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Innate Pharma SA

Innate Pharma SAIPHAEarnings & Financial Report

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 — 2022 vs 2023

Top changes in Innate Pharma SA's 2023 20-F

1096 paragraphs added · 1124 removed · 872 edited across 6 sections

Item 2. Properties

Properties — owned and leased real estate

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Item 2. Offer Statistics and Expected Timetable. 9 Item 3. Key Information. 9 A. Selected Financial Data 9 B. Capitalization and Indebtedness 11 C. Reasons for the Offer and Use of Proceeds 11 D. Risk Factors 11 Item 4. Information on the Company. 76 A. History and Development of the Company 76 B. Business Overview 77 C.
Item 2. Offer Statistics and Expected Timetable. 10 Item 3. Key Information. 10 A. Reserved 10 B. Capitalization and Indebtedness 10 C. Reasons for the Offer and Use of Proceeds 10 D. Risk Factors 10 Item 4. Information on the Company. 74 A. History and Development of the Company 74 B. Business Overview 75 C. Organizational Structure. 132 D.
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Organizational Structure. 137 D. Property, Plants and Equipment. 137

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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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; 11 • 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; • 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, 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; • 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 Company may not ultimately be able to provide the FDA, European Medicines Agency, or EMA, or other regulatory authorities with substantial clinical evidence to support a claim of efficacy and durability of response to enable the applicable regulators to approve its product candidates for any indication.
The Company may not ultimately be able to provide the FDA, European Medicines Agency (EMA) or other regulatory authorities with substantial clinical evidence to support a claim of efficacy and durability of response to enable the applicable regulators to approve its product candidates for any indication.
Additionally, because product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and earlier clinical trials its collaborators in earlier stages of clinical trials may eventually choose to discontinue later stage trials.
Additionally, because product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and earlier clinical studies, its collaborators in earlier stages of clinical trials may eventually choose to discontinue later stage studies.
Delays in the preclinical development of a product candidate could lead to delays in initiating its clinical development. A failure in the preclinical development of a product candidate could lead to abandoning its development.
Delays in the preclinical development of a product candidate could lead to delays in initiating clinical development. A failure in the preclinical development of a product candidate could lead to abandoning its development.
A drug’s launch in the market may expose a large number of patients to potential risks associated with the treatment with a new pharmaceutical product. Certain side effects, which may not have been identified during clinical trials, can subsequently appear. For these reasons, regulatory agencies require companies to implement post-approval monitoring.
A drug’s launch in the market may expose a large number of patients to potential risks associated with treatment with a new pharmaceutical product. Certain side effects, which may not have been identified during clinical trials, can subsequently appear. For these reasons, regulatory agencies require companies to implement post-approval monitoring.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the United States or the Social Security in France, and commercial payors are critical to new product acceptance.
Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the United States or Social Security in France, and commercial payors are critical to new product acceptance.
Beyond the financial impacts, the direct consequence of this decision was the immediate reduction of commercial operations in the Company's U.S. affiliate. A retrospective analysis identified two major causes: (i) a more complex patient access than expected due to geographic dispersion and (ii) the global pandemic of COVID-19. The COVID-19 pandemic significantly limited the interactions with prescribing physicians.
Beyond the financial impacts, the direct consequence of this decision was the immediate reduction of commercial operations in the Company's U.S. affiliate. A retrospective analysis identified two major causes: (i) a more complex patient access than expected due to geographic dispersion and (ii) the global pandemic of COVID-19. The COVID-19 pandemic significantly limited interactions with prescribing physicians.
The Company has received fast track designation in the U.S. and PRIME designation in EU for lacutamab for the treatment of adult patients with relapsed or refractory Sézary syndrome, or SS, who have received at least two prior systemic therapies.
The Company has received fast track designation in the U.S. and PRIME designation in the EU for lacutamab for the treatment of adult patients with relapsed or refractory Sézary Syndrome (SS) who have received at least two prior systemic therapies.
The ADSs being offered in the U.S. offering are quoted in U.S. dollars on Nasdaq, while Innate's ordinary shares trade in euro on Euronext Paris. Innate's financial statements are prepared in euro. Therefore, fluctuations in the exchange rate between the euro and the U.S. dollar will also affect, among other matters, the value of Innate's ordinary shares and ADSs.
The ADSs being offered in the U.S. offering are quoted in U.S. dollars on the Nasdaq, while Innate's ordinary shares trade in euro on Euronext Paris. Innate's financial statements are prepared in euro. Therefore, fluctuations in the exchange rate between the euro and the U.S. dollar will also affect, among other matters, the value of Innate's ordinary shares and ADSs.
The Company is unable to predict what tax law may be proposed or enacted in the future or what effect such changes would have on its business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect its effective tax rates in the future in countries where it has operations and have an adverse effect on its overall tax rate in the future, along with increasing the complexity, burden and cost of tax compliance.
The Company is unable to predict what tax law may be proposed or enacted in the future or what effect such changes would have on its business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect its effective tax rates in the future in countries where it has operations and could have an adverse effect on its overall tax rate in the future, along with increasing the complexity, burden and cost of tax compliance.
In addition, in order to support the development of the Company and changes in strategy, the Company must continue to implement and improve its management, operational and financial systems, adapt its facilities and recruit and train qualified personnel.
In addition, in order to support the development of the Company and changes in strategy, the Company must continue to implement and improve its management and operational and financial systems, adapt its facilities and recruit and train qualified personnel.
Innate must also comply with French regulations concerning the use and handling of genetically modified organisms, or GMOs, in confined spaces. If Innate fails to comply with applicable regulations, it could be subject to fines and may have to suspend all or part of its operations.
Innate must also comply with French regulations concerning the use and handling of genetically modified organisms (GMOs) in confined spaces. If Innate fails to comply with applicable regulations, it could be subject to fines and may have to suspend all or part of its operations.
Innate's and its licensors’ patents and patent applications, if issued, may be challenged, invalidated or circumvented by third parties. U.S. patents and patent applications may also be subject to interference proceedings, re-examination proceedings, derivation proceedings, post-grant review or inter partes review in the United States Patent and Trademark Office, or USPTO, challenging Innate's or its licensors’ patent rights.
Innate's and its licensors’ patents and patent applications, if issued, may be challenged, invalidated or circumvented by third parties. U.S. patents and patent applications may also be subject to interference proceedings, re-examination proceedings, derivation proceedings, post-grant review or inter partes review in the United States Patent and Trademark Office (USPTO), challenging Innate's or its licensors’ patent rights.
The dual listing of Innate's ordinary shares and the ADSs may adversely affect the liquidity and value of the ADSs. Innate's ADSs are listed on Nasdaq, and its ordinary shares are admitted to trading on Euronext Paris.
The dual listing of Innate's ordinary shares and the ADSs may adversely affect the liquidity and value of the ADSs. Innate's ADSs are listed on the Nasdaq, and its ordinary shares are admitted to trading on Euronext Paris.
Trading of the ADSs or ordinary shares in these markets take place in different currencies (U.S. dollars on Nasdaq and euro on Euronext Paris), and at different times (resulting from different time zones, different trading days and different public holidays in the United States and France).
Trading of the ADSs or ordinary shares in these markets take place in different currencies (U.S. dollars on the Nasdaq and euro on Euronext Paris), and at different times (resulting from different time zones, different trading days and different public holidays in the United States and France).
For example, neither the corporate laws of France nor the Company's bylaws require a majority of its Supervisory Board members to be independent and although the corporate governance code to which the Company currently refers (the AFEP/MEDEF code) recommends that, in a widely-held company like its, a majority of the Supervisory Board members be independent (as construed under such code), this code only applies on a “comply-or-explain” basis and Innate may in the future either decide not to apply this recommendation or change the corporate code to which it refers.
For example, neither the corporate laws of France nor the Company's bylaws require a majority of its Supervisory Board members to be independent, and although the corporate governance code to which the Company currently refers (the AFEP/MEDEF code) recommends that, in a widely held company like Innate, a majority of the Supervisory Board members be independent (as construed under such code), this code only applies on a “comply-or-explain” basis, and Innate may in the future either decide not to apply this recommendation or change the corporate code to which it refers.
In the future, the Company would lose its foreign private issuer status if the Company to 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.
The market price for Innate Pharma's ordinary shares and ADSs may be influenced by many factors, including: • actual or anticipated fluctuations in its financial condition and operating results; • actual or anticipated changes in its growth rate relative to its competitors; • competition from existing products or new products that may emerge; • announcements by Innate or its competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • adverse results of delays in Innate's or any of its competitors’ preclinical studies or clinical trials; • adverse regulatory decisions, including failure to receive regulatory approval for any of its product candidates; • the termination of a strategic alliance or the inability to establish additional strategic alliances; • failure to meet or exceed financial estimates and projections of the investment community or that the Company provides to the public; • issuance of new or updated research or reports by securities analysts; • fluctuations in the valuation of companies perceived by investors to be comparable to us; • ordinary share and American Deposit Share (ADS) price and volume fluctuations attributable to inconsistent trading volume levels of its ordinary shares and ADSs; • price and volume fluctuations in trading of its ordinary shares on Euronext Paris; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and its ability to obtain patent and other intellectual property protection for its technologies; 67 • 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 American Deposit Share (ADS) price and volume fluctuations attributable to inconsistent trading volume levels of its ordinary shares and ADSs; • price and volume fluctuations in trading of its ordinary shares on Euronext Paris; • additions or departures of key management or scientific personnel; • disputes or other developments related to proprietary rights, including patents, litigation matters and its ability to obtain patent and other intellectual property protection for its technologies; • changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels; • announcement or expectation of additional debt or equity financing efforts; • sales of its ordinary shares or ADSs by Innate, its insiders or its other shareholders; and • general economic and market conditions.
For example: • others may be able to make products that are the same as or similar to Lumoxiti and 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 • 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.
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; 70 • 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.
In particular, such filings are required in connection with investments exceeding €15,000,000 that lead to the acquisition of at least 10% of the Company's share capital or voting rights or cross such 10% threshold; • under French law, certain investments in a French company relating to certain strategic industries by individuals or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy; • a merger (i.e., in a French law context, a share for share exchange following which the Company would be dissolved into the acquiring entity and its shareholders would become shareholders of the acquiring entity) of the Company into a company incorporated in the European Union would require the approval of the Company's Executive Board, as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting; 68 • a merger of the Company into a company incorporated outside of the European Union would require 100% of its shareholders to approve it; • under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; • Innate's shareholders may in the future grant the Company's Executive Board broad authorizations to increase Innate's share capital or to issue additional ordinary shares or other securities (for example, warrants) to Innate's shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for Innate's ordinary shares; • its shareholders have preferential subscription rights on a pro rata basis on the issuance by Innate of any additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of the Company's shareholders or on an individual basis by each shareholder; • Innate's Supervisory Board appoints the members of the Executive Board and shall fill any vacancy within two months; • Innate's Supervisory Board has the right to appoint members of the Supervisory Board to fill a vacancy created by the resignation or death of a member of the Supervisory Board for the remaining duration of such member’s term of office, and subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on the Company's Supervisory Board; • its Executive Board can be convened by the chairman of the Executive Board or other members of the Executive Board delegated for this purpose; • its Supervisory Board can be convened by the chairman or the vice-chairman of the Supervisory Board.
For example, the Company cannot guarantee: • that the Company will file all necessary or desirable patent applications or that the Company will obtain the patents that the Company has applied for and that are under review; • that the Company will be able to develop new patentable product candidates or technologies or obtain patents to protect such new product candidates or technologies; • that the Company or its licensing or collaboration partners were the first to make the product candidates or technologies covered by the issued patents or pending patent applications that the Company licenses or own; • that the Company will be able to obtain sufficient rights to all necessary or desirable patents or other intellectual property rights, whether at all or on reasonable terms; • that the scope of any issued patents that the Company owns or licenses will be broad enough to protect its product candidates or effectively prevent others from commercializing competitive technologies and product candidates; and • that there is no risk of its owned and licensed patents being challenged, invalidated or circumvented by a third-party.
For example, the Company cannot guarantee: • that the Company will file all necessary or desirable patent applications or that the Company will obtain the patents that the Company has applied for and that are under review; • that the Company will be able to develop new patentable product candidates or technologies or obtain patents to protect such new product candidates or technologies; • that the Company or its licensing or collaboration partners were the first to make the product candidates or technologies covered by the issued patents or pending patent applications that the Company licenses or owns; • that the Company will be able to obtain sufficient rights to all necessary or desirable patents or other intellectual property rights, whether at all or on reasonable terms; • that the scope of any issued patents that the Company owns or licenses will be broad enough to protect its product candidates or effectively prevent others from commercializing competitive technologies and product candidates; and • that there is no risk of its owned and licensed patents being challenged, invalidated or circumvented by a third party.
If the chairman does not convene the Supervisory Board 15 days following the receipt of such request, the authors of the request may themselves convene the Supervisory Board; • its Supervisory Board meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference enabling the members’ identification and ensuring their effective participation in the Supervisory Board’s decisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the Executive Board and/or members of the Supervisory Board with or without cause; • the crossing of certain ownership thresholds has to be disclosed and can impose certain obligations; 71 • 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.
If the chairman does not convene the Supervisory Board 15 days following the receipt of such request, the authors of the request may themselves convene the Supervisory Board; • its Supervisory Board meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference enabling the members’ identification and ensuring their effective participation in the Supervisory Board’s decisions; • approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the Executive Board and/or members of the Supervisory Board with or without cause; • the crossing of certain ownership thresholds has to be disclosed and can impose certain obligations; • advance notice is required for nominations to the Supervisory Board or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a member of the Supervisory Board can be proposed at any shareholders’ meeting without notice; • transfers of shares shall comply with applicable insider trading rules and regulations, and in particular with the Market Abuse Regulation 596/2014 of April 16, 2014, as amended; and 69 • pursuant to French law, the Company's bylaws, including the sections relating to the number of members of the Executive and Supervisory Boards, and election and removal of members of the Executive and Supervisory Boards from office may only be modified by a resolution adopted by two-thirds of the votes of the Company's shareholders present, represented by a proxy or voting by mail at the meeting.
In Europe, the United States and other countries, regulations can potentially: • significantly delay or increase the cost of development, testing, manufacturing and marketing of Innate's products; • limit the indications for which the Company will be authorized to market its products; and 20 • impose new, more stringent, requirements, suspend marketing authorizations, or request the suspension of clinical trials or the marketing of its products if unexpected results are obtained during trials performed by other researchers on products similar to its products.
In Europe, the United States and other countries, regulations can potentially: • significantly delay or increase the cost of development, testing, manufacturing and marketing of Innate's products; • limit the indications for which the Company will be authorized to market its products; and • impose new, more stringent requirements, suspend marketing authorizations or request the suspension of clinical trials or the marketing of its products if unexpected results are obtained during trials performed by other researchers on products similar to its products.
If clinical investigators or CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to Innate's protocol or regulatory requirements, or for other reasons, its clinical trials or those of its collaborators may be extended, delayed or terminated, and the Company or its collaborators may not be able to obtain regulatory approval for or successfully 38 commercialize its product candidates.
If clinical investigators or CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to Innate's protocol or regulatory requirements, or for other reasons, its clinical trials or those of its collaborators may be extended, delayed or terminated, and the Company or its collaborators may not be able to obtain regulatory approval for or successfully commercialize its product candidates.
In addition, the Company may face claims by third parties that its 62 agreements with employees, contractors, or consultants obligating them to assign intellectual property to itself are ineffective, or in conflict with prior or competing contractual obligations of assignment, which could result in ownership disputes regarding intellectual property the Company has developed or will develop and interfere with its ability to capture the commercial value of such inventions.
In addition, the Company may face claims by third parties that its agreements with employees, contractors or consultants obligating them to assign intellectual property to itself are ineffective, or in conflict with prior or competing contractual obligations of assignment, which could result in ownership disputes regarding intellectual property the Company has developed or will develop and interfere with its ability to capture the commercial value of such inventions.
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 trial design; • delays in reaching agreement on acceptable terms with prospective Contract Research Organisations, or 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 trial 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; • 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.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. Innate Pharma's employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements, engaging in insider trading or violate the terms of their confidentiality agreements, which could significantly harm Innate's business.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. Innate Pharma's employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements, engaging in insider trading or violating the terms of their confidentiality agreements, which could significantly harm Innate's business.
Unless this happens, the likelihood and amount of its future operational losses will depend on several factors, including the pace and amount of its future expenditures in connection with its product candidates and development programs and its ability to obtain funding through milestone or royalty payments under its license and collaboration agreements, equity or debt financings, strategic collaborations and government grants and tax credits.
Unless this happens, the likelihood and amount of its future operational losses will depend on several factors, including the pace and amount of its future expenditures in connection with its product 39 candidates and development programs and its ability to obtain funding through milestone or royalty payments under its license and collaboration agreements, equity or debt financings, strategic collaborations and government grants and tax credits.
Further, the FDA, EMA and other regulatory authorities require that the Company complies with standards, commonly referred to as Good Clinical Practice, or GCP, and other local legal requirements, including data privacy regulations, for conducting, recording and reporting clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial subjects are protected.
Further, the FDA, EMA and other regulatory authorities require that the Company complies with standards, commonly referred to as Good Clinical Practice (GCP), and other local legal requirements, including data privacy regulations, for conducting, recording and reporting clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial subjects are protected.
For its most advanced clinical product candidate, monalizumab, the Company entered into an agreement with AstraZeneca, in part because of their late-stage development and marketing capabilities. As the Company identifies new product 40 candidates, Innate Pharma will determine the appropriate strategy for development and marketing, which may result in the need to establish collaborations with major biopharmaceutical companies.
For its most advanced clinical product candidate, monalizumab, the Company entered into an agreement with AstraZeneca, in part because of their late-stage development and marketing capabilities. As the Company identifies new product candidates, Innate Pharma will determine the appropriate strategy for development and marketing, which may result in the need to establish collaborations with major biopharmaceutical companies.
The resolution of any contract dispute that may arise could narrow what Innate believes to be the scope of its rights to the relevant intellectual property, or modify in a manner adverse to Innate what the Company believes to be Innate's or its counterpart’s financial or other obligations under the relevant agreement, any of which could have material adverse effect on its business, financial condition, results of operations and 63 prospects.
The resolution of any contract dispute that may arise could narrow what Innate believes to be the scope of its rights to the relevant intellectual property, or modify in a manner adverse to Innate what the Company believes to be Innate's or its counterpart’s financial or other obligations under the relevant agreement, any of which could have a material adverse effect on its business, financial condition, results of operations and prospects.
If Innate fails to receive future Research Tax Credit amounts or if its calculations are challenged, even if Innate Pharma complies with the current requirements in terms of documentation and eligibility of its expenditure, its business, prospects, financial condition and results of operations could be adversely affected. The Company may be unable to carry forward existing tax losses.
If Innate fails to receive future Research Tax Credit amounts or if its calculations are challenged, even if Innate Pharma complies with the current requirements in terms of documentation and eligibility of its expenditure, its business, prospects, financial condition and results of operations could be adversely affected. 44 The Company may be unable to carry forward existing tax losses.
These sanctions could include, for example, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.
These sanctions could include, for example, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or withdrawals from the market, product seizures, total or 19 partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
Any additional fundraising efforts may divert Innate's management from their day-to-day activities, which may adversely affect its ability to develop and commercialize its product candidates. In addition, the Company cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
Any additional fundraising efforts may divert Innate's management from their day-to-day activities, which may adversely affect the Company's ability to develop and commercialize its product candidates. In addition, the Company cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
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.
This could prove to be impossible or costly in terms of time and financial resources and could be detrimental to Innate's marketing efforts. Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 63 Intellectual property rights do not necessarily address all potential threats.
It is possible that some of these parties have interests that are different from, or in addition to, your interests as a shareholder or holder of ADSs. See “Item 16G.—Corporate Governance.” 69 U.S. investors may have difficulty enforcing civil liabilities against the Company and members of the Executive Board and the Supervisory Board.
It is possible that some of these parties have interests that are different from, or in addition to, your interests as a shareholder or holder of ADSs. See “Item 16G.—Corporate Governance.” U.S. investors may have difficulty enforcing civil liabilities against the Company and members of the Executive Board and the Supervisory Board.
Innate's failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with its products, manufacturers or manufacturing processes, may yield various results, including: • litigation involving patients taking its products; • restrictions on such products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on product distribution or use; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that the Company submits; 22 • recall of products; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • damage to relationships with any potential collaborators; • unfavorable press coverage and damage to its reputation; • refusal to permit the import or export of its products; • product seizure; or • injunctions or the imposition of civil or criminal penalties.
The Company's failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with its products, manufacturers or manufacturing processes, may yield various results, including: • litigation involving patients taking its products; • restrictions on such products, manufacturers or manufacturing processes; • restrictions on the labeling or marketing of a product; • restrictions on product distribution or use; • requirements to conduct post-marketing studies or clinical trials; • warning letters or untitled letters; • withdrawal of the products from the market; • refusal to approve pending applications or supplements to approved applications that the Company submits; • recall of products; • fines, restitution or disgorgement of profits or revenues; • suspension or withdrawal of marketing approvals; • damage to relationships with any potential collaborators; • unfavorable press coverage and damage to its reputation; • refusal to permit the import or export of its products; 22 • product seizure; or • injunctions or the imposition of civil or criminal penalties.
These requirements include, but are not limited to, restrictions governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, current good manufacturing practice, or cGMP, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping.
These requirements include, but are not limited to, restrictions governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, current good manufacturing practice (cGMP), requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents and requirements regarding the distribution of samples to physicians and recordkeeping.
Additional legislative proposals to reform healthcare and government 25 insurance programs, along with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce demand and prices for Innate's product candidates, if approved. This could harm Innate's or its partners’ ability to market any drugs and generate revenues.
Additional legislative proposals to reform healthcare and government insurance programs, along with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce demand and prices for Innate's product candidates, if approved. This could harm Innate's or its partners’ ability to market any drugs and generate revenues.
If clinical investigators or CROs fail to meet their obligations to Innate or comply with GCP procedures or other applicable legal requirements, the data generated in these trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require Innate to perform additional trials before approving Innate Pharma's marketing applications.
If clinical investigators or CROs fail to meet their obligations to Innate or comply with GCP procedures or other applicable legal requirements, the data generated in these trials may be deemed unreliable, and the FDA, EMA or comparable foreign regulatory authorities may require Innate to perform additional studies before approving Innate Pharma's marketing applications.
The patent positions of companies in the biotechnology and pharmaceutical market are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of U.S. patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained.
The patent positions of companies in the biotechnology and pharmaceutical market are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the 58 scope of U.S. patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained.
Depending upon the timing, duration and conditions of FDA marketing authorization of Lumoxiti and Innate's product candidates, one or more of its U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, and similar legislation in the European Union.
Depending upon the timing, duration and conditions of FDA marketing authorization of Innate's product candidates, one or more of its U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Amendments, and similar legislation in the European Union.
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 licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that the Company may consider attractive. These established 61 companies may have a competitive advantage over Innate due to their size, capital resources and greater clinical development and commercialization capabilities.
