €32.6 million for the year ended December 31, 2022 to €38.4 million for the year ended December 31, 2023.
The total amount of expenses incurred with respect to research and development activities increased by €2.1 million, or 5,6%, from €38,4 million for the year ended December 31, 2023 to €40.5 million for the year ended December 31, 2024.
This one-off negative impact is partially offset by Other Revenues recognized in 2024 that positively impact Nanobiotix cash position including Sales of Clinical Products and services to Janssen for €7.7 million and Research Tax Credit for €3.3 million.
This one-time negative impact is partially offset by Other Revenues recognized in 2024 that positively impact Nanobiotix cash position including Sales of Clinical Products and services to Janssen for €7.7 million. As of December 31, 2024, we also recognized €4.4 million of Other income, of which Research Tax Credit for €3.3 million.
During the year ended December 31, 2024, net lease liabilities decreased by €0.9 million to €4.2 million since December 31, 2023. See Note 13.2. - Lease liabilities of our consolidated financial statements for details regarding the lease liabilities.
During the year ended December 31, 2025, net lease liabilities decreased by €1.1 million to €3.1 million since December 31, 2024. See Note 13.1 - Details of financial liabilities of our consolidated financial statements for details regarding the lease liabilities.
Grants and Subsidies We have received various grants and other assistance from the government of France and French public authorities, including through Bpifrance (formerly OSEO Innovation), since our inception. The funds are intended to finance our operations or specific projects. Grants and subsidies are recognized in other income only when the corresponding expenses are incurred, independently of cash flows received.
Grants and Subsidies We have received various grants and other assistance from the government of France and French public authorities, including through Bpifrance (formerly OSEO Innovation), since our inception. The funds are intended to finance our operations or specific projects.
From our inception in 2003 through December 31, 2024, we have received more than €384.0 million in financing in the form of external fundraising, loans and repayable advances. See ‘‘—Liquidity and Capital Resources’’ below for additional information.
From our inception in 2003 through December 31, 2025, we have received approximately €425.7 million in financing in the form of external fundraising, loans, royalty financing and repayable advances. See ‘‘—Liquidity and Capital Resources’’ below for additional information.
Cash Flows from / used in investing activities Our net cash flows used in investing activities was an outflow of €955 thousand for the year ended December 31, 2024, mainly due to fixed asset acquisitions (annual rent adjustment impacting the right of use for Wattignies and Wacano leases and office, laboratory and IT equipment renewals and additions). 108 Our net cash flows used in investing activities was an outflow of €349 thousand for the year ended December 31, 2023, mainly composed by a €328 thousand outflow for fixed asset acquisitions (activation of an irradiator and prepayment for the purchase of a new reactor).
Our net cash flows used in investing activities was an outflow of €955 thousand for the year ended December 31, 2024, mainly due to fixed asset acquisitions (annual rent adjustment impacting the right of use for Wattignies and Wacano leases and office, laboratory and IT equipment renewals and additions).
Research and Development Expenses Research and development expenses for the years ended December 31, 2024, 2023 and 2022 are summarized below: For the year ended December 31, (in thousands of euros) 2024 2023 2022 Purchases, sub-contracting and other expenses (27,048) (26,380) (20,415) Payroll costs (including share-based payments) (12,345) (10,721) (10,868) Depreciation, amortization and provision expenses (1,148) (1,295) (1,353) Total research and development expenses (40,541) (38,396) (32,636) The total amount of expenses incurred with respect to research and development activities increased by €2.1 million, or 5,6%, from €38,4 million for the year ended December 31, 2023 to €40.5 million for the year ended December 31, 2024.
Research and Development Expenses Research and development expenses for the years ended December 31, 2025, 2024 and 2023 are summarized below: For the year ended December 31, (in thousands of euros) 2025 2024 2023 Purchases, sub-contracting and other expenses (9,755) (27,048) (26,380) Payroll costs (including share-based payments) (12,206) (12,345) (10,721) Depreciation, amortization and provision expenses (1,154) (1,148) (1,295) Total research and development expenses (23,115) (40,541) (38,396) The total amount of expenses incurred with respect to research and development activities decreased by €17.4 million, or 42,9%, from €40,5 million for the year ended December 31, 2024 to €23.1 million for the year ended December 31, 2025.
We have not generated significant revenues to date from product sales, milestones or royalties, and we do not expect to generate significant revenues from product sales or royalties unless and un til our product candidates are approved for marketing and are successfully commercialized.
We have not generated significant revenues through the date of this Annal Report from product sales, milestones or royalties, and we do not expect to generate significant revenues from product sales or royalties unless and until our product candidates are approved for marketing and are successfully commercialized.
As part of the restructuring implemented by the Amendment Agreements, we were subject to a minimum cash and cash equivalents covenant requiring maintenance of a minimum cash and cash equivalents balance equal to the outstanding principal owed to EIB. This minimum cash and cash equivalents covenant was removed on October 13, 2023, as described below.
As part of the restructuring implemented by the Amendment Agreements, we were subject to a minimum cash and cash equivalents covenant requiring maintenance of a minimum cash and cash equivalents balance equal to the outstanding principal owed to EIB.
Selling, General and Administrative (“SG&A”) Expenses 103 SG&A expenses for the years ended December 31, 2023, 2022 and 2021 are summarized below: For the year ended December 31, (in thousands of euros) 2024 2023 2022 Purchases, fees and other expenses (8,073) (9,889) (7,792) Payroll costs (including share-based payments) (11,986) (11,772) (9,688) Depreciation, amortization and provision expenses (467) (387) (378) Total SG&A expenses (20,527) (22,049) (17,857) Our SG&A expenses decreased by €1.5 million, or 6.9%, from €22.0 million for the year ended December 31, 2023 to €20.5 million for the year ended December 31, 2024.
Selling, General and Administrative (“SG&A”) Expenses The Selling, General and Administrative expenses for the years ended December 31, 2025, 2024 and 2023 are summarized below: For the year ended December 31, (in thousands of euros) 2025 2024 2023 Purchases, fees and other expenses (7,996) (8,073) (9,889) Payroll costs (including share-based payments) (12,226) (11,986) (11,772) Depreciation, amortization and provision expenses (138) (467) (387) Total SG&A expenses (20,360) (20,527) (22,049) The total amount of expenses incurred with respect to Selling, General and Administrative activities decreased by €0.2 million, or 0.8%, from €20.5 million for the year ended December 31, 2024 to €20.4 million for the year ended December 31, 2025.
Other Operating Income (Loss) For the year ended December 31, 2024, the other operating expenses mainly relates to some employment termination indemnities for €129 thousand.
Other Operating Income (Loss) For the year ended December 31, 2025, the other operating income and expenses, amounting to €64 thousand net income, relate mainly to some employment termination indemnities expenses and other non‑significant items. For the year ended December 31, 2024, the other operating expenses mainly relates to some employment termination indemnities for €129 thousand.
The audited consolidated financial statements are also compliant with IFRS as adopted by the EU. Financial Operations Overview Revenues and Other Income For the year-ended December 31, 2024, the Company recognized a negative €11.6 million net revenue and a positive ‘other income’ of €4.4 million for a total negative €7.2 million ‘Revenue and Other Income’.
The audited consolidated financial statements are also compliant with IFRS as adopted by the EU. 91 Financial Operations Overview Revenues and Other Income For the year-ended December 31, 2025, the Company recognized €29.6 million of revenues and €3.0 million of other income for a total ‘Revenue and Other Income’ of €32.6 million.
Consequently the Company has not requested the final tranche of the EIB loan, and the third tranche is no longer available. 105 On October 18, 2022, the Company and the EIB amended the finance contract and the royalty agreement described below (all together, the “Amendment Agreements”) to re-align the Company’s outstanding debt obligations with its expected development and commercialization timelines.
On October 18, 2022, we and the EIB amended the finance contract and the royalty agreement described below (all together, the “Amendment Agreements”) to re-align the Company’s outstanding debt obligations with its expected development and commercialization timelines.
Unfavorable net cash flows used in operating activities is also driven by an unfavourable net working capital amounting to €4.7 million in 2024 as compared to 2023 mainly driven by a strict cash management monitoring related to vendors payments that occurred at the year-end 2023.
Net cash flows used in operating activities in 2024 were also impacted by an unfavourable net working capital amounting to €4.7 million as compared to 2023 mainly driven by a strict cash management monitoring related to vendors payments occurred at the year-end 2023 (See Note 14 - Trade and other payables to the financial statements included elsewhere in this Annual Report).
All other covenants included in the 2018 finance contract remain unchanged. PGE Loans On June 5, 2020, the Company received initial approval from each of HSBC France and Bpifrance for two State-guaranteed loans (prêts garantis par l’État) of €5.0 million each, representing a total amount of €10 million.
PGE Loans On June 5, 2020, the Company received initial approval from each of HSBC France and Bpifrance for two State-guaranteed loans (prêts garantis par l’État) of €5.0 million each, representing a total amount of €10 million. Accordingly, the Company entered into two agreements with HSBC France and Bpifrance Financement, respectively, each providing for a €5.0 million State guaranteed loan.
The following summary consolidated financial data for the periods and as of the dates indicated are qualified by reference to, and should be read in conjunction with, our consolidated financial statements and related notes beginning on page F-1 of this Annual Report. 95 Our historical results for any prior period do not necessarily indicate our results to be expected for any future period.
Our audited consolidated financial statements have been prepared in accordance with IFRS, as issued by the IASB. The following summary consolidated financial data for the periods and as of the dates indicated are qualified by reference to, and should be read in conjunction with, our consolidated financial statements and related notes beginning on page F-1 of this Annual Report.
At December 31, 2023, our workforce totaled 102 employees, which is stable as compared to the same period in 2022. Net Financial Income (Loss) Net financial loss favorably decreased by €13.2 million, from a €12.8 million loss for the year ended December 31, 2023 to a €0,4 million income for the year ended December 31, 2024.
Net financial loss favorably decreased by €13.2 million, from a €12.8 million loss for the year ended December 31, 2023 to a €0,4 million income for the year ended December 31, 2024.
For the year ended December 31, 2024, the financial expenses are fully compensated by financial income. See Note 19 - Net financial income (loss) below for further details. A. Operating results We have one operating segment, which is the research and development of product candidates that use proprietary nanotechnology to transform cancer treatment.
See Note 19 - Net financial income (loss) to our C onsolidated financial statements included elsewhere in this Annual Report for further details. A. Operating results We have one operating segment, which is the research and development of product candidates that use proprietary nanotechnology to transform cancer treatment.
This net increase was mainly due to: • Purchases, sub-contracting and other expenses, which increased by €5.9 million, or 29.2% for the year ended December 31, 2023 as compared with the same period in 2022.
This net decrease was mainly due to: • Purchases, sub-contracting and other expenses decreased by €17.3 million or 63.8% for the year ended December 31, 2025 as compared with the same period in 2024.
See Item 5 - Part A Operating Results - ‘Revenue’ section below for additional information, and Refer to Note 16 – Revenues and other income to the financial statements included elsewhere in this Annual Report.
The regulatory transfer process is still ongoing in Philippines and expected to be finalized by third quarter of 2026 See Item 5 - Part A Operating Results - ‘Revenue’ section below for additional information, and Refer to Note 16 – Revenues and other income and Note 4.1 – The Janssen Agreement to the financial statements included elsewhere in this Annual Report.
Pursuant to the amendment to the Janssen Agreement signed as of March 17, 2025, we anticipate that our research and development operating expenses will remain stable or decrease modestly, in the near future, due to our reduced cost obligations for the NANORAY-312 study.
Pursuant to the amendment to the Janssen Agreement signed as of March 17, 2025, our research and development operating expenses decreased due to our reduced cost obligations for the NANORAY-312 study. However, we expect our research and development expenses will continue to be significant in the foreseeable future as we advance the clinical development plan beyond the NANORAY-312 study.
For the year ended December 31, (in thousands of Euros) 2024 2023 2022 Statement of consolidated operations data: Total revenues and other income (7,191) 36,207 4,776 Operating income (loss) (68,392) (26,779) (46,702) Net loss for the period (68,132) (39,700) (57,041) As of December 31, (in thousands of Euros) 2024 2023 2022 Statement of consolidated financial position data: Cash and cash equivalents 49,737 75,283 41,388 Total assets 67,418 93,897 59,769 Total shareholders’ equity (65,704) (1,843) (27,045) Total non-current liabilities 74,187 45,866 48,878 Total current liabilities 58,935 49,873 37,936 96 Operation Overview We are a late-stage clinical biotechnology company focused on developing first-in-class, physics-based product candidates that use our proprietary nanotechnology to seek to improve treatment outcomes for millions of patients around the world.
