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What changed in Inventiva S.A.'s 20-F — 2023 vs 2024

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Paragraph-level year-over-year comparison of Inventiva S.A.'s 2023 and 2024 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+659 added−1504 removedSource: 20-F (2025-04-15) vs 20-F (2024-04-03)

Top changes in Inventiva S.A.'s 2024 20-F

659 paragraphs added · 1504 removed · 223 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeIn addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. ● HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services. ● HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates and their subcontractors that perform services for them that involve individually identifiable health information.
Biggest changeThe federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.
Further, on December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.
For example, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, or IRA, into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025.
For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025.
Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.
Additionally, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.
Also, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
Further, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drugs.
In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.
As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. In addition, the FDA currently requires pre-approval of promotional materials as a condition for accelerated approval, which could adversely impact the timing of the commercial launch of the product.
Under the Orphan Drug Act of 1983, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if it affects more than 200,000, there is no reasonable expectation that sales of the drug in the United States will be sufficient to offset the costs of developing and making the drug available in the United States.
Orphan Drug Designation The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be recovered from sales in the United States.
Breakthrough Therapy Designation with the FDA may be requested and granted for products that are intended, alone or in combination with one or more other products, to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints.
A sponsor may seek FDA designation of a product candidate as a “breakthrough therapy” if the product is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
While Medicare Part D applies only to drug benefits for Medicare beneficiaries, private third-party payors often follow Medicare coverage policy and payment limitations in setting their own payment rates, but also have their own methods and approval process apart from Medicare determinations.
Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement for drugs can differ significantly from payor to payor.
While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.
While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.
It is unclear how such challenges and the healthcare reform measures of the Biden administration will impact the Affordable Care Act and our business.
It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the Affordable Care Act. In addition, other health reform measures have been proposed and adopted in the United States since the Affordable Care Act was enacted.
It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA.
For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada.
If a product is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the product sponsor may apply for Fast Track Designation with the FDA.
For example, new drugs are eligible for Fast Track Designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track Designation applies to the combination of the product and the specific indication for which it is being studied.
In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government.
In addition, Affordable Care Act clarifies that the government may assert that a claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
The laws that may affect our ability to operate include, but are not limited to: ● The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.
Anti-kickback laws including, without limitation, the federal Anti-Kickback Statute that applies to items and services reimbursable under governmental healthcare programs such as Medicare and Medicaid, make it illegal for a person or entity to, among other things, knowingly and willfully solicit, receive, offer or pay remuneration, directly or indirectly, to induce, or in return for, purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any good, facility, item, or service reimbursable, in whole or in part, under a federal healthcare program.
On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry.
These provisions will take effect progressively starting in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges.
Even though we have received Fast Track and Breakthrough Therapy Designations from the FDA and Breakthrough Therapy Designation from the NMPA for lanifibranor for the treatment of NASH we may not experience a faster development, review or approval process compared to conventional FDA or NMPA procedures and these designations do not change the approval standards of the FDA and the NMPA.
If a product is designated as breakthrough therapy, the FDA will work to expedite the development and review of such drug. Fast Track Designation, Breakthrough Therapy Designation, priority review, and accelerated approval do not change the standards for approval, but may expedite the development or approval process.
In addition, the IRA, among other things, (1) directs HHS to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions take effect progressively starting in fiscal year 2023.
Department of Health and Human Services, or HHS, to negotiate the price of certain single-source drugs that have been on the market for at least 7 years covered under Medicare, or Medicare Drug Price Negotiation Program, and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.
Generally, if a drug with an orphan drug designation subsequently receives the first marketing approval for an indication for which it receives the designation, then the drug is eligible for a seven-year period of marketing exclusivity in the United States and a ten-year period of marketing exclusivity in the European Union during which the competent authority may not approve another marketing application for the same drug for the same indication, except in limited circumstances, such as if a subsequent application demonstrates that its product is clinically superior.
In addition, if a drug receives FDA approval for the indication for which it has orphan drug designation, the drug may be entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the drug with orphan exclusivity.
A product may be eligible for accelerated approval if it treats a serious or life-threatening condition, generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
Drug products intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
Moreover, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor.
Moreover, a payor’s decision to provide coverage for a drug does not imply that an adequate reimbursement rate will be approved. Additionally, no uniform policy for coverage and reimbursement exists in the United States.
There have been judicial, Congressional, and executive branch challenges to certain aspects of the Affordable Care Act. In addition, there have been a number of health reform measures by the Biden administration that have impacted the Affordable Care Act.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2009, or collectively, the Affordable Care Act, was enacted, which includes measures that have significantly changed health care financing by both governmental and private insurers. 84 Table of Contents There have been judicial, Congressional and executive branch challenges and amendments to certain aspects of the Affordable Care Act.
These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011 and subsequent laws, which began in 2013 and, due to subsequent legislative amendments to the statute, including the BBA, and the Infrastructure Investment and Jobs Act, will remain in effect until 2032 unless additional Congressional action is taken.
For example, as a result of the Budget Control Act of 2011, as amended, providers are subject to Medicare payment reductions of 2% per fiscal year until 2032, unless additional Congressional action is taken.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary product recalls; ● fines, untitled or warning letters or holds on clinical trials; 19 Table of Contents ● refusal by the FDA, the EMA, NMPA or any other comparable regulatory authority to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product approvals; ● product seizure or detention, or refusal to permit the import or export of products; and ● injunctions or the imposition of civil or criminal penalties.
Other potential consequences may include: ● restrictions on the marketing or manufacturing of the drug, complete withdrawal of the drug from the market or drug recalls; ● fines, warning letters or holds on post-approval clinical studies; ● the FDA refusing to approve pending NDAs or supplements to approved NDAs, or suspending or revoking of drug license approvals; ● drug seizure or detention, or refusal to permit the import or export of drugs; or ● injunctions or the imposition of civil or criminal penalties.
The extended patent term cannot exceed the shorter of five years beyond the non-extended expiration of the patent or 14 years from the date of the FDA approval of the drug.
The period of extension may be up to five years beyond the expiration of the patent but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent among those eligible for an extension may be extended.
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Item 3. Key Information A. [Reserved] B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors Our business faces significant risks.
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Item 3.D Risk Factors—Risks Relating to Our Intellectual Property .” As of March 1, 2025, with respect to lanifibranor, we own 6 issued U.S. patents, 9 U.S. patent applications and approximately 235 patents and patent applications in other jurisdictions. As of March 1, 2025, with respect to odiparcil, we own 2 issued U.S. patents, and approximately 84patents in other jurisdictions.
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You should carefully consider all of the information set forth in this annual report and in our other filings with the United States Securities and Exchange Commission, or the SEC, including the following risk factors which we face and which are faced by our industry.
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We cannot predict whether the patent applications we pursue will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide any proprietary protection from competitors. The patent portfolios for our lead product candidates as of March 1, 2025 are summarized below.
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Our business, financial condition or results of operations could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties.
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The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we are seeking patent protection for our product candidates, the patent term is 20 years from the earliest date if filing a non-provisional patent application.
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Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described below and elsewhere in this annual report and our other SEC filings.
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In the United States, the term of a patent may be lengthened by a patent term adjustment, which provides for term extension in the case of administrative delays at the United States Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over another patent with an earlier expiration date.
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See “Special Note Regarding Forward-Looking Statements” above. 7 Table of Contents Risks related to our Financial Position and Need for Additional Capital We require substantial additional funding, which may not be available to us on acceptable terms, or at all, and failure to obtain this necessary capital when needed may force us to curtail, delay or discontinue our product candidate development efforts or other operations.
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Furthermore, in the United States, the term of a patent covering an FDA approved drug may be eligible for a patent term extension under the Hatch-Waxman Amendments as compensation for the loss of patent term during the FDA regulatory review process.
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These factors raise substantial doubt regarding our ability to continue as a going concern. As of December 31, 2023, we had €26.9 million of available cash and cash equivalents, consisting of cash and short-term deposit accounts that are liquid and easily convertible within 3 months without penalty or risk of change in value.
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In the future, if any of our product candidates receives FDA approval, we expect to apply for a patent term extension, if available, to extend the term of the patent covering such approved product candidate.
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We also had €0.01 million of short-term deposits we consider liquid and easily available, and a €9.0 million long-term, two-year deposit forward contract entered into during the first quarter of 2023, included in “other non-current assets”, but accessible prior to the expiration of the term upon 31 days written notice.
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We also expect to seek patent term extensions in any jurisdictions where they are available, however, there is no guarantee that the applicable authorities, including the FDA, will agree with our assessment of whether such an extension should be granted, and even if granted, the length of such an extension. 77 Table of Contents Lanifibranor With respect to lanifibranor patent rights, as of March 1, 2025, we own 6 U.S. patents, which are due to expire by December 2026, September 2027, June 2035, November 2039, and December 2041 excluding any additional term for patent term extension, and 9 U.S. patent applications.
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On January 18, 2024, we also drew down the second tranche of €25.0 million under the finance contract, or Finance Contract, with the European Investment Bank, or EIB.
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Outside the United States, we own approximately 154 patents issued in approximately 55 jurisdictions, including Australia, Canada, China, a number of European countries, Japan, Korea, Israel and Russia.