Should any of these events occur, they could have a material adverse effect on Innate's business, financial condition, results of operations, and prospects. 66 Risks Related to Ownership of the Company's Ordinary Shares and the ADSs The trading price of Innate's equity securities may be volatile, and purchasers of its ordinary shares or ADSs could incur substantial losses.
Should any of these events occur, they could have a material adverse effect on Innate's business, financial condition, results of operations and prospects. Risks Related to Ownership of the Company's Ordinary Shares and the ADSs The trading price of Innate's equity securities may be volatile, and purchasers of its ordinary shares or ADSs could incur substantial losses.
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 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 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.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. The terms of Innate's loans agreements with Société Générale, BNP Paribas and certain other loan obligations place restrictions on its operating and financial flexibility.
Should any of these risks materialize, this could have a material adverse effect on Innate's business, prospects, financial condition and results of operations. 41 The terms of Innate's loans agreements with Société Générale, BNP Paribas and certain other loan obligations place restrictions on its operating and financial flexibility.
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.
As a foreign private issuer, the Company is permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance 71 listing standards, and these practices may afford less protection to shareholders than they would enjoy if Innate complied fully with Nasdaq corporate governance listing standards.
Other risks inherent in the production process may have the same effect, such as: • contamination of the controlled atmosphere area; • unusable premises and equipment; • new regulatory requirements requiring a partial and/or extended stop to the production unit to meet the requirements; • unavailable qualified personnel; • power failure of extended duration; and • logistical error.
Other risks inherent in the production process may have the same effect, such as: • contamination of the controlled atmosphere area; • unusable premises and equipment; • new regulatory requirements requiring a partial and/or extended stop to the production unit to meet the requirements; • unavailable qualified personnel; • power failure of extended duration; and 34 • logistical error.
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.
Litigation may be necessary to resolve an ownership dispute, and if the Company is not successful, Innate may be precluded from using certain intellectual property, may lose its exclusive rights in such 60 intellectual property or may be required to acquire a license to such intellectual property, which may not be available on commercially reasonable terms or at all.
This may occur because later clinical trials fail to reproduce favorable data obtained in earlier clinical trials, because the applicable regulator disagrees with how the Company interprets the data from these clinical trials or because the applicable regulator does not accept these therapeutic effects as valid endpoints in pivotal clinical trials that are sufficient to grant marketing approval.
This may occur because later clinical studies fail to reproduce favorable data obtained in earlier clinical trials, because the applicable regulator disagrees with how the Company interprets the data from these clinical trials or because the applicable regulator does not accept these therapeutic effects as valid endpoints in pivotal clinical trials that are sufficient to grant marketing approval.
The outcome 59 following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, Innate Pharma cannot be certain that there is no invalidating prior art, of which the Company or its licensing partners and the patent examiner were unaware during prosecution.
The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, Innate Pharma cannot be certain that there is no invalidating prior art of which the Company or its licensing partners and the patent examiner were unaware during prosecution.
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.
If these shareholders or ADS holders sell substantial amounts of ordinary shares or ADSs in the public market, or the market perceives that such sales may occur, the 66 market price of Innate's ADSs or ordinary shares and its ability to raise capital through an issue of equity securities in the future could be adversely affected.
The Company is currently developing monalizumab, lacutamab and IPH5201, and may develop other product candidates, in combination with one or more currently approved cancer therapies. Specifically, AstraZeneca is currently evaluating monalizumab in ongoing Phase 1, 2 and 3 trials in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor.
The Company is currently developing monalizumab, lacutamab, IPH5201 and IPH5301, and may develop other product candidates, in combination with one or more currently approved cancer therapies. Specifically, AstraZeneca is currently evaluating monalizumab in ongoing Phase 1, 2 and 3 trials in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor.
Because its product candidates represent new approaches to the treatment of cancer and accordingly, may have a higher cost than conventional therapies and may require long-term follow-up evaluations, the risk that coverage and reimbursement rates may be inadequate for the Company to achieve profitability may be elevated.
Because its product candidates represent new approaches to the treatment of cancer and, accordingly, may have a higher cost than conventional therapies and may require long-term follow-up evaluations, the risk 23 that coverage and reimbursement rates may be inadequate for the Company to achieve profitability may be elevated.
The regulatory processes that will govern the approval of Innate's product candidates are complex and changes in regulatory requirements could result in delays or discontinuation of development or unexpected costs in obtaining regulatory approval. Innate's product candidates are based on new approaches and/or technologies that are constantly evolving and have not been extensively tested on humans.
The regulatory processes that will govern the approval of Innate's product candidates are complex and changes in regulatory requirements could result in delays or discontinuation of development or unexpected costs in obtaining regulatory approval. The Company's product candidates are based on new approaches and/or technologies that are constantly evolving and have not been extensively tested on humans.
In some countries, the proposed pricing for a biopharmaceutical product must be approved before it may be lawfully marketed. In addition, in certain foreign markets, the pricing of biopharmaceutical product is subject to government control and reimbursement may in some cases be unavailable. The requirements governing drug pricing vary widely from country to country.
In some countries, the proposed pricing for a biopharmaceutical product must be approved before it may be lawfully marketed. In addition, in certain foreign markets, the pricing of biopharmaceutical products is subject to government control and reimbursement may in some cases be unavailable. The requirements governing drug pricing vary widely from country to country.
If the Company does not succeed in maintaining the appropriate level of internal control, it could result in material misstatements in its financial statements, result in the loss of investor confidence in the reliability of its financial statements and subject it to regulatory scrutiny and sanctions, which in turn could harm the market value of its ordinary shares and ADSs.
If the Company does not succeed in maintaining the appropriate level of internal control, it could result in material misstatements in its financial statements, result in the loss of investor confidence in the reliability 47 of its financial statements and subject it to regulatory scrutiny and sanctions, which in turn could harm the market value of its ordinary shares and ADSs.
Challenges from competitors or other third parties could reduce the scope of Innate's patents or render them invalid or unenforceable, which could limit its ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection for Lumoxiti and Innate Pharma's product candidates.
Challenges from competitors or other third parties could reduce the scope of Innate's patents or render them invalid or unenforceable, which could limit its ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection for Innate Pharma's product candidates.
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; 58 • pay damages, which may include treble damages and attorney’s fees if the Company is found to have willfully infringed a third-party’s patent rights; • cease developing, manufacturing and commercializing the infringing technology or product candidates; and • acquire a license to such third-party intellectual property rights, which may not be available on commercially reasonable terms, or at all, and may be non-exclusive thereby giving the Company's competitors and other third parties access to the same technologies licensed to us.
If the Company is found to infringe a third party’s intellectual property rights, and the Company is unsuccessful in demonstrating that such rights are invalid or unenforceable, the Company could be required to: • bear the potentially significant costs of proceedings brought against us; 56 • pay damages, which may include treble damages and attorney’s fees if the Company is found to have willfully infringed a third party’s patent rights; • cease developing, manufacturing and commercializing the infringing technology or product candidates; and • acquire a license to such third-party intellectual property rights, which may not be available on commercially reasonable terms, or at all, and may be non-exclusive, thereby giving the Company's competitors and other third parties access to the same technologies licensed to us.
In this case, the Company would be exposed to the same competitive risks as the product used in combination with its product, such as a product that is marketed before the combination therapy, has lower prices, covers a wider therapeutic spectrum or proves to be more effective or better tolerated.
In this case, the Company would be exposed to the same competitive risks as the product used in combination with its product, such as a product that is marketed before the combination therapy, has lower prices, covers a wider therapeutic spectrum or proves to be more effective 18 or better tolerated.
In the European Union, the requisite approval is a Marketing 19 Authorization, or MA, which for products developed by the means of antibody-based therapeutics, gene or cell therapy products as well as tissue engineered products, is issued through a centralized procedure involving the EMA (see “Business—Regulation”).
In the European Union, the requisite approval is a Marketing Authorization (MA), which for products developed by the means of antibody-based therapeutics, gene or cell therapy products as well as tissue engineered products, is issued through a centralized procedure involving the EMA (see “Business—Regulation”).
Supreme Court ruling, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period which began on February 15, 2021 and remained open through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace.
Supreme Court ruling, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period which began on February 15, 2021, and 24 remained open through August 15, 2021, for purposes of obtaining health insurance coverage through the ACA marketplace.
For example, its liability could be sought after by patients participating in the clinical trials in the context of the development of the therapeutic products tested and unexpected side effects resulting from the administration of these products. Once a product is approved for sale and commercialized, the likelihood of product liability lawsuits increases.
For example, its liability could be sought by patients participating in the clinical trials in the context of the development of the therapeutic products tested and unexpected side effects resulting from the administration of these products. Once a product is approved for sale and commercialized, the likelihood of product liability lawsuits increases.
These risks include: • failure of third-party manufacturers to comply with regulatory and quality-control standards; 35 • production of insufficient quantities; • damage during transport and/or storage of its product candidates; • breach of agreements by third-party manufacturers; and • termination or non-renewal of the agreements for reasons beyond its control.
These risks include: • failure of third-party manufacturers to comply with regulatory and quality control standards; • production of insufficient quantities; • damage during transport and/or storage of its product candidates; • breach of agreements by third-party manufacturers; and • termination or non-renewal of the agreements for reasons beyond its control.
The occurrence of any of these events concerning any of Innate's patents or intellectual property rights could have a material adverse effect its business, prospects, financial condition and results of operations. These risks are even higher for the Company, because of its limited financial and human resources.
The occurrence of any of these events concerning any of Innate's patents or intellectual property rights could have a material adverse effect on its business, prospects, financial condition and results of operations. These risks are even higher for the Company, because of its limited financial and human resources.
Competitors may use Innate's technologies in jurisdictions where Innate Pharma does not pursue and obtain patent protection to develop their own products and further, may export otherwise infringing products to territories where the Company has patent protection, and enforcement is not as strong as that in the United 61 States.
Competitors may use Innate's technologies in jurisdictions where Innate Pharma does not pursue and obtain patent protection to develop their own products and, further, may export otherwise infringing products to territories where the Company has patent protection, and enforcement is not as strong as that in the United States.
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.
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 64 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 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 67 procedure would still be governed by the law of the jurisdiction in which the foreign court resides.
This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase the Company's costs and could increase its overall compliance risk.
This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase the Company's costs and could increase its overall 32 compliance risk.
Should its third-party manufacturers breach their obligations or should the Company fails to renew its contracts with them, the Company cannot guarantee that the Company will be able to find new suppliers within a timeframe and under conditions that would not be detrimental.
Should its third-party manufacturers breach their obligations or should the Company fails to renew its contracts with them, the Company cannot guarantee that it will be able to find new suppliers within a timeframe and under conditions that would not be detrimental.
The Company cannot control the timing or quantity of resources that its existing or future collaborators will dedicate to research, preclinical and clinical development, manufacturing or marketing of its products. Innate's collaborators may not perform their obligations according to its expectations or standards of quality.
The Company cannot control the timing or quantity of resources that its existing or future collaborators will dedicate to research, preclinical and clinical development, manufacturing or marketing of its products. Innate's collaborators may not perform their obligations according to its expectations or 37 standards of quality.
Innate Pharma's registered trademarks may be challenged, infringed, circumvented or declared generic or determined to be infringing 65 on other marks. In addition, there could be potential trademark infringement claims brought by owners of other trademarks that incorporate variations of Innate's registered or unregistered trademarks.
Innate Pharma's registered trademarks may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. In addition, there could be potential trademark infringement claims brought by owners of other trademarks that incorporate variations of Innate's registered or unregistered trademarks.
In addition, exchange rate fluctuations may affect the amount of euro that the Company is able to distribute, and the amount in U.S. dollars that its shareholders receive upon the payment of cash dividends or other distributions the Company declares and pays in euro, if any.
In addition, exchange rate fluctuations may affect the amount of euros that the Company is able to distribute, and the amount in U.S. dollars that its shareholders receive upon the payment of cash dividends or other distributions the Company declares and pays in euro, if any.
By definition, the financing, design and conduct of an investigator-sponsored trial are the sole responsibility of the sponsor, and the Company or its collaborators, as applicable, have limited control over these aspects of these clinical trials, or the timing and reporting of the data from these trials.
By definition, the financing, design and conduct of an investigator-sponsored trial are the sole responsibility of the sponsor, and the Company or its collaborators, as applicable, have limited control over these 35 aspects of these clinical trials, or the timing and reporting of the data from these trials.
The deposit agreement provides that, upon receipt of notice of any meeting of holders of Innate's ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the 72 exercise of voting rights.
The deposit agreement provides that, upon receipt of notice of any meeting of holders of Innate's ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the exercise of voting rights.
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.
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 59 problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
The Company cannot guarantee that its product candidates will: • obtain regulatory authorizations or become commercially available before those of its competitors; • remain competitive in the face of other products developed by its competitors, which may prove to be safer, are more effective, have fewer or less severe side effects, are more convenient, have a broader label, have more robust intellectual property protection or are less expensive; • remain competitive in the face of products of competitors that are more efficient in their manufacturing or more effective in their marketing; and 18 • not become obsolete or unprofitable due to technological progress or other therapies developed by its competitors.
The Company cannot guarantee that its product candidates will: • obtain regulatory authorizations or become commercially available before those of its competitors; • remain competitive in the face of other products developerid by its competitors, which may prove to be safer, more effective, have fewer or less severe side effects, be more convenient, have a broader label, have more robust intellectual property protection or be less expensive; • remain competitive in the face of products of competitors that are more efficient in their manufacturing or more effective in their marketing; and • not become obsolete or unprofitable due to technological progress or other therapies developed by its competitors.
Both the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012, or ATRA, further reduced Medicare payments to several providers and the ATRA increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
Both the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012 (ATRA) further reduced Medicare payments to several providers and the ATRA increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
This legislation imposes requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside of the European Economic Area, or EEA, including to the United States, providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing 34 agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping.
This legislation imposes requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside of the European Economic Area (EEA), including to the United States, providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping.
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.
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 70 withdraw those ordinary shares.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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In Europe, brentuximab vedotin is indicated for the treatment of adult patients with R/R CD30 + CTCL who require systemic therapy. • Mogamulizumab (marketed as Poteligeo), was approved by the FDA in 2018 and the EMA for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
In Europe, brentuximab vedotin is indicated for the treatment of adult patients with R/R CD30 + CTCL who require systemic therapy; and • Mogamulizumab (marketed as Poteligeo), was approved in 2018 by the FDA and the EMA for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
Lacutamab was generally well tolerated. The most common adverse effects, or AEs, were peripheral edema (27%) and fatigue (20%), all of which were grade 1 or 2. Lymphopenia was the most frequent IPH4102-related adverse event and occurred in six (14%) patients (three (7%) grade 3). One patient developed possibly treatment-related fulminant hepatitis six weeks after lacutamab discontinuation and subsequently died.
Lacutamab was generally well tolerated. The most common adverse effects (AEs) were peripheral edema (27%) and fatigue (20%), all of which were grade 1 or 2. Lymphopenia was the most frequent IPH4102-related adverse event and occurred in six (14%) patients (three (7%) grade 3). One patient developed possibly treatment-related fulminant hepatitis six weeks after lacutamab discontinuation and subsequently died.
Median follow-up was 16.3 months (4.4-25.7); 13 patients had a confirmed response, ORR=32.5% [95%CI: 20-48], including three complete responses. 95 Median time to response was 1.8 months [1.6-3.7]. 6/13 responders were still on treatment, with median duration of response not yet reached [7.1-NR]. Median PFS was 6.9 months [4.4-9.3], and 12 months OS was 59% [45-77].
Median follow-up was 16.3 months (4.4-25.7); 13 patients had a confirmed response, ORR=32.5% [95%CI: 20-48], including three complete responses. Median time to response was 1.8 months [1.6-3.7]. 6/13 responders were still on treatment, with median duration of response not yet reached [7.1-NR]. Median PFS was 6.9 months [4.4-9.3], and 12 months OS was 59% [45-77].
In addition, IPH5301 has been observed to have a differentiated and superior activity compared to benchmark antibodies that are currently in clinical development (Perrot, 2019). In syngeneic murine tumor-bearing human CD73 knock-in mice, IPH5301 enhanced the antitumor effects of PD-1 blockade, as shown in figure below.
In addition, IPH5301 has been observed to have a differentiated and superior activity compared to benchmark antibodies that are currently in clinical development (Perrot, 2019). In syngeneic murine tumor-bearing human CD73 knock-in mice, IPH5301 enhanced the antitumor effects of PD-1 blockade, as shown in the figure below.
BiKEs and TriKEs can be effective both in vitro and in vivo in preclinical models. These multi-specific molecules that engage NK cells could reduce the risks associated with toxicity, as NK cell counts only represent approximately 10% of T cell counts, thereby potentially limiting the likelihood of inducing a cytokine storm.
BiKEs and TriKEs can be effective both in vitro and in vivo in preclinical models. These multi-specific molecules that engage NK cells could reduce the risks associated with toxicity, as NK cell counts represent only approximately 10% of T cell counts, thereby potentially limiting the likelihood of inducing a cytokine storm.
In vitro studies established that IPH6501´s main modes of action were NK cell proliferation and antibody-dependent cell cytotoxicity (ADCC) against CD20-expressing cells. Non-saturating doses of IPH6501 on NK cells and on CD20 + cells were sufficient to promote maximal killing activity. Furthermore, IPH6501 promoted NK cell cytotoxicity against tumor cells expressing very low levels of CD20.
In vitro studies established that IPH6501´s main modes of action were NK cell proliferation and antibody-dependent cell cytotoxicity (ADCC) against CD20-expressing cells. • In vitro Non-saturating doses of IPH6501 on NK cells and on CD20 + cells were sufficient to promote maximal killing activity. Furthermore, IPH6501 promoted NK cell cytotoxicity against tumor cells expressing very low levels of CD20.
Its competitors also may obtain regulatory approval for their products more rapidly than the Company may obtain approval for its, which could result in its competitors establishing a strong market position before the Company is able to enter the market.
Its competitors also may obtain regulatory approval for their products more rapidly than the Company may obtain approval for its products, which could result in its competitors establishing a strong market position before the Company is able to enter the market.
Suspension or termination of development during any Phase of clinical trials can occur if it is determined that the participants or patients are being exposed to an unacceptable health risk. Other reasons for suspension or termination may be made by Innate based on evolving business objectives and/or competitive climate.
Suspension or termination of development during any Phase of clinical trials can occur if it is determined that the participants or patients are being exposed to an unacceptable health risk. Other reasons for suspension or termination may be made by Innate based on evolving business objectives and/or the competitive climate.
Under Article 3 of the Regulation (EC) No 726/2004, the Centralized Procedure is optional for any other human medicinal product if: (1) the medicinal product contains a new active substance ; or (2) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization in accordance with this Regulation is in the interests of patients health at EU level.
Under Article 3 of the Regulation (EC) No 726/2004, the Centralized Procedure is optional for any other human medicinal product if: (1) the medicinal product contains a new active substance ; or (2) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization in accordance with this Regulation is in the interests of patients health at the EU level.
However, marketing authorization may be granted to a similar medicinal product for the same indication at any time if: • the holder of the MA for the original orphan medicinal product has given its consent to the second applicant; • the holder of the MA for the original orphan medicinal product cannot supply sufficient quantities of the orphan medicinal product; or • the second applicant can establish in the application that its product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior.
However, marketing authorization may be granted to a similar medicinal product for the same indication at any time if: • the holder of the marketing authorization, or MA, for the original orphan medicinal product has given its consent to the second applicant; • the holder of the MA for the original orphan medicinal product cannot supply sufficient quantities of the orphan medicinal product; or • the second applicant can establish in the application that its product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior.
Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; • the U.S. civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the U.S.
Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; • the U.S. civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to be made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government; • the U.S.
There have been a number of federal and state proposals during the last few years regarding the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for biologics and other medical products, government control and other changes to the healthcare system in the United States.
There have been a number of federal and state proposals and changes during the last few years regarding the pricing of pharmaceutical and biopharmaceutical products, limiting coverage and reimbursement for biologics and other medical products, government control and other changes to the healthcare system in the United States.
Health Insurance Portability and Accountability Act of 1996, or 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, or 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; 126 • the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.
This multicenter, open-label, dose-escalation Phase 1 study evaluated the safety, tolerability, antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of IPH5201 alone, or in combination with AstraZeneca’s anti-PD-L1 therapy, durvalumab, with or without its anti-CD73 monoclonal antibody, oleclumab. The current study status is completed and results were presented 100 at the ESMO-IO congress (Imbimbo, Poster 188P, abstract 472).
This multicenter, open-label, dose-escalation Phase 1 study evaluated the safety, tolerability, antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of IPH5201 alone, or in combination with AstraZeneca’s anti-PD-L1 therapy, durvalumab, with or without its anti-CD73 monoclonal antibody, oleclumab. The current study status is completed and results were presented at the ESMO-IO congress (Imbimbo, Poster 188P, abstract 472).
The latest drugs approved by the FDA for CTCL: Adcetris (brentuximab vedotin), marketed by Seattle Genetics and approved in combination with chemotherapy for treatment of patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing MF who have received prior systemic therapy, and Poteligeo (mogamulizumab), marketed by Kyowa Kirin and approved for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
The latest drugs approved by the FDA for CTCL are: Adcetris (brentuximab vedotin), marketed by Seattle Genetics and approved in combination with chemotherapy for treatment of patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing MF who have received prior systemic therapy, and Poteligeo (mogamulizumab), marketed by Kyowa Kirin and approved for the treatment of adult patients with R/R MF or Sézary syndrome after at least one prior systemic therapy.
Wild type mice showed decreased tumor growth and metastases in some models when administered with an anti-CD73 antibody alone (Antonioli, 2016, Antoniolli 2017). The small anti-tumor effect of anti-CD73 antibodies in mouse 103 models was greatly enhanced by combination with checkpoint inhibition such as PD-1 or an adenosine receptor antagonist (Allard, 2013; Young, 2016).
Wild type mice showed decreased tumor growth and metastases in some models when administered with an anti-CD73 antibody alone (Antonioli, 2016, Antoniolli 2017). The small anti-tumor effect of anti-CD73 antibodies in mouse models was greatly enhanced by combination with checkpoint inhibition such as PD-1 or an adenosine receptor antagonist (Allard, 2013; Young, 2016).
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revising the approved labeling to add new safety information; imposing post- 129 market studies or clinical trials to assess new safety risks; or imposing distribution or other restrictions under a REMS program.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revising the approved labeling to add new safety information; imposing post-market studies or clinical trials to assess new safety risks; or imposing distribution or other restrictions under a REMS program.
Reference pricing used by various European Union member states, and parallel trade, i.e., arbitrage between low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.
Reference pricing used by various European Union member states, and parallel trade, i.e., arbitrage between low-priced and high-priced member states, can further reduce prices. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical 129 products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.
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 87 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 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.
Good clinical practices (GCP) In most countries, clinical trials must comply with the current GCP (cGCP) standards as defined by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH. Directive 2005/28/EC dated April 8, 2005 adopted the cGCP principles in the context of strengthening the regulatory structure specified by Directive 2001/20/EC.
Good clinical practices (GCP) In most countries, clinical trials also must comply with the current GCP, or cGCP, standards as defined by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Directive 2005/28/EC dated April 8, 2005 adopted the cGCP principles in the context of strengthening the regulatory structure specified by Directive 2001/20/EC.
Certain exceptions and waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver for certain small businesses, an exception from the establishment fee when the establishment does not engage in manufacturing the product during a particular fiscal year, and an exception from the product fee for a product that is the same as another product approved under an abbreviated pathway.
Certain exceptions and waivers are available for some of these fees, such as an exception from the application fee for products with orphan drug designation and a waiver for certain small businesses, an exception from the establishment fee when the establishment does not engage in manufacturing the product during a particular fiscal year, and an exception from the product fee for a product that is the same as another product approved under an abbreviated pathway.
As further evidence for the negative role of CD73 in anti-tumor response, Loi and al., 2013, examined gene expression data from 6,000 breast cancer patients and found that high CD73 expression was associated with poor prognosis in triple-negative breast cancer (TNBC), as was the association between high CD73 gene expression and pre-surgery treatment with the standard of care chemotherapy anthracycline.
