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 — 2024 vs 2025
Top changes in Innate Pharma SA's 2025 20-F
825 paragraphs added · 963 removed · 635 edited across 6 sections
- Item 4. Mine Safety Disclosures+262 / −373 · 196 edited
- Item 6. [Reserved]+173 / −189 · 121 edited
- Item 5. Market for Registrant's Common Equity+158 / −183 · 122 edited
- Item 3. Legal Proceedings+187 / −182 · 165 edited
- Item 7. Management's Discussion & Analysis+44 / −35 · 30 edited
Item 2. Properties
Properties — owned and leased real estate
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Item 2. Properties
Properties — owned and leased real estate
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2024 filing
2025 filing
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 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. 116 D.
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
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Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
165 edited+22 added−17 removed555 unchanged
2024 filing
2025 filing
The success in development of its current and future product candidates by the Company or its collaborators will depend on many factors, including: • obtaining positive results in clinical trials, including by demonstrating efficacy, safety and durability of effect of such product candidates; • completing preclinical studies and receiving regulatory approvals or clearance for conducting clinical trials for its preclinical programs; • receiving and maintaining approvals for commercialization of such product candidates from regulatory authorities; • manufacturing or overseeing the manufacturing of its product candidates in acceptable quantities and at an acceptable cost; • negotiating favorable terms in any collaboration, licensing or other arrangements into which the Company may enter, and performing its obligations pursuant to such arrangements; 11 • maintaining, protecting, enforcing and expanding its portfolio of intellectual property rights, including patents, trade secrets and know-how; • avoiding and defending against third-party interference, infringement or other intellectual property claims; and • maintaining and growing an organization of scientists, medical professionals and marketing, distribution and sales personnel and executives who can develop its product candidates and commercialize any approved products.
The success in development of its current and future product candidates by the Company or its collaborators will depend on many factors, including: • obtaining positive results in clinical trials, including by demonstrating efficacy, safety and durability of effect of such product candidates; • completing preclinical studies and receiving regulatory approvals or clearance for conducting clinical trials for its preclinical programs; • receiving and maintaining approvals for commercialization of such product candidates from regulatory authorities; • manufacturing or overseeing the manufacturing of its product candidates in acceptable quantities and at an acceptable cost; 11 • negotiating favorable terms in any collaboration, licensing or other arrangements into which the Company may enter, and performing its obligations pursuant to such arrangements; • maintaining, protecting, enforcing and expanding its portfolio of intellectual property rights, including patents, trade secrets and know-how; • avoiding and defending against third-party interference, infringement or other intellectual property claims; and • maintaining and growing an organization of scientists, medical professionals and marketing, distribution and sales personnel and executives who can develop its product candidates and commercialize any approved products.
Events that may prevent successful or timely completion of clinical development include: • inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical trials; • delays or failure in reaching a consensus with regulatory agencies on clinical study design; 15 • delays in reaching agreement on acceptable terms with prospective Contract Research Organisations (CROs) and investigational sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and investigational sites; • imposition of a temporary or permanent clinical hold by regulatory agencies, including as a result of a new safety finding that presents unreasonable risk to clinical study participants, a negative finding from an inspection of its clinical trial operations or investigational sites, developments in trials conducted by competitors for related technology that raise regulators’ concerns about risk to patients of the technology broadly or if a regulatory body finds that the investigational protocol or plan is clearly deficient to meet its stated objectives.
Events that may prevent successful or timely completion of clinical development include: • inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical trials; 15 • delays or failure in reaching a consensus with regulatory agencies on clinical study design; • delays in reaching agreement on acceptable terms with prospective Contract Research Organisations (CROs) and investigational sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and investigational sites; • imposition of a temporary or permanent clinical hold by regulatory agencies, including as a result of a new safety finding that presents unreasonable risk to clinical study participants, a negative finding from an inspection of its clinical trial operations or investigational sites, developments in trials conducted by competitors for related technology that raise regulators’ concerns about risk to patients of the technology broadly or if a regulatory body finds that the investigational protocol or plan is clearly deficient to meet its stated objectives.
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.
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; 35 • 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; • mandating product recalls or seizing products; • imposing operating restrictions; and • seeking criminal prosecutions.
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.
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; 67 • 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 • 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.
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.
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; • 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 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; 63 • 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.
For example: • others may be able to make products that are the same as or similar to its product candidates or utilize similar technology but that are not covered by the claims of the patents that the Company licenses or may own in the future; • the Company, or its license partners or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that the Company licenses or may own in the future; • the Company, or its license partners or current or future collaborators, might not have been the first to file patent applications covering certain of its or their inventions; • others may independently develop similar or alternative technologies or duplicate any of the Company's technologies without infringing its owned or licensed intellectual property rights; • it is possible that the Company's owned or licensed pending patent applications will not lead to issued patents; • issued patents that the Company holds rights to may be held invalid or unenforceable, including as a result of legal challenges by its competitors; • its competitors might conduct research and development activities in countries where the Company does not have patent rights and then use the information learned from such activities to develop competitive products for sale in its major commercial markets; • the Company may not develop additional proprietary technologies that are patentable; • the patents of others may harm the Company's business; and • the Company may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
For example: • others may be able to make products that are the same as or similar to its product candidates or utilize similar technology but that are not covered by the claims of the patents that the Company licenses or may own in the future; • the Company, or its license partners or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that the Company licenses or may own in the future; • the Company, or its license partners or current or future collaborators, might not have been the first to file patent applications covering certain of its or their inventions; • others may independently develop similar or alternative technologies or duplicate any of the Company's technologies without infringing its owned or licensed intellectual property rights; • it is possible that the Company's owned or licensed pending patent applications will not lead to issued patents; • issued patents that the Company holds rights to may be held invalid or unenforceable, including as a result of legal challenges by its competitors; • its competitors might conduct research and development activities in countries where the Company does not have patent rights and then use the information learned from such activities to develop competitive products for sale in its major commercial markets; • the Company may not develop additional proprietary technologies that are patentable; • the patents of others may harm the Company's business; and 62 • the Company may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
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.
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 • 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.
These provisions include the following: • under French law, the owner of 90% of the share capital or voting rights of a public company listed on a regulated market in a Member State of the European Union or in a state party to the EEA Agreement, including from the main French stock exchange, has the right to force out minority shareholders following a tender offer made to all shareholders; • under French law, a non-resident of France, as well as any French entity controlled by non-residents of France, may have to file a declaration for statistical purposes with the Bank of France (Banque de France) within 20 working days following the date of certain direct foreign investments in us, including any purchase of the Company's ADSs.
These provisions include the following: • under French law, the owner of 90% of the share capital or voting rights of a public company listed on a regulated market in a Member State of the European Union or in a state party to the 66 EEA Agreement, including from the main French stock exchange, has the right to force out minority shareholders following a tender offer made to all shareholders; • under French law, a non-resident of France, as well as any French entity controlled by non-residents of France, may have to file a declaration for statistical purposes with the Bank of France (Banque de France) within 20 working days following the date of certain direct foreign investments in us, including any purchase of the Company's 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; • 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.
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 • 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.
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.
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.
In addition, disputes may arise regarding intellectual property subject to a license agreement, including: • the scope of rights granted under the license agreement and other interpretation-related issues; • the extent to which its technology and processes infringe on intellectual property of the counterparty that is not subject to the license agreement; • Innate's diligence obligations under the license agreement and what activities satisfy those diligence obligations; • the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by its counterparties and us; and • the priority of invention of patented technology.
In addition, disputes may arise regarding intellectual property subject to a license agreement, including: • the scope of rights granted under the license agreement and other interpretation-related issues; • the extent to which its technology and processes infringe on intellectual property of the counterparty that is not subject to the license agreement; • Innate's diligence obligations under the license agreement and what activities satisfy those diligence obligations; 59 • the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by its counterparties and us; and • the priority of invention of patented technology.
See “Risk Factors—The Company's future growth depends, in part, on its ability to penetrate multiple markets, in which the Company would be subject to additional regulatory burdens and other political, social and geopolitical risks and uncertainties.” 51 Risks Related to Intellectual Property Rights Its ability to compete may be adversely affected if the Company does not adequately obtain, maintain, protect and enforce Innate's intellectual property or proprietary rights, or if the scope of intellectual property protection the Company obtains is not sufficiently broad.
See “Risk Factors—The Company's future growth depends, in part, on its ability to penetrate multiple markets, in which the Company would be subject to additional regulatory burdens and other political, social and geopolitical risks and uncertainties.” Risks Related to Intellectual Property Rights Its ability to compete may be adversely affected if the Company does not adequately obtain, maintain, protect and enforce Innate's intellectual property or proprietary rights, or if the scope of intellectual property protection the Company obtains is not sufficiently broad.
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.
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.
Despite the Company's efforts, its product candidates may not: • offer improvement over existing, comparable products; • be proven safe and effective in clinical trials; or • meet applicable regulatory standards. This process can take many years and may include post-marketing studies and surveillance, which will require the expenditure of substantial resources beyond the existing cash on hand.
Despite the Company's efforts, its product candidates may not: • offer improvement over existing, comparable products; • be proven safe and effective in clinical trials; or • meet other applicable regulatory standards. This process can take many years and may include post-marketing studies and surveillance, which will require the expenditure of substantial resources beyond the existing cash on hand.
If the Company is unable to manage such changes or has difficulty integrating any acquisitions, it could have a material adverse effect on its business, prospects, financial condition and results of operations. The Company relies on certain independent organizations, partners, advisors and consultants to provide certain services and needs to hire new employees and expand its use of service providers.
If the Company is unable to manage such changes or has difficulty integrating any acquisitions, it could have a material adverse effect on its business, prospects, financial condition and results of operations. 47 The Company relies on certain independent organizations, partners, advisors and consultants to provide certain services and needs to hire new employees and expand its use of service providers.
The French tax authorities may challenge Innate's eligibility for, or its calculation of, certain tax reductions or deductions in respect of its research and development activities (and therefore the amount of Research Tax Credit claimed), or the accelerated reimbursement allowed for small- and medium-size businesses and the Company's credits may be reduced, which would have a negative impact on its revenue and future cash flows.
The French tax authorities may challenge Innate's eligibility for, or its calculation of, certain tax reductions or deductions in respect of its research and development activities (and therefore the amount of Research 43 Tax Credit claimed), or the accelerated reimbursement allowed for small- and medium-size businesses and the Company's credits may be reduced, which would have a negative impact on its revenue and future cash flows.
Failure to comply with the requirements of the GDPR and related national data protection laws of the member states of the European Union may result in substantial fines, other administrative penalties and civil claims being brought against us, which could have a material adverse effect on Innate's business, prospects, financial condition and results of operations.
Failure to comply with the requirements of the GDPR and related national data protection laws of the member states of the 31 European Union may result in substantial fines, other administrative penalties and civil claims being brought against us, which could have a material adverse effect on Innate's business, prospects, financial condition and results of operations.
For example, in November 2019, Impletio Wirkstoffabfüllung GmbH (formerly known as Rentschler Fill Solutions GmbH), the subcontractor in charge of the fill-and-finish manufacturing operations of lacutamab, unilaterally decided to withdraw the certificates of conformance of all clinical batches produced at their facilities, including the lacutamab batch used for the TELLOMAK Phase 2 clinical study assessing lacutamab in multiple indications.
For example, in November 2019, Impletio Wirkstoffabfüllung GmbH (formerly known as Rentschler Fill Solutions GmbH), the subcontractor in charge of the fill-and-finish manufacturing operations of 32 lacutamab, unilaterally decided to withdraw the certificates of conformance of all clinical batches produced at their facilities, including the lacutamab batch used for the TELLOMAK Phase 2 clinical study assessing lacutamab in multiple indications.
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.
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 42 above may have a material adverse impact 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.
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.
In accordance with Innate's business decisions, its exposure to this type of risk could change depending on: • the currencies in which Innate receives its revenues; • the currencies chosen when agreements are signed, such as licensing agreements, or co-marketing or co-development agreements; • the location of clinical trials on product candidates; and • its policy for insurance cover.
In accordance with Innate's business decisions, its exposure to this type of risk could change depending on: • the currencies in which Innate receives its revenues; 44 • the currencies chosen when agreements are signed, such as licensing agreements, or co-marketing or co-development agreements; • the location of clinical trials on product candidates; and • its policy for insurance cover.
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.
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.
The agreements or other arrangements to protect the Company's trade secrets may fail to provide the protection sought, or may be breached, or its trade secrets may be disclosed to, or developed independently by, its competitors. 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 agreements or other arrangements to protect the Company's trade secrets may fail to provide the protection sought, or may be breached, or its trade secrets may be disclosed to, or developed independently by, its competitors. 61 Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations.
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.
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. Intellectual property rights do not necessarily address all potential threats.
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.
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.
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 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 companies may have a competitive advantage over Innate due to their size, capital resources and greater clinical development and commercialization capabilities.
The clinical success of these product candidates will depend on a number of factors, including the ability and willingness of AstraZeneca, Sanofi and the Company's other collaborators to complete ongoing clinical studies respectively for monalizumab and IPH6401/SAR'514 13 or other partnered assets, the ability to complete the clinical trials for which the Company is responsible and the safety, tolerability and efficacy of its product candidates.
The clinical success of these product candidates will depend on a number of factors, including the ability and willingness of AstraZeneca, Sanofi and the Company's other collaborators to complete ongoing clinical studies respectively for monalizumab and IPH6401/SAR'514 or other partnered assets, the ability to complete the clinical trials for which the Company is responsible and the safety, tolerability and efficacy of its product candidates.
In order to prevent the risk of fire, fire prevention measures are implemented, such as pruning shrubs in the surrounding green areas and implementing a maintenance plan for fire-fighting equipment. In addition, computer data backup and archiving measures are implemented, allowing the regularly backed-up data to be stored on the premises of a specialized service provider.
In order to prevent the risk of fire, fire prevention measures are implemented, such as pruning shrubs in the surrounding green areas and implementing a maintenance plan for fire-fighting equipment. In addition, computer data backup and archiving measures are implemented, allowing the regularly backed- 48 up data to be stored on the premises of a specialized service provider.
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.
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 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.
Should any of these risks materialize, this could harm its business. 20 Innate Pharma's failure to obtain marketing approval in jurisdictions other than the United States and Europe would prevent Innate's product candidates from being marketed in these other jurisdictions, and any approval the Company is granted for its product candidates in the United States and Europe would not assure approval of product candidates in other jurisdictions.
Should any of these risks materialize, this could harm its business. 20 Innate Pharma's failure to obtain marketing approval in jurisdictions other than the United States and Europe could prevent Innate's product candidates from being marketed in some of other jurisdictions, and any approval the Company is granted for its product candidates in the United States and Europe would not assure approval of product candidates in other jurisdictions.
Even if marketing authorization of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including the FDA requirement to implement a risk evaluation and mitigation strategy to ensure that the benefits of a drug or biological product outweigh its risks.
Even 26 if marketing authorization of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including the FDA requirement to implement a risk evaluation and mitigation strategy to ensure that the benefits of a drug or biological product outweigh its risks.
Should any of these risks materialize, this could have a material adverse effect its business, prospects, financial condition and results of operations. The Company relies on third parties to supply key materials used in its research and development, to provide services to Innate and to assist with clinical studies.
Should any of these risks materialize, this could have a material adverse effect its business, prospects, financial condition and results of operations. 33 The Company relies on third parties to supply key materials used in its research and development, to provide services to Innate and to assist with clinical studies.
Accordingly, although there can be no assurance that the Company will undertake or successfully complete any transactions of the nature described above, any transactions that the Company does complete may be subject to the foregoing or other risks and have a material and adverse effect on its business, financial condition, results of operations and prospects.
Accordingly, although there 37 can be no assurance that the Company will undertake or successfully complete any transactions of the nature described above, any transactions that the Company does complete may be subject to the foregoing or other risks and have a material and adverse effect on its business, financial condition, results of operations and prospects.
In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. Developments in patent law could have a negative impact on the Company's business.
In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 56 Developments in patent law could have a negative impact on the Company's business.
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.
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.
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.
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 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.
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.
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.