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The amount and timing of our future funding requirements will depend on many factors, including but not limited to: ● the progress, costs, results of and timing of our ongoing and planned clinical trials; ● our ability to reach milestones under our existing partnership arrangements, including our partnerships with CTTQ and Hepalys, or enter into additional partnership agreements that would generate milestone payments, licensing fees or other sources of income; ● the willingness of the FDA, EMA, NMPA and other comparable regulatory authorities to accept the clinical trials and pre-clinical studies and other work from us or our partners as the basis for review and approval of product candidates; ● the outcome, costs and timing of seeking and obtaining regulatory approvals from the FDA, EMA and other comparable regulatory authorities; ● the need for additional or expanded pre-clinical studies and clinical trials beyond those that we envision conducting with respect to our current and future product candidates; ● the success of our current partners, including CTTQ and Hepalys, and any future partners, and the economic and other terms of any licensing, cooperation or other similar arrangements into which we may enter; ● the number of product candidates and indications that we pursue; ● the timing and costs associated with manufacturing our product candidates for clinical trials and pre-clinical studies and, if approved, for commercial sale; ● the timing and costs associated with establishing sales and marketing capabilities; ● market acceptance of any approved product candidates; ● the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; ● the cost to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; ● our need and ability to hire additional management, development and scientific personnel; and ● our need to implement additional internal systems and infrastructure, including financial and reporting systems. 8 Table of Contents As of the date hereof, we estimate, given our current cost structure and our projected expenditure commitments, that we should have sufficient funds to finance our activities until the beginning of the third quarter of 2024.
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We also own approximately 81 patent applications pending in approximately 22 jurisdictions including in Patent Cooperation Treaty, or PCT, jurisdictions, such as Australia, Brazil, Canada, China, Europe, Egypt, Israel, Japan, Hong Kong, Mexico, Korea, Malaysia, Singapore, Thailand, New Zealand, South Africa, Qatar, Saudi Arabia, Macao, India and the United States, and non-PCT jurisdictions such as Argentina, Bolivia, Paraguay, Uruguay, and Taiwan.
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Accordingly, our current cash and cash equivalents and short and long-term deposits are not sufficient to cover our operating needs for at least the next 12 months. In order to cover our needs for the next 12 months, taking into account our current business plan, we estimate needing approximately an additional €100 million during this period.
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The foregoing patents and patent applications cover lanifibranor, methods of making and using lanifibranor, polymorphic forms of lanifibranor, combination therapies and diagnostic methods. On November 28, 2022, we announced that the United States Patent and Trademark Office granted a patent (U.S.
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To fund our activities until the publication of topline results from our NATiV3 trial, which is targeted for the first half of 2026, we estimate we would need approximately an additional €175 million (assuming we receive approximately €25 million in potential milestone or other payments during the period) to €200 million (assuming no potential milestone payments) (each estimate inclusive of the above referenced €100 million).
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Patent No. 11,504,380) that protects the use of lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage, whereby portal hypertension is decreased in the subject.
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These events and conditions indicate that a material uncertainty exists that may cast significant doubt on our ability to continue as a going concern and, therefore, we may be unable to realize our assets and discharge our liabilities in the normal course of business.
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Odiparcil With respect to odiparcil, as of March 1, 2025, we own 2 issued U.S. patents, which are due to expire in October 2034, excluding any additional term for patent term extension.
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These estimates are based on our current business plan and exclude (i) other expenses related to the potential development of odiparcil or resulting from any potential in-licensing or acquisition of additional product candidates or technologies, or any associated development we may pursue, (ii) any potential milestone payments (other than those referenced above) that may be received or paid by us or potential financing.
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Outside the United States, we own approximately 84 patents issued in approximately 42 jurisdictions, including a number of European countries, Ukraine, Russia, Kazakhstan, Japan, Israel, Mexico, Korea, China, Canada, Australia, Azerbaijan, South Africa, Algeria, Brazil, Belarus, Morocco, and Tunisia. The foregoing patents and patent applications cover methods of using odiparcil.
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We may have based these estimates on incorrect assumptions and may have to use our resources sooner than expected. These estimates may be shortened in the event of an increase, beyond our expectations, in expenditure relating to the development programs, or if our development programs progress more quickly than expected.
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Other molecules As of March 1, 2025, we own various patents and have filed patent applications that cover new compounds inhibitors of the YAP/TAZ-TEAD interaction and their use in the treatment of cancer, including 2 issued U.S. patents, which are due to expire in October 2036 and October 2039, excluding any additional term for patent term extension and approximately 48 patents issued outside the United States in approximately 30 jurisdictions, including a number of European countries, Ukraine, Japan, Israel, Mexico, Korea, China, Canada, and Australia, and 4 patent applications, including one international application.
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In order to finance our activities, we need to raise additional funds, and we are actively reviewing potential financing (including debt, equity and equity-linked or other instruments) and strategic options and are discussing with potential counterparties and our financial advisors.
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Manufacturing We rely on contract manufacturing organizations, or CMOs, to produce our drug candidates in accordance with the FDA’s current Good Manufacturing Practices, or cGMPs, regulations for use in our clinical trials.
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In particular, we may seek to raise additional funds to achieve our development goals for our research and development programs through: ● potential sales of ADSs under our existing At-The-Market program, having an aggregate offering price of $58.0 million from time to time, which has a term until August 2, 2024; ● other potential public or private securities offerings; and ● potential strategic transactions such as business development partnerships and/or royalty deals.
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The manufacture of pharmaceuticals is subject to extensive cGMP regulations, which impose various procedural and documentation requirements and govern all areas of record keeping, production processes and controls, personnel and quality control. Our small molecule drug candidate lanifibranor is manufactured using common chemical engineering and synthetic processes from commercially available raw materials.
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Global macroeconomic conditions or disruptions and volatility in the U.S. and global financial markets linked in particular to geopolitical events that continue to impact the markets (including Russia’s invasion of Ukraine or the state of war between Israel and Hamas, including with respect to some clinical trial sites in Israel for the NATiV3 trial, and the related risk of a larger conflict) could affect our ability to obtain new financing.
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To meet our projected needs for clinical supplies to support our activities through regulatory approval and commercial manufacturing, the CMOs with whom we currently work will need to increase the scale of production or we will need to secure alternate suppliers.
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The implementation and terms of any new financing will depend on factors, particularly economic and market factors, over which we have no control. Future financing could take the form of financial debt, which would affect our financial structure, a capital increase, which would result in shareholder dilution, other securities offerings or strategic transactions, such as a partnership or other arrangement.
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If we are unable to obtain sufficient quantities of drug candidates or receive raw materials in a timely manner, we could be required to delay our ongoing clinical trials and seek alternative manufacturers, which would be costly and time-consuming. 78 Table of Contents Government Regulation and Approval United States - FDA Process In the United States, the FDA regulates drugs.
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In addition, we cannot guarantee that we will be able to obtain the necessary financing or execute any transaction, through any of the foregoing measures or otherwise, to meet our needs or to obtain funds at acceptable terms and conditions, on a timely basis, or at all especially taking into account the generally challenging environment for financing of biotech companies.
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The Federal Food, Drug, and Cosmetic Act and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of drugs.
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If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved product or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could impair our prospects or our business operations.
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To obtain regulatory approvals in the United States and in foreign countries, and subsequently comply with applicable statutes and regulations, we will need to spend substantial time and financial resources. Approval Process The FDA must approve any new drug or a drug with certain changes to a previously approved drug before a manufacturer can market it in the United States.
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The perception that we may be unable to continue as a going concern may impede our ability to pursue any potential financing or strategic opportunities or to operate our business.
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If a company does not comply with applicable United States requirements it may be subject to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending applications, warning or untitled letters, clinical holds, drug recalls, drug seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.
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Ultimately, if we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or part of their investment.
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The steps we must complete before we can market a drug include: ● completion of pre-clinical laboratory tests, animal studies, and formulation studies, all performed in accordance with the FDA’s good laboratory practice, or GLP, regulations; ● submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical studies start.
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Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and, if approved, commercialize our product candidates. ​ 9 Table of Contents We are a clinical-stage company with no approved products and no historical product revenues, which makes it difficult to assess our future prospects and financial results.
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The sponsor must update the IND application annually; ● approval of the study by an independent IRB or ethics committee representing each clinical site before each clinical study begins; ● performance of adequate and well-controlled human clinical studies to establish the safety and efficacy of the drug for each indication to the FDA’s satisfaction; ● submission to the FDA of an NDA; ● potential review of the drug application by an FDA advisory committee, where appropriate and if applicable; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities to assess compliance with current good manufacturing practices, cGMPs, or regulations; and ● FDA review and approval of the NDA.
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We are a clinical-stage biotechnology company and we have not yet generated any revenue from product sales. Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.
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It generally takes companies many years to satisfy the FDA approval requirements, but this varies substantially based upon the type, complexity, and novelty of the drug or disease. Pre-clinical tests include laboratory evaluation of a drug’s chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the drug.
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Our operations to date have been limited to developing our technology and undertaking clinical trials of our product candidates lanifibranor and odiparcil, and pre-clinical and clinical studies of other compounds in development. Lanifibranor is in clinical development and has not been approved for sale, and we may never have any product approved for commercialization.
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The conduct of the pre-clinical tests must comply with federal regulations and requirements, including GLP. The company submits the results of the pre-clinical testing to the FDA as part of an IND along with other information, including information about the product drug’s chemistry, manufacturing and controls, and a proposed clinical study protocol.
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We decided to focus our clinical efforts on the development of lanifibranor and suspend our clinical efforts relating to odiparcil, and we are reviewing available options to optimize potential further development of odiparcil for the treatment of MPS VI and may seek a third-party partner to help pursue any potential development and commercialization of odiparcil.
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Long term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after submitting the initial IND. The FDA requires a 30-day waiting period after the submission of each IND before the company can begin clinical testing in humans.
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We have not yet demonstrated an ability to overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical area. Consequently, the ability to predict our future operating results or business prospects is more limited than if we had a longer operating history or approved products on the market.
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The FDA may, within the 30-day time period, raise concerns or questions relating to one or more proposed clinical studies and place the study on a clinical hold. In such a case, the company and the FDA must resolve any outstanding concerns before the company begins the clinical study.
