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Innate Pharma SA

Innate Pharma SAIPHA财报

Nasdaq · pharmaceutical industry

aTyr Pharma is a public biotherapeutics company that is focused on researching the extracellular functionality and signaling pathways of tRNA synthetases.

What changed in Innate Pharma SA's 20-F — 2023 vs 2024

Top changes in Innate Pharma SA's 2024 20-F

841 paragraphs added · 822 removed · 605 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

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Item 2. Offer Statistics and Expected Timetable. 10 Item 3. Key Information. 10 A. Reserved 10 B. Capitalization and Indebtedness 10 C. Reasons for the Offer and Use of Proceeds 10 D. Risk Factors 10 Item 4. Information on the Company. 74 A. History and Development of the Company 74 B. Business Overview 75 C. Organizational Structure. 132 D.
Item 2. Offer Statistics and Expected Timetable. 10 Item 3. Key Information. 10 A. Reserved 10 B. Capitalization and Indebtedness 10 C. Reasons for the Offer and Use of Proceeds 10 D. Risk Factors 11 Item 4. Information on the Company. 72 A. History and Development of the Company 72 B. Business Overview 73 C. Organizational Structure. 130 D.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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In addition, if the Company makes manufacturing or formulation changes to its product candidates, it may be required to or it may elect to 16 conduct additional studies to bridge its modified product candidates to earlier versions.
In addition, if the Company makes 16 manufacturing or formulation changes to its product candidates, it may be required to or it may elect to conduct additional studies to bridge its modified product candidates to earlier versions.
In this case, the Company would be exposed to the same competitive risks as the product used in combination with its product, such as a product that is marketed before the combination therapy, has lower prices, covers a wider therapeutic spectrum or proves to be more effective 18 or better tolerated.
In this case, the Company would be exposed to the same competitive risks as the product used in combination with its product, such as a product that is marketed before the 18 combination therapy, has lower prices, covers a wider therapeutic spectrum or proves to be more effective or better tolerated.
These sanctions could include, for example, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or withdrawals from the market, product seizures, total or 19 partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
These sanctions could include, for example, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution 19 injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The early termination of a contract, the non-renewal of a contract or its inability to find new collaborators would adversely affect its business. Should any of these risks materialize, this could have an adverse effect on Innate's business, prospects, financial condition and results of operations. The Company benefits from tax credits in France that could be reduced or eliminated.
The early termination of a contract, the non-renewal of a contract or Innate's inability to find new collaborators would adversely affect its business. Should any of these risks materialize, this could have an adverse effect on Innate's business, prospects, financial condition and results of operations. The Company benefits from tax credits in France that could be reduced or eliminated.
As a French biopharmaceutical company, Innate benefits from certain tax advantages, including the Research Tax Credit ( Crédit Impôt Recherche ), which is a French tax credit aiming at stimulating research and development.
As a French biopharmaceutical company, Innate benefits from certain tax advantages, including the French research tax credit ( Crédit Impôt Recherche ) (the "Research Tax Credit"), which is a French tax credit aiming at stimulating research and development.
If Innate Pharma is unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights Innate Pharma has, Innate may have to abandon the development and commercialization of the relevant program, and its business, financial conditions, results of operations and prospects could be adversely affected.
If Innate Pharma is unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights Innate has, Innate may have to abandon the development and commercialization of the relevant program, and its business, financial conditions, results of operations and prospects could be adversely affected.
In particular, such filings are required in connection with investments exceeding €15,000,000 that lead to the acquisition of at least 10% of the Company's share capital or voting rights or cross such 10% threshold; • under French law, certain investments in a French company relating to certain strategic industries by individuals or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy; • a merger (i.e., in a French law context, a share for share exchange following which the Company would be dissolved into the acquiring entity and its shareholders would become shareholders of the acquiring entity) of the Company into a company incorporated in the European Union would require the approval of the Company's Executive Board, as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting; 68 • a merger of the Company into a company incorporated outside of the European Union would require 100% of its shareholders to approve it; • under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; • Innate's shareholders may in the future grant the Company's Executive Board broad authorizations to increase Innate's share capital or to issue additional ordinary shares or other securities (for example, warrants) to Innate's shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for Innate's ordinary shares; • its shareholders have preferential subscription rights on a pro rata basis on the issuance by Innate of any additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of the Company's shareholders or on an individual basis by each shareholder; • Innate's Supervisory Board appoints the members of the Executive Board and shall fill any vacancy within two months; • Innate's Supervisory Board has the right to appoint members of the Supervisory Board to fill a vacancy created by the resignation or death of a member of the Supervisory Board for the remaining duration of such member’s term of office, and subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on the Company's Supervisory Board; • its Executive Board can be convened by the chairman of the Executive Board or other members of the Executive Board delegated for this purpose; • its Supervisory Board can be convened by the chairman or the vice-chairman of the Supervisory Board.
In particular, such filings are required in connection with investments exceeding €15,000,000 that lead to the acquisition of at least 10% of the Company's share capital or voting rights or cross such 10% threshold; • under French law, certain investments in a French company relating to certain strategic industries by individuals or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy; • a merger (i.e., in a French law context, a share for share exchange following which the Company would be dissolved into the acquiring entity and its shareholders would become shareholders of the acquiring entity) of the Company into a company incorporated in the European Union would require the approval of the Company's Executive Board, as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting; 66 • a merger of the Company into a company incorporated outside of the European Union would require 100% of its shareholders to approve it; • under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; • Innate's shareholders may in the future grant the Company's Executive Board broad authorizations to increase Innate's share capital or to issue additional ordinary shares or other securities (for example, warrants) to Innate's shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for Innate's ordinary shares; • its shareholders have preferential subscription rights on a pro rata basis on the issuance by Innate of any additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of the Company's shareholders or on an individual basis by each shareholder; • Innate's Supervisory Board appoints the members of the Executive Board and shall fill any vacancy within two months; • Innate's Supervisory Board has the right to appoint members of the Supervisory Board to fill a vacancy created by the resignation or death of a member of the Supervisory Board for the remaining duration of such member’s term of office, and subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on the Company's Supervisory Board; • its Executive Board can be convened by the chairman of the Executive Board or other members of the Executive Board delegated for this purpose; • its Supervisory Board can be convened by the chairman or the vice-chairman of the Supervisory Board.
The market price for Innate Pharma's ordinary shares and ADSs may be influenced by many factors, including: • actual or anticipated fluctuations in its financial condition and operating results; • actual or anticipated changes in its growth rate relative to its competitors; • competition from existing products or new products that may emerge; • announcements by Innate or its competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • adverse results of delays in Innate's or any of its competitors’ preclinical studies or clinical trials; • adverse regulatory decisions, including failure to receive regulatory approval for any of its product candidates; • the termination of a strategic alliance or the inability to establish additional strategic alliances; • failure to meet or exceed financial estimates and projections of the investment community or that the Company provides to the public; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • ordinary share and American Deposit Share (ADS) price and volume fluctuations attributable to inconsistent trading volume levels of its ordinary shares and ADSs; • price and volume fluctuations in trading of its ordinary shares on Euronext Paris; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and its ability to obtain patent and other intellectual property protection for its technologies; • changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; • announcement or expectation of additional debt or equity financing efforts; • sales of its ordinary shares or ADSs by Innate, its insiders or its other shareholders; and • general economic and market conditions.
The market price for Innate Pharma's ordinary shares and ADSs may be influenced by many factors, including: • actual or anticipated fluctuations in its financial condition and operating results; • actual or anticipated changes in its growth rate relative to its competitors; • competition from existing products or new products that may emerge; • announcements by Innate or its competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • adverse results of delays in Innate's or any of its competitors’ preclinical studies or clinical trials; • adverse regulatory decisions, including failure to receive regulatory approval for any of its product candidates; • the termination of a strategic alliance or the inability to establish additional strategic alliances; • failure to meet or exceed financial estimates and projections of the investment community or that the Company provides to the public; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • ordinary share and ADS price and volume fluctuations attributable to inconsistent trading volume levels of its ordinary shares and ADSs; • price and volume fluctuations in trading of its ordinary shares on Euronext Paris; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and its ability to obtain patent and other intellectual property protection for its technologies; • changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; • announcement or expectation of additional debt or equity financing efforts; • sales of its ordinary shares or ADSs by Innate, its insiders or its other shareholders; and • general economic and market conditions.
A failure to receive any such milestone payment may cause Innate to: • delay, reduce or terminate certain research and development programs; • reduce headcount; • raise funds through additional equity or convertible debt financings that could be dilutive to its shareholders and holders of its ADSs; • obtain funds through collaboration agreements that may require Innate to assign rights to technologies or products that Innate would have otherwise retained; • sign new collaboration or license agreements that may be less favorable than those the Company would have obtained under different circumstances; and • consider strategic transactions or engaging in a joint venture with a third party.
A failure to receive any such milestone payment may cause Innate to: • delay, reduce or terminate certain research and development programs; • reduce headcount; • raise funds through additional equity or convertible debt financings that could be dilutive to its shareholders and holders of its ADSs; 41 • obtain funds through collaboration agreements that may require Innate to assign rights to technologies or products that Innate would have otherwise retained; • sign new collaboration or license agreements that may be less favorable than those the Company would have obtained under different circumstances; and • consider strategic transactions or engaging in a joint venture with a third party.
If the chairman does not convene the Supervisory Board 15 days following the receipt of such request, the authors of the request may themselves convene the Supervisory Board; • its Supervisory Board meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference enabling the members’ identification and ensuring their effective participation in the Supervisory Board’s decisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the Executive Board and/or members of the Supervisory Board with or without cause; • the crossing of certain ownership thresholds has to be disclosed and can impose certain obligations; • advance notice is required for nominations to the Supervisory Board or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a member of the Supervisory Board can be proposed at any shareholders’ meeting without notice; • transfers of shares shall comply with applicable insider trading rules and regulations, and in particular with the Market Abuse Regulation 596/2014 of April 16, 2014, as amended; and 69 • pursuant to French law, the Company's bylaws, including the sections relating to the number of members of the Executive and Supervisory Boards, and election and removal of members of the Executive and Supervisory Boards from office may only be modified by a resolution adopted by two-thirds of the votes of the Company's shareholders present, represented by a proxy or voting by mail at the meeting.
If the chairman does not convene the Supervisory Board 15 days following the receipt of such request, the authors of the request may themselves convene the Supervisory Board; • its Supervisory Board meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference enabling the members’ identification and ensuring their effective participation in the Supervisory Board’s decisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the Executive Board and/or members of the Supervisory Board with or without cause; • the crossing of certain ownership thresholds has to be disclosed and can impose certain obligations; • advance notice is required for nominations to the Supervisory Board or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a member of the Supervisory Board can be proposed at any shareholders’ meeting without notice; • transfers of shares shall comply with applicable insider trading rules and regulations, and in particular with the Market Abuse Regulation 596/2014 of April 16, 2014, as amended; and 67 • pursuant to French law, the Company's bylaws, including the sections relating to the number of members of the Executive and Supervisory Boards, and election and removal of members of the Executive and Supervisory Boards from office may only be modified by a resolution adopted by two-thirds of the votes of the Company's shareholders present, represented by a proxy or voting by mail at the meeting.
The Company cannot guarantee that its product candidates will: • obtain regulatory authorizations or become commercially available before those of its competitors; • remain competitive in the face of other products developerid by its competitors, which may prove to be safer, more effective, have fewer or less severe side effects, be more convenient, have a broader label, have more robust intellectual property protection or be less expensive; • remain competitive in the face of products of competitors that are more efficient in their manufacturing or more effective in their marketing; and • not become obsolete or unprofitable due to technological progress or other therapies developed by its competitors.
The Company cannot guarantee that its product candidates will: • obtain regulatory authorizations or become commercially available before those of its competitors; • remain competitive in the face of other products developed by its competitors, which may prove to be safer, more effective, have fewer or less severe side effects, be more convenient, have a broader label, have more robust intellectual property protection or be less expensive; • remain competitive in the face of products of competitors that are more efficient in their manufacturing or more effective in their marketing; and • not become obsolete or unprofitable due to technological progress or other therapies developed by its competitors.
Innate Pharma has a Code of Ethics that applies to all employees and consultants, and other policies and charters, but it is not always possible to identify and deter employee misconduct, and the precautions it takes to detect and prevent this activity may be ineffective in controlling unknown or unmanaged risks or losses or in protecting Innate from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
Innate has a Code of Ethics that applies to all employees and consultants, and other policies and charters, but it is not always possible to identify and deter employee misconduct, and the precautions it takes to detect and prevent this activity may be ineffective in controlling unknown or unmanaged risks or losses or in protecting Innate from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
If the Company is a PFIC for any taxable year during which a U.S. holder holds its ordinary shares or ADSs, the U.S. holder may be subject to adverse tax consequences regardless of whether Innate Pharma continues to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.
If the Company is a PFIC for any taxable year during which a U.S. holder holds its ordinary shares or ADSs, the U.S. holder may be subject to adverse tax consequences regardless of whether Innate Pharma continues to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional 71 reporting requirements.
Failure to comply with these requirements may lead to financial penalties, compliance expenditures, total or partial suspension of production and/or distribution, product seizure or detention, refusal to permit the import or export of 27 products, suspension of the applicable regulator’s review of a company’s submissions, enforcement actions, product recalls, injunctions and even criminal prosecution, any of which could materially and adversely affect the Company's business, financial condition and results of operations.
Failure to comply with these requirements may lead to financial penalties, compliance expenditures, total or partial suspension of production and/or distribution, product seizure or detention, refusal to permit the import or export of products, suspension of the applicable regulator’s review of a company’s submissions, enforcement actions, product recalls, injunctions and even criminal prosecution, any of which could materially and adversely affect the Company's business, financial condition and results of operations.
The Company is subject to healthcare laws and regulations which may require substantial compliance efforts and could expose Innate to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties. Healthcare providers and third-party payors play a primary role in the recommendation and prescription of biologic products that are granted marketing approval.
The Company is subject to healthcare laws and regulations that may require substantial compliance efforts and could expose Innate to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties. Healthcare providers and third-party payors play a primary role in the recommendation and prescription of biologic products that are granted marketing approval.
Even if its collaborators exercise such options with respect to a particular program, Innate Pharma may never achieve the related milestones for any number of reasons. The failure to receive milestone or royalty payments and the occurrence of any of the events above may have a material adverse impact on Innate's business, prospects, financial condition and results of operations.
Even if its collaborators exercise such options with respect to a particular program, Innate may never achieve the related milestones for any number of reasons. The failure to receive milestone or royalty payments and the occurrence of any of the events above may have a material adverse impact on Innate's business, prospects, financial condition and results of operations.
In this context, in order to comply with Section 404(a) of the Sarbanes-Oxley Act within the prescribed timeframe, and over the last five years, the Company has reinforced its internal control processes and has implemented a standard and more robust Information System including an Enterprise Resource Planning (ERP) tool supporting the production and the management of its financial information.
In this context, in order to comply with Section 404(b) of the Sarbanes-Oxley Act within the prescribed timeframe, and over the last five years, the Company has reinforced its internal control processes and has implemented a standard and more robust Information System including an Enterprise Resource Planning (ERP) tool supporting the production and the management of its financial information.
For its most advanced clinical product candidate, monalizumab, the Company entered into an agreement with AstraZeneca, in part because of their late-stage development and marketing capabilities. As the Company identifies new product candidates, Innate Pharma will determine the appropriate strategy for development and marketing, which may result in the need to establish collaborations with major biopharmaceutical companies.
For its most advanced clinical product candidate, monalizumab, the Company entered into an agreement with AstraZeneca, in part because of their late-stage development and marketing capabilities. As the Company identifies new product candidates, Innate will determine the appropriate strategy for development and marketing, which may result in the need to establish collaborations with major biopharmaceutical companies.
If Innate fails to receive future Research Tax Credit amounts or if its calculations are challenged, even if Innate Pharma complies with the current requirements in terms of documentation and eligibility of its expenditure, its business, prospects, financial condition and results of operations could be adversely affected. 44 The Company may be unable to carry forward existing tax losses.
If Innate fails to receive future Research Tax Credit amounts or if its calculations are challenged, even if Innate Pharma complies with the current requirements in terms of documentation and eligibility of its expenditure, its business, prospects, financial condition and results of operations could be adversely affected. The Company may be unable to carry forward existing tax losses.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and 25 transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Any failure to follow and document the Company's or third parties' adherence to such GMP and GLP regulations or other regulatory requirements may lead to significant delays in the 36 availability of products for commercial sale or clinical trials, may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications for its products.
Any failure to follow and document the Company's or third parties' adherence to such GMP and GLP regulations or other regulatory requirements may lead to significant delays in the availability of products for commercial sale or clinical trials, may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications for its products.
If its product candidates receive regulatory approval, its future revenues will depend upon the size of any markets in which its product candidates have received approval, and market acceptance, reimbursement from third-party payors and market share. Any of these factors could have a material adverse effect on Innate's business, prospects, financial condition and results of operations.
If its product candidates receive regulatory approval, its future revenues will depend upon the size of any markets in which its product candidates have received approval, and 38 market acceptance, reimbursement from third-party payors and market share. Any of these factors could have a material adverse effect on Innate's business, prospects, financial condition and results of operations.
A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, the Company expects that it might contest such assessment. Contesting such an assessment may be lengthy and costly, and if Innate was unsuccessful in disputing the assessment, the result could increase its anticipated effective tax rate.
A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, the Company expects that it might contest such assessment. 44 Contesting such an assessment may be lengthy and costly, and if Innate was unsuccessful in disputing the assessment, the result could increase its anticipated effective tax rate.
Even if the medical community accepts a product as safe and efficacious for its indicated use, physicians may choose to restrict the use of the product if the Company is unable to demonstrate that, based on experience, clinical data, side-effect profiles and other factors, its drug is preferable to any existing drugs or treatments.
Even if the medical community accepts a product as safe and efficacious for its indicated use, physicians may choose to restrict the use of the product if the Company is unable to demonstrate that, based on experience, clinical data, side-effect profiles and other factors, its drug is preferable to any existing drugs 25 or treatments.
If the investigators sponsoring studies of its product candidates, independent investigators participating in clinical studies that Innate Pharma or its collaborators are sponsoring or CROs fail to devote sufficient resources to its clinical studies and development of its product candidates or product candidates the Company has licensed to others, or if their performance is substandard, it may delay or compromise the prospects for approval and commercialization of any product candidates that the Company or its collaborators develop.
If the investigators sponsoring studies of its product candidates, independent investigators participating in clinical studies that Innate or its collaborators are sponsoring or CROs fail to devote sufficient resources to its clinical studies and development of its product candidates or product candidates the Company has licensed to others, or if their performance is substandard, it may delay or compromise the prospects for approval and commercialization of any product candidates that the Company or its collaborators develop.
Failure to pass such inspections by Innate Pharma or any of its suppliers would affect its ability to commercialize its product candidates in Europe, the United States or elsewhere. Should any of these risks materialize, this could have a material adverse effect on the Company's business, prospects, financial condition and results of operations.
Failure to pass such inspections by Innate or any of its suppliers would affect its ability to commercialize its product candidates in Europe, the United States or elsewhere. Should any of these risks materialize, this could have a material adverse effect on the Company's business, prospects, financial condition and results of operations.
The patent positions of companies in the biotechnology and pharmaceutical market are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the 58 scope of U.S. patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained.
The patent positions of companies in the biotechnology and pharmaceutical market are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of U.S. patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 41 The terms of Innate's loans agreements with Société Générale, BNP Paribas and certain other loan obligations place restrictions on its operating and financial flexibility.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. The terms of Innate's loans agreements with Société Générale, BNP Paribas and certain other loan obligations place restrictions on its operating and financial flexibility.
Innate Pharma will need to recruit qualified scientific and medical personnel to carry out its clinical studies and expand into new areas that require specialized skills, such as regulatory matters, marketing and manufacturing. Innate competes with other companies, research organizations and academic institutions in recruiting and retaining highly qualified scientific, technical and management personnel.
Innate will need to recruit qualified scientific and medical personnel to carry out its clinical studies and expand into new areas that require specialized skills, such as regulatory matters, marketing and manufacturing. Innate competes with other companies, research organizations and academic institutions in recruiting and retaining highly qualified scientific, technical and management personnel.
Given that the Company develops therapeutic products intended to be tested on humans and used to treat humans, the risk that Innate Pharma may be sued on product liability claims is inherent in its business. Side effects of, or manufacturing defects in, products that the Company develops could result in the deterioration of a patient’s condition, injury or even death.
Given that the Company develops therapeutic products intended to be tested on humans and used to treat humans, the risk that Innate may be sued on product liability claims is inherent in its business. Side effects of, or manufacturing defects in, products that the Company develops could result in the deterioration of a patient’s condition, injury or even death.
Other risks inherent in the production process may have the same effect, such as: • contamination of the controlled atmosphere area; • unusable premises and equipment; • new regulatory requirements requiring a partial and/or extended stop to the production unit to meet the requirements; • unavailable qualified personnel; • power failure of extended duration; and 34 • logistical error.
Other risks inherent in the production process may have the same effect, such as: • contamination of the controlled atmosphere area; • unusable premises and equipment; • new regulatory requirements requiring a partial and/or extended stop to the production unit to meet the requirements; • unavailable qualified personnel; • power failure of extended duration; and • logistical error.
Trademarks In addition, changes to or different interpretations of patent laws in the United States and other countries may permit others to use Innate's or its partners’ discoveries or to develop and commercialize Innate's technology and product candidates without providing any compensation to Innate, or may limit the number of patents or claims it can obtain.
Trademarks In addition, changes to or different interpretations of patent laws in the United States and other countries may permit others to use Innate's or its partners’ discoveries or to develop and commercialize Innate's technology and product candidates without providing any compensation to Innate, or may limit the 56 number of patents or claims it can obtain.
As a result, its ability to generate clinical safety and efficacy data sufficient to support submission of a marketing application or commercialization of its product candidates is uncertain and is subject to significant risk. The Company intends to develop several of its product candidates in combination with other therapies, which exposes the Company to additional risks.
As a result, its ability to generate clinical safety 12 and efficacy data sufficient to support submission of a marketing application or commercialization of its product candidates is uncertain and is subject to significant risk. The Company intends to develop several of its product candidates in combination with other therapies, which exposes the Company to additional risks.
In addition, certain component materials are currently available from a single supplier, or a small number of suppliers. The Company cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of its competitors or another company that is not interested in continuing to manufacture these materials for us.
In addition, certain component materials are currently available from a single supplier, or a small number of suppliers. The Company cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of its competitors or another company that is not interested in continuing to manufacture these materials for the Company.
The participation in these collaborations may generate revenue and funding in the form of operating grants or the reimbursement of research and development expenses. Innate Pharma may not be able to renew or maintain its license agreements or collaborative research contracts or may be unable to sign new agreements with new collaborators on reasonable terms or at all.
The participation in these collaborations may generate revenue and funding in the form of operating grants or the reimbursement of research and development expenses. Innate may not be able to renew or maintain its license agreements or collaborative research contracts or may be unable to sign new agreements with new collaborators on reasonable terms or at all.
In addition, the use of third-party service providers requires Innate to disclose its proprietary information to these parties, which could increase the risk that this information will be misappropriated, and the Company may not be able to obtain adequate remedies for such disclosure or misappropriation.
In addition, the use of third-party service providers requires Innate to disclose its proprietary information to these parties, which could increase the risk that this information will be misappropriated, and the Company may 34 not be able to obtain adequate remedies for such disclosure or misappropriation.
Failure to comply with applicable regulations could also result in national authorities, the EMA, FDA or other applicable regulatory authorities taking various actions, including: • levying fines and other civil penalties; • imposing consent decrees or injunctions; • requiring Innate to suspend or put on hold one or more of its clinical trials; • suspending or withdrawing regulatory approvals; • delaying or refusing to approve pending applications or supplements to approved applications; • requiring Innate Pharma to suspend manufacturing activities or product sales, imports or exports; • requiring Innate to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy and other issues involving its products; • mandating product recalls or seizing products; • imposing operating restrictions; and • seeking criminal prosecutions.
Failure to comply with applicable regulations could also result in national authorities, the EMA, FDA or other applicable regulatory authorities taking various actions, including: • levying fines and other civil penalties; • imposing consent decrees or injunctions; • requiring Innate to suspend or put on hold one or more of its clinical trials; • suspending or withdrawing regulatory approvals; • delaying or refusing to approve pending applications or supplements to approved applications; • requiring Innate to suspend manufacturing activities or product sales, imports or exports; • requiring Innate to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy and other issues involving its products; 35 • mandating product recalls or seizing products; • imposing operating restrictions; and • seeking criminal prosecutions.
Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a disease that affects a patient population of fewer than 200,000 people in the United States.
Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug intended to treat a rare disease or condition 28 which is generally defined as a disease that affects a patient population of fewer than 200,000 people in the United States.
Should any of these risks materialize, this could have a material adverse effect on its business, prospects, financial condition and results of operations. European data collection is governed by restrictive regulations governing the collection, use, processing and cross-border transfer of personal information.
Should any of these risks materialize, this could have a material adverse effect on its business, prospects, reputation, financial condition and results of operations. European data collection is governed by restrictive regulations governing the collection, use, processing and cross-border transfer of personal information.
For example, if the Company fails to meet its minimum cash covenant and Innate is unable to raise additional funds or obtain a waiver or other amendment to the Loan Agreement, Innate Pharma may be required to delay, limit, reduce or terminate certain of its clinical development efforts.
For example, if the Company fails to meet its minimum cash covenant and Innate is unable to raise additional funds or obtain a waiver or other amendment to the Loan Agreement, Innate may be required to delay, limit, reduce or terminate certain of its clinical development efforts.