As further evidence for the negative role of CD73 in anti-tumor response, Loi et al., 2013, examined gene expression data from 6,000 breast cancer patients and found that high CD73 expression was associated with poor prognosis in triple-negative breast cancer (TNBC), as was the association between high CD73 gene expression and pre-surgery treatment with the standard of care chemotherapy anthracycline.
These molecules have demonstrated the ability to reduce or slow the growth of tumors in cancer patients, but also carry a significant toxicity risk. This toxicity risk occurs by engaging all T cells, irrespective of their specificity and development status, potentially leading to an overt production of cytokines by these T cells, referred to as a cytokine storm.
These molecules have demonstrated the ability to reduce or slow the growth of tumors in cancer patients, but they also carry a significant toxicity risk. This toxicity risk occurs by engaging all T cells, irrespective of their specificity and development status, potentially leading to an overt production of cytokines by these T cells, referred to as a cytokine storm.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There are also continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.
After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There are also continuing, annual user fee requirements for any marketed products and the establishments at which such 124 products are manufactured, as well as new application fees for supplemental applications with clinical data.
Innate Pharma France S.A.S. was dissolved without liquidation on November 30, 2020 under article 1844-5 section 3 of the French Civil Code. The Company is registered at the Marseille Business and Company Registry (Registre du commerce et des sociétés) under the number SIREN 424 365 336 RCS Marseille.
Innate Pharma France S.A.S. was dissolved without liquidation on November 30, 2020, under article 1844-5, Section 3 of the French Civil Code. 74 The Company is registered at the Marseille Business and Company Registry ( Registre du commerce et des sociétés ) under the number SIREN 424 365 336 RCS Marseille.
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.
These competitors are also likely to compete with Innate to recruit and retain top qualified scientific and management personnel, acquire rights for promising product candidates and technologies, establish clinical trial sites and patient registration for clinical trials, acquire 111 technologies complementary to, or necessary for, its programs and enter into collaborations with potential partners who have access to innovative technologies.
Given the high unmet medical need for certain cancer patients, deviations from the typical Phases of development are frequent in oncology and particularly in the field of immunotherapy. Disclosure of clinical trial information Sponsors of clinical trials of FDA-regulated drugs are required to register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov.
Given the high unmet medical need for certain cancer patients, deviations from the typical Phases of development are frequent in oncology and particularly in the field of immunotherapy. Disclosure of clinical trial information Sponsors of applicable clinical trials of FDA-regulated drugs are required to register and disclose certain clinical trial information, which is publicly available at www.clinicaltrials.gov.
In November 2020, Innate Pharma received Priority Medicines (PRIME) designation from the EMA for lacutamab, for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. Lacutamab has also been granted orphan drug designation by the FDA and orphan designation by the EMA for the treatment of CTCL.
In November 2020, Innate Pharma received Priority Medicines (PRIME) designation from the EMA for lacutamab, for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. Lacutamab has also been granted orphan drug designation by the FDA and orphan designation by the EMA for the treatment of CTCL. The U.S.
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, or GemOx, is listed as one of the preferred treatment combinations (ESMO Lymphoma Guidelines).
Despite these approvals, current treatment guidelines (NCCN 2021) recommend participation in a clinical trial as a preferred option for patients with relapsed PTCL after first line treatment. If clinical trials are not available, a chemotherapy combination of gemcitabine and oxaliplatin (GemOx) is listed as one of the preferred treatment combinations (ESMO Lymphoma Guidelines).
The EMA, FDA and the various national regulatory authorities impose considerable constraints on the development, manufacture and sale of products that the Company develops and clinical trials it conducts. In case of non-compliance with these regulations, the regulatory authorities may impose fines, seize or withdraw products from the market or even partially or totally suspend their production.
The EMA, FDA and the various national regulatory authorities impose considerable constraints on the development, manufacture and sale of products that the Company develops and clinical trials it conducts. In case of non-compliance with these laws or regulations, the regulatory authorities may impose fines, seize or withdraw products from the market or even partially or totally suspend their production.
Clinical trial Phases Clinical trials may be conducted in the United States, in Europe or in other parts of the world as long as such trials have been approved by health authorities and ethics committees in each country where the trial is conducted. There are three well-established and internationally-recognized clinical Phases: Phase 1, 2 and 3.
Clinical trial Phases Clinical trials may be conducted in the United States, in Europe or in other parts of the world as long as such trials have been approved by health authorities and ethics committees or IRBs in each country where the trial is conducted. There are three well-established and internationally recognized clinical Phases: Phase 1, 2 and 3.
Arrangements with providers, consultants, third- 130 party payors and customers are subject to broadly applicable fraud and abuse, anti-kickback, false claims laws, transparency laws and patient data privacy laws and regulations and other healthcare laws and regulations that may constrain business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations, include the following: • the U.S.
Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse, anti-kickback, false claims laws, transparency laws and patient data privacy laws and regulations and other healthcare laws and regulations that may constrain business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations, include the following: • the U.S.
The downward pressure on health care costs 134 in general, particularly prescription products, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
The downward pressure on health care costs in general, particularly prescription products, has become intense. As a result, increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.
Several studies have been published on the role of GemOx in patients with relapsed lymphoma and it is one of the most widely used regimens for this patient population in the United States, Europe and Asia (Mounier, 2013; Yamaguchi, 2012). c. Clinical Trials Below is a summary of the clinical trials of lacutamab.
Several studies have been published on the role of GemOx in patients with relapsed lymphoma and it is one of the most widely used regimens for this patient population in the United States, Europe and Asia (Mounier, 2013; Yamaguchi, 2012). c. Clinical Trials Below is a summary of the clinical trials of lacutamab. i.
Rationale for combinations with monalizumab The Company is primarily focused on investigating monalizumab in combination with durvalumab is an antibody directed against PD-L1. PD-L1 and HLA-E are both up-regulated on many cancer cells, and they have both been observed to suppress tumor immune response and contribute to tumor progression.
Rationale for combinations with monalizumab The Company is primarily focused on investigating monalizumab in combination with durvalumab, which is an antibody directed against PD-L1. PD-L1 and HLA-E are both up-regulated on many cancer cells, and they have both been observed to suppress tumor immune response and contribute to tumor progression.
In July and December 2018, CMS published final rules with respect to permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under its risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment.
In July and December 2018, CMS published final rules with respect to 127 permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under its risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment.
Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by a third-party payor not to cover a product candidate could reduce physician utilization once the product is approved and have a material adverse effect on sales, results of operations and financial condition.
Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by a third-party payor not to cover a product candidate could reduce physician utilization once the product is approved, which could have a material adverse effect on sales, results of operations and financial condition.
Orphan medicinal products are also eligible for financial incentives such as reduction of fees or fee waivers and scientific assistance for study proposals. (Articles 6 and 9 of the above-mentioned regulation). The application for orphan drug designation must be submitted before the application for marketing authorization (Article 5).
Orphan medicinal products are also eligible for financial incentives such as reduction of fees or fee waivers and scientific assistance for study proposals. (Articles 6 and 9 of the above-mentioned regulation). The application for orphan drug 123 designation must be submitted before the application for marketing authorization (Article 5).
In addition, targeting CD73 was shown to enhance efficacy of treatment with anti-HER2 therapy (Turcotte, 2017). On the other hand, several chemotherapeutic agents including taxanes, anthracyclines 104 and platinum salts were shown to increase the release of ATP (Martins and Tesniere, 2009); (Martins and Wang, 2014).
In addition, targeting CD73 was shown to enhance efficacy of treatment with anti-HER2 therapy (Turcotte, 2017). On the other hand, several chemotherapeutic agents including taxanes, anthracyclines and platinum salts were shown to increase the release of ATP (Martins and Tesniere, 2009); (Martins and Wang, 2014).
For example, adenosine is one of the components of the TME that most broadly affects immune response. It is produced by the sequential degradation of extracellular adenosine triphosphate, or ATP, by the following two enzymes: first CD39, which degrades the ATP into adenosine monophosphate, or AMP, and then second, CD73, which impairs the AMP into adenosine.
For example, adenosine is one of the components of the TME that most broadly affects immune response. It is produced by the sequential degradation of extracellular adenosine triphosphate (ATP) by the following two enzymes: first CD39, which degrades the ATP into adenosine monophosphate (AMP), and then second, CD73, which impairs the AMP into adenosine.
Similarly, in Europe, Sponsors are required to register and disclose certain clinical trial information on a single portal, CTIS (Clinical Trial Information System), replacing Eudra-CT, set up by the European Medicines Agency (EMA). CTIS is as single entry point centralizing information and databases on clinical trials in the EU.
Similarly, in Europe, Sponsors are required to register and disclose certain clinical trial information on a single portal, CTIS (Clinical Trial Information System), replacing Eudra-CT, set up by the European Medicines Agency (EMA). CTIS is a single entry point centralizing information and databases on clinical trials in the EU.
In parallel, bispecific killer cell engagers, or BiKEs, that engage CD16 receptors found on NK cells, and tri-specific killer cell engagers, or TriKEs, that engage CD16 receptors and contain IL-15, a cytokine that promotes NK cell activation and survival, have also been developed to target antigens expressed on solid tumors.
In parallel, bispecific killer cell engagers (BiKEs) that engage CD16 receptors found on NK cells, and tri-specific killer cell engagers (TriKEs) that engage CD16 receptors and contain IL-15, a cytokine that promotes NK cell activation and survival, have also been developed to target antigens expressed on solid tumors.
An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.
An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it 116 represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.
Regulations concerning marketing authorizations In order to be marketed, a drug product must have regulatory authorization (known as approval of a New Drug Application, or NDA, or a Biologics License Application, or BLA, in the United States, a Marketing Authorization Application, or 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 Application (MAA) in the European Union and a Great Britain Marketing Authorisation Application).
The review process and the Prescription Drug User Fee Act goal date may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.
The review process and the Prescription Drug User Fee Act goal date for an original application may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.
The 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is 128 sufficiently profitable not to justify maintenance of market exclusivity (Article 8).
The 10-year market exclusivity may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity (Article 8).
The key elements of its strategy include: 78 • Drive near-term value with Innate's wholly owned product candidate, lacutamab ◦ Execute the clinical development of its fully owned product candidate, lacutamab, for the treatment of patients with cutaneous T cell lymphoma (CTCL), namely Sézary syndrome and Mycosis Fungoides, or MF, and patients with peripheral T cell lymphoma (PTCL). • Advance its innovative R&D pipeline ◦ Expand its pipeline of proprietary product candidates that target novel pathways in immuno-oncology using its internal development engine. ◦ Drive the development of its proprietary portfolio, including the next generation asset NK cell engagers (NKCEs) through Innate's proprietary Antibody-based NK cell Engager Therapeutics (ANKET ® ) platform and continuing to explore Antibody Drug Conjugates (ADC) formats. • Build a sustainable business ◦ Maximize the value of its partnered product candidates under its various collaboration, licence and option agreements, under which the Company has the potential to be eligible to receive up to an aggregate of approximately $3.6 billion in future contingent payments, including up-front option exercise fees and payments upon the achievement of specified development and sales milestones. ◦ Invest in the ongoing clinical programs of monalizumab for the treatment of Non-small-cell lung carcinoma (NSCLC). ◦ Continue to explore opportunities to accelerate the development of Innate's proprietary pipeline programs through additional collaborations. ◦ Combine its disciplined business development strategy with its immuno-oncology research and development capabilities to further expand its product portfolio. ◦ Manage its resources carefully and implement the efficiency measures necessary to optimize its resources.
The key elements of its strategy include: • Drive near-term value with Innate's wholly owned product candidate, lacutamab ◦ Execute the clinical development of its fully owned product candidate, lacutamab, for the treatment of patients with cutaneous T cell lymphoma (CTCL), namely Sézary syndrome and Mycosis Fungoides (MF), and patients with peripheral T cell lymphoma (PTCL). • Advance its innovative R&D pipeline ◦ Expand its pipeline of proprietary product candidates that target novel pathways in immuno-oncology using its internal development engine. ◦ Drive the development of its proprietary portfolio, including the next generation asset NK cell engagers (NKCEs) through Innate's proprietary Antibody-based NK cell Engager Therapeutics (ANKET ® ) platform and continuing to explore Antibody Drug Conjugates (ADC) formats. • Build a sustainable business ◦ Maximize the value of its partnered product candidates under its various collaboration, license and option agreements, under which the Company has the potential to be eligible to receive up to an aggregate of approximately $3.6 billion in future contingent payments, including up-front option exercise fees and payments upon the achievement of specified development and sales milestones. ◦ Invest in the ongoing clinical programs of monalizumab for the treatment of non-small cell lung carcinoma (NSCLC). ◦ Continue to explore opportunities to accelerate the development of Innate's proprietary pipeline programs through additional collaborations. ◦ Combine its disciplined business development strategy with its immuno-oncology research and development capabilities to further expand its product portfolio. ◦ Manage its resources carefully and implement the efficiency measures necessary to optimize its resources.
The Company cannot be sure that patents will be granted with respect to any of its pending patent applications or to any patent applications filed by Innate in the future, nor can the Company be sure that any of its existing patents or any patents that may be granted to Innate in the future will be sufficient to protect its technology or will not be challenged, invalidated or circumvented.
The Company cannot be sure 112 that patents will be granted with respect to any of its pending patent applications or to any patent applications filed by Innate in the future, nor can the Company be sure that any of its existing patents or any patents that may be granted to Innate in the future will be sufficient to protect its technology or will not be challenged, invalidated or circumvented.
An IND is an exemption from the Federal Food, Drug, and Cosmetic Act, or FDCA, that allows an unapproved product candidate to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization to administer an investigational product to humans.
An IND is an exemption from the Federal Food, Drug, and Cosmetic Act (FDCA) that allows an unapproved product candidate to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization to administer an investigational product to humans.
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 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.
There are several approved agents for the treatment of CTCL: 84 • Bexarotene, approved by FDA in 1999, for use in patients with advanced stage of MF who are refractory to at least one prior systemic therapy • Vorinostat, approved by FDA in 2006 for the treatment of cutaneous manifestations of CTCL in patients with progressive, persistent, or recurrent disease on or following two systemic therapies • Denileukin diftitox (DD) approved by the FDA in 2008 for patients with resistant and recurrent CTCL • Romidepsin, approved by FDA in 2009 for patients with CTCL who have received at least one prior systemic therapy • Brentuximab vedotin (marketed as Adcetris), was approved by the FDA in 2017 for the treatment of patients with primary cutaneous anaplastic large cell lymphoma, or pcALCL, or CD30-expressing MF who have received prior systemic therapy.
There are several approved agents for the treatment of CTCL: • Bexarotene, approved by FDA in 1999, for use in patients with advanced stage of MF who are refractory to at least one prior systemic therapy; • Vorinostat, approved by FDA in 2006 for the treatment of cutaneous manifestations of CTCL in patients with progressive, persistent, or recurrent disease on or following two systemic therapies; • Denileukin diftitox (DD) approved by the FDA in 2008 for patients with resistant and recurrent CTCL; • Romidepsin, approved by FDA in 2009 for patients with CTCL who have received at least one prior systemic therapy; • Brentuximab vedotin (marketed as Adcetris), was approved by the FDA in 2017 for the treatment of patients with primary cutaneous anaplastic large cell lymphoma, or pcALCL, or CD30- 81 expressing MF who have received prior systemic therapy.
CD73 has been shown to be expressed by tumor cells as well as stromal cells, endothelial cells, B and T lymphocytes within the tumor microenvironment, and to play a significant role in promoting immunosuppression through the pathway degrading AMP into adenosine.
CD73 has been shown to be expressed by tumor cells as well as stromal cells, endothelial cells and B and T lymphocytes within the tumor microenvironment, and it has been shown to play a significant role in promoting immunosuppression through the pathway degrading AMP into adenosine.
Pharmaceutical firms who wish to market their medicinal drugs outside the European Union and the United States must submit marketing authorization application to the national authorities of the concerned countries, such as the Pharmaceutical and Medical Device Agency, or PMDA in Japan.
Pharmaceutical firms who wish to market their medicinal drugs outside the European Union and the United States must submit marketing authorization application to the national authorities of the concerned countries, such as the Pharmaceutical and Medical Device Agency (PMDA) in Japan.
All these statutes generally prohibit offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a government or a foreign government official or employees of public international organizations in order to influence official action, or otherwise obtain or retain business.
These statutes generally prohibit offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a government or a foreign government official or employees of public international organizations in order to influence official action, or otherwise obtain or retain business.
The four graphs show changes in tumor volume over time depending on the type of treatment group, which included a control group (black), an IPH5301 (mouse version) group (pink), an anti-mouse PD-1 group (blue) and an PD-1 and IPH5301 combination group (green).
The four graphs show changes in tumor volume over time depending on the type of treatment group, which included a control group (black), an IPH5301 100 (mouse version) group (pink), an anti-mouse PD-1 group (blue) and an PD-1 and IPH5301 combination group (green).
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. e.
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.
By leveraging its extensive experience in immuno-oncology research and development, the Company strives to continue to discover and develop a broad and diversified portfolio of first and best-in class immunotherapies across various therapeutic modalities.
By leveraging its extensive experience in immuno-oncology research and development, the Company strives to continue to discover and develop a broad and diversified portfolio 76 of first- and best-in-class immunotherapies across various therapeutic modalities.
If a product with orphan designation receives the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product will generally receive orphan drug exclusivity.
Regarding orphan drug exclusivity, if a product with orphan drug designation receives the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare disease or condition for which it was designated, the product will generally receive orphan drug exclusivity.
Some Phase 1b studies evaluate biomarkers or surrogate markers that may be associated with efficacy in patients with specific types of diseases. 122 • Phase 2: This Phase involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and appropriate dosage. • Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites.
Some Phase 1b studies evaluate biomarkers or surrogate markers that may be associated with efficacy in patients with specific types of diseases. • Phase 2: This Phase involves clinical trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and appropriate dosage. 117 • Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites.
For this reason, this pathway has attracted significant development efforts that have been focused primarily on the downstream part of the adenosine degradation cascade, CD73 and the adenosine receptors.
For this reason, this pathway has attracted 79 significant development efforts that have been focused primarily on the downstream part of the adenosine degradation cascade, CD73 and the adenosine receptors.
Data from this trial were presented at the 2018 meeting of the American Society of Hematology, and reported in Lancet Oncology in 2019 by Bagot et al.
Data from this trial were presented at the 2018 meeting of the American Society of Hematology ("ASH"), and reported in Lancet Oncology in 2019 by Bagot et al.
Furthermore, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically, there have been several recent U.S.
Furthermore, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. There have been several recent U.S.
Innate Pharma's preclinical data support its hypothesis that a monalizumab and durvalumab combination 90 therapy may result in a greater anti-tumor immune response than durvalumab alone by blocking both the PD-1/PD-L1 and the NKG2A/HLA-E inhibitory pathways. The following illustration depicts the way in which monalizumab, in combination with durvalumab, is designed to result in greater anti-tumor activity.
Innate Pharma's preclinical data support its hypothesis that a monalizumab and durvalumab 88 combination therapy may result in a greater anti-tumor immune response than durvalumab alone by blocking both the PD-1/PD-L1 and the NKG2A/HLA-E inhibitory pathways. The following illustration depicts the way in which monalizumab, in combination with durvalumab, is designed to result in greater anti-tumor activity.
Based on these results, a randomized Phase 3 trial, INTERLINK-1, had started to evaluate the combination monalizumab + cetuximab versus cetuximab + placebo in R/M SCCHN post platinum and post anti-PD-(L)1 patients. • Phase 2: Expansion cohort 3 As of August 1, 2021, 40 patients were enrolled in the cohort 3 evaluating monalizumab, cetuximab and durvalumab in first line treatment of R/M SCCHN.
Based on these results, a randomized Phase 3 trial, INTERLINK-1, was started to evaluate the combination monalizumab + cetuximab versus cetuximab + placebo in R/M SCCHN post platinum and post anti-PD-(L)1 patients. • Phase 2: Expansion cohort 3 As of August 1, 2021, 40 patients were enrolled in the cohort 3 evaluating monalizumab, cetuximab and durvalumab in first line treatment of R/M SCCHN.
The decision to terminate development of an investigational biological product may be made by either a health authority body such as the FDA, an IRB, or by Innate for various reasons. Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee.
The decision to suspend or terminate development of an investigational biological product may be made by either a health authority body such as the FDA, an IRB, or by Innate for various reasons. Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee (DSMB).
In a post-hoc analysis of seven patients with Sézary syndrome who were previously treated with mogamulizumab, three (43%) achieved a global overall response and three others 86 had stable disease as best response. The remaining patient had a progressive disease. The median duration of response in these patients was 13.8 months and median progression-free survival was 16.8 months.
In a post hoc analysis of seven patients with Sézary syndrome who were previously treated with mogamulizumab, three (43%) achieved a global overall response and three others had stable disease as best response. The remaining patient had a progressive 83 disease. The median duration of response in these patients was 13.8 months and median progression-free survival was 16.8 months.
In syngeneic tumor-bearing human CD39 knock-in mice, the Company observed that a mouse version of IPH5201 enhanced the antitumor effects of PD-L1 blockade. 99 CD39 is expressed in both squamous and adenocarcinoma subtypes of NSCLC with expression noted across disease stages (Anceriz, ESMO-IO 2022, Poster 190P, abstract 384).
In syngeneic tumor-bearing human CD39 knock-in mice, the Company observed that a mouse version of IPH5201 enhanced the antitumor effects of PD-L1 blockade. 95 CD39 is expressed in both squamous and adenocarcinoma subtypes of NSCLC with expression noted across disease stages (Anceriz, ESMO-IO 2022, Poster 190P, abstract 384).
The conduct of preclinical studies is subject to federal regulations and requirements, including Good Laboratory Practices (GLP) regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical studies, among other things, are submitted to the applicable regulatory agency in connection with the application to begin human testing.
The conduct of preclinical studies is subject to national regulations and requirements, including Good Laboratory Practices (GLP) regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical studies, among other things, are submitted to the applicable regulatory agency in connection with the application to begin human testing.
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 5‑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 (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).
The Clinical Trial Regulation allows better consistency throughout EU Member States: • Single submission of the clinical trial application dossier through the EU Clinical Trials Information System (Article 5) including a common part assessed jointly by all participating EU Member States, and a national part covering the ethical and operational aspects of the trial assessed by each EU Member State independently. • A clinical trial authorization issued in the form of a single decision.
The CTR allows better consistency throughout EU Member States: • Single submission of the clinical trial application dossier through the EU Clinical Trials Information System (Article 5) including a common part assessed jointly by all participating EU Member States, and a national part covering the ethical and operational aspects of the trial assessed by each EU Member State independently. • A clinical trial authorization issued in the form of a single decision.
Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to enforcement actions.
Certain 130 payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to enforcement actions.
Despite these successes, the breadth and durability of the clinical benefit achieved has been limited to a subset of patients and tumor types because of limited effect against solid tumors and toxicity. Its innovative approach to immuno-oncology aims to broaden and amplify anti-tumoral immune responses by leveraging both the adaptive and the innate immune systems.
Despite these successes, the breadth and durability of the clinical benefit achieved has been limited to a subset of patients and tumor types because of limited effect against solid tumors and toxicity. The Company's innovative approach to immuno-oncology aims to broaden and amplify anti-tumoral immune responses by leveraging both the adaptive and the innate immune systems.
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 GCP.
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.
Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the "individual mandate" was repealed by Congress. Thus the ACA will remain in effect in its current form. It is unclear how judicial and Congressional challenges and other efforts to repeal and replace the ACA will impact the ACA.
Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the "individual mandate" was repealed by Congress. Thus the ACA remains in effect in its current form. It is unclear how judicial and Congressional challenges and other efforts to repeal and replace the ACA will impact the ACA.
In the respective non-randomized clinical registration trials, the response rate to belinostat, pralatrexate and romidepsin were each less than 30%, and the median duration of response was approximately 10 months for belinostat and pralatrexate (O'Connor, 2015 ; O'Connor, 2011; Coiffier, 2012). None of these treatments have been approved by the EMA.
In the respective non-randomized clinical registration trials, the response rates to belinostat, pralatrexate and romidepsin were each less than 30%, and the median duration of response was approximately 10 months for belinostat and pralatrexate (O'Connor, 2015 ; O'Connor, 2011; Coiffier, 2012). None of these treatments have been approved by the EMA.
Finally, as shown in the figure below, in vivo, in a mouse tumor model engrafted in huCD39KI mice, moIPH5201 improved the anti-tumor efficacy of gemcitabine and anti-PD-L1 combination. The 3 graphs on the left (A) show the best tumor volume change in percentage, for each treated group in comparison to the control group.
Finally, as shown in the figure below, in vivo, in a mouse tumor model engrafted in huCD39KI mice, moIPH5201 improved the anti-tumor efficacy of gemcitabine and anti-PD-L1 combination. The three graphs on the left (A) show the best tumor volume change in percentage, for each treated group in comparison to the control group.
Although there are differences from one country to another, the development of therapeutic products for human use is subject to similar procedures and must comply with the same types of regulations in all ICH countries (countries part of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Although there are differences from one country to another, the development of therapeutic products for human use is subject to similar procedures and companies must comply with the same types of regulations in all ICH countries (countries that are part of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Orphan exclusivity does not block the approval of a different product for the same rare disease or condition, nor does it block the approval of the same product for different indications.
Orphan drug exclusivity does not block the approval of a different product for the same rare disease or condition, nor does it block the approval of the same product for different indications.
Partnership with AstraZeneca On April 24, 2015, the Company signed a co‑development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab. AstraZeneca obtained full oncology rights to monalizumab in October 2018. The financial terms of the agreement include potential cash payments of up to $1.225 billion to Innate Pharma.
Partnership with AstraZeneca On April 24, 2015, the Company signed a co‑development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab. AstraZeneca obtained full oncology rights to monalizumab in October 2018. The financial terms of the agreement include potential cash payments of up to $1.275 billion to Innate Pharma.
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, 2022, 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, 2023, the principal intellectual property rights related to monalizumab are in-licensed from Novo Nordisk A/S and include U.S.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