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Our ability to generate revenue from product sales and achieve and maintain profitability depends on our ability, alone or with any current or future partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, lanifibranor, odiparcil and any additional product candidates that we may pursue in the future.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeAlthough the FDA’s guidance during a consultation preceding the January 2023 protocol amendments was to continue our NATiV3 trial as originally planned, the FDA did not object to the January 2023 protocol amendments, which we expected to improve enrollment rates and compress the time to completion of the trial and thus benefit the overall lanifibranor clinical program by: * reducing the number of biopsies a patient undergoes during the trial from three, as originally planned, to two, * reducing the trial duration a patient has to consent to from 7 years, as originally planned, to 72 weeks, * offering all patients in the trial access to a lanifibranor treatment for at least 48 weeks by allowing them to enter into a new active treatment extension study, and * potentially expanding the addressable patient population to include patients with NASH and compensated cirrhosis through the conduct of an additional Phase III trial, rather than the originally planned Part 2 of our NATiV3 Phase III clinical trial of lanifibranor in NASH.
Biggest changeAlthough the FDA’s guidance during a consultation preceding the January 2023 protocol amendments was to continue our NATiV3 trial as originally planned, the FDA did not object to the January 2023 protocol amendments, which we expected to compress the time to completion of the trial and thus benefit the overall lanifibranor clinical program by: ● reducing the number of biopsies a patient undergoes during the trial from three, as originally planned, to two, ● reducing the trial duration a patient has to consent to from 7 years, as originally planned, to 72 weeks, ● offering all patients in the trial access to a lanifibranor treatment for at least 48 weeks by allowing them to enter into a new active treatment extension study, and ● potentially expanding the addressable patient population to include patients with MASH and compensated cirrhosis through an additional Phase 3 trial, rather than the originally planned Part 2 of our NATiV3 Phase 3 clinical trial of lanifibranor in MASH. 72 Table of Contents The NATiV3 trial, including the amended protocol, has been designed as a double-blind, placebo-controlled global pivotal Phase 3 clinical trial to assess the potential benefit of lanifibranor treatment on liver-related clinical outcomes.
We have built a pipeline backed by a discovery engine with an extensive library of proprietary molecules, a wholly-owned research and development facility and a team with significant expertise and experience in the development of compounds that target nuclear receptors, transcription factors and epigenetic modulation.
We have built a pipeline backed by a specialized discovery engine with an extensive library of proprietary molecules, a wholly-owned research and development facility and a team with significant expertise and experience in the development of compounds that target nuclear receptors, transcription factors and epigenetic modulation.
In addition, our Fast Track and Breakthrough Designations may be negatively impacted as well as our ability to develop and commercialize our product candidates, including lanifibranor, and our prospects. Even if we ultimately obtain approval of our product candidates, including lanifibranor, competitors may negatively impact our revenues and ability to achieve milestones.
In addition, our Fast Track and Breakthrough Designations may be negatively impacted as well as our ability to develop and commercialize our product candidates, including lanifibranor. Even if we ultimately obtain approval of our product candidates, including lanifibranor, competitors may negatively impact our revenues and ability to achieve milestones.
If the results of the outcome trial in patients with NASH and compensated cirrhosis confirm sufficient clinical benefit, we anticipate the results will be used in our planned submission of an NDA to the FDA for full approval and the potential expansion of the addressable patient population beyond patients with F2 and F3 fibrosis to include patients with NASH and compensated cirrhosis, a patient population at an increased risk of liver-related morbidity and mortality and for which the anti-fibrotic properties of lanifibranor could potentially prevent worsening of the disease.
If the results of the outcome trial in patients with MASH and compensated cirrhosis confirm sufficient clinical benefit, we anticipate the results will be used in our planned submission of an NDA to the FDA for full approval and the potential expansion of the addressable patient population beyond patients with F2 and F3 fibrosis to include patients with MASH and compensated cirrhosis, a patient population at an increased risk of liver-related morbidity and mortality and for which the anti-fibrotic properties of lanifibranor could potentially prevent worsening of the disease.
The LEGEND trial was a proof-of-concept intended to demonstrate proof of concept and the potential additional benefits of the combination between lanifibranor and empagliflozin and the possibility to address the weight gain observed in some patients treated with lanifibranor alone.
The LEGEND trial was intended to demonstrate proof of concept and the potential additional benefits of the combination between lanifibranor and empagliflozin and the possibility to address the weight gain observed in some patients treated with lanifibranor alone.
Under the new trial design, the originally-planned Part 2 of the NATiV3 trial, a clinical outcome trial that was planned to be conducted in approximately 2,000 patients with F2 and F3 fibrosis for a maximum period of seven years, will be replaced by a placebo-controlled Phase III outcome trial which will be event driven and is expected to last approximately three years depending on patient enrollment.
Under the new trial design, the originally-planned Part 2 of the NATiV3 trial, a clinical outcome trial that was planned to be conducted in approximately 2,000 patients with F2 and F3 fibrosis for a maximum period of seven years, will be replaced by a placebo-controlled Phase 3 outcome trial which will be event driven and is expected to last approximately three years, depending on patient enrollment.
PPARs are well-characterized nuclear receptor proteins that regulate gene expression, and their relevance for the fibrotic, inflammatory, vascular and metabolic processes that characterize NASH is well-established. While there are other PPAR agonists that target only one or two PPAR isoforms, lanifibranor is the only pan-PPAR agonist, meaning that it targets the three isoforms, in clinical development.
PPARs are well-characterized nuclear receptor proteins that regulate gene expression, and their relevance for the fibrotic, inflammatory, vascular and metabolic processes that characterize MASH is well-established. While there are other PPAR agonists that target only one or two PPAR isoforms, lanifibranor is the only pan-PPAR agonist, meaning that it targets the three isoforms, in clinical development.
The study achieved the primary efficacy endpoint with an absolute reduction in Hemoglobin A1c, or HbA1c, of 1.14% and 1.59% in patients with NASH and T2D treated with lanifibranor (800mg daily) or in combination with empagliflozin (10mg daily) at week 24 compared to an increase of 0.26% observed in the placebo arm.
The study achieved the primary efficacy endpoint with an absolute reduction in Hemoglobin A1c, or HbA1c, of 1.14% and 1.59% in patients with MASH and T2D treated with lanifibranor (800mg daily) or in combination with empagliflozin (10mg daily) at week 24 compared to an increase of 0.26% observed in the placebo arm.
Lanifibranor is an orally-available small molecule in development for the treatment of NASH that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor, or PPAR, isoforms.
Lanifibranor is an orally-available small molecule in development for the treatment of MASH that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor, or PPAR, isoforms.
In September 2021, the FDA decided that the Fast Track designation previously granted to lanifibranor in NASH also encompasses the treatment of NASH patients with compensated cirrhosis. We believe that lanifibranor is the first oral drug candidate to be granted this status for the treatment of NASH since January 2015.
In September 2021, the FDA decided that the Fast Track designation previously granted to lanifibranor in MASH also encompasses the treatment of MASH patients with compensated cirrhosis. We believe that lanifibranor is the first oral drug candidate to be granted this status for the treatment of MASH since January 2015.
The trial was double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm. The diagnosis of non-cirrhotic NASH was based on historic histology evaluation or a combination of non-invasive methods including diagnostic methods including imaging.
The trial was double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm. The diagnosis of non-cirrhotic MASH was based on historic histology evaluation or a combination of non-invasive methods including diagnostic methods including imaging.
In October 2021, we announced the publication of results from our NATIVE Phase IIb clinical trial in the New England Journal of Medicine. In December 2021, we announced positive results of a clinical QT/QTc study demonstrating lanifibranor had no impact on QT/QTc intervals.
In October 2021, we announced the publication of results from our NATIVE Phase 2b clinical trial in the New England Journal of Medicine. In December 2021, we announced positive results of a clinical QT/QTc study demonstrating lanifibranor had no impact on QT/QTc intervals.
Using these assets and this expertise, we focus on discovering small molecule compounds that target nuclear receptors, transcription factors and epigenetic modulation with the goal of identifying and developing compounds addressing a wide range of indications.
Using these assets and this expertise, we focused on discovering small molecule compounds that target nuclear receptors, transcription factors and epigenetic modulation with the goal of identifying and developing compounds addressing a wide range of indications.
NASH is characterized by a metabolic process known as steatosis, or the excessive accumulation of fat in the liver, inflammation and ballooning of liver cells and progressive liver fibrosis that can ultimately lead to cirrhosis.
MASH is characterized by a metabolic process known as steatosis, or the excessive accumulation of fat in the liver, inflammation and ballooning of liver cells and progressive liver fibrosis that can ultimately lead to cirrhosis.
This study assessed lanifibranor impact on cardiac repolarization and was conducted in accordance with FDA guidance in a Phase I double-blind clinical trial. The QT/QTc study was conducted in 217 healthy subjects who were randomized into 4 arms: placebo, lanifibranor 1200mg/day, lanifibranor 2400 mg/day and moxifloxacin 400mg/ day (positive control).
This study assessed lanifibranor’s impact on cardiac repolarization and was conducted in accordance with FDA guidance in a Phase 1 double-blind clinical trial. The QT/QTc study was conducted in 217 healthy subjects who were randomized into 4 arms: placebo, lanifibranor 1200mg/day, lanifibranor 2400 mg/day and moxifloxacin 400mg/ day (positive control).
This result is consistent with the Phase IIb NATiVE trial findings, in which lanifibranor demonstrated a statistically significant effect on steatosis reduction as measured by CAP/Fibroscan.
This result is consistent with the Phase 2b NATiVE trial findings, in which lanifibranor demonstrated a statistically significant effect on steatosis reduction as measured by CAP/Fibroscan.