For the year ended December 31, (in thousands of Euros) 2025 2024 2023 Statement of consolidated operations data: Total revenues and other income 32,593 (7,191) 36,207 Operating income (loss) (10,818) (68,392) (26,779) Net loss for the period (23,961) (68,132) (39,700) 88 As of December 31, (in thousands of Euros) 2025 2024 2023 Statement of consolidated financial position data: Cash and cash equivalents 52,750 49,737 75,283 Total assets 67,760 67,418 93,897 Total shareholders’ equity (84,483) (65,704) (1,843) Total non-current liabilities 94,735 74,187 45,866 Total current liabilities 57,507 58,935 49,873 89 Operation Overview We are a late-stage clinical biotechnology company focused on re-inventing medicine by building new therapies atom by atom, developing widely applicable, first-in-class, physics-based nanotherapeutics to transform treatment outcomes and expand life for millions of patients.
This one-off negative impact is partially offset by sales of services to Janssen for €1.8 million, and Other Sales recognized in 2024 that positively impact Nanobiotix cash position including Sales of Clinical Products for €5.9 million and and Research Tax Credit for €3.3 million.
This net negative impact is partially offset by sales of services for €1.8 million and by clinical product supplies for €5.9 million to Janssen, and by Research Tax Credit for €3.3 million.
There was no revenue recognized for the year ended December 31, 2022. See Note 16 – Revenues and other income to our Consolidated financial statements included elsewhere in this Annual Report).
See Note 16 – Revenues and other income to our Consolidated financial statements included elsewhere in this Annual Report).
Operating Income (Loss) Our operating loss unfavourably increased by €41,7 million, from €26,8 million for the year ended December 31, 2023 to €68,4 million for the year ended December 31, 2024.
Operating Income (Loss) Our operating loss favourably decreased by €57.6 million, from €68.4 million for the year ended December 31, 2024 to €10.8 million for the year ended December 31, 2025.
Further, should we secure non-dilutive capital through the execution of any business development deal, this accelerated payment schedule for the additional milestone payment would be triggered by reflecting a prorated payment amount not exceeding 10% of any upfront or milestone payment received by Nanobiotix.
Further, should we secure non-dilutive capital through the execution of any business development deal, this accelerated payment schedule for the additional milestone payment would be triggered by reflecting a prorated payment amount not exceeding 10% of any upfront or milestone payment received by Nanobiotix. 100 The additional prepayment condition on the €20.0 million milestone was met further to the global offering equity raise subscribed at the end of 2023 and further to the upfront and milestone received from Janssen between 2023 and 2024, triggering milestone prepayment to the EIB.
Until such time that we can generate substantial revenue from milestones and royalty income, we expect to finance these expenses and our operating activities through our cash balance.
Until such time that we can generate substantial revenue from milestones and royalty income, we expect to finance these expenses and our operating activities through our existing cash balance and through the payment of the second installment of the Royalty deal to be received in December 2026, provided the corresponding conditions are met.
The disbursement of the third tranche was dependent on conditions which were not met by July 31, 2021.
The disbursement of the third tranche was dependent on conditions which were not met by July 31, 2021. Consequently the Company has not requested the final tranche of the EIB loan, and the third tranche is no longer available.
Research Tax Credits The French tax authorities grant a research tax credit ( Crédit d’Impôt Recherche ) to companies in order to encourage them to conduct technical and scientific research.
Grants and subsidies are recognized in other income only when the corresponding expenses are incurred, independently of cash flows received. 92 Research Tax Credits The French tax authorities grant a research tax credit ( Crédit d’Impôt Recherche ) to companies in order to encourage them to conduct technical and scientific research.
At December 31, 2024, our workforce totaled 108 employees, an increase of 6 positions as compared to the same period in 2023. Our operating loss decreased by €19.9 million, or 42.7%, from €46.7 million for the year ended December 31, 2022 to €26.8 million for the year ended December 31, 2023.
At December 31, 2025, our workforce totaled 97 employees, a decrease of 11 positions as compared to the same period in 2024. Our operating loss unfavourably increased by €41.7 million, from €26.8 million for the year ended December 31, 2023 to €68.4 million for the year ended December 31, 2024.
Accordingly, the Company entered into two agreements with HSBC France and Bpifrance Financement, respectively, each providing for a €5.0 million State guaranteed loan. The HSBC PGE Loan is 90% guaranteed by the French State and had an initial 12-month term during which it bore no interest.
The HSBC PGE Loan is 90% guaranteed by the French State and had an initial 12-month term during which it bore no interest.
The new agreements define the conditions of the transfer of the global sponsorship of NANORAY-312 study to Janssen, the parties having mutually agreed that Janssen will progressively take over from the Company the operational conduct and execution responsibility of the study, on a country by country basis, starting November 2024, with the objective to complete the transfer of sponsorship in the short term, whereas the Company remains liable for the overall costs of the study.
In accordance with the conditions of the transfer of global sponsorship agreed, Janssen has progressively taken over from the Company the operational conduct and execution responsibility of the study, on a country by country basis, starting November 2024, with the objective to complete the transfer of sponsorship as soon as possible.
Historically, we have financed our operations and growth through issuances of new shares, refunds of research tax credits, conditional advances and grants awarded by governmental agencies, and cash inflows resulting from upfront license fees, a development milestone and 22 Any references to “NBTXR3” or “JNJ-1900” should be understood as referring to the licensed product under the Janssen Agreement.
Historically, we have financed our operations and growth through issuances of new shares, refunds of research tax credits, conditional advances and grants awarded by governmental agencies, and cash inflows resulting from upfront license fees, a development milestone and clinical products and services revenues further to our 2023 partnership agreement with Janssen, as well as bank loans and our 2025 royalty financing transaction with HCRx.
Comparison of the years ended as of December 31, 2024, 2023 and 2022 Our results of operations for the years ended as of December 31, 2024, 2023 and 2022 are summarized in the table below: For the year ended December 31, (in thousands of euros) 2024 2023 2022 Revenues and other income Revenues (11,609) 30,058 — Other income 4,419 6,150 4,776 Total revenues and other income (7,191) 36,207 4,776 Research and development expenses (40,541) (38,396) (32,636) Selling, general and administrative expenses (20,527) (22,049) (17,857) Other operating income and expenses (134) (2,542) (985) Total operating expenses (61,202) (62,986) (51,478) Operating income (loss) (68,392) (26,779) (46,702) Financial income 7,849 2,002 3,533 Financial expenses (7,488) (14,803) (13,863) Financial income (loss) 361 (12,801) (10,329) Income tax (101) (120) (10) Net loss for the period (68,132) (39,700) (57,041) Total Revenues and Other Income Revenues and other income decreased by €43.4 million, from €36.2 million for the year ended December 31, 2023 to negative €7.2 million revenue for the year ended December 31, 2024, mainly driven by the Janssen AAA and related agreements signed with Janssen in the fourth quarter of 2024 which allow the transfer of the global 101 sponsorship of the NANORAY-312 study from the Company to Janssen.
Comparison of the years ended as of December 31, 2025, 2024 and 2023 Our results of operations for the years ended as of December 31, 2025, 2024 and 2023 are summarized in the table below: 94 For the year ended December 31, (in thousands of euros) 2025 2024 2023 Revenues and other income Revenues 29,643 (11,609) 30,058 Other income 2,950 4,419 6,150 Total revenues and other income 32,593 (7,191) 36,207 Research and development expenses (23,115) (40,541) (38,396) Selling, general and administrative expenses (20,360) (20,527) (22,049) Other operating income and expenses 64 (134) (2,542) Total operating expenses (43,411) (61,202) (62,986) Operating income (loss) (10,818) (68,392) (26,779) Financial income 2,092 7,849 2,002 Financial expenses (15,233) (7,488) (14,803) Financial income (loss) (13,141) 361 (12,801) Income tax (3) (101) (120) Net loss for the period (23,961) (68,132) (39,700) Total Revenues and Other Income Revenues and Other Income increased by €39.8 million, from a negative €7.2 million for the year ended December 31, 2024 to a positive €32.6 million revenue for the year ended December 31, 2025, mainly due to a one‑time revenue recognition impact amounting to €21.8 million, directly attributable to the impact of a contract modification recognized further to the amendment letter executed in March 2025 with Janssen which did not change the scope of the Company’s performance obligations but increased the remaining transaction price of the Global License Agreement.
These new agreements result in a change of the transaction price allocated to the R&D performance obligation, as the Company remains liable for the overall costs of the NANORAY-312 study and rebills few development activities to Janssen.
These new agreements result in a change of the transaction price allocated to the R&D performance obligation, as the Company remained liable for the overall NANORAY-312 study costs resulting in a one-time contract modification and a negative transaction price that must be recognized in its entirety as of December 31, 2024, causing a negative revenue in 2024.
Total Other income 102 Total other income decreased to €4,4 million for the year ended December 31, 2024 compared to €6.2 million and €4,8 million for the years ended December 31, 2023 and 2022, respectively.
Total Other income Total other income decreased to €3.0 million for the year ended December 31, 2025, as compared to €4.4 million and €6.1 million for the years ended December 31, 2024 and 2023, respectively, further to the transfer of the global sponsorship of NANORAY-312 study to Janssen.
Cash Flows from / used in financing activities Our net cash flows used in financing activities was an outflow of €5.1 million for the year ended December 31, 2024 as compared to net cash inflow of €46.8 million for the year ended December 31, 2023.
Cash Flows from / used in financing activities Our net cash flows from financing activities was a net inflow of €37.4 million for the year ended December 31, 2025 as compared to a net cash outflow of €5.1 million for the year ended December 31, 2024. 103 The net cash flows from financing activities significantly increased by €42.6 million between 2025 and 2024, primarily driven by €42.2 million in net proceeds from the Royalty Financing Agreement (as described above).
In comparison, the revenue recognized in 2023 was directly related to the initial signature of the Janssen Agreement, generating license upfront and first development milestone revenue, according to IFRS15 standards application and transaction price allocation rules. There was no revenue (supply or services revenue) recognized for 2022, other than Other Income.
In comparison, the revenue recognized in 2023 was directly related to the initial signature of the Janssen Agreement, generating license upfront and first development milestone revenue, according to IFRS15 standards application and transaction price allocation rules. 90 See Item 5 - Part A Operating Results - ‘Revenue’ section below for additional information, and Refer to Note 16 – Revenues and other income to the financial statements included elsewhere in this Annual Report.
NBTXR3’s characteristics have lead us to investigate its use in several tumor types including: head and neck, lung, pancreatic, esophageal, liver, prostate, soft tissue sarcoma and rectal. We have seen positive signals or evidence of activity and safety in all of these tumor types.
JNJ-1900 (NBTXR3)’s characteristics have lead to investigation of its potential use in several tumor types that include: head and neck, lung, pancreatic, esophageal, liver, prostate, soft tissue sarcoma and rectal cancers.
The additional prepayment condition on the €20.0 million milestone was met further to the global offering equity raise subscribed at the end of 2023 and further to the upfront and milestone received from Janssen between 2023 and 2024, triggering milestone prepayment to the EIB: For the year ended December 31, 2023 and 2024, €0.8 million and €0.2 million were respectively prepaid to the EIB, resulting in an outstanding balance, still due, of €19.2 million and €19.0 million as of December 31, 2023 and 2024, respectively.
For the year ended December 2023 and 2024, €0.8 million and €0.2 million were respectively prepaid to the EIB, resulting in an outstanding balance, still due, of €19.0 million as of December 2024. As of December 31, 2025 the milestones prepayment mechanism was amended following the 2025 EIB Agreements signed in October 2025, as described below.
Because this amendment eliminated substantially all of the Company’s funding obligations with respect to NANORAY-312, we anticipate that our cash runway now extends into mid-2026. 110 The Company’s current level of cash and cash equivalents combined with the signature of the aforementioned amendment are expected to be sufficient to meet our projected financial obligations and fund our operations beyond the next twelve months from the date of this Annual Report.
Any of these events could significantly harm our business, financial condition and prospects. However, the Company’s current level of cash and cash equivalents are expected to be sufficient to meet our projected financial obligations and fund our operations beyond the next twelve months from the date of this Annual Report.