If the Company does not succeed in maintaining the appropriate level of internal control, it could result in material misstatements in its financial statements, result in the loss of investor confidence in the reliability 47 of its financial statements and subject it to regulatory scrutiny and sanctions, which in turn could harm the market value of its ordinary shares and ADSs.
If the Company does not succeed in maintaining the appropriate level of internal control, it could result in material misstatements in its financial statements, result in the loss of investor confidence in the reliability of its financial statements and subject it to regulatory scrutiny and sanctions, which in turn could harm the market value of its ordinary shares and ADSs.
If the Company is found to infringe a third party’s intellectual property rights, and the Company is unsuccessful in demonstrating that such rights are invalid or unenforceable, the Company could be required to: • bear the potentially significant costs of proceedings brought against us; 56 • pay damages, which may include treble damages and attorney’s fees if the Company is found to have willfully infringed a third party’s patent rights; • cease developing, manufacturing and commercializing the infringing technology or product candidates; and • acquire a license to such third-party intellectual property rights, which may not be available on commercially reasonable terms, or at all, and may be non-exclusive, thereby giving the Company's competitors and other third parties access to the same technologies licensed to us.
If the Company is found to infringe a third party’s intellectual property rights, and the Company is unsuccessful in demonstrating that such rights are invalid or unenforceable, the Company could be required to: • bear the potentially significant costs of proceedings brought against us; • pay damages, which may include treble damages and attorney’s fees if the Company is found to have willfully infringed a third party’s patent rights; • cease developing, manufacturing and commercializing the infringing technology or product candidates; and 54 • acquire a license to such third-party intellectual property rights, which may not be available on commercially reasonable terms, or at all, and may be non-exclusive, thereby giving the Company's competitors and other third parties access to the same technologies licensed to us.
The transfer of the manufacturing process to another contract manufacturing organization took a few months and came with additional costs but allowed Innate to have a conform batch in the middle of 2020 and to resume the enrollment and treatment of patients in the clinical trials after getting Regulatory Agencies' approval.
The transfer of the manufacturing process to another contract manufacturing organization took a few months and came with additional costs but allowed Innate to have a conform batch in the middle of 2020 32 and to resume the enrollment and treatment of patients in the clinical trials after getting Regulatory Agencies' approval.
If the Company is not a foreign private issuer, Innate Pharma will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer.
If the Company is not a foreign private issuer, Innate will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer.
If competing products are marketed before Innate's ones, or at lower prices, or cover a wider therapeutic spectrum, or if they prove to be more effective or better tolerated, the Company's business, prospects, financial condition and results of operations could be affected.
If competing products are marketed before Innate's products, or at lower prices, or cover a wider therapeutic spectrum, or if they prove to be more effective or better tolerated, the Company's business, prospects, financial condition and results of operations could be affected.
If the physicians or other providers or entities with whom the Company expects to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
If the physicians or other providers or entities with whom the 30 Company expects to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase the Company's costs and could increase its overall 32 compliance risk.
This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase the Company's costs and could increase its overall compliance risk.
The Company does not and will not have access to all information regarding its product candidates that are subject to collaboration and license agreements. Consequently, its ability to inform its shareholders about the status of product candidates that are subject to these agreements, and its ability to make business and operational decisions, may be limited.
The Company does not and will not have access to all information regarding its product candidates that are subject to collaboration and license agreements. Consequently, its ability to inform its 37 shareholders about the status of product candidates that are subject to these agreements, and its ability to make business and operational decisions, may be limited.
The Company may request priority review for its product candidates. The FDA has broad discretion with respect to whether or not to grant priority review status to a product candidate, so even if the Company believes a particular product candidate is eligible for such 30 designation or status, the FDA may decide not to grant it.
The Company may request priority review for its product candidates. The FDA has broad discretion with respect to whether or not to grant priority review status to a product candidate, so even if the Company believes a particular product candidate is eligible for such designation or status, the FDA may decide not to grant it.
By definition, the financing, design and conduct of an investigator-sponsored trial are the sole responsibility of the sponsor, and the Company or its collaborators, as applicable, have limited control over these 35 aspects of these clinical trials, or the timing and reporting of the data from these trials.
By definition, the financing, design and conduct of an investigator-sponsored trial are the sole responsibility of the sponsor, and the Company or its collaborators, as applicable, have limited control over these aspects of these clinical trials, or the timing and reporting of the data from these trials.
The portion of tax credit in excess which is not being offset, if any, represents a receivable against the French Treasury which can in principle be offset against the French corporate income tax due by the company with respect to the three following years.
The 42 portion of tax credit in excess which is not being offset, if any, represents a receivable against the French Treasury which can in principle be offset against the French corporate income tax due by the company with respect to the three following years.
Therefore, its ability to keep its shareholders informed about the status of product candidates subject to such agreements will be limited by the degree to which its collaborators keep Innate informed and allow Innate Pharma to disclose information to the public or provide such information to the public themselves.
Therefore, its ability to keep its shareholders informed about the status of product candidates subject to such agreements will be limited by the degree to which its collaborators keep Innate informed and allow Innate to disclose information to the public or provide such information to the public themselves.
Monalizumab is currently being investigated in multiple Phase 1, Phase 2 and Phase 3 clinical studies under a co-development agreement with AstraZeneca. Lacutamab is currently being investigated in an open-label, multi-cohort Phase 2 clinical study in CTCL and in Phases 1 and 2 in PTCL. IPH5201 is currently being investigated in an open-label Phase 2 clinical study.
Monalizumab is currently being investigated in multiple Phase 1, Phase 2 and Phase 3 clinical studies under a co-development agreement with AstraZeneca. Lacutamab is currently being investigated in an open-label, multi-cohort Phase 2 clinical study in CTCL and in a Phase 2 in PTCL. IPH5201 is currently being investigated in an open-label Phase 2 clinical study.
However, there is no assurance the Company will be able to receive orphan drug designation for other product candidates 29 that the Company may develop in the United States and/or Europe or for any other product candidate in any jurisdiction.
However, there is no assurance the Company will be able to receive orphan drug designation for other product candidates that the Company may develop in the United States and/or Europe or for any other product candidate in any jurisdiction.
The Company incurs some of its expenses, and derives certain of its revenues, in currencies other than the euro. In particular, as Innate expands its operations and conducts additional clinical studies in the United States, Innate will incur additional expenses in U.S. dollars.
The Company incurs some of its expenses, and derives certain of its revenues, in currencies other than the euro. In particular, as Innate expands its operations and conducts clinical studies in the United States, Innate will incur expenses in U.S. dollars.
In addition, increases in inflation raise the Company's costs for labor, materials and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact its financial condition.
In addition, increases in inflation raise the Company's costs for labor, materials and services and other costs required to grow and operate its business, and failure to secure these on reasonable terms may adversely impact its financial condition.
Department of Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.
Department of 26 Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.
Although the Company is involved in establishing the protocols for the production of these materials, the Company does not control all the stages of production and cannot guarantee that the third parties will fulfil their contractual and regulatory obligations.
Although the Company is involved in establishing the protocols for the production of these materials, the Company does not control all the 33 stages of production and cannot guarantee that the third parties will fulfil their contractual and regulatory obligations.
Innate Pharma currently depends to a large degree on these milestone payments from its existing collaborators in order to fund its operations, and Innate may enter into new collaboration agreements that also provide for milestone payments.
Innate currently depends to a large degree on these milestone payments from its existing collaborators in order to fund its operations, and Innate may enter into new collaboration agreements that also provide for milestone payments.
As a public company listed in the United States, the Sarbanes-Oxley Act requires, among other things, that the Company assess the effectiveness of its internal control over financial reporting as of the end of 46 each fiscal year.
As a public company listed in the United States, the Sarbanes-Oxley Act requires, among other things, that the Company assess the effectiveness of its internal control over financial reporting as of the end of each fiscal year.
The risks inherent in entry into these contracts are as follows: • the negotiation and execution of these agreements is a long process that may not result in an agreement being signed or that can delay the development or commercialization of the product candidate concerned; • these agreements are subject to cancellation or non-renewal by its collaborators or may not be fully complied with by its collaborators; • in the case of a license granted by us, the Company loses control of the development of the product candidate licensed; in such cases the Company would have only limited control over the means and resources allocated by its partner for the commercialization of its product; and • collaborators may not properly obtain, maintain, enforce or defend Innate's intellectual property or proprietary rights or may use its proprietary information in such a way as to invite litigation that could jeopardize or invalidate its proprietary information or expose the Company to potential litigation.
The risks inherent in entry into these contracts are as follows: • the negotiation and execution of these agreements is a long process that may not result in an agreement being signed or that can delay the development or commercialization of the product candidate concerned; • these agreements are subject to cancellation or non-renewal by its collaborators or may not be fully complied with by its collaborators; • in the case of a license granted by Innate, the Company loses control of the development of the product candidate licensed; in such cases the Company would have only limited control over the means and resources allocated by its partner for the commercialization of its product; and 36 • collaborators may not properly obtain, maintain, enforce or defend Innate's intellectual property or proprietary rights or may use its proprietary information in such a way as to invite litigation that could jeopardize or invalidate its proprietary information or expose the Company to potential litigation.
Innate may encounter numerous difficulties in developing, manufacturing and marketing any new products resulting from an acquisition that delays or prevents Innate from realizing their expected benefits or enhancing its business.
Innate may encounter numerous difficulties in developing, manufacturing and marketing any new products resulting from an acquisition that delays or prevents Innate from realizing their expected benefits or enhancing its 50 business.
These and other market and industry factors may cause the market price and demand for Innate's ordinary shares and ADSs to fluctuate substantially, regardless of its actual operating performance, which may limit or prevent investors from readily selling their ordinary shares or ADSs and may otherwise negatively affect the liquidity of the trading market for the ordinary shares and ADSs. 65 If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about Innate's business, the price of the ordinary shares or ADSs and their trading volume could decline.
These and other market and industry factors may cause the market price and demand for Innate's ordinary shares and ADSs to fluctuate substantially, regardless of its actual operating performance, which may limit or prevent investors from readily selling their ordinary shares or ADSs and may otherwise negatively affect the liquidity of the trading market for the ordinary shares and ADSs. 63 If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about Innate's business, the price of the ordinary shares or ADSs and their trading volume could decline.
If the Company is not able to effectively expand its organization by hiring new employees and expanding its groups of consultants and contractors, it may not be able to successfully implement the tasks necessary to further develop and commercialize its product candidates and, accordingly, may not achieve its research, development and commercialization goals. 49 The Company depends on qualified management personnel, and its business could be harmed if Innate loses key personnel and cannot attract new personnel.
If the Company is not able to effectively expand its organization by hiring new employees and expanding its groups of consultants and contractors, it may not be able to successfully implement the tasks necessary to further develop and commercialize its product candidates and, accordingly, may not achieve its research, development and commercialization goals. 47 The Company depends on qualified management personnel, and its business could be harmed if Innate loses key personnel and cannot attract new personnel.
However, Innate cannot guarantee that it has entered into such agreements with each party that may have or have had access to its trade secrets and confidential information, and these agreements may be breached, and Innate may not have adequate remedies for any breach. 62 In addition to contractual measures, the Company tries to protect the confidential nature of its proprietary information using physical and technological security measures.
However, Innate cannot guarantee that it has entered into such agreements with each party that may have or have had access to its trade secrets and confidential information, and these agreements may be breached, and Innate may not have adequate remedies for any breach. 60 In addition to contractual measures, the Company tries to protect the confidential nature of its proprietary information using physical and technological security measures.
Under the Loan Agreement, an event of default will occur if, among other things, Innate fails to make payments under the Loan Agreement or Innate breaches its covenant under the Loan Agreement.
Under the Loan Agreement, an event of default will occur if, 40 among other things, Innate fails to make payments under the Loan Agreement or Innate breaches its covenant under the Loan Agreement.
In the future, the Company would lose its foreign private issuer status if the Company fails to meet the requirements necessary to maintain its foreign private issuer status as of the relevant determination date.
In the future, 70 the Company would lose its foreign private issuer status if the Company fails to meet the requirements necessary to maintain its foreign private issuer status as of the relevant determination date.
This could prove to be impossible or costly in terms of time and financial resources and could be detrimental to Innate's marketing efforts. Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 63 Intellectual property rights do not necessarily address all potential threats.
This could prove to be impossible or costly in terms of time and financial resources and could be detrimental to Innate's marketing efforts. Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 61 Intellectual property rights do not necessarily address all potential threats.
If clinical investigators or CROs fail to meet their obligations to Innate or comply with GCP procedures or other applicable legal requirements, the data generated in these trials may be deemed unreliable, and the FDA, EMA or comparable foreign regulatory authorities may require Innate to perform additional studies before approving Innate Pharma's marketing applications.
If clinical investigators or CROs fail to meet their obligations to Innate or comply with GCP procedures or other applicable legal requirements, the data generated in these trials may be deemed unreliable, and the FDA, EMA or comparable foreign regulatory authorities may require Innate to perform additional studies before approving Innate's marketing applications.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that the Company may consider attractive. These established 61 companies may have a competitive advantage over Innate due to their size, capital resources and greater clinical development and commercialization capabilities.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that the Company may consider attractive. These established 59 companies may have a competitive advantage over Innate due to their size, capital resources and greater clinical development and commercialization capabilities.
The value of the 73 Company’s assets may be determined in large part by reference to the market value of the ordinary shares or ADSs, which may fluctuate substantially.
The value of the Company’s assets may be determined in large part by reference to the market value of the ordinary shares or ADSs, which may fluctuate substantially.
As a foreign private issuer, the Company is permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance 71 listing standards, and these practices may afford less protection to shareholders than they would enjoy if Innate complied fully with Nasdaq corporate governance listing standards.
As a foreign private issuer, the Company is permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance 69 listing standards, and these practices may afford less protection to shareholders than they would enjoy if Innate complied fully with Nasdaq corporate governance listing standards.
Its near-term prospects depend heavily on AstraZeneca’s successful clinical development and commercialization of monalizumab, as well as the successful clinical 13 development of its other product candidates.
Its near-term prospects depend heavily on AstraZeneca’s successful clinical development and commercialization of monalizumab, as well as the successful clinical development of its other product candidates.
Litigation may be necessary to resolve an ownership dispute, and if the Company is not successful, Innate may be precluded from using certain intellectual property, may lose its exclusive rights in such 60 intellectual property or may be required to acquire a license to such intellectual property, which may not be available on commercially reasonable terms or at all.
Litigation may be necessary to resolve an ownership dispute, and if the Company is not successful, Innate may be precluded from using certain intellectual property, may lose its exclusive rights in such 58 intellectual property or may be required to acquire a license to such intellectual property, which may not be available on commercially reasonable terms or at all.
Moreover, in 2022, AstraZeneca informed Innate Pharma of the discontinuation of the Interlink-1 Phase 3 clinical study assessing monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, as this combination did not meet a pre-defined threshold for efficacy.
For example, in 2022, AstraZeneca informed Innate Pharma of the discontinuation of the Interlink-1 Phase 3 clinical study assessing monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, as this combination did not meet a pre-defined threshold for efficacy.
If these shareholders or ADS holders sell substantial amounts of ordinary shares or ADSs in the public market, or the market perceives that such sales may occur, the 66 market price of Innate's ADSs or ordinary shares and its ability to raise capital through an issue of equity securities in the future could be adversely affected.
If these shareholders or ADS holders sell substantial amounts of ordinary shares or ADSs in the public market, or the market perceives that such sales may occur, the 64 market price of Innate's ADSs or ordinary shares and its ability to raise capital through an issue of equity securities in the future could be adversely affected.
The Inflation Reduction Act of 2022 also caps Medicare beneficiaries’ annual out-of-pocket drug expenses. Substantial penalties can be assessed for noncompliance with the IRA drug pricing provisions. Provisions of the IRA are subject to legal challenges, and the full impact of the IRA on the pharmaceutical industry remains uncertain. The U.S.
The Inflation Reduction Act of 2022 also caps Medicare beneficiaries’ annual out-of-pocket drug expenses. Substantial penalties can be assessed for noncompliance with the IRA drug pricing provisions. Provisions of the IRA are subject to legal challenges, and the full impact of the IRA on the pharmaceutical industry remains uncertain.
The government can exercise its march-in rights if it determines that action is necessary because the Company failed to achieve practical 55 application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry.
The government can exercise its march-in rights if it determines that action is necessary because the Company failed to achieve practical 53 application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry.
The Company has agreements with AstraZeneca with respect to the advanced development, clinical study collaboration and potential future registration and marketing of several of its product candidates, including monalizumab and IPH5201, and with Sanofi for the research and development of IPH6101/SAR'579, IPH6401/SAR’514, IPH62 and of another program in solid tumors.
The Company has agreements with AstraZeneca with respect to the advanced development, clinical study collaboration and potential future registration and marketing of several of its product candidates, including monalizumab and IPH5201, and with Sanofi for the research and development of IPH6401/SAR’514, IPH62 and of another program in solid tumors.
These include imposing fines on us, imposing restrictions on the product or its manufacture and requiring Innate to recall or remove the product from the market. The regulators could also suspend or withdraw their marketing authorizations, requiring Innate to conduct additional clinical studies, change its product labeling or submit additional applications for marketing authorization.
These include imposing fines on the Company, imposing restrictions on the product or its manufacture and requiring Innate to recall or remove the product from the market. The regulators could also suspend or withdraw their marketing authorizations, requiring Innate to conduct additional clinical studies, change its product labeling or submit additional applications for marketing authorization.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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The innate immune system is comprised of a variety of cells, including Natural Killer cells (NK cells), which are involved in anti-cancer immunosurveillance through a variety of modalities. Activation of the innate immune system also helps trigger the adaptive immune system to elicit a response directed against specific antigens and can provide durable immune memory.
The innate immune system is comprised of a variety of cells, including Natural Killer (NK) cells, which are involved in anti-cancer immunosurveillance through a variety of modalities. Activation of the innate immune system also helps trigger the adaptive immune system to elicit a response directed against specific antigens and can provide durable immune memory.
A number of studies of bispecific antibodies are currently underway, such as those assessing the safety and efficacy of bispecific T cell engagers, such as BiTEs, which engage T cells via the antigen receptor on one side of the bispecific T cell engager, and a tumor antigen on the other side of the BiTE.
A number of studies of bispecific antibodies are currently underway, such as those assessing the safety and efficacy of bispecific T cell engagers (BiTEs), which engage T cells via the antigen receptor on one side of the bispecific T cell engager, and a tumor antigen on the other side of the BiTE.
Median PFS was 12.0 months (4.6-15.4) and Median Duration of Response was 10.2 months (4.6-NA). ◦ Patients in the KIR3DL2 ◦ Within the advanced and heavily pre-treated population enrolled in TELLOMAK, Lacutamab continues to demonstrates clinical activity with a favorable safety profile. ◦ Lacutamab showed low immunogenicity and reached target concentration in both the KIR3DL2 expressing and non-expressing patients. • In 2023, MF Cohorts 2 and 3 interim efficacy results according to updated guidelines were presented at the International Conference on Malignant Lymphoma and EORTC Cutaneous Lymphoma Tumour Group Annual Meeting congresses in June and October 2023, respectively. ◦ As of the March 4, 2022 data cutoff, patients in the KIR3DL2-expressing MF cohort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months.
Median PFS was 12.0 months (4.6-15.4) and Median Duration of Response was 10.2 months (4.6-NA). ◦ Patients in the KIR3DL2 ◦ Within the advanced and heavily pre-treated population enrolled in TELLOMAK, Lacutamab continues to demonstrates clinical activity with a favorable safety profile. ◦ Lacutamab showed low immunogenicity and reached target concentration in both the KIR3DL2 expressing and non-expressing patients. • In 2023, MF Cohorts 2 and 3 interim efficacy results according to updated guidelines were presented at the International Conference on Malignant Lymphoma and EORTC Cutaneous Lymphoma Tumour Group Annual Meeting congresses in June and October 2023, respectively. 85 ◦ As of the March 4, 2022 data cutoff, patients in the KIR3DL2-expressing MF cohort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months.
Clinical Trials in PTCL • Despite objective responses observed, the Company-sponsored Phase 1b clinical trial evaluating lacutamab as monotherapy in patients with KIR3DL2-expressing refractory/relapsing PTCL will 87 not be reopened to recruitment as the prespecified threshold for meaningful clinical activity was not reached. • At the ASH Annual Congress 2023, Innate presented a poster with preclinical data demonstrating a synergistic effect between lacutamab and chemotherapy in preclinical models of PTCL, supporting the rationale for combination strategy in this clinical indication. • The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing.
Clinical Trials in PTCL • Despite objective responses observed, the Company-sponsored Phase 1b clinical trial evaluating lacutamab as monotherapy in patients with KIR3DL2-expressing refractory/relapsing PTCL will not be reopened to recruitment as the prespecified threshold for meaningful clinical activity was not reached. • At the ASH Annual Congress 2023, Innate presented a poster with preclinical data demonstrating a synergistic effect between lacutamab and chemotherapy in preclinical models of PTCL, supporting the rationale for combination strategy in this clinical indication. • The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing.
Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; 126 • the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created additional federal criminal laws that prohibit, among other things, knowingly and willfully 124 executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; • the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
Fast Track designation does not necessarily lead to a Priority Review or Accelerated Approval. 121 • The Breakthrough Therapy Designation: Section 506(a) of the FDCA provides for designation of a drug as a breakthrough therapy “if the drug is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The standard for breakthrough therapy designation is not the same as the standard for drug approval as the clinical evidence needed to support breakthrough designation is preliminary.
Fast Track designation does not necessarily lead to a Priority Review or Accelerated Approval. • The Breakthrough Therapy Designation: Section 506(a) of the FDCA provides for designation of a drug as a breakthrough therapy “if the drug is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The standard for breakthrough therapy designation is not the same as the standard for drug approval as the clinical evidence needed to support breakthrough designation is preliminary.
Clinical results in Sézary Syndrome (SS) (Cohort 1) • Final results from the Phase 2 TELLOMAK study in Sézary Syndrome were presented at the ASH Meeting in December 2023. ◦ As of May 1, 2023, the study’s data cutoff, patients in the Sézary Syndrome cohort (cohort 1, n=56) received a median of five prior systemic therapies, including mogamulizumab, and had a median follow-up of 14.4 months. 85 ◦ The data demonstrated that lacutamab showed robust clinical activity and an overall favorable safety profile.
Clinical results in Sézary Syndrome (SS) (Cohort 1) • Final results from the Phase 2 TELLOMAK study in Sézary Syndrome were presented at the ASH Meeting in December 2023. ◦ As of May 1, 2023, the study’s data cutoff, patients in the Sézary Syndrome cohort (cohort 1, n=56) received a median of five prior systemic therapies, including mogamulizumab, and had a median follow-up of 14.4 months. ◦ The data demonstrated that lacutamab showed robust clinical activity and an overall favorable safety profile.
Some Phase 1b studies evaluate biomarkers or surrogate markers that may be associated with efficacy in patients with specific types of diseases. • Phase 2: This Phase involves clinical trials 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 and to determine dosage tolerance and appropriate dosage. 117 • Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites.
Some Phase 1b studies evaluate biomarkers or surrogate markers that may be associated with efficacy in patients with specific types of diseases. • Phase 2: This Phase involves clinical trials 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 and to determine dosage tolerance and appropriate dosage. • Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites.
Several NK cell therapies have been shown to induce antitumor responses, without the complications frequently associated with T cell therapies, such as cytokine release syndrome (CRS) or neurotoxicity. b. Indication and Rationale Acute myeloid leukemia (AML) is the most common acute leukemia in adults, mostly affecting elderly patients, with a median age at diagnosis of 65-70 years.
Several NK cell therapies have been shown to induce antitumor responses, without the complications frequently associated with T cell therapies, such as cytokine release syndrome (CRS) or neurotoxicity. 91 b. Indication and Rationale Acute myeloid leukemia (AML) is the most common acute leukemia in adults, mostly affecting elderly patients, with a median age at diagnosis of 65-70 years.
It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform. b. Clinical trial A Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626) is evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA).
It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform. b. Clinical trial 95 A Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626) is evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA).
NK cell-based therapies may provide new treatment perspectives and a safer alternative for targeting tumor cells in this context. 103 c. Preclinical Development In its preclinical studies, Innate and Sanofi investigated whether NKp46-based NKCE technology could provide more effective antitumor activity than regular IgG antibodies for AML treatment by generating a NKCE molecule targeting CD123.
NK cell-based therapies may provide new treatment perspectives and a safer alternative for targeting tumor cells in this context. c. Preclinical Development In its preclinical studies, Innate and Sanofi investigated whether NKp46-based NKCE technology could provide more effective antitumor activity than regular IgG antibodies for AML treatment by generating a NKCE molecule targeting CD123.
Compared to a classical IgG1-based antibody which engages Fc receptors and a tumor antigen, IPH6501 co-engages on one hand NKp46 and Fc receptors, as well as CD122 subunit of the IL-2 receptor (but not CD25 subunit), and on the other hand CD20 as a targeted antigen on malignant B cells, leading to potent NK cell activation, cytotoxicity and control of tumor growth.
Compared to a classical IgG1-based antibody which engages Fc receptors and a tumor antigen, IPH6501 co-engages on one hand NKp46 and Fc receptors, as well as CD122 subunit of the IL-2 receptor (but not CD25 subunit), and on the other hand CD20 as a targeted 96 antigen on malignant B cells, leading to potent NK cell activation, cytotoxicity and control of tumor growth.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There are also continuing, annual user fee requirements for any marketed products and the establishments at which such 124 products are manufactured, as well as new application fees for supplemental applications with clinical data.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There are also continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
Innate Pharma France S.A.S. was dissolved without liquidation on November 30, 2020, under article 1844-5, Section 3 of the French Civil Code. 74 The Company is registered at the Marseille Business and Company Registry ( Registre du commerce et des sociétés ) under the number SIREN 424 365 336 RCS Marseille.