These lawsuits may divert Innate's management from pursuing its business strategy and may be costly to defend. In addition, if the Company is held liable in any of these lawsuits, it may incur substantial liabilities, may be forced to limit or forgo further commercialization of the affected products and may suffer damage to its reputation.
These lawsuits may divert Innate's management from pursuing its business strategy and may be costly to defend. In addition, if the Company is held liable in any of these lawsuits, it may 49 incur substantial liabilities, may be forced to limit or forgo further commercialization of the affected products and may suffer damage to its reputation.
Litigation may be necessary to defend against these claims. If Innate fails in defending any such claims, in addition to paying monetary damages, Innate may lose valuable intellectual property rights or personnel. Even if Innate is successful in defending against such claims, litigation could result in substantial costs and be a distraction to its management and other employees.
Litigation may be necessary to defend against these claims. If Innate fails in defending any such claims, in addition to paying monetary damages, Innate may lose valuable intellectual property rights or 60 personnel. Even if Innate is successful in defending against such claims, litigation could result in substantial costs and be a distraction to its management and other employees.
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.
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 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 FDA and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use, and if the Company does not market its products for their approved indications, the Company may be subject to enforcement action for off-label marketing. Prescription products may be promoted only for the approved indications and in accordance with the provisions of the approved label.
The FDA and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use, and if the Company does not market its products for their approved indications, the Company may be subject to enforcement action for off-label marketing. Prescription products are promoted only for the approved indications and in accordance with the provisions of the approved label.
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.
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.
The stringent standards set by the Sarbanes-Oxley Act require that the Company's audit committee be advised and regularly updated on management’s review of internal control over financial reporting. To comply with this obligation, the Company must maintain an extensive framework of internal control over financial reporting, that needs to be regularly updated and tested.
The stringent standards set by the Sarbanes-Oxley Act require that the 70 Company's audit committee be advised and regularly updated on management’s review of internal control over financial reporting. To comply with this obligation, the Company must maintain an extensive framework of internal control over financial reporting, that needs to be regularly updated and tested.
In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets and received directly its proportionate share of the income of such other corporation.
In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets and received directly its proportionate share of the income of such other 71 corporation.
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.
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.
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 government can exercise its march-in rights if it determines that action is necessary because the Company failed to achieve practical 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.
Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable federal and state laws and regulations that may constrain the business and/or financial arrangements, including those pertaining to fraud and abuse, anti-kickback, false claims, transparency, and patient data privacy.
Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable federal and state laws and regulations that 30 may constrain the business and/or financial arrangements, including those pertaining to fraud and abuse, anti-kickback, false claims, transparency, and patient data privacy.
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.
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.
However, in order to complete the development process, obtain regulatory approval and, if approved, commercialize its product candidates that the Company is 39 developing in-house, including lacutamab, IPH5301, IPH6501 and IPH4502; develop its proprietary technology; and develop a pipeline of additional product candidates, the Company will require additional funding.
However, in order to complete the development process, obtain regulatory approval and, if approved, commercialize its product candidates that the Company is developing in-house, including lacutamab, IPH5301, IPH6501 and IPH4502; develop its proprietary technology; and develop a pipeline of additional product candidates, the Company will require additional funding.
A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect Innate's ability to commercialize any product candidates it may develop and any other product candidates or technologies covered by the asserted third-party patents.
A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect Innate's ability to 54 commercialize any product candidates it may develop and any other product candidates or technologies covered by the asserted third-party patents.
In order to optimize the launch and market penetration of certain of its future product candidates, the Company may enter into distribution and marketing agreements with pharmaceutical industry leaders. For these product candidates, the Company would not market its products alone once they have obtained marketing authorization.
In order to optimize the launch and market penetration of certain of its future product candidates, the Company may enter into distribution and marketing agreements with pharmaceutical industry leaders. For 36 these product candidates, the Company would not market its products alone once they have obtained marketing authorization.
Even if the Company has not experienced any cyber breach to date, 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 Company has subscribed to insurance covering "cyber" and fraud.
Even if the 46 Company has not experienced any cyber breach to date, 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 Company has subscribed to insurance covering "cyber" and fraud.
Consequently, Innate may not be able to prevent third parties from exploiting products that are the same as or similar to its products and product candidates in countries in which it does not obtain patent protection, or from selling or importing such products in and into the countries in which it does have patent protection.
Consequently, Innate may not be able to prevent third parties from exploiting products that are the same as or similar to its products and product candidates in countries in which it does not obtain patent protection, or from selling or importing 52 such products in and into the countries in which it does have patent protection.
Equity markets are subject to considerable price fluctuations, and often these movements do not reflect the operational and financial performance of the listed companies concerned. In particular, biotechnology 62 companies’ share prices have been highly volatile and may continue to be highly volatile in the future.
Equity markets are subject to considerable price fluctuations, and often these movements do not reflect the operational and financial performance of the listed companies concerned. In particular, biotechnology companies’ share prices have been highly volatile and may continue to be highly volatile in the future.
Further, if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of 65 procedure would still be governed by the law of the jurisdiction in which the foreign court resides.
Further, if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.
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.
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.
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 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.
Data from preclinical and clinical studies are likely to give rise to different interpretations, which could delay regulatory authorization, restrict the scope of any such authorization or force Innate to repeat trials in order to meet the requirements of the various regulators.
Data from preclinical and clinical studies are likely to give rise to different interpretations, which could delay regulatory authorization, restrict the scope of any such authorization or force Innate to repeat studies in order to meet the requirements of the various regulators.
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.
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.
Although the Company gained some experience in the late stage development and marketing and commercialization of pharmaceutical products, such experience was short and may not have resulted in a 46 sufficient acquisition of skills to anticipate and tackle the marketing and commercialization of Innate's other drug candidates.
Although the Company gained some experience in the late stage development and marketing and commercialization of pharmaceutical products, such experience was short and may not have resulted in a sufficient acquisition of skills to anticipate and tackle the marketing and commercialization of Innate's other drug candidates.
Further, under French law, the determination of whether the Company has been sufficiently profitable to pay dividends is made on the basis of its statutory financial statements prepared and presented in accordance with accounting standards applicable in France.
Further, under French law, the determination of whether the Company has been sufficiently profitable to pay dividends is made on the basis of its statutory financial statements prepared and presented in 64 accordance with accounting standards applicable in France.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the federal and state laws in the United States. Many companies have encountered significant 57 problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the federal and state laws in the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
The Company is under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, the Company may not be able to establish an exemption from registration under the Securities Act.
The Company is under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, the Company may not be able to establish an exemption from registration under the Securities 68 Act.
You may instruct the depositary of your ADSs to vote the ordinary shares underlying your ADSs. Otherwise, you will not be able to exercise your right to vote, unless you withdraw the ordinary shares underlying the ADSs you hold. However, you may not know about the meeting far enough in advance to 68 withdraw those ordinary shares.
You may instruct the depositary of your ADSs to vote the ordinary shares underlying your ADSs. Otherwise, you will not be able to exercise your right to vote, unless you withdraw the ordinary shares underlying the ADSs you hold. However, you may not know about the meeting far enough in advance to withdraw those ordinary shares.
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.
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.
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.
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.
For example, in the performance of its duties, Innate's Executive Board is required by French law to consider the interests of Innate, its shareholders, its employees and other stakeholders, rather than solely Innate's shareholders and/or creditors.
For example, in the performance of its duties, Innate's Executive Board is required by French law to consider the interests of Innate, its shareholders, its employees and other stakeholders, 65 rather than solely Innate's shareholders and/or creditors.
Innate is a foreign private issuer, as defined in the SEC’s rules and regulations and, consequently, it is not subject to all of the disclosure requirements applicable to public companies organized within the United States.
Innate is a foreign private issuer, as defined in the SEC’s rules and regulations and, consequently, it is not subject to all of the disclosure requirements applicable to public companies organized within the United 69 States.
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.
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.
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 addition, if the Company makes 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.
For example, pursuant to its license agreement with AstraZeneca for monalizumab, AstraZeneca retains 52 control of such activities for certain patents that the Company licenses to it under the agreement and patents that arise under the collaboration.
For example, pursuant to its license agreement with AstraZeneca for monalizumab, AstraZeneca retains control of such activities for certain patents that the Company licenses to it under the agreement and patents that arise under the collaboration.
Innate has written agreements with partners or other third parties that provide for the ownership of intellectual property arising from its collaborations and its other work with such third parties.
Innate has written agreements with partners or other third parties that provide for the ownership of intellectual property arising from its collaborations and its other 58 work with such third parties.
See “Risk Factors—The Company incurs significant costs as a result of being a public company.” Innate's internal computerized systems, or those of its third-party contractors or consultants, may fail or suffer security breaches and be subject to malicious intent or cyberattack, which could result in a material disruption of its product development programs and in its operations in general.
See “Risk Factors—The Company incurs significant costs as a result of being a public company.” The Company's internal computerized systems, or those of its third-party contractors or consultants, may fail or suffer security breaches and be subject to malicious intent or cyberattack, which could result in a material disruption of its product development programs and in its operations in general.
They are entitled to request additional clinical data before authorizing the commencement or resumption of a study, which could result in delays or changes to the product development plan. As the Company advances its product candidates, the Company will be required to consult with these regulatory agencies and comply with all applicable guidelines, rules and regulations.
They are entitled to request additional clinical data before authorizing the commencement or resumption of a study, which could result in delays or changes to the product development plan. As the Company advances its product candidates, the Company will be required to consult with these regulatory agencies for regulatory approval and comply with all applicable guidelines, rules and regulations.
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.
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.
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.
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.
Under standards established by the Public Company Accounting Oversight Board, a material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement in Innate's annual or interim financial statements will not be prevented or detected and corrected on a timely basis.
Under standards established by the Public Company Accounting Oversight Board, a material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement in Company's annual or interim financial statements will not be prevented or detected and corrected on a timely basis.
Even if resolved in Innate's favor, litigation or other intellectual property proceedings may cause Innate to incur significant expenses and could distract its management and other personnel from their normal responsibilities. For example, Orega Biotech claims joint ownership of certain patents relating to IPH5201, which the Company disputed.
Even if resolved in Innate's favor, litigation or other intellectual property proceedings may cause Innate to incur significant expenses and could distract its management and other personnel from their normal responsibilities. For example, Orega Biotech claimed joint ownership of certain patents relating to IPH5201, which the Company disputed.
Any product candidate for which the Company obtains marketing approval will be subject to strict enforcement of post-marketing requirements and the Company could be subject to substantial penalties, including withdrawal of its product from the market, if the Company fails to comply with all 21 regulatory requirements or if the Company experiences unanticipated problems with its product and product candidates, when and if any of them are approved.
Any product candidate for which the Company obtains marketing approval will be subject to strict enforcement of post-marketing requirements and the Company could be subject to substantial penalties, including withdrawal of its product from the market, if the Company fails to comply with 21 relevant regulatory requirements or if the Company experiences unanticipated problems with its product and product candidates, when and if any of them are approved.
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Item 4. Mine Safety Disclosures
Mine Safety Disclosures — required of mining issuers
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Item 4. Mine Safety Disclosures
Mine Safety Disclosures — required of mining issuers
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2024 filing
2025 filing
Cohorts 2 and 3 recruited KIR3DL2 expressing and non-expressing patients respectively based on an IHC assay for use on frozen tissue. The cohorts were designed using Simon 2-stage approach which pre-defined an efficacy threshold in Stage 1 before continuing to stage 2.
Cohorts 2 and 3 recruited KIR3DL2 expressing and non-expressing patients respectively based on an IHC assay for use on frozen tissue. The cohorts were designed using the Simon 2-stage approach, which pre-defined an efficacy threshold in Stage 1 before continuing to Stage 2.
In the United States, a patent may also be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.
In the United States, a patent may also be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process.
Once the results of the pending studies are provided, it can become a “regular” marketing authorization. • Approval under exceptional circumstances: a marketing authorization may be granted in exceptional cases, reviewed each year to reassess the risk-benefit balance when the initial dossier for assessment of the drug cannot contain all required data, for instance when the condition to be treated is rarely encountered. • Accelerated assessment : the evaluation process is accelerated (150 days instead of 210 days) when a drug is of major interest from the standpoint of public health or in particular from the viewpoint of therapeutic innovation. • The PRIME (priority medicines) scheme refers to a process for enhanced interactions and early dialogue with EMA to facilitate the development and speed up examination of drugs which target unmet medical needs or offer a major therapeutic advantage over existing treatments.
Once the results of the pending studies are provided, it can become a “regular” marketing authorization. • Approval under exceptional circumstances: a marketing authorization may be granted in exceptional cases, reviewed each year to reassess the risk-benefit balance when the initial dossier for assessment of the drug cannot contain all required data, for instance when the condition to be treated is rarely encountered. 106 • Accelerated assessment : the evaluation process is accelerated (150 days instead of 210 days) when a drug is of major interest from the standpoint of public health or in particular from the viewpoint of therapeutic innovation. • The PRIME (priority medicines) scheme refers to a process for enhanced interactions and early dialogue with EMA to facilitate the development and speed up examination of drugs which target unmet medical needs or offer a major therapeutic advantage over existing treatments.
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.
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. 1.
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.
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 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.
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.
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; • 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 110 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.
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.
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.
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.
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.
Resectable, early‑stage NSCLC is considered a potentially curable disease, and the standard of care is surgery alone or surgery with adjuvant or neoadjuvant platinum‑based doublet chemotherapy (NCCN 2022). However, patients had five‑year survival rates ranging from approximately 70% for Stage IA1 NSCLC to 20% for Stage IIIA NSCLC (Chansky, 2017).
Resectable, early‑stage NSCLC is considered a potentially curable disease, and the standard of care is surgery alone or surgery with adjuvant or neoadjuvant platinum‑based doublet chemotherapy 89 (NCCN 2022). However, patients had five‑year survival rates ranging from approximately 70% for Stage IA1 NSCLC to 20% for Stage IIIA NSCLC (Chansky, 2017).
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.
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 technologies complementary to, or necessary for, its programs and enter into collaborations with potential partners who have access to innovative technologies.
The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with cGCP.
The FDA will not approve an application unless it determines that the manufacturing and packaging processes and facilities are in compliance with the BLA and cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with cGCP.
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).
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).
These provisions require, among others, the filing of compliance undertakings with “standard methodologies” and a specific framework applicable to the retention of personal data when researching in the health sector (July 2020) adopted by the French Data Protection Authority (the CNIL), or, if not compliant, obtaining a specific authorization from the CNIL.
These provisions require, among others, the filing of compliance 115 undertakings with “standard methodologies” and a specific framework applicable to the retention of personal data when researching in the health sector (July 2020) adopted by the French Data Protection Authority (the CNIL), or, if not compliant, obtaining a specific authorization from the CNIL.
Clinical trials are sometimes necessary or required by regulatory authorities after marketing authorization to explain certain side-effects, investigate a specific pharmacological effect or obtain more accurate or additional data. Additional trials are also commonly conducted to explore new indications. Regulatory authorization and ethics approvals are needed to carry out clinical trials.
Clinical trials are sometimes necessary or required by regulatory authorities after marketing authorization to explain certain side-effects, investigate a specific pharmacological effect or obtain more accurate or additional data. Additional trials are also commonly conducted to explore new indications. Regulatory authorization and ethics approvals are needed to carry 101 out clinical trials.
The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
The applicant will receive a fee reduction for the marketing authorization application if the orphan drug 107 designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy.
After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in 86 unresectable, Stage III NSCLC patients following chemoradiation therapy.
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.
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.
External Sponsored studies are currently ongoing in bladder cancer and small cell lung cancer. Below is a summary of ongoing clinical trials in NSCLC that AstraZeneca is conducting to evaluate monalizumab: Lung cancer is the leading cause of cancer death, accounting for about one-third of all cancer deaths.
External Sponsored studies are currently ongoing in bladder cancer and small cell lung cancer. 85 Below is a summary of ongoing clinical trials in NSCLC that AstraZeneca is conducting to evaluate monalizumab: Lung cancer is the leading cause of cancer death, accounting for about one-third of all cancer deaths.
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.
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.
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.
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.
For a period of two years from January 1, 2021, when determining an application for a Great Britain Marketing Authorization, the MHRA was allowed to rely on on a decision taken by the European Commission on the approval of a new MA in the centralized procedure (the European Decision Reliance Procedure).