The address of that site is http://www.sec.gov. Our website address is www.inventivapharma.com. The reference to our website is an inactive textual reference only and information contained in, or that can be accessed through, our website or any other website cited in this annual report is not part of this annual report. ​ 72 Table of Contents B.
The address of that site is http://www.sec.gov. Our website address is www.inventivapharma.com. The reference to our website is an inactive textual reference only and information contained in, or that can be accessed through, our website or any other website cited in this annual report is not part of this annual report. B.
As planned per protocol, the interim analysis was done once half of the 63 planned randomized patients with NASH completed the 24-week treatment period or prematurely discontinued from treatment.
As planned per protocol, the interim analysis was done once half of the 63 planned randomized patients with MASH completed the 24-week treatment period or prematurely discontinued from treatment.
We plan to selectively form research, development and commercial strategic partnerships around product candidates or disease areas that we believe could benefit from the resources of either larger biopharmaceutical companies or those specialized in a particular area of relevance.
We plan to selectively form research, development and commercial strategic partnerships around lanifibranor or disease areas that we believe could benefit from the resources of either larger biopharmaceutical companies or those specialized in a particular area of relevance.
The protocol amendments, submitted to the FDA in January 2023, were designed to align with an FDA public communication suggesting that an alternative approach to seek full approval in patients with NASH could be considered upon submission of positive results of a Phase III trial using a histology surrogate endpoint in patients with NASH and a Phase III clinical outcome trial in patients with NASH and compensated cirrhosis.
The protocol amendments, submitted to the FDA in January 2023, were designed to align with an FDA public communication suggesting that an alternative approach to seek full approval in patients with MASH could be considered upon submission of positive results of a Phase 3 trial using a histology surrogate endpoint in patients with MASH and a Phase 3 clinical outcome trial in patients with MASH and compensated cirrhosis.
The Phase II clinical trial randomized 38 patients into two arms, with patients receiving placebo or treatment with lanifibranor at 800mg/day for 24 weeks.
The Phase 2 clinical trial randomized 38 patients into two arms, with patients receiving placebo or treatment with lanifibranor at 800mg/day for 24 weeks.
We do not expect to further study the combination of lanifibranor and empagliflozin but expect to include the safety data from the LEGEND trial in a potential submission for marketing approval. 75 Table of Contents In June 2023, we announced positive topline results of the investigator-initiated Phase II clinical trial evaluating lanifibranor in patients with NAFLD and T2D.
We do not expect to further study the combination of lanifibranor and empagliflozin but expect to include the safety data from the LEGEND trial in a potential submission for marketing approval. In June 2023, we announced positive topline results of the investigator-initiated Phase 2 clinical trial evaluating lanifibranor in patients with NAFLD and T2D.
NASH is believed to affect up to 12% of the United States adult population and is a leading cause of cirrhosis, liver transplantation and liver cancer. Compared to the general population, patients with NASH have a ten-fold greater risk of liver-related mortality.
MASH is believed to affect up to 12% of the United States adult population and is considered as a leading cause of cirrhosis, liver transplantation and liver cancer. Compared to the general population, patients with MASH have a ten-fold greater risk of liver-related mortality.
Item 4. Information on the Company. A. History and Development of the Company We were founded in 2011 and incorporated in France under the legal name Inventiva S.A. as a société anonyme, or S.A., in 2016.
Item 4. Information on the Company. A. History and Development of the Company We were founded in 2011 and incorporated in France in 2016 under the legal name Inventiva S.A. as a société anonyme, or S.A., for a period of 99 years.
We have entered into agreements with CTTQ to support the clinical development and potential commercialization of lanifibranor in China and with Hepalys to develop and commercialize lanifibranor for the treatment of NASH in the Hepalys Territory, if approved, and we are also evaluating other potential partnerships and arrangements for the clinical development and potential commercialization of lanifibranor. ● Potentially Optimize the Development of Odiparcil .
We have entered into agreements with CTTQ to support the clinical development and potential commercialization of lanifibranor in China and with Hepalys to develop and commercialize lanifibranor for the treatment of MASH in the Hepalys Territory, if approved, and we are also evaluating other potential partnerships and arrangements for the clinical development and potential commercialization of lanifibranor.
Our actual capital expenditures for the years ended December 31, 2023, 2022 and 2021 amounted to €539,827, €561,000 and €534,000, respectively. These capital expenditures primarily consisted of acquisition of research equipment and technical installation. The SEC maintains an Internet site that contains reports, proxy information statements and other information regarding issuers that file electronically with the SEC.
Our actual capital expenditures for the years ended December 31, 2024, 2023 and 2022 amounted to €422,385, €539,827, and €561,000, respectively. These capital expenditures primarily consisted of acquisition of research equipment and technical installation in France. The SEC maintains an Internet site that contains reports, proxy information statements and other information regarding issuers that file electronically with the SEC.
On October 12, 2020, the FDA granted Breakthrough Therapy Designation to lanifibranor for the treatment of NASH based on Phase IIb data, in addition to Fast Track designation which was previously granted to lanifibranor in this indication.
On October 2020, the FDA granted Breakthrough Therapy Designation to lanifibranor for the treatment of MASH based on Phase 2b data, in addition to Fast Track designation which was previously granted to lanifibranor in this indication.
Business Overview Overview We are a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis, or NASH, and other diseases with significant unmet medical need.
Business Overview Overview We are a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of MASH and other diseases with significant unmet medical need.
Please see above “Item 4.B Information on the Company—Business Overview—Overview—Lanifibranor for the Treatment of NASH” for information about the clinical trials evaluating lanifibranor. Lanifibranor has received Fast Track Designation from the FDA for the treatment of NASH.
Please see above “ Item 4.B Information on the Company-Business Overview—Overview—Lanifibranor for the Treatment of MASH ” for information about the clinical trials evaluating lanifibranor. Lanifibranor has received Fast Track Designation from the FDA for the treatment of MASH.
In addition, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach.
In addition, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach. For more information, please see “
The Phase III outcome trial is expected to randomize approximately 800 patients with NASH and compensated cirrhosis.
The Phase 3 outcome trial is expected to randomize approximately 800 patients with MASH and compensated cirrhosis.
Based on the broad anti-fibrotic and anti-inflammatory properties, as well as beneficial vascular and metabolic effects, of lanifibranor observed in pre-clinical and clinical development to date, we may also pursue development of lanifibranor for the treatment of NASH patients with stage 4 fibrosis, which is considered cirrhosis of the liver.
Based on the broad anti-fibrotic and anti-inflammatory properties, as well as beneficial vascular and metabolic effects, of lanifibranor observed in pre-clinical and clinical development to date, we may also pursue development of lanifibranor for the treatment of MASH patients with compensated cirrhosis.
In March 2024, Madrigal announced that it had received FDA approval of Rezdiffra for the treatment of patients with NASH with moderate to advanced liver fibrosis. In addition to Madrigal, other competitors could obtain marketing authorization in the indications targeted by us.
In March 2024, Madrigal announced that it had received FDA approval of Rezdiffra for the treatment of patients with MASH with moderate to advanced liver fibrosis and are expected to receive a marketing authorization response from the EMA in 2025. In addition to Madrigal, other competitors could obtain marketing authorization in the indications targeted by us.
For the potential development of odiparcil, we had proposed to the FDA a potential single 52-week randomized, double-blind, placebo-controlled trial, followed by a 52-week safety extension with fifty MPS VI patients aged 5 to 15 receiving placebo or a low or high dose of odiparcil, depending on the patient’s weight, with approval potentially being sought after the initial 52 weeks of treatment if the primary end-point of improvement of a 6-minute walk test were met.
This plan is expected to be implemented in the course of the second quarter of 2025, subject to ongoing negotiations with our Worker’s Council. 74 Table of Contents For the previous potential development of odiparcil, we had proposed to the FDA a potential single 52-week randomized, double-blind, placebo-controlled trial, followed by a 52-week safety extension with fifty MPS VI patients aged 5 to 15 receiving placebo or a low or high dose of odiparcil, depending on the patient’s weight, with approval potentially being sought after the initial 52 weeks of treatment if the primary end-point of improvement of a 6-minute walk test were met.
Odiparcil is an orally-available small molecule designed to modify how GAGs are synthesized. Odiparcil acts to facilitate the production of soluble GAGs that can be excreted in the urine, rather than accumulating in cells. Odiparcil has received orphan drug designation from the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of MPS VI.
Odiparcil acts to facilitate the production of soluble GAGs that can be excreted in the urine, rather than accumulating in cells. Odiparcil has received orphan drug designation from the FDA and EMA and Rare Pediatric Disease Designation from the FDA for the treatment of MPS VI. Discovery Engine .
As part of the clinical development program of lanifibranor, we entered into an agreement with CTTQ in September 2022 to support the clinical development and potential commercialization of lanifibranor in China.
As part of the clinical development program of lanifibranor, we entered into an agreement with CTTQ in September 2022 to support the clinical development and potential commercialization of lanifibranor in China and with Hepalys to develop and commercialize lanifibranor for the treatment of MASH in the Hepalys Territory, if approved.
As of the date of this report, approximately 70 Phase I, II and III clinical trials enrolling patients are listed on the clinicaltrials.gov website.
As of the date of this report, approximately 76 Phase 1, 2 and 3 clinical trials enrolling patients are listed on the clinicaltrials.gov website.
Lanifibranor was well tolerated at both dose levels. 73 Table of Contents In light of the results of our NATiVE Phase IIb clinical trial of lanifibranor in patients with NASH, we initiated a Phase III clinical trial of lanifibranor in NASH, NATiV3, in the second half of 2021.
Lanifibranor was well tolerated at both dose levels. In light of the results of our NATiVE Phase 2b clinical trial of lanifibranor in patients with MASH, we initiated a Phase 3 clinical trial of lanifibranor in MASH, NATiV3, in September 2021.