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Item 6. [Reserved]

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

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Biggest changeNo incentive stock option may be granted to any person who, at the time of grant, owns or is deemed to own shares representing more than 10% of our total combined voting power or that of any of our affiliates unless (1) the exercise price is at least 110% of the fair market value of the shares subject to the employee stock option on the date of grant and (2) the term of the incentive stock option does not exceed five years from the date of grant. 125 As of December 31, 2024, the following types of stock options that we have issued are outstanding: Grant OSA 2016-1 P (1) OSA 2016-2 (2) OSA 2017 O (3) OSA 2018 (4) OSA 2019-1 (5) OSA LLY 2019 (6) OSA 2020 (7) OSA 2021-04 O (8) OSA 2021-04 P (9) OSA 2021-06 P (10) OSA 2021-06 O (11) OSA 2022-06 P (12) OSA 2022-06 O (13) OSA 2023-01 O (14) OSA 2024-01 O (15) Date of the shareholders meeting June 25, 2015 June 23, 2016 June 23, 2016 June 14, 2017 May 23, 2018 April 11, 2019 April 11, 2019 November 30, 2020 November 30, 2020 November 30, 2020 April 28, 2021 April 28, 2021 April 28, 2021 June 27, 2023 May 23, 2024 Grant date February 2, 2016 November 3, 2016 January 7, 2017 March 6, 2018 March 29, 2019 October 24, 2019 March 11, 2020 April 20, 2021 April 20, 2021 June 21, 2021 June 21, 2021 June 22, 2022 June 22, 2022 July 20, 2023 May 23, 2024 Total number of stock options authorized 450,000 450,000 450,000 526,800 648,000 500,000 500,000 850,000 1,000,000 1,000,000 850,000 1,000,000 850,000 1,700,000 1,700,000 Total number of stock options granted 6,400 4,000 3,500 62,000 37,500 500,000 407,972 143,200 428,000 60,000 60,000 170,400 410,500 338,860 1,224,780 Starting date of the exercise of the stock options February 2, 2017 November 3, 2017 January 8, 2018 March 7, 2019 March 30, 2021 October 24, 2019 March 11, 2021 April 20, 2022 April 20, 2022 June 21, 2022 June 21, 2022 June 22, 2023 June 22, 2023 July 20, 2023 May 23, 2024 Stock options expiry date (16) February 2, 2026 November 3, 2026 January 7, 2027 March 6, 2028 March 29, 2029 October 24, 2029 March 11, 2030 April 20, 2031 April 20, 2031 June 21, 2031 June 21, 2031 June 22, 2032 June 22, 2032 July 20, 2033 May 23, 2034 Exercise price per stock option €13.05 €14.26 €14.97 €12.87 €11.08 €6.41 €6.25 €13.74 €13.74 €12.99 €12.99 €4.16 €4.16 €5.00 €5.81 Number of shares subscribed as of December 31, 2024 — — — — — — — — — — — — — — — Total number of stock options lapsed or cancelled as of December 31, 2024 6,000 — 3,000 12,000 12,750 — 39,265 104,668 82,400 — — 37,320 24,167 20,000 3,240 Total number of stock options outstanding as of December 31, 2024 400 4,000 500 50,000 24,750 500,000 368,707 38,532 345,600 60,000 60,000 133,080 386,333 318,860 1,221,540 Maximum number of shares available for subscription as of December 31, 2024 400 4,000 500 50,000 24,750 — 368,707 38,532 — — 60,000 — 286,750 106,288 — Maximum total number of shares that can be issued 400 4,000 500 50,000 24,750 500,000 368,707 38,532 345,600 60,000 60,000 133,080 386,333 318,860 1,221,540 126 (1) All of the outstanding OSA 2016-1 Performance may be exercised (2) All of the outstanding OSA 2016-2 may be exercised.
Biggest changeNo incentive stock option may be granted to any person who, at the time of grant, owns or is deemed to own shares representing more than 10% of our total combined voting power or that of any of our affiliates unless (1) the exercise price is at least 110% of the fair market value of the shares subject to the employee stock option on the date of grant and (2) the term of the incentive stock option does not exceed five years from the date of grant. 118 As of December 31, 2025, the following types of stock options that we have issued are outstanding: Grant OSA 2016-1 P (1) OSA 2016-2 (2) OSA 2017 O (3) OSA 2018 (4) OSA 2019-1 (5) OSA LLY 2019 (6) OSA 2020 (7) OSA 2021-04 O (8) Date of the shareholders meeting June 25, 2015 June 23, 2016 June 23, 2016 June 14, 2017 May 23, 2018 April 11, 2019 April 11, 2019 November 30, 2020 Grant date February 2, 2016 November 3, 2016 January 7, 2017 March 6, 2018 March 29, 2019 October 24, 2019 March 11, 2020 April 20, 2021 Total number of stock options authorized 450,000 450,000 450,000 526,800 648,000 500,000 500,000 850,000 Total number of stock options granted 6,400 4,000 3,500 62,000 37,500 500,000 407,972 143,200 Starting date of the exercise of the stock options February 2, 2017 November 3, 2017 January 8, 2018 March 7, 2019 March 30, 2021 October 24, 2019 March 11, 2021 April 20, 2022 Stock options expiry date (18) February 2, 2026 November 3, 2026 January 7, 2027 March 6, 2028 March 29, 2029 October 24, 2029 March 11, 2030 April 20, 2031 Exercise price per stock option €13.05 €14.26 €14.97 €12.87 €11.08 €6.41 €6.25 €13.74 Number of shares subscribed as of December 31, 2025 — — — — — — 53,900 — Total number of stock options lapsed or cancelled as of December 31, 2025 6,000 — 3,000 12,000 12,750 — 47,265 104,668 Total number of stock options outstanding as of December 31, 2025 400 4,000 500 50,000 24,750 500,000 306,807 38,532 Maximum number of shares available for subscription as of December 31, 2025 400 4,000 500 50,000 24,750 50,000 306,807 38,532 Maximum total number of shares that can be issued 400 4,000 500 50,000 24,750 500,000 306,807 38,532 119 Grant OSA 2021-04 P (9) OSA 2021-06 P (10) OSA 2021-06 O (11) OSA 2022-06 P (12) OSA 2022-06 O (13) OSA 2023-01 O (14) OSA 2024-01 O (15) OSA 2025-01 O (16) OSA 2025-02 O (17) Date of the shareholders meeting November 30, 2020 November 30, 2020 April 28, 2021 April 28, 2021 April 28, 2021 June 27, 2023 May 23, 2024 May 28, 2024 February 18, 2025 Grant date April 20, 2021 June 21, 2021 June 21, 2021 June 22, 2022 June 22, 2022 July 20, 2023 May 23, 2024 February 18, 2025 May 16, 2025 Total number of stock options authorized 1,000,000 1,000,000 850,000 1,000,000 850,000 1,700,000 1,700,000 1,300,000 1,300,000 Total number of stock options granted 428,000 60,000 60,000 170,400 410,500 338,860 1,224,780 8,000 1,241,005 Starting date of the exercise of the stock options April 20, 2022 June 21, 2022 June 21, 2022 June 22, 2023 June 22, 2023 July 20, 2023 May 23, 2024 February 18, 2025 May 16, 2025 Stock options expiry date (18) April 20, 2031 June 21, 2031 June 21, 2031 June 22, 2032 June 22, 2032 July 20, 2033 May 23, 2034 February 18, 2035 May 16, 2026 Exercise price per stock option €13.74 €12.99 €12.99 €4.16 €4.16 €5.00 €5.81 3.36 € 2.97 € Number of shares subscribed as of December 31, 2025 — — — 510 17,734 — 25,286 — 100 Total number of stock options lapsed or cancelled as of December 31, 2025 87,400 — — 46,700 30,500 20,000 5,350 — 1 Total number of stock options outstanding as of December 31, 2025 340,600 60,000 60,000 123,190 362,266 318,860 1,194,144 8,000 1,240,904 Maximum number of shares available for subscription as of December 31, 2025 34,060 6,000 60,000 30,319 362,266 106,287 398,048 — — Maximum total number of shares that can be issued 340,600 60,000 60,000 123,190 362,366 318,860 1,194,144 8,000 1,240,904 120 (1) All of the outstanding OSA 2016-1 Performance may be exercised (2) All of the outstanding OSA 2016-2 may be exercised.
The definitive acquisition of the free shares is conditional on the beneficiaries' presence in the Group at the end of the vesting period.The satisfaction of these conditions was acknowledged by the Executive Board February 9, 2024.
The definitive acquisition of the free shares is conditional on the beneficiaries' presence in the Group at the end of the vesting period.The satisfaction of these conditions was acknowledged by the Executive Board February 9, 2024.
Companies Anat has nurtured and on whose boards she has served include 89bio (Nasdaq: ETNB), currently running two cardiometabolic Phase 3 trials, where she led the creation of the company as a pharma spinout and was instrumental in driving a public offering 18 months later, subsequently continuing to serve on the board and several committees; Azura Ophthalmics, in Phase 3 with a drug for Meibomian Gland Disorder which is the root cause behind most dry eye disease; ForSight Vision 6, running a pivotal trial with a truly Accommodating Intraocular Lens under a strategic alliance; TytoCare, a growth-stage company commercializing the Home Smart Clinic; and MDClone, commercializing a synthetic data and analytics platform.
Companies Anat has nurtured and on whose boards she has served include 89bio (Nasdaq: ETNB), currently running two cardiometabolic Phase 3 trials, where she led the creation of the company as a pharma spinout and was instrumental in driving a public offering 18 months later, subsequently continuing to serve on the board and several 108 committees; Azura Ophthalmics, in Phase 3 with a drug for Meibomian Gland Disorder which is the root cause behind most dry eye disease; ForSight Vision 6, running a pivotal trial with a truly Accommodating Intraocular Lens under a strategic alliance; TytoCare, a growth-stage company commercializing the Home Smart Clinic; and MDClone, commercializing a synthetic data and analytics platform.
The committee makes recommendations on the amount and structure of Executive Board member compensation, taking into account strategy, objectives, outcomes, and general market practice, and ◦ the free share and stock option plans, as well as any similar equity incentive instrument and in particular, the allocation to members of the Executive Board, ▪ making recommendations to the Supervisory Board regarding compensation, including equity-based compensation and expense reimbursement, for the members of the Supervisory Board, taking into account corporate goals and objectives and performance of Supervisory Board members in light of such goals and objectives; ▪ preparing and presenting the reports provided for in the Supervisory Board internal rules of procedure (règlement intérieur); ▪ making any other recommendation that might be requested by the Supervisory Board regarding compensation; and ▪ generally advising the Supervisory Board and making recommendations with respect to all of the areas above.
The committee 127 makes recommendations on the amount and structure of Executive Board member compensation, taking into account strategy, objectives, outcomes, and general market practice, and ◦ the free share and stock option plans, as well as any similar equity incentive instrument and in particular, the allocation to members of the Executive Board, ▪ making recommendations to the Supervisory Board regarding compensation, including equity-based compensation and expense reimbursement, for the members of the Supervisory Board, taking into account corporate goals and objectives and performance of Supervisory Board members in light of such goals and objectives; ▪ preparing and presenting the reports provided for in the Supervisory Board internal rules of procedure (règlement intérieur); ▪ making any other recommendation that might be requested by the Supervisory Board regarding compensation; and ▪ generally advising the Supervisory Board and making recommendations with respect to all of the areas above.
(4) See also “—Free Shares (AGA)—Vesting” and “—Free Shares (AGA)—Change In Control.” Compensation recovery policy In October 2022, the SEC adopted rules, pursuant to Rule 10D-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requiring national securities exchanges and national securities associations, such as Nasdaq, to amend their relevant listing standards no later than November 28, 2023 to require listed companies to adopt a written compensation recovery (clawback) policy providing for the recovery, in the event of a required accounting restatement, of incentive-based compensation received by the Chief Executive Officer and certain other “executive officers” as defined in Rule 10D-1(d) under the Exchange Act that is wholly or partially contingent on the attainment of financial performance criteria based on reported financial information that has been determined to be erroneous and has required restatement of the financial statements for accounting purposes.
(3) See also “—Free Shares (AGA)—Vesting” and “—Free Shares (AGA)—Change In Control.” Compensation recovery policy In October 2022, the SEC adopted rules, pursuant to Rule 10D-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requiring national securities exchanges and national securities associations, such as Nasdaq, to amend their relevant listing standards no later than November 28, 2023 to require listed companies to adopt a written compensation recovery (clawback) policy providing for the recovery, in the event of a required accounting restatement, of incentive-based compensation received by the Chief Executive Officer and certain other “executive officers” as defined in Rule 10D-1(d) under the Exchange Act that is wholly or partially contingent on the attainment of financial performance criteria based on reported financial information that has been determined to be erroneous and has required restatement of the financial statements for accounting purposes.