Innate Pharma France S.A.S. was dissolved without liquidation on November 30, 2020, under article 1844-5, Section 3 of the French Civil Code. The Company is registered at the Marseille Business and Company Registry ( Registre du commerce et des sociétés ) under the number SIREN 424 365 336 RCS Marseille.
In a post hoc analysis of seven patients with Sézary syndrome who were previously treated with mogamulizumab, three (43%) achieved a global overall response and three others had stable disease as best response. The remaining patient had a progressive 83 disease. The median duration of response in these patients was 13.8 months and median progression-free survival was 16.8 months.
In a post hoc analysis of seven patients with Sézary syndrome who were previously treated with mogamulizumab, three (43%) achieved a global overall response and three others had stable disease as best response. The remaining patient had a progressive disease. The median duration of response in these patients was 13.8 months and median progression-free survival was 16.8 months.
However, it remains unclear whether these multifunctional CD16 engager antibodies can activate NK cells in solid tumors since they often express low levels of CD16. ANKET ® (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer.
However, it remains unclear whether these multifunctional CD16 engager antibodies can activate NK cells in solid tumors since solid tumors often express low levels of CD16. ANKET ® (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer.
It is granted only if the benefit / risk ratio is positive, if the product addresses unmet medical needs, and if the benefits to public health outweigh the risks associated with uncertainty because of an incomplete evaluation of the drug (for instance, because of clinical trials still ongoing at the time of the evaluation, or when additional clinical trials are needed).
It is granted only if the benefit / risk ratio is positive, if the product addresses unmet medical needs, and if the benefits to public health outweigh the risks associated with uncertainty because of an incomplete evaluation of the drug (for instance, because of clinical trials still ongoing at the time of the 119 evaluation, or when additional clinical trials are needed).
Several studies have been published on the role of GemOx in patients with relapsed lymphoma and it is one of the most widely used regimens for this patient population in the United States, Europe and Asia (Mounier, 2013; Yamaguchi, 2012). c. Clinical Trials Below is a summary of the clinical trials of lacutamab. i.
Several studies have been published on the role of GemOx in patients with relapsed lymphoma and it is one of the most widely used regimens for this patient population in the United States, Europe and Asia (Mounier, 2013; Yamaguchi, 2012). 81 c. Clinical Trials Below is a summary of the clinical trials of lacutamab. i.
Separately, AstraZeneca evaluated the effectiveness and safety of neoadjuvant durvalumab alone or in combination with monalizumab or oleclumab in subjects with resectable, early-stage (Stage I [>2 cm] to IIIA) non-small cell lung cancer (NeoCOAST) and in 2022 initiated the Phase 2 trial, NeoCOAST-2, with neoadjuvant and adjuvant treatment, that includes an arm with durvalumab in combination with chemotherapy and monalizumab. iii.
Separately, AstraZeneca evaluated the effectiveness and safety of neoadjuvant durvalumab alone or in combination with monalizumab or oleclumab in subjects with resectable, early-stage (Stage I [>2 cm] to IIIA) non-small cell lung cancer (NeoCOAST) and in 2022 initiated the Phase 2 trial, NeoCOAST-2, with neoadjuvant and adjuvant treatment, that includes an arm with durvalumab in combination with chemotherapy and monalizumab.
In the Part II-Expansion cohort, a total of 12 HER2 + cancer patients, respectively six breast cancer patients and six gastric cancer patients, are planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
In the Part II-Expansion cohort, a total of 12 HER2 + 107 cancer patients, respectively six breast cancer patients and six gastric cancer patients, are planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
To support its evaluation, the FDA may request advice from an advisory committee. Preliminary plans on whether to hold an advisory committee are included in the Day 74 Letter. The FDA requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and 119 applications for marketing approval of drug products.
To support its evaluation, the FDA may request advice from an advisory committee. Preliminary plans on whether to hold an advisory committee are included in the Day 74 Letter. The FDA requests advice from advisory committees on a variety of matters, including various aspects of clinical investigations and applications for marketing approval of drug products.
Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. • In dose levels with a highest dose of 1000 μg/kg QW, 5 out of 15 (33.3%) AML patients achieved a complete remission, or CR, (4 CRs and 1 CR with incomplete hematological recovery) as of the cut-off date. 105 • Data from preliminary pharmacokinetics / pharmacodynamic and in vitro mechanistic analyses studying dose-response relations were also presented. • SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML.
Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. • In dose levels with a highest dose of 1000 μg/kg QW, 5 out of 15 (33.3%) AML patients achieved a complete remission, or CR, (4 CRs and 1 CR with incomplete hematological recovery) as of the cut-off date. • Data from preliminary pharmacokinetics / pharmacodynamic and in vitro mechanistic analyses studying dose-response relations were also presented. 94 • SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML.
Eudra-CT will be definitively abandoned at the end of the transition period, i.e., on January 30, 2025. Information related to the product, patient population, Phase of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration.
Eudra-CT will be definitively abandoned at the end of the transition period, i.e., on January 30, 2025. Information related to the product, patient population, Phase of investigation, study sites and 115 investigators, and other aspects of the clinical trial is then made public as part of the registration.
Orphan medicinal products are also eligible for financial incentives such as reduction of fees or fee waivers and scientific assistance for study proposals. (Articles 6 and 9 of the above-mentioned regulation). The application for orphan drug 123 designation must be submitted before the application for marketing authorization (Article 5).
Orphan medicinal products are also eligible for financial incentives such as reduction of fees or fee waivers and scientific assistance for study proposals. (Articles 6 and 9 of the above-mentioned regulation). The application for orphan drug designation must be submitted before the application for marketing authorization (Article 5).
Peripheral T Cell Lymphoma PTCL is a diverse group of aggressive non-Hodgkin’s lymphomas that develop from mature T cells and NK cells. PTCL arises in the lymphoid tissues outside of the bone marrow, such as in the lymph nodes, spleen, gastrointestinal tract and skin (Hsi, 2017).
Peripheral T Cell Lymphoma PTCL is a diverse group of aggressive non-Hodgkin’s lymphomas that develop from mature T cells and NK cells. PTCL arises in the lymphoid tissues outside of the bone marrow, such as in the lymph nodes, 80 spleen, gastrointestinal tract and skin (Hsi, 2017).
For 2021, estimates for the United States include 81,560 new cases and 20,720 deaths from NHL (American Cancer Society 2021a, American Cancer Society 2021b). In 2020, Europe had 122,979 new cases of NHL reported, and 107 49,684 deaths were attributable to NHL (World Health Organization (WHO) 2020).
For 2021, estimates for the United States include 81,560 new cases and 20,720 deaths from NHL (American Cancer Society 2021a, American Cancer Society 2021b). In 2020, Europe had 122,979 new cases of NHL reported, and 49,684 deaths were attributable to NHL (World Health Organization (WHO) 2020).
For more information regarding the risks related to intellectual property, please see “Risk Factors—Risks Related to Intellectual Property Rights.” Patents The Company files patent applications to protect its product candidates, technical processes and the processes used to prepare its product candidates, the compounds or molecules contained in these product candidates and medical treatment methods.
For more information regarding the risks related to intellectual property, please see “Risk Factors—Risks Related to Intellectual Property Rights.” Patents The Company files patent applications to protect its product candidates, technical processes and the processes used to prepare its product candidates, the compounds or molecules contained in these product 110 candidates and medical treatment methods.
The FDA has agreed to specified performance goals in the BLA review process. Under that agreement, FDA committed to review and act on 90% of applications seeking approval of original BLA's within 10 months of the filing date and on 90% of original BLA submissions that have been designated for “priority review” within six months of the filing date.
The FDA has agreed to specified 116 performance goals in the BLA review process. Under that agreement, FDA committed to review and act on 90% of applications seeking approval of original BLA's within 10 months of the filing date and on 90% of original BLA submissions that have been designated for “priority review” within six months of the filing date.
The Commission may then adopt a final decision to grant an MA. Once granted, 120 the MA is valid across all EEA countries for an initial period of five years. Since 2008, as a consequence of a European directive, a marketing authorization is now renewed only once, five years after the initial registration.
The Commission may then adopt a final decision to grant an MA. Once granted, the MA is valid across all EEA countries for an initial period of five years. Since 2008, as a consequence of a European directive, a marketing authorization is now renewed only once, five years after the initial registration.
Multi-agent chemotherapy is the recommended first line treatment for the majority of patients with PTCL. Brentuximab vedotin is approved in combination with first line chemotherapy for patients with CD30- 82 positive PTCL. For patients who are eligible, subsequent stem cell transplantation is a potentially curative option but it is limited to a minority of patients.
Multi-agent chemotherapy is the recommended first line treatment for the majority of patients with PTCL. Brentuximab vedotin is approved in combination with first line chemotherapy for patients with CD30-positive PTCL. For patients who are eligible, subsequent stem cell transplantation is a potentially curative option but it is limited to a minority of patients.
The rationale for this combination is further supported by the favorable tolerability profile of monalizumab that the Company observed in preclinical studies and earlier clinical trials, suggesting that monalizumab is generally not expected to negatively impact the safety profile of combination partner drugs. c. Clinical Development Plan i.
The rationale for this combination is further supported by the favorable tolerability profile of monalizumab that the Company observed in preclinical studies and earlier clinical trials, suggesting that monalizumab is generally not expected to negatively impact the safety profile of combination partner drugs. c. Clinical Development Plan and results i.
High circulating NK cell numbers have been associated with better clinical responses to anti-CD20-targeting monoclonal antibodies, supporting the role of NK cells in efficacy of these treatments. c. Preclinical Development IPH6501 preclinical activity was explored both in vitro and in vivo.
High circulating NK cell numbers have been associated with better clinical responses 97 to anti-CD20-targeting monoclonal antibodies, supporting the role of NK cells in efficacy of these treatments. c. Preclinical Development IPH6501 preclinical activity was explored both in vitro and in vivo.
The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. Registration procedures in the European Union To access the European markets through community procedures, drug products must be submitted through the Centralized Procedure, the Mutual Recognition Procedure or the Decentralized Procedure.
The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. 117 Registration procedures in the European Union To access the European markets through community procedures, drug products must be submitted through the Centralized Procedure, the Mutual Recognition Procedure or the Decentralized Procedure.
Licensed biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label, including information consistent with the FDA required labeling and not otherwise false or misleading. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Licensed biologics 123 may be promoted only for the approved indications and in accordance with the provisions of the approved label, including information consistent with the FDA required labeling and not otherwise false or misleading. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it 116 represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.
An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.
The application includes all relevant data available from pertinent preclinical and clinical trials, including negative or ambiguous results as well as positive findings, 118 together with detailed information relating to the product’s chemistry, manufacturing, controls and proposed labeling, among other things.
The application includes all relevant data available from pertinent preclinical and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls and proposed labeling, among other things.
Patent term restoration and extension in the United States A patent claiming a new biologic product may be eligible for a limited patent term extension under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during 125 product development and the FDA regulatory review period.
Patent term restoration and extension in the United States A patent claiming a new biologic product may be eligible for a limited patent term extension under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review period.
That is why business activity may be subject to anti-bribery or anti-corruption laws, regulations or rules of other countries in which the Company operates, including without limitation the Foreign Corrupt Practices Act, the U.K. Bribery Act or the French Sapin 2 Law.
That is why business activity may 128 be subject to anti-bribery or anti-corruption laws, regulations or rules of other countries in which the Company operates, including without limitation the Foreign Corrupt Practices Act, the U.K. Bribery Act or the French Sapin 2 Law.
The global confirmed objective response rate, or ORR, was 37.5% (21 out of 56), including two complete responses and 19 partial responses. ORR in the skin was 46.4% (26 out of 56), including five complete responses and 21 partial responses and ORR in the blood was 48.2% (27 out of 56) with 15 CR and 12 PR.
The global confirmed objective response rate (ORR), was 37.5% (21 out of 56), including two complete responses and 19 partial responses. ORR in the skin was 46.4% (26 out of 56), including five complete responses and 21 partial responses and ORR in the blood was 48.2% (27 out of 56) with 15 CR and 12 PR.
By providing the initial catalyst for the multilayered immune response, the activation of the innate immune system through the targeting of NK cells could potentially result in an optimal anti-tumoral T cell response. 78 Innate Pharma's response to cancer: harnessing the innate immunity against cancer The Company has developed a pipeline around two main innovative strategies in modern immuno-oncology: • The first of these strategies is to directly target cancer cells through an antibody targeting a tumor antigen and causing its destruction. ◦ Innate's most advanced proprietary program, lacutamab, is a potentially first-in-class tumor-targeting antibody targeting KIR3DL2, seeking to induce the killing of cells expressing the tumor antigen.
By providing the initial catalyst for the multilayered immune response, the activation of the innate immune system through the targeting of NK cells could potentially result in an optimal anti-tumoral T cell response. 76 Innate Pharma's response to cancer: harnessing the innate immunity against cancer The Company has developed a pipeline around two main innovative strategies in modern immuno-oncology: • The first of these strategies is to directly target cancer cells through an antibody targeting a tumor antigen and causing its destruction. ◦ Innate's most advanced proprietary program, lacutamab, is a potentially first-in-class tumor-targeting antibody targeting KIR3DL2, seeking to induce the killing of cells expressing the tumor antigen.
Ongoing Clinical Trial IPH6101/SAR443579 is currently being evaluated in a Phase 1/2 clinical trial (NCT05086315) in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS).
Ongoing Clinical Trial • Phase 1/2 clinical trial monotherapy IPH6101/SAR443579 is currently being evaluated in a Phase 1/2 clinical trial (NCT05086315) in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS).
The Company cannot be sure 112 that patents will be granted with respect to any of its pending patent applications or to any patent applications filed by Innate in the future, nor can the Company be sure that any of its existing patents or any patents that may be granted to Innate in the future will be sufficient to protect its technology or will not be challenged, invalidated or circumvented.
The Company cannot be sure that patents will be granted with respect to any of its pending patent applications or to any patent applications filed by Innate in the future, nor can the Company be sure that any of its existing patents or any patents that may be granted to Innate in the future will be sufficient to protect its technology or will not be challenged, invalidated or circumvented.
The all-comers cohort was planned to recruit both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a companion diagnostic.
The all-comers cohort was planned to recruit both KIR3DL2 expressors and 82 non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a companion diagnostic.
Recent interim data from the Phase III AEGEAN study (NCT03800134) showed that perioperative durvalumab (anti-PD-L1) plus neoadjuvant CT significantly improved both pathological complete response (pCR) rate (17.2% in the durvalumab-based regimen arm vs 4.3% in the CT arm) and Event-Free Survival (EFS) (median not reached in the durvalumab-based regimen arm vs 25.9 months in the CT arm) in patients with resectable, Stage IIA–IIIB[N2] NSCLC. ii.
Recent interim data from the Phase III AEGEAN study (NCT03800134) showed that perioperative durvalumab (anti-PD-L1) plus neoadjuvant CT significantly improved both pathological complete response (pCR) rate (17.2% in the durvalumab-based regimen arm vs 4.3% in the CT arm) and Event-Free Survival (EFS) (median not reached in the durvalumab-based regimen arm vs 25.9 months in the CT arm) in patients with resectable, Stage IIA–IIIB[N2] NSCLC. 1.
Orphan drugs Generally, orphan drugs are drugs used for the prevention or treatment of life-threatening or serious rare conditions. 122 In the United States, the 1983 Orphan Drug Act was passed to encourage the development of drugs for rare disease or conditions.
Orphan drugs Generally, orphan drugs are drugs used for the prevention or treatment of life-threatening or serious rare conditions. In the United States, the 1983 Orphan Drug Act was passed to encourage the development of drugs for rare disease or conditions.
Surrogate moIPH6501 also showed 108 a dose dependent and significant control of tumor growth in a model of CD20-expressing B16F10 cells injected intravenously (IV) in immunocompetent mice, as shown in figure below. Updated preclinical data were presented at the European Hematology Association (EHA) congress in June 2023, including experiments on non-human primates and samples from R/R B-NHL patients.
Surrogate moIPH6501 also showed 98 a dose dependent and significant control of tumor growth in a model of CD20-expressing B16F10 cells injected intravenously (IV) in immunocompetent mice, as shown in figure below. Updated preclinical data were presented at the European Hematology Association (EHA) congress in June 2023, including experiments on non-human primates and samples from R/R B-NHL patients.
In certain specific cases, entities processing health personal data may have to comply with article L1111-8 of the French Public Health Code which imposes certain certifications for the hosting service providers. C. Organizational Structure. On December 31, 2023, Innate Pharma is the sole shareholder of Innate Pharma Inc., a Delaware corporation. D. Property, Plants and Equipment.
In certain specific cases, entities processing health personal data may have to comply with article L1111-8 of the French Public Health Code which imposes certain certifications for the hosting service providers. C. Organizational Structure. On December 31, 2024, Innate Pharma is the sole shareholder of Innate Pharma Inc., a Delaware corporation. D. Property, Plants and Equipment.
Public information includes clinical trial authorization information, protocol data, and a summary of the results 12 months after the end of the trial (or six months in case of pediatric clinical trials).
Public information includes 113 clinical trial authorization information, protocol data, and a summary of the results 12 months after the end of the trial (or six months in case of pediatric clinical trials).
This approach has the potential to more effectively mobilize NK cells than anti-tumor cytotoxic antibodies because, in the TME of many solid tumors, CD16, the receptor mediating the killing of tumor cells by IgG1 antibodies can be downregulated on NK cells whereas NKp46 expression is frequently expressed on tumor-infiltrating NK cells. ◦ The Company is using its leading antibody engineering capabilities to generate classic antibody formats as well as new products by exploring antibody drug conjugate (ADC) formats. • Another strategy, known as immuno-oncology, consists in unleashing the immune system against cancer.
This approach has the potential to more effectively mobilize NK cells than anti-tumor cytotoxic antibodies because, in the tumor's microenvironment (TME) of many solid tumors, CD16, the receptor mediating the killing of tumor cells by IgG1 antibodies can be downregulated on NK cells whereas NKp46 expression is frequently expressed on tumor-infiltrating NK cells. ◦ The Company is using its antibody engineering capabilities to generate classic antibody formats as well as new products by exploring antibody drug conjugate (ADC) formats. • Another strategy, known as immuno-oncology, consists of unleashing the immune system against cancer.
These competitors are also likely to compete with Innate to recruit and retain top qualified scientific and management personnel, acquire rights for promising product candidates and technologies, establish clinical trial sites and patient registration for clinical trials, acquire 111 technologies complementary to, or necessary for, its programs and enter into collaborations with potential partners who have access to innovative technologies.
These competitors are also likely to compete with Innate to recruit 108 and retain top qualified scientific and management personnel, acquire rights for promising product candidates and technologies, establish clinical trial sites and patient registration for clinical trials, acquire technologies complementary to, or necessary for, its programs and enter into collaborations with potential partners who have access to innovative technologies.
Should Innate Pharma elect not to co-promote, its share of profits in Europe will be reduced by a specified amount of percentage points not to exceed the mid-single digits. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation on Innate’s financial commitment.
Should Innate Pharma elect not to co-promote, its share of profits in Europe will be reduced by a specified amount of percentage points not to exceed the mid-single digits. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation on Innate’s financial commitment. ANKET ® Platform a.
Certain 130 payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to enforcement actions.
Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to enforcement actions.
Lacutamab/Anti-KIR3DL2 As of December 31, 2023, the principal intellectual property rights related to lacutamab are wholly owned by Innate and include U.S. Patent Nos. 10,280,222 and 11,066,470, European patent EP 3 116 908 B1 and counterpart patent applications in certain other countries.
Lacutamab/Anti-KIR3DL2 As of December 31, 2024, the principal intellectual property rights related to lacutamab are wholly owned by Innate and include U.S. Patent Nos. 10,280,222 and 11,066,470, European patent EP 3 116 908 B1 and counterpart patent applications in certain other countries.
Innate's scientific expertise, strategic collaborations and discovery engine to seek to harness the potential of the innate immune system. 75 The Company is developing a pipeline of innovative immunotherapies that it believes have the potential to provide si gnificant clinical benefits to cancer patients. The following table summarizes Innate's current pipeline.
Innate's scientific expertise, strategic collaborations and discovery engine to seek to harness the potential of the innate immune system. 73 The Company is developing a pipeline of innovative immunotherapies that it believes have the potential to provide si gnificant clinical benefits to cancer patients. The following table summarizes Innate's current pipeline.
The Company also licenses rights to patents owned by third parties, academic partners or other companies in its field. Monalizumab/IPH2201 As of December 31, 2023, the principal intellectual property rights related to monalizumab are in-licensed from Novo Nordisk A/S and include U.S.
The Company also licenses rights to patents owned by third parties, academic partners or other companies in its field. Monalizumab/IPH2201 As of December 31, 2024, the principal intellectual property rights related to monalizumab are in-licensed from Novo Nordisk A/S and include U.S.
In addition, KIR3DL2 is expressed in T cell lymphoma: 65% of CTCL patients express KIR3DL2 with approximately 50% of 80 patients with MF, the most common type of CTCL expressing KIR3DL2 (Battistella, 2017). This frequency increases for the most aggressive CTCL subtypes, including 90% of Sézary syndrome (Roelens, 2019).
In addition, KIR3DL2 is expressed in T cell lymphoma: 65% of CTCL patients express KIR3DL2 with approximately 50% of patients with MF, the most common type of CTCL expressing KIR3DL2 (Battistella, 2017). This 78 frequency increases for the most aggressive CTCL subtypes, including 90% of Sézary syndrome (Roelens, 2019).
The Company has developed, internally and through its business development strategy, a broad and diversified portfolio including seven clinical product candidates and a robust preclinical pipeline. Innate has entered into collaborations with leaders in the biopharmaceutical industry, such as AstraZeneca and Sanofi.
The Company has developed, internally and through its business development strategy, a broad and diversified portfolio including eight clinical product candidates and a robust preclinical pipeline. Innate has entered into collaborations with leaders in the biopharmaceutical industry, such as AstraZeneca and Sanofi.
Lung Cancer: Phase 2 NeoCOAST-2 In June 2023, AstraZeneca presented at the ASCO conference a trial-in-progress poster on the NeoCOAST-2: study: "NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC)." NeoCOAST-2 started in April 2022 and continues to enroll patients. 92 v.
Lung Cancer: Phase 2 NeoCOAST-2 In June 2023, AstraZeneca presented at the ASCO conference a trial-in-progress poster on the NeoCOAST-2: study: "NeoCOAST-2: A Phase 2 study of neoadjuvant durvalumab plus novel immunotherapies (IO) and chemotherapy (CT) or MEDI5752 (volrustomig) plus CT, followed by surgery 89 and adjuvant durvalumab plus novel IO or volrustomig alone in patients with resectable non-small-cell lung cancer (NSCLC)." NeoCOAST-2 started in April 2022 and continues to enroll patients.
Treatment with CD123-NKCE promoted a sustained and complete depletion of CD123 + cells in the blood of all monkeys, for more than 10 days, at both the 3 mg/kg and 3 µg/kg doses, with only very small amounts ( 104 d.
Treatment with CD123-NKCE promoted a sustained and complete depletion of CD123 + cells in the blood of all monkeys, for more than 10 days, at both the 3 mg/kg and 3 µg/kg doses, with only very small amounts ( 93 d.
IPH5301/Anti-CD73 As of December 31, 2023, the principal intellectual property rights related to IPH5301 are solely owned by us, and include one U.S. non-provisional patent application, one European patent application, and other patent applications in certain other countries.
IPH5301/Anti-CD73 As of December 31, 2024, the principal intellectual property rights related to IPH5301 are solely owned by us, and include one U.S. non-provisional patent application, one European patent application, and other patent applications in certain other countries.
In March 2022, The Institut Paoli Calmettes announced that the first patient had been dosed. In December 2022, a "Trial in Progress" poster was presented by the Institut Paoli Calmettes at ESMO-IO 2022 congress (Goncalvez, ESMO-IO 2022, Poster 199, abstract 290). This trial is ongoing. ANKET ® Platform a.
In March 2022, The Institut Paoli Calmettes announced that the first patient had been dosed. In December 2022, a "Trial in Progress" poster was presented by the Institut Paoli Calmettes at ESMO-IO 2022 congress (Goncalvez, ESMO-IO 2022, Poster 199, abstract 290). This trial is ongoing.
IPH6501 As of December 31, 2023, the principal intellectual property rights related to IPH6501 are solely owned by us, and include one U.S. non-provisional patent application, one European patent application, and other patent applications in certain other countries.
IPH6501 As of December 31, 2024, the principal intellectual property rights related to IPH6501 are solely owned by us, and include one U.S. non-provisional patent application, one European patent application, and other patent applications in certain other countries.
With respect to the programs for which Innate Pharma has an existing collaboration or similar agreement, future contingent payments are dependent upon Innate's achievement of specified development, regulatory and commercial related milestones.
With respect to the programs f or which Innate Pharma has an existing collaboration or similar agreement, future contingent payments are dependent upon Innate's achievement of specified development, regulatory and commercial related milestones.
All together, these preclinical results indicate that CD73 blockade with IPH5301 has also the potential to enhance antitumor activity observed with not only PD1 immunotherapy, but also with chemotherapy and trastuzumab. 101 d. Ongoing Clinical Trial In December 2021, an investigator-sponsored Phase 1 trial of IPH5301 was initiated by the Institut Paoli-Calmettes.
All together, these preclinical results indicate that CD73 blockade with IPH5301 has also the potential to enhance antitumor activity observed with not only PD1 immunotherapy, but also with chemotherapy and trastuzumab. i. Ongoing Clinical Trial In December 2021, an investigator-sponsored Phase 1 trial of IPH5301 was initiated by the Institut Paoli-Calmettes.