For a period of two years from January 1, 2021, when determining an application for a Great Britain Marketing Authorization, the 108 MHRA was allowed to rely on a decision taken by the European Commission on the approval of a new MA in the centralized procedure (the European Decision Reliance Procedure).
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.
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.
This is consistent with the review conducted by the Independent Data Monitoring Committee (IDMC), which concluded there were no safety issues related to lacutamab, and the product appeared to be well-tolerated among current patients enrolled in the trial.
This is consistent with the review conducted by the independent data monitoring committee, which concluded there were no safety issues related to lacutamab, and the product appeared to be well-tolerated among current patients enrolled in the trial.
IL-2v incorporated into IPH6501 is directed towards NK cells through the binding with high affinity to NKp46 and CD16a, providing its ability to interact with IL-2R preferentially on NK cells and to promote their activation and proliferation at pM doses. b.
IL-2v incorporated into IPH6501 is directed towards NK cells through the binding with high affinity to NKp46 and CD16a, providing its ability to interact with IL-2R preferentially on NK cells and to promote their activation and proliferation at pM doses.
On the basis of the FDA’s evaluation of the application and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
On the basis of the FDA’s evaluation of the application and accompanying information, including the results of the inspection of the manufacturing and packaging facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.
Following the dosing of the first patient on March 9, 2020, in the IPH5201 Phase 1 clinical trial, AstraZeneca made a $5 million milestone 105 payment to Innate under the collaboration and option agreement relating to IPH5201.
Following the dosing of the first patient on March 9, 2020, in the IPH5201 Phase 1 clinical trial, AstraZeneca made a $5 million milestone payment to Innate under the collaboration and option agreement relating to IPH5201.
These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the applicable regulator may mandate the performance of Phase 4 clinical trials as a condition of approval.
These trials are used to gain additional experience from the treatment of patients in the 103 intended therapeutic indication. In certain instances, the applicable regulator may mandate the performance of Phase 4 clinical trials as a condition of approval.
IPH6501 was designed to induce NK cell mediated-cytotoxicity and cytokine secretion by co-engaging CD16a and NKp46. Only the binding of IPH6501 to CD20, bridging the NK cells to the target cells, was able to trigger the cytotoxic activity of NK cells.
IPH6501 was designed to induce NK cell mediated-cytotoxicity and cytokine secretion by co-engaging CD16a and NKp46. Only the binding of IPH6501 to CD20, bridging the NK cells to the target cells, was 95 able to trigger the cytotoxic activity of NK cells.
Mechanism IPH6101/SAR443579 is the first trifunctional anti-CD123 NK cell engager NKp46/CD16 using Innate’s proprietary multi-specific antibody format ANKET ® . It has shown anti-tumor activity in preclinical models, including supporting pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies, leading to its selection as a drug candidate for development.
IPH6101/SAR'579, a CD123-targeting NK Cell Engager a. Mechanism IPH6101/SAR443579 is the first trifunctional anti-CD123 NK cell engager NKp46/CD16 using Innate’s proprietary multi-specific antibody format ANKET ® . It has shown anti-tumor activity in preclinical models, including supporting pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies, leading to its selection as a drug candidate for development.
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.
Lung Cancer: Phase 2 NeoCOAST-2 87 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.
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.
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, 2025, Innate Pharma is the sole shareholder of Innate Pharma Inc., a Delaware corporation. D. Property, Plants and Equipment.
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.
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). 77 c. Clinical Trials Below is a summary of the clinical trials of lacutamab. i.
IPH5201/Anti-CD39 As of December 31, 2024, the principal intellectual property rights related to IPH5201 are co-owned by Innate together with Orega Biotech, and include U.S. patent No. 11,377,503, European patent No. EP 3 807 316 B1, and other patent applications in certain other countries.
IPH5201/Anti-CD39 As of December 31, 2025, the principal intellectual property rights related to IPH5201 are co-owned by Innate together with Orega Biotech, and include U.S. patent No. 11,377,503, European patent No. EP 3 807 316 B1, and other patent applications in certain other countries.
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.
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, 2025, the principal intellectual property rights related to monalizumab are in-licensed from Novo Nordisk A/S and include U.S.
Lacutamab fill and finish manufacturing operations were transferred to alternative CMOs In October 2023, the FDA placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).
Lacutamab fill and finish manufacturing operations were transferred to alternative CMOs In October 2023, the FDA placed a partial clinical hold on the lacutamab investigational new drug (IND) leading to a pause in new patient enrollment to the Company’s lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).
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).
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 frequency increases for the most aggressive CTCL subtypes, including 90% of Sézary syndrome (SS) (Roelens, 2019).
Following on the signal observed in this Phase 2 study, AstraZeneca has started a randomized Phase 3 study PACIFIC-9 of monalizumab or oleclumab plus durvalumab in unresectable, Stage III NSCLC setting for patients who have not progressed after concurrent chemoradiation therapy.
Following the signal observed in this Phase 2 study, AstraZeneca started a randomized Phase 3 study, PACIFIC-9, of monalizumab or oleclumab plus durvalumab in unresectable, Stage III NSCLC setting for patients who have not progressed after concurrent chemoradiation therapy.
Regulations concerning marketing authorizations In order to be marketed, a drug product must have regulatory authorization (known as approval of a New Drug Application (NDA) or licensure of a Biologics License Application (BLA) in the United States, a Marketing Authorization Application (MAA) in the European Union and a Great Britain Marketing Authorisation Application).
Regulations concerning marketing authorizations In order to be marketed, a drug product must have regulatory authorization (known as approval of a New Drug Application (NDA) or licensure of a Biologics License Application (BLA) in the United States, a Marketing Authorization (MA) in the European Union and a Great Britain Marketing Authorisation).
The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition, a designation which carries with it the following incentives: the possibility of obtaining research grants from the American government for clinical trials; tax credits for a portion of research costs; a possible exemption from user fees; and the potential for a seven-year period of exclusivity if a marketing authorization is granted.
In the United States, the FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition, a designation which carries with it the following incentives: the possibility of obtaining research grants from the American government for clinical trials; tax credits for a portion of research costs; a possible exemption from user fees; and the potential for a seven-year period of exclusivity if a marketing authorization is granted.
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.
Median progression-free survival (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. 80 ◦ 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.
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.
Recent interim data from the Phase III AEGEAN study (NCT03800134) showed that perioperative durvalumab (anti-PD-L1) plus neoadjuvant CT significantly improved both 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.
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.
IPH5301/Anti-CD73 As of December 31, 2025, 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.
Cytotoxic antibodies targeting CD123 displayed limited antileukemic activity in several clinical trials, even when tested in the form of Fc-engineered antibodies designed specifically to increase antibody-dependent cell cytotoxicity (ADCC). By contrast, T cell engager molecules and CAR-T cell therapies have some clinical efficacy, but are also highly toxic, confirming the need for alternative targeted approaches for the treatment of AML.
Cytotoxic antibodies targeting CD123 displayed limited antileukemic activity in several clinical trials, even when tested in the form of Fc-engineered antibodies designed specifically to increase ADCC. By contrast, T cell engager molecules and CAR-T cell therapies have some clinical efficacy, but are also highly toxic, confirming the need for alternative targeted approaches for the treatment of AML.
In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of 26.7% [95% CI; 16.1–39.7] and a major pathological response rate of 53.3% [95% CI; 40.0–66.3] which are numerically higher than the durvalumab plus platinum doublet approved regimen.
In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pCR rate of 26.7% [95% CI; 16.1–39.7] and a major pathological response (mPR) rate of 53.3% [95% CI; 40.0–66.3] which are numerically higher than the durvalumab plus platinum doublet approved regimen.
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.
IPH6501 As of December 31, 2025, 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 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.
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.
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).
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 GemOx is listed as one of the preferred treatment combinations (European Society for Medical Oncology (ESMO) Lymphoma Guidelines).
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.
Clinical results in Sézary Syndrome (SS) (Cohort 1) • Final results from the Phase 2 TELLOMAK study in SS were presented at the American Society of Hematology (ASH) Annual Meeting in December 2023. ◦ As of May 1, 2023, the study’s data cutoff, patients in the SS 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.
Lung cancer is the second most common cancer in both men and women, with an estimated 234,030 new cases of lung cancer in the United States in 2018, and remains the main cause of cancer-related deaths worldwide.
Overview and indications Lung cancer is the second most common cancer in both men and women, with an estimated 234,030 new cases of lung cancer in the United States in 2018, and remains the main cause of cancer-related deaths worldwide.
Phase I in advanced solid tumors A Phase 1 clinical trial (NCT04261075), sponsored by AstraZeneca, with first patient treated in March 2020, evaluated IPH5201, an anti-CD39 blocking monoclonal antibody, in adult patients with advanced solid tumors.
Clinical development • Phase 1 in advanced solid tumors A Phase 1 clinical trial (NCT04261075), sponsored by AstraZeneca, with first patient treated in March 2020, evaluated IPH5201, an anti-CD39 blocking monoclonal antibody, in adult patients with advanced solid tumors.
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.
Lacutamab/Anti-KIR3DL2 As of December 31, 2025, 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 99 counterpart patent applications in certain other countries.
There were no new safety findings. ii.Lung Cancer: Phase 2 COAST Study In September 2021, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Congress.
There were no new safety findings. ii.Lung Cancer: Phase 2 COAST Study In September 2021, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III NSCLC at the European Society for Medical Oncology (ESMO) Congress.
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.
If a patent directed to IPH4502 issues from such U.S. patent 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.
The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety. Innate is responsible for conducting the study and shares study costs with AstraZeneca. AstraZeneca supplies clinical trial drugs. The first patient was dosed in June 2023.
The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pCR and safety. Innate is responsible for conducting the study and shares study costs with AstraZeneca. AstraZeneca supplies clinical trial drugs. The first patient was dosed in June 2023.
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.
The global confirmed ORR was 37.5% (21 out of 56), including two complete responses (CR) and 19 partial responses (PR). ORR in the skin was 46.4% (26 out of 56), including five CR and 21 PR and ORR in the blood was 48.2% (27 out of 56) with 15 CR and 12 PR.
The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKET ® asset, in various CD123-expressing hematological malignancies.
The purpose of the dose escalation and dose expansion study, sponsored by Sanofi, was to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKET ® asset, in various CD123-expressing hematological malignancies.
The trial aims to evaluate the efficacy and safety of lacutamab in patients with advanced T cell Lymphoma. 160 patients have been recruited, approximately 60 patients with Sézary syndrome who have received at least two prior treatments (Cohort 1), and approximately 100 patients with MF who have received at least two prior systemic therapies (Cohorts 2, 3 and all-comers).
The trial aims to evaluate the efficacy and safety of lacutamab in patients with advanced T cell Lymphoma. 160 patients have been recruited, approximately 60 patients with SS who have received at least two prior treatments (Cohort 1), and approximately 100 patients with MF who have received at least two prior systemic therapies (Cohorts 2, 3 and all-comers).
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.
Under Innate's existing collaboration and license agreements that become effective upon the exercise by its collaborators of o ptions to license future product candidates, the Company may be eligible to receive an aggregate of approximately up to $2.8 billion 3 in future contingent payments.
As of the March 4, 2022 data cutoff: ◦ Patients in the KIR3DL2 ≥1% subgroup (cohort 2) received a median of four prior systemic therapies, and had a median follow-up of 12.2 months. Objective response rate (ORR) was 28.6% (95% CI 13.8-50.0) including two complete responses and four partial responses.
As of the March 4, 2022 data cutoff: ◦ Patients in the KIR3DL2 ≥1% subgroup (cohort 2) received a median of four prior systemic therapies, and had a median follow-up of 12.2 months. Objective response rate (ORR) was 28.6% (95% CI 13.8-50.0) including two CR and four PR.
This supports the evaluation of the combined blockade of CD39 and PD-L1, with IPH5201 and durvalumab, respectively, that can hypothetically increase activity when compared to durvalumab monotherapy by altering the balance of ATP and adenosine in the tumor microenvironment. 103 i. Clinical development 1.
This supports the evaluation of the combined blockade of CD39 and PD-L1, with IPH5201 and durvalumab, respectively, that can hypothetically increase activity when compared to durvalumab monotherapy by altering the balance of ATP and adenosine in the tumor microenvironment. i.
Also, in the NeoCoast randomized Phase 2 study, one cycle of neoadjuvant oleclumab in combination with durvalumab improved major pathological response (MPR) and pathological complete response (pCR) rates versus durvalumab alone, in stage I-IIIA resectable NSCLC patients (Cascone, AACR 2022).
Also, in the NeoCoast randomized Phase 2 study, one cycle of neoadjuvant oleclumab in combination with durvalumab improved mPR and pCR rates versus durvalumab alone, in stage I-IIIA resectable NSCLC patients (Cascone, AACR 2022).
IPH45 As of December 31, 2024, the principal intellectual property rights related to IPH45 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.
IPH4502 As of December 31, 2025, the principal intellectual property rights related to IPH4502 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.
Clinical trial authorization in the United States In the United States, an Investigational New Drug (IND) application must be submitted to the FDA and accepted before clinical trials can start on humans.
Clinical trial authorization in the United States In the United States, an IND application must be submitted to the FDA and accepted before clinical trials can start on humans.
In Cohort 3, comprising 18 patients with KIR3DL2 • In 2024, favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF) were presented at the ASCO 2024 ◦ As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months. ◦ The data demonstrated that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile.
In Cohort 3, comprising 18 patients with KIR3DL2 • In 2024, favorable results from the Phase 2 TELLOMAK study with lacutamab in MF were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting: ◦ As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months. ◦ The data demonstrated that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile.
Overview 87 Monalizumab has been evaluated in clinical trials in head and neck, lung and other cancer indications. Innate was responsible for the conduct of the IPH2201-203 study in head and neck squamous cell carcinoma (study completed), while AstraZeneca is conducting all other trials (except for the External Sponsored studies).
Overview Monalizumab has been evaluated in clinical trials in head and neck, lung and other cancer indications. Innate was responsible for conducting an IPH2201-203 study in head and neck squamous cell carcinoma (the study is now completed), while AstraZeneca is conducting all other trials (except for the External Sponsored studies).
Additionally, only one patent applicable to an approved product is eligible for the extension, the application for the extension must be submitted prior to the expiration of the patent in question, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
Additionally, only one patent applicable to an approved product is eligible for the extension, the application for the extension must be submitted within 60 days of FDA approval of the product and prior to the expiration of the patent in question, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended.
Since 2015, the Company has received an aggregate of $696.1 million (€619.7 million) in upfront and milestone payments and equity investments from its collaborations. This amount includes a total of €62.6 million received from AstraZeneca following its investment in the Company's capital in October 2018.
Since 2015, the Company has received an aggregate of $696.6 million (€620.2 million) in upfront and milestone payments and equity investments from its collaborations. This amount includes a total of €62.6 million received from AstraZeneca following its investment in the Company's capital in October 2018.
With respect to its lead product candidate, lacutamab, a monoclonal antibody product candidate targeting KIR3DL2, the Company is aware of several pharmaceutical companies marketing and developing products for the treatment of patients with CTCL, including MF and Sézary syndrome, and PTCL.
With respect to its lead product candidate, lacutamab, a monoclonal antibody product candidate targeting KIR3DL2, the Company is aware of several pharmaceutical companies marketing and developing 97 products for the treatment of patients with CTCL, including MF and SS, and PTCL.
The PD profile, including inhibition of 104 CD39 activity in the tumors of patients treated with IPH5201, was consistent with the proposed mechanism of action for IPH5201. As clinical activity results, 22/57 patients (38.6%) had stable disease as their best overall response; there were no partial or complete responses.
The PD profile, including inhibition of CD39 activity in the tumors of patients treated with IPH5201, was consistent with the proposed mechanism of action for IPH5201. As clinical activity results, 22/57 patients (38.6%) had stable disease as their best overall response; there were no PR or CR.
Based on these criteria, results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc].
Based on these criteria, results showed that lacutamab produced an increased global ORR of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 CR and 7 PR. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc].