Anat Naschitz is a life science investor and entrepreneur, with over three decades of experience across biotech, pharmaceuticals, computational R&D, digital health and medical devices, in multiple therapy areas and stages. Throughout her career Ms. Naschitz has founded companies and nurtured them through success with public 115 and private board involvement and investment.
Anat Naschitz is a life science investor and entrepreneur, with over three decades of experience across biotech, pharmaceuticals, computational R&D, digital health and medical devices, in multiple therapy areas and stages. Throughout her career Ms. Naschitz has founded companies and nurtured them through success with public and private board involvement and investment.
The supervisory board then divides all or part (at the supervisory board’s discretion) of this aggregate amount among some or all of its members by a simple majority vote. In addition, the supervisory board may grant exceptional compensation (rémunérations exceptionnelles) to individual members on a case-by-case basis for special and temporary assignments.
The supervisory board then divides all or part (at the supervisory board’s discretion) of this aggregate amount among some or all of its members by a simple majority vote. In addition, the supervisory board may grant exceptional compensation (rémunérations 110 exceptionnelles) to individual members on a case-by-case basis for special and temporary assignments.
Phillips earned a Bachelor’s degree in Biochemistry ( summa cum laude) from the University of Pennsylvania’s College of Arts and Sciences, an MBA from the Wharton School, and an MD with Alpha Omega Alpha distinction from the University of Pennsylvania 114 School of Medicine. He holds an active medical license and served as a clinician/general medical officer in the U.S.
Phillips earned a Bachelor’s degree in Biochemistry ( summa cum laude) from the University of Pennsylvania’s College of Arts and Sciences, an MBA from the Wharton School, and an MD with Alpha Omega Alpha distinction from the University of Pennsylvania School of Medicine. He holds an active medical license and served as a clinician/general medical officer in the U.S.
(5) All outstanding BSAs may be exercised, provided that, on the day the BSA is exercised, (i) the relevant holder has attended at least 75% of the Supervisory Board meetings held during the 12-months preceding the exercise of the warrants or, as the case may be, the date the holder ceases to be part of the Group, and (ii) the recommended dose for two out of the three patient cohorts enrolled in Study 1100 has been determined in order to define the next steps of the immuno-oncology development plan, it being specified that (i) the Executive Board, with the prior approval of the Supervisory Board, shall acknowledge the satisfaction of such condition and (ii) such condition shall automatically be waived in the event of a change of control.
(4) All outstanding BSAs may be exercised, provided that, on the day the BSA is exercised, (i) the relevant holder has attended at least 75% of the Supervisory Board meetings held during the 12-months preceding the exercise of the warrants or, as the case may be, the date the holder ceases to be part of the Group, and (ii) the recommended dose for two out of the three patient cohorts enrolled in Study 1100 has been determined in order to define the next steps of the immuno-oncology development plan, it being specified that (i) the Executive Board, with the prior approval of the Supervisory Board, shall acknowledge the satisfaction of such condition and (ii) such condition shall automatically be waived in the event of a change of control.
Under French law, the audit committee may only have an advisory role and the appointment of our statutory auditors, in particular, must be approved by our shareholders at our annual meeting. Therefore, in accordance with Rule 10A-3, our audit committee only has an advisory role with respect to the aforementioned responsibilities.
Under French law, the audit committee may only have an advisory role and the appointment of our statutory auditors, in particular, must be approved by our shareholders at our annual meeting. Therefore, in accordance with Rule 125 10A-3, our audit committee only has an advisory role with respect to the aforementioned responsibilities.
Van Rhijn is entitled to an annual base salary of $390,668 in 2022 (and variable compensation in an amount up to 50%), $438,000 in 2023 (and variable compensation in an amount up to 40%) and $455,000 in 2024 (and variable compensation in an amount based on 45% of the annual base salary), depending on the achievement of specified performance objectives.
Van Rhijn is entitled to an annual base salary of $390,668 in 2022 (and variable compensation in an amount up to 50%), $438,000 in 2023 (and variable compensation in an amount up to 40%) $455,000 in 2024 and 2025 (and variable compensation in an amount based on 45% of the annual base salary), depending on the achievement of specified performance objectives.
Stock options may be granted to any individual employed by us or our subsidiaries. Stock options may also be granted to the members of our executive board. Incentive stock options may not be granted to holders of 10% or more of our share capital. Administration 124 Our executive board has the authority to administer and interpret the Stock Option Plans.
Stock options may be granted to any individual employed by us or our subsidiaries. Stock options may also be granted to the members of our executive board. Incentive stock options may not be granted to holders of 10% or more of our share capital. Administration Our executive board has the authority to administer and interpret the Stock Option Plans.
Subject to the terms and conditions of the Stock Option Plans, our executive board, with the prior approval of the supervisory board, determines the recipients, grant dates, exercise prices, number of ordinary shares underlying and the terms and conditions of the stock options, including their periods of exercisability and their vesting schedules.
Subject to the terms and conditions of the Stock Option Plans, our executive board, with the prior approval of the supervisory board, 117 determines the recipients, grant dates, exercise prices, number of ordinary shares underlying and the terms and conditions of the stock options, including their periods of exercisability and their vesting schedules.
Anne-Juliette Hermant. Ms. Hermant was entitled to an annual base salary of €210,000 in 2022 and 2023 (and variable compensation in an amount based on 50%), €260,000 in 2024 and variable compensation in an amount based on 45% of the annual base salary, depending on the achievement of specified performance objectives.
Anne-Juliette Hermant. Ms. Hermant was entitled to an annual base salary of €210,000 in 2022 and 2023 (and variable compensation in an amount based on 50%), €260,000 in 2024 and 2025 and variable compensation in an amount based on 45% of the annual base salary, depending on the achievement of specified performance objectives.
Similar to stock options, founders’ warrants entitle a holder to exercise the warrant for the underlying vested shares at an exercise price per share determined by our executive board and at least equal to the fair market value of an ordinary share on the date of grant. 121 Administration Our shareholders, or pursuant to delegations granted by our shareholders, our executive board, determine, with prior approval of the supervisory board, the recipients of the founders’ warrants, the grant dates, the number and exercise price of the founders’ warrants to be granted, the number of shares issuable upon exercise of the founders’ warrants and certain other terms and conditions of the founders’ warrants, including the period of their exercisability and their vesting schedule.
Similar to stock options, founders’ warrants entitle a holder to exercise the warrant for the underlying vested shares at an exercise price per share determined by our executive board and at least equal to the fair market value of an ordinary share on the date of grant. 114 Administration Our shareholders, or pursuant to delegations granted by our shareholders, our executive board, determine, with prior approval of the supervisory board, the recipients of the founders’ warrants, the grant dates, the number and exercise price of the founders’ warrants to be granted, the number of shares issuable upon exercise of the founders’ warrants and certain other terms and conditions of the founders’ warrants, including the period of their exercisability and their vesting schedule.
Anne-Juliette Hermant Member 2019 2028 Mr. Louis Kayitalire Member 2024 2028 Supervisory Board The members of the supervisory board exercise control over the management of the executive board. The supervisory board operates pursuant to a separate charter adopted by its members on March 18, 2019.
Anne-Juliette Hermant Member 2019 2028 Mr. Louis Kayitalire Member 2024 2028 123 Supervisory Board The members of the supervisory board exercise control over the management of the executive board. The supervisory board operates pursuant to a separate charter adopted by its members on March 18, 2019.
Louis Kayitalire. Mr. Kayitalire is entitled to an annual base salary of €400,000 in 2023 (and variable compensation in an amount based on 50%) and €415,000 in 2024, and variable compensation in an amount based on 45% of the annual base salary, depending on the achievement of specified performance objectives.
Louis Kayitalire. Mr. Kayitalire is entitled to an annual base salary of €400,000 in 2023 (and variable compensation in an amount based on 50%) and €415,000 in 2024 and 2025, and variable compensation in an amount based on 45% of the annual base salary, depending on the achievement of specified performance objectives.
(3) The AGA 2023 P2 granted to members of the executive board or employees are conditioned upon the achievement of the conditions below in the next 24 months upon attribution: • Closing of a collaboration/development deal with the pharmaceutical partner mentioned in the press release of the Company issued on May 5, 2023; and • The achievement of one of the two following events: o the dosing of the 50th patient in the NANORAY-312 study; or o the start by such pharmaceutical partner of a clinical trial in one indication.
(2) The AGA 2023 P2 granted to members of the executive board or employees are conditioned upon the achievement of the conditions below in the next 24 months upon attribution: • Closing of a collaboration/development deal with the pharmaceutical partner mentioned in the press release of the Company issued on May 5, 2023; and • The achievement of one of the two following events: o the dosing of the 50th patient in the NANORAY-312 study; or o the start by such pharmaceutical partner of a clinical trial in one indication.
His research at the frontier of biotechnology and nanotechnologies has resulted in the development of a number of concrete applications such as NBTXR3 23 , which could open a new method for cancer treatment.
His research at the frontier of biotechnology and nanotechnologies has resulted in the development of a number of concrete applications such as NBTXR3, which could open a new method for cancer treatment.
Board Practices Board Structure Our two-tier board structure consists of an executive board and a supervisory board. The roles and functions of each board and the interactions between them are described below. 129 Executive Board We are managed by an executive board under the control of a supervisory board.
Board Practices Board Structure Our two-tier board structure consists of an executive board and a supervisory board. The roles and functions of each board and the interactions between them are described below. Executive Board We are managed by an executive board under the control of a supervisory board.
Navy, honorably discharged as a Lieutenant Commander. He currently serves as a non-executive board member of Aldeyra Therapeutics, Oryn Therapeutics, and Rheon Medical SA as well as Board Chair of BioConnection BV. Ms.
Navy, honorably discharged as a Lieutenant Commander. He currently serves as a non-executive board member of Aldeyra Therapeutics, Oryn Therapeutics, and Rheon Medical SA as well as Board Chair of BioConnection BV. 107 Ms.
Hermant and us under the conditions 119 provided for by regulation and the collective labor agreement applicable to the employee, and subject to a three-month prior notice. As Executive Board member, Ms.
Hermant and us under the conditions provided for by regulation and the collective labor agreement applicable to the employee, and subject to a three-month prior notice. As Executive Board member, Ms.
Our executive board has also previously adopted the 2022 Stock Option, the 2021 Stock Option Plan, 2020 Stock Option Plan, the 2019 Stock Option Plan, the LLY 2019 Plan, the 2018 Stock Option Plan, the 2017 Stock Option Plan and the 2016 Stock Option Plan (collectively, the “Former Plans” and together with the 2023 Plan, the “Stock Option Plans”).
Our executive board has also previously adopted the 2023 Stock Option, 2022 Stock Option, the 2021 Stock Option Plan, 2020 Stock Option Plan, the 2019 Stock Option Plan, the LLY 2019 Plan, the 2018 Stock Option Plan, the 2017 Stock Option Plan and the 2016 Stock Option Plan (collectively, the “Former Plans” and together with the 2025 Plan, the “Stock Option Plans”).
Further, the agreement provides for an exclusivity undertaking during the term of the agreement, and a confidentiality undertaking for the term of the agreement and 10 years thereafter. This employment agreement may be terminated by both Ms.
Further, the agreement provides for an exclusivity undertaking during the term of the agreement, and a confidentiality undertaking for the 112 term of the agreement and 10 years thereafter. This employment agreement may be terminated by both Ms.
Any warrant not exercised for any reason on or prior to the date of completion of the relevant Liquidity Event will automatically lapse after this date. 123 The terms of these warrants provide their holder with the right to exercise all of his or her warrants in the event of a change of control (i.e., through a merger, a transfer of shares or assets, an operation on share capital or liquidation).
Any warrant not exercised for any reason on or prior to the date of completion of the relevant Liquidity Event will automatically lapse after this date. 116 The terms of these warrants provide their holder with the right to exercise all of his or her warrants in the event of a change of control (i.e., through a merger, a transfer of shares or assets, an operation on share capital or liquidation).
The 117 supervisory board may also authorize the reimbursement of reasonable travel and accommodation expenses, as well as other expenses incurred by its members in the corporate interest.
The supervisory board may also authorize the reimbursement of reasonable travel and accommodation expenses, as well as other expenses incurred by its members in the corporate interest.