146 edited+61 added−55 removed88 unchanged
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 the research tax credits, as well as other grants.
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.
This increase is due to (i) a €3.0 million increase in other expenses related to the €1.3 million increase in non-scientific fees and the €1.0 million increase in scientific fees allocated to research and development, mainly explained by the increase in the use of external medical and regulatory experts, as well as (ii) the €1.2 million million increase in staff costs allocated to research and development.
This increase is due to (i) a €3.0 million increase in other expenses related to the €1.3 million increase in non-scientific fees and the €1.0 million increase in scientific fees allocated to research and development, mainly explained by the increase in the use of external medical and regulatory experts, as well as (ii) the €1.2 million increase in staff costs allocated to research and development.
During 2022 fourth quarter, the Company was informed by the sponsor of the Phase 2 clinical trial evaluating avdoralimab in inflammation in bullous pemphigoid ("BP") indication of its decision to stop said trial.
During the fourth quarter of 2022, the Company was informed by the sponsor of the Phase 2 clinical trial evaluating avdoralimab in inflammation in bullous pemphigoid ("BP") indication of its decision to stop said trial.
The actual value of the Company's assets, liabilities and shareholders’ equity as well as its income and expenses could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. See Note 2 to its consolidated financial statements appearing elsewhere in this Annual Report.
The actual value of the Company's assets, liabilities and shareholders’ equity, as well as its income and expenses, could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted. See Note 2 to the Company's consolidated financial statements appearing elsewhere in this Annual Report.
In August 2022, the Company has 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 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.
Cash flows from / (used in) financing activities The Company's net cash flows used in financing activities for the year ended December 31, 2022 decreased by €28.6 million to €1.8 million for year ended December 31, 2022 as compared to net cash flows from financing activities of €26.8 million for the year ended December 31, 2021.
Cash flows from / (used in) financing activities The Company's net cash flows used in financing activities for the year ended December 31, 2022 decreased by €28.6 million to €1.8 million as compared to net cash flows from financing activities of €26.8 million for the year ended December 31, 2021.
In January 2019, Innate Pharma paid to AstraZeneca an initial payment for the license related to Lumoxiti ($50.0 million, or €43.8 million, using the foreign exchange rate of 1.1422 at the date of payment), and in February 2019, Innate paid to Novo Nordisk A/S additional consideration relating to monalizumab ($15.0 million, or €13.1 million using the exchange of 1.1394 at the date of payment).
In January 2019, Innate Pharma paid to AstraZeneca an initial payment for the license related to Lumoxiti ($50.0 million, or €43.8 million, using the foreign exchange rate of 1.1422 at the date of payment), and in February 2019, Innate paid to Novo Nordisk A/S additional consideration relating to monalizumab ($15.0 million, or €13.1 million, using the exchange rate of 1.1394 at the date of payment).
Year ended December 31, 2021 2022 (in thousands) Revenue from collaboration and licensing agreements € 12,112 € 49,580 Government financing for research expenditures 12,591 8,035 Other income — 59 Revenue and other income 24,703 57,674 Research and development expenses (47,004) (51,663) General and administrative expenses (25,524) (22,436) Impairment of intangible assets — (41,000) Operating expenses (72,528) (115,099) Operating income (loss) (47,825) (57,425) Financial income 6,344 4,775 Financial expenses (3,997) (5,321) Net financial income (loss) 2,347 (546) Net income (loss) before tax (45,478) (57,972) Income tax expense — — Net income (loss) from continuing operations (45,478) (57,972) Net income (loss) from discontinued operations (7,331) (131) Net income (loss) € (52,809) € (58,103) 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, 2021 2022 (in thousands) Revenue from collaboration and licensing agreements € 12,112 € 49,580 Government financing for research expenditures 12,591 8,035 Sales — 59 Revenue and other income 24,703 57,674 Research and development expenses (47,004) (51,663) General and administrative expenses (25,524) (22,436) Impairment of intangible assets — (41,000) Operating expenses (72,528) (115,099) Operating income (loss) (47,825) (57,425) Financial income 6,344 4,775 Financial expenses (3,997) (5,321) Net financial income (loss) 2,347 (546) Net income (loss) before tax (45,478) (57,972) Income tax expense — — Net income (loss) from continuing operations (45,478) (57,972) Net income (loss) from discontinued operations (7,331) (131) Net income (loss) € (52,809) € (58,103) 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, 2021 2022 Research Tax Credit(1) € 10,310 € 7,925 Grant and other tax credit(2) 2,281 110 Government financing for research expenditures € 12,591 € 8,035 (1) As of December 31, 2022, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2022 financial year for an amount of €9.2 million from which is subtracted (ii) a provision amounting to €1.3 million following the tax inspection carried out in 2022 by the French tax authorities and relating to the 2019 and 2020 financial years as well as to the research tax credit and the accuracy of its calculation for the 2018 to 2018 financial years 2020.
Year ended December 31, 2021 2022 (in thousands) Research Tax Credit(1) € 10,310 € 7,925 Grant and other tax credit(2) € 2,281 € 110 Government financing for research expenditures € 12,591 € 8,035 (1) As of December 31, 2022, the amount is mainly composed of (i) the research tax credit calculated and recognized for the 2022 financial year for an amount of €9.2 million from which is subtracted (ii) a provision amounting to €1.3 million following the tax inspection carried out in 2022 by the French tax authorities and relating to the 2019 and 2020 financial years as well as to the research tax credit and the accuracy of its calculation for the 2018 to 2018 financial years 2020.
Year ended December 31, 2021 2022 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca € 7,497 € 22,376 of which IPH5201 agreement - AstraZeneca — 4,677 of which preclinical molecules agreement - AstraZeneca — 17,400 of which Sanofi agreement 3,000 4,000 of which other agreements — 353 Proceeds from collaboration and licensing agreements 10,497 48,806 Invoicing of research and development costs (IPH5201) 1,613 1,391 Exchange gains (loss) on collaboration agreements — (627) Others — 10 Revenue from collaboration and licensing agreements € 12,112 € 49,580 Proceeds related to monalizumab .
Year ended December 31, 2021 2022 (in thousands) Proceeds from collaboration and licensing agreements of which monalizumab agreement - AstraZeneca € 7,497 € 22,376 of which IPH5201 agreement - AstraZeneca — 4,677 of which preclinical molecules agreement - AstraZeneca — 17,400 of which Sanofi agreement 2016 3,000 4,000 of which other agreements — 353 Proceeds from collaboration and licensing agreements 10,497 48,806 Invoicing of research and development costs (IPH5201) 1,613 1,391 Exchange gains (loss) on collaboration agreements — (627) Others — 10 Revenue from collaboration and licensing agreements 12,112 € 49,580 Proceeds related to monalizumab .
Innate have 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 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 Pharma lost its status as a small or medium size business at the end of the year ended December 31, 2019 and, therefore, was no longer be entitled to the immediate reimbursement of the Research Tax Credit for the fiscal year ended 2019 and 2020 but instead will be reimbursed within the expiry of a three-year period.
Innate lost its status as a small or medium size business at the end of the year ended December 31, 2019 and, therefore, was no longer entitled to the immediate reimbursement of the research tax credit for the fiscal year ended 2019 and 2020 but instead will be reimbursed within the expiry of a three-year period.
Selling, general and administrative expenses also consist of fees for professional services, mainly related to audit, IT, accounting, recruitment and legal services, communication and travel costs, real-estate leasing costs, office furniture and equipment costs, allowance for amortization and depreciation, director’s attendance fees and insurance costs and overhead costs, such as postal and telecommunications expenses.
Selling, general and administrative expenses also 137 consist of fees for professional services, mainly related to audit, IT, accounting, recruitment and legal services, communication and travel costs, real-estate leasing costs, office furniture and equipment costs, allowance for amortization and depreciation, director’s attendance fees and insurance costs and overhead costs, such as postal and telecommunications expenses.
This additional payment has been treated as an increase of the collaboration commitment ("collaboration liabilities" in the consolidated statements of financial position) for an amount 149 of $36.0 million (€34.3 million) in connection to the Phase 3 study co-funding commitment made by the Company and notified to AstraZeneca in July 2019.
This additional payment has been treated as an increase of the collaboration commitment ("collaboration liabilities" in the consolidated statements of financial position) for an amount of $36.0 million (€34.3 million) in connection to the Phase 3 study co-funding commitment made by the Company and notified to AstraZeneca in July 2019.
The table below presents the components of our net financial result for the years ended December 31, 2021 and 2022: 151 Year ended December 31, 2021 2022 (in thousands) Interests and gains on financial assets € 327 € 546 Unrealized gains on financials assets 1,177 418 Foreign exchange gains 4,839 3,810 Other financial income — — Financial income 6,344 4,775 Foreign exchange losses (3,591) (2,983) Unrealized losses on financial assets (95) (2,050) Interest on financial liabilities (312) (288) Other financial expenses — — Financial expenses (3,997) (5,321) Net financial income (loss) € 2,347 € (546) For the years ended December 31, 2021 and 2022, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the U.S. dollar on U.S. dollar-denominated cash and cash equivalents, short-term investments and financial assets.
The table below presents the components of our net financial result for the years ended December 31, 2021 and 2022: 156 Year ended December 31, 2021 2022 (in thousands) Interests and gains on financial assets € 327 € 546 Unrealized gains on financials assets 1,177 418 Foreign exchange gains 4,839 3,810 Other financial income — — Financial income 6,344 4,775 Foreign exchange losses (3,591) (2,983) Unrealized losses on financial assets (95) (2,050) Interest on financial liabilities (312) (288) Other financial expenses — — Financial expenses (3,997) (5,321) Net financial income (loss) € 2,347 € (546) For the years ended December 31, 2021 and 2022, the foreign exchange gains and losses mainly result from the variance of the exchange rate between the Euro and the U.S. dollar on U.S. dollar-denominated cash and cash equivalents, short-term investments and financial assets.
Due to the listing of its ordinary shares on Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, the Company also prepares and publishes its consolidated financial statements in accordance with IFRS as adopted by the European Union, or EU.
Due to the listing of its ordinary shares on Euronext Paris and in accordance with the European Union’s regulation No. 1606/2002 of July 19, 2002, the Company also prepares and publishes its consolidated financial statements in accordance with IFRS as adopted by the European Union (EU).
The Company has concluded that the research tax credit meets the definition of a government grant as defined in IAS 20 Accounting for government grants and disclosure of government assistance, or IAS 20, and that the classification as “Revenue and other income” in its consolidated statement of income (loss) is appropriate.
The Company has concluded that the research tax credit meets the definition of a government grant as defined in IAS 20 Accounting for government grants and disclosure of government assistance (IAS 20), and that the classification as “Revenue and other income” in its consolidated statement of income (loss) is appropriate.
The Company has other license agreements pursuant to which has acquired intellectual property and under which the Company will be required to make payments to the counterparty upon the achievement of certain milestone events and commercial sales related to its product candidates.
The Company has other license agreements, pursuant to which it has acquired intellectual property and under which the Company will be required to make payments to the counterparty upon the achievement of certain milestone events and commercial sales related to its product candidates.
This increase is mainly explained by the increase of 1.7 million euros share-based payments expenses. As of December 31, 2022, the Company had 152 employees in research and development functions, compared to 148 as of December 31, 2021.
This increase is mainly explained by the increase of €1.7 million share-based payments expenses. As of December 31, 2022, the Company had 152 employees in research and development functions, compared to 148 as of December 31, 2021.
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, 2025. 167 C. Research and Development For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item 5.A—Operating Results.” D.
Innate acquired the rights of avdoralimab from Novo Nordisk A/S in 2017. The Company paid an upfront of €40.0 million, of which €37.2 million was contributed in new ordinary shares and €2.8 million in cash.
Innate acquired the rights of avdoralimab from Novo Nordisk A/S in 2017. The Company paid an upfront fee of €40.0 million, of which €37.2 million was contributed in new ordinary shares and €2.8 million in cash.
The company recognizes milestone payments when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the counterparty has no right to refund of the payment.
The Company recognizes milestone payments when the triggering event has occurred, there are no further contingencies or services to be provided with respect to that event, and the counterparty has no right to a refund of the payment.
As part of the Termination and Transition Agreement, Innate and AstraZeneca agreed to split these manufacturing costs, and Innate has paid $6.2 million (€5.5 million as of December 31, 2021) to AstraZeneca on April 30, 2022.
As part of the Termination and Transition Agreement, Innate and AstraZeneca agreed to split these manufacturing costs, and Innate paid $6.2 million (€5.5 million as of December 31, 2021) to AstraZeneca on April 30, 2022.
This increase was partially offset by payments made in 2022 to AstraZeneca related to the co-funding of the monalizumab program, including the Phase 3 INTERLINK-1 and PACIFIC-9 trials.
This increase was partially offset by 154 payments made in 2022 to AstraZeneca related to the co-funding of the monalizumab program, including the Phase 3 INTERLINK-1 and PACIFIC-9 trials.
This increase mainly results from (i) the collection of €47.7 million ($50.0 million) and €4,6 million ($5.0 million) in June 2022 and August 2022,respectively, under the monalizumab agreement and the amendment to the IPH5201 collaboration and option agreement, (ii) the collection of €3.0 million received from Sanofi under the 2016 agreement and following Sanofi's decision to advance IPH6401/SAR'514 into regulatory preclinical studies for an investigational new drug.
This increase mainly results from (i) the collection of €47.7 million ($50.0 million) and €4.9 million ($5.0 million) in June 2022 and August 2022,respectively, under the monalizumab agreement and the amendment to the IPH5201 collaboration and option agreement, (ii) the collection of €3.0 million received from Sanofi under the 2016 agreement and following Sanofi's decision to advance IPH6401/SAR'514 into regulatory preclinical studies for an investigational new drug.
The Company anticipate 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 license 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.
The Company anticipates that such expenses will increase substantially if and as the Company: • continues the research and development of its product candidates; • initiates clinical trials for, or additional preclinical development of, its product candidates; • further develops and refines the manufacturing processes for its product candidates; • changes or adds manufacturers or suppliers of biological materials; • seeks regulatory and marketing authorizations for any of its product candidates that successfully complete development; • seeks to identify and validate additional product candidates; • acquires or licenses other product candidates, technologies or biological materials; • makes milestone, royalty or other payments under any current or future license agreements; • obtains, maintains, protects and enforces its intellectual property portfolio; • secures manufacturing arrangements for commercial production; • seeks to attract and retain new and existing skilled personnel; • creates additional infrastructure to support its operations as a U.S. public company and incurs increased legal, accounting, investor relations and other expenses; and 133 • experiences delays or encounters issues with any of the above.
Until such time that the Company can generate significant revenues from sales of its product candidates, if approved, the Company expect to finance its operating activities through a combination of milestone payments received pursuant to its strategic alliances, equity offerings, debt financings, government or other third-party funding and collaborations, and licensing arrangements.
Until such time that the Company can generate significant revenues from sales of its product candidates, if approved, the Company expects to finance its operating activities through a combination of milestone payments received pursuant to its strategic alliances, equity offerings, debt financings, government or other third-party funding and collaborations, and licensing arrangements.
The remaining amount of $14.0 million (€13.4 million) has been treated as an increase of the transaction price, recognized in the income statement in 146 line with the progress of the Phase 1/2 studies. This increase in the transaction price generated a €12.6 million favorable cumulative adjustment in the revenue related to monalizumab agreements over the period.
The remaining amount of $14.0 million (€13.4 million) has 151 been treated as an increase of the transaction price, recognized in the income statement in line with the progress of the Phase 1/2 studies. This increase in the transaction price generated a €12.6 million favorable cumulative adjustment in the revenue related to monalizumab agreements over the period.
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, 2020 , 2021 and 2022 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, 2021 , 2022 and 2023 have been prepared in accordance with IFRS as issued by the IASB.
Because of the numerous risks and uncertainties associated with product development and 140 regulatory approval, the Company is unable to predict the amount, timing or whether will be able to obtain product revenue. Government financing for research expenditures The Company's government financing for research expenditures consists of research tax credits (crédit d’impôt recherche ) and grants.
Because of the numerous risks and uncertainties associated with product development and regulatory approval, the Company is unable to predict the amount, timing or whether it will be able to obtain product revenue. Government financing for research expenditures The Company's government financing for research expenditures consists of research tax credits (crédit d’impôt recherche ) and grants.
During this grace period, the Company will only be liable for the payment of interest and the guarantee fees, with amortization of the two loans starting in 2024 over a period of four years. The state guarantee fees amounts to €877 thousand and €379 thousand for Société Générale and BNP Paribas loans respectively.
During this grace period, the Company will only be liable for the payment of interest and the guarantee fees, with amortization of the two loans starting in 2024 over a period of four years. The state guarantee fees amount to €877 thousand and €379 thousand for Société Générale and BNP Paribas loans respectively.
Research and development activities are central to Innate's business. As product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, the Company expect that its research and development costs will increase in the foreseeable future.
Research and development activities are central to Innate's business. As product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, the Company expects that its research and development costs will increase in the foreseeable future.
The Company anticipates that will need to raise additional funding, prior to completing clinical development of any of its product candidates.
The Company anticipates that it will need to raise additional funding, prior to completing clinical development of any of its product candidates.
Innate Pharma leases some of its computer equipment under operating lease agreements. 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, 2020 , 2021 and 2022 primarily related to laboratory equipment.
Innate Pharma leases some of its computer equipment under operating lease agreements. 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, 2021 , 2022 and 2023 primarily related to laboratory equipment.
Since its inception, Innate has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of Innate's ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of the Company's initial public offering of its ordinary shares on Nasdaq New-York in 2019.
Since its inception, Innate has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of Innate's ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of the Company's initial public offering of its ordinary shares on Nasdaq in 2019.
This increase of €22.8m mainly results from the additional payment of $50.0 million (€47.7 million) made by AstraZeneca in June 2022 and triggered by the treatment of the first patient in a second Phase 3 trial “PACIFIC-9” evaluating monalizumab in April 2022.
This increase of €22.8 million mainly results from the additional payment of $50.0 million (€47.7 million) made by AstraZeneca in June 2022 and triggered by the treatment of the first patient in a second Phase 3 trial “PACIFIC-9” evaluating monalizumab in April 2022.
Any change in these assumptions could 162 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.
Any change in these assumptions could 159 lead to the recognition of an impairment charge that could have a significant impact on the Company's consolidated financial statements. In case of failure of the clinical trials in progress, the Company may have to fully depreciate the intangible asset.
Revenue and other income from continuing operations increased by €33.0 million, to €57.7 million for the year ended December 31, 2022, as compared to revenue and other income of €24.7 million for the year ended December 31, 2021. 145 Year ended December 31, 2021 2022 (in thousands) Revenue from collaboration and licensing agreements € 12,112 € 49,580 Government financing for research expenditures 12,591 8,035 Other income — 59 Revenue and other income € 24,703 € 57,674 Revenue from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations increased by €37.5 million, to €49.6 million for the year ended December 31, 2022, as compared to revenue from collaboration and licensing agreements of €12.1 million for the year ended December 31, 2021.
Revenue and other income from continuing operations increased by €33.0 million, to €57.7 million for the year ended December 31, 2022, as compared to revenue and other income of €24.7 million for the year ended December 31, 2021. 150 Year ended December 31, 2021 2022 (in thousands) Revenue from collaboration and licensing agreements € 12,112 € 49,580 Government financing for research expenditures 12,591 8,035 Other income — 59 Revenue and other income € 24,703 € 57,674 Revenues from collaboration and licensing agreements Revenue from collaboration and licensing agreements from continuing operations increased by €37.5 million, to €49.6 million for the year ended December 31, 2022, as compared to revenue from collaboration and licensing agreements of €12.1 million for the year ended December 31, 2021.
As a reminder, Innate has received a total of cash of €306.4 million 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.
As a reminder, Innate has received a total of €306.4 million in cash from capital increases, before deducting the costs associated with capital increases, and after excluding proceeds from share 162 compensation instruments, between 1999 and December 31, 2019.
Innate Pharma has also financed its operations since its inception through several rounds of public and private financings.
Innate has also financed its operations since its inception through several rounds of public and private financings.
This provision is based on estimated amounts and adjustments not disputed by the 147 Company.The table below details government funding for research expenditures for the years ended December 31, 2021 and 2022.
This provision is based on estimated amounts and adjustments not disputed by the 152 Company.The table below details government funding for research expenditures for the years ended December 31, 2021 and 2022.
Consequently, the Company decided in December 2022 to stop the development of avdoralimab in bullous pemphigoid ("BP") indication in inflammation, only indication supporting the recoverable amount of the asset as of December 31, 2021 (as well that as of June 30, 2022).
Consequently, the Company decided in December 2022 to stop the development of avdoralimab in BP indication in inflammation, only indication supporting the recoverable amount of the asset as of December 31, 2021 (as well that as of June 30, 2022).
Therefore, the 139 Company audited consolidated financial statements for the years ended December 31, 2020 , 2021 and 2022 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, 2021 , 2022 and 2023 are compliant with both IFRS as issued by the IASB and IFRS as adopted by the EU. The preparation of financial statements in accordance with IFRS requires the Company to make significant judgments and estimates which are presented below.