While Cohort 2 continues to Stage 2, the pre-specified threshold for Cohort 3 was not met, and was therefore closed in March 2022. In March 2022, the Company announced the opening of a new mycosis fungoides (MF) all-comers cohort in the TELLOMAK study.
While 78 Cohort 2 continued to Stage 2, the pre-specified threshold for Cohort 3 was not met, and was therefore closed in March 2022. In March 2022, the Company announced the opening of a new MF all-comers cohort in the TELLOMAK study.
Key secondary measures include incidence of treatment-emergent AEs, the effect of skin disease on quality of life as measured by the Skindex29 questionnaire, pruritus as measured by the Visual Analog Scale, progression-free survival and overall survival. The results of the dedicated Sézary syndrome cohort may support a future Biologics License Application (BLA) submission to the FDA.
Key secondary measures include incidence of treatment-emergent adverse events, the effect of skin disease on quality of life as measured by the Skindex29 questionnaire, pruritus as measured by the Visual Analog Scale, progression-free survival and overall survival. The results of the dedicated SS cohort may support a future Biologics License Application (BLA) submission to the FDA.
Innate received a $5 million milestone payment from AstraZeneca upon signature of the amendment and is responsible for conducting a Phase 2 multicenter, open label, non-randomized study of neoadjuvant and adjuvant treatment with IPH5201, durvalumab, and chemotherapy in patients with resectable, early-stage non-small cell lung cancer (NSCLC). The "MATISSE" Study has started and is recruiting patients.
Innate received a $5 million milestone payment from AstraZeneca upon signature of the amendment and is responsible for conducting a Phase 2 multicenter, open label, non-randomized study of neoadjuvant and adjuvant treatment with IPH5201, durvalumab, and chemotherapy in patients with resectable, early-stage NSCLC. The "MATISSE" Study is ongoing and is recruiting patients.
In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide. Eighty to eighty-five percent are classified as NSCLC. Stage III NSCLC represents approximately one quarter of NSCLC incidence. In 2018, the FDA approved durvalumab for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
In 2022, an estimated 2.5 million people were diagnosed with lung cancer worldwide. 80 to 85% are classified as NSCLC. Stage III NSCLC represents approximately one quarter of NSCLC incidence. In 2018, the FDA approved durvalumab for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
The activity of IPH45 in various indications and its enhanced anti-tumor activity in combination with anti-PD-1 therapies in preclinical models support its development beyond UC. 3.
The activity of IPH4502 in various indications and its enhanced anti-tumor activity in combination with anti-PD-1 therapies in preclinical models support its development beyond UC. d.
Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group. Time to response was 1.0 month (95% CI 1, 5). iii.
Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group.
These characteristics contribute to enhanced anti-tumor activity compared to EV across a broad range of Nectin-4 expression levels, from low to high, in PDX models. – Superior efficacy to EV in bladder cancer models with low Nectin-4 expression. – Potential beyond bladder cancer in tumors with low and heterogeneous Nectin-4 expression: Leveraging its bystander activity, IPH4502 is active in tumor models with low and heterogeneous Nectin-4 expression beyond UC. – Activity in models with primary or acquired resistance to EV: IPH4502 demonstrates efficacy in an in vivo model with primary resistance to MMAE due to MDR1 transporter expression and shows anti-tumor activity in a PDX model of UC with acquired resistance to EV. – Strong combination potential with PD-1-targeting agents: In syngeneic mouse models, the combination of IPH4502 with an anti-PD-1 antibody induces synergistic anti-tumor activity in both EV-sensitive and EV-resistant models. – Hydrophilic and stable linker enables high ADC exposure and minimal free exatecan release in cynomolgus monkey plasma.
These characteristics contribute to enhanced anti-tumor activity compared to EV across a broad range of Nectin-4 expression levels, from low to high, in patient-derived xenograft (PDX) models. – Superior efficacy to EV in bladder cancer models with low Nectin-4 expression. – Potential beyond bladder cancer in tumors with low and heterogeneous Nectin-4 expression : Leveraging its bystander activity, IPH4502 is active in tumor models with low and heterogeneous Nectin-4 expression beyond UC. – Activity in models with primary or acquired resistance to EV : IPH4502 demonstrates efficacy in an in vivo model with primary resistance to MMAE due to MDR1 (Multidrug Resistance Protein 1) transporter expression and shows anti-tumor activity in a PDX model of UC with acquired resistance to EV. – Strong combination potential with PD-1-targeting agents : In syngeneic mouse models, the combination of IPH4502 with an anti-PD-1 antibody induces synergistic anti-tumor activity in both EV-sensitive and EV-resistant models. – Hydrophilic and stable linker enables high ADC exposure and minimal free exatecan release in cynomolgus monkey plasma. 83 Anti-tumor activity in EV-resistant PDX model supports the potential of IPH4502 as a therapeutic option for patients who do not respond to EV.
Lacutamab was generally well tolerated. ii. Phase 2 Clinical Trial (TELLOMAK) - CTCL 1. Study overview In May 2019, the Company initiated a global, open-label, multi-cohort Phase 2 clinical trial, known as TELLOMAK. This clinical trial is being conducted at approximately 50 sites within the United States and Europe (France, Italy, Spain, Germany, Belgium, Poland and Austria).
Study overview In May 2019, the Company initiated a global, open-label, multi-cohort Phase 2 clinical trial, known as TELLOMAK. This clinical trial is being conducted at approximately 50 sites within the United States and Europe (France, Italy, Spain, Germany, Belgium, Poland and Austria).
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.
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 35 U.S.C. § 156 (as enacted by the Hatch-Waxman Act), which permits a patent term extension of up to five years for patent term lost during product development and the FDA regulatory review period.
Lastly, approximately 50% of patients with PTCL also express KIR3DL2 (Cheminant, ICML Meeting, 2019). b. Indication i. Cutaneous T Cell Lymphoma CTCL is a heterogeneous group of non-Hodgkin’s lymphomas that are characterized by the abnormal accumulation of malignant T cells, primarily in the skin.
Lastly, approximately 50% of patients with PTCL also express KIR3DL2 (Cheminant, ICML Meeting, 2019). b. Indication i. Cutaneous T Cell Lymphoma CTCL is a heterogeneous group of non-Hodgkin’s lymphomas that are characterized by the abnormal accumulation of malignant T cells, primarily in the skin and have a significant impact on patients’ quality 75 of life.
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Market for Common Equity — stock, dividends, buybacks
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Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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2024 filing
2025 filing
Revenues related to monalizumab result from the partial recognition of the $250.0 million non-refundable upfront payment and the $100.0 million milestone resulting from the exercise of the option received in June 2015 and October 2018 from AstraZeneca.
Revenues related to monalizumab result from the partial recognition of the $250.0 million non-refundable upfront payment and the $100.0 million milestone resulting from the exercise of the option received in June 2015 and October 2018 from AstraZeneca.
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.
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.
This additional payment has been treated as a collaboration commitment ("collaboration liability" in the consolidated balance sheet) for an amount of $36.0 million (€34.3 million) in view to the contractual commitment linked to the Phase 1/2 studies (co-funding under the initial contract).
This additional payment has been treated as a collaboration commitment ("collaboration liability" in the consolidated balance sheet) for an amount of $36.0 million (€34.3 million) in view to the contractual commitment linked to the Phase 1/2 studies (co-funding under the initial contract).
The table below presents the components of our net financial result for the years ended December 31, 2023 and 2024: Year ended December 31, 2023 2024 (in thousands) Interests and gains on financial assets € 3,177 € 2,437 Unrealized gains on financials assets 1,648 1,983 Foreign exchange gains 2,109 1,658 Financial income 6,934 6,079 Foreign exchange losses (1,195) (3,409) Interest on financial liabilities (640) (566) Financial expenses (1,835) (3,975) Net financial income (loss) € 5,099 € 2,104 For the years ended December 31, 2023 and 2024, 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 145 cash and cash equivalents, short-term investments, financial assets and collaboration debt based on U.S. dollar.
The table below presents the components of our net financial result for the years ended December 31, 2023 and 2024: Year ended December 31, 2023 2024 (in thousands) Interests and gains on financial assets € 3,177 € 2,437 Unrealized gains on financials assets 1,648 1,983 Foreign exchange gains 2,109 1,658 Financial income 6,934 6,079 Foreign exchange losses (1,195) (3,409) Unrealized losses on financial assets — Interest on financial liabilities (640) (566) Financial expenses (1,835) (3,975) Net financial income (loss) € 5,099 € 2,104 For the years ended December 31, 2023 and 2024, 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, financial assets and collaboration debt based on U.S. dollar.
However, the Company may not receive milestone payments when expected, or at all, and the Company may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on its financial condition and could force the Company to delay, limit, reduce or terminate its development programs or commercialization efforts or grant to others rights to develop or market product candidates that the Company would otherwise prefer to develop and market itself.
However, the Company may not receive milestone payments when expected, or at all, and the Company may be unable to raise additional funds or enter into such arrangements when needed on 117 favorable terms, or at all, which would have a negative impact on its financial condition and could force the Company to delay, limit, reduce or terminate its development programs or commercialization efforts or grant to others rights to develop or market product candidates that the Company would otherwise prefer to develop and market itself.
These expenses increased by €1.2 million or 19.0% to €7.8 million for the year ended December 31, 2024, as compared to an amount of €6.5 million for the year ended December 31, 2023, is primarily related to the repayment of interest on the 2023 R&D Tax Credit amounting to €0.8 million, the rise in IT service costs of €0.1 million and the impact of IFRS 16 following the restitution of leased spaces, which generated a non-recurring credit of €0.2 million in 2023.
These expenses increased by €1.2 million or 19.0% to €7.8 million for the year ended December 31, 2024, as compared to an amount of €6.5 million for the year ended December 31, 2023, is primarily related to the repayment of interest on the 2023 R&D Tax Credit 138 amounting to €0.8 million, the rise in IT service costs of €0.1 million and the impact of IFRS 16 following the restitution of leased spaces, which generated a non-recurring credit of €0.2 million in 2023.
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.
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; 148 • 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; • 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.
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.
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. 118 Government financing for research expenditures The Company's government financing for research expenditures consists of research tax credits (crédit d’impôt recherche ) and grants.
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).
Overview Innate Pharma S.A. is a 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).
As a reminder, in 2023, the net cash flow used in operating activities included (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.
As a reminder, in 2023, the net cash flow used in operating activities included (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 an exclusive license 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.
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.
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.
In this respect, no revenue has been recognized in the income statement, and the 140 amount of €1.7 million is presented under current contract liabilities (€0.4 million) and non-current contract liabilities (€1.3 million). On October 9, 2024, the Company received a termination letter for the license agreement concerning this option. The termination ends the research work.
In this respect, no revenue has been recognized in the income statement, and the amount of €1.7 million is presented under current contract liabilities (€0.4 million) and non-current contract liabilities (€1.3 million). On October 9, 2024, the Company received a termination letter for the license agreement concerning this option. The termination ends the research work.
Proceeds related to Sanofi 2022 agreement On December 19, 2022, the Company announced that it had entered into a research collaboration and license agreement with Genzyme Corporation, a wholly-owned subsidiary of Sanofi (“Sanofi”) pursuant to which the Company granted Sanofi an exclusive license on the Innate Pharma's B7-H3 ANKET ® program and options on two additional targets.
Proceeds related to Sanofi 2022 agreement On December 19, 2022, the Company announced that it had entered into a research collaboration and license agreement with Genzyme Corporation, a wholly-owned subsidiary of Sanofi pursuant to which the Company granted Sanofi an exclusive license on the Innate Pharma's B7-H3 ANKET ® program and options on two additional targets.
Lastly, during 2023, the Company benefited from the early repayment of the CIR claim relating to the 2022 financial year, amounting to €9.2 million, paid to the Company by the French Treasury in July 2023. Excluding these specific effects, net cash flows used by operating activities for the year ended December 31, 2024 decreased by €9.4 million.
Lastly, during 2023, the Company benefited from the early repayment of the CIR claim relating to the 2022 financial year, amounting to €9.2 million, paid to the Company by the French Treasury in July 2023. 147 Excluding these specific effects, net cash flows used by operating activities for the year ended December 31, 2024 decreased by €9.4 million.
Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period. Non-refundable advance payments for research and development goods or services to be received in the future from third parties are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period. Non-refundable advance payments for research and 119 development goods or services to be received in the future from third parties are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
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.
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 141 amounts are expected to be paid after a three-year period.
On February 13, 141 2024, the Company received from the tax authorities the rectification proposal and adjusted the provision to €0.1 million following the final settlement. (2) The company can be eligible to local or European grants dedicated to R&D program and benefit from tax credit related to employee benefits.
On February 13, 2024, the Company received from the tax authorities the rectification proposal and adjusted the provision to €0.1 million following the final settlement. (2) The company can be eligible to local or European grants dedicated to R&D program and benefit from tax credit related to employee benefits.
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.
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, 2023 , 2024 and 2025 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.
This variation is mainly due to (i) the receipt of €29.5 million related to 2019 and 2020 tax credit refunds, (ii) the receipt of €8.6 million pursuant to a financing agreement with Natixis including the assignment of the Company's receive with respect to future CIR payments (corresponding to the CIR for the financial year ending December 31, 2023 that will be paid in 2027), (iii) the receipt of €15.0 millions in January 162 2024 following Sanofi's decision to exercise one of its two license option for an NK Cell Engager program in solid tumors, derived from the Company's ANKET® (Antibody-based NK Cell Engager Therapeutics) platform, pursuant to the terms of the research collaboration and license agreement signed in December 2022, (iv) the collection in May 2024 of €4.8 million (including value-added tax) the treatment of the first patient in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial evaluating NK Cell Engager SAR443579/ IPH6101 in various blood cancer.
This variation is mainly due to (i) the receipt of €29.5 million related to 2019 and 2020 tax credit refunds, (ii) the receipt of €8.6 million pursuant to a financing agreement with Natixis including the assignment of the Company's receivables with respect to future CIR payments (corresponding to the CIR for the financial year ending December 31, 2023 that will be paid in 2027), (iii) the receipt of €15.0 millions in January 2024 following Sanofi's decision to exercise one of its two license option for an NK Cell Engager program in solid tumors, derived from the Company's ANKET® (Antibody-based NK Cell Engager Therapeutics) platform, pursuant to the terms of the research collaboration and license agreement signed in December 2022, (iv) the collection in May 2024 of €4.8 million (including value-added tax) the treatment of the first patient in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial evaluating NK Cell Engager SAR443579/ IPH6101 in various blood cancer.
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.
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.
As a result, the Company was eligible for the early repayment by the French treasury of the 2021 CIR during the fiscal year 2022. As of 158 December 31, 2024, the Company received reimbursement for its the CIR up to that of the financial year ending December 31, 2022.
As a result, the Company was eligible for the early repayment by the French treasury of the 2021 CIR during the fiscal year 2022. As of December 31, 2024, the Company received reimbursement for its the CIR up to that of the financial year ending December 31, 2022.
Trend Information For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.” Other than as disclosed in these sections, we are not aware of any trends, uncertainties, demands, commitments or events since December 31, 2023 that are reasonably likely to have a material effect on our operating revenues, profitability, liquidity or capital resources, or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
Trend Information For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.” Other than as disclosed in these sections, we are not aware of any trends, uncertainties, demands, commitments or events since December 31, 2025 that are reasonably likely to have a material effect on our operating revenues, profitability, liquidity or capital resources, or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial conditions.
Proceeds related to Sanofi 2016 agreement. 139 Revenues under the collaboration and license agreement signed with Sanofi in 2016 amounted to €4.0 million for the year ended December 31, 2024 as compared to €2.0 million for the year ended December 31, 2023.
Proceeds related to Sanofi 2016 agreement. Revenues under the collaboration and license agreement signed with Sanofi in 2016 amounted to €4.0 million for the year ended December 31, 2024 as compared to €2.0 million for the year ended December 31, 2023.
The additional payment of $50.0 million (€47.7 million) received from AstraZeneca in December 2020 triggered by the dosing of the first patient in the Phase 3 138 trial evaluating monalizumab was treated in full as a collaboration commitment ("collaboration liability" in the consolidated balance sheet) in view to the commitment linked to the agreement for the Phase 1/2 (co-financing) and Phase 3 studies (amendment signed in September 2020).