These molecules have demonstrated the ability to reduce or slow the growth of tumors in cancer patients, but they also carry a significant toxicity risk. This toxicity risk occurs by engaging all T cells, irrespective of their specificity and development status, potentially leading to an overt production of cytokines by these T cells, referred to as a cytokine storm.
These molecules have demonstrated the ability to reduce or slow the growth of tumors in cancer patients, but they also carry a significant toxicity risk. This toxicity risk occurs by engaging all T cells, irrespective of their specificity and development status, potentially leading to an over production of cytokines by these T cells, referred to as a cytokine 90 storm.
The Centralized Procedure results in a single MA, granted by the European Commission that is valid across the European Economic Area or EEA (i.e., the European Union as well as Iceland, Liechtenstein and Norway).
The Centralized Procedure results in a single Marketing Authorization (MA), granted by the European Commission that is valid across the European Economic Area or EEA (i.e., the European Union as well as Iceland, Liechtenstein and Norway).
The ACA, among other things, imposed a significant annual fee on companies that manufacture or import branded prescription drug products; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations; and establishes a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
The ACA, among other things, imposed a significant annual fee on companies that manufacture or import branded prescription drug products; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations; and established a new Medicare Part D coverage gap discount program, in which manufacturers were required to agree to offer 50% point-of-sale discounts off 125 negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
Innate Pharma's collaborations with leaders in the biopharmaceutical industry, such as AstraZeneca and Sanofi, allow Innate to leverage the expertise and resources of large pharmaceutical companies and research institutions with the goal of accelerating the development, registration and launch of several of Innate Pharma's assets while providing the Company with financing to expand the development of its proprietary product candidates.
Innate Pharma's collaborations with leaders in the biopharmaceutical industry, such as AstraZeneca and Sanofi, allow Innate to leverage the expertise and resources of large pharmaceutical companies and research institutions with the goal of accelerating the development, registration and launch of several of Innate Pharma's assets while p roviding the Company with financing to expand the development of its proprietary product candidates.
For this reason, this pathway has attracted 79 significant development efforts that have been focused primarily on the downstream part of the adenosine degradation cascade, CD73 and the adenosine receptors.
For this reason, this pathway has attracted significant development efforts that have been focused primarily on the downstream part 77 of the adenosine degradation cascade, CD73 and the adenosine receptors.
Despite these approvals, current treatment guidelines (NCCN 2021) recommend participation in a clinical trial as a preferred option for patients with relapsed PTCL after first line treatment. If clinical trials are not available, a chemotherapy combination of gemcitabine and oxaliplatin (GemOx) is listed as one of the preferred treatment combinations (ESMO Lymphoma Guidelines).
Despite these approvals, current treatment guidelines (NCCN 2021) recommend participation in a clinical trial as a preferred option for patients with relapsed PTCL after first line treatment. If clinical trials are not available, a chemotherapy combination of gemcitabine and oxaliplatin (GemOx) is listed as one of the preferred treatment combinations (European Society for Medical Oncology (ESMO) Lymphoma Guidelines).
Innate's latest innovation, the tetra-specific ANKET ® molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an 102 IL-2 variant, IL-2v) via a single molecule.
Innate's latest innovation in the ANKET ® platform, the tetra-specific ANKET ® molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin (IL)-2 receptor (via an IL-2 variant, IL-2v) via a single molecule.
This application contains early research data as well as the pharmaceutical dossier, preclinical and clinical data (if any) and includes the clinical protocol. If there is no objection from the FDA, the IND application becomes valid 30 days after it is received by the FDA.
This application contains early research data as well as the pharmaceutical dossier, preclinical and clinical data (if any) and includes the clinical protocol. If there are no objections from the FDA, the IND application becomes valid 30 days after it is received by the FDA.
Under the terms of the license agreement, Innate has received an upfront payment of $5 million and is eligible to receive up to $410 million in future development, regulatory and commercial milestones if all milestones are achieved during the term of the agreement, plus royalties on potential net sales of any commercial product resulting from the license.
Under the terms of the license agreement, Innate has received an upfront payment of $5 million and would have been eligible to receive up to $410 million in future development, regulatory and commercial milestones if all milestones are achieved during the term of the agreement, plus royalties on potential net sales of any commercial product resulting from the license.
The latest drugs approved by the FDA for CTCL are: Adcetris (brentuximab vedotin), marketed by Seattle Genetics and approved in combination with chemotherapy for treatment of patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing MF who have received prior systemic therapy, and Poteligeo (mogamulizumab), marketed by Kyowa Kirin and approved for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
Adcetris (brentuximab vedotin), marketed by Seattle Genetics and approved in combination with chemotherapy for treatment of patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing MF who have received prior systemic therapy, and Poteligeo (mogamulizumab), marketed by Kyowa Kirin and approved for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
The partial clinical hold followed one fatal case of hemophagocytic lymphohistiocytosis, a rare hematologic disorder. In January 2024, Innate announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold.
The partial clinical hold followed one fatal case of hemophagocytic lymphohistiocytosis, a rare hematologic disorder. In January 2024, Innate announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold.
Under Innate's existing collaboration and license agreements that become effective upon the exercise by its collaborators of options to license future product candidates, the Company may be eligible to receive an aggregate of approximately up to $3.6 billion in future contingent payments.
Under Innate's existing collaboration and license agreements that become effective upon the exercise by its collaborators of options to license future product candidates, the Company may be eligible to receive an aggregate of approximately up to $2.8 billion in future contingent payments.
Monalizumab, a Dual Checkpoint Inhibitor Targeting T Cells and NK Cells a. Mechanism & Rationale Monalizumab (IPH2201) is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8 + T cells and NK cells. NKG2A is an inhibitory receptor for HLA-E.
Monalizumab, a Dual Checkpoint Inhibitor Targeting T Cells and NK Cells a. Mechanism & Rationale 86 Monalizumab (IPH2201) is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8 + T cells and NK cells. NKG2A is an inhibitory receptor for HLA-E (Human Leukocyte Antigen-E).
If a patent directed to IPH6501 issues from such U.S. patent application, it would have a statutory expiration date in 2042, not including patent term adjustment or any potential patent term extension. The term of individual patents depends upon the legal term of patents in the countries in which they are obtained.
If a patent directed to IPH45 issues from such U.S. patent 111 application, it would have a statutory expiration date in 2043, not including patent term adjustment or any potential patent term extension. The term of individual patents depends upon the legal term of patents in the countries in which they are obtained.
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas; monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types.
Innate’s portfolio includes our lead proprietary program lacutamab, developed for advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas indications; monalizumab developed with AstraZeneca for non-small cell lung cancer (NSCLC) indications, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types.
Next Step Competition The biotechnology and pharmaceutical industry, and notably the cancer field, is characterized by rapidly advancing technologies, products protected by intellectual property rights and intense competition and is subject to significant and rapid changes as researchers learn more about diseases and develop new technologies and treatments.
Next Steps for Clinical Trials Competition The biotechnology and pharmaceutical industry, and notably the cancer field, is characterized by rapidly advancing technologies, products protected by intellectual property rights and intense competition and is subject to significant and rapid changes as researchers learn more about diseases and develop new technologies and treatments.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Following the signature on June 1, 2022 of an amendment to the initial agreement signed in October 2018 specifying the terms of the collaboration following the decision to advance IPH5201 to a Phase 2 study, the parties are committed to sharing the external costs of the study incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial.
Following the signature on June 1, 2022 of an amendment to the initial agreement signed in October 2018 specifying the terms of the collaboration following the decision to advance IPH5201 to a Phase 2 study, the parties are committed to sharing the external costs of the study incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial.
This variation is mainly due to (i) the receipt of €25.0 million from Sanofi in March 2023 following the entry into force of the research collaboration and licensing agreement signed in December 2022 under which the Company granted Genzyme Corporation, a wholly-owned subsidiary of Sanofi ("Sanofi") an exclusive licence to Innate Pharma's B7H3 ANKET ® 163 program and options on two additional targets, (ii) the receipt in May 2023 of a payment of €4.6 million ($5.0 million) received from Takeda following the conclusion of an exclusive licensing agreement under which Innate granted Takeda exclusive worldwide rights for the research and development of ADCs, (iii) the receipt in July 2023 of €2.0 million following the treatment of the first patient in the Phase 1/2 clinical trial sponsored by Sanofi evaluating IPH6401/SAR'514 in patients with relapsed or refractory multiple myeloma.
This variation is mainly due to (i) the receipt of €25.0 million from Sanofi in March 2023 following the entry into force of the research collaboration and licensing agreement signed in December 2022 under which the Company granted Genzyme Corporation, a wholly-owned subsidiary of Sanofi ("Sanofi") an exclusive licence to Innate Pharma's B7H3 ANKET ® program and options on two additional targets, (ii) the receipt in May 2023 of a payment of €4.6 million ($5.0 million) received from Takeda following the conclusion of an exclusive licensing agreement under which Innate granted Takeda exclusive worldwide rights for the research and development of ADCs, (iii) the receipt in July 2023 of €2.0 million following the treatment of the first patient in the Phase 1/2 clinical trial sponsored by Sanofi evaluating IPH6401/SAR'514 in patients with relapsed or refractory multiple myeloma.
Year ended December 31, 2022 2023 (in thousands) Revenue from collaboration and licensing agreements € 49,580 € 51,901 Government financing for research expenditures 8,035 9,729 Other income 59 11 Revenue and other income 57,674 61,641 Research and development expenses (51,663) (56,022) General and administrative expenses (22,436) (18,288) Impairment of intangible assets (41,000) — Operating expenses (115,099) (74,310) Operating income (loss) (57,425) (12,669) Financial income 4,775 6,934 Financial expenses (5,321) (1,835) Net financial income (loss) (546) 5,099 Net income (loss) before tax (57,972) (7,570) Income tax expense — — Net income (loss) from continuing operations (57,972) (7,570) Net income (loss) from discontinued operations (131) — Net income (loss) € (58,103) € (7,570) Revenue and other income Revenue and other income from continuing operations resulted from collaboration and licensing agreements and government financing for research expenditure.
Year ended December 31, 2022 2023 (in thousands) Revenue from collaboration and licensing agreements € 49,580 € 51,901 Government financing for research expenditures 8,035 9,729 Sales 59 11 Revenue and other income 57,674 61,641 Research and development expenses (51,663) (56,022) General and administrative expenses (22,436) (18,288) Impairment of intangible assets (41,000) — Operating expenses (115,099) (74,310) Operating income (loss) (57,425) (12,669) Financial income 4,775 6,934 Financial expenses (5,321) (1,835) Net financial income (loss) (546) 5,099 Net income (loss) before tax (57,972) (7,570) Income tax expense — — Net income (loss) from continuing operations (57,972) (7,570) Net income (loss) from discontinued operations (131) — Net income (loss) € (58,103) € (7,570) Revenue and other income Revenue and other income from continuing operations resulted from collaboration and licensing agreements and government financing for research expenditure.
As a consequence, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2021 financial year in accordance with IFRS5 "non-current assets held for sale and discontinued operations." Thus, the net result from discontinued operations relating to Lumoxiti represents a net loss of €0.1 million as compared to a net loss nil for the years ended December 31, 2022 and 2023, respectively, presented as follows : 148 Year ended December 31, 2022 2023 Revenue and other income (in thousands) Revenue from collaboration and licensing agreements € 194 € — Sales 22 — Total revenue and other income 216 — Research and development expenses (1) — — Selling, general and administrative expenses (2) (346) — Total operating expenses (346) — Net income (loss) from distribution agreements — — Impairment of intangible assets — Operating income (loss) (131) — Financial income — — Financial expenses — — Net financial income (loss) — — Net income (loss) before tax (131) — Income tax expense — — Net income (loss) from discontinued operations (131) — (1) Research and development expenses .
As a consequence, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2021 financial year in accordance with IFRS5 "non-current assets held for sale and discontinued operations." Thus, the net result from discontinued operations relating to Lumoxiti represents a net loss of €0.1 million as compared to a net loss nil for the years ended December 31, 2022 and 2023, respectively, presented as follows : Year ended December 31, 2022 2023 Revenue and other income (in thousands) Revenue from collaboration and licensing agreements 194 € — Sales 22 — Total revenue and other income 216 — Research and development expenses (1) — — Selling, general and administrative expenses (2) (346) — Total operating expenses (346) — Net income (loss) from distribution agreements — — Impairment of intangible assets — — Operating income (loss) (131) — Financial income — — Financial expenses — — Net financial income (loss) — — Net income (loss) before tax (131) — Income tax expense — — Net income (loss) from discontinued operations (131) — (1) Research and development expenses .
As a consequence of the termination of the Lumoxiti Agreement, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2023, 2022 and 2021 financial years in accordance with IFRS5 "non-current assets held for sale and discontinued operations." The Company ability to generate significant product revenue and to become profitable will depend upon its ability to successfully develop, obtain regulatory approval for and commercialize any product candidates.
As a consequence of the termination of the Lumoxiti Agreement, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a 132 discontinued operation for the 2023, 2022 and 2021 financial years in accordance with IFRS5 "non-current assets held for sale and discontinued operations." The Company ability to generate significant product revenue and to become profitable will depend upon its ability to successfully develop, obtain regulatory approval for and commercialize any product candidates.
Innate's present and future funding requirements will depend on many factors, including, among other things: • the size, progress, timing and completion of its clinical trials and preclinical studies for any current or future product candidates, including its lead product candidates, monalizumab and lacutamab; • the number of potential new product candidates Innate identifies and decides to develop; • costs associated with its payment obligations to third parties in connection with its development and potential commercialization of certain of its product candidates; • costs associated with expanding its organization; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringement raised by third parties; 166 • the time and costs involved in obtaining regulatory approval for its product candidates and any delays the Company may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates; • the amount of revenues, if any, Innate Pharma may derive either directly, or in the form of milestone or royalty payments from any future potential partnership agreements, from monalizumab, IPH5201, IPH6101/SAR443579, IPH6401/SAR'514, B7H3 or other target or relating to its other product candidates.
Innate's present and future funding requirements will depend on many factors, including, among other things: • the size, progress, timing and completion of its clinical trials and preclinical studies for any current or future product candidates, including its lead product candidates, monalizumab and lacutamab; • the number of potential new product candidates Innate identifies and decides to develop; • costs associated with its payment obligations to third parties in connection with its development and potential commercialization of certain of its product candidates; • costs associated with expanding its organization; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringement raised by third parties; 165 • the time and costs involved in obtaining regulatory approval for its product candidates and any delays the Company may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates; • the amount of revenues, if any, Innate Pharma may derive either directly, or in the form of milestone or royalty payments from any future potential partnership agreements, from monalizumab, IPH5201, IPH6101/SAR443579, IPH6401/SAR'514, B7H3 or other target or relating to its other product candidates.
Such cost increases are expected to occur as the Company conducts existing clinical trials and initiates future clinical trials, manufactures pre-commercial clinical trial and preclinical study materials, expands its research and development efforts, seeks regulatory approvals for its product candidates that successfully complete clinical trials, accesses and develops additional technologies and hires additional personnel to support its research and development efforts.
Such cost increases are expected to occur as the Company conducts existing clinical trials and initiates future clinical trials, manufactures pre-commercial clinical trial and preclinical study materials, expands its research and development efforts, seeks regulatory approvals for its product candidates that successfully complete 134 clinical trials, accesses and develops additional technologies and hires additional personnel to support its research and development efforts.
For instruments for which the valuation may be subject to certain events, the Company has ensured that no such events have occurred a of December 31, 2023. Net result from discontinued operations Subsequently to the Termination and Transition Agreement, operations related to Lumoxiti are presented as a discontinued operation as of October 1, 2021.
For instruments for which the 155 valuation may be subject to certain events, the Company has ensured that no such events have occurred a of December 31, 2023. Net result from discontinued operations Subsequently to the Termination and Transition Agreement, operations related to Lumoxiti are presented as a discontinued operation as of October 1, 2021.
Year ended December 31, 2022 2023 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca 22,376 € 9,499 of which IPH5201 agreement - AstraZeneca 4,677 — of which preclinical molecules agreement - AstraZeneca 17,400 — of which Sanofi agreement 2016 4,000 2,000 of which Sanofi agreement 2022 - ANKET IPH62 - Recognition of license initial payment and income related to the completion of work in line with the joint research program — 18,873 of which Sanofi agreement 2022 - ANKET IPH67 -Recognition of license initial payment and income related to the option exercise — 15,800 of which Takeda agreement 2023 — 4,553 of which other agreements 353 — Proceeds from collaboration and licensing agreements 48,806 50,725 Invoicing of research and development costs (IPH5201) 1,391 1,165 Exchange gains (loss) on collaboration agreements (627) — Others 10 11 Revenue from collaboration and licensing agreements € 49,580 € 51,901 140 Proceeds related to monalizumab .
Year ended December 31, 2022 2023 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca 22,376 9,499 of which IPH5201 agreement - AstraZeneca 4,677 — of which preclinical molecules agreement - AstraZeneca 17,400 — of which Sanofi agreement 2016 4,000 2,000 of which Sanofi agreement 2022 - ANKET IPH62 - Recognition of license initial payment and income related to the completion of work in line with the joint research program — 18,873 of which Sanofi agreement 2022 - ANKET IPH67 -Recognition of license initial payment and income related to the option exercise — 15,800 of which Takeda agreement 2023 — 4,553 of which other agreements 353 — Proceeds from collaboration and licensing agreements 48,806 50,725 Invoicing of research and development costs (IPH5201) 1,391 1,165 Exchange gains (loss) on collaboration agreements (627) — Others 10 11 Revenue from collaboration and licensing agreements 49,580 € 51,901 148 Proceeds related to monalizumab .
Selling, general and administrative expenses also 137 consist of fees for professional services, mainly related to audit, IT, accounting, recruitment and legal services, communication and travel costs, real-estate leasing costs, office furniture and equipment costs, allowance for amortization and depreciation, director’s attendance fees and insurance costs and overhead costs, such as postal and telecommunications expenses.
Selling, general and administrative expenses also consist of fees for professional services, mainly related to audit, IT, accounting, recruitment and legal services, communication and travel costs, real-estate leasing costs, office furniture and equipment costs, allowance for amortization and depreciation, director’s attendance fees and insurance costs and overhead costs, such as postal and telecommunications expenses.
Under the terms of this agreement, the Company has also granted two exclusive options, exercisable no later than three years after the effective date, for exclusive licenses to Innate's intellectual property for the 142 research, development, manufacture and commercialization of NKCEs specifically targeting two preclinical molecules.
Under the terms of this agreement, the Company has also granted two exclusive options, exercisable no later than three years after the effective date, for exclusive licenses to Innate's intellectual property for the research, development, manufacture and commercialization of NKCEs specifically targeting two preclinical molecules.
In August 2022, the Company requested the extension of these two loans repayment for an additional period of five years starting in 2022 and including a one-year grace period (2023). Consequently, the Company has obtained agreements from Société Générale and BNP Paribas.
In 159 August 2022, the Company requested the extension of these two loans repayment for an additional period of five years starting in 2022 and including a one-year grace period (2023). Consequently, the Company has obtained agreements from Société Générale and BNP Paribas.
Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly in sections titled “Item 3.D – Risk Factors” and “Special Note Regarding Forward-Looking Statements.” The Company audited consolidated financial statements as of and for the years ended December 31, 2021 , 2022 and 2023 have been prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including the United States.
Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly in sections titled “Item 3.D – Risk Factors” and “Special Note Regarding Forward-Looking Statements.” The Company audited consolidated financial statements as of and for the years ended December 31, 2022 , 2023 and 2024 have been prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including the United States.
The table below presents the components of our net financial result for the years ended December 31, 2022 and 2023: 147 Year ended December 31, 2022 2023 (in thousands) Interests and gains on financial assets € 546 € 3,177 Unrealized gains on financials assets 418 1,648 Foreign exchange gains 3,810 2,109 Other financial income — — Financial income 4,775 6,934 Foreign exchange losses (2,983) (1,195) Unrealized losses on financial assets (2,050) — Interest on financial liabilities (288) (640) Other financial expenses — — Financial expenses (5,321) (1,835) Net financial income (loss) € (546) € 5,099 For the years ended December 31, 2022 and 2023, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the U.S. dollar on U.S. dollar-denominated cash and cash equivalents, short-term investments and financial assets.
The table below presents the components of our net financial result for the years ended December 31, 2022 and 2023: Year ended December 31, 2022 2023 (in thousands) Interests and gains on financial assets € 546 € 3,177 Unrealized gains on financials assets 418 1,648 Foreign exchange gains 3,810 2,109 Financial income 4,775 6,934 Foreign exchange losses (2,983) (1,195) Unrealized losses on financial assets (2,050) — Interest on financial liabilities (288) (640) Financial expenses (5,321) (1,835) Net financial income (loss) € (546) € 5,099 For the years ended December 31, 2022 and 2023, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the U.S. dollar on U.S. dollar-denominated cash and cash equivalents, short-term investments and financial assets.
On March 13, 2023, the Company signed an amendment to the lease for "Le Virage Building" in order to reduce the rental area of its premises located in the "Le Virage" building. This amendment has the effect of reducing the amount of the commitment relating to rent by €685 thousand.
On March 13, 2023, the Company signed an amendment to the lease for "Le Virage Building" in order to reduce the rental area of its premises located in the "Le Virage" building. This amendment has the effect 166 of reducing the amount of the commitment relating to rent by €685 thousand.
The Company remains committed under this contract until June 30, 2025. 167 C. Research and Development For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item 5.A—Operating Results.” D.
The Company remains committed under this contract until June 30, 2025. C. Research and Development For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item 5.A—Operating Results.” D.
The Company also uses its employee and infrastructure resources across multiple research and development programs, and does not track these indirect expenses on a program-by-program basis. 136 Research and development costs are expensed as incurred.
The Company also uses its employee and infrastructure resources across multiple research and development programs, and does not track these indirect expenses on a program-by-program basis. Research and development costs are expensed as incurred.
If the Company does not pay any corporate income tax, the Company can offset the remaining research tax credit the year following its record in the income statement; and 135 • the research tax credit is not included in the determination of the corporate income tax.
If the Company does not pay any corporate income tax, the Company can offset the remaining research tax credit the year following its record in the income statement; and • the research tax credit is not included in the determination of the corporate income tax.
As of December 31, 2022, impairment of intangible assets consisted of the full depreciation of avdoralimab rights for an amount of €41.0 million, following the Company's decision to stop avdoralimab development in bullous phemphigoid ("BP") indication in inflammation following a decision taken by a sponsor to stop the Phase 2 clinical trial in said indication during the fourth quarter of 2022. 138 A.
As of December 31, 2022, impairment of intangible assets consisted of the full depreciation of avdoralimab rights for an amount of €41.0 million, following the Company's decision to stop avdoralimab development in bullous phemphigoid ("BP") indication in inflammation following a decision taken by a sponsor to stop the Phase 2 clinical trial in said indication during the fourth quarter of 2022. 136 A.
Failure to receive additional funding could cause the Company to cease operations, in part or in full. Presentation of Financial Information The Company audited consolidated financial statements included herein as of and for the years ended December 31, 2021 , 2022 and 2023 have been prepared in accordance with IFRS as issued by the IASB.
Failure to receive additional funding could cause the Company to cease operations, in part or in full. Presentation of Financial Information The Company audited consolidated financial statements included herein as of and for the years ended December 31, 2022 , 2023 and 2024 have been prepared in accordance with IFRS as issued by the IASB.
Therefore, the Company audited consolidated financial statements for the years ended December 31, 2021 , 2022 and 2023 are compliant with both IFRS as issued by the IASB and IFRS as adopted by the EU. The preparation of financial statements in accordance with IFRS requires the Company to make significant judgments and estimates which are presented below.
Therefore, the Company audited consolidated financial statements for the years ended December 31, 2022 , 2023 and 2024 are compliant with both IFRS as issued by the IASB and IFRS as adopted by the EU. The preparation of financial statements in accordance with IFRS requires the Company to make significant judgments and estimates which are presented below.
This decrease mainly results from operating efficiency measures, which led to a reduction in the number of new hires, and use of external communication and consulting services. 146 Other general and administrative expenses relate to intellectual property, depreciation and amortization and other general, administrative expenses.
This decrease mainly results from operating efficiency measures, which led to a reduction in the number of new hires, and use of external communication and consulting services. 154 Other general and administrative expenses relate to intellectual property, depreciation and amortization and other general, administrative expenses.
Impairment of intangible assets For the year ended December 31, 2022, impairment of intangible assets results from full impairment of anti-C5aR rights acquired from Novo/Nordisk A/S (avdoralimab intangible asset) for an amount of €41.0 million.
Impairment of intangible assets As a reminder, for the year ended December 31, 2022, impairment of intangible assets results from full impairment of anti-C5aR rights acquired from Novo/Nordisk A/S (avdoralimab intangible asset) for an amount of €41.0 million.
The table below details government funding for research expenditures for the years ended December 31, 2022 and 2023. 143 Year ended December 31, 2022 2023 Research Tax Credit(1) € 7,925 € 9,729 Grant and other tax credit(2) 110 — Government financing for research expenditures € 8,035 € 9,729 (1) As of December 31, 2023, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2023 financial year for an amount of €9.8 million compared to €9.2 million for the 2022 financial year which is subtracted (ii) a provision amounting to €0.1 million following the tax inspection compared to €1.3 million last year.
The table below details government funding for research expenditures for the years ended December 31, 2022 and 2023. 151 Year ended December 31, 2022 2023 (in thousands) Research Tax Credit(1) 7,925 9,729 Grant and other tax credit (2) 110 — Government financing for research expenditures 8,035 9,729 (1) As of December 31, 2023, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2023 financial year for an amount of €9.8 million compared to €9.2 million for the 2022 financial year which is subtracted (ii) a provision amounting to €0.1 million following the tax inspection compared to €1.3 million last year.