When the research tax credit is not deductible from taxes payable by us, it is generally reimbursed by the French government three years after the fiscal year for which it is determined.
When the research tax credit is not deductible from taxes payable by the Company, it is generally reimbursed by the French government three years after the fiscal year for which it is determined.
The Company cannot determine with certainty the duration and total costs of its future clinical trials of its product candidates or if, when, or to what extent Innate will generate revenues from the commercialization and sale of any of our product candidates, or those of our collaborators, that might obtain regulatory approval.
The Company cannot determine with certainty the duration and total costs of its future clinical trials of its product candidates or if, when, or to what extent it will generate revenues from the commercialization and sale of any of its product candidates, or those of its collaborators, that might obtain regulatory approval.
Funding requirements Innate Pharma believes that its existing cash, cash equivalents, short-term investments and non-current financial assets, will enable Innate to fund its operations for the next twelve months. Innate has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than it currently expects.
Funding requirements Innate Pharma believes that its existing cash, cash equivalents, short-term investments and non-current financial assets, will enable it to fund its operations for at least the next 12 months. Innate has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than it currently expects.
Substantially all of its net losses has resulted from costs incurred in connection with its research and development programs and from selling, general and administrative expenses associated with its operations.
Substantially all of its net losses have resulted from costs incurred in connection with its research and development programs and from selling, general and administrative expenses associated with its operations.
General and administrative expenses represented a total of 30.3% and 35.2% of our total operating expenses for the years ended December 31, 2022 and 2021, respectively.
General and administrative expenses represented a total of 30.3% and 35.2% of our total operating expenses before impairment for the years ended December 31, 2022 and 2021, respectively.
Research and development expenses represented a total of 69.7% and 64.8% of operating expenses for years ended December 31, 2022 and December 31, 2021, respectively.
Research and development expenses represented a total of 69.7% and 64.8% of operating expenses before impairment for years ended December 31, 2022 and December 31, 2021, respectively.
All the standards published by the IASB that are mandatorily applicable in the years ended December 2020 , 2021 and 2022 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 2021 , 2022 and 2023 are endorsed by the EU and are mandatorily applicable in the EU.
Clinical research and development costs are not capitalized until marketing authorizations are obtained. 170 Innate Pharma's corporate office in Luminy, Marseille, France is leased under a finance lease agreement signed in 2008 with Sogebail, a subsidiary of Société Générale, for an aggregate of €6.6 million. The lease-financing agreement has a 12-year term.
Clinical research and development costs are not capitalized until marketing authorizations are obtained. Innate's corporate office in Luminy, Marseille, France is leased under a finance lease agreement signed in 2008 with Sogebail, a subsidiary of Société Générale, for an aggregate amount of €6.6 million. The lease-financing agreement has a 12-year term.
This increase is mainly related to the payment to AstraZeneca of €5.9 million in April 2022 under the termination and transition agreement for Lumoxiti. 167 Cash flows from / (used in) investing activities The Company's net cash flows from investing activities for the year ended December 31, 2022 amounted to €1.9 million and are mainly composed of a disposal of a non-current financial instrument which generated a net cash collection of €2.9 million partially offset by acquisitions of property, plant and equipment and intangible assets for €1.1 million.
This increase is mainly related to the payment to AstraZeneca of €5.9 million in April 2022 under the Termination and Transition Agreement. 165 Cash flows from / (used in) investing activities The Company's net cash flows from investing activities for the year ended December 31, 2022 amounted to €1.9 million and are mainly composed of a disposal of a non-current financial instrument which generated a net cash collection of €3.0 million partially offset by acquisitions of property, plant and equipment and intangible assets for €1.1 million.
Research and development expenses relating to Lumoxiti discontinued operations amounted to €0.6 million and nil for the years ended December 31, December 31, 2021 and 2022, respectively. (2) Selling, general and administrative expenses. Selling, general and administrative expenses relating to Lumoxiti discontinued operations amounted to €8.5 million and €0.3 million for the years ended December 31, 2021 and 2022, respectively.
Research and development expenses relating to Lumoxiti discontinued operations amounted to €0.6 million and nil for the years ended December 31, December 31, 2021 and 2022, respectively. (2) Selling, general and administrative expenses .
These collections are partially offset by the €5.9 million payment to AstraZeneca on April 20, 2022 persuant to the Lumoxiti termination and transition agreement and cash outflows related to the Company's operating activities .
These collections are partially offset by the €5.9 million payment to AstraZeneca on April 20, 2022 pursuant to the Termination and Transition Agreement and cash outflows related to the Company's operating activities .
If the carrying amount of any asset is above its recoverable amount, the Company recognize an impairment loss to reduce the carrying amount to the recoverable amount.
If the carrying amount of any asset is above its recoverable amount, the Company recognizes an impairment loss to reduce the carrying amount to the recoverable amount.
Government financing for research expenditures Government funding for research expenditures decreased by €4.6 million, or 9%, to €8.0 million for the year ended December 31, 2022, as compared to €12.6 million for the year ended December 31, 2021.
Government financing for research expenditures Government funding for research expenditures decreased by €4.6 million, or 36.2%, to €8.0 million for the year ended December 31, 2022, as compared to €12.6 million for the year ended December 31, 2021.
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 rents by €692 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 the Company continue advancing its product candidates through research and development programs, the Company expect to continue to incur significant expenses and may again incur operating losses in future periods.
As the Company continues advancing its product candidates through research and development programs, the Company expects to continue to incur significant expenses and may again incur operating losses in future periods.
For the 2021 and 2022 financial year, the Company met again the criteria of an SME according to the criteria of the European Union. As a result, the Company was eligible for the early repayment by the French treasury of the 2021 Research Tax Credit during the fiscal year 2022.
The 2019 tax credit was refunded on February 2023. For the 2021 and 2022 financial year, the Company again met the criteria of an SME according to the criteria of the European Union. As a result, the Company was eligible for the early repayment by the French treasury of the 2021 research tax credit during the fiscal year 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. 156 Operating expenses The table below presents our operating expenses from continuing operations for the years ended December 31, 2021 and 2020.
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.
Since its inception, the Company has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of its ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of our ordinary shares on Euronext and ADS on Nasdaq New-York in 2019.
Since its inception, the Company has raised a total of €311.4 million through the sale of equity securities, including €33.7 million in the initial public offering of its ordinary shares on Euronext Paris in 2006 and €66.0 million in the initial public offering of our ordinary shares on Euronext and ADS on The Nasdaq Global Select Market, or Nasdaq, in 2019.
As of December 31, 2022, impairment of intanglible assets consisted to 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 followingdecision taken by sponsor to stop the Phase 2 clinical trial in said indication during the 2022 fourth semester. 144 A.
As of December 31, 2022, impairment of intangible assets consisted of the full depreciation of avdoralimab rights for an amount of €41.0 million, following the Company's decision to stop avdoralimab development in bullous phemphigoid ("BP") indication in inflammation following a decision taken by a sponsor to stop the Phase 2 clinical trial in said indication during the fourth quarter of 2022. 138 A.
The Company also use its employee and infrastructure resources across multiple research and development programs, and do not track these indirect expenses on a program-by-program basis. Research and development costs are expensed as incurred.
The Company also uses its employee and infrastructure resources across multiple research and development programs, and does not track these indirect expenses on a program-by-program basis. 136 Research and development costs are expensed as incurred.
For example, if the FDA, the European Medicines Agency, or EMA, or another regulatory authority were to require Innate to conduct preclinical studies and clinical trials beyond those that currently anticipate will be required for the completion of clinical development, or if the Company experience significant delays in enrollment in any clinical trials, the Company could be required to spend significant additional financial resources and time on the completion of clinical development.
For example, if the FDA, the EMA or another regulatory authority were to require Innate to conduct preclinical studies and clinical trials beyond those that it currently anticipates will be required for the completion of clinical development, or if the Company experiences significant delays in enrollment in any clinical trials, the Company could be required to spend significant additional financial resources and time on the completion of clinical development.
The main characteristics of the research tax credit are: • the research tax credit results in a cash inflow to us, i.e., it is used to offset the payment of corporate income tax the year after the date of its record as a tax credit in the income statement, or is paid directly to us from the tax authorities for the portion that remains unused, in principle three years after the fiscal year for which it is determined; • The Company's corporate income tax liability does not limit the amount of the research tax credit—if the Company does not pay any corporate income tax, the Company can offset the remaining research tax credit the year following its record in the income statement; and • the research tax credit is not included in the determination of the corporate income tax.
The main characteristics of the research tax credit are: • the research tax credit results in a cash inflow to the Company, i.e., it is used to offset the payment of corporate income tax the year after the date of its record as a tax credit in the income statement, or is paid directly to the Company from the tax authorities for the portion that remains unused, in principle, three years after the fiscal year for which it is determined; • The Company's corporate income tax liability does not limit the amount of the research tax credit.
As of December 31, 2022, given the significant progress of the work to be performed (94.5%) and the level of budget consumption, the impact of accounting estimates is no longer a determining factor in the calculation of revenue related to the monalizumab agreement.
As of December 31, 2023, given the significant progress of the work to be performed (98.1%) and the level of budget consumption, the impact of accounting estimates is no longer a determining factor in the calculation of revenue related to the monalizumab agreement.
In addition, Innate has received an aggregate of €90.9 million in research tax credits through December 31, 2022. As a French biopharmaceutical company, Innate Pharma has benefited from certain tax advantages, including, for example, the research tax credit.
In addition, Innate has received an aggregate of €100.1 million in research tax credits through December 31, 2023. As a French biopharmaceutical company, Innate Pharma has benefited from certain tax advantages, including, for example, the research tax credit.
Until Innate can generate a sufficient amount of revenue from sale of approved products, if ever, it expects to finance its operating activities through its existing liquidity and expected milestone payments from collaborators. 169 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; • 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 relating to its other product candidates.
Innate's present and future funding requirements will depend on many factors, including, among other things: • the size, progress, timing and completion of its clinical trials and preclinical studies for any current or future product candidates, including its lead product candidates, monalizumab and lacutamab; • the number of potential new product candidates Innate identifies and decides to develop; • costs associated with its payment obligations to third parties in connection with its development and potential commercialization of certain of its product candidates; • costs associated with expanding its organization; • the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims of infringement raised by third parties; 166 • the time and costs involved in obtaining regulatory approval for its product candidates and any delays the Company may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates; • the amount of revenues, if any, Innate Pharma may derive either directly, or in the form of milestone or royalty payments from any future potential partnership agreements, from monalizumab, IPH5201, IPH6101/SAR443579, IPH6401/SAR'514, B7H3 or other target or relating to its other product candidates.
Since its inception, the Company has devoted substantially all of its financial resources to research and development efforts, including conducting preclinical studies and clinical trials of its product candidates, providing general and administrative support for its operations and protecting its intellectual property. The Company marketed product, Lumoxiti, was approved by the U.S.
Since its inception, the Company has devoted substantially all of its financial resources to research and development efforts, including conducting preclinical studies and clinical trials of its product candidates, providing general and administrative support for its operations and protecting its intellectual property.
(2) Selling, general and administrative expenses. Selling, general and administrative expenses relating to Lumoxiti discontinued operations amounted to €8.5 million and €12.3 million for the years ended December 31, 2020 and 2021, respectively.
Selling, general and administrative expenses relating to Lumoxiti discontinued operations amounted to €8.5 million and €0.3 million for the years ended December 31, 2021 and 2022, respectively.
Sources and uses of liquidity As of December 31, 2022, The Company has primarily financed its operations through its receipt of $601.4 million (€528.0 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, 2023, the Company has primarily financed its operations through its receipt of $635.4 million (€560.1 million) in payments from its collaborators, including AstraZeneca and Sanofi, since 2011, excluding payments received for purchases of Innate's equity securities by its collaborators.
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, 2020 , 2021 and 2022 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. 137 Overview Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients.
Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly in sections titled “Item 3.D – Risk Factors” and “Special Note Regarding Forward-Looking Statements.” The Company audited consolidated financial statements as of and for the years ended December 31, 2021 , 2022 and 2023 have been prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including the United States.
As a consequence, net result from discontinued operations relating to Lumoxiti represents a net loss of €7.3 million as compared to a net loss €0.1 million for the years ended December 31, 2021 and 2022, respectively, presented as follows : 152 Year ended December 31, 2021 2022 Revenue and other income (in thousands) Revenue from collaboration and licensing agreements € 926 € 194 Sales 874 22 Total revenue and other income 1,800 216 Research and development expenses (1) (624) — Selling, general and administrative expenses (2) (8,507) (346) Total operating expenses (9,131) (346) Net income (loss) from distribution agreements — — Impairment of intangible assets (3) — Operating income (loss) (7,331) (131) Financial income — — Financial expenses — — Net financial income (loss) — — Net income (loss) before tax (7,331) (131) Income tax expense — — Net income (loss) from discontinued operations (7,331) (131) (1) Research and development expenses.
As a consequence, the Lumoxiti activity (including sales) is presented in the consolidated income statement and the notes to the consolidated financial statements as a discontinued operation for the 2021 financial year in accordance with IFRS5 "non-current assets held for sale and discontinued operations." As a consequence, net result from discontinued operations relating to Lumoxiti represents a net loss of €7.3 million as compared to a net loss €0.1 million for the years ended December 31, 2021 and 2022, respectively, presented as follows: 157 Year ended December 31, 2021 2022 Revenue and other income (in thousands) Revenue from collaboration and licensing agreements 926 € 194 Sales 874 22 Total revenue and other income 1,800 216 Research and development expenses (1) (624) — Selling, general and administrative expenses (2) (8,507) (346) Total operating expenses (9,131) (346) Net income (loss) from distribution agreements — — Impairment of intangible assets — — Operating income (loss) (7,331) (131) Financial income — — Financial expenses — — Net financial income (loss) — — Net income (loss) before tax (7,331) (131) Income tax expense — — Net income (loss) from discontinued operations (7,331) (131) (1) Research and development expenses .
Under the Termination and Transition Agreement, Innate and AstraZeneca delivered a notice to the FDA requesting that the U.S. marketing authorization be transferred back to AstraZeneca as from October 1, 2021. AstraZeneca has reimbursed Innate for all Lumoxiti related costs, expenses and benefited net sales.
Under the Termination and Transition Agreement, Innate and AstraZeneca delivered a notice to the FDA requesting that the U.S. marketing authorization be transferred back to AstraZeneca as from October 1, 2021. AstraZeneca has reimbursed Innate for all Lumoxiti related costs, expenses and benefited net sales. As of December 31, 2023, this transfer has now been completed.
Year ended December 31, 2021 2022 (in thousands) Lacutamab € (14,834) € (12,473) Monalizumab (1,913) (1,224) Avdoralimab (3,330) (385) IPH5201 (558) (1,648) IPH5301 — (625) Sub-total programs in clinical development (20,635) (16,355) Sub-total programs in preclinical development (6,089) (11,129) Total direct research and development expenses (26,724) (27,484) Personnel expenses (including share-based payments) (15,208) (16,373) Depreciation and amortization (3,153) (2,928) Other expenses (1,918) (4,877) Personnel and other expenses (20,279) (24,178) Total research and development expenses € (47,004) € (51,663) Research and development expenses from continuing operations increased by €4.7 million, or 9.9%, to €51.7 million for the year ended December 31, 2022, as compared to research and development of €47.0 million for the year ended December 31, 2021.
Year ended December 31, 2021 2022 (in thousands) Research and development € (47,004) € (51,663) Selling, general and administrative (25,524) (22,436) Total operating expenses € (72,528) € (115,099) 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, 2021 and 2022. 153 Year ended December 31, 2021 2022 (in thousands) Lacutamab € (14,834) € (12,473) Monalizumab (1,913) (1,224) Avdoralimab (3,330) (385) IPH5201 (558) (1,648) IPH5301 — (625) Sub-total programs in clinical development (20,635) (16,355) Sub-total programs in preclinical development (6,089) (11,129) Total direct research and development expenses (26,724) (27,484) Personnel expenses (including share-based payments) (15,208) (16,373) Depreciation and amortization (3,153) (2,928) Other expenses (1,918) (4,877) Personnel and other expenses (20,279) (24,178) Total research and development expenses € (47,004) € (51,663) Research and development expenses from continuing operations increased by €4.7 million, or 9.9%, to €51.7 million for the year ended December 31, 2022, as compared to research and development of €47.0 million for the year ended December 31, 2021.
The table below summarizes the main capital increases between 1999 and December 31, 2022 : Date Gross Proceeds April 2000 € 1.2 million March 2001 3.3 million July 2002 20.0 million March 2004 5.0 million July 2004 10.0 million March 2006 10.0 million November 2006 33.7 million December 2009 24.3 million November 2013 20.3 million June 2014 50.0 million October 2018 62.6 million October 2019 66.0 million Total € 306.4 million 166 Cash flows Comparisons for the year ended December 31, 2021 and 2022 The following table sets forth cash flow data for the years ended December 31, 2021 and 2022: Year ended December 31, 2021 2022 (in thousands) Cash flows from / (used in) operating activities € (58,457) € (19,154) Cash flows from / (used in) investing activities (917) 1,877 Cash flows from / (used in) financing activities 26,818 (1,828) Effect of the exchange rate changes (483) (428) Net increase / (decrease) in cash and cash equivalents € (33,037) € (19,531) Cash flows from / (used in) operating activities The Company's net cash flow used in operating activities decreased by €39.3 million to €19.2 million for the year ended December 31, 2022 as compared to net cash flows used in operating activities of €58.5 million for the year ended December 31, 2021.
The table below summarizes the main capital increases between 1999 and December 31, 2023 : Date Gross Proceeds April 2000 € 1.2 million March 2001 3.3 million July 2002 20.0 million March 2004 5.0 million July 2004 10.0 million March 2006 10.0 million November 2006 33.7 million December 2009 24.3 million November 2013 20.3 million June 2014 50.0 million October 2018 62.6 million October 2019 66.0 million Total € 306.4 million Cash flows Comparisons for the year ended December 31, 2022 and 2023 The following table sets forth cash flow data for the years ended December 31, 2022 and 2023: Year ended December 31, 2022 2023 (in thousands) Cash flows from / (used in) operating activities € (19,155) € (32,558) Cash flows from / (used in) investing activities 1,877 20,631 Cash flows from / (used in) financing activities (1,828) (1,966) Effect of the exchange rate changes (428) 274 Net increase / (decrease) in cash and cash equivalents € (19,532) € (13,619) Cash flows from / (used in) operating activities The Company's net cash flow used in operating activities decreased by €13.4 million to €32.6 million for the year ended December 31, 2023 as compared to net cash flows used in operating activities of €19.2 million for the year ended December 31, 2022.
Further Innate's decision to terminate the Lumoxiti Agreement in December 2020, a Termination and Transition Agreement was negotiated and executed, effective as of June 30, 2021 terminating the Lumoxiti Agreement as well as Lumoxiti related agreements (including the supply agreement, the quality agreement and other related agreements) and transferring the U.S. marketing authorization and distribution rights of Lumoxiti back to AstraZeneca.
As a result of Innate's decision to terminate the agreement entered into with AstraZeneca in October 2018 and relating to the license of Lumoxiti (the "Lumoxiti Agreement") in December 2020, a termination and transition agreement was negotiated and executed, effective as of June 30, 2021 terminating the Lumoxiti Agreement as well as Lumoxiti related agreements (including the supply agreement, the quality agreement and other related agreements) and transferring the U.S. marketing authorization and distribution rights of Lumoxiti back to AstraZeneca, or the Termination and Transition Agreement.
As a result, the Company considers that there are no longer any critical estimates in line with intangible assets in 2022. There are therefore no longer any critical assumptions that could call into question the recoverable amount of the asset. B.
As a result, the Company considers that there are no longer any critical estimates in line with intangible assets since 2022. Without any new event to be considered since then, there are therefore no longer any critical assumptions that could call into question the recoverable amount of the asset. B.
As of December 31, 2022, given the Company's decision in December 2022 to discontinue the development of avdoralimab in the indication of bullous pemphigoid supporting the recoverable amount of the asset as of December 31, 2021 and June 30, 2022, the rights related to the intangible asset have been fully impaired for the net carrying amount of the intangible asset, of €41,000 thousand , without using the historical assumptions described above (see note 6).
As of December 31, 2022, given the Company's decision in December 2022 to discontinue the development of avdoralimab in the indication of BP supporting the recoverable amount of the asset as of December 31, 2021 and June 30, 2022, the rights related to the intangible asset have been fully impaired for the net carrying amount of the intangible asset, of €41,000 thousand, without using the historical assumptions described above (see Note 6 to the Company's consolidated financial statements which are included elsewhere in this Annual Report).
The Company has incurred net losses in each year since our inception except for the years ended December 31, 2016 and 2018. The Company net income (loss) was €(64.0) million, €(52.8) million and 138 €(58.1) million for the years ended December 31, 2020 , 2021 and 2022, 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 €(52.8) million, €(58.1) million and €(7.6) million for the years ended December 31, 2021 , 2022 and 2023, respectively.