Herrera has also served as a Hematologist Consultant at Antoine Beclere Hospital until 2019. Mr. Enno Spillner has served as a Supervisory Board member and chairman of the audit committee since 2014. He has 25 years of experience in the life science industry and currently serves as Chief Financial Officer and Member of the Executive Board at Formycon AG.
Herrera has also served as a Hematologist Consultant at Antoine Beclere Hospital until 2019. Mr. Enno Spillner has served as a Supervisory Board member and chairman of the audit committee since 2014. He has 27 years of experience in the life science industry and currently serves as Chief Financial Officer and Member of the Executive Board at Formycon AG.
The following table sets forth information regarding the compensation earned by our supervisory board members and our supervisory board observer for service on our supervisory board during the year ended December 31, 2024. Name Fees earned (€) Additional fees earned (€) Equity Incentives (€) Total (€) Dr. Gary Phillips 75,000 37,500 — 112,500 Ms.
The following table sets forth information regarding the compensation earned by our supervisory board members and our supervisory board observer for service on our supervisory board during the year ended December 31, 2025. Name Fees earned (€) Additional fees earned (€) Equity Incentives (€) Total (€) Dr. Gary Phillips 75,000 37,500 — 112,500 Ms.
The appointments and compensation committee shall be comprised of at least two members from and appointed by the Supervisory Board. No member of the appointments and compensation committee may be a person exercising any management function within the Company and its subsidiaries. Currently, the appointments and compensation committee is comprised of three members: Anne-Marie Graffin (chairman and independent member), Dr.
The appointments and compensation committee shall be comprised of at least two members from and appointed by the Supervisory Board. No member of the appointments and compensation committee may be a person exercising any management function within the Company and its subsidiaries. Currently, the appointments and compensation committee is comprised of four members: Anne-Marie Graffin (chairman and independent member), Dr.
The duties specifically assigned to the audit committee by the Supervisory Board include, but are not limited to: ▪ monitoring the financial reporting process; ▪ monitoring the effectiveness of internal control and risk management systems; ▪ monitoring the legal audit of the annual and consolidated accounts of the statutory auditors; ▪ making recommendations regarding the selection of the Company’s statutory auditors to be appointed by its shareholders, determining their compensation and ensuring their independence; ▪ making recommendations regarding the selection of any accounting firm, other than the Company’s statutory auditors, to be appointed for non-audit services; ▪ examining the Company’s procedures for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls or auditing matters, as well as for the confidential, anonymous submissions by its employees of concerns regarding questionable accounting or auditing matters; and ▪ generally advising the Supervisory Board and making recommendations with respect to all of the areas above.
The duties specifically assigned to the audit committee by the Supervisory Board include, but are not limited to: 126 ▪ monitoring the financial reporting process; ▪ monitoring the effectiveness of internal control and risk management systems; ▪ monitoring the audit of the annual consolidated accounts and the audit of the Company’s Internal Control Over Financial Reporting (ICOFR) performed by the statutory auditors; ▪ making recommendations regarding the selection of the Company’s statutory auditors to be appointed by its shareholders, determining their compensation and ensuring their independence; ▪ making recommendations regarding the selection of any accounting firm, other than the Company’s statutory auditors, to be appointed for non-audit services; ▪ examining the Company’s procedures for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls or auditing matters, as well as for the confidential, anonymous submissions by its employees of concerns regarding questionable accounting or auditing matters; and ▪ generally advising the Supervisory Board and making recommendations with respect to all of the areas above.
Members of our supervisory board are elected, re-elected and may be removed, with or without cause, at a shareholders general meeting with a simple majority vote of our shareholders. Pursuant to our By-laws, the members of our supervisory board are elected for six-year terms.
Members of our supervisory board are elected, re-elected and may be removed, with or without cause, at a shareholders general meeting with a simple majority vote of our shareholders. Pursuant to our By-laws, the members of our supervisory board are elected for four-year terms.
Upon the Appointments and Compensation Committee’s and according to the 2024 compensation policy applicable to the mechanism relating to bonus with regard to the assessment of their respective performance, the final performance evaluation rated by the Appointments and Compensation Committee and validated by the Supervisory Board has been for (1) Laurent Levy to 100%, (2) Bart Van Rhijn to 95%, (3) Anne-Juliette Hermant to 100% and (4) Louis Kayitalire to 100%.
Upon the Appointments and Compensation Committee’s and according to the 2024 compensation policy applicable to the mechanism relating to bonus with regard to the assessment of their respective performance, the final performance evaluation rated by the Appointments and Compensation Committee and validated by the Supervisory Board has been for (1) Laurent Levy to 110%, (2) Bart Van Rhijn to 90%, (3) Anne-Juliette Hermant to 110% and (4) Louis Kayitalire to 100%.
(3) All of the BSAs may be exercised, provided that on the day the BSA is exercised, the market value of a Nanobiotix share shall be at least equal to €50. (4) All BSAs may be exercised, provided that on the day the BSA is exercised, the market value of a Nanobiotix share shall be at least equal to €40.
(2) All of the BSAs may be exercised, provided that on the day the BSA is exercised, the market value of a Nanobiotix share shall be at least equal to €50. (3) All BSAs may be exercised, provided that on the day the BSA is exercised, the market value of a Nanobiotix share shall be at least equal to €40.
Under French law, an audit committee may have only two members, whereas Nasdaq listing standards require a three-member audit committee. We currently have only two members on our audit committee in accordance with French law. French law does not require our independent directors to hold regularly scheduled meetings at which only independent directors are present.
Under French law, an audit committee may have only two members, whereas Nasdaq listing standards require a three-member audit committee. We currently have three members on our audit committee. French law does not require our independent directors to hold regularly scheduled meetings at which only independent directors are present.
From September 2005 to March 2013 he acted as Chief Financial Officer of 4SC AG. Enno Spillner started his life science industry career as Head of Finance and Managing Partner of the Munich-based biotech venture fund, BioM AG. He was also Managing Director of two portfolio companies, ACTIPAC Biosystems GmbH and Munich innovative Biomaterials GmbH.
From September 2005 to March 2013 he acted as Chief Financial Officer of 4SC AG. Enno Spillner started his life science industry career as Head of Finance and Managing Partner of the Munich-based biotech venture fund, BioM AG. In addition, he became also Managing Director of two portfolio companies, ACTIPAC Biosystems GmbH and Munich innovative Biomaterials GmbH.
The shareholders’ general meeting held on May 28, 2024 set such compensation to an annual aggregate amount of up to €431,250 for the 2024 financial year and for each subsequent financial year, until a decision to the contrary is made by the shareholders of the Company at any further annual shareholders' meeting, as it might be the case in the 2025 annual shareholders’ meeting.
The shareholders’ general meeting held on May 19, 2025 set such compensation to an annual aggregate amount of up to €431,250 for the 2025 financial year and for each subsequent financial year, until a decision to the contrary is made by the shareholders of the Company at any further annual shareholders' meeting, as it might be the case in the 2026 annual shareholders’ meeting.
(7) All of the outstanding OSA 2020 may be exercised, subject to the ongoing presence of the beneficiary within the Group.The satisfaction of this performance condition was acknowledged by the Executive Board, with the approval of the Supervisory Board, on March 17, 2021.
(7) All of the outstanding OSA 2020 may be exercised, subject to the ongoing presence of the beneficiary within the Group.The satisfaction of this performance condition was acknowledged by the Executive Board, with the approval of the Supervisory Board, on March 17, 2021. (8) All of the outstanding OSA 2021-04 O may be exercised.
In addition, any appointment made in violation of the gender equality rule described above that is not remedied within six months of such appointment, will be null and void. We currently have four members of the supervisory board and two observers.
In addition, any appointment made in violation of the gender equality rule described above that is not remedied within six months of such appointment, will be null and void. We currently have six members of the supervisory board.
As of December 31, 2024, the following types of warrants that we have issued are outstanding: Grant BSA 2014 (1) BSA 2015-1 (2) BSA 2015-2(a) (3) BSA 2018-2 (4) BSA 2019-1 (2) BSA 2020 (2) BSA 2021(a) (5) Date of the shareholders meeting June 18, 2014 June 18, 2014 June 18, 2014 May 23, 2018 May 23, 2018 April 11, 2019 November 30, 2020 Grant date September 16, 2014 February 10, 2015 June 25, 2015 July 27, 2018 March 29, 2019 March 17, 2020 April 20, 2021 Total number of BSA authorized 100,000 100,000 100,000 140,000 140,000 500,000 650,000 Total number of BSA granted 14,000 26,000 64,000 5,820 18,000 18,000 48,103 Starting date of the exercise of the BSA September 16, 2014 February 10, 2015 June 25, 2015 July 27, 2018 March 29, 2019 March 17, 2020 April 20, 2021 BSA expiry date (6) September 16, 2024 February 10, 2025 June 25, 2025 July 27, 2028 March 29, 2029 March 17, 2030 April 20, 2031 Exercise price per BSA €17.67 €17.67 €19.54 €16.10 €11.66 €6.59 €13.47 Number of shares subscribed as of December 31, 2024 — — — — — — — Total number of forfeited or cancelled BSAs as of December 31, 2024 14,000 5,000 — — — — 33,672 Total number of BSAs outstanding as of December 31, 2024 — 21,000 64,000 5,820 18,000 18,000 14,431 Total number of shares available for subscription as of December 31, 2024 — — — — — — 14,431 Maximum total number of shares that can be issued — 21,000 64,000 5,820 18,000 18,000 14,431 (1) All of the BSAs may be exercised, provided that, on the day the BSA is exercised, the relevant holder, when a Supervisory Board member, has attended at least 75% of the Supervisory Board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the holder ceases to be part of the Group.
As of December 31, 2025, the following types of warrants that we have issued are outstanding: Grant BSA 2015-1 (1) BSA 2015-2(a) (2) BSA 2018-2 (3) BSA 2019-1 (3) BSA 2020 (3) BSA 2021(a) (4) Date of the shareholders meeting June 18, 2014 June 18, 2014 May 23, 2018 May 23, 2018 April 11, 2019 November 30, 2020 Grant date February 10, 2015 June 25, 2015 July 27, 2018 March 29, 2019 March 17, 2020 April 20, 2021 Total number of BSA authorized 100,000 100,000 140,000 140,000 500,000 650,000 Total number of BSA granted 26,000 64,000 5,820 18,000 18,000 48,103 Starting date of the exercise of the BSA February 10, 2015 June 25, 2015 July 27, 2018 March 29, 2019 March 17, 2020 April 20, 2021 BSA expiry date (5) February 10, 2025 June 25, 2025 July 27, 2028 March 29, 2029 March 17, 2030 April 20, 2031 Exercise price per BSA €17.67 €19.54 €16.10 €11.66 €6.59 €13.47 Number of shares subscribed as of December 31, 2025 — — — — — — Total number of forfeited or cancelled BSAs as of December 31, 2025 26,000 64,000 — — — 33,672 Total number of BSAs outstanding as of December 31, 2025 — — 5,820 18,000 18,000 14,431 Total number of shares available for subscription as of December 31, 2025 — — — — — 14,431 Maximum total number of shares that can be issued — — 5,820 18,000 18,000 14,431 (1) All of the BSAs may be exercised, provided that, on the day the BSA is exercised, (i) the relevant holder, when a Supervisory Board member, has attended at least 75% of the Supervisory Board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the holder ceases to be part of the Group (ii) the market value of a Nanobiotix share shall be at least equal to €40.
We currently have two members on our audit committee in accordance with French law. Currently, the audit committee is comprised of two members: Enno Spillner (chairman and independent member) and Gary Phillips (independent member).
We currently have two members on our audit committee in accordance with French law. Currently, the audit committee is comprised of three members: Enno Spillner (chairman and independent member), Anat Naschitz and Gary Phillips (independent members).
(14) The outstanding OSA 2023-01 Ordinary may be exercised as follows: • up to one-third of the OSA 2023-01 Ordinary as from July 20, 2024; • an additional one-third of the OSA 2023-01 Ordinary as from June 20, 2025; and • the balance, i.e., one-third of the OSA 2023-01 Ordinary as from June 20, 2026, subject to, for each increment, a continued service condition (15) The outstanding OSA 2024-01 Ordinary may be exercised as follows: • up to one-third of the OSA 2024-01 Ordinary as from May 23, 2025; • an additional one-third of the OSA 2024-01 Ordinary as from May 23, 2026; and • the balance, i.e., one-third of the OSA 2024-01 Ordinary as from May 23, 2027, subject to, for each increment, a continued service condition (16) See also “ Stock Options (OSA) Term” and “—Stock Options (OSA)—Change in Control.” 127 Free Shares (AGA) We have granted free shares to our employees, employees of our subsidiaries and members of our executive board pursuant to our free share plans (the “AGA Plans”).