During this grace period, the Company will only be liable for the payment of interest and the guarantee fees, with amortization of the two loans starting in 2024 over a period of four years. The state guarantee fees amount to €877 thousand and €379 thousand for Société Générale and BNP Paribas loans respectively.
During this grace period, the Company was only liable for the payment of interest and the guarantee fees, with amortization of the two loans starting in 2024 over a period of four years. The state guarantee fees amount to €877 thousand and €379 thousand for Société Générale and BNP Paribas loans respectively.
During 2022 fourth quarter, the Company was informed by the sponsor of the Phase 2 clinical trial evaluating avdoralimab in inflammation in BP indication of its decision to stop said trial.
During the fourth quarter of 2022, the Company was informed by the sponsor of the Phase 2 clinical trial evaluating avdoralimab in inflammation in bullous pemphigoid ("BP") indication of its decision to stop said trial.
The Company anticipates that such expenses will increase substantially if and as the Company: • continues the research and development of its product candidates; • initiates clinical trials for, or additional preclinical development of, its product candidates; • further develops and refines the manufacturing processes for its product candidates; • changes or adds manufacturers or suppliers of biological materials; • seeks regulatory and marketing authorizations for any of its product candidates that successfully complete development; • seeks to identify and validate additional product candidates; • acquires or licenses other product candidates, technologies or biological materials; • makes milestone, royalty or other payments under any current or future license agreements; • obtains, maintains, protects and enforces its intellectual property portfolio; • secures manufacturing arrangements for commercial production; • seeks to attract and retain new and existing skilled personnel; • creates additional infrastructure to support its operations as a U.S. public company and incurs increased legal, accounting, investor relations and other expenses; and 133 • experiences delays or encounters issues with any of the above.
The Company anticipates that such expenses will increase substantially if and as the Company: • continues the research and development of its product candidates; • initiates clinical trials for, or additional preclinical development of, its product candidates; • further develops and refines the manufacturing processes for its product candidates; • changes or adds manufacturers or suppliers of biological materials; • seeks regulatory and marketing authorizations for any of its product candidates that successfully complete development; • seeks to identify and validate additional product candidates; • acquires or licenses other product candidates, technologies or biological materials; • makes milestone, royalty or other payments under any current or future license agreements; • obtains, maintains, protects and enforces its intellectual property portfolio; • secures manufacturing arrangements for commercial production; • seeks to attract and retain new and existing skilled personnel; • creates additional infrastructure to support its operations as a U.S. public company and incurs increased legal, accounting, investor relations and other expenses; and • experiences delays or encounters issues with any of the above. 131 The Company anticipates that it will need to raise additional funding, prior to completing clinical development of any of its product candidates.
The Company lost its SME status at the end of the 2019 fiscal year but has been eligible again since the end of the 2021 financial year. As of December 31, 2023, the company lost again the SME status due to two consecutive year with a statutory turnover over €50 000 thousands.
The Company lost its SME status at the end of the 2019 fiscal year but has been eligible again since the end of the 2021 financial year. Since December 31, 2023, the company lost again the SME status due to two consecutive year with a statutory turnover over €50,000 thousand.
Pursuant to the Company's agreements with AstraZeneca, research and development costs related to IPH5201 in connection with preclinical work are fully borne by AstraZeneca, in accordance with the initial 2018 agreement. These costs were re-invoiced on a quarterly basis.
Invoicing of research and development costs - IPH5201 . 149 Pursuant to the Company's agreements with AstraZeneca, research and development costs related to IPH5201 in connection with preclinical work are fully borne by AstraZeneca, in accordance with the initial 2018 agreement. These costs were re-invoiced on a quarterly basis.
Because of the numerous risks and uncertainties associated with product development and regulatory approval, the Company is unable to predict the amount, timing or whether it will be able to obtain product revenue. Government financing for research expenditures The Company's government financing for research expenditures consists of research tax credits (crédit d’impôt recherche ) and grants.
Because of the numerous risks and uncertainties associated with product development and regulatory approval, the Company is unable to predict the amount, timing or whether it will be able to obtain product revenue from any such candidates. Government financing for research expenditures The Company's government financing for research expenditures consists of research tax credits (crédit d’impôt recherche ) and grants.
Year ended December 31, 2022 2023 (in thousands) Revenue from collaboration and licensing agreements € 49,580 € 51,901 Government financing for research expenditures 8,035 9,729 Other income 59 11 Revenue and other income € 57,674 € 61,641 Revenue from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations increased by €2.3 million, to €51.9 million for the year ended December 31, 2023, as compared to revenue from collaboration and licensing agreements of €49.6 million for the year ended December 31, 2022.
Revenue and other income from continuing operations increased by €4.0 million, to €61.6 million for the year ended December 31, 2023, as compared to revenue and other income of €57.7 million for the year ended December 31, 2022. 147 Year ended December 31, 2022 2023 (in thousands) Revenue from collaboration and licensing agreements 49,580 51,901 Government financing for research expenditures 8,035 9,729 Other income 59 11 Revenue and other income € 57,674 € 61,641 Revenues from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations increased by €2.3 million, to €51.9 million for the year ended December 31, 2023, as compared to revenue from collaboration and licensing agreements of €49.6 million for the year ended December 31, 2022.
All the standards published by the IASB that are mandatorily applicable in the years ended December 2021 , 2022 and 2023 are endorsed by the EU and are mandatorily applicable in the EU.
All the standards published by the IASB that are mandatorily applicable in the years ended December 2022 , 2023 and 2024 are endorsed by the EU and are mandatorily applicable in the EU.
The agreement does not stipulate that Innate's activities will significantly affect the intellectual property granted during the life of the agreement. Consequently, the $5.0 million (or €4.6 million) initial payment, received by the Company in May 2023, was fully recognized in revenue since June 30, 2023.
The agreement did not stipulate that Innate's activities would significantly affect the intellectual property granted during the life of the agreement. Consequently, the $5.0 million (or €4.6 million) initial payment, received by the Company in May 2023, was fully recognized in revenue since June 30, 2023.
Year ended December 31, 2022 2023 (in thousands) Research and development expenses (51,663) (56,022) General and administrative expenses (22,436) (18,288) Impairment of intangible assets (41,000) — Total operating expenses after impairment € (115,099) € (74,310) Research and development expenses Our research and development expenses are broken down as set forth in the table below for the years ended December 31, 2022 and 2023. 144 Year ended December 31, 2022 2023 (in thousands) Lacutamab € (12,473) € (12,248) Monalizumab (1,224) (791) Avdoralimab (385) (175) IPH5201 (1,648) (2,313) IPH5301 (625) (296) Sub-total programs in clinical development (16,355) (15,823) Sub-total programs in preclinical development (11,129) (14,356) Total direct research and development expenses (27,484) (30,179) Personnel expenses (including share-based payments) (16,373) (17,121) Depreciation and amortization (2,928) (3,891) Other expenses (4,877) (4,831) Personnel and other expenses (24,178) (25,843) Total research and development expenses (1) € (51,663) € (56,022) (1) 2022 Total Research and Development expenses excludes €41.0 million of avdoralimab impairment.
Year ended December 31, 2022 2023 (in thousands) Research and development expenses (51,663) (56,022) General and administrative expenses (22,436) (18,288) Impairment of intangible assets (41,000) — Total operating expenses after impairment € (115,099) € (74,310) Research and development expenses Our research and development expenses from continuing operations are broken down as set forth in the table below for the years ended December 31, 2022 and 2023. 152 Year ended December 31, 2022 2023 (in thousands) Lacutamab (12,473) (12,248) Monalizumab (1,224) (791) Avdoralimab (385) (175) IPH5201 (1,648) (2,313) IPH5301 (625) (296) Sub-total programs in clinical development (16,355) (15,823) Sub-total programs in preclinical development (11,129) (14,356) Total direct research and development expenses (27,484) (30,179) Personnel expenses (including share-based payments) (16,373) (17,121) Depreciation and amortization (2,928) (3,891) Other expenses (4,877) (4,831) Personnel and other expenses (24,178) (25,843) Total research and development expenses (51,663) (56,022) Research and development expenses from continuing operations increased by €4.4 million, or 8.4%, to €56.0 million for the year ended December 31, 2023, as compared to research and development expenses of €51.7 million for the year ended December 31, 2022.
Any change in these assumptions could 159 lead to the recognition of an impairment charge that could have a significant impact on the Company's consolidated financial statements. In case of failure of the clinical trials in progress, the Company may have to fully depreciate the intangible asset.
Financial Statements" of this Annual Report. Any change in these 157 assumptions could lead to the recognition of an impairment charge that could have a significant impact on the Company's consolidated financial statements. In case of failure of the clinical trials in progress, the Company may have to fully depreciate the intangible asset.
Since its inception, the Company has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of its ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of our ordinary shares on Euronext and ADS on The Nasdaq Global Select Market, or Nasdaq, in 2019.
Since its inception, the Company has raised a total of €314.3 million through the sale of equity securities, including €33.7 million in the initial public offering of its ordinary shar es on Euronext Paris in 2006 and €66.0 million in the initial public offering of our ordinary shares on Euronext and ADS on The Nasdaq Global Select Market, or Nasdaq, in 2019.
The main assumptions used for the impairment test include (a) the amount of cash flows that are set on the basis of the development and commercialization plans and budgets approved by management, (b) assumptions related to the achievement of the clinical trials and the launch of the commercialization, (c) the discount rate, (d) assumptions on risk related to the development and (e) for the commercialization, selling price and volume of sales, and are provided in Note 6 to the Company's consolidated financial statements which are included elsewhere in this Annual Report.
The main assumptions used for the impairment test include (a) the amount of cash flows that are set on the basis of the development and commercialization plans and budgets approved by management, (b) assumptions related to the achievement of the clinical trials and the launch of the commercialization, (c) the discount rate, (d) assumptions on risk related to the development and (e) for the commercialization, selling price and volume of sales, and are provided in Note 6 to the Company's consolidated financial statements included under "Item 18.
As part of the Termination and Transition Agreement, Innate and AstraZeneca agreed to split these manufacturing costs, and Innate paid $6.2 million (€5.5 million as of December 31, 2021) to AstraZeneca on April 30, 2022.
As part of the Termination and Transition Agreement, Innate and AstraZeneca agreed to split these manufacturing costs, and Innate paid $6.2 million (€5.9 million) to AstraZeneca on April 30, 2022.
Both parties will share the external cost related to the study and incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial. For more information on this amendment, see Note 1.1 to the consolidated financial statements are included as part of this Annual Report.
Both parties will share the external cost related to the study and incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial. For more information on this amendment, see Note 1.1 to the consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report.
The actual value of the Company's assets, liabilities and shareholders’ equity, as well as its income and expenses, could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. See Note 2 to the Company's consolidated financial statements appearing elsewhere in this Annual Report.
The actual value of the Company's assets, liabilities and shareholders’ equity, as well as its income and expenses, could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. See Note 2 to the Company's consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report.
The Company has incurred net losses in each year since its inception except for the years ended December 31, 2016 and 2018. The Company net income (loss) was €(52.8) million, €(58.1) million and €(7.6) million for the years ended December 31, 2021 , 2022 and 2023, respectively.
The Company has incurred net losses in each year since its inception except for the years ended December 31, 2016 and 2018. The Company net income (loss) was €(58.1) million, €(7.6) million and €(49.5) million for the years ended December 31, 2022 , 2023 and 2024, respectively.
As of December 31, 2023, given the significant progress of the work to be performed (98.1%) and the level of budget consumption, the impact of accounting estimates is no longer a determining factor in the calculation of revenue related to the monalizumab agreement.
As of December 31, 2024, given the significant progress of the work to be performed (99.92%) and the level of budget consumption, the impact of accounting estimates is no longer a determining factor in the calculation of revenue related to the monalizumab agreement.
Sources and uses of liquidity As of December 31, 2023, the Company has primarily financed its operations through its receipt of $635.4 million (€560.1 million) in payments from its collaborators, including AstraZeneca and Sanofi, since 2011, excluding payments received for purchases of Innate's equity securities by its collaborators.
Sources and uses of liquidity As of December 31, 2024, the Company has primarily financed its operations through its receipt of $656.1 million (€579.1 million) in payments from its collaborators, including AstraZeneca and Sanofi, since 2011, excluding payments received for purchases of Innate's equity securities by its collaborators.
Net result from discontinued operations Pursuant to the Termination and Transition Agreement, in the year ended December 31, 2020 results announcement, the Company reported a contingent liability of up to $12.8 million in its consolidated financial statements, which was related to the splitting of certain manufacturing costs.
Innate expects to continue this investment philosophy in the future. 135 Net result from discontinued operations Pursuant to the Termination and Transition Agreement, in the year ended December 31, 2020 results announcement, the Company reported a contingent liability of up to $12.8 million in its consolidated financial statements, which was related to the splitting of certain manufacturing costs.
This decrease of €10.5 million mainly results from (i) net repayment of €8.4 million during year 2023 to AstraZeneca linked to the Monalizumab cofinancing program, including phase 3 trial INTERLINK-1 launched in October 2020 and PACIFIC-9 launched in April 2022, and (ii) the decrease of the collaboration commitment 145 ("collaboration liabilities" in the consolidated statements of financial position) for an amount of €2.0 million linked to the Euro-dollar parity exchange rate variation.
This decrease of €4.1 143 million mainly results from (i) net repayment of €7.8 million during year 2024 to AstraZeneca linked to the Monalizumab cofinancing program, including phase 3 trial INTERLINK-1 launched in October 2020 and PACIFIC-9 launched in April 2022, and (ii) the increase of the collaboration commitment ("collaboration liabilities" in the consolidated statements of financial position) for an amount of €3.6 million linked to the Euro-dollar parity exchange rate variation.
As a consequence of the termination of the Lumoxiti Agreement, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2023, 2022 and 2021 financial years in accordance with IFRS5 "non-current assets held for sale and discontinued operations." Therefore, the income statement for the years ended December 31, 2020 and subsequent years have been prepared with the Lumoxiti activity (including sales) as a discontinued operation for the 2020 and subsequent financial years in accordance with the same IFRS standard.
As a consequence of the termination of the Lumoxiti Agreement, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2024, 2023 and 2022 financial years in accordance with IFRS5 "non-current assets held for sale and discontinued operations." Therefore, since December 31, 2020 the income statement and subsequent years have been prepared with the Lumoxiti activity (including sales) as a discontinued operation in accordance with the same IFRS standard.The Lumoxiti activity has not had an impact on the consolidated income statement since 2022.
Under the loan, Innate is subject to a covenant that its total cash, cash equivalents and current and non-current financial assets as of each fiscal year end will be at least equal to the amount of outstanding principal under the loan. The repayment period started on August 30, 2019.
Under the loan, Innate is subject to a covenant that its total cash, cash equivalents and current and non-current financial assets as of each fiscal year end will be at least equal to the amount of outstanding principal under the loan.
As the rights related to these four preclinical programs have been returned to the Company, the entire upfront payment of $20.0 million (€17.4 million) has been recognized as revenue as of June 30, 2022. Invoicing of research and development costs - IPH5201 .
As the rights related to these four preclinical programs have been returned to the Company, the entire upfront payment of $20.0 million (€17.4 million) has been recognized as revenue as of June 30, 2022.
Loan repayments amounted to €2.0 million for the year ended December 31, 2022 as compared to €2.1 million for the year ended December 31, 2021. In addition, net cash flow from financing activities related to Lumoxiti discontinued operation are nil for year ended December 31, 2022 and 2021, respectively.
Loan repayments amounted to €2.4 million for the year ended December 31, 2023 as compared to €2.0 million for the year ended December 31, 2022. In addition, net cash flows from financing activities related to Lumoxiti discontinued operations are nil for the year ended December 31, 2022 and 2021, respectively.
The table below presents our general and administrative expenses by nature for the years ended December 31, 2022 and 2023: Year ended December 31, 2022 2023 (in thousands) Personnel expenses (including share based payments) € (10,229) € (8,842) Non scientific advisory and consulting (4,244) (2,906) Other expenses (1) (7,963) (6,540) Total general and administrative € (22,436) € (18,288) .
The table below presents our general and administrative expenses by nature for the years ended December 31, 2022 and 2023: Year ended December 31, 2022 2023 (in thousands) Personnel expenses (including share based payments) (10,229) (8,842) Non scientific advisory and consulting (4,244) (2,906) Other expenses (1) (7,963) (6,540) Total general and administrative € (22,436) € (18,288) (1) Other expenses are related to intellectual property, maintenance costs for laboratory equipment and our headquarters, depreciation and amortization and other general and administrative expenses.
The table below summarizes the main capital increases between 1999 and December 31, 2023 : Date Gross Proceeds April 2000 € 1.2 million March 2001 3.3 million July 2002 20.0 million March 2004 5.0 million July 2004 10.0 million March 2006 10.0 million November 2006 33.7 million December 2009 24.3 million November 2013 20.3 million June 2014 50.0 million October 2018 62.6 million October 2019 66.0 million Total € 306.4 million Cash flows Comparisons for the year ended December 31, 2022 and 2023 The following table sets forth cash flow data for the years ended December 31, 2022 and 2023: Year ended December 31, 2022 2023 (in thousands) Cash flows from / (used in) operating activities € (19,155) € (32,558) Cash flows from / (used in) investing activities 1,877 20,631 Cash flows from / (used in) financing activities (1,828) (1,966) Effect of the exchange rate changes (428) 274 Net increase / (decrease) in cash and cash equivalents € (19,532) € (13,619) Cash flows from / (used in) operating activities The Company's net cash flow used in operating activities decreased by €13.4 million to €32.6 million for the year ended December 31, 2023 as compared to net cash flows used in operating activities of €19.2 million for the year ended December 31, 2022.
The table below summarizes the main capital increases between 1999 and December 31, 2024 : 161 Date Gross Proceeds April 2000 € 1.2 million March 2001 3.3 million July 2002 20.0 million March 2004 5.0 million July 2004 10.0 million March 2006 10.0 million November 2006 33.7 million December 2009 24.3 million November 2013 20.3 million June 2014 50.0 million October 2018 62.6 million October 2019 66.0 million December 2024 2.9 million Total € 309.3 million Cash flows Comparisons for the year ended December 31, 2023 and 2024 The following table sets forth cash flow data for the years ended December 31, 2023 and 2024: Year ended December 31, 2023 2024 (in thousands) Cash flows from / (used in) operating activities € (32,559) € (6,896) Cash flows from / (used in) investing activities 20,630 9,200 Cash flows from / (used in) financing activities (1,966) (6,008) Effect of the exchange rate changes 274 (505) Net increase / (decrease) in cash and cash equivalents € (13,619) € (4,209) Cash flows from / (used in) operating activities The Company's net cash flow used in operating activities decreased by €25.7 million to €6.9 million for the year ended December 31, 2024 as compared to net cash flows used in operating activities of €32.6 million for the year ended December 31, 2023.
Direct research and development expenses increased by €2.7 million, or 9.8%, to €30.2 million for the year ended December 31, 2023, as compared to direct research and development expenses of €27.5 million for the year ended December 31, 2022.
Indirect expenses increased by €1.7 million mainly in personnel expenses and amortization and depreciation. Direct research and development expenses increased by €2.7 million, or 9.8%, to €30.2 million for the year ended December 31, 2023, as compared to direct research and development expenses of €27.5 million for the year ended December 31, 2022.
E. Critical Accounting Estimates. The Company applies IFRS as issued by the IASB in its primary financial statements (see Note 2 to the Company’s consolidated financial statements appearing elsewhere in this Annual Report).
E. Critical Accounting Estimates. The Company applies IFRS as issued by the IASB in its primary financial statements (see Note 2 to the Company’s consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report).
Takeda will be responsible for the future development, manufacture and commercialization of any potential products developed using the licensed antibodies. As such, the Company considers that the license granted is a right to use the relevant intellectual property, which is granted fully and perpetually to Takeda.
Takeda would have beeen responsible for the future development, manufacture and commercialization of any potential products developed using the licensed antibodies. As such, the Company considered that the license granted was a right to use the relevant intellectual property, which was granted fully and perpetually to Takeda.
In addition, Innate has received an aggregate of €100.1 million in research tax credits through December 31, 2023. As a French biopharmaceutical company, Innate Pharma has benefited from certain tax advantages, including, for example, the research tax credit.
In addition, Innate has received an aggregate of €109.4 million in French research tax credit ("CIR") through December 31, 2024. As a French biopharmaceutical company, Innate Pharma has benefited from certain tax advantages, including, for example, the CIR.
This increase is mainly due to: (i) a €5.0 million increase in expenses related to preclinical development programs relating notably to IPH6501, partly offset by a €4.3 million decrease in expenses related to the Company's clinical programs.
This decrease is mainly due to a €2.3 million increase in expenses related to preclinical development programs relating notably to the ADC field, partly offset by a €4.2 million decrease in expenses related to the Company's clinical programs.
Overview Innate is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
Overview Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multispecific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC).
Revenue related to IPH5201 for the year ended December 31, 2022 is €4.7 million and results from the entire recognition in revenue of the $5.0 million (€4.7 million) milestone payment received from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018.
Revenue related to IPH5201 for the year ended December 31, 2024 is $0.0 same as year ended December 31, 2023, compared with $5.0 million (€4.7 million) for the year 2022. This revenue related to the milestone payment received from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018.
As of December 31, 2023, the Company had €102.3 million in cash, cash equivalents, short-term investments and non-current financial assets.
As of December 31, 2024, the Company had €91.1 million in cash, cash equivalents, short-term investments and non-current financial assets.
Research and development expenses from continuing operations increased by €4.4 million, or 8.4%, to €56.0 million for the year ended December 31, 2023, as compared to research and development expenses of €51.7 million for the year ended December 31, 2022.
Research and development expenses from continuing operations decreased by €4.0 million, or 7.2%, to €52.0 million for the year ended December 31, 2024, as compared to research and development expenses of €56.0 million for the year ended December 31, 2023.
Clinical research and development costs are not capitalized until marketing authorizations are obtained. Innate's corporate office in Luminy, Marseille, France is leased under a finance lease agreement signed in 2008 with Sogebail, a subsidiary of Société Générale, for an aggregate amount of €6.6 million. The lease-financing agreement has a 12-year term.
Innate's corporate office in Luminy, Marseille, France is leased under a finance lease agreement signed in 2008 with Sogebail, a subsidiary of Société Générale, for an aggregate amount of €6.6 million. The lease-financing agreement has a 12-year term.
Personnel expenses, which includes the compensation paid to our employees and consultants, decreased by €0.7 million, or 6.0%, to €10.2 million for the year ended December 31, 2022, as compared to personnel expenses of €10.9 million for the year ended December 31, 2021.
Personnel expenses, which includes the compensation paid to our employees and consultants, decreased by €0.3 million, or 3.2%, to €8.6 million for the year ended December 31, 2024, as compared to personnel expenses of €8.8 million for the year ended December 31, 2023.
Since its inception, Innate has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of Innate's ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of the Company's initial public offering of its ordinary shares on Nasdaq in 2019.
Since its inception, Innate has raised a total of €314.3 million through the sale of equity securities, including €33.7 million in the initial public offering of Innate's ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of the Company's initial public offering of its ordinary shares on Nasdaq in 2019 and €5.0 million from Novo Nordisk related to NKG2A agreement.
Financial income (loss), net Net financial result decreased by €2.9 million, to a €0.5 million loss for the year ended December 31, 2022, as compared to a €2.3 million gain for the year ended December 31, 2021.
Financial income (loss), net The net financial result decreased by €3.0 million, to a €2.1 million profit for the year ended December 31, 2024, as compared to a €5.1 million loss for the year ended December 31, 2023.
Personnel and other expenses allocated to research and development increased by €1.7 million, or 6.9%, to €25.8 million for the year ended December 31, 2023, as compared to an amount of €24.2 million for the year ended December 31, 2022.
Personnel and other expenses allocated to research and development decreased by €2.2 million, or 8.4%, to €23.7 million for the year ended December 31, 2024, as compared to an amount of €25.8 million for the year ended December 31, 2023.
Operating Results Comparisons for the years ended December 31, 2022 and 2023 The operating result is not impacted by hyperinflation on the Company's business. The following table sets forth a summary of the Company's consolidated statements of income (loss) for the periods presented.
Operating Results Comparisons for the years ended December 31, 2023 and 2024 The following table sets forth a summary of the Company's consolidated statements of income (loss) for the periods presented.
If necessary, the Company could mobilize the receivable. Innate is potentially eligible to earn milestone payments and royalties under its agreements with AstraZeneca in the event that the Company satisfies certain pre-specified milestones. Innate may enter into new collaboration agreements that also provide milestone payments.
The Company recognized this amount as "Other non-current assets". Innate is potentially eligible to earn milestone payments and royalties under its agreements with AstraZeneca in the event that the Company satisfies certain pre-specified milestones. Innate may enter into new collaboration agreements that also provide milestone payments.
Consequently, the Company decided in December 2022 to stop the development of avdoralimab in BP indication in inflammation, only indication supporting the recoverable amount of the asset as of December 31, 2021 (as well that as of June 30, 2022).
Consequently, the Company decided in December 2022 to stop the development of avdoralimab in BP indication in inflammation, only indication supporting the recoverable amount of the asset as of December 31, 2021 (as well that as of June 30, 2022). Without any new event since then, the impairment has not been reassessed.
This change results mainly from the change in the fair value of certain financial instruments (net loss of €1.6 million in 2022 as compared to a €1.1 million gain in 2021) and a net foreign exchange gain of €0.8 million in 2022 as compared to a net foreign exchange gain of €1.2 million in 2021.