The additional payment of $50.0 million (€47.7 million) received from AstraZeneca in December 2020 triggered by the dosing of the first patient in the Phase 3 trial evaluating monalizumab was treated in full as a collaboration commitment ("collaboration liability" in the consolidated balance sheet) in view to the commitment linked to the agreement for the Phase 1/2 123 (co-financing) and Phase 3 studies (amendment signed in September 2020).
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.
Since its inception, Innate has raised a total of €324.3 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.
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.
Their purpose is to finance Innate's activities, including Innate's research and development costs. As a reminder, Innate has received a total of €324.3 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.
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.
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, 2023 , 2024 and 2025 have been prepared in accordance with IFRS as issued by the IASB.
Innate accounts for its payments for these items as operating expenses in the consolidated statement of income. The Company's capital expenditures in the years ended December 31, 2022 , 2023 and 2024 primarily related to laboratory equipment. Clinical research and development costs are not capitalized until marketing authorizations are obtained.
Innate accounts for its payments for these items as operating expenses in the consolidated statement of income. The Company's capital expenditures in the years ended December 31, 2023 , 2024 and 2025 primarily related to laboratory equipment. Clinical research and development costs are not capitalized until marketing authorizations are obtained.
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.
Therefore, the Company audited consolidated financial statements for the years ended December 31, 2023 , 2024 and 2025 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.
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.
Financial Statements" of this Annual Report. Any change in these 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 140 Company may have to fully depreciate the intangible asset.
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.
Sources and uses of liquidity As of December 31, 2025, 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.
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.
In August 2022, the Company requested the extension of these two loans repayment for an additional period 142 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.
Revenue and other income from continuing operations decreased by €41.5 million, to €20.1 million for the year ended December 31, 2024, as compared to revenue and other income of €61.6 million for the year ended December 31, 2023. 137 Year ended December 31, 2023 2024 (in thousands) Revenue from collaboration and licensing agreements € 51,901 € 12,622 Government financing for research expenditures 9,729 7,488 Other income 11 11 Revenue and other income € 61,641 € 20,121 Revenue from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations decreased by €39.3 million, to €12.6 million for the year ended December 31, 2024, as compared to revenue from collaboration and licensing agreements of €51.9 million for the year ended December 31, 2023.
Revenue and other income from continuing operations decreased by €41.5 million, to €20.1 million for the year ended December 31, 2024, as compared to revenue and other income of €61.6 million for the year ended December 31, 2023. 131 Year ended December 31, 2023 2024 (in thousands) Revenue from collaboration and licensing agreements 51,901 12,622 Government financing for research expenditures 9,729 7,488 Other income 11 11 Revenue and other income € 61,641 € 20,121 Revenues from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations decreased by €39.3 million, to €12.6 million for the year ended December 31, 2024, as compared to revenue from collaboration and licensing agreements of €51.9 million for the year ended December 31, 2023.
The research tax credit is calculated as 30% of the amount of research and development expenses, net of grants received, eligible for the research tax credit for the fiscal year. Operating expenses The table below presents our operating expenses from continuing operations for the years ended December 31, 2023 and 2022.
The research tax credit is calculated as 30% of the amount of research and development expenses, net of grants received, eligible for the research tax credit for the fiscal year. Operating expenses The table below presents our operating expenses from continuing operations for the years ended December 31, 2024 and 2023.
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 remains committed under this contract until June 30, 2026. 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 newly issued shares were admitted to trading on the regulated market of Euronext in Paris on the same day. See Note 21 to the consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report.
The newly issued shares were admitted to trading on the regulated market of Euronext in Paris on the same day. See Note 11 to the consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report.
As of December 31, 2024, the remaining capital of these loans amounted to €21.7 million. On April 24, 2025, the Company announced that, given the satisfactory market conditions, Sanofi subscribed to 8,345,387 new ordinary shares of Innate, at a price of €1.7974 per share, representing a total capital increase of €14,999,998.59 (€417,269.35 in nominal amount and €14,582,729.24 of issue premium).
As of December 31, 2025, the remaining capital of these loans amounted to €14.5 million. On April 24, 2025, the Company announced that, given the satisfactory market conditions, Sanofi subscribed to 8,345,387 new ordinary shares of Innate, at a price of €1.7974 per share, representing a total capital increase of €14,999,998.59 (€417,269.35 in nominal amount and €14,582,729.24 of issue premium).
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.
Since its inception, the Company has raised a total of €324.3 116 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 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 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.
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. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study. The Company will conduct the study.
As a reminder, the revenue is 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. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study. The Company will conduct the study.
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.
Operating Results Comparisons for the years ended December 31, 2024 and 2025 The following table sets forth a summary of the Company's consolidated statements of income (loss) for the periods presented.
Loan repayments amounted to €8.9 million for the year ended December 31, 2024 as compared to €2.4 million for the year ended December 31, 2023. The start of PGE loans repayment in 2024 result in an increase in repayment amounting to €7.0 million. Receipts from capital transactions amount to €2.9 million in 2024, compared with €0.4 million in 2023.
Loan repayments amounted to €8.9 million for the year ended December 31, 2024 as compared to €2.4 million for the year ended December 31, 2023. The start of PGE loans repayment in 2024 resulted in an increase in repayment amounting to €7.0 million. Receipts from capital transactions amounted to €2.9 million in 2024, compared with €0.4 million in 2023.
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.
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.
Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca signed in April 2015 and October 2018, as well as the agreement signed with Sanofi in 2016 and 2022 and also with Takeda in 2023.
Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca signed in April 2015 and October 2018, as well as the agreement signed with Sanofi in 2016 and 2022.
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.
All the standards published by the IASB that are mandatorily applicable in the years ended December 2023 , 2024 and 2025 are endorsed by the EU and are mandatorily applicable in the EU.
Following first patient dosed in June 2024, this program is now in clinical stage therefore we have reclassed 2023 expenses in the sub-total programs in clinical development 2. Total direct research and development expenses are composed of subcontracting costs and cost of supplies and consumables materials.
Following first patient dosed in January 2025, this program is now in clinical stage therefore we have reclassed 2024 expenses in the sub-total programs in clinical development 2. Total direct research and development expenses are composed of subcontracting costs and cost of supplies and consumables materials.
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, 2024. 146 Comparisons for the years ended December 31, 2022 and 2023 The following table sets forth a summary of our consolidated statements of income (loss) for the periods presented.
For instruments for which the valuation may be subject to certain events, the Company has ensured that no such events have occurred as of December 31, 2025. 130 Comparisons for the years ended December 31, 2023 and 2024 The following table sets forth a summary of our consolidated statements of income (loss) for the periods presented.
This option exercise also resulted in a milestone payment of €15.0 million, including €13.3 million in respect of the exclusive license, which was fully recognized in income as of December 31, 2023, and €1.7 million in respect of research services to be carried out by the Company.
As a consequence, the Company recognized related income of €2.5 million as of December 31, 2023. 134 This option exercise also resulted in a milestone payment of €15.0 million, including €13.3 million in respect of the exclusive license, which was fully recognized in income as of December 31, 2023, and €1.7 million in respect of research services to be carried out by the Company.
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.
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. Invoicing of research and development costs - IPH5201 .
The main capital increases since 1999 are described in Item 5 - B Liquidity and Capital Resources. As of December 31, 2024, the Company has also received $656.1 million (€579.1 million) in payments from its collaborators, including AstraZeneca, since 2011, excluding payments received for purchases of its equity securities by its collaborators.
The main capital increases since 1999 are described in Item 5 - B Liquidity and Capital Resources. As of December 31, 2025, the Company has also received $656.7 million (€579.6 million) in payments from its collaborators, including AstraZeneca, since 2011, excluding payments received for purchases of its equity securities by its collaborators.
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.
This decrease of €10.3 million mainly results from (i) net repayment of €4.8 million during year 2025 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 ("collaboration liabilities" in the consolidated statements of financial position) for an amount of €5.7 million linked to the Euro-dollar parity exchange rate variation.
For a discussion of the risks associated with completing the development projects on schedule, see “Risk Factors—Risks Related to the Development of the Product Candidates.” General and administrative expenses General and administrative expenses consist primarily of personnel costs and share-based compensation for personnel other than research and development staff.
For a discussion of the risks associated with completing the development projects on schedule, see “Item 3.D Risk Factors—Risks Related to the Development of the Product Candidates.” General and administrative expenses General and administrative expenses consist primarily of personnel costs and share-based compensation for personnel other than research and development staff.
Innate has a purchase option for all of the buildings and land for the lump sum of €1 at the end of the term of the contract on June 9, 2020, which it has exercised. The Company now owns its corporate office in Luminy, Marseille. Since July 2017, Innate also rents office space in Marseille, France under a commercial lease.
Innate exercised a purchase option for all of the buildings and land for the lump sum of €1 at the end of the term of the contract on June 9, 2020. Since then, the Company owns its corporate office in Luminy, Marseille. 149 Since July 2017, Innate also rents office space in Marseille, France under a commercial lease.
Year ended December 31, 2023 2024 (in thousands) Revenue from collaboration and licensing agreements € 51,901 € 12,622 Government financing for research expenditures 9,729 7,488 Other income 11 11 Revenue and other income 61,641 20,121 Research and development expenses (56,022) (51,980) General and administrative expenses (18,288) (19,716) Operating expenses (74,310) (71,696) Operating income (loss) (12,669) (51,575) Financial income 6,934 6,079 Financial expenses (1,835) (3,975) Net financial income (loss) 5,099 2,104 Net income (loss) before tax (7,570) (49,471) Income tax expense — — Net income (loss) from continuing operations (7,570) (49,471) Net income (loss) € (7,570) € (49,471) 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, 2023 2024 (in thousands) Revenue from collaboration and licensing agreements € 51,901 € 12,622 Government financing for research expenditures 9,729 7,488 Sales 11 11 Revenue and other income 61,641 20,121 Research and development expenses (56,022) (51,980) General and administrative expenses (18,288) (19,716) Impairment of intangible assets (41,000) — Operating expenses (115,099) (71,696) Operating income (loss) (12,669) (51,575) Financial income 6,934 6,079 Financial expenses (1,835) (3,975) Net financial income (loss) 5,099 2,104 Net income (loss) before tax (7,570) (49,471) Income tax expense — — Net income (loss) from continuing operations (7,570) (49,471) Net income (loss) from discontinued operations — — Net income (loss) € (7,570) € (49,471) Revenue and other income Revenue and other income from continuing operations resulted from collaboration and licensing agreements and government financing for research expenditure.
Consequently, the €5.0 million initial payment relating to these options was recognized in deferred revenue—non-current portion as of June 30, 2023. On December 19, 2023, the Company announced that Sanofi had exercised an option for one of the two preclinical molecules. As a consequence, the Company recognized related income of €2.5 million as of December 31, 2023.
Consequently, the €5.0 million initial payment relating to these options was recognized in deferred revenue—non-current portion as of June 30, 2023. On December 19, 2023, the Company announced that Sanofi had exercised an option for one of the two preclinical molecules.
Year ended December 31, 2023 2024 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca 9,499 € 4,404 of which Sanofi agreement 2016 2,000 4,000 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 18,873 401 of which Sanofi agreement 2022 - ANKET IPH67 -Recognition of license initial payment and income related to the option exercise 15,800 1,700 of which Takeda agreement 2023 4,553 — Proceeds from collaboration and licensing agreements 50,725 10,505 Invoicing of research and development costs (IPH5201) 1,165 2,060 Others 11 56 Revenue from collaboration and licensing agreements € 51,901 € 12,622 Proceeds related to monalizumab .
Year ended December 31, 2023 2024 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca 9,499 4,404 of which IPH5201 agreement - AstraZeneca — — of which preclinical molecules agreement - AstraZeneca — — of which Sanofi agreement 2016 2,000 4,000 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 18,873 401 of which Sanofi agreement 2022 - ANKET IPH67 -Recognition of license initial payment and income related to the progress of related research program 15,800 1,700 of which Takeda agreement 2023 4,553 — of which other agreements — — Proceeds from collaboration and licensing agreements 50,725 10,505 Invoicing of research and development costs (IPH5201) 1,165 2,060 Exchange gains (loss) on collaboration agreements — — Others 11 56 Revenue from collaboration and licensing agreements € 51,901 € 12,622 132 Proceeds related to monalizumab .
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 ("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. 153 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.
This decrease of €4.1 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. 137 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.
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.
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 €(7.6) million, €(49.5) million and €(49.2) million for the years ended December 31, 2023 , 2024 and 2025, respectively.
Revenue from invoicing of research and development costs for the year ended December 31, 2023 was €1.2 million compared to €1.4 million for the year ended December 31, 2022, or a decrease of € 0.2 million. Proceeds related to Sanofi 2016 agreement.
Revenue from invoicing of research and development costs for the year ended December 31, 2025 was €1.7 million compared to €2.1 million for the year ended December 31, 2024, or a decrease of € 0.4 million. Proceeds related to Sanofi 2016 agreement.
Net cash as of December 31, 2024 amounted to €72.1 million (€83.5 million as of December 31, 2023). Net cash is equal to cash, cash equivalents and short-term investments less current financial liabilities.
Net cash as of December 31, 2025 amounted to €25.5 million (€72.1 million as of December 31, 2024). Net cash is equal to cash, cash equivalents and short-term investments less current financial liabilities.
For more information as to the risks associated with Innate's future funding needs, see “Risk Factors—The Company may need to raise additional funding to complete the development and any commercialization of its product candidates, which may not be available on acceptable terms, or at all, and failure to obtain this necessary capital when needed may force the Company to delay, limit or terminate its product development efforts or other operations.” Capital expenditures Innate Pharma's operations mainly require investment in intangible assets.
For more information as to the risks associated with Innate's future funding needs, see Note 2 to our consolidated financial statements for more information and “Item 3.D Risk Factors—The Company may need to raise additional funding to complete the development and any commercialization of its product candidates, which may not be available on acceptable terms, or at all, and failure to obtain this necessary capital when needed may force the Company to delay, limit or terminate its product development efforts or other operations.” Capital expenditures Innate Pharma's operations mainly require investment in intangible assets.
Year ended December 31, 2023 2024 Research Tax Credit(1) € 9,729 € 7,463 Grant and other tax credit (2) — 25 Government financing for research expenditures € 9,729 € 7,488 (1) As of December 31, 2024, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2024 financial year for an amount of €7.5 million compared to €9.8 million for the 2023 financial year which is subtracted (ii) a provision amounting to €0.1 million following the tax inspection.
The table below details government funding for research expenditures for the years ended December 31, 2023 and 2024. 135 Year ended December 31, 2023 2024 (in thousands) Research Tax Credit 9,729 7,463 Grant and other tax credit (1) — 25 Government financing for research expenditures €9,729 €7,488 (1) As of December 31, 2024, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2024 financial year for an amount of €7.5 million compared to €9.8 million for the 2023 financial year which is subtracted (ii) a provision amounting to €0.1 million following the tax inspection.
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.
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 Board of Directors' decision on 11th December 2025 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. 121 A.
As of December 31, 2024, the remaining capital of this loan amounted to €8.9 million as compared to €10.2 million as of December 31, 2023. As expected, the financial investment amounting to €4.2 million was released on July 2024.
As of December 31, 2025, the remaining capital of this loan amounted to €7.6 million as compared to €8.9 million as of December 31, 2024. As expected, the financial investment amounting to €4.2 million was released on July 2024.
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.
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.
For more information, see Note 1.1 to the consolidated financial statements included under "Item 18. Financial Statements" of this Annual Report. Consequently, this additional payment has no impact on the transaction price.
For more information, see Note 1.1 to the consolidated financial statements included as part of this Annual Report. Consequently, this additional payment has no impact on the transaction price.
Non-scientific advisory and consulting expenses mostly consist of auditing, accounting, legal and hiring services. These expenses decreased by €1.3 million, or 31.5%, to €2.9 million for the year ended December 31, 2023, as compared to an amount of €4.2 million for the year ended December 31, 2022.