(14) The outstanding OSA 2023-01 Ordinary may be exercised as follows: • up to one-third of the OSA 2023-01 Ordinary as from July 20, 2024; • an additional one-third of the OSA 2023-01 Ordinary as from June 20, 2025; and • the balance, i.e., one-third of the OSA 2023-01 Ordinary as from June 20, 2026, subject to, for each increment, a continued service condition (15) The outstanding OSA 2024-01 Ordinary may be exercised as follows: • up to one-third of the OSA 2024-01 Ordinary as from May 23, 2025; • an additional one-third of the OSA 2024-01 Ordinary as from May 23, 2026; and • the balance, i.e., one-third of the OSA 2024-01 Ordinary as from May 23, 2027, subject to, for each increment, a continued service condition (16) The outstanding OSA 2025-01 Ordinary may be exercised as follows: • up to one-third of the OSA 2025-01 Ordinary as from February 18, 2026; • an additional one-third of the OSA 2025-01 Ordinary as from February 18, 2027; and • the balance, i.e., one-third of the OSA 2025-01 Ordinary as from February 18, 2028, subject to, for each increment, a continued service condition (17) The outstanding OSA 2025-02 Ordinary may be exercised as follows: • up to one-third of the OSA 2025-02 Ordinary as from May 16, 2026; • an additional one-third of the OSA 2025-012Ordinary as from May 16, 2027; and • the balance, i.e., one-third of the OSA 2025-02 Ordinary as from May 16, 2028, subject to, for each increment, a continued service condition (18) See also “ Stock Options (OSA) Term” and “—Stock Options (OSA)—Change in Control.” 121 Free Shares (AGA) We have granted free shares to our employees, employees of our subsidiaries and members of our executive board pursuant to our free share plans (the “AGA Plans”).
Furthermore, the Supervisory Board has established the performance of the Company objectives to 100%. Therefore, the Supervisory Board has decided to submit to the approval of shareholders at the 2025 annual general assembly a final variable remuneration for Laurent Lévy, Bart Van Rhijn, Anne-Juliette Hermant and Louis Kayitalire for 2024 of, respectively 100%, 95%, 100% and 100% of their bonus.
Furthermore, the Supervisory Board has established the performance of the Company objectives to 120%. Therefore, the Supervisory Board has decided to submit to the approval of shareholders at the 2025 annual general assembly a final variable remuneration for Laurent Lévy, Bart Van Rhijn, Anne-Juliette Hermant and Louis Kayitalire for 2024 of, respectively 132%, 108%, 132% and 120% of their bonus.
(5) Reflects the valuation of 500,000 stock options granted during the year ended December 31, 2024. (6) Reflects the value of premiums paid for an unemployment insurance policy with the Garantie Sociale des Chefs et Dirigeants d’Entreprise.
(5) Reflects the valuation of 505,000 stock options granted during the year ended December 31, 2025. (6) Reflects the value of premiums paid for an unemployment insurance policy with the Garantie Sociale des Chefs et Dirigeants d’Entreprise.
Currently, she is building 9vc, a novel lifescience fund. Ms. Naschitz co-founded and co-led OrbiMed Israel as part of the ± $17bn global healthcare investment firm and was previously with ± €65bn private equity firm Apax where she invested in healthcare companies.
Currently, she is the Managing Director of 9vc, a novel lifescience fund. Ms. Naschitz co-founded and co-led OrbiMed Israel as part of the ± $20bn global healthcare investment firm and was previously with ± €65bn private equity firm Apax where she invested in healthcare companies.
Laurent Levy, for each of the 2022, 2023 and 2024 fiscal years, at an annual cost of €18,025, and €19,276, and €20,317 respectively. Severance Pay 118 On May 27, 2004 and July 2, 2013, our supervisory board approved terms for severance pay to be awarded to our Chairman of the executive board, Dr. Laurent Levy. The terms provide that Dr.
Laurent Levy, for each of the 2023, 2024 and 2025 fiscal years, at an annual cost of €19,276, and €20,317, and €20,639 respectively. 111 Severance Pay On May 27, 2004 and July 2, 2013, our supervisory board approved terms for severance pay to be awarded to our Chairman of the executive board, Dr. Laurent Levy. The terms provide that Dr.
Pursuant to the “say on pay” regime applicable to companies listed on the regulated market of Euronext in Paris, the payment of compensation (whether fixed, variable or exceptional) attributed for a financial year to any member of the supervisory or executive board is subject to approval at the next ordinary general meeting.
Compensation Compensation of Supervisory Board and Executive Board Members Pursuant to the “say on pay” regime applicable to companies listed on the regulated market of Euronext in Paris, the payment of compensation (whether fixed, variable or exceptional) attributed for a financial year to the Chairman of the Supervisory Board, the Chairman of the Executive Board and any members of the Executive Board is subject to approval at the next ordinary general meeting (ex-post vote).
As of December 31, 2024, founders’ warrants, warrants, employee stock options and free shares were outstanding allowing for the issuance or purchase of an aggregate of 4,936,540 ordinary shares (assuming that such instruments’ vesting conditions are met) at a weighted average exercise price, if any, of €6.43 per ordinary share.
As of December 31, 2025, founders’ warrants, warrants, employee stock options and free shares were outstanding allowing for the issuance or purchase of an aggregate of 4,985,304 ordinary shares (assuming that such instruments’ vesting conditions are met) at a weighted average exercise price, if any, of €6.42 per ordinary share.
Prior to Sanofi-Aventis, he served as Chairman of Chiron Therapeutics Europe, Managing Director at Pierre Fabre Oncology Laboratories and Head of the Oncology Platform at Roger Bellon (Rhône Poulenc). He serves as a non-executive board member of Emercell SAS (Montpellier, Fr), ErVimmune SA (Lyon, Fr), Onward Therapeutics SA (Lausanne, Sw), PDC’Line (Liège, Belgium) and Isofol Medical (Gotenborg, Sweden). Dr.
Prior to Sanofi-Aventis, he served as Chairman of Chiron Therapeutics Europe, Managing Director at Pierre Fabre Oncology Laboratories and Head of the Oncology Platform at Roger Bellon (Rhône Poulenc). He serves as a non-executive board member of Emercell SAS (Montpellier, Fr), ErVimmune SA (Lyon, Fr), Onward Therapeutics Inc. (Taipei, Taiwan) and Isofol Medical (Gotenborg, Sweden). Dr.
Laurent Levy, Ph.D. 53 Chairman of the Executive Board and Co-founder ( Principal Executive Officer ) Mr. Bart Van Rhijn 52 Chief Financial and Business Officer ( Principal Financial Officer ) Ms. Anne-Juliette Hermant 51 Chief People Officer Mr. Louis Kayitalire 67 Chief Medical Officer Supervisory Board Members: Dr. Gary Phillips 59 Chairman Ms. Anne-Marie Graffin 63 Vice Chairwoman Dr.
Laurent Levy, Ph.D. 55 Chairman of the Executive Board and Co-founder ( Principal Executive Officer ) Mr. Bart Van Rhijn 53 Chief Financial and Business Officer ( Principal Financial Officer ) Ms. Anne-Juliette Hermant 52 Chief People Officer Mr. Louis Kayitalire 68 Chief Medical Officer Supervisory Board Members: Dr. Gary Phillips 60 Chairman Ms. Anne-Marie Graffin 64 Vice Chairwoman Dr.
From July 2016 to March 2023, he served as Chief Financial Officer and Member of the Management Board at German biotech company Evotec SE. From March 2013 until June 2016, he served as Chairman of the Management Board, Chief Executive Officer and Chief Financial Officer of 4SC AG.
From July 2016 to March 2023, he served as Chief Financial Officer and Member of the Management Board at NASDAQ listed biotech company Evotec SE (Germany). From March 2013 until June 2016, he served as Chairman of the Management Board, Chief Executive Officer and Chief Financial Officer of Prime Standard listed 4SC AG.
The Supervisory Board has determined that Enno Spillner is an “audit committee financial expert,” as defined by SEC rules and regulations, and that each member qualifies as financially sophisticated under the Nasdaq listing rules. 133 The audit committee met four (4) times during the 2024 financial year.
The Supervisory Board has determined that Enno Spillner is an “audit committee financial expert,” as defined by SEC rules and regulations, and that each member qualifies as financially sophisticated under the Nasdaq listing rules. The audit committee met three (3) times during the 2025 financial year.
For foreign tax residents, if the change in control t occurs before the second anniversary of the grant, on the first anniversary of the grant, it being specified that the relevant free shares will then be subject to a year-long holding period as from their date of acquisition.
For foreign tax residents, if the change in control occurs before the second anniversary of the grant, on the first anniversary of the grant, it being specified that the relevant free shares will then be subject to a year-long holding period as from their date of acquisition. As of December 31, 2025, there are no outstanding free shares.
She is currently a board member of Ipsen, where she chairs the Ethics and Governance Committee and is a member of the Innovation and Development Committee, and is a member of the board and President Emerita, of the International Society for Vaccines. She also serves on the board of MacroGenics and is a member the Science and Technology Committee.
She is currently a board member of Ipsen, where she chairs the Ethics and Governance Committee and is a member of the Innovation and Development Committee, and is a member of the board and President Emerita, of the International Society for Vaccines.
As of December 31, 2024, the following types of founders’ warrants that we have issued are outstanding: 122 Grant BSPCE 09-2014 (1) BSPCE 2015-01 (1) BSPCE 2015-03 (1) BSPCE 2016 (1) BSPCE 2016 Performance (1) BSPCE 2017 Ordinary (1) BSPCE 2017 (1) Date of the shareholders' meeting 18-juin-14 18-juin-14 18-juin-14 25-juin-15 25-juin-15 23-juin-16 23-juin-16 Grant date 16-sept-14 10-févr-15 10-juin-15 02-févr-16 02-févr-16 07-janv-17 07-janv-17 Total number of BSPCE authorized 450,000 450,000 450,000 450,000 450,000 450,000 450,000 Total number of BSPCE granted 97,200 71,650 53,050 126,400 129,250 117,650 80,000 Starting date of the exercise of the BSPCE September 16, 2015 February 10, 2016 June 10, 2016 February 2, 2017 February 2, 2016 January 7, 2017 January 7, 2017 BSPCE expiry date (2) September 16, 2024 February 10, 2025 June 10, 2025 February 2, 2026 February 2, 2026 January 7, 2027 January 7, 2027 Exercise price per BSPCE €18.68 €18.57 €20.28 €14.46 €14.46 €15.93 €15.93 Number of shares subscribed as of December 31, 2024 — — — 333 — — — Total number of BSPCEs lapsed or cancelled as of December 31, 2024 97,200 3,900 25,700 29,250 31,150 20,600 — Total number of BSPCEs outstanding as of December 31, 2024 — 67,750 27,350 96,817 98,100 97,050 80,000 Total number of shares available for subscription as of December 31, 2024 — 67,750 27,350 96,817 98,100 97,050 80,000 Maximum total number of shares that can be issued — 67,750 27,350 96,817 98,100 97,050 80,000 (1) As of December 31, 2024, all outstanding BSPCEs may be exercised.
As of December 31, 2025, the following types of founders’ warrants that we have issued are outstanding: 115 Grant BSPCE 2015-01 (1) BSPCE 2015-03 (1) BSPCE 2016 O (1) BSPCE 2016 P (1) BSPCE 2017 O (1) BSPCE 2017 (1) Date of the shareholders' meeting 18-juin-14 18-juin-14 25-juin-15 25-juin-15 23-juin-16 23-juin-16 Grant date 10-févr-15 10-juin-15 02-févr-16 02-févr-16 07-janv-17 07-janv-17 Total number of BSPCE authorized 450,000 450,000 450,000 450,000 450,000 450,000 Total number of BSPCE granted 71,650 53,050 126,400 129,250 117,650 80,000 Starting date of the exercise of the BSPCE February 10, 2016 June 10, 2016 February 2, 2017 February 2, 2016 January 7, 2017 January 7, 2017 BSPCE expiry date (2) February 10, 2025 June 10, 2025 February 2, 2026 February 2, 2026 January 7, 2027 January 7, 2027 Exercise price per BSPCE €18.57 €20.28 €14.46 €14.46 €15.93 €15.93 Number of shares subscribed as of December 31, 2025 — — 30,300 42,900 3,000 — Total number of BSPCEs lapsed or cancelled as of December 31, 2025 71,650 53,050 29,250 31,150 20,600 — Total number of BSPCEs outstanding as of December 31, 2025 — — 66,850 55,200 94,050 80,000 Total number of shares available for subscription as of December 31, 2025 — — 66,850 55,200 94,050 80,000 Maximum total number of shares that can be issued — — 66,850 55,200 94,050 80,000 (1) As of December 31, 2025, all outstanding BSPCEs may be exercised.