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Item 6. [Reserved]

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

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If 100% of the basic target objectives are achieved, 100% of the corresponding bonus is paid. If 100% of the targets are not achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the targets.
If 100% of the basic target objectives are achieved, 100% of the corresponding bonus is paid. If not 100% of the targets are achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the targets.
Free Preferred Shares (AGAP) Free preferred shares, or 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 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.
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. The Company's Supervisory Board has determined that Dr. Bennett, Dr. Staatz-Granzer and Ms.
From May 2022, the members of the Audit Committee as of the date of this Annual Report are Pascale Boissel, Irina Staatz-Granzer and Sally Bennett. Ms. Boissel is the Chairman of the Audit Committee. The Company's Supervisory Board has determined that Dr. Bennett, Dr. Staatz-Granzer and Ms.
Beltraminelli served as Chief Technical Officer at Lysogene, where he led the CMC activities for two late-stage assets. Prior to Lysogene, he held senior level positions at HiFiBiO Therapeutics and BliNK 175 Biomedical SAS. At HiFiBiO, Dr. Beltraminelli led the R&D activities of the company’s French site, as well as its global CMC efforts, bringing three projects to the clinic.
Beltraminelli served as Chief Technical Officer at Lysogene, where he led the CMC activities for two late-stage assets. Prior to Lysogene, he held senior level positions at HiFiBiO Therapeutics and BliNK Biomedical SAS. At HiFiBiO, Dr. Beltraminelli led the R&D activities of the company’s French site, as well as its global CMC efforts, bringing three projects to the clinic. Dr.
There is no quorum requirement under French law when an ordinary general meeting or an extraordinary general meeting is reconvened where shareholders are voting on a capital increase by capitalization of reserves, profits or share premium, but the reconvened meeting may consider only questions that were on the agenda of the adjourned meeting.
There is no 192 quorum requirement under French law when an ordinary general meeting or an extraordinary general meeting is reconvened where shareholders are voting on a capital increase by capitalization of reserves, profits or share premium, but the reconvened meeting may consider only questions that were on the agenda of the adjourned meeting.
In addition to the ex-post vote described above, French law also requires that the compensation policy for the members of the Executive and Supervisory Board for the year ending December 31, 2023 is subject to the approval at the ordinary general meeting relating to the year ending December 31, 2022.
In addition to the ex-post vote described above, French law also requires that the compensation policy for the members of the Executive and Supervisory Board for the year ending December 31, 2023 is subject to the approval at the ordinary general meeting relating to the year ending December 31, 2023.
He is a member of the European Union Committee of Experts of Rare Disease, the European Commission’s Scientific Panel for Health (SPH) and served as a Faculty Coordinator for Sarcoma for the European Society of Medical Oncology (ESMO) between 2012 and 2016.
He is a member of the European Union Committee of Experts of Rare Disease, the European Commission’s Scientific Panel for Health (SPH) and served as a Faculty Coordinator for Sarcoma for the European Society of Medical Oncology (ESMO) between 2012 and 2016. Prof.
Trained as a medical oncologist with a PhD from the University Claude Bernard in Lyon (France), his research activities have been focused on the role of immune effector cells and cytokines in cancer. Prof.
Blay trained as a medical oncologist with a PhD from the University Claude Bernard in Lyon (France); his research activities have been focused on the role of immune effector cells and cytokines in cancer. Prof.
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 Executive Committee); • reviewing the compensation of the members of the Executive Board and the Executive Committee, 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 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.
Compensation of Members of the Executive and Supervisory Boards Following the entry into force of the Sapin 2 Law (French law no. 2016-1691 of December 9, 2016), the Ordonnance no. 2019-1234 dated November 27, 2019 and the Decree no. 2019-1235 dated November 27, 2019, the payment of any variable or exceptional compensation attributed for a financial year to the Chairman of the Supervisory Board, the Chairman of the Executive Board and members of the Executive Board, is subject to approval at the next ordinary general meeting (ex-post vote).
Compensation of Members of the Executive and Supervisory Boards Following the entry into force of the Sapin 2 Law (French law no. 2016-1691 of December 9, 2016), the Ordonnance no. 2019-1234 dated November 27, 2019 and the Decree no. 2019-1235 dated November 27, 2019, the payment of any variable or exceptional compensation attributed for a financial year to the Chairman of the Supervisory Board, the Chairman of the Executive Board and members of the Leadership Team, is subject to approval at the next ordinary general meeting ( ex-post vote).
Consistent with French Law, its bylaws provide that when first convened, general meetings of shareholders may validly convene only if the shareholders present or represented hold at least (1) 20% of the voting shares in the case of an ordinary general meeting or of an extraordinary general meeting where shareholders are voting on a capital increase by capitalization of reserves, profits or share premium, or (2) 25% of the voting shares in the case of any other extraordinary general meeting.
Consistent with French Law, the Company's bylaws provide that when first convened, general meetings of shareholders may validly convene only if the shareholders present or represented hold at least (1) 20% of the voting shares in the case of an ordinary general meeting or of an extraordinary general meeting where shareholders are voting on a capital increase by capitalization of reserves, profits or share premium, or (2) 25% of the voting shares in the case of any other extraordinary general meeting.
Prior to HealthCor, she spent ten years as a senior analyst at ING Financial Markets and then at Piper Jaffray. Dr Bennett serves as an Independent Non-Executive Director at BerGenBio, a publicly traded European biopharmaceutical company, where she Chairs the Audit Committee and is also an Advisory Board member of the P4 Precision Medicine Accelerator Programme in the UK.
Prior to HealthCor, she spent 10 years as a senior analyst at ING Financial Markets and then at Piper Jaffray. Dr. Bennett serves as an Independent Non-Executive Director at BerGenBio, a publicly traded European biopharmaceutical company, where she Chairs the Audit Committee and is also an Advisory Board member of the P4 Precision Medicine Accelerator Programme in the UK.
However, French law allows sociétés anonymes to contract for and maintain liability insurance against civil liabilities incurred by members of Executive and Supervisory 183 Boards involved in a third-party action, provided that they acted in good faith and within their capacities as members of such board of the company.
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.
Innate's Supervisory Board has specifically assigned the following duties to the audit committee: • legal control of the half-year and annual accounts; • evaluating internal control practices, risk analysis; • supervising the creation of the financial statements published by us; • assessing accounting methods; and 192 • selecting statutory auditors, negotiating their fees, reviewing of their conclusions and reviewing their independence.
Innate's Supervisory Board has specifically assigned the following duties to the Audit Committee: • legal control of the half-year and annual accounts; • evaluating internal control practices, risk analysis; • supervising the creation of the financial statements published by us; 188 • assessing accounting methods; and • selecting statutory auditors, negotiating their fees, reviewing of their conclusions and reviewing their independence.
In addition, Nasdaq rules require that a listed company specify that the quorum for any meeting of the holders of share capital be at least 33 1/3% of the outstanding shares of the company’s ordinary voting 196 shares. The Company intends to follow its French home country practice, rather than complying with this Nasdaq rule.
In addition, Nasdaq Listing Rules require that a listed company specify that the quorum for any meeting of the holders of share capital be at least 33 1/3% of the outstanding shares of the company’s ordinary voting shares. The Company intends to follow its French home country practice, rather than complying with this Nasdaq Listing Rule.
Claire de Saint-Blanquat has nearly 20 years of experience in diverse legal positions in the pharmaceutical industry. Admitted to the Paris Bar in 1998, she started her career at Clifford Chance and then held senior positions, notably at Teva, Servier and Biogaran, where she was Legal and Compliance Director since 2016.
Ms. de Saint-Blanquat has nearly 20 years of experience in diverse legal positions in the pharmaceutical industry. Admitted to the Paris Bar in 1998, she started her career at Clifford Chance and then held senior positions, notably at Teva, Servier and Biogaran, where she was Legal and Compliance Director since 2016.
Chabernaud founded Créer la Vitalité, which helps companies and organizations in the development of health innovations and prevention. Véronique Chabernaud graduated in 2017 from the Institut Français des Administrateurs and Sciences Po Paris with a Certificate in Corporate Directorship and has been involved in this program since 2017. Dr.
Chabernaud founded " Créer la Vitalité ", which helps companies and organizations in the development of health innovations and prevention. Dr. Chabernaud graduated in 2017 from the Institut Français des Administrateurs and Sciences Po Paris with a Certificate in Corporate Directorship and has been involved in this program since 2017. Dr.
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) BSAs, which have historically only been granted to independent members of the Supervisory Board and consultants, (ii) 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 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.
The Company can then, subject to a time period for notifying the holders that will permit them to exercise their BSAAR, decide to purchase the unexercised BSAAR at a unit price equal to the BSAAR acquisition price initially paid by its holder. Innate's redeemable share warrants cannot be sold.
The Company can then, subject to a time period for notifying the holders that will permit them to exercise their BSAAR, decide to purchase the unexercised BSAAR at a unit price equal to the BSAAR acquisition price initially paid by their holders. Innate's redeemable share warrants cannot be sold.
Boisse 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 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.
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 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.
His clinical practice is dedicated to early Phase clinical trials of cancer immunotherapies at the Gustave Roussy Cancer Center where he 194 also leads a translational research laboratory dedicated to cancer immunology & immunotherapies (INSERM U1015 & CIC1428). He is a full professor of Clinical Immunology at the University of Paris Saclay.
His clinical practice is dedicated to early Phase clinical trials of cancer immunotherapies at the Gustave Roussy Cancer Center where he also leads a translational research laboratory dedicated to cancer immunology & immunotherapies (INSERM U1015 & CIC1428). He is a full professor of Clinical Immunology at the University of Paris Saclay. Prof.
She is a member of the Institute of Directors (IoD) and has been awarded the CertIoD qualification. Dr Bennett received a BSc in Anatomical Sciences and a Medical Degree, awarded with Honours, both from the University of Manchester. She is a British citizen.
She is a member of the Institute of Directors (IoD) and has been awarded the CertIoD qualification. Dr. Bennett received a BSc in Anatomical Sciences and a Medical Degree, awarded with honors, both from the University of Manchester. She is a British citizen.
He trained in internal medicine at BCM and completed a medical oncology fellowship in the Department of Neoplastic Diseases, Mount Sinai Hospital, New York. He spent the next twelve years in the Biologics Evaluation Section (BES), Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program of the National Cancer Institute, and was Head of the BES from 1994-1999.
He trained in internal medicine at BCM and completed a fellowship in medical oncology in the Department of Neoplastic Diseases at Mount Sinai Hospital, New York. He spent the next twelve years in the Biologics Evaluation Section (BES), Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program of the National Cancer Institute, and was BES Chief from 1994 to 1999.
Pascale Boissel are independent within the meaning of the applicable listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act. The Supervisory Board has further determined that Ms.
Boissel are independent within the meaning of the applicable Nasdaq listing rules and the independence requirements contemplated by Rule 10A-3 under the Exchange Act. The Supervisory Board has further determined that Ms.
The Company has granted BSA to Supervisory Board members and certain consultants of the Company. The Company's share warrants 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 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 compensation of members of the Executive Board is decided by the Supervisory Board upon recommendation by the compensation and nomination committee. The compensation of Dr. Mahjoubi, the Chairman of the Executive Board, is paid under his social mandate, whereas the compensation of Dr. Morel is paid under his employment contract.
The compensation of members of the Executive Board is decided by the Supervisory Board upon recommendation by the Compensation and Nomination Committee. The compensation of Dr. Mahjoubi, as Chairman of the Executive Board, is paid under his social mandate ( mandat social ), whereas the compensation of Dr. Morel is paid under his employment contract.
Between 2009 and 2012 he held the position of President of the European Organisation for Research and Treatment of Cancer (EORTC). Prof. Blay currently holds various other university and hospital positions.
Between 2009 and 2012 he held the position of President of the European Organization for Research and Treatment of Cancer (EORTC). Prof. Blay currently holds various other university and hospital positions.
Before, she was Chief Financial Officer of ENYO Pharma. Pascale was the Deputy-Chief Executive Officer and Administrative and Financial Director of the BIOASTER Institute (IRT) in the field of infectious diseases and microbiology. In 2009, Madame Boissel joined Ipsogen a listed company developing and marketing molecular diagnostic products as Chief Financial Officer.
Before, she was Chief Financial Officer of ENYO Pharma. Ms. Boissel was the Deputy-Chief Executive Officer and Administrative and Financial Director of the BIOASTER Institute (IRT) in the field of infectious diseases and microbiology. In 2009, Ms. Boissel joined Ipsogen a listed company developing and marketing molecular diagnostic products as Chief Financial Officer. Ms.
Under Rule 10A-3, if the laws of a foreign private issuer’s home country require that any such matter be approved by the board of directors or the shareholders of the Company, the audit committee’s responsibilities or powers with respect to such matter may instead be advisory.
Under Rule 10A-3, if the laws of a foreign private issuer’s home country require that any such matter be approved by our Supervisory Board or the shareholders of the Company, the Audit Committee’s responsibilities or powers with respect to such matter may instead be advisory.
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 Executive Committee and other key employees.
Compensation and Nomination Committee Innate's Compensation and Nomination Committee assists the Supervisory Board in reviewing and making recommendations to the Supervisory Board with respect to the appointment and the compensation of the members of the Executive Board, Supervisory Board and Leadership Team and other key employees.
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. 193 CSR Committee The Supervisory Board of 14 September 2022, on the recommendation of the Remuneration and Nomination Committee of 12 September 2022, decided to set up a CSR Committee.
Innate Pharma's Supervisory Board has specifically assigned the following duties to the Transactions Committee: • to analyze the fundamentals of the products and/or companies targeted by us, the feasibility of targeted acquisitions; and • to participate in the selection of investment bankers and/or consultants. 189 CSR Committee The Supervisory Board of September 14, 2022, on the recommendation of the Compensation and Nomination Committee of September 12, 2022, decided to set up a CSR Committee.
Eric Vivier, the Senior Vice President, Chief Scientific Officer, is a permanent guest to the meetings of the Executive Committee. Corporate Governance Practices As a French société anonyme , the Company is subject to various corporate governance requirements under French law. The Company is a “foreign private issuer” under the U.S. federal securities laws and the Nasdaq listing rules.
Eric Vivier, the Senior Vice President, Chief Scientific Officer, is a permanent guest to the meetings of the Leadership Team. Corporate Governance Practices As a French société anonyme , the Company is subject to various corporate governance requirements under French law. The Company is a “foreign private issuer” under the U.S. federal securities laws and the Nasdaq listing rules.
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 Executive Committee, Vice President, Legal and Corporate Affairs and Secretary of the Supervisory Board, joined Innate Pharma in October 2020 and was appointed to the executive committee 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 , 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.
Irina Staatz-Granzer, Ph.D ., Vice Chairman and member of the Supervisory Board, has served on the Supervisory Board of the Company since 2009. Dr.
Irina Staatz-Granzer, Ph.D ., Vice Chairman and member of the Supervisory Board, has served on the Supervisory Board of the Company since June 23, 2009. Dr.
Staatz-Granzer has held business development positions at Hermal (subsidiary of Merck KGaA), Boots Healthcare International, Knoll (BASF Pharma, later Abbott) and as CEO of Scil Technology Gmbh, CEO of U3 Pharma AG and CEO of Blink Biomedical SAS. Ms. Staatz-Granzer also serves as Chairman of PLCD (German Pharma Licensing Club).
Staatz-Granzer has held business development positions at Hermal (subsidiary of Merck KGaA), Boots Healthcare International, Knoll (BASF Pharma, later Abbott) and as Chief Executive Officer of Scil Technology Gmbh, Chief Executive Officer of U3 Pharma AG and Chief Executive Officer of Blink Biomedical SAS. Ms. Staatz-Granzer also serves as Chairman of PLCD (German Pharma Licensing Club).
Laurent holds a PhD in Physical Sciences from the Institut National Polytechnique of Toulouse and a Master of Business Administration in Human Resources from the Institut d’Administration des Entreprises of Toulouse (France). Frederic Lombard , Member of the Executive Committee, Chief Financial Officer, joined Innate Pharma in April 2021. Mr.
Laurent holds a PhD in Physical Sciences from the Institut National Polytechnique of Toulouse and a Master of Business Administration in Human Resources from the Institut d’Administration des Entreprises of Toulouse (France). Frederic Lombard , member of the Leadership Team, Chief Financial Officer, joined Innate Pharma in April 2021. Mr.
She spent 15 years in senior roles as both a public and private investor at HealthCor, a US based global healthcare and life science investment manager and most recently co-led the firms move into private investing. She is now acting as a Senior Advisor to Catalio Capital in conjunction with its acquisition of HealthCor 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. She is now acting as a Senior Advisor to Catalio Capital in conjunction with its acquisition of HealthCor Management.
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 of these individuals 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 any Executive or Supervisory Board member in any action or proceeding arising out of his or her actions in that capacity.
Transactions Committee Innate's transactions committee assists the Supervisory Board in examining the business and corporate development opportunities available to us, which may include the acquisition of rights to products or the acquisition of other companies as well as out-licensing opportunities. The members of this committee are Irina Staatz-Granzer, Hervé Brailly, Bpifrance Participations and Gilles Brisson. Currently, Dr.
Transactions Committee Innate's Transactions Committee assists the Supervisory Board in examining the business and corporate development opportunities available to us, which may include the acquisition of rights to products or the acquisition of other companies as well as out-licensing opportunities. As of December 31, 2023, the members of this committee are Irina Staatz-Granzer, Hervé Brailly, Bpifrance Participations and Gilles Brisson.
Laurent has spent most of her career at Sanofi-Aventis where from 2005 she was successively in charge of the Multi-site and European Human Resources Department of the ‘Matures Products and OTC’ business unit, and later of the Supply-Chain business unit worldwide. Ms.
Laurent has spent most of her career at Sanofi-Aventis where from 2005 she was successively in charge of the Multi-site and European Human Resources Department of the "Matures Products and OTC" business unit, and later of the Supply-Chain business unit worldwide. Ms.
If 100% of the targets are not achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the targets. In case of outperformance for the year 2022, it may be decided to increase the amount of the bonus beyond 100% up to a limit of 150% on other predefined criteria.
If not 100% of the targets is achieved, the percentage of the bonus paid is proportional to the percentage of achievement of the targets. In case of outperformance for the year 2023, it may be decided to increase the amount of the bonus beyond 100% up to a limit of 150% based on other predefined criteria.
None of those events have occurred yet. The Company's BSA have an exercise period of 10 years – BSA not exercised after that time lapse and are automatically cancelled.
None of those events have occurred yet. The Company's BSA have an exercise period of 10 years – BSA not exercised after that time lapse and are automatically cancelled. The Company's BSA cannot be sold.
In the event of certain changes in its share capital structure, such as a consolidation or share split or dividend, French law and applicable grant documentation provides for appropriate adjustments of the numbers of ordinary shares issuable and/or the exercise price of the outstanding warrants.
In the event of certain changes in its share capital structure, such as a consolidation or share split or dividend, French law and applicable issuance agreement provides for appropriate adjustments of the numbers of ordinary shares issuable and/or the exercise price of the outstanding warrants.
The 2017 AGAP are not convertible since the performance criteria were not met. 190 The following table shows the AGAPs outstanding as of December 31, 2022: Plan title AGAP Management 2016-1 AGAP Management 2016-2 AGAP Employees 2016-1 General assembly meeting date June 2, 2016 June 2, 2016 June 2, 2016 Date of grant October 21, 2016 December 30, 2016 October 21, 2016 Number of AGAP granted 2,000 3,000 2,486 Maximum number of ordinary shares into which each AGAP can be converted 130 111 130 Number of AGAP lapsed during the vesting period 450 — 105 Number of AGAP vested 1,550 3,000 2,381 Number of AGAP lapsed during the lock up period 100 — 146 Number of outstanding AGAP 1,200 3,000 2,068 C.
The 2017 AGAP are not convertible since the performance criteria were not met. 186 The following table shows the AGAPs outstanding as of December 31, 2023: Plan title AGAP Management 2016-1 AGAP Management 2016-2 AGAP Employees 2016-1 Shareholder general meeting date June 2, 2016 June 2, 2016 June 2, 2016 Date of grant October 21, 2016 December 30, 2016 October 21, 2016 Number of AGAP granted 2,000 3,000 2,486 Maximum number of ordinary shares into which each AGAP can be converted 130 111 130 Number of AGAP lapsed during the vesting period 450 — 105 Number of vested AGAP 1,550 3,000 2,381 Number of lapsed AGAP during the lock up period 100 — 146 Number of outstanding AGAP 1,200 3,000 2,063 C.