Treatment with lanifibranor at doses of 800 mg and 1,200 mg also met the key secondary endpoints of resolution of NASH with no worsening of fibrosis and, at the 1,200 mg dose, improvement in liver fibrosis without worsening NASH, which are the primary endpoints relevant for seeking accelerated approval from the U.S.
Treatment with lanifibranor at doses of 800 mg/day and 1,200 mg/day also met the key secondary endpoints of resolution of MASH with no worsening of fibrosis and, at the 1,200 mg/day dose, improvement in liver fibrosis without worsening MASH, which are the primary endpoints relevant for seeking accelerated approval from the FDA and conditional approval from the EMA, after completion of our Phase 3 clinical trial, if successful.
Discovery Engine . We have a scientific team of approximately 90 people with deep biology, medicinal and computational chemistry, pharmacokinetics, pharmacology and clinical development expertise. We also own a library of approximately 240,000 pharmacologically relevant molecules, 60% of which are proprietary, as well as a wholly-owned research and development facility.
As of December 31, 2024, we have a scientific team of approximately 90 people. We also own a library of approximately 240,000 pharmacologically relevant molecules, 60% of which are proprietary, as well as a wholly-owned research and development facility.
Our second clinical-stage asset is odiparcil, which we were previously developing for the treatment of patients with mucopolysaccharidoses, or MPS, a group of rare genetic disorders characterized by an excessive accumulation of large sugar chains, known as glycosaminoglycans, or GAGs, in cells.
The treatment with lanifibranor 800mg/once daily was well tolerated, with no safety concerns reported. Odiparcil for the Treatment of MPS . We were previously developing odiparcil for the treatment of patients with mucopolysaccharidoses, or MPS, a group of rare genetic disorders characterized by an excessive accumulation of large sugar chains, known as glycosaminoglycans, or GAGs, in cells.
This competition may have a negative effect on our ability to recruit patients into our clinical trials, as certain patients could prefer to undergo treatment that has obtained a marketing authorization, such as Rezdiffra from Madrigal or others that may obtain a marketing authorization in the future, rather than participate or continue their participation in an ongoing clinical study with the possibility of being assigned to the placebo-controlled part.
Other companies, including Sagimet, Boston Pharmaceutical, Altimmune, AstraZeneca, Lilly, NorthSea, Terns, Viking, BMS, Pfizer, Regeneron and Gilead Sciences have drug candidates for the treatment of MASH that are in less advanced clinical or pre-clinical development stages. 76 Table of Contents This competition may have a negative effect on our ability to recruit patients into our clinical trials, as certain patients could prefer to undergo treatment that has obtained a marketing authorization, such as Rezdiffra from Madrigal or others that may obtain a marketing authorization in the future, rather than participate or continue their participation in an ongoing clinical study with the possibility of being assigned to the placebo-controlled part.
We anticipate submission of a new drug application, or NDA, to the FDA for accelerated approval based on liver histological endpoints of approximately 900 patients treated over a 72-week period for our Phase III trial, if the data is positive.
Patients will be randomized 1:1:1 to receive lanifibranor (800mg once daily or 1200mg once daily) or placebo. We anticipate submission of an NDA to the FDA for accelerated approval based on liver histological endpoints of approximately 950 patients treated over a 72-week period for our Phase 3 trial, if the data is positive.
In March 2024, we announced positive results from our LEGEND trial, a multi-center, randomized, 24-week treatment, placebo-controlled Phase II Proof-of-Concept trial to assess the safety and efficacy of lanifibranor in combination with the SGLT2 inhibitor empagliflozin for the treatment of patients with non-cirrhotic NASH and T2D.
We completed randomization of the last patient in NATiV3 in April 2025 and target the publication of the topline results for the second half of 2026, and the potential NDA submission for the first half of 2027. 73 Table of Contents In March 2024, we announced positive results from our LEGEND trial, a multi-center, randomized, 24-week treatment, placebo-controlled Phase 2 Proof-of-Concept trial to assess the safety and efficacy of lanifibranor in combination with the SGLT2 inhibitor empagliflozin for the treatment of patients with non-cirrhotic MASH and T2D.
Leveraging these assets and expertise, we are advancing lanifibranor for the treatment of NASH, as well as a pipeline of earlier stage programs in oncology and other diseases with significant unmet medical need. Lanifibranor for the Treatment of NASH . We are developing our lead product candidate, lanifibranor, for the treatment of patients with NASH, a progressive, chronic liver disease.
Leveraging our expertise, we are advancing lanifibranor for the treatment of MASH and have a pipeline of earlier stage therapeutic programs in oncology and other diseases with significant unmet medical need.
If our product candidates fail to gain regulatory approvals and acceptance in their intended markets, we may not generate meaningful revenues or achieve profitability. 78 Table of Contents Intellectual Property Our success will significantly depend upon our ability to obtain and maintain patent and other intellectual property and proprietary protection for our drug candidates in the United States and internationally, including composition-of-matter, dosage and formulation patents, as well as patent and other intellectual property and proprietary protection for our novel biological discoveries and other important technology inventions and know-how.
Intellectual Property Our success will significantly depend upon our ability to obtain and maintain patent and other intellectual property and proprietary protection for our drug candidates particularly in the United States, Europe, China and Japan, including composition-of-matter, dosage and formulation patents, as well as patent and other intellectual property and proprietary protection for our novel biological discoveries and other important technology inventions and know-how.
It is anticipated that these studies could support, if positive, the initiation of a dedicated pivotal trial in patients with NASH in the Hepalys Territory, which is planned to start once the results of our ongoing NATiV3 trial are available. 74 Table of Contents In the first quarter of 2024 following a routine visit in our NATiV3 clinical trial of lanifibranor in NASH, an adverse event of elevated aminotransferases in liver tests in a patient enrolled in the trial was reported.
If positive, this trial is expected to support the initiation of a dedicated pivotal trial in patients with MASH in the Hepalys Territory, which is planned to start once the results of NATiV3 are available. On February 15, 2024, an adverse event of elevated aminotransferases in liver tests in a patient enrolled in the trial was reported.
In August 2022, we received feedback from the FDA that a single Phase II/III clinical trial with odiparcil in children with MPS VI could potentially support a marketing application.
In August 2022, we received feedback from the FDA that a single Phase 2/3 clinical trial with odiparcil in children with MPS VI could potentially support a marketing application. Odiparcil is an orally-available small molecule designed to modify how GAGs are synthesized.
As part of this decision, we may seek a strategic partner to help pursue the development of odiparcil in MPS patients. Competition The commercialization of new drugs is competitive, and we may face worldwide competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies and ultimately generic companies.
Competition The commercialization of new drugs is competitive, and we may face worldwide competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies and ultimately generic companies.
CTTQ joined our ongoing NATiV3 Phase III clinical trial evaluating lanifibranor in NASH with the randomization of the first patient in China in 2023, and has initiated a Phase I clinical pharmacology study in parallel. ● Leverage the Power of Our Discovery Engine to Identify and Advance Additional Novel Programs in Areas with High Unmet Medical Need .
CTTQ joined our ongoing NATiV3 Phase 3 clinical trial evaluating lanifibranor in MASH with the randomization of the first patient in China in 2023, and has initiated a Phase 1 clinical pharmacology study in parallel.
There is no assurance that we will achieve the anticipated benefits of any protocol amendments or additional measures we have made or may make in the future. In December 2023, we announced that our partner CTTQ, who joined our NATiV3 trial, randomized the first patient in China and that lanifibranor was granted Breakthrough Therapy Designation for NASH by the NMPA.
In December 2023, we announced that our partner CTTQ, who joined our NATiV3 trial, randomized the first patient in China and that lanifibranor was granted Breakthrough Therapy Designation for MASH by the Chinese NMPA.
We believe that this pan-PPAR approach provides for a combination of anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic effects that cannot be obtained with single and dual PPAR agonists. Currently, lanifibranor is our only product candidate in clinical development. In June 2020, we announced positive topline results from our NATIVE Phase IIb clinical trial of lanifibranor in patients with NASH.
We believe that this pan-PPAR approach provides for a combination of anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic effects that cannot be obtained with single and dual PPAR agonists.
In July 2020, we completed the initial public offering of our ordinary shares in the form of American Depositary Shares, or ADSs, on the Nasdaq Global Market, raising approximately $107.7 million in gross proceeds (or €94.1 million based on exchange rate on July 15, 2020, the date of receipt of funds).
In February 2017, we completed the initial public offering of our ordinary shares on Euronext Paris and in July 2020, we completed the initial public offering of our ordinary shares in the form of American Depositary Shares, or ADSs, on the Nasdaq Global Market.
We anticipate that this exploratory cohort may allow the generation of additional results using non-invasive tests and contribute to the safety database requirement to support the planned submission for potential accelerated approval.
A placebo-controlled exploratory cohort has been initiated in parallel to the NATiV3 trial and will include approximately 350 patients with MASH and fibrosis who are not eligible for the NATiV3 trial. We anticipate that this exploratory cohort may generate additional results using non-invasive tests and contribute to the safety database requirement to support the planned submission for potential accelerated approval.
For example, Novo Nordisk is conducting a Phase III clinical study for the treatment of NASH with its lead molecule semaglutide, which is already marketed for the treatment of type 2 diabetes and obesity, and Akero Therapeutics and 89 Bio are also evaluating their respective investigational NASH medications in a Phase III clinical trials.
For example, Novo Nordisk announced in November 2024 the positive results of their Phase 3 clinical trial for the treatment of NASH with its lead molecule semaglutide, which is already marketed for the treatment of type 2 diabetes and obesity, and is expected to submit a marketing authorization application in 2025.