Non-scientific advisory and consulting expenses mostly consist of auditing, accounting, legal and hiring services. These expenses increased by €0.5 million, or 16.2%, to €3.4 million for the year ended December 31, 2024, as compared to an amount of €2.9 million for the year ended December 31, 2023.
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.
In addition, Innate has received an aggregate of €115.9 million in French research tax credit ("CIR") through December 31, 2025. As a French biopharmaceutical company, Innate Pharma has benefited from certain tax advantages, including, for example, the CIR.
The remaining $14.0 million was treated as a change in estimate of the transaction price, recognized in the income statement in line with the progress of the Phase 1/2 studies. Revenue related to monalizumab decreased by €12.9 million, to €9.5 million for the year ended December 31, 2023, as compared to €22.4 million for the year ended December 31, 2022.
The remaining $14.0 million was treated as a change in estimate of the transaction price, recognized in the income statement in line with the progress of the Phase 1/2 studies. Revenue related to monalizumab decreased by €4.2 million, to €0.2 million for the year ended December 31, 2025, as compared to €4.4 million for the year ended December 31, 2024.
The table below presents our general and administrative expenses by nature for the years ended December 31, 2023 and 2024: Year ended December 31, 2023 2024 (in thousands) Personnel expenses (including share based payments) € (8,842) € (8,556) Non scientific advisory and consulting (2,906) (3,377) Other expenses (1) (6,540) (7,783) Total general and administrative € (18,288) € (19,716) .
The table below presents our general and administrative expenses by nature for the years ended December 31, 2023 and 2024: Year ended December 31, 2023 2024 (in thousands) Personnel expenses (including share based payments) (8,842) (8,556) Non scientific advisory and consulting (2,906) (3,377) Other expenses (1) (6,540) (7,783) Total general and administrative € (18,288) € (19,716) (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.
For a description of its principal collaboration and licensing agreements, see “Item 10C.—Material Contracts.” Principal Components of the Company Results of Operations Revenue and other income The Company revenue and other income mainly consists of revenues from collaboration and licensing agreements and government financing for research expenditure in the form of research tax credits, as well as other grants.
For a description of its principal collaboration and licensing agreements, see “Item 10.C—Material Contracts” and “ Item 4.B—Business Overview .” Principal Components of the Company Results of Operations Revenue and other income The Company revenue and other income mainly consists of revenues from collaboration and licensing agreements and government financing for research expenditure in the form of research tax credits, as well as other grants.
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.
The table below summarizes the main capital increases between 1999 and December 31, 2025: 144 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 April 2025 15.0 million Total € 324.3 million Cash flows Comparisons for the year ended December 31, 2024 and 2025 The following table sets forth cash flow data for the years ended December 31, 2024 and 2025: Year ended December 31, 2024 2025 (in thousands) Cash flows from / (used in) operating activities € (6,896) € (52,755) Cash flows from / (used in) investing activities 9,200 7,289 Cash flows from / (used in) financing activities (6,008) 6,070 Effect of the exchange rate changes (505) 1,092 Net increase / (decrease) in cash and cash equivalents € (4,209) € (38,304) Cash flows from / (used in) operating activities The Company's net cash flow used in operating activities increased by €45.9 million to €52.8 million for the year ended December 31, 2025 as compared to net cash flows used in operating activities of €6.9 million for the year ended December 31, 2024.
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.
The research tax credit decreased by €1.3 million, or 17%, to €6.2 million for the year ended December 31, 2025, as compared to a research tax credit of €7.5 million for the year ended December 31, 2024.
As of December 31, 2024, the Company had €91.1 million in cash, cash equivalents, short-term investments and non-current financial assets.
As of December 31, 2025, the Company had €44.8 million in cash, cash equivalents, short-term investments and non-current financial assets.
Year ended December 31, 2023 2024 (in thousands) Research and development expenses (56,022) (51,980) General and administrative expenses (18,288) (19,716) Impairment of intangible assets — — Total operating expenses after impairment € (74,310) € (71,696) 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, 2023 and 2024. 142 Year ended December 31, 2023 2024 (in thousands) Lacutamab € (12,248) € (8,976) Monalizumab (791) (63) Avdoralimab (175) (50) IPH5201 (2,313) (4,013) IPH5301 (296) (461) IPH6501 (1) (4,214) (2,307) Sub-total programs in clinical development (20,037) (15,870) Sub-total programs in preclinical development (10,142) (12,429) Total direct research and development expenses (2) (30,179) (28,299) Personnel expenses (including share-based payments) (17,121) (17,536) Depreciation and amortization (3,891) (1,075) Other expenses (4,831) (5,070) Personnel and other expenses (25,843) (23,681) Total research and development expenses € (56,022) € (51,980) 1. 2023 expenses from program IPH6501 were reported in 2023 20-F in sub-total programs in preclinical development.
Year ended December 31, 2023 2024 (in thousands) Research and development expenses (56,022) (51,980) General and administrative expenses (18,288) (19,716) Total operating expenses after impairment € (74,310) € (71,696) 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, 2023 and 2024. 136 Year ended December 31, 2023 2024 (in thousands) Lacutamab (12,248) (8,976) Monalizumab (791) (63) Avdoralimab (175) (50) IPH5201 (2,313) (4,013) IPH5301 (296) (461) Sub-total programs in clinical development (20,037) (13,563) Sub-total programs in preclinical development (10,142) (14,356) Total direct research and development expenses (30,179) (28,298) Personnel expenses (including share-based payments) (17,121) (17,536) Depreciation and amortization (3,891) (1,075) Other expenses (4,831) (5,070) Personnel and other expenses (25,843) (23,681) Total research and development expenses €(56,022) €(51,979) 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.
Whether or not there is any indication of impairment, intangible assets not yet available for use are tested for impairment annually by comparing their carrying amount with their recoverable amount.
If any indication exists, the Group estimates the recoverable amount of the related asset. 120 Whether or not there is any indication of impairment, intangible assets not yet available for use are tested for impairment annually by comparing their carrying amount with their recoverable amount.
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.
Personnel and other expenses allocated to research and development decreased by €0.9 million, or 3.7%, to €22.8 million for the year ended December 31, 2025, as compared to an amount of €23.7 million for the year ended December 31, 2024.
Revenues under the collaboration and license agreement signed with Sanofi in 2016 amounted to €2.0 million for the year ended December 31, 2023 as compared to €4.0 million for the year ended December 31, 2022.
Revenues under the collaboration and license agreement signed with Sanofi in 2016 was nil for the year ended December 31, 2025 as compared to €4.0 million for the year ended December 31, 2024.
The change is mainly explained by the amount received from a new equity partner for €2.9 million. 163 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) € (32,559) Cash flows from / (used in) investing activities 1,877 20,630 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 change is mainly explained by the amount received from Sanofi for €15.0 million, compared with a new partner in 2024. 146 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.
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.
Research and development expenses from continuing operations decreased by €8.4 million, or 16.1%, to €43.6 million for the year ended December 31, 2025, as compared to research and development expenses of €52.0 million for the year ended December 31, 2024.
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2024 filing
2025 filing
Yannis Morel holds a Ph.D. in oncology (from Aix-Marseille University) and is an alumnus of Ecole Normale Supérieure de Paris Saclay (previously Cachan), with a BS in physical and molecular chemistry. Sonia Quaratino, M.D., Ph.D. , joined Innate Pharma in November 2023 as Executive Vice President and Chief Medical Officer (CMO) and as a member of Innate's Leadership Team.
Yannis Morel holds a Ph.D. in oncology (from Aix-Marseille University) and is an alumnus of Ecole Normale Supérieure de Paris Saclay (previously Cachan), with a BS in physical and molecular chemistry. Sonia Quaratino, M.D., Ph.D. , joined Innate Pharma in November 2023 as Executive Vice President and Chief Medical Officer (CMO) and is a member of Innate's Leadership Team.
Free Preferred Shares (AGAP) Free preferred shares (AGAP) are another employee equity incentive instrument similar to the free shares or AGA, except that, after a one-year vesting period, the beneficiaries receive a preferred shares (shares B) which will become convertible into ordinary shares following a lock-up period of two additional years, if the performance conditions (and a presence condition) are met at the end of this lock-up period.
Free Preferred Shares (AGAP) Free preferred shares (AGAP) are another employee equity incentive instrument similar to the free shares or AGA, except that, after a one-year vesting period, the beneficiaries receive preferred shares (shares B) which will become convertible into ordinary shares following a lock-up period of two additional years, if the performance conditions (and a presence condition) are met at the end of this lock-up period.
The Company has issued BSA to Supervisory Board members and certain consultants of the Company. The Company's BSA plans include provisions that allow for the adjustment of the one-for-one exercise ratio to compensate for certain modifications of its share capital, such as rights issues, stock splits, mergers and other events affecting all existing shareholders.
The Company has issued BSA to Supervisory Board and Board of Directors members and certain consultants of the Company. The Company's BSA plans include provisions that allow for the adjustment of the one-for-one exercise ratio to compensate for certain modifications of its share capital, such as rights issues, stock splits, mergers and other events affecting all existing shareholders.
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.
At its general meeting of shareholders held on May 23, 2024, the 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 variable portion based on attendance at meetings of the Supervisory Board and its committees.
Equity Warrants and Redeemable Share Subscription Warrants Share Warrants (BSA) Share warrants (BSA) are issued at a de minimi s price and entitle the holder of one BSA to exercise the warrant for one underlying share, at an exercise price per share determined by the Executive Board of the Company at the time of issue by reference to the then prevailing share price.
Equity Warrants and Redeemable Share Subscription Warrants Share Warrants (BSA) Share warrants (BSA) are issued at a de minimi s price and entitle the holder of one BSA to exercise the warrant for one underlying share, at an exercise price per share determined by the Board of Directors of the Company at the time of issue by reference to the then prevailing share price.
Upon grant by the Executive Board of the Company, the AGA are subject to an acquisition, or vesting, period of at least one year. At the end of this period, the free shares vest and the beneficiary becomes a full shareholder.
Upon grant by the Board of Directors of the Company, the AGA are subject to an acquisition, or vesting, period of at least one year. At the end of this period, the free shares vest and the beneficiary becomes a full shareholder.
For the year ended on December 31, 2024, 176 such objectives were 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 executives to exceed their objectives.
For the year ended on December 31, 2025, such objectives were 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 executives to exceed their objectives.
He holds a BA in Economics & Finance from Lyon 2 University and a MBA from EM Lyon Business School. Claire de Saint-Blanquat , member of the Leadership Team, Vice President, Legal and Corporate Affairs and Secretary of the Supervisory Board, joined Innate Pharma in October 2020 and was appointed to the Leadership Team in January 2023.
He holds a BA in Economics & Finance from Lyon 2 University and a MBA from EM Lyon Business School. Claire de Saint-Blanquat is a member of the Leadership Team and is Vice President, Legal and Corporate Affairs and Secretary of the Board. She joined Innate Pharma in October 2020 and was appointed to the Leadership Team in January 2023.
The Supervisory Board has further determined that Pascale Boissel is an “audit committee financial expert” as defined by the Nasdaq listing rules and that each of the members qualifies as financially sophisticated under the Nasdaq Listing Rules.
The Board of Directors has further determined that Pascale Boissel is an “audit committee financial expert” as defined by the Nasdaq listing rules and that each of the members qualifies as financially sophisticated under the Nasdaq listing rules.
Each free preferred share is convertible into a number of ordinary shares of the Company – which number depends upon the degree of fulfilment of the performance conditions. The free preferred shares remain convertible into ordinary shares for a period of six years and six months.
Each free preferred share is convertible into a number of ordinary shares of the Company – which number depends upon the degree of fulfillment of the performance conditions. The free preferred shares remain convertible into ordinary shares for a period of six years and six months.
For an overview of Innate's corporate governance practices and the ways they may differ from Nasdaq’s corporate governance listing rules, see “Item 16G.—Corporate Governance.” Code of Ethics The Company has adopted a Code of Ethics applicable to all of its employees and members of its Executive Board and Supervisory Board. The Code of Ethics is available on its website.
For an overview of Innate's corporate governance practices and the ways they may differ from Nasdaq’s corporate governance listing rules, see “Item 16G.—Corporate Governance.” Code of Ethics The Company has adopted a Code of Ethics applicable to all of its employees and members of its Board of Directors. The Code of Ethics is available on its website.
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 Supervisory Board expected 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 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 received a fixed compensation pursuant to their employment agreements or, in the case of the Chairman, his social mandate ( mandat social ). • Annual Variable Compensation.
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.
Leadership Team The Company also has a Leadership Team composed of the Chief Executive Officer and 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 members of the Executive Board are eligible to receive annual variable compensation upon the recommendation of the Compensation and Nomination Committee based on the achievement of pre-specified objectives.
The members of the Executive Board were eligible to receive annual variable compensation upon the recommendation of the Compensation and Nomination Committee based on the achievement of pre-specified objectives.
The members of the Executive Board may also receive other benefits consisting of a supplementary pension plan, in-kind benefits and, for the Chairman of the Executive Board, an unemployment insurance.
The members of the Executive Board could also receive other benefits consisting of a supplementary pension plan, in-kind benefits and, for the Chairman of the Executive Board, an unemployment insurance.
Other Committees The Strategic Advisory Board The Company also has a Strategic Advisory Board composed of six external consultants, consisting of three individuals from the medical community and three individuals from the scientific community.
Other Committees The Strategic Advisory Board The Company also has a Strategic Advisory Board composed of two external consultants, consisting of three individuals from the medical community and three individuals from the scientific community.
Audit Committee Innate's Audit Committee assists the Supervisory Board in its oversight of the corporate accounting and financial reporting and oversees the selection of the auditors, their remuneration and independence and keeps the Supervisory Board informed on control systems, key processes and procedures, security and risks.
Audit and Sustainability Committee Innate's Audit and Sustainability Committee assists the Board of Directors in its oversight of the corporate accounting and financial reporting and oversees the selection of the auditors, their remuneration and independence and keeps the Board of Directors informed on control systems, key processes and procedures, security and risks.
Due to French corporate law and tax considerations, the Company has historically granted several different equity incentive instruments to its Executive Board and Supervisory Board members, employees and consultants, including (i) warrants (BSAs), which have historically only been granted to independent members of the Supervisory Board and consultants, (ii) redeemable warrants (BSAARs) and (iii) free shares.
Due to French corporate law and tax considerations, the Company has historically granted several different equity incentive instruments to its Executive Board, Supervisory Board and Board of Directors members, employees and consultants, including (i) warrants (BSAs), which have historically only been granted to independent members of the Supervisory Board and consultants, (ii) redeemable warrants (BSAARs), (iii) stock options and (iv) free shares.
With certain exceptions and subject to limitations on indemnification under French law, these agreements provide for indemnification for damages and expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred by any Executive or Supervisory Board member in any action or proceeding arising out of his or her actions in that capacity.
With certain exceptions and subject to limitations on indemnification under French law, these agreements provide for indemnification for damages and expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred by the Chief Executive Officer and any Board of Directors member in any action or proceeding arising out of his or her actions in that capacity.
Each member must own at least one of our ordinary shares for the entire term of the appointment. Members of the Supervisory Board cannot be members of the Executive Board. The number of members of the Supervisory Board who have reached the age of seventy years cannot be higher than a third of the members of the Supervisory Board.
Each member must own at least one of our ordinary shares for the entire term of the appointment. 170 The number of members of the Board of Directors who have reached the age of seventy years cannot be higher than a third of the members of the Board of Directors.
She founded and is currently Chief Executive Officer of Staatz Business Development & Strategy. She is also member of the Supervisory Board of Aelis Farma SAS. Irina Staatz-Granzer received a degree in pharmacy from Philipps-Universität Marburg (Germany) and a Ph.D. from the University of Tübingen (Germany).
She founded and is currently Chief Executive Officer of Staatz Business Development & Strategy. She is also member of the Supervisory Board of Aelis Farma SAS. Irina Staatz-Granzer received a degree in pharmacy from Philipps-Universität Marburg (Germany) and a Ph.D. from the University of Tübingen (Germany). Pascale Boissel is Vice Chairwoman of the Board of Directors.
These provisions also may have the effect of reducing the likelihood of derivative litigation against the Executive and Supervisory Board members, even though such an action, if successful, might otherwise benefit the Company and its shareholders.