This change mainly results from the net foreign exchange loss of €1.8 million (net foreign exchange gain of €0.9 million in 2023), interest income on financial investments (net gain of €2.4 million in 2024 compared to €3.2 millions in 2023) and the change in the fair value of certain financial instruments (net gain of €2.0 million in 2024 as compared to a net gain of €1.6 million in 2023).
The research tax credit increased by €1.8 million, or 23% , to €9.7 million for the year ended December 31, 2023, as compared to a research tax credit of €7.9 million for the year ended December 31, 2022.
The research tax credit decreased by €2.3 million, or 23%, to €7.5 million for the year ended December 31, 2024, as compared to a research tax credit of €9.7 million for the year ended December 31, 2023.
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types.
Innate’s portfolio includes its lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, several ANKET® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors.
As a reminder, Innate has received a total of €306.4 million in cash from capital increases, before deducting the costs associated with capital increases, and after excluding proceeds from share 162 compensation instruments, between 1999 and December 31, 2019.
Their purpose is to finance Innate's activities, including Innate's research and development costs. As a reminder, Innate has received a total of €309.3 million in cash from capital increases, before deducting the costs associated with capital increases, and after excluding proceeds from share compensation instruments, between 1999 and December 31, 2019.
This decrease is mainly explained by the decrease in the Company's research and development activities, notably related to preclinical trials, and also by higher cash outflows related to the re-invoicing of costs to AstraZeneca for the Phase 3 trials evaluating monalizumab, INTERLINK-1 and PACIFIC-9, in accordance with the Company's co-financing commitments and the reduction in staff costs related to the reduction of staff in the Company.
This decrease is mainly explained by the decrease in the Company's research and development activities, notably related to preclinical trials, and also by higher cash outflows related to the re-invoicing of costs to AstraZeneca for the Phase 3 trials evaluating monalizumab, INTERLINK-1 and PACIFIC-9, in accordance with the Company's co-financing commitments and the reduction in staff costs related to the reduction of staff in the Company. 164 Net cash flow consumed by operating activities in connection with the Lumoxiti discontinued operation are nil for the year ended December 31, 2023 as compared to € 5.1 million for the year 2022.
This decrease in clinical programs expenses mainly results from a €2.9 million and decrease in expenses relating to the avdoralimab program and a €2.4 million decrease in expenses relating to the lacutamab program, partly offset by a €1.1 million increase in expenses related to IPH5201.
This decrease in clinical programs expenses mainly results from a €0.7 million decrease in expenses relating to the monalizumab program and a €3.3 million decrease in expenses relating to the lacutamab program, partly offset by a €1.7 million increase in expenses related to the growth in IPH5201 phase 2 trials patient recruitment.
Also, as of December 31, 2022, the collaboration liabilities relating to monalizumab and the agreements signed with AstraZeneca in April 2015, October 2018 and September 2020 amounted to €63.2 million, as compared to collaborations liabilities of €40.4 million as of December 31, 2021.
As of December 31, 2024, the collaboration liabilities relating to monalizumab and the agreements signed with AstraZeneca in April 2015, October 2018 and September 2020 amounted to €48.6 million, as compared to collaborations liabilities of €52.7 million as of December 31, 2023.
As of December 31, 2023, the remaining capital of these loans amounted to €28.7 million. Lastly, during the years ended December 31, 2016 and 2017, Innate also used lease-financing and bank loans to finance the acquisition of laboratory equipment and to set up new laboratories.
Lastly, during the years ended December 31, 2016 and 2017, Innate also used lease-financing and bank loans to finance the acquisition of laboratory equipment and to set up new laboratories. The debt related to these loans amounts to €42,000 at December 31, 2024.
This increase of €22.8 million mainly results from the additional payment of $50.0 million (€47.7 million) made by AstraZeneca in June 2022 and triggered by the treatment of the first patient in a second Phase 3 trial “PACIFIC-9” evaluating monalizumab in April 2022.
In addition to these amounts, AstraZeneca made an additional payment of $50.0 million (€47.7 million) in June 2022, triggered by the treatment of the first patient in a second Phase 3 trial evaluating monalizumab in April 2022.
The Company will also be eligible for the early repayment by the French treasury of the 2022 research tax credit during the fiscal year 2023. As of December, 31 2023 financial 160 year, the Company lost again the SME status. As a consequence, the 2023 research tax credit will be paid after a three-year period.
The Company has been eligible for the early repayment by the French treasury of the 2022 CIR during the fiscal year 2023. As of the end of the financial year ending December, 31 2023, the Company again lost SME status. As a consequence, the 2023 and 2024 CIR amounts are expected to be paid after a three-year period.
Since its inception, the Company has devoted substantially all of its financial resources to research and development efforts, including conducting preclinical studies and clinical trials of its product candidates, providing general and administrative support for its operations and protecting its intellectual property.
Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. 130 Since its inception, the Company has devoted substantially all of its financial resources to research and development efforts, including conducting preclinical studies and clinical trials of its product candidates, providing general and administrative support for its operations and protecting its intellectual property.
Cash flows from / (used in) financing activities The Company's net cash flows used in financing activities for the year ended December 31, 2022 decreased by €28.6 million to €1.8 million as compared to net cash flows from financing activities of €26.8 million for the year ended December 31, 2021.
Cash flows from / (used in) financing activities The Company's net cash flows used in financing activities for the year ended December 31, 2024 increased by €4.0 million to €6.0 million for the year ended December 31, 2024 as compared to net cash flows from financing activities of €2.0 million for the year ended December 31, 2023.

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Item 6. [Reserved]

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

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Innate's Supervisory Board has specifically assigned the following duties to the Audit Committee: • legal control of the half-year and annual accounts; • evaluating internal control practices, risk analysis; • supervising the creation of the financial statements published by us; 188 • assessing accounting methods; and • selecting statutory auditors, negotiating their fees, reviewing of their conclusions and reviewing their independence.
Innate's Supervisory Board has specifically assigned the following duties to the Audit Committee: • legal control of the half-year and annual accounts; • evaluating internal control practices, risk analysis; • supervising the creation of the financial statements published by us; • assessing accounting methods; and • selecting statutory auditors, negotiating their fees, reviewing of their conclusions and reviewing their independence.
He was on the inpatient units of the Biological Response Modifiers Program, NCI, from 1988 to 1996, and on the immunotherapy service of the Surgery Branch, NCI, from 1997 to 1999. From 1999 to 2004, he served as Vice President of Clinical Development of Vion Pharmaceuticals in New Haven, Connecticut. Dr.
He was on the inpatient units of the Biological Response Modifiers Program, NCI, from 1988 to 1996, and on the immunotherapy service of the Surgery Branch, NCI, from 1997 to 1999. From 1999 to 2004, he served as Vice President of Clinical Development of Vion Pharmaceuticals in New Haven, Connecticut.
Sally Bennett, MBChB ., has served as a member of the Supervisory Board since May 20, 2022. She has a significant experience and expertise in financial analysis and capital markets in the healthcare and biotechnology sectors. Dr. Bennett has a career spanning medicine, equity & capital markets and investment management.
Sally Bennett, MBChB ., has served as a member of the Supervisory Board since May 20, 2022. She has a significant experience and expertise in financial analysis and capital markets in the healthcare and biotechnology sectors. Sally Bennett has a career spanning medicine, equity & capital markets and investment management.
Henry Wheeler, MSc, member of the Leadership Team, Investor Relations and Communications, joined Innate Pharma as Vice President, Investor Relations in June 2021 and was appointed to the Leadership Team in January 2023. Mr. Wheeler has over 15 years’ experience across the pharmaceutical and financial industries. Mr.
Henry Wheeler, MSc, member of the Leadership Team, Investor Relations and Communications, joined Innate Pharma as Vice President, Investor Relations in June 2021 and was appointed to the Leadership Team in January 2023. Henry Wheeler has over 15 years’ experience across the pharmaceutical and financial industries.
Leadership Team The Company also has a Leadership Team composed of members with significant experience in strategy, financial management, medical research, research and development project management, the negotiation of industrial and commercial agreements in the field of innovative companies, including biotechnology 191 companies, compliance and regulations and in business development.
Leadership Team The Company also has a Leadership Team composed of members with significant experience in strategy, financial management, medical research, research and development project management, the negotiation of industrial and commercial agreements in the field of innovative companies, including biotechnology companies, compliance and regulations and in business development.
The Company believes that this insurance and these agreements are necessary to attract qualified Executive and Supervisory Board members. These agreements may discourage shareholders from bringing a lawsuit against the Executive and Supervisory Board members for breach of their fiduciary duty.
The Company believes that this insurance and these agreements are necessary to attract qualified Executive and Supervisory Board members. 182 These agreements may discourage shareholders from bringing a lawsuit against the Executive and Supervisory Board members for breach of their fiduciary duty.
He is a member of the European Union Committee of Experts of Rare Disease, the European Commission’s Scientific Panel for Health (SPH) and served as a Faculty Coordinator for Sarcoma for the European Society of Medical Oncology (ESMO) between 2012 and 2016. Prof.
He is a member of the European Union Committee of Experts of Rare Disease, the European Commission’s Scientific Panel for Health (SPH) and served as a Faculty Coordinator for Sarcoma for the European Society of Medical Oncology (ESMO) between 2012 and 2016.
Compensation and Nomination Committee Innate's Compensation and Nomination Committee assists the Supervisory Board in reviewing and making recommendations to the Supervisory Board with respect to the appointment and the compensation of the members of the Executive Board, Supervisory Board and Leadership Team and other key employees.
Compensation and Nomination Committee Innate's Compensation and Nomination Committee assists the Supervisory Board in reviewing and making recommendations to the Supervisory Board with respect to the appointment and the compensation of the members of the Executive Board, Supervisory Board and Leadership Team and other key 191 employees.
Mr. Brisson has worked in management positions at Rhône-Poulenc and then at Aventis Pharma (Sanofi), where he served as Chairman of the Executive Board, Chairman of the Supervisory Board and Europe Manager. He received a degree from Hautes Etudes Commerciales de Paris (France). Véronique Chabernaud, M.D ., has served as a member of the Supervisory Board since April 27, 2015.
Gilles Brisson has worked in management positions at Rhône-Poulenc and then at Aventis Pharma (Sanofi), where he served as Chairman of the Executive Board, Chairman of the Supervisory Board and Europe Manager. He received a degree from Hautes Etudes Commerciales de Paris (France). Véronique Chabernaud, M.D ., has served as a member of the Supervisory Board since April 27, 2015.
Innate Pharma's Supervisory Board has specifically assigned the following duties to the Transactions Committee: • to analyze the fundamentals of the products and/or companies targeted by us, the feasibility of targeted acquisitions; and • to participate in the selection of investment bankers and/or consultants. 189 CSR Committee The Supervisory Board of September 14, 2022, on the recommendation of the Compensation and Nomination Committee of September 12, 2022, decided to set up a CSR Committee.
Innate Pharma's Supervisory Board has specifically assigned the following duties to the Transactions Committee: • to analyze the fundamentals of the products and/or companies targeted by us, the feasibility of targeted acquisitions; and • to participate in the selection of investment bankers and/or consultants. 192 CSR Committee The Supervisory Board of September 14, 2022, on the recommendation of the Compensation and Nomination Committee of September 12, 2022, decided to set up a CSR Committee.
Staatz-Granzer has held business development positions at Hermal (subsidiary of Merck KGaA), Boots Healthcare International, Knoll (BASF Pharma, later Abbott) and as Chief Executive Officer of Scil Technology Gmbh, Chief Executive Officer of U3 Pharma AG and Chief Executive Officer of Blink Biomedical SAS. Ms. Staatz-Granzer also serves as Chairman of PLCD (German Pharma Licensing Club).
Irina Staatz-Granzer has held business development positions at Hermal (subsidiary of Merck KGaA), Boots Healthcare International, Knoll (BASF Pharma, later Abbott) and as Chief Executive Officer of Scil Technology Gmbh, Chief Executive Officer of U3 Pharma AG and Chief Executive Officer of Blink Biomedical SAS. Irina Staatz-Granzer also serves as Chairman of PLCD (German Pharma Licensing Club).
Laurent has spent most of her career at Sanofi-Aventis where from 2005 she was successively in charge of the Multi-site and European Human Resources Department of the "Matures Products and OTC" business unit, and later of the Supply-Chain business unit worldwide. Ms.
Odile Laurent has spent most of her career at Sanofi-Aventis where from 2005 she was successively in charge of the Multi-site and European Human Resources Department of the "Matures Products and OTC" business unit, and later of the Supply-Chain business unit worldwide.
Prior to HealthCor, she spent 10 years as a senior analyst at ING Financial Markets and then at Piper Jaffray. Dr. Bennett serves as an Independent Non-Executive Director at BerGenBio, a publicly traded European biopharmaceutical company, where she Chairs the Audit Committee and is also an Advisory Board member of the P4 Precision Medicine Accelerator Programme in the UK.
Prior to HealthCor, she spent 10 years as a senior analyst at ING Financial Markets and then at Piper Jaffray. Sally Bennett serves as an Independent Non-Executive Director at BerGenBio, a publicly traded European biopharmaceutical company, where she Chairs the Audit Committee and is also an Advisory Board member of the P4 Precision Medicine 170 Accelerator Programme in the UK.
She also works as a consultant for companies in the field of innovative technologies with a high impact on public health, on a national and international level. Such companies include Genomic Health, BioSystems International, MaunaKea Technologies, Ariana Pharma, Qynapse, Omicure. In 2007, Dr.
She also works as a consultant for companies in the field of innovative technologies with a high impact on public health, on a national and international level. Such companies include Genomic Health, BioSystems International, MaunaKea Technologies, Ariana Pharma, Qynapse, Omicure.
Ms. de Saint-Blanquat holds a master's degree in private law from the University of Paris II - Panthéon Assas (1995), a DEA in civil and commercial obligations law from the University of Paris V - Malakoff (1996) and a DESS in biotechnology law from the University of Versailles- Saint Quentin (2003).
Claire de Saint-Blanquat holds a master's degree in private law from the University of Paris II - Panthéon Assas (1995), a DEA in civil and commercial obligations law from the University of Paris V - Malakoff (1996) and a DESS in biotechnology law from the University of Versailles- Saint Quentin (2003).
Share Ownership For information regarding the share ownership of the directors and executive officers, see “Item 6.B—Compensation” and “Item 7.A—Major Shareholders.” F. Disclosure of any action to recover erroneously awarded compensation Not applicable. 194
Share Ownership For information regarding the share ownership of the directors and executive officers, see “Item 6.B—Compensation” and “Item 7.A—Major Shareholders.” F. Disclosure of any action to recover erroneously awarded compensation Not applicable. 196
She is a member of the Institute of Directors (IoD) and has been awarded the CertIoD qualification. Dr. Bennett received a BSc in Anatomical Sciences and a Medical Degree, awarded with honors, both from the University of Manchester. She is a British citizen.
She is a member of the Institute of Directors (IoD) and has been awarded the CertIoD qualification. Sally Bennett received a BSc in Anatomical Sciences and a Medical Degree, awarded with honors, both from the University of Manchester. She is a British citizen.
He has been four times laureate of the prestigious European Research Council (ERC) grants. During his career, Prof. Vivier has been a visiting professor at The Scripps Research Institute, The Rockefeller University, and The Walter and Elisa Hall Institute.
He has been four times laureate of the prestigious European Research Council (ERC) grants. During his career, Eric Vivier has been a visiting professor at The Scripps Research Institute, The Rockefeller University, and The Walter and Elisa Hall Institute.
Blay is a member of various scientific societies and academic expert groups, has been awarded several honors and is the author of more than 200 publications over the last three years. Gilles Brisson , member of the Supervisory Board, has served on the Supervisory Board of the Company since June 26, 2007 and was the Chairman until December 30, 2016.
Jean-Yves Blay is a member of various scientific societies and academic expert groups, has been awarded several honors and is the author of more than 200 publications over the last three years. 169 Gilles Brisson , member of the Supervisory Board, has served on the Supervisory Board of the Company since June 26, 2007 and was the Chairman until December 30, 2016.
Wheeler joined from AstraZeneca, where he led investor relations for the company’s oncology portfolio, having previously served within AstraZeneca’s Oncology Business Unit. 173 Prior to this, Mr. Wheeler worked in various healthcare financial roles, including at Third Bridge and Morgan Stanley in London. Mr.
Henry Wheeler joined from AstraZeneca, where he led investor relations for the company’s oncology portfolio, having previously served within AstraZeneca’s Oncology Business Unit. Prior to this, Henry Wheeler worked in various healthcare financial roles, including at Third Bridge and Morgan Stanley in London.
In addition to the ex-post vote described above, French law also requires that the compensation policy for the members of the Executive and Supervisory Board for the year ending December 31, 2023 is subject to the approval at the ordinary general meeting relating to the year ending December 31, 2023.
In addition to the ex-post vote described above, French law also requires that the compensation policy for the members of the Executive and Supervisory Board for the year ending December 31, 2025 is subject to the approval at the ordinary general meeting relating to the year ending December 31, 2024.
Lombard joined Innate with more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Throughout his career, Mr. Lombard has developed international financial teams with the aim of strengthening team members’ skill sets and positioning the function as a collaborative business partner.
Frédéric Lombard joined Innate with more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Throughout his career, Frédéric Lombard has developed international financial teams with the aim of strengthening team members’ skill sets and positioning the function as a collaborative business partner.
Arrangements with existing Major Shareholders and Customers There are no arrangements with major shareholders, customers, suppliers or others, pursuant to which any person referred to above was selected as member of the Executive Board, the Supervisory Board, or of the Leadership Team of the Company. 174 B. Compensation.
Arrangements with existing Major Shareholders and Customers There are no arrangements with major shareholders, customers, suppliers or others, pursuant to which any person referred to above was selected as member of the Executive Board, the Supervisory Board, or of the Leadership Team of the Company.
Chabernaud founded " Créer la Vitalité ", which helps companies and organizations in the development of health innovations and prevention. Dr. Chabernaud graduated in 2017 from the Institut Français des Administrateurs and Sciences Po Paris with a Certificate in Corporate Directorship and has been involved in this program since 2017. Dr.
In 2007, Véronique Chabernaud founded " Créer la Vitalité ", which helps companies and organizations in the development of health innovations and prevention. Véronique Chabernaud graduated in 2017 from the Institut Français des Administrateurs and Sciences Po Paris with a Certificate in Corporate Directorship and has been involved in this program since 2017.
He is also Chevalier de la Légion d’Honneur and Officier de l'Ordre National du Mérite . Odile Laurent , member of the Leadership Team, Vice President, Human Resources Director, joined Innate in that role in September 2017. Ms. Laurent has been appointed Vice President, Human Resources Director in January 2020. Before joining Innate Pharma, Ms.
He is also Chevalier de la Légion d’Honneur and Officier de l'Ordre National du Mérite . Odile Laurent , member of the Leadership Team, Vice President, Human Resources Director, joined Innate in that role in September 2017. Odile Laurent has been appointed Vice President, Human Resources Director in January 2020.
The following table shows the BSA outstanding as of December 31, 2023: Plan title BSA 2014 BSA 2015-1 BSA 2015-2 BSA 2017 BSA 2022 BSA 2023 Shareholder general meeting date March 27, 2014 April 27, 2015 April 27, 2015 June 2, 2016 May 20, 2022 May 12, 2023 Date of issue July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 October 3, 2022 October 19, 2023 Total number of BSA authorized 150,000 150,000 150,000 150,000 50,000 70,000 Total number of BSA issued 150,000 70,000 14,200 37,000 8,260 38,000 Start date of the exercise period July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 October 3, 2024 October 19, 2025 End date of the exercise period July 16, 2024 April 26, 2025 June 30, 2025 September 20, 2027 October 3, 2032 October 19, 2033 Exercise price per BSA/share €8.65 €9.59 €14.05 €11 €2.31 €2.26 Number of BSA exercised as of December 31, 2023 75,000 — — — — — BSA cancelled or lapsed as of December 31, 2023 — — — — — — BSA remaining as of December 31, 2023 75,000 70,000 14,200 37,000 8,260 38,000 Redeemable Share Warrants (BSAAR) Redeemable share warrants, or BSAAR, are identical to the share warrants of BSA (including the one-for-one exercise ratio, its potential adjustment for certain modifications of the share capital and the exercise period of 10 years), except for the following features: • the BSAAR are initially purchased by the beneficiary at their fair value, as determined by an expert, and 183 • the BSAAR plans include a “forcing” clause making it possible to encourage holders to exercise their BSAAR when the market price exceeds the exercise price and reaches a threshold defined in the BSAAR issuance agreement.
The Company's BSA cannot be sold. 184 The following table shows the BSA outstanding as of December 31, 2024: Plan title BSA 2015-1 BSA 2015-2 BSA 2017-1 BSA 2022-1 BSA 2023-1 Shareholder general meeting date April 27, 2015 April 27, 2015 June 2, 2016 May 20, 2022 May 12, 2023 Date of issue April 27, 2015 July 1, 2015 September 20, 2017 October 3, 2022 October 19, 2023 Total number of BSA authorized 150,000 150,000 50,000 70,000 Total number of BSA issued 70,000 14,200 37,000 8,260 38,000 Start date of the exercise period April 27, 2015 July 1, 2015 September 20, 2019 October 3, 2024 October 19, 2025 End date of the exercise period April 26, 2025 June 30, 2025 September 20, 2027 October 3, 2032 October 19, 2033 Exercise price per BSA/share €9.59 €14.05 €11.00 €2.31 €2.26 Number of BSA exercised as of December 31, 2024 0 0 0 0 0 BSA cancelled or lapsed as of December 31, 2024 0 0 0 0 0 BSA remaining as of December 31, 2024 70,000 14,200 37,000 8,260 38,000 Redeemable Share Warrants (BSAAR) Redeemable share warrants, or BSAAR, are identical to the share warrants of BSA (including the one-for-one exercise ratio, its potential adjustment for certain modifications of the share capital and the exercise period of 10 years), except for the following features: • the BSAAR are initially purchased by the beneficiary at their fair value, as determined by an expert, and • the BSAAR plans include a “forcing” clause making it possible to encourage holders to exercise their BSAAR when the market price exceeds the exercise price and reaches a threshold defined in the BSAAR issuance agreement.
He also specializes in project management, successfully conducting significant transformation projects in multi-cultural environments. Prior to his financial career in the healthcare sector, Mr. Lombard worked in the information technology industry, where he became familiar with the information systems standards in fast-changing environments.
He also specializes in project management, successfully conducting significant transformation projects in multi-cultural environments. Prior to his financial career in the healthcare sector, Frédéric Lombard worked in the information technology industry, where he became familiar with the information systems standards in fast-changing environments.
Transactions Committee Innate's Transactions Committee assists the Supervisory Board in examining the business and corporate development opportunities available to us, which may include the acquisition of rights to products or the acquisition of other companies as well as out-licensing opportunities. As of December 31, 2023, the members of this committee are Irina Staatz-Granzer, Hervé Brailly, Bpifrance Participations and Gilles Brisson.
Transactions Committee Innate's Transactions Committee assists the Supervisory Board in examining the business and corporate development opportunities available to us, which may include the acquisition of rights to products or the acquisition of other companies as well as out-licensing opportunities. As of December 31, 2024, the members of this committee are Irina Staatz-Granzer, Bpifrance and Gilles Brisson.
None of those events have occurred yet. The Company's BSA have an exercise period of 10 years – BSA not exercised after that time lapse and are automatically cancelled. The Company's BSA cannot be sold.
None of those events have occurred yet. The Company's BSA have an exercise period of 10 years – BSA not exercised after that time lapse and are automatically cancelled.
Ms. de Saint-Blanquat has nearly 20 years of experience in diverse legal positions in the pharmaceutical industry. Admitted to the Paris Bar in 1998, she started her career at Clifford Chance and then held senior positions, notably at Teva, Servier and Biogaran, where she was Legal and Compliance Director since 2016.
Claire de Saint-Blanquat has more than 20 years of experience in diverse legal positions in the pharmaceutical industry. Admitted to the Paris Bar in 1998, she started her career at Clifford Chance and then held senior positions, notably at Teva, Servier and Biogaran, where she was Legal and Compliance Director since 2016.
The compensation of members of the Executive Board includes the following components: • Fixed Compensation. The members of the Executive Board receive a fixed compensation pursuant to their employment agreements or, in the case of the Chairman, his social mandate ( mandat social ). • Annual Variable Compensation.
The members of the Executive Board receive a fixed compensation pursuant to their employment agreements or, in the case of the Chairman, his social mandate ( mandat social ). • Annual Variable Compensation.
The following table shows the BSAAR outstanding as of December 31, 2023: Plan title BSAAR 2015 Shareholder general meeting date April 27, 2015 Date of issue July 1, 2015 Total number of BSAAR issued 1,050,382 Start date of the exercise period July 1, 2015 End date of the exercise period June 30, 2025 BSAAR initial purchase price €1.15 Exercise price per BSAAR/share €7.20 Number of BSAAR exercised as of December 31, 2023 1,940 BSAAR cancelled or lapsed as of December 31, 2023 2,720 BSAAR remaining as of December 31, 2023 1,045,722 Free Shares (AGA) Free shares (AGA) are employee equity incentive instruments pursuant to which the beneficiaries are granted, for free, the possibility to receive ordinary shares under certain conditions.
The BSAAR have been granted to certain of the executive officers and employees. 185 The following table shows the BSAAR outstanding as of December 31, 2024: Plan title BSAAR 2015 Shareholder general meeting date April 27, 2015 Date of issue July 1, 2015 Total number of BSAAR issued 1,050,382 Start date of the exercise period July 1, 2015 End date of the exercise period June 30, 2025 BSAAR initial purchase price €1.15 Exercise price per BSAAR/share €7.20 Number of BSAAR exercised as of December 31, 2024 1,940 BSAAR cancelled or lapsed as of December 31, 2024 2,720 BSAAR remaining as of December 31, 2024 1,045,722 Free Shares (AGA) Free shares (AGA) are employee equity incentive instruments pursuant to which the beneficiaries are granted, for free, the possibility to receive ordinary shares under certain conditions.