Blay is a member of various scientific societies and academic expert groups, has been awarded several honors and is the author of more than 200 publications over the last three years. Gilles Brisson , member of the Supervisory Board, has served on the Supervisory Board of the Co since 2007 and was the Chairman until December 30, 2016. Mr.
Blay is a member of various scientific societies and academic expert groups, has been awarded several honors and is the author of more than 200 publications over the last three years. Gilles Brisson , member of the Supervisory Board, has served on the Supervisory Board of the Company since June 26, 2007 and was the Chairman until December 30, 2016.
Board Diversity Matrix Board Diversity Matrix (As of December 31, 2022) Country of Principal Executive Offices: France Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law Yes 191 Total Number of Directors 8 Female Male Non-Binary Did Not Disclose Gender Part I : Gender Identity Directors - - - - Part II : Demographic Background Underrepresented Individual in Home Country Jurisdiction - LGBTQ+ - Did Not Disclose Demographic Background - Supervisory Board Committees The Supervisory Board has established an audit committee, a compensation and nomination committee, a Corporate and Social Responsibility Committee and a transactions committee, which operate pursuant to rules of procedure adopted by the Supervisory Board.
Board Diversity Matrix Board Diversity Matrix Country of Principal Executive Offices: France 187 Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law Yes As of December 31, 2022 As of December 31, 2023 Total Number of Members 8 8 Gender Identity Female Male Non-Binary Did Not Disclose Gender Members - - - - Demographic Background Underrepresented Individual in Home Country Jurisdiction - - LGBTQ+ - - Did Not Disclose Demographic Background - - Supervisory Board Committees The Supervisory Board has established an Audit Committee, a Compensation and Nomination Committee, a Corporate and Social Responsibility Committee and a Transactions Committee, which operate pursuant to rules of procedure adopted by the Supervisory Board.
He is Chairman of the Board of Directors of NH Theraguix (oncology, Grenoble) and member of the Board of Directors of Deinove (microbiology, Montpellier). Mr. Brailly graduated from the Ecole des Mines de Paris (1983, France) and he holds a PhD in immunology with a specialty in immune-pharmacology.
He is Chairman of the Board of Directors of NH Theraguix (oncology, Grenoble). Mr. Brailly graduated from the Ecole des Mines de Paris (1983, France) and he holds a PhD in immunology with a specialty in immune-pharmacology.
The main duties of the CSR Committee are to: • make recommendations on the CSR policy and its implementation by the Company; • examine the content of the non-financial information; • review the Company's CSR publications; and • determine the CSR criteria for the annual and multi-annual variable remuneration of the members of the Management Board and the Executive Committee.
The main duties of the CSR Committee are to: • make recommendations on the CSR policy and its implementation by the Company; • examine the content of the non-financial information; • review the Company's CSR publications; and • determine the CSR criteria for the annual and multi-annual variable remuneration.
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 the right to 130 ordinary shares.
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.
The Strategic Advisory Board is comprised of Sebastian Amigorena, Aurélien Marabelle, Ruslan Medzhitov, Miriam Merad, Tanguy Seiwert and Mario Sznol. Dr. Merad is the Chairman of the Strategic Advisory Board. Sebastian Amigorena, Ph.D ., is “Directeur de Recherche de Classe Exceptionnelle” at the Centre National de la Recherche Scientifique.
The Strategic Advisory Board is comprised of Sebastian Amigorena, Aurélien Marabelle, Ruslan Medzhitov, Miriam Merad, Tanguy Seiwert and Mario Sznol. Dr. Merad is the Chairman of the Strategic Advisory Board. Sebastian Amigorena, Ph.D ., is “ Directeur de Recherche de Classe Exceptionnelle ” at the Centre National de la Recherche Scientifique .
Nicolas Beltraminelli, PhD , Member of the Executive Committee, Vice President, Chief Development Officer, joined Innate Pharma as Vice President and Chief Development Officer in January 2022. Dr. Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Dr.
Nicola Beltraminelli, PhD , member of the Leadership Team, Vice President, Chief Development Officer, joined Innate Pharma as Vice President and Chief Development Officer in January 2022. Dr. Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Dr.
The payments of the below variable compensations, for the year ended December 31, 2022, will be submitted for approval to the ordinary and extraordinary shareholder meeting to be held on May 12, 2023.
The payments of the below variable compensations, for the year ended December 31, 2023, will be submitted for approval to the ordinary and extraordinary shareholder meeting to be held on May 23, 2024.
Pascale Boissel, member of the Supervisory Board, is, with more than 30 years of financial experience, an expert in finance, audit, transactions, internal control, growth management and restructuring operations. Her experience has been represented in a variety of industries, including: food and beverage (Danone), building materials (Lafarge Holcim), education and, for more than 10 years now, healthcare and biotechnology.
She is, with more than 30 years of financial experience, an expert in finance, audit, transactions, internal control, growth management and restructuring operations. Her experience has been represented in a variety of industries, including: food and beverage (Danone), building materials (Lafarge Holcim), education and, for more than 10 years now, healthcare and biotechnology.
The compensation of members of the Executive Board includes the following components: • Fixed Compensation. The members of the Executive Board receive fixed compensation pursuant to their employment agreement or, in the case of the Chairman, his social mandate. • Annual Variable Compensation.
The compensation of members of the Executive Board includes the following components: • Fixed Compensation. The members of the Executive Board receive a fixed compensation pursuant to their employment agreements or, in the case of the Chairman, his social mandate ( mandat social ). • Annual Variable Compensation.
Staatz-Granzer is an independent member and Chairman of the transactions committee.
Currently, Dr. Staatz-Granzer is an independent member and Chairman of the Transactions Committee.
Dr. Beltraminelli holds a PhD in Molecular Biology from the University of Lausanne, Switzerland. Eric Vivier, D.V.M., Ph.D ., Permanent guest to the Executive Committee, Senior Vice President, Chief Scientific Officer, joined Innate in that role in 2018.
Beltraminelli holds a PhD in Molecular Biology from the University of Lausanne, Switzerland. Eric Vivier, D.V.M., Ph.D ., permanent guest to the Leadership Team, Senior Vice President, Chief Scientific Officer, joined Innate in that role in 2018. Prof.
Mahjoubi during the year ended December 31, 2022: Type of Compensation Amount of Compensation Description Fixed Compensation €470,000 Gross fixed compensation pursuant to Dr. Mahjoubi’s social mandate. Annual Variable Compensation—Cash €141,000 This amount represents 50% of Dr. Mahjoubi’s annual variable compensation, based on his achievement of 100%% of the annual objectives. Dr.
Mahjoubi during the year ended on December 31, 2023: Type of Compensation Amount of Compensation Description Fixed Compensation €470,000 Gross fixed compensation pursuant to Dr. Mahjoubi’s social mandate ( mandat social ). Annual Variable Compensation—Cash €282,000 This amount represents Dr. Mahjoubi’s annual variable compensation, based on his achievement of 100% of the annual objectives.
At its general meeting of shareholders held on May 20, 2022, 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 177 and a variable portion based on attendance at meetings of the Supervisory Board and its committees.
At its general meeting of shareholders held on May 12, 2023, shareholders set the total attendance fees to be distributed among the members of the Supervisory Board at €300,000. The attendance fees consist of a fixed portion 175 and a variable portion based on attendance at meetings of the Supervisory Board and its committees.
He founded Innate Pharma in 1999 and led the Company from 1999 to 2016 as Chief Executive Officer and Chairman of the Executive Board before being appointed Chairman of the Supervisory Board in 2017. Mr. Brailly is also the acting CEO and co-founder of Kalsiom (immunology, Brest), and co-founded MI-MAbs SAS (immuno-technology, Marseille) in 2020 and Systol Dynamics (cardiology, Marseille).
As a biotech entrepreneur, he founded Innate Pharma in 1999 and led the Company from 1999 to 2016 as Chief Executive Officer and Chairman of the Executive Board. Mr. Brailly is also the acting CEO and co-founder of Kalsiom (immunology, Brest), and co-founded MI-MAbs SAS (immuno-technology, Marseille) in 2020 and Systol Dynamics (cardiology, Marseille).
Morel during the year ended December 31, 2022: 181 Type of Compensation Amount of Compensation Description Fixed Compensation €252,000 Gross fixed compensation pursuant to Dr. Morel’s employment contract. Annual Variable Compensation— Cash €50,400 This amount represents 50% of Dr. Morel’s annual variable compensation, based on his achievement of 100.00% of the annual objectives . Dr.
Morel during the year ended on December 31, 2023: Type of Compensation Amount of Compensation Description Fixed Compensation €252,000 Gross fixed compensation pursuant to Dr. Morel’s employment contract. Annual Variable Compensation—Cash €100,800 This amount represents Dr. Morel’s annual variable compensation, based on his achievement of 100% of the annual objectives .
During his career, he has been involved in the governance of several public and academic bodies in the field of higher education, research and technology transfer. He is currently Chairman of the School of Engineering of Aix-Marseille University (AMU, France). He is also a member of the Board of Directors of Deinove SA.
During his career, he has been involved in the governance of several public and academic bodies in the field of higher education, research and technology transfer. He is currently Chairman of the School of Engineering of Aix-Marseille University (AMU, France).
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 members of the Executive Board, Supervisory Board, or other executive offers of the Company. B. Compensation.
Arrangements with existing Major Shareholders and Customers There are no arrangements with major shareholders, customers, suppliers or others, pursuant to which any person referred to above was selected as member of the Executive Board, the Supervisory Board, or of the Leadership Team of the Company. 174 B. Compensation.
Executive Committee The Company also has an Executive Committee 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 members with significant experience in strategy, financial management, medical research, research and development project management, the negotiation of industrial and commercial agreements in the field of innovative companies, including biotechnology 191 companies, compliance and regulations and in business development.
Odile Belzunce joined Innate Pharma in February 2005. She was Quality Manager during 10 years before becoming Head of Compliance. 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.
She was Quality Manager for 10 years before becoming Head of Compliance. During her career at Innate, Ms. Belzunce contributed to the structuration of the processes as the Company was growing, developing its portfolio and its activities. Ms. Belzunce currently holds the position of VP, Compliance and Operations.
The last allocation in 2015 of BSAARs no longer continue 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 grant documents.
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.
Jean-Yves Blay, Ph.D ., member of the Supervisory Board, has held the post of General Director of the Centre Léon Bérard in Lyon, France, since 2014 and renewed in 2019. He became President of Unicancer 173 in 2019. He is President of the French Sarcoma Group and Director of the European Reference Network for Rare Adult Cancers (EURACAN).
He has held the post of General Director of the Centre Léon Bérard in Lyon, France, since 2014 and renewed in 2019. He became President of Unicancer in 2019. He is President of the French Sarcoma Group and Director of the European Reference Network for Rare Adult Cancers (EURACAN).
In case of outperformance for the year 2022, it may be decided to increase the amount of the bonus beyond 100% up to a limit of 150% on other predefined criteria. The outperformance targets may only be reached if 100% of the baseline targets are reached.
In case of outperformance for the year 2024, the amount of the bonus may be increased beyond 100% up to a limit of 150% based on other predefined criteria. The outperformance targets may only be reached if 100% of the baseline targets are reached.
Board Practices Supervisory Board The Supervisory Board is made up of a minimum of three members and a maximum of eighteen. The members of the Supervisory Board are appointed for a renewable term of two years at the general meeting of shareholders.
Board Practices Supervisory Board The Supervisory Board is made up of a minimum of three members and a maximum of eighteen. The members of the Supervisory Board are appointed for a renewable term of two years at the general meeting of shareholders, which may revoke their appointments at any time.
Henry Wheeler has over 15 years’ experience across the pharmaceutical and financial industries. Henry Wheeler joined from AstraZeneca, where he led investor relations for the company’s oncology portfolio, having previously served within AstraZeneca’s Oncology Business Unit. Prior to this, Henry Wheeler worked in various healthcare financial roles including at Third Bridge and Morgan Stanley in London.
Wheeler joined from AstraZeneca, where he led investor relations for the company’s oncology portfolio, having previously served within AstraZeneca’s Oncology Business Unit. 173 Prior to this, Mr. Wheeler worked in various healthcare financial roles, including at Third Bridge and Morgan Stanley in London. Mr.
In accordance with operating rules adopted by the Supervisory Board, the nomination and compensation committee is composed of at least two members appointed by the Supervisory Board. Following the Supervisory Board on May 20, 2022, the members of the committee are Pascale Boissel, Hervé Brailly, Véronique Chabernaud and Dr. Jean-Yves Blay.
In accordance with operating rules adopted by the Supervisory Board, the Compensation and Nomination Committee is composed of at least two members appointed by the Supervisory Board. As of December 31, 2023, the members of the committee are Pascale Boissel, Hervé Brailly, Véronique Chabernaud and Jean-Yves Blay.
The Company's share warrants cannot be sold. 185 The following table shows the BSA outstanding as of December 31, 2022: Plan title BSA 2013 BSA 2014 BSA 2015-1 BSA 2015-2 BSA 2017 General assembly meeting date June 28, 2013 March 27, 2014 April 27, 2015 April 27, 2015 June 2, 2016 Date of grant July 17, 2013 July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 Total number of BSA authorized 300,000 150,000 150,000 150,000 150,000 Total number of BSA granted 237,500 150,000 70,000 14,200 37,000 Start date of the exercise period July 17, 2013 July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 End date of the exercise period July 17, 2023 July 16, 2024 April 26, 2025 June 30, 2025 September 20, 2027 Exercise price per BSA/share €2.36 €8.65 €9.59 €14.05 €11 Number of BSA exercised as of December 31, 2022 191,140 75,000 — — — BSA cancelled or lapsed as of June 30, 2022 — — — — — BSA remaining as of December 31, 2022 46,360 75,000 70,000 14,200 37,000 Redeemable Share Warrants (BSAAR) Redeemable share warrants, or BSAAR, are identical to the share warrants of BSA (including the one-for-one exercise ratio, its potential adjustment for certain modifications of the share capital and the exercise period of 10 years), except for the following features: • the BSAAR are initially purchased by the beneficiary at their fair value, as determined by an expert, and • the BSAAR plans include a “forcing” clause making it possible to encourage holders to exercise their BSAAR when the market price exceeds the exercise price and reaches a threshold defined in the BSAAR plan.
The following table shows the BSA outstanding as of December 31, 2023: Plan title BSA 2014 BSA 2015-1 BSA 2015-2 BSA 2017 BSA 2022 BSA 2023 Shareholder general meeting date March 27, 2014 April 27, 2015 April 27, 2015 June 2, 2016 May 20, 2022 May 12, 2023 Date of issue July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 October 3, 2022 October 19, 2023 Total number of BSA authorized 150,000 150,000 150,000 150,000 50,000 70,000 Total number of BSA issued 150,000 70,000 14,200 37,000 8,260 38,000 Start date of the exercise period July 16, 2014 April 27, 2015 July 1, 2015 September 20, 2017 October 3, 2024 October 19, 2025 End date of the exercise period July 16, 2024 April 26, 2025 June 30, 2025 September 20, 2027 October 3, 2032 October 19, 2033 Exercise price per BSA/share €8.65 €9.59 €14.05 €11 €2.31 €2.26 Number of BSA exercised as of December 31, 2023 75,000 — — — — — BSA cancelled or lapsed as of December 31, 2023 — — — — — — BSA remaining as of December 31, 2023 75,000 70,000 14,200 37,000 8,260 38,000 Redeemable Share Warrants (BSAAR) Redeemable share warrants, or BSAAR, are identical to the share warrants of BSA (including the one-for-one exercise ratio, its potential adjustment for certain modifications of the share capital and the exercise period of 10 years), except for the following features: • the BSAAR are initially purchased by the beneficiary at their fair value, as determined by an expert, and 183 • the BSAAR plans include a “forcing” clause making it possible to encourage holders to exercise their BSAAR when the market price exceeds the exercise price and reaches a threshold defined in the BSAAR issuance agreement.
At the general meeting of shareholders of the Company to be held on or about May 12, 2023, the allocation of free performance shares subject to capitalisation evolution and internal conditions will be put to the vote of its shareholders.
At the general meeting of shareholders of the Company to be held on May 23, 2024, the allocation of free performance shares subject to capitalization evolution and internal conditions will be put to the vote of its shareholders.
Benefits in Kind €23,719 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits. Total Compensation €1,091,442 2022 Compensation of Yannis Morel The following table sets forth the compensation earned by Dr.
Benefits in Kind €22,733 Primarily represents amounts paid for use of a company car and additional retirement benefits (known as “article 83”), among other benefits. Total Compensation €774,733 2023 Compensation of Yannis Morel 179 The following table sets forth the compensation earned by Dr.
Ruslan Medzhitov, Ph.D., is a Sterling Professor at Yale University School of Medicine in New Haven, Connecticut and an Investigator of the Howard Hughes Medical Institute. His research interests include biology of inflammation, biological bases of diseases and evolutionary design of biological systems. Dr.
He has published more than 250 peer reviewed publications and has an H-index of 66. 190 Ruslan Medzhitov, Ph.D., is a Sterling Professor at Yale University School of Medicine in New Haven, Connecticut, and an Investigator of the Howard Hughes Medical Institute. His research interests include biology of inflammation, biological bases of diseases and evolutionary design of biological systems. Dr.
Miriam Merad, M.D., Ph.D. , is the Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York and the Director of the Mount Sinai Human Immune Monitoring Center (HIMC). Dr.
Miriam Merad, M.D.; Ph.D. , is Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York (PrIISM) and Director of the Mount Sinai Human Immune Monitoring Center (HIMC). Dr. Merad is an internationally renowned physician-scientist with expertise in human disease immunology. Dr.
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 baseline targets are reached. • Performance Free Shares . The members of the Executive Board are able to receive, upon authorization of the Supervisory Board and upon recommendation of the Compensation and Nomination Committee, equity compensation in the form of performance free shares. • Other Benefits.
Total Compensation €511,783 2023 Executive Board Compensation At the general meeting of shareholders of the Company to be held on May 12, 2023 the compensation of the members of the Executive Board set forth in the following table for the year ended December 31, 2023 will be put to the vote of its shareholders: 182 Type of Compensation Mondher Mahjoubi Yannis Morel Fixed Compensation €470,000 €252,000 Maximum Annual Variable Compensation if 100% of the objectives are reached €282,000 €100,800 Maximum Annual Variable Compensation if case of over-performance (150%) €423,000 €151,200 The variable compensation for the year ended December 31, 2023 is based on the achievement of 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 €599,918 2024 Executive Board Members' Compensation At the general meeting of shareholders of the Company to be held on May 23, 2024, the compensation of the members of the Executive Board sets forth in the following table for the year ended on December 31, 2023 will be put to the vote of the shareholders: Type of Compensation Hervé Brailly Yannis Morel Sonia Quaratino Arvind Sood Fixed Compensation €470,000 €300,000 €350,000 $300,000 Maximum Annual Variable Compensation if 100% of the objectives are reached €282,000 €120,000 €140,000 $120,000 Maximum Annual Variable Compensation in case of over-performance (150%) €423,000 €180,000 €210,000 $180,000 The variable compensation for the year ended on December 31, 2024 is based on the achievement of the Company's main strategic pillars and operational targets defined according to Innate Pharma's activities in order to (i) take into account the outperformance inherent to a fast-growing biotech company and (ii) motivate the managers to exceed their objectives.
The BSAAR have been granted to certain of the executive officers and employees. 186 The following table shows the BSAAR outstanding as of December 31, 2022: Plan title BSAAR 2012 BSAAR 2015 General assembly meeting date June 28, 2012 April 27, 2015 Date of grant May 27, 2013 July 1, 2015 Total number of BSAAR granted 146,050 1,050,382 Start date of the exercise period May 27, 2013 July 1, 2015 End date of the exercise period May 27, 2023 June 30, 2025 BSAAR initial purchase price €0.11 €1.15 Exercise price per BSAAR/share €2.04 €7.20 Number of BSAAR exercised as of December 31, 2022 86,700 1,940 BSAAR cancelled or lapsed as of Decmber 31,2022 — 2,720 BSAAR remaining as of December 31, 2022 59,350 1,045,722 Free Shares (AGA) Free shares, or AGA, are employee equity incentive instruments pursuant to which the beneficiaries are granted, for free, the possibility to receive ordinary shares under certain conditions.
The following table shows the BSAAR outstanding as of December 31, 2023: Plan title BSAAR 2015 Shareholder general meeting date April 27, 2015 Date of issue July 1, 2015 Total number of BSAAR issued 1,050,382 Start date of the exercise period July 1, 2015 End date of the exercise period June 30, 2025 BSAAR initial purchase price €1.15 Exercise price per BSAAR/share €7.20 Number of BSAAR exercised as of December 31, 2023 1,940 BSAAR cancelled or lapsed as of December 31, 2023 2,720 BSAAR remaining as of December 31, 2023 1,045,722 Free Shares (AGA) Free shares (AGA) are employee equity incentive instruments pursuant to which the beneficiaries are granted, for free, the possibility to receive ordinary shares under certain conditions.
He attended on the inpatient units of the 195 Biological Response Modifiers Program, NCI, from 1988-1996 and the Immunotherapy Service of the Surgery Branch, NCI, from 1997-1999. From 1999-2004, he served as Vice President of Clinical Development and Executive Officer of Vion Pharmaceuticals in New Haven, Connecticut. Dr. Sznol is past President of the Society for Immunotherapy of Cancer (SITC).
He was on the inpatient units of the Biological Response Modifiers Program, NCI, from 1988 to 1996, and on the immunotherapy service of the Surgery Branch, NCI, from 1997 to 1999. From 1999 to 2004, he served as Vice President of Clinical Development of Vion Pharmaceuticals in New Haven, Connecticut. Dr.
Sally Bennett, MBChB ., member of the Supervisory Board, has been selected for her significant experience and expertise in financial analysis and capital markets, in the healthcare and biotechnology sectors. Dr Sally Bennett has a career spanning medicine, equity & capital markets and investment management.
Sally Bennett, MBChB ., has served as a member of the Supervisory Board since May 20, 2022. She has a significant experience and expertise in financial analysis and capital markets in the healthcare and biotechnology sectors. Dr. Bennett has a career spanning medicine, equity & capital markets and investment management.