These provisions also may have the effect of reducing the likelihood of derivative litigation against the Chief Executive Officer and Board of Directors members, even though such an action, if successful, might otherwise benefit the Company and 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.
At the General Meeting to be held on May 21, 2026, 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.
Furthermore, a shareholder’s investment may be adversely affected to the extent the Company pays the costs of settlement and damages awards against its Executive and Supervisory Board members pursuant to these insurance agreements.
Furthermore, a shareholder’s investment may be adversely affected to the extent the Company pays the costs of settlement and damages awards against its Chief Executive Officer and Board of Directors members pursuant to these insurance agreements.
She is also President of the International Union of Immunological Societies (IUIS) Katy Rezvani, M.D., Ph.D. , is a professor of medicine at the University of Texas MD Anderson Cancer Center, where she serves as the Vice President & Head, Cell Therapy Institute for Discovery and Innovation, Sally Cooper Murray Chair in Cancer Research, and medical director of the GMP Facility.
Katy Rezvani, M.D., Ph.D. , is a professor of medicine at the University of Texas MD Anderson Cancer Center, where she serves as the Vice President & Head, Cell Therapy Institute for Discovery and Innovation, Sally Cooper Murray Chair in Cancer Research, and medical director of the GMP Facility.
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.
The following table shows the AGAPs outstanding as of December 31, 2025: 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 AGAP exercised as of December 31, 2025 250 — 357 Number of outstanding AGAP 1,200 3,000 1,878 169 C.
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.
The Company believes that this insurance and these agreements are necessary to attract qualified Chief Executive Officer and Board of Directors members. These agreements may discourage shareholders from bringing a lawsuit against the Chief Executive Officer and Board of Directors members for breach of their fiduciary duty.
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.
The attendance fees consist of a fixed portion and a variable portion based on attendance at meetings of the Board of Directors and its committees. 156 The following table shows the breakdown of the attendance fees for the year ended December 31, 2025: 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.
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.
Compensation and Nomination Committee Innate's Compensation and Nomination Committee assists the Board of Directors in reviewing and making recommendations to the Board of Directors with respect to the appointment and the compensation of the members of the Board of Directors and Leadership Team and other key employees.
Benefits in Kind €6,928 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits.
Benefits in Kind €2,137 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits.
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.
If not 100% of the core objectives is achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the core objectives.
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.
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.
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.
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, 2025, the members of the Leadership Team were Jonathan Dickinson, Yannis Morel, Sonia Quaratino, Odile Belzunce, Odile Laurent, Nicola Beltraminelli, Claire de Saint Blanquat, Stéphanie Cornen and Frédéric Lombard.
The Company has various compensation plans for its Executive Board members, Supervisory Board members, employees and consultants that have been approved by the shareholders.
The Company has various compensation plans for its Board of Directors members, employees and consultants that have been approved by the shareholders.
The principal responsibility of the Audit Committee is to monitor the existence and efficacy of the financial audit and risk control procedures on an ongoing basis, and the Audit Committee charter is contained in the Supervisory Board’s charter.
The principal responsibility of the Audit and Sustainability Committee is to monitor the existence and efficacy of the financial audit and risk control procedures on an ongoing basis, and the Audit and Sustainability Committee charter is contained in the Board of Directors’ charter.
However, French law allows sociétés anonymes to contract for and maintain liability insurance against civil liabilities incurred by members of Executive and Supervisory Boards involved in a third-party action, provided that they acted in good faith and within their capacities as members of such Boards of the Company.
However, French law allows sociétés anonymes to contract for and maintain liability insurance against civil liabilities incurred by the Chief Executive Officer and members of the Board of Directors involved in a third-party action, provided that they acted in good faith and within their capacities as Chief Executive Officer or members of the Board of Directors 163 of the Company.
She is also co-author of the book " Capital Humain versus Humain Capital ." From July 2019 to July 2021, Véronique Chabernaud has been member of the Board of Directors and Chairman of the Compensation and nomination committee of Groupe Bastide le confort médical (BLC).
She is also co-author of the book " Capital Humain versus Humain Capital ." From July 2019 to July 2021, Véronique Chabernaud has been member of the Board of Directors and Chairman of the Compensation and nomination committee of Groupe Bastide le confort médical (BLC). Olivier Martinez has been permanent representative of Bpifrance Participations S.A.
The last allocation of BSAARs which occurred in 2015 no longer continues to vest following termination of the employment, office or service of the holder within the first two years and all vested warrants must be exercised within post-termination exercise periods set forth in the issuance agreement.
The last allocation of BSAARs which occurred in 2015 no longer continues to vest following termination of the employment, office or service of the holder within the first two years and all vested warrants must be exercised within post-termination exercise periods set forth in the issuance agreement. Therefore, there are no BSAAR outstanding as of December 31, 2025.
The Strategic Advisory Board is comprised of Aurélien Marabelle, Diane Mathis, Miriam Merad, Katy Rezvani, and Mario Sznol. Dr. Merad is the Chairman of the Strategic Advisory Board. Aurélien Marabelle, M.D., Ph.D. , is a medical oncologist and immunologist.
The Strategic Advisory Board is comprised of Aurélien Marabelle and Katy Rezvani. Diane Mathis, Miriam Merad and Mario Sznol are no longer members of the Strategic Advisory Board. Aurélien Marabelle, M.D., Ph.D. , is a medical oncologist and immunologist.
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 Company's Board of Directors has determined that Sally Bennett, Olivier Martinez 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 compensation of Hervé Brailly and Jonathan Dickinson as Chairman of the Executive Board, is paid under their social mandate ( mandat social ), whereas the compensation of Yannis Morel, Sonia Quaratino and Arvind Sood is paid under their employment contract. The compensation of members of the Executive Board includes the following components: • Fixed Compensation.
The compensation of Jonathan Dickinson as Chairman of the Executive Board, was paid under his social mandate ( mandat social ), whereas the compensation of Yannis Morel, Sonia Quaratino and Arvind Sood was paid under their employment contract. The compensation of members of the Executive Board included the following components: • Fixed Compensation.
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
Share Ownership For information regarding the share ownership of the directors and executive officers, see “Item 6. Directors, Senior Management and Employees—B. Compensation” and “Item 7. Major Shareholders and Related Party Transactions—A. Major Shareholders.” F. Disclosure of any action to recover erroneously awarded compensation Not applicable. 176
Executive Board Jonathan Dickinson, MBA, BSc, has served as Chairman of the Executive Board since November 1, 2024. Prior to joining Innate Pharma, Jonathan Dickinson most recently served as Executive Vice President and General Manager, Europe at Incyte, a role he held since 2016.
Jonathan Dickinson, MBA, BSc, is Chief Executive Officer and previously served as Chairman of the Executive Board from November 1, 2024 to May 22, 2025. Prior to joining Innate Pharma, Jonathan Dickinson most recently served as Executive Vice President and General Manager, Europe at Incyte, a role he held since 2016.
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.
The payments of the below variable compensations, for the year ended December 31, 2025, will be submitted for approval to the ordinary shareholder meeting to be held on May 21 , 2026 .
The Executive Board’s authority to grant these warrants and free shares and the aggregate amount authorized to be granted must be approved by two-thirds of the shareholders present at the relevant extraordinary shareholders’ meeting. Once approved by the shareholders, the Executive Board can continue to grant such awards for a specified period upon prior authorization of the Supervisory Board.
The Board of Directors’ authority to grant these warrants, stock options and free shares and the aggregate amount authorized to be granted must be approved by two-thirds of the shareholders present at the relevant extraordinary shareholders’ meeting. Once approved by the shareholders, the Board of Directors can continue to grant such awards for a specified period.
Pascale Boissel, has served as a member of the Supervisory Board since May 19, 2020 and now serves as Vice Chairwoman of the Supervisory Board since January 1, 2024. She is, with more than 30 years of financial experience, an expert in finance, audit, transactions, internal control, growth management and restructuring operations.
She previously served as a member of the Supervisory Board from May 19, 2020 to May 22, 2025 and as Vice Chairwoman of the Supervisory Board from January 1, 2024 to May 22, 2025. She is, with more than 30 years of financial experience, an expert in finance, audit, transactions, internal control, growth management and restructuring operations.
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.
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 Board of Directors or of the Leadership Team of the Company. Subsequent Developments Not applicable. B. Compensation.
The Audit Committee reviews and approves the report from the Chairman of the Supervisory Board on internal control.
The Audit and Sustainability Committee reviews and approves the report from the Board of Directors on internal control.
Limitations on Liability and Indemnification Matters Under French law, provisions of bylaws that limit the liability of the members of Executive and Supervisory Boards are prohibited.
Limitations on Liability and Indemnification Matters Under French law, provisions of bylaws that limit the liability of the Chief Executive Officer and members of the Board of Directors are prohibited.
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.
In addition to the ex-post vote described above, French law also requires that the compensation policy for the members of the Board of Directors and the Chief Executive Officer for the year ending December 31, 2026 be submitted for approval at the ordinary general meeting relating to the year ended December 31, 2025.
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.
The following tables show the number of employees as of December 31, 2025, broken out by department: Full-time equivalent employees of Innate Pharma SA and Innate Pharma Inc. As of December 31, 2025 Research and development 120 General and administrative 35 Leadership Team 9 Total 164 E.
He has a diploma in biology and holds a Ph.D. in cell biology summa cum laude from the University of Basel, Switzerland and performed post-doctoral research at the Biocenter of Basel University and at Stanford University School of Medicine, California. B. Compensation.
He has a diploma in biology and holds a PhD in cell biology summa cum laude from the University of Basel, Switzerland and performed post-doctoral research at the Biocenter of Basel University and at Stanford University School of Medicine, CA, USA. Marty J.
On October 21, 2019, the performance criteria of the 2016-1 AGAP were assessed and the conversion ratio was determined as follows: one 2016-1 AGAP gives right to 130 ordinary shares. On December 30, 2019, the performance criteria of the 2016-2 AGAP were assessed and the conversion ratio was determined as follows: one 2016-2 AGAP gives right to 111 ordinary shares.
On December 30, 2019, the performance criteria of the 2016-2 AGAP were assessed and the conversion ratio was determined as follows: one 2016-2 AGAP gives right to 111 ordinary shares. The 2017 AGAP are not convertible since the performance criteria were not met.
Leadership Team Members Odile Belzunce , member of the Leadership Team, Vice President, Compliance and Operations, was appointed as a member of the Executive Committee of the Company on January 31, 2019. Odile Belzunce joined Innate Pharma in February 2005. She was Quality Manager for 10 years before becoming Head of Compliance.
Odile Belzunce , is Vice President, Compliance and Operations and a member of the Leadership Team. She joined the Company in 2005 and was a member of the Executive Committee from January 31, 2019 to May 22, 2025. She was Quality Manager for 10 years before becoming Head of Compliance.
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).
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). 154 Stéphanie Cornen is a member of the Leadership Team and is Vice President, Investor Relations, Communication & Commercial Strategy.
The Company's Supervisory Board has specifically assigned the following duties to the Compensation and Nomination Committee: • reviewing the remuneration policy, in particular the description of the collective objectives (applicable company-wide) and individual objectives (for members of the Executive Board and the Leadership Team); • reviewing the compensation of the members of the Executive Board and the Leadership Team, the policy concerning the distribution of equity such as warrants, stock options, grants and capital increases reserved for members of the savings plan, examining the amount of attendance fees among the Supervisory Board and the committees members; • assisting the Supervisory Board in the selection of the members of the Executive Board and committees; and • making recommendations with respect to the independence of the members of the Supervisory Board and committees and preventing conflicts of interest within the Supervisory Board.
The Company's Board of Directors has specifically assigned the following duties to the Compensation and Nomination Committee: • reviewing the remuneration policy, in particular the description of the collective objectives (applicable company-wide) and individual objectives (for members of the Leadership Team); • reviewing the compensation of the members of the Leadership Team, the policy concerning the distribution of equity such as warrants, stock options, grants and capital increases reserved for members of the savings plan, examining the amount of attendance fees among the Board of Directors and the committees members; • assisting the Board of Directors in the selection of the Chief Executive Officer, members of the Board of Directors and members of the committees; and • making recommendations with respect to the independence of the members of the Board of Directors and committees and preventing conflicts of interest within the Board of Directors. 173 Transactions Committee Innate's Transactions Committee assists the Board of Directors 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.
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 weights of each pillar are: Core objectives Outperformance targets Finance 40% 20% Clinical 30% 15% Clinical 20% 10% Research and Explanatory Development 10% 5% The annual objectives thus defined make it possible to reward the Company's expected performance but also to assess outperformance. If 100% of the basic core objectives are achieved, 100% of the corresponding bonus is paid.
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.
Sally Bennett, MBChB ., is a member of the Board of Directors since May 22, 2025 and previously served as a member of the Supervisory Board from May 20, 2022 to May 22, 2025. She has a significant experience and expertise in financial analysis and capital markets in the healthcare and biotechnology sectors.
The Strategic Advisory Board is not a committee of the Supervisory Board within the meaning of Article R.225-29 of the French Commercial Code; its members are chosen by the Executive Board. This kind of advisory committee is common in French companies in the biotechnology sector.
The Strategic Advisory Board is not a committee of the Board of Directors within the meaning of Article R.225-29 of the French Commercial Code; its members are chosen by the Chief Executive Officer.
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 outperformance targets may only be reached if 100% of the core objectives are reached. 159 • Performance Free Shares . The members of the Executive Board were 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.
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.
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 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.
The Company's Board of Directors has determined that Olivier Martinez, Véronique Chabernaud and Christian Itin are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act.
Since the end of the lock-up period, holders of the 2016 AGAP that have not yet converted them into ordinary shares, are entitled to vote at the shareholders’ meetings, to dividends and to preferential subscription rights, on the basis of the number of ordinary shares to which they are entitled if they convert their AGAP.
Since the end of the lock-up period, holders of the 2016 AGAP that have not yet converted them into ordinary shares, are entitled to vote at the shareholders’ meetings, to dividends and to preferential subscription rights, on the basis of the number of ordinary shares to which they are entitled if they convert their AGAP. 168 On October 21, 2019, the performance criteria of the 2016-1 AGAP were assessed and the conversion ratio was determined as follows: one 2016-1 AGAP gives right to 130 ordinary shares.
She is an oncologist, a graduate of ESSEC Business School (France) and has worked for 20 years in the pharmaceutical industry. In particular, she was the Director of the French Oncological Operational Unit at Sanofi Aventis, a Vice President of Marketing and Sales at Aventis Intercontinental and Europe, and Director of Oncology Global Medical Affairs at Rhône Poulenc Rorer.
In particular, she was the Director of the French Oncological Operational Unit at Sanofi Aventis, a Vice President of Marketing and Sales at Aventis Intercontinental and Europe, and Director of Oncology Global Medical Affairs at Rhône Poulenc Rorer.
Subject to available exemptions, the composition and functioning of all of the committees will comply with all applicable requirements of the French Commercial Code, the Exchange Act, the Nasdaq listing rules and SEC rules and regulations. In accordance with French law, committees of the Supervisory Board only have an advisory role and can only make recommendations to the Supervisory Board.
Subject to available exemptions, the composition and functioning of all of the committees will comply with all applicable requirements of the French Commercial Code, the Exchange Act, the Nasdaq listing rules and SEC rules and regulations.
Criminal liability cannot be indemnified under French law, whether directly by the Company or through liability insurance. The Company has a liability insurance for its Executive and Supervisory Board members, and insurance coverage for liability under the Securities Act. The Company also entered into agreements with its Executive and Supervisory Board members to provide contractual indemnification.
Criminal liability cannot be indemnified under French law, whether directly by the Company or through liability insurance. The Company has a liability insurance for its Chief Executive Officer and Board of Directors members, and insurance coverage for liability under the Securities Act.
Board Practices Boards composition The following table sets forth the names of our current members of the Executive Board and of the Supervisory Board, the years of their initial appointment as directors and the expiration dates of their current term.
Board Practices Board composition The following table sets forth the names of our current members of the Board of Directors, the years of their initial appointment as directors and the expiration dates of their current term. Name Current Position Year of Initial Appointment (1) Term Expiration Year Board of Directors Members Irina Staatz-Granzer, Ph.D.