Sznol is a past president of the Society for Immunotherapy of Cancer (SITC). Dr. Sznol's areas of interest include early drug development, immunotherapy and treatments for advanced melanoma and kidney cancer.
Mario Sznol is a past president of the 194 Society for Immunotherapy of Cancer (SITC). Mario Sznol's areas of interest include early drug development, immunotherapy and treatments for advanced melanoma and kidney cancer.
Merad has identified the tissue-resident macrophage lineage and revealed its distinct role in organ physiology and pathophysiology. She has demonstrated the contribution of this macrophage lineage to cancer progression and inflammatory diseases. She is currently working on the development of new therapies targeting macrophages for these pathologies. In addition to her work on macrophages, Dr.
Miriam Merad has identified the tissue-resident macrophage lineage and revealed its distinct role in organ physiology and pathophysiology. She has demonstrated the contribution of this macrophage lineage to cancer progression and inflammatory diseases. She is currently working on the development of new therapies targeting macrophages for these pathologies.
Mario Sznol, MD, is Professor of Internal Medicine, Leader of the Clinical Research Team in Melanoma and Kidney Cancer, and Co-Leader of the Cancer Immunology Program. Dr. Sznol is a graduate of Rice University and Baylor College of Medicine (BCM) in Houston, Texas.
Mario Sznol, M.D. , is Professor of Internal Medicine, Leader of the Clinical Research Team in Melanoma and Kidney Cancer, and Co-Leader of the Cancer Immunology Program. Mario Sznol is a graduate of Rice University and Baylor College of Medicine (BCM) in Houston, Texas.
Miriam Merad, M.D.; Ph.D. , is Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York (PrIISM) and Director of the Mount Sinai Human Immune Monitoring Center (HIMC). Dr. Merad is an internationally renowned physician-scientist with expertise in human disease immunology. Dr.
Miriam Merad, M.D., Ph.D. , is Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York (PrIISM), Inaugural chai of the Department of Immunology and Immunotherapy and the Director of the Mount Sinai Human Immune Monitoring Center (HIMC). Miriam Merad is an internationally renowned physician-scientist with expertise in human disease immunology.
Currently, Dr. Staatz-Granzer is an independent member and Chairman of the Transactions Committee.
Currently, Irina Staatz-Granzer is an independent member and Chairman of the Transactions Committee.
The payments of the below variable compensations, for the year ended December 31, 2023, will be submitted for approval to the ordinary and extraordinary shareholder meeting to be held on May 23, 2024.
The payments of the below variable compensations, for the year ended December 31, 2024, will be submitted for approval to the ordinary and extraordinary shareholder meeting to be held on May 22, 2025.
Merad is known for her work on dendritic cells, a group of cells that control adaptive immunity. She has identified a new subset of dendritic cells, which is now considered to be a key target for antiviral and antitumor immunity. Dr.
In addition to her work on macrophages, Miriam Merad is known for her work on dendritic cells, a group of cells that control adaptive immunity. She has identified a new subset of dendritic cells, which is now considered to be a key target for antiviral and antitumor immunity.
Nicola Beltraminelli, PhD , member of the Leadership Team, Vice President, Chief Development Officer, joined Innate Pharma as Vice President and Chief Development Officer in January 2022. Dr. Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Dr.
Nicola Beltraminelli, Ph.D. , member of the Leadership Team, Vice President, Chief Development Officer, joined Innate Pharma as Vice President and Chief Development Officer in January 2022. Nicola Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture.
The Company's Supervisory Board has determined that Pascale Boissel, Hervé Brailly, Véronique Chabernaud and Dr. Jean-Yves Blay are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act.
The Company's Supervisory Board has determined that Pascale Boissel, Irina Staatz-Granzer, Véronique Chabernaud and Jean-Yves Blay are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act.
In case of outperformance for the year 2024, the amount of the bonus may be increased beyond 100% up to a limit of 150% based on other predefined criteria. The outperformance targets may only be reached if 100% of the baseline targets are reached.
In case of outperformance for the year 2025, the amount of the bonus may be increased beyond 100% up to a limit of 150% based on other predefined criteria. The outperformance targets may only be reached if 100% of the core objectives are reached.
Laurent was Group Human Resources Director at Marie Brizard Wine&Spirits Group from 2015 to 2017. Previously, Ms. Laurent was Director of Human Resources for the "Power Transformers" business unit at Areva T&D, and was subsequently appointed Head of Global Sales at Alstom Grid. Ms.
Before joining Innate Pharma, Odile Laurent was Group Human Resources Director at Marie Brizard Wine&Spirits Group from 2015 to 2017. Previously, Odile Laurent was Director of Human Resources for the "Power Transformers" business unit at Areva T&D, and was subsequently appointed Head of Global Sales at Alstom Grid.
Compensation of Members of the Supervisory Board Attendance Fees The Company pays attendance fees to the members of the Supervisory Board, except for the permanent representative of Bpifrance Participations and the Chairman of the Supervisory Board.
Compensation of Members of the Supervisory Board Attendance Fees The Company pays attendance fees to the members of the Supervisory Board, except for the permanent representative of Bpifrance and the Chairwoman of the Supervisory Board.
If 100% of the basic target objectives are achieved, 100% of the corresponding bonus is paid. If not 100% of the targets are achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the targets.
If 100% of the basic core objectives are achieved, 100% of the corresponding bonus is paid. If not 100% of the core objectives are achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the core objectives.
The Leadership Team meets at least once a month and deals with all subjects regarding the activities and the management of the Company. As of December 31, 2023, the members of the Leadership Team were Mondher Mahjoubi, Yannis Morel, Sonia Quaratino, Odile Belzunce, Odile Laurent, Frédéric Lombard, Nicola Beltraminelli, Claire de Saint Blanquat and Henry Wheeler.
The Leadership Team meets at least once a month and deals with all subjects regarding the activities and the management of the Company. As of December 31, 2024, the members of the Leadership Team were Jonathan Dickinson, Yannis Morel, Sonia Quaratino, Arvind Sood, Odile Belzunce, Odile Laurent, Nicola Beltraminelli, Claire de Saint Blanquat, Henry Wheeler and Frédéric Lombard.
At its general meeting of shareholders held on May 12, 2023, shareholders set the total attendance fees to be distributed among the members of the Supervisory Board at €300,000. The attendance fees consist of a fixed portion 175 and a variable portion based on attendance at meetings of the Supervisory Board and its committees.
At its general meeting of shareholders held on May 23, 2024, shareholders set the total attendance fees to be distributed among the members of the Supervisory Board at €300,000. The attendance fees consist of a fixed portion and a 174 variable portion based on attendance at meetings of the Supervisory Board and its committees.
Blay trained as a medical oncologist with a PhD from the University Claude Bernard in Lyon (France); his research activities have been focused on the role of immune effector cells and cytokines in cancer. Prof.
Jean-Yves Blay trained as a medical oncologist with a Ph.D. from the University Claude Bernard in Lyon (France); his research activities have been focused on the role of immune effector cells and cytokines in cancer.
Employees As of December 31, 2023, the Company had 179 full-time employees. Pursuant to French law, employees of Innate Pharma are subject to the French national collective bargaining agreement of Pharmaceutical Industries ( Convention collective Nationale des Industries Pharmaceutiques ). The Company believes that 193 it maintains good relations with its employees.
Employees As of December 31, 2024, the Company had 181 employees. Pursuant to French law, employees of Innate Pharma are subject to the French national collective bargaining agreement of Pharmaceutical Industries ( Convention collective Nationale des Industries Pharmaceutiques ). The Company believes that it maintains good relations with its employees.
His clinical practice is dedicated to early Phase clinical trials of cancer immunotherapies at the Gustave Roussy Cancer Center where he also leads a translational research laboratory dedicated to cancer immunology & immunotherapies (INSERM U1015 & CIC1428). He is a full professor of Clinical Immunology at the University of Paris Saclay. Prof.
His clinical practice is dedicated to early Phase clinical trials of cancer immunotherapies at the Gustave Roussy Cancer Center where he also leads a translational research laboratory dedicated to cancer immunology & immunotherapies (INSERM U1015 & CIC1428).
The weights of each pillar are: Baseline target Outperformance target Clinical & BD 25% 25% Clinical 20% 20% Research and Explanatory Development 20% 20% Finance 25% 25% Corporate 10% 10% The annual objectives thus defined make it possible to reward the Company's expected performance but also to assess outperformance.
The weights of each pillar are: Core objectives Outperformance targets Clinical & BD 25% 25% Clinical 20% 20% Clinical 20% 20% Research and Explanatory Development 15% 15% Finance 20% 20% The annual objectives thus defined make it possible to reward the Company's expected performance but also to assess outperformance.
The following table shows the breakdown of Innate's attendance fees for the year ended December 31, 2024: 176 Member Role Attendance Fee Fixed Portion (annual fee) Supervisory Board Member €15,000 Chair of the Audit Committee and Compensation and Nomination Committee €25,000 Chair of the Corporate Social Responsibility (CSR) Committee €19.000 Variable Portion (attendance fee at each meeting of the Supervisory Board, the Audit Committee and the Compensation and Nomination Committee) Supervisory Board Member (1) €2,000 Committee Member €2,000 Variable Portion (attendance fee at each meeting of an additional Supervisory Board, a Transaction Committee or a CSR Committee) Supervisory Board Member €1,000 Transaction Committee or CSR Member €1,000 (1) reduction of 50% of variable portion received in the event of remote participation in the Supervisory Board meeting held to approve the annual and half-yearly financial statements, the annual strategic Supervisory Board meeting, the Supervisory Board meeting held to approve the budget, and the Supervisory Board meeting following the Annual General Meeting.
The following table shows the breakdown of the attendance fees for the year ended December 31, 2024: Member Role Attendance Fee Fixed Portion (annual fee) Supervisory Board Member €30,000 Chair of the Audit Committee and Compensation and Nomination Committee €10,000 Variable Portion (attendance fee at each meeting of the Supervisory Board, the Audit Committee, the Compensation and Nomination Committee and the Transaction Committee) Supervisory Board Member (1) €3,000 Member of the Audit Committee or Compensation and Nomination Committee Variable Portion (attendance fee at each meeting of an additional Supervisory Board, an Audit Committee, a Compensation and Nomination Committee and a Transaction Committee) Supervisory Board Member €1,500 Transaction Committee or CSR Member (1) reduction of 50% of variable portion received in the event of remote participation in the Supervisory Board meeting held to approve the annual and half-yearly financial statements, the annual strategic Supervisory Board meeting, the Supervisory Board meeting held to approve the budget, and the Supervisory Board meeting following the Annual General Meeting.
Martinez was Investment Director at CDC Entreprises (2010-2013) and Partner at 171 Bioam Gestion (2000-2010). Mr. Martinez is an alumnus of the Ecole Normale Supérieure and holds a PhD in cell biology from the University of Paris XI and an MBA from the Collège des Ingénieurs (France).
Prior to that, Olivier Martinez was Investment Director at CDC Entreprises (2010-2013) and Partner at Bioam Gestion (2000-2010). Olivier Martinez is an alumnus of the Ecole Normale Supérieure and holds a Ph.D. in cell biology from the University of Paris XI and an MBA from the Collège des Ingénieurs (France).
Laurent holds a PhD in Physical Sciences from the Institut National Polytechnique of Toulouse and a Master of Business Administration in Human Resources from the Institut d’Administration des Entreprises of Toulouse (France). Frederic Lombard , member of the Leadership Team, Chief Financial Officer, joined Innate Pharma in April 2021. Mr.
Odile Laurent holds a Ph.D. in Physical Sciences from the Institut National 171 Polytechnique of Toulouse and a Master of Business Administration in Human Resources from the Institut d’Administration des Entreprises of Toulouse (France). Frédéric Lombard , member of the Leadership Team, Chief Financial Officer, joined Innate Pharma in April 2021.
Sonia Quaratino, EVP, Chief Medical Officer have joined Hervé Brailly, interim Chief Executive Officer and Yannis Morel, EVP, Chief Operating Officer.
Operations, and Sonia Quaratino, Executive Vice President, Chief Medical Officer have joined Hervé Brailly, interim Chief Executive Officer and Yannis Morel, Executive Vice President, Chief Operating Officer.
The 2017 AGAP are not convertible since the performance criteria were not met. 186 The following table shows the AGAPs outstanding as of December 31, 2023: Plan title AGAP Management 2016-1 AGAP Management 2016-2 AGAP Employees 2016-1 Shareholder general meeting date June 2, 2016 June 2, 2016 June 2, 2016 Date of grant October 21, 2016 December 30, 2016 October 21, 2016 Number of AGAP granted 2,000 3,000 2,486 Maximum number of ordinary shares into which each AGAP can be converted 130 111 130 Number of AGAP lapsed during the vesting period 450 — 105 Number of vested AGAP 1,550 3,000 2,381 Number of lapsed AGAP during the lock up period 100 — 146 Number of outstanding AGAP 1,200 3,000 2,063 C.
The following table shows the AGAPs outstanding as of December 31, 2024: Plan title AGAP Management 2016-1 AGAP Management 2016-2 AGAP Employees 2016-1 Shareholder general meeting date June 2, 2016 June 2, 2016 June 2, 2016 Date of grant October 21, 2016 December 30, 2016 October 21, 2016 Number of AGAP granted 2,000 3,000 2,486 Maximum number of ordinary shares into which each AGAP can be converted 130 111 130 Number of AGAP lapsed during the vesting period 450 0 105 Number of vested AGAP 1,550 3,000 2,381 Number of lapsed AGAP during the lock up period 100 0 146 Number of outstanding AGAP 1,200 3,000 2,048 189 C.
Yannis Morel, current EVP, Business Development and Product Portfolio Strategy and member of the Executive Board broadened his remit to become EVP, Chief Operating Officer extending his operational responsibility to the management of research and early development, working with Innate Pharma’s Chief Scientific Officer Prof. Eric Vivier, and Chief Development Officer, Nicola Beltraminelli. Dr.
Yannis Morel, current Executive Vice President, Business Development and Product Portfolio Strategy, member of the Executive Board and member of the Leadership Team broadened his remit to become Executive Vice President, Chief Operating Officer extending his operational responsibility to the management of research and early development, working with Innate Pharma’s Chief Scientific Officer Prof.
Total Compensation €599,918 2024 Executive Board Members' Compensation At the general meeting of shareholders of the Company to be held on May 23, 2024, the compensation of the members of the Executive Board sets forth in the following table for the year ended on December 31, 2023 will be put to the vote of the shareholders: Type of Compensation Hervé Brailly Yannis Morel Sonia Quaratino Arvind Sood Fixed Compensation €470,000 €300,000 €350,000 $300,000 Maximum Annual Variable Compensation if 100% of the objectives are reached €282,000 €120,000 €140,000 $120,000 Maximum Annual Variable Compensation in case of over-performance (150%) €423,000 €180,000 €210,000 $180,000 The variable compensation for the year ended on December 31, 2024 is based on the achievement of the Company's main strategic pillars and operational targets defined according to Innate Pharma's activities in order to (i) take into account the outperformance inherent to a fast-growing biotech company and (ii) motivate the managers to exceed their objectives.
Total Compensation $854,358 2025 Executive Board Members' Compensation At the General Meeting to be held on May 22, 2025, the compensation of the members of the Executive Board sets forth in the following table for the year ending on December 31, 2025 will be put to the vote of the shareholders: Type of Compensation Jonathan Dickinson (1) Yannis Morel Sonia Quaratino Fixed Compensation €550,000 €300,000 €350,000 Maximum Annual Variable Compensation if 100% of the objectives are reached €275,000 €120,000 €140,000 Maximum Annual Variable Compensation in case of over-performance (150%) €330,000 €180,000 €210,000 (1) Jonathan Dickinson was not eligible for the Annual Variable Compensation for the year ended on December 31, 2024. 181 The variable compensation for the year ending on December 31, 2025 is based on the achievement of the Company's main strategic pillars and operational targets defined according to Innate Pharma's activities in order to (i) take into account the outperformance inherent to a fast-growing biotech company and (ii) motivate the managers to exceed their objectives.
The following table shows the breakdown of the attendance fees for the year ended December 31, 2023: Member Role Attendance Fee Fixed Portion (annual fee) Supervisory Board Member €15,000 Chair of the Audit Committee and Compensation and Nomination Committee €25,000 Chair of the Corporate Social Responsibility (CSR) Committee €19.000 Variable Portion (attendance fee at each meeting of the Supervisory Board, the Audit Committee and the Compensation and Nomination Committee) Supervisory Board Member (1) €2,000 Committee Member €2,000 Variable Portion (attendance fee at each meeting of an additional Supervisory Board, a Transaction Committee or a CSR Committee) Supervisory Board Member €1,000 Transaction Committee or CSR Member €1,000 (1) reduction of 50% of variable portion received in the event of remote participation in the Supervisory Board meeting held to approve the annual and half-yearly financial statements, the annual strategic Supervisory Board meeting, the Supervisory Board meeting held to approve the budget, and the Supervisory Board meeting following the Annual General Meeting.
The following table shows the breakdown of Innate's attendance fees for the year ending December 31, 2025: 175 Member Role Attendance Fee Fixed Portion (annual fee) Supervisory Board Member €30,000 Chair of the Audit Committee and Compensation and Nomination Committee €10,000 Variable Portion (attendance fee at each meeting of the Supervisory Board, the Audit Committee, the Compensation and Nomination Committee and the Transaction Committee) Supervisory Board Member (1) €3,000 Member of the Audit Committee or Compensation and Nomination Committee Variable Portion (attendance fee at each meeting of an additional Supervisory Board, an Audit Committee, a Compensation and Nomination Committee and a Transaction Committee) Supervisory Board Member €1,500 Transaction Committee or CSR Member (1) reduction of 50% of variable portion received in the event of remote participation in the Supervisory Board meeting held to approve the annual and half-yearly financial statements, the annual strategic Supervisory Board meeting, the Supervisory Board meeting held to approve the budget, and the Supervisory Board meeting following the Annual General Meeting.
There are five pillars which are essential to the achievement of the strategic axes mentioned above. Each pillar has been subdivided into: 180 (i) a baseline target; and (ii) an outperformance target.
There are five pillars which are essential to the achievement of the strategic axes mentioned above. Each pillar has been subdivided into: (i) core objectives; and (ii) outperformance targets.
From May 2022, the members of the Audit Committee as of the date of this Annual Report are Pascale Boissel, Irina Staatz-Granzer and Sally Bennett. Ms. Boissel is the Chairman of the Audit Committee. The Company's Supervisory Board has determined that Dr. Bennett, Dr. Staatz-Granzer and Ms.
From May 2022, the members of the Audit Committee as of the date of this Annual Report are Pascale Boissel, Irina Staatz-Granzer and Sally Bennett. Pascale Boissel is the Chairman of the Audit Committee.
Boissel are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act. The Supervisory Board has further determined that Ms.
The Company's Supervisory Board has determined that Sally Bennett, Irina Staatz-Granzer and Pascale Boissel are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act.
The first meeting of the committee was held on July, 5th 2023. As of December 31, 2023, the members of the CSR Committee are Sally Bennett, Véronique Chabernaud, Hervé Brailly and Olivier Martinez.
The first meeting of the committee was held on July 5, 2023. As of December 31, 2024, the members of the CSR Committee are Sally Bennett, Véronique Chabernaud, Irina Staatz-Granzer and Olivier Martinez.
The outperformance targets may only be reached if 100% of the baseline targets are reached. • Performance Free Shares . The members of the Executive Board are able to receive, upon authorization of the Supervisory Board and upon recommendation of the Compensation and Nomination Committee, equity compensation in the form of performance free shares. • Other Benefits.
The members of the Executive Board are able to receive, upon authorization of the Supervisory Board and upon recommendation of the Compensation and Nomination Committee, equity compensation in the form of performance free shares. • Other Benefits.
At the general meeting of shareholders of the Company to be held on May 23, 2024, the allocation of free performance shares subject to capitalization evolution and internal conditions will be put to the vote of its shareholders.
At the General Meeting to be held on May 22, 2025, the allocation of free performance shares subject to capitalization evolution and internal conditions as well as the allocation of free shares subject to specific performance criteria will be put to the vote of its shareholders.
The following table sets forth information regarding the attendance fees earned by members of the Supervisory Board during the year ended December 31, 2023: Member Attendance Fees Gilles Brisson €29,000 Irina Staatz-Granzer €42,000 Véronique Chabernaud €48,000 Jean-Yves Blay €29,000 Pascale Boissel €60,000 Sally Bennett €45,000 The Supervisory Board of January 25, 2024 decided to put to the vote of the shareholders at the general meeting of shareholders to be held on May 23, 2024, a total attendance fees envelop to be distributed among the members of the Supervisory Board amounting to €300,000 for the year ending December 31, 2024 .
The following table sets forth information regarding the attendance fees earned by members of the Supervisory Board during the year ended December 31, 2024: Member Attendance Fees Irina Staatz-Granzer €100,000 Gilles Brisson €29,000 Véronique Chabernaud €53,000 Jean-Yves Blay €34,000 Pascale Boissel €64,000 Sally Bennett €52,000 The Supervisory Board of March 26, 2025 decided to put to the vote of the shareholders at the General Meeting to be held on May 22, 2025, a total attendance fees envelope to be distributed among the members of the Supervisory Board amounting to €500,000 for the year ending December 31, 2025 .
Chairman Compensation Hervé Brailly, the Chairman of the Supervisory Board, receives a specific compensation pursuant to article L.225-84 of the French Commercial Code for his duties as Chairman of the Supervisory Board. For the year ended December 31, 2023, Innate paid Mr. Brailly a specific compensation of €100,000 for the performance of his duties as Chairman of the Supervisory Board.
Chairman Compensation Irina Staatz-Granzer, the Chairwoman of the Supervisory Board, receives a specific compensation pursuant to article L.225-84 of the French Commercial Code for her duties as Chairwoman of the Supervisory Board. For the year ended December 31, 2024, Innate paid Irina Staatz-Granzer a specific compensation of €100,000 for the performance of her duties as Chairwoman of the Supervisory Board.
The following tables show the number of employees as of December 31, 2023, broken out by department: Full-time equivalent employees of Innate Pharma SA and Innate Pharma Inc. As of December 31, 2023 Research and development 136 General and administrative 34 Leadership Team 9 Total 179 E.
The following tables show the number of employees as of December 31, 2024, broken out by department: Full-time equivalent employees of Innate Pharma SA and Innate Pharma Inc. As of December 31, 2024 Research and development 135 General and administrative 36 Leadership Team 10 Total 181 195 E.
Vivier joined the Center of Immunology at Marseille-Luminy (CIML) in 1993, becoming its director in 2008 and serving in that role until 2017. A pioneer in the field of innate immunity, he is one of the four immunologists whose research led to the creation of Innate Pharma.
After completing his post-doctoral fellowship at Harvard Medical School (Dana-Faber Cancer Institute), Eric Vivier joined the Center of Immunology at Marseille-Luminy (CIML) in 1993, becoming its director in 2008 and serving in that role until 2017. A pioneer in the field of innate immunity, he is one of the four immunologists whose research led to the creation of Innate Pharma.
Performance Free Shares 2023 €240,000 This amount was calculated in accordance with the IFRS 2 valuation of the grant to Dr. Morel of 150,000 performance free shares 2023. Benefits in Kind €7,118 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits.
Free Shares 2024 €324,000 This amount was calculated in accordance with the IFRS 2 valuation of the grant to Jonathan Dickinson of 200,000 free shares 2024. Benefits in Kind €19,583 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits.
She was Quality Manager for 10 years before becoming Head of Compliance. During her career at Innate, Ms. Belzunce contributed to the structuration of the processes as the Company was growing, developing its portfolio and its activities. Ms. Belzunce currently holds the position of VP, Compliance and Operations.
During her career at Innate, Odile Belzunce contributed to the structuration of the processes as the Company was growing, developing its portfolio and its activities. Odile Belzunce currently holds the position of VP, Compliance and Operations.
The following table sets forth information concerning the members of the Supervisory Board , the Executive Board and the Leadership Team (formerly named “Executive Committee”) as of December 31, 2023.
Sood is challenging his departure conditions. 167 The following table sets forth information concerning the members of the Supervisory Board, the Executive Board and the Leadership Team (formerly named “Executive Committee”) as of December 31, 2024.
In accordance with operating rules adopted by the Supervisory Board, the Compensation and Nomination Committee is composed of at least two members appointed by the Supervisory Board. As of December 31, 2023, the members of the committee are Pascale Boissel, Hervé Brailly, Véronique Chabernaud and Jean-Yves Blay.
In accordance with the Compensation and Nomination Committee charter contained in the Supervisory Board's charter, the Compensation and Nomination Committee is composed of at least two members appointed by the Supervisory Board. As of December 31, 2024, the members of the committee are Pascale Boissel, Irina Staatz-Granzer, Véronique Chabernaud and Jean-Yves Blay.
On October 13, 2023, the Supervisory Board approved the adoption of a clawback policy, applicable from October 2, 2023, requiring the recovery in full or in part of the components of the Chief Executive Officer's compensation that are wholly or partially contingent on the attainment of financial performance criteria based on financial information that has been determined to be erroneous and has required restatement of the financial statements for accounting purposes. 178 2023 Compensation of Mondher Mahjoubi The following table sets forth the compensation earned by Dr.