Alain Herrera, M.D. 74 Member Mr. Enno Spillner 55 Member Dr. Margaret Liu 68 Observer Ms. Anat Naschitz 57 Observer Executive Board Members The following is a brief summary of the business experience of the members of our executive board. Dr.
Alain Herrera, M.D. 75 Member Mr. Enno Spillner 56 Member Dr. Margaret Liu 69 Member Ms. Anat Naschitz 58 Member Executive Board Members The following is a brief summary of the business experience of the members of our executive board. Dr.
(6) See also “—Warrants (BSA)—Term” and “—Warrants (BSA)—Change in Control.” Stock Options (OSA) During the year 2024, we have granted stock options to our employees and the employees of our subsidiaries pursuant to the 2023 Stock Option Plan (“2023 Plan”), which was adopted by our executive board on July 20, 2023 and approved by our shareholders during the combined shareholders’ meeting held on June 27, 2023.
(5) See also “—Warrants (BSA)—Term” and “—Warrants (BSA)—Change in Control.” Stock Options (OSA) During the year 2025, we have granted stock options to our employees and the employees of our subsidiaries pursuant to the 2025 Stock Option Plan (“2025 Plan”), which was adopted by our executive board on February 18, 2025 and May 16,2025 and approved by our shareholders during the combined shareholders’ meeting held on May 28, 2024.
Previously she served on the boards of Transgéne, Sangamo Biosciences, Adjuvance Technologies and the United Nations Development Programme-established International Vaccine Institute and was Senior Advisor in Vaccinology at the Bill & Melinda Gates Foundation. Dr.
She also serves on the board of MacroGenics and is a member of the Science and Technology and the Nominations and Governance Committees. Previously, she served on the boards of Transgéne, Sangamo Biosciences, Adjuvance Technologies and the United Nations Development Programme-established International Vaccine Institute and was Senior Advisor in Vaccinology at the Bill & Melinda Gates Foundation. Dr.
Executive Board Compensation The following table sets forth information regarding the compensation earned by our executive board members for service on our executive board during the year ended December 31, 2024. Name Fixed Compensation (€) Bonus (€) Stock Options (€) All Other Compensation (€) Total (€) Dr. Laurent Levy, Ph.D. 460,000 (1) 276,000 (3) 1,268,333 (5) 20,317 (6) €2,024,650 Ms.
Executive Board Compensation The following table sets forth information regarding the compensation earned by our executive board members for service on our executive board during the year ended December 31, 2025. Name Fixed Compensation (€) Bonus (€) Stock Options (€) All Other Compensation (€) Total (€) Dr. Laurent Levy, Ph.D. 460,000 (1) 364,320 (3) 1,026,833 (5) 20,639 (6) €1,871,792 Ms.
Anat Naschitz Observer 2024* 2030 *Nominations submitted for ratification at the Nanobiotix shareholders’ meeting Supervisory Board Member Independence As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent members on our supervisory board, except with respect to our audit committee.
Supervisory Board Member Independence As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent members on our supervisory board, except with respect to our audit committee.
All payments of variable or exceptional compensation for the year ended December 31, 2024 detailed below are subject to approval at the annual combined shareholders’ meeting to be held to approve the financial statements for the year ended December, 2024.
Therefore, all payments of variable or exceptional compensation for the year ended December 31, 2025 detailed below will be submitted for approval to the next annual combined shareholders’ meeting to be held to, among others, approve the financial statements for the year ended December, 2025.
By exception to the foregoing, if the Following Event occurs (a) within the 6-month period following the effective date of the employment contract of the concerned Executive Board member, the severance package shall be equal to six months of his/her fixed salary, (b) from the 7-month period until the end of 12-month period following the effective date of the employment contract of such member, the severance package shall be equal to his/her prorated fixed salary. 120 Limitations on Liability Under French law, provisions of our By-laws that limit the liability of directors and officers are ineffective.
By exception to the foregoing, if the Following Event occurs (a) within the 6-month period following the effective date of the employment contract of the concerned Executive Board member, the severance package shall be equal to six months of his/her fixed salary, (b) from the 7-month period until the end of 12-month period following the effective 113 date of the employment contract of such member, the severance package shall be equal to his/her prorated fixed salary.
(Euronext Paris: ALVAL) since March 2017, as a founding member of the Nanomedicine Translation Advisory Board since June 2014 and as vice chairman of the executive board of the European Technology Platform on Nanomedicine since December 2012.
(Euronext Paris: ALVAL) since March 2017, as a founding member of the Nanomedicine Translation Advisory Board since June 2014 and was vice chairman of the executive board of the European Technology Platform on Nanomedicine from 2012 to 2017. He has been elected Chairman of the executive board of the European Technology Platform of Nanomedecine in May 2025.
(7) Reflects the valuation of 90,000 stock options granted during the year ended December 31, 2024 (8) Reflects the valuation of 180,000 stock options granted during the year ended December 31, 2024 (9) Reflects the valuation of 160,000 stock options granted during the year ended December 31, 2024 (10) Amount converted into euros (1€ = $1,0821) .
(7) Reflects the valuation of 100,000 stock options granted during the year ended December 31, 2025 (8) Reflects the valuation of 190,000 stock options granted during the year ended December 31, 2025 (9) Reflects the valuation of 150,000 stock options granted during the year ended December 31, 2025 (10) Amount converted into euros (1€ = $1,175) .
(2) The AGA 2023 P1 granted to members of the executive board are conditioned upon the achievement of three of the seven below events in the next 24 months upon attribution: • Establish a collaboration / development deal with a pharma or industry (signed term sheet); • Non-dilutive financing to reach interim readout; • Double share price as compared to weighted average value of the first 6 months of 2023 or share price to outperform a biotech index over the next 12 months starting at attribution date; • Launch a new trial I-O combo with NBTXR3; • 2 new trials launched by our partner(s); • Complete half of the patients recruitment of 312 (to exceed the number needed for the Futility Analysis); • Positive data in phase I pancreatic cancer allowing to consider moving into next clinical phase.
Grant AGA 2023 - P1 (1) AGA 2023 - P2 (2) Date of the shareholders meeting June 27, 2023 June 27, 2023 Grant date June 27, 2023 June 27, 2023 Total number of free shares authorized 1,200,000 1,200,000 Total number of free shares granted 427,110 439,210 Date of acquisition (end of the acquisition period) June 27, 2025 June 27, 2025 Duration of the holding period 1 year 1 year Number of shares acquired as of December 31, 2025 392,060 417,760 Total number of free shares lapsed or cancelled as of December 31, 2025 35,050 21,450 Total number of free shares outstanding as of December 31, 2025 — — Maximum total number of shares that may be created — — (1) The AGA 2023 P1 granted to members of the executive board are conditioned upon the achievement of three of the seven below events in the next 24 months upon attribution: • Establish a collaboration / development deal with a pharma or industry (signed term sheet); • Non-dilutive financing to reach interim readout; 122 • Double share price as compared to weighted average value of the first 6 months of 2023 or share price to outperform a biotech index over the next 12 months starting at attribution date; • Launch a new trial I-O combo with NBTXR3; • 2 new trials launched by our partner(s); • Complete half of the patients recruitment of 312 (to exceed the number needed for the Futility Analysis); • Positive data in phase I pancreatic cancer allowing to consider moving into next clinical phase.
In making these determinations, our supervisory board considered the current and prior relationships that each member has and has had with our company and all other facts and circumstances that our supervisory board deemed relevant in determining their independence, including the beneficial ownership of our ordinary shares by each member and his or her affiliate entities, if any.
In making these determinations, our supervisory board considered the current and prior relationships that each member has and has had with our company and all other facts and circumstances that our supervisory board deemed relevant in determining their independence, including the beneficial ownership of our ordinary shares by each member and his or her affiliate entities, if any. 124 Furthermore, the MiddleNext Corporate Governance Code is a reference governance code, as amended in September 2021, published by MiddleNext that is specifically tailored for small and mid-cap companies.
Anne-Juliette Hermant 260,000 (2) 117,000 (3) 228,300 (7) — €605,300 Mr. Bart Van Rhijn 420,478 (2)(10) 179,754 (3)(10) 456,600 (8) — €1,056,823 Mr. Louis Kayitalire 415,000 (2) 186,750 (4) 405,867 (9) — €1,007,617 (1) Compensation earned for his corporate office (Chairman of the executive board) that was set by the supervisory board. (2) Compensation earned under an employment agreement.
Anne-Juliette Hermant 260,000 (2) 154,440 (3) 203,333 (7) — €617,773 Mr. Bart Van Rhijn 420,478 (2)(10) 179,754 (3)(10) 386,333 (8) — €961,763 Mr. Louis Kayitalire 415,000 (2) 188,196 (4) 305,000 (9) — €944,100 (1) Compensation earned for his corporate office (Chairman of the executive board) that was set by the supervisory board. (2) Compensation earned under an employment agreement.
As of the date of this Annual Report, women are represented on both the Supervisory Board and the Executive Board and represent 55% of our total employees. 116 B.
As of the date of this Annual Report, women represent 50% of the Supervisory Board, 25% of the Executive Board and 54% of our total employees. 109 B.
Mr. Bart Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joined Nanobiotix in 2021 after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US). 23 Any references to “NBTXR3” or “JNJ-1900” should be understood as referring to the licensed product under the Janssen Agreement.
Mr. Bart Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joined Nanobiotix in 2021 after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US).
Finally, we follow French law with respect to shareholder approval requirements in lieu of the various shareholder approval of Nasdaq Rule 5635, which requires a Nasdaq listed company to obtain shareholder approval prior to certain issuances of securities, including: (a) issuances in connection with the acquisition of the stock or assets of another company if upon issuance the issued shares will equal 20% or more of the number of shares or voting power outstanding prior to the issuance, or if certain specified persons have a 5% or greater interest in the assets or company to be acquired (Rule 5635(a)); (b) issuances or potential issuances that will result in a change of control of us (Rule 5635(b) ; (c) issuances in connection with equity compensation; and (d) 20% or greater issuances in transactions other than public offerings, as defined in the Nasdaq rules (Rule 5635(d)). 132 Under French law our shareholders may approve issuances of equity, as a general matter through the adoption of delegation of authority resolutions at the Company’s shareholders’ meeting pursuant to which shareholders may delegate their authority to the Executive Board to increase the Company’s share capital within specified parameters set by the shareholders, which may include a time limitation to carry out the share capital increase, the cancellation of their preferential subscription rights to the benefit of named persons or a category of persons, specified price limitations and/or specific or aggregate limitations on the size of the share capital increase.
Finally, we follow French law with respect to shareholder approval requirements in lieu of the various shareholder approval of Nasdaq Rule 5635, which requires a Nasdaq listed company to obtain shareholder approval prior to certain issuances of securities, including: (a) issuances in connection with the acquisition of the stock or assets of another company if upon issuance the issued shares will equal 20% or more of the number of shares or voting power outstanding prior to the issuance, or if certain specified persons have a 5% or greater interest in the assets or company to be acquired (Rule 5635(a)); (b) issuances or potential issuances that will result in a change of control of us (Rule 5635(b) ; (c) issuances in connection with equity compensation; and (d) 20% or greater issuances in transactions other than public offerings, as defined in the Nasdaq rules (Rule 5635(d)).
Bart Van Rhijn’s track record reflects a relentless commitment to streamlining business operations, driving growth, and unlocking value. His varied experiences include the successful reorganization of a healthcare technology-enabled services business, coordination and execution of strategic financing transactions, and the efficient building and scaling of commercial businesses.
His varied experiences include the successful reorganization of a 106 healthcare technology-enabled services business, coordination and execution of strategic financing transactions, and the efficient building and scaling of commercial businesses.