For example, we are in the process of selecting a development candidate for our Hippo program, which we anticipate entering pre-clinical development in 2024. 77 Table of Contents ● Selectively Seek Strategic Partnerships to Maximize the Value of Our Assets . Our differentiated product candidates and robust discovery engine may enable us to address a wide variety of indications.
On July 25, 2024, we announced that we had been granted a new patent in Japan, extending the protection of lanifibranor’s intellectual property. ● Selectively Seek Strategic Partnerships to Maximize the Value of Our Assets . Our differentiated product candidates and robust discovery engine may enable us to address a wide variety of indications.
Our agent for service of process in the United States is Cogency Global Inc., 122 East 42 nd Street, 18 th Floor, New York, New York 10168. In February 2017, we completed the initial public offering of our ordinary shares on Euronext Paris, raising €48.5 million in gross proceeds.
Our agent for service of process in the United States is Cogency Global Inc., 122 East 42nd Street, 18th Floor, New York, New York 10168.
In January 2023, we announced that we had decided to modify the clinical development plan of lanifibranor for the treatment of NASH.
As announced in 2020, we have decided to focus our clinical efforts on the development of lanifibranor for the treatment of MASH.
We are currently targeting: the last patient first visit for the first half of 2024, the randomization of the last patient for the second half of 2024, the last patient last visit for the first half of 2026, the publication of the topline results for the first half of 2026, and the NDA submission for the second half of 2026.
We target the publication of the topline results for the second half of 2026, and the potential NDA submission for the first half of 2027. In January 2023, we announced modifications to the clinical development plan of lanifibranor for the treatment of MASH.
Although we believe our product candidates possess attractive attributes, we cannot ensure that our product candidates will achieve regulatory or market acceptance.
Although we believe lanifibranor possesses attractive attributes, we cannot ensure that it will achieve regulatory or market acceptance. If lanifibranor fails to gain regulatory approvals and acceptance in its intended markets, we may not generate meaningful revenues or achieve profitability.
Our goal is to rapidly deliver multiple, novel and differentiated oral small molecule therapies to patients suffering from NASH, MPS, cancer and other diseases with significant unmet medical need. To work towards achieving our goal, we are pursuing the following strategies: ● Demonstrate the Safety and Efficacy of Lanifibranor in the Treatment of NASH with Two Pivotal Clinical Trials.
Our Pipeline ​ ​ 75 Table of Contents Following the announcement of the 2025 Pipeline Prioritization Plan, our goal is to prioritize all activities pertaining to lanifibranor pursuing to the following strategies: ● Demonstrate the Safety and Efficacy of Lanifibranor in the Treatment of MASH with Two Pivotal Clinical Trials.
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In August 2021, we established the 2021 ATM Program for an aggregate gross sales proceeds of up to $100 million in August 2021 and raised $30 million in gross proceeds through that program in September 2021, $1.9 million in October 2021, and €9.4 million in June 2022.
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In February 2025, we informed the representatives of our Worker’s Council of our 2025 Pipeline Prioritization Plan to focus exclusively on the development of lanifibranor, to expand the lanifibranor program team to prepare for potential filings for marketing approval and, if approved, the subsequent commercialization of lanifibranor for patients with MASH, and to stop all pre-clinical research activities related to pre-clinical programs, including the termination of the YAP-TEAD and NR4A1 programs.
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In September 2023, we terminated the 2021 ATM Program and established the new 2023 ATM Program for an aggregate offering price of up to $58.0 million.
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This plan is expected to be implemented in the course of the second quarter of 2025, subject to ongoing negotiations with our Worker’s Council. Lanifibranor for the Treatment of MASH . We are developing lanifibranor for the treatment of patients with metabolic dysfunction-associated steatohepatitis, a progressive, chronic liver disease.
Removed
On August 31, 2023, we announced a financing of €35.7 million, in gross proceeds, consisting of two transactions: (i) a capital increase reserved to specified categories of investors through the issuance of 9,618,638 newly-issued ordinary shares, at a subscription price of €3.18 per share and aggregate gross proceeds of €30.6 million and (ii) the issuance of Royalty Certificates for an aggregate amount of €5.1 million.
Added
Currently, lanifibranor is our only product candidate in development. 71 Table of Contents In June 2020, we announced positive topline results from our NATIVE Phase 2b clinical trial (Nash Trial to Validate IVA337 Efficacity) of lanifibranor in patients with MASH.
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Food and Drug Administration, or FDA, and conditional approval from the European Medical Agency, or EMA, after completion of our Phase III clinical trial, if successful.
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There is no assurance that we will achieve the anticipated benefits of any protocol amendments or additional measures we have made or may make in the future.
Removed
However, due to the invasion of Ukraine by Russia in 2022, we determined to put recruitment for our NATiV3 trial in Ukraine on hold and to remove all of the planned sites in Russia from the trial.
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In the first quarter of 2025, Hepalys initiated the clinical development program of lanifibranor with the first dosing of the first participant in a Phase 1 trial in Japan in patients and healthy volunteers.
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In addition, from 2021 until mid-2023 we faced a higher than originally projected screen failure rate resulting in slower than anticipated enrollment rate, which caused a delay in the enrollment of patients in the trial, and we saw slower than predicted site activation, screening and enrollment due to negative impacts from the COVID-19 pandemic in 2020 and 2021.
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As of the date of this annual report, we have not found a suitable option to optimize the development of odiparcil for the treatment of MPS VI, which may include entering into a partnership with a third party for the development and commercialization of odiparcil.
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The NATiV3 trial, including the amended protocol, has been designed as a double-blind, placebo-controlled global pivotal Phase III clinical trial to assess the potential benefit of lanifibranor treatment on liver-related clinical outcomes. Patients will be randomized 1:1:1 to receive lanifibranor (800mg once daily or 1200mg once daily) or placebo.
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In February 2025, we informed the representatives of our Worker’s Council of our 2025 Pipeline Prioritization Plan to focus exclusively on the development of lanifibranor and to stop all pre-clinical research activities related to pre-clinical programs, including the termination of the YAP-TEAD and NR4A1 programs.
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A placebo-controlled exploratory cohort has been initiated in parallel to the NATiV3 trial and will include approximately 200 patients with NASH and fibrosis who are not eligible for the NATiV3 trial.
Added
In February 2025, we informed the representatives of our Worker’s Council of our 2025 Pipeline Prioritization Plan to focus exclusively on the development of lanifibranor and to stop all pre-clinical research activities related to pre-clinical programs, including the termination of the YAP-TEAD and NR4A1 programs.
Removed
In addition, our partner Hepalys is expected to conduct two Phase I clinical trials in patients and healthy volunteers in Japan.
Added
According to this plan, our workforce should comprise a development team of 38 people in total, and also include a research position to continue supporting lanifibranor’s pre-clinical activities until the end of 2025.
Removed
Prior to the voluntary pause, 478 sites were activated in 24 countries, 913 patients were randomized, including 731 in the main cohort, and over 550 patients were in screening. On March 7, 2024, we announced that we had lifted this voluntary pause.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe components of our research and development expenses were as follows for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2022 2023 % change Research, pre‑clinical study and clinical trial expenses ​ 42,375 ​ 88,162 108 % Personnel costs, other than share‑based compensation ​ 9,751 ​ 10,895 12 % Share‑based compensation expense ​ 1,397 ​ 2,673 91 % Other expenses ​ 6,945 ​ 8,283 19 % Total research and development expenses ​ 60,469 ​ 110,012 82 % ​ The increase in our research and development expenses was primarily the result of (i) a €45.8 million increase in research, pre-clinical study and clinical trial expenses, mainly related to research and development for lanifibranor, particularly for the NATiV3 Phase III trial and the LEGEND Phase IIa trial; (ii) a €1.1 million increase related to salary increases and the increase in the headcount of the development and executive team working on the lanifibranor trials; (iii) a €1.3 million increase in share-based compensation expense related to new share-based payment plans; and (iv) a €1.3 million increase in other expenses due to the amortization costs of the right to use Fibroscans equipment.
Biggest changeResearch and Development Expenses Our research and development expenses were €90.9 million in the year ended December 31, 2024, a decrease of €19.1 million compared to research and development expenses of €110.0 million in the year ended December 31, 2023. 98 Table of Contents The components of our research and development expenses were as follows for the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2023 2024 % change Research, pre‑clinical study and clinical trial expenses ​ 88,162 ​ 68,599 (22) % Personnel costs, other than share‑based compensation ​ 10,895 ​ 10,960 1 % Share‑based compensation expense ​ 2,673 ​ 2,345 (12) % Other expenses ​ 8,283 ​ 8,977 8 % Total research and development expenses ​ 110,012 ​ 90,880 (17) % ​ The decrease in our research and development expenses was primarily the result of (i) a €19.6 million decrease in research, pre-clinical study and clinical trial expenses, mainly due to the temporary pause in the recruitment of the patients in the NATiV3 Phase 3 clinical trial of lanifibranor in MASH following the SUSAR reported in the first quarter of 2024 and, to a lesser extent, due to the completion of the LEGEND trial with lanifibranor and empagliflozin in patients with MASH and T2D; (ii) a €0.1 million increase related to salary increases; (iii) a €0.3 million decrease in share-based compensation expense related to share-based payment plans; and (iv) a €0.7 million increase in other expenses due to the amortization costs of the right to use Fibroscans equipment.
We have built a pipeline backed by a discovery engine with an extensive library of proprietary molecules, a wholly-owned research and development facility and a team with significant expertise and experience in the development of compounds that target nuclear receptors, transcription factors and epigenetic modulation.
We have built a pipeline backed by a specialized discovery engine with an extensive library of proprietary molecules, a wholly-owned research and development facility and a team with significant expertise and experience in the development of compounds that target nuclear receptors, transcription factors and epigenetic modulation.