On October 13, 2023, the Supervisory Board approved the adoption of a clawback policy, applicable from October 2, 2023, requiring the recovery in full or in part of the components of the Chief Executive Officer's compensation that are wholly or partially contingent on the attainment of financial performance criteria based on financial information that has been determined to be erroneous and has required restatement of the financial statements for accounting purposes. 177 2024 Compensation of Hervé Brailly The following table sets forth the compensation earned by Hervé Brailly during the year ended on December 31, 2024: Type of Compensation Amount of Compensation Description Fixed Compensation €391,667 Gross fixed compensation pursuant to Hervé Brailly's social mandate ( mandat social ).
Before, she was Chief Financial Officer of ENYO Pharma. Ms. Boissel was the Deputy-Chief Executive Officer and Administrative and Financial Director of the BIOASTER Institute (IRT) in the field of infectious diseases and microbiology. In 2009, Ms. Boissel joined Ipsogen a listed company developing and marketing molecular diagnostic products as Chief Financial Officer. Ms.
Pascale Boissel was the Deputy-Chief Executive Officer and Administrative and Financial Director of the BIOASTER Institute (IRT) in the field of infectious diseases and microbiology. In 2009, Pascale Boissel joined Ipsogen a listed company developing and marketing molecular diagnostic products as Chief Financial Officer. Pascale Boissel began her career in audit and corporate finance at PricewaterhouseCoopers Paris.
There was no directors' service contracts with the Company or any of its subsidiaries providing for benefits upon termination of employment, for the Company's last completed fiscal year.
If the age limitation is exceeded, the eldest member is deemed to have resigned automatically. There was no directors' service contracts with the Company or any of its subsidiaries providing for benefits upon termination of employment, for the Company's last completed fiscal year.
The Supervisory Board expects the management to consider risk and risk management in each business decision, to proactively develop and monitor risk management strategies and processes for day-to-day activities and to effectively implement risk management strategies adopted by the Supervisory Board. The Company believes this division of responsibilities is the most effective approach for addressing the risks the Company faces.
The Supervisory Board expects the management to consider risk and risk management in each business decision, to proactively develop and monitor risk management strategies and processes for day-to-day activities and to effectively implement risk management strategies adopted by the Supervisory Board.
Name Age Position Executive Board Members Mondher Mahjoubi, M.D. 65 Chairman of the Executive Board, Chief Executive Officer, Member of the Leadership Team Yannis Morel, Ph.D. 50 Member of the Executive Board, EVP, Product Portfolio Strategy & Business Development, Member of the Leadership Team Supervisory Board Members Hervé Brailly, Ph.D. 62 Chairman of the Supervisory Board Irina Staatz-Granzer, Ph.D. 63 Member and Vice Chairman of the Supervisory Board Jean-Yves Blay, Ph.D. 61 Member of the Supervisory Board Gilles Brisson 72 Member of the Supervisory Board Véronique Chabernaud, M.D. 62 Member of the Supervisory Board Olivier Martinez 53 Member of the Supervisory Board Sally Bennett 52 Member of the Supervisory Board Pascale Boissel 57 Member of the Supervisory Board Members of the Leadership Team Sonia Quaratino 57 Member of the Leadership Team, EVP, Chief Medical Officer Odile Belzunce 43 Member of the Leadership Team, VP Compliance, IT and Portfolio Management Eric Vivier, D.V.M., Ph.D. 59 Permanent Guest to the Leadership Team, SVP, Chief Scientific Officer Nicolas Beltraminelli 54 Member of the Leadership Team, VP Chief Development Officer Odile Laurent 62 Member of the Leadership Team, VP Human Resources Frédéric Lombard 49 Member of the Leadership Team, Chief Financial Officer Claire de Saint Blanquat 51 Member of the Leadership Team, VP Legal and Corporate Affairs Henry Wheeler 41 Member of the Leadership Team, VP Investor Relations and Communications 169 Executive Board Mondher Mahjoubi, M.D ., Chief Executive Officer and Chairman of its Executive Board, was appointed Chief Executive Officer and Chairman of its Executive Board on December 30, 2016.
Name Age Position Executive Board Members Jonathan Dickinson, MBA, BSc 57 Chairman of the Executive Board, member of the Leadership Team Yannis Morel, Ph.D. 51 Member of the Executive Board, Executive Vice President, Chief Operating Officer and member of the Leadership Team Sonia Quaratino, M.D., Ph.D. 62 Member of the Executive Board, Executive Vice President, Chief Medical Officer and member of the Leadership Team Arvind Sood* 66 Member of the Executive Board, Executive Vice President, President of US Operations and member of the Leadership Team Supervisory Board Members Irina Staatz-Granzer, Ph.D. 64 Chairwoman of the Supervisory Board Pascale Boissel 58 Vice Chairwoman of the Supervisory Board Jean-Yves Blay, Ph.D. 64 Member of the Supervisory Board Gilles Brisson 73 Member of the Supervisory Board Véronique Chabernaud, M.D. 63 Member of the Supervisory Board Olivier Martinez 54 Member of the Supervisory Board Sally Bennett 53 Member of the Supervisory Board Members of the Leadership Team Odile Belzunce 44 Member of the Leadership Team, VP Compliance, IT and Portfolio Management Eric Vivier, D.V.M., Ph.D. 60 Permanent Guest to the Leadership Team, SVP, Chief Scientific Officer Nicolas Beltraminelli, Ph.D. 55 Member of the Leadership Team, VP Chief Development Officer Odile Laurent, Ph.D., MBA 63 Member of the Leadership Team, VP Human Resources Frédéric Lombard, MBA 50 Member of the Leadership Team, Chief Financial Officer Claire de Saint Blanquat 52 Member of the Leadership Team, VP Legal and Corporate Affairs Henry Wheeler, MSc 42 Member of the Leadership Team, VP Investor Relations and Communications * Arvind Sood resigned from his position on the Executive Board in February 2025.
He joined Innate in December 2001 and until 2007, was in R&D positions, initially as a scientist in the immunology team, before becoming team manager, and finally becoming responsible for research programs. From 2007, he was in charge of business development for the company. Mr.
Between 2001 and 2007, he was in R&D positions, initially as a scientist in the immunology team, before becoming team manager, and finally becoming responsible for research programs. He is in charge of business development for the company since 2007, adding product portfolio strategy since 2017 and research and early development since 2024.
Between 2009 and 2012 he held the position of President of the European Organization for Research and Treatment of Cancer (EORTC). Prof. Blay currently holds various other university and hospital positions.
He is President of the French Sarcoma Group and Director of the European Reference Network for Rare Adult Cancers (EURACAN). Between 2009 and 2012 he held the position of President of the European Organization for Research and Treatment of Cancer (EORTC). Jean-Yves Blay currently holds various other university and hospital positions.

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Item 7. Management's Discussion & Analysis

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

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In addition, under its Code of Business Conduct and Ethics, which Innate Pharma adopted on September 12, 2019, its employees and Executive and Supervisory Board members have an affirmative responsibility 199 to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
In addition, under its Code of Business Conduct and Ethics, which Innate Pharma adopted on September 12, 2019, its employees and Executive and Supervisory Board members have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
The cost and provision of these services are negotiated on an arm's-length basis, and none of these arrangements are material. Related Person Transaction Policy The Company complies with French law regarding approval of transactions with related parties.
The cost and provision of these services are negotiated on an arm's-length basis, and none of these arrangements are material. 200 Related Person Transaction Policy The Company complies with French law regarding approval of transactions with related parties.
All of the transactions described above were evaluated and approved by the Supervisory Board. C. Interests of Experts and Counsel. Not applicable.
All of the transactions described above were evaluated and approved by the Supervisory Board. 201 C. Interests of Experts and Counsel. Not applicable.
Since January 1, 2023, the Company has engaged in the following transactions with members of its Executive and Supervisory Boards and holders of more than 5% of its outstanding voting securities, and their respective affiliates, which Innate refers to as its related parties.
Since January 1, 2024, the Company has engaged in the following transactions with members of its Executive and Supervisory Boards and holders of more than 5% of its outstanding voting securities, and their respective affiliates, which Innate refers to as its related parties.
Agreement with Jean-Yves Blay as member of the Supervisory Board On May 12, 2023, the Supervisory Board authorized the conclusion of an agreement between Innate Pharma and Jean-Yves Blay in his capacity as member of the Supervisory Board in order to define the terms and conditions under which Jean-Yves Blay participates in the Supervisory Board.
On May 12, 2023, the Supervisory Board authorized the conclusion of an agreement between Innate Pharma and Jean-Yves Blay in his capacity as a member of the Supervisory Board, to define the terms and conditions under which Jean-Yves Blay participates in the Supervisory Board.
Major Shareholders The following table and accompanying footnotes set forth, as of December 31, 2023, information regarding beneficial ownership of the ordinary shares by: • each person, or group of affiliated persons, known by Innate to beneficially own more than 5% of the ordinary shares; • each of the Leadership Team and Supervisory Board members individually; and • all of the Executive Board and Supervisory Board members as a group.
Major Shareholders The following table and accompanying footnotes set forth, as of April 25, 2025, information regarding beneficial ownership of the ordinary shares by: • each person, or group of affiliated persons, known by Innate to beneficially own more than 5% of the ordinary shares; • each of the Leadership Team and Supervisory Board members individually; and • all of the Executive Board and Supervisory Board members as a group.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of December 31, 2023 and options and warrants that are currently exercisable or exercisable within 60 days of December 31, 2023.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of April 25, 2025 and options and warrants that are currently exercisable or exercisable within 60 days of April 25, 2025.
Ordinary shares subject to free shares, options and warrants currently exercisable or exercisable within 60 days of December 31, 2023 are deemed to be outstanding for computing the percentage ownership of the person holding these free shares, options or warrants and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
Ordinary shares subject to free shares, options and warrants currently exercisable or exercisable within 60 days of April 25, 2025 are deemed to be outstanding for computing the percentage of ownership of the person holding these free shares, options or warrants and the percentage of ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
Assuming that all of the ordinary shares represented by ADSs are held by residents of the United States, as of December 31, 2023, the Company estimates that approximately 4.8 million shares, or 5.97% of the ordinary shares were held of record by residents of the United States.
Assuming that all of the ordinary shares represented by ADSs are held by residents of the United States, as of December 31, 2024, the Company estimates that approximately 4.7 million shares, or 5.67% of the outstanding ordinary shares were held of record by residents of the United States.
Arrangements with the Members of the Executive and Supervisory Boards Director and Executive Officer Compensation See “Item 6B—Compensation—Limitations on Liability and Indemnification Matters” for information regarding compensation of the members of the Supervisory and Executive Boards. Termination letter for Mondher Mahjoubi Following the resignation of Mr.
Arrangements with the Members of the Executive and Supervisory Boards Director and Executive Officer Compensation See “Item 6B—Compensation—Limitations on Liability and Indemnification Matters” for information regarding compensation of the members of the Supervisory and Executive Boards.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Innate Pharma S.A., 117, Avenue de Luminy – BP 30191, 13009 Marseille, France. 195 Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% Shareholders : Novo Nordisk A/S(1) 9,817,546 12.14% MedImmune Limited(2) 7,485,500 9.26% Bpifrance Participations(3) 6,389,406 7.90% Executive Board and Supervisory Board members and other executive officers : Mondher Mahjoubi, M.D.(4) 631,088 0.78% Yannis Morel, Ph.D.(5) 194,192 0.24% Hervé Brailly, Ph.D.(6) 739,784 0.92% Irina Staatz-Granzer (7) 25,100 0.03% Jean-Yves Blay(8) 50 —% Gilles Brisson (9) 73,059 0.09% Véronique Chabernaud(10) 660 —% Olivier Martinez(11) — —% Pascale Boissel(12) 1,000 —% Sally Bennett(13) 2,500 —% Sonia Quaratino — —% Odile Belzunce(14) 62,249 0.08% Eric Vivier, D.V.M.(15) 210,228 0.26% Odile Laurent (16) 37,979 0.05% Frédéric Lombard (17) 11,362 0.01% Nicola Beltraminelli (18) 9,246 0.01% Henry Wheeler (19) 3,185 —% Claire de St Blanquat (20) 3,185 —% All members of our Executive Board, Supervisory Board and other Leadership Team member as a group 25,697,319 32% (1) Consists of 9,817,546 ordinary shares.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Innate Pharma S.A., 117, Avenue de Luminy – BP 30191, 13009 Marseille, France. 197 Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% Shareholders : Novo Nordisk A/S(1) 9,817,546 10.65% Sanofi(2) 8,345,387 9.05% MedImmune Limited(3) 7,485,500 8.12% Bpifrance Participations S.A.(4) 6,389,406 6.93% All 5% Shareholders 32,037,839 34.76% Executive Board and Supervisory Board members and other executive officers : Jonathan Dickinson, MBA, BSc(5) 0 —% Yannis Morel, Ph.D.(6) 420,692 *% Sonia Quaratino, MD, PhD (7) 0 —% Arvind Sood (8) 0 —% Irina Staatz-Granzer (9) 45,100 *% Gilles Brisson (10) 98,059 *% Véronique Chabernaud(11) 24,860 *% Jean-Yves Blay (12) 50 *% Pascale Boissel(13) 9,260 *% Sally Bennett(14) 2,500 *% Eric Vivier, D.V.M.(15) 235,911 *% Odile Belzunce(16) 102,749 *% Odile Laurent (17) 63,662 *% Frédéric Lombard (18) 35,362 *% Nicola Beltraminelli (19) 4,246 *% Claire de St Blanquat (20) 25,668 *% Henry Wheeler (21) 18,785 *% All members of our Executive Board, Supervisory Board and other Leadership Team member as a group 1,086,904 1.18% (1) Amounts beneficially owned were reported pursuant to a Schedule 13G filed with the SEC on February 3, 2020.
(7) Consists of 25,100 ordinary shares, 10,000 warrants (BSA 2015-1) , 10,000 warrants (BSA 2017) and 10,000 warrants (BSA 2023). 196 (8) Consists of 50 ordinary shares and 8,000 warrants (BSA 2023). (9) Consists of 73,059 ordinary shares, 15,000 warrants (BSA 2015-1) , 10,000 warrants (BSA 2017) and 10,000 warrants (BSA 2023).
(7) N/A (8) N/A (9) Consists of 25,100 ordinary shares, 10,000 warrants which are exercisable since April 27, 2015 (BSA 2015-1), 10,000 warrants which are exercisable since September 20, 2019 (BSA 2017). (10) Consists of 73,059 ordinary shares, 15,000 warrants which are exercisable since April 27, 2015 (BSA 2015-1), 10,000 warrants which are exercisable since September 20, 2019 (BSA 2017).
To our knowledge, there are no arrangements that may result in a change of control. B. Related Party Transactions.
Furthermore, we believe that we are not directly or indirectly owned or controlled by another corporation or government, or by any other natural or legal persons. To our knowledge, there are no arrangements that may result in a change of control. 199 B. Related Party Transactions.
To the best of our knowledge, no other shareholder currently holds, directly or indirectly and acting alone or in concert, more than 5% of our share capital or voting rights. Furthermore, we believe that we are not directly or indirectly owned or controlled by another corporation or government, or by any other natural or legal persons.
(20) Consists of 25,668 ordinary shares. (21) Consists of 18,785 ordinary shares. None of the principal shareholders has voting rights different than the other shareholders. To the best of our knowledge, no other shareholder currently holds, directly or indirectly and acting alone or in concert, more than 5% of our share capital or voting rights.
The principal business address for Bpifrance Participations is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France. (4) Consists of 631,088 ordinary shares. (5) Consists of 194,192 ordinary shares and 88,000 redeemable warrants (BSAAR 2015). (6) Consists of 739,784 ordinary shares, 150,000 redeemable warrants (BSAAR 2015) and 10,000 warrants (BSA2023).
(4) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on December 6, 2022. Consists of 6,389,406 ordinary shares. The principal business address for Bpifrance Participations S.A. is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France.
The principal business address for Novo Nordisk A/S is Novo Allé, 2880 Bagsvaerd, Denmark. (2) Consists of 7,485,500 ordinary shares. The principal business address for MedImmune Limited is Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom. (3) Consists of 6,389,406 ordinary shares.
The principal business address for MedImmune Limited is Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom. AstraZeneca PLC and MedImmune Limited may each be deemed to have sole voting and dispositive power over all of the Ordinary Shares held by MedImmune Limited. AstraZeneca PLC may be deemed to beneficially own the ordinary shares.
(10) Consists of 660 ordinary shares, 14,200 warrants (BSA 2015-2) and 10,000 warrants (BSA 2017). (11) As representative of Bpifrance Participations, the legal entity that holds this Supervisory Board seat. (12) Consists of 1,000 ordinary shares. (13) Consists of 2,500 ordinary shares. (14) Consists of 62,249 ordinary shares and 10,000 warrants (BSA). (15) Consists of 210,228 ordinary shares.
(11) Consists of 660 ordinary shares, 14,200 warrants which are exercisable since July 1, 2015 (BSA 2015-2), 10,000 warrants which are exercisable since September 20, 2019 (BSA 2017). (12) Consists of 50 ordinary shares. (13) Consists of 1,000 ordinary shares and 8,260 warrants which are exercisable since October 3, 2024 (BSA 2022). (14) Consists of 2,500 ordinary shares.
Removed
(16) Consists of 37,979 ordinary shares. (17) Consists of 11,362 ordinary shares. (18) Consists of 9,246 ordinary shares. (19) Consists of 3,185 ordinary shares. (20) Consists of 3,185 ordinary shares. None of the principal shareholders has voting rights different than the other shareholders.
Added
Beneficial ownership representing less than 1% is denoted with an asterisk (*).
Removed
Mondher Mahjoubi from his duties as member and Chairman of the Executive Board with effect from December 31, 2023, the Supervisory Board meeting of December 15, 2023 authorized the Company to sign a letter specifying the terms and conditions of Mr. Mahjoubi's departure. These conditions are detailed below.
Added
Consists of 9,817,546 ordinary shares. The principal business address for Novo Nordisk A/S is Novo Allé, 2880 Bagsvaerd, Denmark. The percentage of beneficial ownership is based on 92,157,148 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of April 25, 2025.
Removed
Mondher Mahjoubi, who will remain with the company until December 31, 2023, is eligible for the following: – To his variable remuneration for 2023, in accordance with the level of achievement of the Company's 2023 objectives to be assessed by the Supervisory Board; – To the 2020 free performance shares ("AGAP") granted to him by decision of the Executive Board on August 5, 2020, up to the level of achievement of the performance conditions as assessed by the Executive Board. 197 In addition, Mr.
Added
(2) Amounts beneficially owned were reported pursuant to a Schedule 13G filed with the SEC on April 29, 2025. Consists of 8,345,387 ordinary shares held by Sanofi-Aventis Participations SAS, an indirectly wholly-owned subsidiary of Sanofi. The principal business address of Sanofi is 46, avenue de la Grande Armée, 75017 Paris, France.
Removed
Mondher Mahjoubi's letter of termination specifies that the Supervisory Board authorizes the Executive Board to waive Mr.
Added
Sanofi’s percentage of beneficial ownership is based on 92,157,148 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of April 25, 2025. 198 (3) Amounts beneficially owned were reported pursuant to a Schedule 13D filed with the SEC on October 25, 2019. Consists of 7,485,500 ordinary shares held by MedImmune Limited, a wholly-owned subsidiary of AstraZeneca PLC.
Removed
Mondher Mahjoubi's attendance conditions under the AGAP 2021 and 2022 programs, thereby enabling him to benefit from the shares granted to him by the Executive Board on October 1, 2021 and December 12, 2022 respectively, according to the level of achievement of the conditions by December 31, 2023, as determined by the Executive Board, with a definitive grant date in accordance with the programs concerned, i.e.
Added
The principal business address for AstraZeneca PLC is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom. Percentage of beneficial ownership is based on 92,157,148 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of April 25, 2025.
Removed
December 31, 2024 and December 31, 2025 respectively. Lastly, the non-compete clause has been waived. Mondher Mahjoubi consulting agreement Following the resignation of Mr. Mondher Mahjoubi from his duties as member and Chairman of the Executive Board with effect from December 31, 2023, the Supervisory Board meeting of December 15, 2023 authorized the conclusion of a services agreement with Mr.
Added
Bpifrance S.A. may be deemed to be the beneficial owner of 6,389,406 ordinary shares (corresponding to 6,389,406 voting rights), indirectly through its ownership of Bpifrance Participations S.A. The principal business address for Bpifrance S.A. is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France.
Removed
Mahjoubi for the month of January 2024, for remuneration equivalent to his fixed monthly remuneration, i.e. €39,000. This agreement has no impact on the fiscal year 2023.
Added
EPIC Bpifrance may be deemed to be the beneficial owner of 6,389,406 ordinary shares (corresponding to 6,389,406 voting rights), indirectly through its joint ownership and control of Bpifrance S.A. The principal business address for EPIC Bpifrance is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France.
Removed
This contract took effect on June 12, 2023 for the duration of Jean-Yves Blay's term of office, i.e., until the General Annual Meeting approving the financial statements for the year ending December 31, 2024 and at the latest June 30, 2025. The contract provides that Jean-Yves Blay may receive a maximum remuneration of €43,000 per year.
Added
Caisse des Dépôts et consignations may be deemed to be the beneficial owner of (i) 6,389,406 ordinary shares, indirectly through its joint ownership and control of Bpifrance S.A., and (ii) 797,222 ordinary shares, indirectly through CDC Croissance S.A., its wholly-owned subsidiary. The principal business address for Caisse des Dépôts et consignations is c/o 56, rue de Lille, 75007 Paris, France.
Removed
For the financial year 2023, Jean-Yves Blay received €29,000 under this contract, corresponding to the amount of his fixed and variable remuneration as a member of the Supervisory Board.
Added
Percentage of beneficial ownership is based on 92,157,148 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of April 25, 2025. (5) N/A (6) Consists of 274,192 ordinary shares, 450 preferred shares 2016 which are convertible into 58,500 ordinary shares (AGAP 2016) and 88,000 redeemable warrants which are exercisable since July 1, 2015 (BSAAR 2015).
Removed
Amendments to the Pionner Consortium agreement At its meeting on May 12, 2023, the Supervisory Board authorized the conclusion of amendments no. 1 and 2 to the Pionner Consortium project agreement, involving nine academic and industrial partners, including Innate Pharma, AstraZeneca and the Centre Léon Bérard, in order to define the terms and conditions of the project.
Added
(15) Consists of 235,911 ordinary shares. (16) Consists of 86,249 ordinary shares, 50 preferred shares 2016 which are convertible into 6,500 ordinary shares (AGAP 2016) and 10,000 redeemable warrants which are exercisable since July 1, 2015 (BSAAR 2015). (17) Consists of 63,662 ordinary shares. (18) Consists of 35,362 ordinary shares. (19) Consists of 4,246 ordinary shares.
Removed
The agreement was signed on November 7, 2018, with retroactive effect to November 1, 2017. An amendment n°1 was signed on September 8, 2022 to extend the duration of the project until October 31, 2023. An amendment n° 2 was signed on June 2, 2023.
Added
On December 15, 2023, following Mondher Mahjoubi’s resignation from his position as Chairman of the Executive Board effective December 31, 2023, the Supervisory Board authorized the conclusion of a service agreement with him for the month of January 2024, for compensation equivalent to his monthly fixed salary, i.e., the sum of €39,000 On January 3, 2024, following his appointment as Interim Chairman of the Executive Board, the Supervisory Board authorized the conclusion of a mandate agreement between the Company and Hervé Brailly, which includes the benefit of a French pension contract of €5,503.28.
Removed
This amendment added a new partner to the agreement, the "Institut Gustave Roussy", and extended the duration of the project to October 31, 2024. Indemnification Agreement with Mr. Hervé Brailly, Mrs. Irina Staatz-Granzer, Mr. Jean Yves Blay, Mr. Gilles Brisson, Mrs. Véronique Chabernaud, Mrs. Pascale Boissel, Ms. Sally Bennett and Mr.
Added
On January 3, 2024, following his appointment as Chief Operating Officer, member of the Executive Board, the Supervisory Board authorized the entry into of an amendment to an employment contract between the Company and Yannis Morel, which includes, a fixed annual remuneration of €300,000 and a French pension contract of €5,662.02.
Removed
Olivier Martinez as members of the Supervisory Board and Mr. Mondher Mahjoubi and Mr.
Added
On January 3, 2024, following her appointment as a member of the Executive Board, the Supervisory Board authorized the entry into of an amendment to an employment contract between the Company and Sonia Quaratino, which includes an individual bonus of 40% based on reaching certain specified targets, rising to 60% in the event of outperformance.
Removed
Yannis Morel as members of the Management Board 198 In the context of the Nasdaq IPO and regarding the need to put in place insurance for the liability of officers of listed companies in the United States, the Supervisory Board decided : (i) to subscribe to an insurance policy covering the risks associated with the Nasdaq IPO (IPO insurance) and an insurance policy extension for companies listed on the Nasdaq (D&O insurance policy); and (ii) to enter into an indemnification agreement between the Company and the Supervisory and Executive Board members.
Added
On October 11, 2024, the Supervisory Board authorized the conclusion of a consulting agreement with Addexpert and then, after expiration of that agreement, with Kervrant Biotech, a company wholly owned by Hervé Brailly, to continue the consulting and support services for the new Chairman of the Executive Board during the transition period, until May 31, 2025, at the latest, for a maximum amount of 10,000 € a month, depending on time spent.
Removed
Such indemnification agreement provides that the Company would cover Supervisory Board members and Executive Board members in situations in which the IPO and D&O insurance policies would not cover them, but always within the limits of what is legally possible in terms of indemnification of directors and officers.
Added
On June 1, 2024, the Supervisory Board authorized the conclusion of a consulting agreement with Ariana Pharmaceuticals, a company in which Véronique Chabernaud is acting CMO and Jean-Yves Blay is a scientific advisor, aimed at using artificial intelligence to accelerate the development of the Company's products.

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