The following table sets forth the names of the members of the supervisory board and of the observers, the year of their initial appointment as members or observer of the supervisory board and the expiration dates of their current term. 130 Name Current Position Year of Initial Appointment Current Term Expiration Year (Annual Shareholders' Meeting to be called to approve the (Y-1) financial statements) Dr.
The following table sets forth the names of the members of the supervisory board and of the observers, the year of their initial appointment as members or observer of the supervisory board and the expiration dates of their current term.
Our supervisory board expects our executive board to consider risk and risk management in each business decision and to proactively develop and monitor risk management strategies and processes for day-to-day activities. We believe this division of responsibility is the most effective approach for addressing the risks we face.
While our supervisory board oversees our risk management, our executive board is responsible for our day-to-day risk management processes. Our supervisory board expects our executive board to consider risk and risk management in each business decision and to proactively develop and monitor risk management strategies and processes for day-to-day activities.
The Code of Conduct is available on our website at www.nanobiotix.com . Our supervisory board is responsible for overseeing the Code of Conduct and is required to approve any waivers of the Code of Conduct for employees, executive board members and supervisory board members.
Our supervisory board is responsible for overseeing the Code of Conduct and is required to approve any waivers of the Code of Conduct for employees, executive board members and supervisory board members. We expect that any amendments to the Code of Conduct, or any waivers of its requirements, will be disclosed on our website. D.
However, the Nasdaq listing standards permit foreign private issuers to follow home country corporate governance practices in lieu of the Nasdaq rules, with certain exceptions. Certain corporate governance practices in France may differ significantly from the Nasdaq corporate governance listing standards.
In addition, as a foreign private issuer listed on the Nasdaq Global Select Market, we are subject to the Nasdaq corporate governance listing standards. However, the Nasdaq listing standards permit foreign private issuers to follow home country corporate governance practices in lieu of the Nasdaq rules, with certain exceptions.
Share Ownership For information regarding the share ownership of our Supervisory and Executive Board members, see “Item 6B.Compensation” and “Item 7A. Major Shareholders.”
None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. E. Share Ownership For information regarding the share ownership of our Supervisory and Executive Board members, see “Item 6B.Compensation” and “Item 7A. Major Shareholders.”
Compensation Compensation of Supervisory Board and Executive Board Members The aggregate compensation paid and benefits in kind granted by us to our current executive board members and supervisory board members, including share-based compensation, for the year ended December 31, 2024 was €5,044,400.
The aggregate compensation paid and benefits in kind granted by us to our current executive board members and supervisory board members, including share-based compensation, for the year ended December 31, 2025 was €4,826,366. The total amount set aside or accrued to provide pension, retirement or similar benefits was € 20,639 for the year ended December 31, 2025.
Anat Naschitz (1) 11,667 5,833 — 17,500 (1) Dr Margaret Liu and Ms Anat Naschitz were appointed as observers of the supervisory board. on 28 August 2024; their compensation is prorated accordingly. . Unemployment Insurance We purchased officer unemployment insurance ( assurance perte d’emploi des dirigeants – GSC ) for our Chairman of the executive board, Dr.
(2) Ms Anat Naschitz was appointed as member of the Audit Committee on 19 May 2025; their compensation is prorated accordingly. Unemployment Insurance We purchased officer unemployment insurance ( assurance perte d’emploi des dirigeants – GSC ) for our Chairman of the executive board, Dr.
Even as a foreign private issuer, we are required to comply with Rule 10A-3 of the Exchange Act, relating to audit committee composition and responsibilities.
The Company applies the Middlenext code, which recommends that at least two members of the Supervisory Board be independent (as such term is defined under the code). Even as a foreign private issuer, we are required to comply with Rule 10A-3 of the Exchange Act, relating to audit committee composition and responsibilities.
Corporate Governance Practices As a French société anonyme listed on the regulated market of Euronext in Paris, we are subject to various corporate governance requirements under French law. In addition, as a foreign private issuer listed on the Nasdaq Global Select Market, we are subject to the Nasdaq corporate governance listing standards.
We believe this division of responsibility is the most effective approach for addressing the risks we face. Corporate Governance Practices As a French société anonyme listed on the regulated market of Euronext in Paris, we are subject to various corporate governance requirements under French law.
Additionally, the audit committee reviews and discusses with management all reports regarding our enterprise risk management activities, including management’s assessment of our major risk exposures and the steps taken to monitor and manage those exposures. 131 While our supervisory board oversees our risk management, our executive board is responsible for our day-to-day risk management processes.
The audit committee also monitors our system of disclosure controls and procedures and internal control over financial reporting and reviews contingent financial liabilities. Additionally, the audit committee reviews and discusses with management all reports regarding our enterprise risk management activities, including management’s assessment of our major risk exposures and the steps taken to monitor and manage those exposures.

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Item 7. Management's Discussion & Analysis

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

14 edited+2 added−4 removed17 unchanged
Biggest changeIn considering related-party transactions, our supervisory board 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.
Biggest changeIn considering related-party transactions, our supervisory board 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. 130 The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our supervisory board 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 supervisory board determines in the good faith exercise of its discretion.
Related Party Transactions It is the policy of the supervisory board that in order to mitigate the risk of any actual or perceived conflicts of interest, whenever a matter comes before the supervisory board for its consideration in which a related party supervisory board member has a potential interest, such member shall be recused from participating in any discussions and voting in any decisions on such matter.
Related Party Transactions 129 It is the policy of the supervisory board that in order to mitigate the risk of any actual or perceived conflicts of interest, whenever a matter comes before the supervisory board for its consideration in which a related party supervisory board member has a potential interest, such member shall be recused from participating in any discussions and voting in any decisions on such matter.
The presentation must include a description of, among other things, the material facts, the interests in the transaction, direct and indirect, of the related parties, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the 136 case may be, an unrelated third-party or to or from employees generally.
The presentation must include a description of, among other things, the material facts, the interests in the transaction, direct and indirect, of the related parties, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third-party or to or from employees generally.
The information is not necessarily indicative of beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Securities Act. The information in the table below is based on information furnished to us or ascertained by us from public filings made by the shareholders in France.
The information is not necessarily indicative of beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Securities Act. The information in the table below is based on information furnished to us over the time or ascertained by us from public filings made by the shareholders in France.
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 April 2, 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 December 31, 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 founders’ warrants, warrants, stock options and free shares held by that person that are immediately exercisable or exercisable within 60 days of April 2, 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 founders’ warrants, warrants, stock options and free shares held by that person that are immediately exercisable or exercisable within 60 days of December 31, 2025.
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 December 31, 2024, we estimate that approximately 26% 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 December 31, 2025, we estimate that approximately 28% of our outstanding ordinary shares were held in the United States. B.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of April 2, 2025 for: • each person, or group of affiliated persons, known by us to beneficially own more than 5% of our outstanding ordinary shares; • each of our supervisory board members and executive board members; and • all of our supervisory board members and executive board members as a group.
Major Shareholders The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2026 for: • each person, or group of affiliated persons, known by us to beneficially own more than 5% of our outstanding ordinary shares; • each of our supervisory board members and executive board members; and • all of our supervisory board members and executive board members as a group.
Agreements with Our Directors and Executive Officers Director and Executive Officer Compensation See “Item 6B. Compensation of Directors and Executive Officers” for information regarding compensation of directors and executive officers. Equity Awards Since January 1, 2025, we have not granted equity awards to any of our directors and executive officers. See “Item 7A.
Agreements with Our Directors and Executive Officers Director and Executive Officer Compensation See “Item 6B. Compensation of Directors and Executive Officers” for information regarding compensation of directors and executive officers. Equity Awards Since January 1, 2026, we have not granted equity awards to any of our supervisory board members and executive officers. See “Item 7A.
Payments to Nanobiotix by Janssen during the year ended December 31, 2024 pursuant to the foregoing agreements are discussed in “Note 16 - Revenues and other income ” and “Note 24 - Related Parties ” to the audited financial statements included in this Annual Report. C. Interests of Experts and Counsel Not applicable. 137
Payments to Nanobiotix by Janssen during the year ended December 31, 2025 pursuant to the foregoing agreements are discussed in “Note 16 - Revenues and other income” and “Note 24 - Related Parties” to the audited financial statements included in this Annual Report. C. Interests of Experts and Counsel Not applicable. 131
The registered office of the Qatar Investment Authority is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, P.O. Box 23224, Qatar. (4) Consists of 1,289,060 ordinary shares and 535,271 ordinary shares issuable upon exercise of founders’ warrants, stock options and free shares.
The registered office of the Qatar Investment Authority is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, P.O. Box 23224, Qatar. (4) Consists of 1,394,262 ordinary shares and 962,588 ordinary shares issuable upon exercise of founders’ warrants and stock options.
(1) 5,623,816 11.86 5,623,816 11.43 Entities affiliated with Invus Public Equities, L.P. (2) 5,844,592 12.32 5,844,592 11.88 Qatar Investment Authority (3) 4,298,507 9.06 4,298,507 8.74 Supervisory Board and Executive Board Members: Laurent Levy, Ph.D.
(1) 5,623,816 11.62 5,623,816 11.23 Entities affiliated with Invus Public Equities, L.P. (2) 5,844,592 12.07 5,844,592 11.67 Qatar Investment Authority (3) 4,298,507 8.88 4,298,507 8.58 Supervisory Board and Executive Board Members: Laurent Levy, Ph.D.
The percentage ownership information shown in the table is based upon 47,426,851 ordinary shares outstanding as of April 2, 2025.
The percentage ownership information shown in the table is based, upon 48,410,068 ordinary shares outstanding as 128 of December 31, 2025.
(4) 1,824,331 3.85 2,783,391 5.66 Anne-Juliette Hermant (5) 299,451 0.63 349,451 0.71 Bart Van Rhijn (6) 310,761 0.66 310,761 0.63 Louis Kayitalire (7) 53,333 0.11 53,333 0.11 Alain Herrera, M.D. — [*] — [*] Anne-Marie Graffin — [*] — [*] Gary Phillips — [*] — [*] Enno Spillner — [*] — [*] All Supervisory Board and Executive Board members as a group (8 persons) 2,487,876 5.25 3,496,936 7.11 135 * Represents beneficial ownership of less than 1%.
(4) 2,356,880 4.87 3,200,940 6.39 Anne-Juliette Hermant (5) 446,745 0.92 586,745 1.17 Bart Van Rhijn (6) 687,086 1.42 687,086 1.37 Louis Kayitalire (7) 156,220 0.32 156,220 0.31 Alain Herrera, M.D. — [*] — [*] Anne-Marie Graffin 7,400 0.02 7,400 0.01 Gary Phillips 13,600 0.03 13,600 0.03 Enno Spillner 4,000 0.01 4,000 0.01 Margaret Liu, M.D. — [*] — [*] Anat Naschitz — [*] — [*] All Supervisory Board and Executive Board members as a group (10 persons) 3,671,931 7.59 4,655,991 9.29 * Represents beneficial ownership of less than 1%.
Removed
To the knowledge of the Company, Laurent Levy has pledged 1,289,060 ordinary shares. (5) Consists of 175,000 ordinary shares and 124,451 ordinary shares issuable upon exercise of stock options and free shares. (6) Consists of 128,964 ordinary shares and 181,796 ordinary shares issuable upon exercise of stock options and free shares.
Added
(5) Consists of 241,708 ordinary shares and 205,037 ordinary shares issuable upon exercise of stock options. (6) Consists of 410,747 ordinary shares and 330,339 ordinary shares issuable upon exercise of stock options. (7) Consists of 156,220 ordinary shares issuable upon exercise of stock options.
Removed
(7) Consists of 53,333 ordinary shares issuable upon exercise of stock options. According to a disclosure made to the French AMF, Baillie Gifford & Co acting in behalf of funds that it manages, declared that it had crossed, in the downward direction, the threshold of 5% of the share capital and voting right of the Company.
Added
As the exclusive and worldwide licensee of JNJ-1900 (NBTXR3), which is currently a core asset of Nanobiotix, Janssen may be deemed to possess significant influence in respect of some operating policy decisions as defined by IAS 24, but not control.
Removed
The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our supervisory board 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 supervisory board determines in the good faith exercise of its discretion.
Removed
As of December 31, 2024, Johnson & Johnson Innovation – JJDC, an affiliate of Janssen, beneficially owns approximately 11.86% of the outstanding ordinary shares of Nanobiotix. In addition, Nanobiotix and Janssen are parties to the Janssen Agreement, the “TSA”, and the “AAA”, each as described in this Annual Report. Accordingly, Janssen may be considered a related party of Nanobiotix.