We track certain outsourced development costs by product candidate, but we do not allocate all personnel costs or other internal costs to specific product candidates. 98 Table of Contents We expect that our research and development expenses will increase for the foreseeable future as we seek to advance development of lanifibranor and potentially other product candidates.
We track certain outsourced development costs by product candidate, but we do not allocate all personnel costs or other internal costs to specific product candidates. 96 Table of Contents We expect that our research and development expenses will increase for the foreseeable future as we seek to advance development of lanifibranor and potentially other product candidates.
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any approved product or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could impair our prospects or our business operations.
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our programs or the commercialization of any approved product or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could impair our prospects or our business operations.
Net Financial Income (Expense) Net financial income (expense) of 2023 relates primarily to interest cost, foreign exchange losses and fair value losses on derivatives, partially offset by income received from cash and cash equivalents and short-term investments. Our cash and cash equivalents have been deposited primarily in cash accounts and term deposit accounts with short maturities.
Our cash and cash equivalents have been deposited primarily in cash accounts and term deposit accounts with short maturities. Net financial income (expense) of 2023 primarily related to interest cost, foreign exchange losses and fair value losses on derivatives, partially offset by income received from cash and cash equivalents and short-term investments.
For example, in 2022, due to the Russian invasion in Ukraine, we determined to put recruitment for our NATiV3 trial in Ukraine on hold and to remove all of the planned sites in Russia from the NATiV3 trial, which, together with higher than originally projected screen failure rate resulting in slower than anticipated enrollment rate and higher than originally projected screen failure rate, contributed to a delay in patient enrollment.
For example, in 2022, we put recruitment for our NATiV3 trial on hold in Ukraine and removed all of the planned sites in Russia from the NATiV3 trial due to the Russian invasion in Ukraine, which, together with higher than originally projected screen failure rate resulting in a slower than anticipated enrollment rate, contributed to a delay in patient enrollment.
Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward Looking Statements.” The audited consolidated financial statements as of and for the years ended December 31, 2023, 2022 and 2021 were prepared in accordance with IFRS Accounting Standards, as issued by the IASB.
Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward- Looking Statements.” The audited consolidated financial statements as of and for the years ended December 31, 2024, 2023 and 2022 were prepared in accordance with IFRS Accounting Standards, as issued by the International Accounting Standards Board, or IASB.
We anticipate that our general and administrative expenses will increase in the future as we grow our support functions for the expected increase in our research and development activities and the potential commercialization of our product candidates.
We anticipate that our general and administrative expenses will increase in the future as we grow our support functions for the potential commercialization of our product candidates and a potential increase in our research and development activities.
Income Tax In 2023, 2022 and 2021, we have faced tax losses. As the recoverability of our tax losses is not considered probable in subsequent periods due to the uncertainties inherent in our business, no deferred tax assets were recognized in the consolidated financial statements as of December 31, 2023, 2022 and 2021 in connection with tax losses carry-forward.
Income Tax In 2024 and 2023, we have faced tax losses. As the recoverability of our tax losses is not considered probable in subsequent periods due to the uncertainties inherent in our business, no deferred tax assets were recognized in the consolidated financial statements as of December 31, 2024, and 2023 in connection with tax losses carry-forward.
We also anticipate continuing expenses associated with being a public company in the United States and France, including costs related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with U.S. and French exchange listing and SEC and AMF requirements, director and officer insurance premiums, and investor relations costs.
We also anticipate continuing expenses associated with being a public company in the United States and France, including costs related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with U.S. and French exchange listing and SEC and the French Financial Market Authority, or AMF, requirements, director and officer insurance premiums, and investor relations costs.
The amendments provide for reimbursement over four years, with the first payment due in July 2022 for one loan, and the first payment due in September 2022 for the two loans, €6.5 million is outstanding on December 31, 2023. - The three loans taken out in June 2022 from a syndicate of French banks, in the form of the loans guaranteed by the French government for a total amount of €5.3 million.
The amendments provide for reimbursement over four years, with the first payment due in July 2022 for one loan, and the first payment due in September 2022 for the two loans, €4.0 million is outstanding on December 31, 2024. ● The three loans taken out in June 2022 from a syndicate of French banks, in the form of the loans guaranteed by the French government for a total amount of €5.3 million.
Net Financial Income (Expense) Our net financial loss was €5.1 million for the year ended December 31, 2023.
Our net financial loss was €5.1 million for the year ended December 31, 2023.
Current taxes and deferred tax assets recognized as of December 31, 2023 are related to Inventiva Inc. In 2023, income tax expenses amount to €607 thousand. The tax expenses mainly relate to the deferred tax assets allowance of €481 thousand for Inventiva Inc.
Current taxes and deferred tax assets recognized as of December 31, 2024, are related to Inventiva Inc. In 2024, income tax expenses amount to €313 thousand. The tax expenses mainly relate to the deferred tax assets allowance of €235 thousand for Inventiva Inc. In 2023, income tax expenses amount to €607 thousand.
Bank borrowings and other loans represent a €30.9 million cash requirements as of December 31, 2023 and are related to: - The three loans taken out in May 2020 from a syndicate of French banks, in the form of the loans guaranteed by the French government for a total amount of €10.0 million in the context of the Covid-19 pandemic.
Bank borrowings and other loans represent a €49.7 million cash requirements as of December 31, 2024 and are mainly related to: ● The three loans taken out in May 2020 from a syndicate of French banks, in the form of the loans guaranteed by the French government for a total amount of €10.0 million in the context of the Covid-19 pandemic.
Investing Activities During the year ended December 31, 2023, we used €7.7 million cash in investing activities. Cash used in investing activities reflected mainly the increase in non-current financial assets of €9 million related to new deposits, and in a decrease of €0.7 million due to an anticipated reimbursement of deposit.
Cash used in investing activities reflected mainly the increase in non-current financial assets of €9 million related to new deposits, and in a decrease of €0.7 million due to an anticipated reimbursement of deposit.
Other Income We generated other income of €5.7 million in the year ended December 31, 2023, compared to other income of €6.6 million generated in the year ended December 2022, which represents a decrease of 14%.
Other Income We generated other income of €5.5 million in the year ended December 31, 2024, compared to other income of €5.7 million generated in the year ended December 2023, which represents a decrease of 3.5%.
Critical Accounting Estimates Our consolidated financial statements for the years ended December 31, 2021, 2022, and 2023 respectively, have been prepared in accordance with IFRS Accounting Standards as issued by the IASB. ​ 110 Table of Contents
Critical Accounting Estimates Our consolidated financial statements for the years ended December 31, 2022, 2023, and 2024 respectively, have been prepared in accordance with IFRS as issued by the IASB.
Cash used in operating activities mainly reflects our net loss of €110.4 million (mainly due to research and development expenses which amounted to €110 million for the year ended December 31, 2023, mainly related to research and development expenses for lanifibranor, including the NATiV3 Phase III trial, and which includes the receipt of milestone payments from CTTQ (€4.3 million after deduction of withholding tax for €0.5 million) and the receipt of the upfront payment from Hepalys (€9.5 million)) mainly compensated by an increase of €22.5 million in the working capital.
Cash used in operating activities mainly reflected our net loss of €110.4 million (mainly due to research and development expenses which amounted to €110 million for the year ended December 31, 2023, related to research and development expenses for lanifibranor, including the NATiV3 Phase 3 trial), and were partially offset by the receipt of milestone payments from CTTQ (€4.3 million after deduction of withholding tax for €0.5 million) and by the receipt of the upfront payment from Hepalys (€9.5 million).
Overview We are a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH and other diseases with significant unmet medical need.
Overview We are a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis, or MASH, and other diseases with significant unmet medical need.
For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item 5.A—Operating Results.” D. Trend Information For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.” E.
Research and Development, patents and licenses, etc. For a discussion of our research and development activities, see “ Item 4.B—Business Overview ” and “ Item 5.A—Operating Results .” D. Trend Information For a discussion of trends, see “ Item 4.B—Business Overview ,” “ Item 5.A—Operating Results ” and “ Item 5.B—Liquidity and Capital Resources .” E.
In addition, we cannot guarantee that we will be able to obtain the necessary financing or execute any transaction, through any of the foregoing measures or otherwise, to meet our needs or to obtain funds at acceptable terms and conditions, on a timely basis, or at all especially taking into account the generally challenging environment for financing of biotech companies.
In addition, we cannot guarantee that we will be able to obtain the necessary financing or execute any transaction, through any of the foregoing measures or otherwise, to meet our needs or to obtain funds at acceptable terms and conditions, on a timely basis, or at all.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we advance clinical development and prepare for potential commercialization of lanifibranor and continue our pre-clinical and research and development efforts of our other product candidates.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we advance clinical development and prepare for potential commercialization of lanifibranor.
Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, the payment of milestone and other payments, if any, under our collaborations with CTTQ and Hepalys, and any potential other partners, and our expenditures on other research and development activities.
Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on, among other factors, the timing of our clinical trials, the receipt of milestone payments and other payments, if any, under our collaborations with CTTQ and Hepalys, and any potential other partners, our expenditures on other research and development activities, and changes in fair value and interest costs.
Other income mainly consisted of CIR for 2023 and 2022 in the amounts of €5.3 million and €5.2 million recorded in 2023 and 2022 respectively.
Other income mainly consisted of CIR for 2024 and 2023 in the amounts of €4.9 million and €5.3 million recorded in 2024 and 2023, respectively.
The first milestone payment of $2 million was received in July 2023 following the NMPA’s IND approval and the second milestone of $3 million was received in December 2023 following the randomization by CTTQ of the first patient in China in the global NATiV3 Phase III clinical trial.