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Item 7. Management's Discussion & Analysis

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

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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, 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 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 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.
In addition, under its Code of Business Conduct and Ethics, which Innate Pharma adopted on September 12, 2019, its employees and Executive and Supervisory Board members have an affirmative responsibility 199 to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest.
The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to Innate of the transaction and whether the transaction is on terms that are comparable to the terms available to or 203 from, as the case may be, an unrelated third-party or to or from employees generally.
The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to Innate of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of December 31, 2022 and options and warrants that are currently exercisable or exercisable within 60 days of December 31, 2022.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of December 31, 2023 and options and warrants that are currently exercisable or exercisable within 60 days of December 31, 2023.
Ordinary shares subject to free shares, options and warrants currently exercisable or exercisable within 60 days of December 31, 2022 are deemed to be outstanding for computing the percentage ownership of the person holding these free shares, options or warrants and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
Ordinary shares subject to free shares, options and warrants currently exercisable or exercisable within 60 days of December 31, 2023 are deemed to be outstanding for computing the percentage ownership of the person holding these free shares, options or warrants and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.
Since January 1, 2022, 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, 2023, the Company has engaged in the following transactions with members of its Executive and Supervisory Boards and holders of more than 5% of its outstanding voting securities, and their respective affiliates, which Innate refers to as its related parties.
Such indemnification agreements provides that the Company would cover Supervisory Board members and Executive Board members in situations in which the IPO and D&O insurance policies would not cover them, but always within the limits of what is legally possible in terms of indemnification of directors and officers.
Such indemnification agreement provides that the Company would cover Supervisory Board members and Executive Board members in situations in which the IPO and D&O insurance policies would not cover them, but always within the limits of what is legally possible in terms of indemnification of directors and officers.
The cost and provision of these services are negotiated on an arms-length basis and none of these arrangements are material. Related Person Transaction Policy The Company complies with French law regarding approval of transactions with related parties.
The cost and provision of these services are negotiated on an arm's-length basis, and none of these arrangements are material. Related Person Transaction Policy The Company complies with French law regarding approval of transactions with related parties.
The principal business address for Novo Nordisk A/S is Novo Allé, 2880 Bagsvaerd, Danemark. (2) Consists of 7,485,500 ordinary shares. The principal business address for MedImmune Limited is Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom. 199 (3) Consists of 6,389,406 ordinary shares.
The principal business address for Novo Nordisk A/S is Novo Allé, 2880 Bagsvaerd, Denmark. (2) Consists of 7,485,500 ordinary shares. The principal business address for MedImmune Limited is Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom. (3) Consists of 6,389,406 ordinary shares.
Major Shareholders The following table and accompanying footnotes sets forth, as of December 31, 2022, 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 Executive Board 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 December 31, 2023, information regarding beneficial ownership of the ordinary shares by: • each person, or group of affiliated persons, known by Innate to beneficially own more than 5% of the ordinary shares; • each of the Leadership Team and Supervisory Board members individually; and • all of the Executive Board and Supervisory Board members as a group.
Agreement with Jean-Yves Blay as member of the Supervisory Board On December 17, 2021, the Supervisory Board authorized the conclusion of an agreement between Innate Pharma and Jean-Yves Blay in his capacity as member of the Supervisory Board in order to define the terms and conditions under which Jean-Yves Blay participates in the Supervisory Board.
Agreement with Jean-Yves Blay as member of the Supervisory Board On May 12, 2023, the Supervisory Board authorized the conclusion of an agreement between Innate Pharma and Jean-Yves Blay in his capacity as member of the Supervisory Board in order to define the terms and conditions under which Jean-Yves Blay participates in the Supervisory Board.
Assuming that all of the ordinary shares represented by ADSs are held by residents of the United States, as of December 31, 2022, the Company estimates that approximately 5,8 million shares, or 7.24%% of the ordinary shares were held of record by residents of the United States.
Assuming that all of the ordinary shares represented by ADSs are held by residents of the United States, as of December 31, 2023, the Company estimates that approximately 4.8 million shares, or 5.97% of the ordinary shares were held of record by residents of the United States.
(7) Consists of 25,100 ordinary shares, 10,000.00 warrants (BSA 2015-1) and 10,000.00 warrants (BSA 2017) (8) Consists of 50 ordinary shares. (9) Consists of 73,059 ordinary shares, 15,000.00 warrants (BSA 2015-1) and 10,000.00 warrants (BSA 2017). (10) Consists of 10 ordinary shares, 14,200.00 warrants (BSA 2015-2) and 10,000.00 warrants (BSA 2017).
(7) Consists of 25,100 ordinary shares, 10,000 warrants (BSA 2015-1) , 10,000 warrants (BSA 2017) and 10,000 warrants (BSA 2023). 196 (8) Consists of 50 ordinary shares and 8,000 warrants (BSA 2023). (9) Consists of 73,059 ordinary shares, 15,000 warrants (BSA 2015-1) , 10,000 warrants (BSA 2017) and 10,000 warrants (BSA 2023).
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.
Arrangements with the Members of the Executive and Supervisory Boards Director and Executive Officer Compensation See “Item 6B—Compensation—Limitations on Liability and Indemnification Matters” for information regarding compensation of the members of the Supervisory and Executive Boards. Termination letter for Mondher Mahjoubi Following the resignation of Mr.
The principal business address for Bpifrance Participations is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex. (4) Consists of 514,540 ordinary shares. (5) Consists of 154,775 ordinary shares and 88,000.00 reedemable warrants (BSAAR 2015). (6) Consists of 739,784 ordinary shares and 150,000.00 reedemable warrants (BSAAR 2015).
The principal business address for Bpifrance Participations is 27-31, avenue du Général Leclerc, 94 710 Maisons Alfort Cedex, France. (4) Consists of 631,088 ordinary shares. (5) Consists of 194,192 ordinary shares and 88,000 redeemable warrants (BSAAR 2015). (6) Consists of 739,784 ordinary shares, 150,000 redeemable warrants (BSAAR 2015) and 10,000 warrants (BSA2023).
Yannis Morel as members of the Management Board In the context of the Nasdaq IPO and regarding the need to put in place insurances for the liability of officers of listed companies in the US, the Supervisory board decided : (i) The entering into of a policy insurance covering the risks in relation with the Nasdaq IPO (IPO insurance) and the insurance policy extension for companies listed on the Nasdaq (D&O insurance policy) ; and (ii) The entering into of indemnification agreement between the Company on the one hand and the Supervisory and Executive board member on the other hand.
Yannis Morel as members of the Management Board 198 In the context of the Nasdaq IPO and regarding the need to put in place insurance for the liability of officers of listed companies in the United States, the Supervisory Board decided : (i) to subscribe to an insurance policy covering the risks associated with the Nasdaq IPO (IPO insurance) and an insurance policy extension for companies listed on the Nasdaq (D&O insurance policy); and (ii) to enter into an indemnification agreement between the Company and the Supervisory and Executive Board members.
This contract took effect on May 13, 2022 for the duration of Jean-Yves Blay's term of office, i.e. until May 12, 2023. The contract provides that Jean-Yves Blay may receive a maximum remuneration of €43,000 per year.
This contract took effect on June 12, 2023 for the duration of Jean-Yves Blay's term of office, i.e., until the General Annual Meeting approving the financial statements for the year ending December 31, 2024 and at the latest June 30, 2025. The contract provides that Jean-Yves Blay may receive a maximum remuneration of €43,000 per year.
For the financial year 2022, Jean-Yves Blay received €20,000 under this contract, corresponding to the amount of his fixed and variable remuneration as a member of the Supervisory Board. Motivation : To regulate Jean-Yves Blay's mandate as a member of the Supervisory Board, given his status as a civil servant subject to the provisions applicable to health professionals.
For the financial year 2023, Jean-Yves Blay received €29,000 under this contract, corresponding to the amount of his fixed and variable remuneration as a member of the Supervisory Board.
Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% Shareholders : Novo Nordisk A/S(1) 9,817,546 12.24 % MedImmune Limited(2) 7,485,500 9.33 % Bpifrance Participations(3) 6,389,406 7.97 % Executive Board and Supervisory Board members and other executive officers : Mondher Mahjoubi, M.D.(4) 514,540 0.64 % Yannis Morel, Ph.D.(5) 242,775 0.30 % Hervé Brailly, Ph.D.(6) 889,784 1.11 % Irina Staatz-Granzer(7) 45,100 0.06 % Jean-Yves Blay(8) 50 — % Gilles Brisson(9) 98,059 0.12 % Véronique Chabernaud(10) 24,210 0.03 % Olivier Martinez(11) — — % Pascale Boissel(12) 1,000 — % Sally Bennett(13) 2,500 Joyson Karakunnel — — % Odile Belzunce(14) 55,356 0.07 % Eric Vivier, D.V.M.(15) 184,666 0.23 % Odile Laurent (16) 21,086 0.03 % Frédéric Lombard (17) 960 — % Nicola Beltraminelli(18) Henry Wheeler(19) 960 Claire de St Blanquat20) 960 All members of our Executive Board and Supervisory Board and other executive officers as a group (19) 25,774,458 32.13 % (1) Consists of 9,817,546 ordinary shares.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Innate Pharma S.A., 117, Avenue de Luminy – BP 30191, 13009 Marseille, France. 195 Number of Ordinary Shares Beneficially Owned Percentage of Ordinary Shares Beneficially Owned 5% Shareholders : Novo Nordisk A/S(1) 9,817,546 12.14% MedImmune Limited(2) 7,485,500 9.26% Bpifrance Participations(3) 6,389,406 7.90% Executive Board and Supervisory Board members and other executive officers : Mondher Mahjoubi, M.D.(4) 631,088 0.78% Yannis Morel, Ph.D.(5) 194,192 0.24% Hervé Brailly, Ph.D.(6) 739,784 0.92% Irina Staatz-Granzer (7) 25,100 0.03% Jean-Yves Blay(8) 50 —% Gilles Brisson (9) 73,059 0.09% Véronique Chabernaud(10) 660 —% Olivier Martinez(11) — —% Pascale Boissel(12) 1,000 —% Sally Bennett(13) 2,500 —% Sonia Quaratino — —% Odile Belzunce(14) 62,249 0.08% Eric Vivier, D.V.M.(15) 210,228 0.26% Odile Laurent (16) 37,979 0.05% Frédéric Lombard (17) 11,362 0.01% Nicola Beltraminelli (18) 9,246 0.01% Henry Wheeler (19) 3,185 —% Claire de St Blanquat (20) 3,185 —% All members of our Executive Board, Supervisory Board and other Leadership Team member as a group 25,697,319 32% (1) Consists of 9,817,546 ordinary shares.
(11) As representative of Bpifrance Participations, the legal entity that holds this Supervisory Board seat. (12) Consists of 1,000 ordinary shares. (13) Consists of 2,500ordinary shares. (14) Consists of 40,356 ordinary shares and 15000 reedemable warrants (BSAAR 2012 and 2015). (15) Consists of 184,666 ordinary shares. (16) Consists of 21,086 ordinary shares. (17) Consists of 960 ordinary shares.
(10) Consists of 660 ordinary shares, 14,200 warrants (BSA 2015-2) and 10,000 warrants (BSA 2017). (11) As representative of Bpifrance Participations, the legal entity that holds this Supervisory Board seat. (12) Consists of 1,000 ordinary shares. (13) Consists of 2,500 ordinary shares. (14) Consists of 62,249 ordinary shares and 10,000 warrants (BSA). (15) Consists of 210,228 ordinary shares.
Indemnification Agreement with Mr. Hervé Brailly, Mrs. Irina Staatz-Granzer, Mr. Jean Yves Blay, Mr. Gilles Brisson, Mrs. Véronique Chabernaud, Mrs. Pascale Boissel, Ms. Sally Bennett and Mr. Olivier Martinez as members of the Supervisory Board and Mr. Mondher Mahjoubi and Mr.
This amendment added a new partner to the agreement, the "Institut Gustave Roussy", and extended the duration of the project to October 31, 2024. Indemnification Agreement with Mr. Hervé Brailly, Mrs. Irina Staatz-Granzer, Mr. Jean Yves Blay, Mr. Gilles Brisson, Mrs. Véronique Chabernaud, Mrs. Pascale Boissel, Ms. Sally Bennett and Mr.
(18) NA (19) Consists of 960 ordinary shares. (20) Consists of 960 ordinary shares. None of the principal shareholders has voting rights different than the other shareholders. B. Related Party Transactions.
(16) Consists of 37,979 ordinary shares. (17) Consists of 11,362 ordinary shares. (18) Consists of 9,246 ordinary shares. (19) Consists of 3,185 ordinary shares. (20) Consists of 3,185 ordinary shares. None of the principal shareholders has voting rights different than the other shareholders.
All of the transactions described above were entered into prior to the adoption of the written policy, but the Supervisory Board evaluated and approved all transactions that were considered to be related party transactions under French law at the time at which they were consummated. C. Interests of Experts and Counsel. Not applicable.
All of the transactions described above were evaluated and approved by the Supervisory Board. C. Interests of Experts and Counsel. Not applicable.
The information does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Securities Act. 198 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.
The information does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Securities Act.
Removed
Transactions With The Principal Shareholders AstraZeneca Lumoxiti Termination and Transition Agreement Further to the decision to terminate the Lumoxiti Agreement and termination notice sent in December 2020, a Termination and Transition Agreement was discussed and executed, effective as of June 30, 2021 terminating the Lumoxiti Agreement as well as Lumoxiti related agreements (including the supply agreement, the quality agreement and other related agreements) and transferring of the U.S. marketing authorization and distribution rights of Lumoxiti back to AstraZeneca.
Added
To the best of our knowledge, no other shareholder currently holds, directly or indirectly and acting alone or in concert, more than 5% of our share capital or voting rights. Furthermore, we believe that we are not directly or indirectly owned or controlled by another corporation or government, or by any other natural or legal persons.
Removed
Under the Termination and Transition Agreement, Innate and AstraZeneca delivered a notice to the FDA requesting that the U.S. marketing authorization (BLA) be transferred back to AstraZeneca as from October 1, 2021. The BLA was effectively transferred to AstraZeneca on February 8th 2022. AstraZeneca has reimbursed Innate for all Lumoxiti related costs, expenses and benefited net sales.
Added
To our knowledge, there are no arrangements that may result in a change of control. B. Related Party Transactions.
Removed
In the full year results 2020 announcement, Innate 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.
Added
Mondher Mahjoubi from his duties as member and Chairman of the Executive Board with effect from December 31, 2023, the Supervisory Board meeting of December 15, 2023 authorized the Company to sign a letter specifying the terms and conditions of Mr. Mahjoubi's departure. These conditions are detailed below.
Removed
As part of the Termination and Transition Agreement, the Parties agreed to split these manufacturing costs, and Innate paid $6.2 million to AstraZeneca on April 30, 2022. 200 Agreement with Bpifrance Financement In the context of the COVID-19 pandemic, the French government has launched a call for collaborative research and development projects aiming at developing therapeutic solutions to prevent or cure COVID-19.
Added
Mondher Mahjoubi, who will remain with the company until December 31, 2023, is eligible for the following: – To his variable remuneration for 2023, in accordance with the level of achievement of the Company's 2023 objectives to be assessed by the Supervisory Board; – To the 2020 free performance shares ("AGAP") granted to him by decision of the Executive Board on August 5, 2020, up to the level of achievement of the performance conditions as assessed by the Executive Board. 197 In addition, Mr.
Removed
Projects selected by the French government are eligible to receive funding from the French government under the Programme d'Investissements d'Avenir (PIA) managed by Bpifrance Financement (BPI). Such funding takes the form of grants and repayable advances and provides for profit sharing. Innate Pharma was selected by BPI to finance its current projects relating to COVID-19.
Added
Mondher Mahjoubi's letter of termination specifies that the Supervisory Board authorizes the Executive Board to waive Mr.
Removed
In connection with such selection, the Company executed two agreements with BPI, the Master Agreement and the Beneficiary Agreement.
Added
Mondher Mahjoubi's attendance conditions under the AGAP 2021 and 2022 programs, thereby enabling him to benefit from the shares granted to him by the Executive Board on October 1, 2021 and December 12, 2022 respectively, according to the level of achievement of the conditions by December 31, 2023, as determined by the Executive Board, with a definitive grant date in accordance with the programs concerned, i.e.
Removed
The Master Agreement and the Beneficiary Agreement set forth (i) the terms and conditions for the payment of the aid granted by Bpifrance Financement to Innate Pharma and its partners involved in the "FORCE" project (Assistance Publique – Hôpitaux de Marseille and Centre Léon Bérard) as well as (ii) the terms and conditions for the financial returns due by the beneficiaries of the aid to Bpifrance Financement.
Added
December 31, 2024 and December 31, 2025 respectively. Lastly, the non-compete clause has been waived. Mondher Mahjoubi consulting agreement Following the resignation of Mr. Mondher Mahjoubi from his duties as member and Chairman of the Executive Board with effect from December 31, 2023, the Supervisory Board meeting of December 15, 2023 authorized the conclusion of a services agreement with Mr.
Removed
The "FORCE" project includes the translational research study EXPLORE COVID-19 with AP-HM and the two Phase 2 clinical trials, FORCE with AP-HM and ImmunONCOVID-20 with the Centre Léon Bérard.
Added
Mahjoubi for the month of January 2024, for remuneration equivalent to his fixed monthly remuneration, i.e. €39,000. This agreement has no impact on the fiscal year 2023.
Removed
The funding amounts to a total of €6,800,000, divided as follows: 20% in the form of a grant with no repayment condition and 80% in the form of an advance repayable only in the event of technical and commercial success.
Added
Amendments to the Pionner Consortium agreement At its meeting on May 12, 2023, the Supervisory Board authorized the conclusion of amendments no. 1 and 2 to the Pionner Consortium project agreement, involving nine academic and industrial partners, including Innate Pharma, AstraZeneca and the Centre Léon Bérard, in order to define the terms and conditions of the project.
Removed
The first installment of €1,700,000 was paid on signature of the agreements, and the three remaining installments will be paid depending on the achievement of certain clinical milestones, notably those related to the Phase 2 FORCE trial. The agreement is concluded for a period up to the full repayment of any sums due to Bpifrance Financement.
Added
The agreement was signed on November 7, 2018, with retroactive effect to November 1, 2017. An amendment n°1 was signed on September 8, 2022 to extend the duration of the project until October 31, 2023. An amendment n° 2 was signed on June 2, 2023.
Removed
Under a letter dated May 11, 2022, Bpifrance Financement confirmed to the Company that following the termination of the FORCE trial in 2022: (i) Bpifrance Financement shall pay the remaining amount for the project amounting to €646,756 and (ii) shall waive the debt for an amount of €1,988,000.
Added
Olivier Martinez as members of the Supervisory Board and Mr. Mondher Mahjoubi and Mr.
Removed
Amendment to the biomedical research agreement with the Léon Bérard Centre Innate Pharma and the Centre Léon Bérard entered into a Biomedical Research Agreement on January 11, 2016 (the "Agreement") for the performance of the biomedical research IPH2201-203 entitled "Phase Ib/II trial evaluating IPH2201 in combination with cetuximab in patients with relapsed or metastatic HPV-positive (+) and HPV-negative (-) head and neck squamous cell carcinoma".
Removed
At the date of signature, the Agreement was not a regulated agreement, as Mr. Jean-Yves Blay, General Manager of the Léon Bérard Centre, was not a member of the Supervisory Board.
Removed
In accordance with the authorisation of the Supervisory Board on 17 December 2021, an amendment No. 1 was signed on 9 March 2022 in order to take into account the changes in the implementation of the Study and the budgetary adjustments, applied accordingly. 201 Such Amendment no. 1 ratifies the modification of the duration of the Study and consequently modifies the specific operating costs charged by the Léon Bérard Centre to meet the changes requested and the provisional budget of the Study.
Removed
Framework agreement and order for services and equipment transfer agreement with Mi-mAbs On January 29, 2021, the Company's Supervisory Board approved the conclusion of a framework agreement and an order for services with Mi-mAbs, a company of which Mr. Hervé Brailly, Chairman of the Supervisory Board, was a member of the Strategic Committee at the time of its creation.
Removed
The purpose of the framework agreement is to specify the main conditions under which Mi-mAbs will provide services to Innate. The first service order specifies the services to be provided to Innate. The maximum amount of the sums paid by Innate Pharma to Mi-mAbs under the framework service agreement is €600,000. The amount of the first service order is €352,000.
Removed
This agreement was entered into on February 2, 2021, with retroactive effect to January 1, 2021, for a term of one year, until December 31, 2021. 202 On August 6, 2021, an agreement was signed with Mi-mAbs for the transfer of equipment from Innate Pharma to Mi-mAbs at their residual values, i.e. for a total amount of €1,281 excluding VAT.
Removed
This agreement was ratified by the Supervisory Board on December 17, 2021. On December 17, 2021, two amendments to the framework agreement were signed with Mi-mAbs, the first one modifying the work plan, which generated a credit of €3,578.40 to the benefit of Innate Pharma, the second one renewing the framework agreement for one year.
Removed
These two amendments were ratified by the Supervisory Board on January 26, 2022, although they are no longer regulated agreements, as Mr. Hervé Brailly is no longer a member of the Strategic Committee of Mi-Mabs since November 2021, but is a 15% shareholder.
Removed
Amendment to the biomedical research agreement with the Léon Bérard Center Innate Pharma and the Léon Bérard Center entered into a Biomedical Research Agreement on January 11, 2016 (the "Agreement") for the performance of the IPH2201-203 biomedical research entitled "Phase 1b/2 trial evaluating IPH2201 in combination with cetuximab in patients with relapsed or metastatic HPV-positive (+) and HPV-negative (-) squamous cell carcinoma of the head and neck".
Removed
At the date of signature, the Agreement was not a regulated agreement, as Mr. Jean-Yves Blay, General Manager of the Léon Bérard Center, was not a member of the Supervisory Board.
Removed
In accordance with the authorization of the Supervisory Board of December 17, 2021, an amendment n°1 was signed on March 9, 2022 in order to take into account the changes in the conduct the Study and certain adjustments to the budget.

Other IPHA 10-K year-over-year comparisons