She spent 15 years in senior roles as both a public and private investor at HealthCor, a U.S. based global healthcare and life science investment manager and most recently co-led the firm's move into private investing. She is now acting as a Senior Advisor to Catalio Capital in conjunction with its acquisition of HealthCor Management.
Sally Bennett has a career spanning medicine, equity & capital markets and investment management. She spent 15 years in senior roles as both a public and private investor at HealthCor, a U.S. based global healthcare and life science investment manager and most recently co-led the firm's move into private investing.
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.
Innate Pharma's Board of Directors 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.
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.
Total Compensation €25,866 2026 Chief Executive Officer's Compensation Policy At the General Meeting to be held on May 21, 2026, the compensation of the Chief Executive Officer set forth in the following table for the year ending December 31, 2026 will be put to the vote of the shareholders: 162 Type of Compensation Jonathan Dickinson Fixed Compensation €550,000 Maximum Annual Variable Compensation if 100% of the objectives are reached €275,000 The variable compensation for the year ending on December 31, 2026 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.
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 ).
On October 13, 2023, the Supervisory Board approved the adoption of a clawback policy, applicable from October 2, 2023, as amended on May 22, 2025 and as adopted by the Board of Directors, requiring the recovery in full or in part of the components of the Chief Executive Officer's and certain other "executive officers" as defined in Nasdaq Listing Rule 5608(d) 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. 160 2025 Compensation of Jonathan Dickinson The following table sets forth the compensation earned by Jonathan Dickinson during the year ended on December 31, 2025 as (i) Chairman of the Executive Board from January 1, 2025 to May 22, 2025 and (ii) Chief Executive Officer from May 22, 2025: Type of Compensation Amount of Compensation Description Fixed Compensation • as Chairman of the Executive Board: • as Chief Executive Officer €550,000 €212,466 €337,534 Gross fixed compensation pursuant to Jonathan Dickinson's social mandate ( mandat social ).
Duvall is a biotechnology executive based in the United States, with over 35 years of experience building companies in the pharmaceutical and biotechnology industry, focused in specialty therapeutics. Mr. Duvall’s main pharma experience includes global oncology leadership positions at Aventis and Merck.
Duvall is a member of the Board of Directors since May 22, 2025, and is an accomplished and passionate biotech executive based in the U.S., with over 35 years of experience building companies in the pharma and biotechnology industry, focused in specialty therapeutics. Mr. Duvall’s big pharma experience includes global oncology leadership positions at Aventis and Merck.
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.
Attendance Fees of the Members of the Board of Directors from May 22, 2025 to December 31, 2025 The Company pays attendance fees to the members of the Board of Directors, except for the permanent representative of Bpifrance and the Chairwoman of the Board of Directors.
He holds a Bachelor of Science degree in Genetics and a Master of Business Administration from the University of Nottingham. Yannis Morel, Ph.D. , has served as a member of the Executive Board since June 25, 2015. He is Executive Vice-President and Chief Operating Officer. He joined Innate in December 2001.
Yannis Morel, Ph.D. , is Executive Vice-President and Chief Operating Officer and previously served as a member of the Executive Board from June 25, 2015 to May 22, 2025. He joined Innate in December 2001.
He was replaced by Jonathan Dickinson as CEO and Chairman of the Executive Board effective November 1, 2024. Arvind Sood resigned from his mandate of member of the Executive Board on February 3, 2025. The compensation of members of the Executive Board is decided by the Supervisory Board upon recommendation by the Compensation and Nomination Committee.
Arvind Sood resigned from his mandate of member of the Executive Board on February 3, 2025. A settlement agreement is under discussion. The compensation of members of the Executive Board was decided by the Supervisory Board upon recommendation by the Compensation and Nomination Committee.
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.
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 Accelerator Programme in the UK. She also serves on the Board of a private UK Company, Mosaic Therapeutics, where she represents the Sanger Institute.
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.
From May 2022, the members of the Audit and Sustainability Committee as of the date of this Annual Report are Pascale Boissel, Bpifrance Participations (represented by Olivier Martinez) and Sally Bennett. Pascale Boissel is the Chairwoman of the Audit and Sustainability Committee.
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.
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. Frédéric Lombard joined Innate Pharma in April 2021 as Chief Financial Officer and is a member of the Leadership Team.
In case of outperformance for the year 2024, it may be decided to increase the amount of the bonus 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. • Performance Free Shares .
In case of outperformance for the year 2025, it may be decided to increase the amount of the bonus beyond 100% up to a limit of 150% based on other predefined criteria, except for the Chairman of the Executive Board.
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Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
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2024 filing
2025 filing
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.
The principal business address for Bpifrance S.A. is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France. 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.
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.
On January 3, 2024, following his appointment as Chief Operating Officer and member of the Executive Board, the Supervisory Board authorized the entry into 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.
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.
On January 3, 2024, following her appointment as a member of the Executive Board, the Supervisory Board authorized the entry into 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.
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.
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 179 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.
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.
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. B. Related Party Transactions.
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.
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.
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.
Consists of 6,389,406 ordinary shares. The principal business address for Bpifrance Participations S.A. is 27-31, avenue du Général Leclerc, 94 710 178 Maisons Alfort Cedex, France. 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 policy requires that, in determining whether to approve, ratify or reject a related person transaction, the Supervisory Board must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, the Company's best interests and those of its shareholders, as the Supervisory Board determines in the good faith exercise of its discretion.
The policy requires that, in determining whether to approve, ratify or reject a related person transaction, the Board of Directors must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, the Company's best interests and those of its shareholders, as the Board of Directors determines in the good faith exercise of its discretion.
In considering related person transactions, the Supervisory Board will take into account the relevant available facts and circumstances including, but not limited to: • the risks, costs and benefits to us; • the impact on the independence of a member of the Executive Board or Supervisory Board in the event that the related person is a member of the Executive Board or Supervisory Board, an immediate family member of a member of the Executive Board or Supervisory Board or an entity with which a member of Executive Board or Supervisory Board is affiliated; • the availability of other sources for comparable services or products; and • the terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
In considering related person transactions, the Board of Directors will take into account the relevant available facts and circumstances including, but not limited to: • the risks, costs and benefits to us; • the impact on the independence of the CEO or a member of the Board of Directors in the event that the related person is the CEO or a member of the Board of Directors, an immediate family member of the CEO or a member of the Board of Directors or an entity with which the CEO or a member of the Board of Directors is affiliated; • the availability of other sources for comparable services or products; and • the terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, the management must present information regarding the related person transaction to the Supervisory Board for review, consideration and approval or ratification.
Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, the management must present information regarding the related person transaction to the Board of Directors for review, consideration and approval or ratification.
A related person is any member of the Executive Board or Supervisory Board or beneficial owner of more than 5% of any class of its voting securities, including any of their immediate family members and any entity owned or controlled by such persons.
A related person is the CEO or any member of the Board of Directors or beneficial owner of more than 5% of any class of its voting securities, including any of their immediate family members and any entity owned or controlled by such persons.
On September 12, 2019, the Supervisory Board adopted a related person transaction policy that sets forth its procedures for the identification, review, consideration and approval or ratification of related person transactions. The policy became effective immediately upon the execution of the underwriting agreement for the October 2019 global offering.
On September 12, 2019, the Supervisory Board adopted a related person transaction policy (adopted by the Board of Directors on May 22, 2025) that sets forth its procedures for the identification, review, consideration and approval or ratification of related person transactions. The policy became effective immediately upon the execution of the underwriting agreement for the October 2019 global offering.
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.
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 March 30, 2026 and options and warrants that are currently exercisable or exercisable within 60 days of March 30, 2026.
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.
Ordinary shares subject to free shares, options and warrants currently exercisable or exercisable within 60 days of March 30, 2026 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.
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.
Major Shareholders The following table and accompanying footnotes set forth, as of March 30, 2026, 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 Board of Directors members individually; and • all of the Leadership Team and Board of Directors members as a group.
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.
Assuming that all of the ordinary shares represented by ADSs are held by residents of the United States, as of December 31, 2025, the Company estimates that approximately 4.3 million shares, or 4.62% of the outstanding ordinary shares were held of record by residents of the United States.
(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.
(9) n/a (10) Consists of 660 ordinary shares and 10,000 warrants which are exercisable since September 20, 2019 (BSA 2017). (11) n/a (12) Consists of 1,000 ordinary shares and 8,260 warrants which are exercisable since October 3, 2024 (BSA 2022). (13) Consists of 2,500 ordinary shares.
(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.
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.
Transaction with Related Companies From time to time, in the ordinary course of its business, the Company may contract for services from companies or institutions in which certain members of its Executive Board or Supervisory Board may serve as a director or advisor.
Compensation—Limitations on Liability and Indemnification Matters. Transaction with Related Companies From time to time, in the ordinary course of its business, the Company may contract for services from companies or institutions in which the CEO or certain members of its Board of Directors may serve as a director or advisor.
All of the transactions described above were evaluated and approved by the Supervisory Board. 201 C. Interests of Experts and Counsel. Not applicable.
All of the transactions described above were evaluated and approved by the Supervisory Board or the Board of Directors, as the case may be. C. Interests of Experts and Counsel. Not applicable.
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.
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. The principal business address for AstraZeneca PLC is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom.
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.
Since January 1, 2025, the Company has engaged in the following transactions with members of its Leadership Team, Board of Directors and holders of more than 5% of its outstanding voting securities, and their respective affiliates, which Innate refers to as its related parties. Arrangements with our Executive Officers and Directors Director and Executive Officer Compensation See “Item 6.
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.
The principal business address for EPIC Bpifrance is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France. 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) 1,182,350 ordinary shares, indirectly through CDC Croissance S.A., its wholly-owned subsidiary.
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.
Directors, Senior Management and Employees—B. Compensation—Limitations on Liability and Indemnification Matters” for information regarding compensation of the members of the Supervisory and Executive Boards.
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.
Percentage of beneficial ownership is based on 93,790,043 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of March 30, 2026. (3) Amounts beneficially owned were reported pursuant to a Schedule 13G filed with the SEC on October 21, 2025. Consists of 5,527,970 ordinary shares.
Under the policy, the Company will collect information that the Company deems reasonably necessary from each member of its Executive Board and Supervisory Board and, to the extent feasible, significant shareholder to enable Innate to identify any existing or potential related-person transactions and to effectuate the terms of the policy.
Under the policy, the Company will collect information that the Company deems reasonably necessary from the CEO or each member of its Board of Directors and, to the extent feasible, significant shareholder to enable Innate to identify any existing or potential related-person transactions and to effectuate the terms of the policy. 181 In addition, under its Code of Ethics, which Innate Pharma adopted on May 22, 2025, its employees, executive officers and Board of Directors members have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
(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.
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. Sanofi’s percentage of beneficial ownership is based on 93,790,043 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of March 30, 2026.
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.
The principal business address for Novo Nordisk A/S is Novo Allé, 2880 Bagsvaerd, Denmark. The percentage of beneficial ownership is based on 93,790,043 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of March 30, 2026. (4) Amounts beneficially owned were reported pursuant to a Schedule 13D amendment filed with the SEC on May 7, 2025.
(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).
(5) n/a (6) Consists of 374,192 ordinary shares and 450 preferred shares 2016 which are convertible into 58,500 ordinary shares (AGAP 2016). (7) n/a (8) Consists of 25,100 ordinary shares, 10,000 warrants which are exercisable since September 20, 2019 (BSA 2017) and 10,000 warrants which are exercisable since October 19, 2025 (BSA 2023).
(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.
(14) Consists of 136,249 ordinary shares and 50 preferred shares 2016 which are convertible into 6,500 ordinary shares (AGAP 2016). (15) Consists of 75,143 ordinary shares. (16) Consists of 50,668 ordinary shares. (17) Consists of 29,572 ordinary shares and 15 preferred shares 2016 which are convertible into 1,950 ordinary shares (AGAP 2016).
Removed
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.
Added
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. 177 Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% Shareholders : Sanofi (1) 8,345,387 8.90% MedImmune Limited (2) 7,825,501 8.34% Novo Nordisk A/S (3) 5,527,970 5.89% Bpifrance Participations S.A.
Removed
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.
Added
(4) 6,389,406 6.81% All 5% Shareholders 28,088,264 29.95% Board of Directors and Leadership Team Members : Jonathan Dickinson, MBA, BSc (5) 0 —% Yannis Morel, Ph.D. (6) 432,692 *% Sonia Quaratino, MD, PhD (7) 0 —% Irina Staatz-Granzer (8) 45,100 *% Christian Itin (9) 0 *% Véronique Chabernaud (10) 10,660 *% Marty J.
Removed
(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.
Added
Duvall (11) 0 *% Pascale Boissel (12) 9,260 *% Sally Bennett (13) 2,500 *% Odile Belzunce (14) 142,749 *% Frédéric Lombard (15) 75,143 *% Claire de St Blanquat (16) 50,668 *% Stéphanie Cornen (17) 31,522 *% All members of our Board of Directors and other Leadership Team members as a group 800,294 0.85% (1) Amounts beneficially owned were reported pursuant to a Schedule 13G filed with the SEC on April 29, 2025.
Removed
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).
Added
(2) Amounts beneficially owned were reported pursuant to a Schedule 13D filed with the SEC on February 2, 2026. Consists of 7,825,501 ordinary shares held by MedImmune Limited, a wholly-owned subsidiary of AstraZeneca PLC. The principal business address for MedImmune Limited is Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom.
Removed
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.
Added
The principal business address for Caisse des Dépôts et consignations is c/o 56, rue de Lille, 75007 Paris, France. Percentage of beneficial ownership is based on 93,790,043 ordinary shares outstanding (excluding treasury shares held by the Issuer) as of March 30, 2026.
Added
On October 1, 2024, the Supervisory Board authorized the entry into a consulting agreement with Kervrant Biotech, wholly owned by Hervé Brailly, former Chairman of the Management Board, in connection with an advisory and support assignment for the new Chairman of the Management Board, Jonathan Dickinson, during a transition period.
Added
The consulting agreement became effective on January 1, 2025, for a term expiring no later than May 31, 2025. It provided for fees of up to €10,000 (excluding VAT) per month, depending on the Company’s needs. During the financial year, the Company paid €8,000 in fees to Kervrant Biotech and €844.99 in expenses.
Added
On May 22, 2025, following his appointment as Chief Executive Officer, the Board of Directors authorized the conclusion of a mandate agreement between the Company and Jonathan Dickinson, which includes the benefit of a retirement plan of €82,500, a health insurance plan of €14,550, housing expenses of €20,000 and a non-compete clause providing for an indemnity, equal to a gross amount equal to two years of fixed compensation (calculated on the basis of the last monthly fixed compensation amount) and variable compensation (calculated on the basis of the last variable compensation paid), to compensate the Chief Executive Officer for the non-competition period of 24 months after he no longer serves as Chief Executive Officer.
Added
Indemnification Agreements On May 22, 2025, the Company entered into indemnification agreements with Ms. Irina Staatz-Granzer, Mr. Jonathan Dickinson, Ms. Pascale Boissel, Ms. Sally Bennett, Ms. Véronique Chabernaud, Mr. Olivier Martinez (as representative of BPIFrance Participations), Mr. Marty Duvall, Mr.
Added
Christian Itin, who became members of our Board of Directors on May 22, 2025 pursuant to our transition from an Executive Board and Supervisory Board corporate governance structure to a Board of Directors structure.
Added
We first entered into indemnification agreements with each of member of our then-existing Executive Board and 180 Supervisory Board (now the Board of Directors), and we have since entered into new agreements in relation to the abovementioned transition.
Added
With certain exceptions and subject to limitations on indemnification under French law, indemnification agreements provide for indemnification for damages and expenses including, among other things, attorneys’ fees, judgments, fines and settlement amounts incurred by any of these individuals in any action or proceeding arising out of his or her actions in that capacity.
Added
We have liability insurance for the members of our Executive Leadership Team and our Board of Directors. We believe that this insurance and these agreements are necessary to attract qualified members of the Executive Leadership Team and Board of Directors.
Added
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. See “Item 6. Directors, Senior Management and Employees—B.