In 2023, we received two short-term milestone payments, the first milestone payment of $2 million was received in July 2023 for the NMPA’s IND approval and the second milestone of $3 million was received in December 2023 following the randomization by CTTQ of the first patient in China in the global NATiV3 Phase 3 clinical trial (€4.3 million total).
On August 31, 2023, we announced a financing of €35.7 million, in gross proceeds, consisting of two transactions: (i) a capital increase reserved to specified categories of investors through the issuance of 9,618,638 newly-issued ordinary shares with a nominal value of €0.01 per share, at a subscription price of €3.18 per share and aggregate gross proceeds of €30.6 million, or August 2023 Share Issuance, and (ii) the issuance of the Royalty Certificates for an aggregate amount of €5.1 million.
In August 2023, we announced a financing of €35.7 million, in gross proceeds, consisting of two transactions: (i) a capital increase through the issuance of 9,618,638 newly-issued ordinary shares at a subscription price of €3.18 per share, pursuant to which we raised €30.6 million in gross proceeds (€28.0 million in net proceeds), and (ii) the 2023 Royalty Certificates for an aggregate amount of €5.1 million.
Other Operating Income (Expenses) For the year ended December 31, 2023, our other operating income (expense) of (€44 thousand) were exclusively due to transaction costs.
For the year ended December 31, 2023, our other operating income (expense) of (€44 thousand) were exclusively due to transaction costs. Net Financial Income (Expense) Our net financial loss was €86 million for the year ended December 31, 2024.
As of the date hereof, we estimate, given our current cost structure and our projected expenditure commitments, that we should have sufficient funds to finance our activities until the beginning of the third quarter of 2024.
As of the date of authorization of the issuance of these financial statements, we estimate, given our current cost structure and our projected expenditure commitments, that we should have sufficient funds to finance our activities until the middle of the third quarter of 2025.
We decided to voluntarily pause screening and randomization to implement changes to the enrollment criteria to exclude patients diagnosed or with a predisposition to autoimmune liver or thyroid disease and more frequent liver monitoring for patients enrolled in the trial as recommended by the DMC. On March 7, 2024, we announced that we had lifted this voluntary pause.
As a result of this SUSAR, we decided to voluntarily pause screening and randomization to implement changes to the enrollment criteria to exclude patients diagnosed or with a predisposition to autoimmune liver or thyroid disease and more frequent liver monitoring for patients enrolled in the trial as recommended by the Data Monitoring Committee, or DMC.
On May 16, 2022, we entered into the Finance Contract with the EIB for up to €50 million to support our preclinical and clinical pipeline, including to fund a portion of our Phase III clinical trial of lanifibranor in patients with NASH.
On May 16, 2022, we entered into the Finance Contract with the EIB for up to €50 million to support our preclinical and clinical pipeline, including to fund a portion of our Phase 3 clinical trial of lanifibranor in patients with MASH. The Finance Contract provides for funding in two equal tranches of €25 million subject to conditions precedent.
We anticipate that our sales and marketing expenses will increase in the future as we prepare for the potential launch and commercialization of our product candidates, if approved. 99 Table of Contents Other Operating Income (Expenses) Other operating income (expense) of 2023 relates exclusively to transaction costs.
We anticipate that our sales and marketing expenses will increase in the future as we prepare for the potential launch and commercialization of our product candidates, if approved. 97 Table of Contents Other Operating Income (Expenses) Other operating income (expense) of 2024 consists of the impairment of fixed assets, inventory impairment and transactions costs.
In 2023, 2022 and 2021, the CIR corresponds to the amount of research tax credit recorded for each period and corrective claim established by us following the July 22, 2020 decision of the French administrative supreme court (“ Conseil d’Etat ”).
In 2024 and 2023, the CIR corresponds to the amount of research tax credit recorded for each period and corrective claim established by us following the July 22, 2020, decision of the French administrative supreme court ( Conseil d’Etat ). The CIR for the years ended December 31, 2024 and 2023 amounted to €4.9 million and €5.3 million, respectively.
We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we: ● continue the ongoing and planned clinical development of lanifibranor; ● initiate pre-clinical studies and clinical trials with respect to our other development programs; ● develop, maintain, expand and protect our intellectual property portfolio; ● manufacture, or have manufactured, clinical and commercial supplies of our product candidates; ● seek marketing approvals for our current and future product candidates that successfully complete clinical trials; ● establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval; ● hire additional clinical, quality control and scientific personnel; and ● incur additional costs associated with operating as a public company in the United States. 95 Table of Contents Impact of business and geopolitical events The recruitment and screening of new patients for the investigator-initiated Phase II trial evaluating lanifibranor in NAFLD and T2D was temporarily suspended due to the COVID-19 pandemic in 2021.
We anticipate that our expenses will increase substantially in connection with our ongoing activities, as we: ● continue the ongoing and future development of lanifibranor; ● develop, maintain, expand and protect our intellectual property portfolio; ● manufacture, or have manufactured, clinical and commercial supplies of our product candidates; ● seek marketing approvals for our current and future product candidates that successfully complete clinical trials; ● establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval; ● hire additional clinical, quality control and scientific personnel; and ● continue to incur costs associated with operating as a public company in the United States.
We requested the reimbursement of the CIR for 2020 in 2021 (fully paid in June 2021), the reimbursement of the CIR for 2021 in 2022 (fully paid in April 2022), the reimbursement of the CIR for 2022 in 2023 (fully paid April 2023) and we expect to request the reimbursement of the CIR for 2023 in 2024.
We requested the reimbursement of the CIR for 2022 in 2023 (fully paid April 2023 for an amount of €5.2 million), the reimbursement of the CIR for 2023 in 2024 (fully paid April 2024 for an amount of €5.3 million) and we expect to request the reimbursement of the CIR for 2024 in 2025.
Cash Flow The following table shows a summary of our cash flows for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2021 2022 2023 Net cash used in operating activities (47,629) (44,928) (81,614) Net cash provided by (used in) investing activities (1,793) 8,868 (7,731) Net cash provided by financing activities 25,447 37,268 29,081 Net (decrease) increase in cash and cash equivalents (23,975) 1,208 (60,263) ​ Operating Activities During the year ended December 31, 2023, we used €81.6 million cash in operating activities.
Cash Flow The following table shows a summary of our cash flows for the periods indicated: ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2023 2024 Net cash used in operating activities (81,614) (85,928) Net cash provided by (used in) investing activities (7,731) 8,745 Net cash provided by financing activities 29,081 145,592 Net (decrease) increase in cash and cash equivalents (60,263) 68,409 ​ Operating Activities During the year ended December 31, 2024, we used €85.9 million cash in operating activities, an increase of €4.3 million compared to €81.6 million for the year ended December 31, 2023.
Financing Activities During the year ended December 31, 2023 financing activities provided €29.1 million cash, consisting of (i) a capital increase reserved to specified categories of investors through the issuance of 9,618,638 newly-issued ordinary shares, at a subscription price of €3.18 per share and aggregate gross proceeds of €30.6 million (€28.0 million in net proceeds, and €2.5 million of transactions costs) and (ii) the issuance of Royalty Certificates for an aggregate amount of €5.1 million.
Financing Activities During the year ended December 31, 2024, financing activities provided €145.6 million cash, primarily consisting of (i) €25 million drawn in January 2024 under Tranche B of the Finance Contract, (ii) aggregate gross proceeds of €20.1 million (net proceeds €19.7 million) from the issuance of 2024 Royalty Certificates in July 2024, (iii) aggregate gross proceeds of €94.1 million (net proceeds €86.2 million) from the issuance of the T1 Shares and the T1 BSAs in October 2024, (iv) aggregate gross proceeds of €21.4 million (net proceeds €19.8 million) from the T1 bis Shares and T1 bis BSAs. 103 Table of Contents During the year ended December 31, 2023, financing activities provided €29.1 million cash, consisting of (i) a capital increase reserved to specified categories of investors through the issuance of 9,618,638 newly issued ordinary shares, at a subscription price of €3.18 per share and aggregate gross proceeds of €30.6 million and (ii) the issuance of 2023 Royalty Certificates for an aggregate amount of €5.1 million.
In September 2022, we entered into the CTTQ License Agreement with CTTQ to develop and commercialize lanifibranor, in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.
On June 12, 2024, we amended the warrant agreement with EIB to modify the rules for adjusting the exercise ratios of the EIB Warrants. In September 2022, we entered into the CTTQ License Agreement with CTTQ to develop and commercialize lanifibranor, in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan.
Operating Results Comparison of the Years Ended December 31, 2022 and 2023 100 Table of Contents Revenue In the year ended December 31, 2023, the revenue generated amounted to €17.5 million, an increase of €5.3 million compared to revenue of €12.2 million generated for the year ended December 31, 2022.
Operating Results Comparison of the Years Ended December 31, 2023, and 2024 Revenue In the year ended December 31, 2024, the revenue generated amounted to €9.2 million, a decrease of €8.3 million compared to revenue of €17.5 million generated during the year ended December 31, 2023.
Subject to regulatory approval, we have the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea. Due to our status as a European small and medium-sized enterprise, we receive payment for research tax credits granted in the previous period.
Subject to regulatory approval, we have the right to receive tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea.
In January 2023, we announced that we had decided to modify the clinical development plan of lanifibranor for the treatment of NASH, which we expect should improve enrollment rates and compress the time to completion of the trial.
In January 2023, we announced modifications to the clinical development plan of lanifibranor for the treatment of MASH, with the goal to improve enrollment rates and decrease the time to completion of the trial.
The net financial loss mainly includes interests related to the PGE loans, the PPR loans and the Finance Contract, financial interest on lease liabilities in which €6.9 million correspond to interests related to the Finance Contract (€5.2 million); change in fair value of the EIB Warrants issued in connection with the first tranche (€0.4 million); and foreign exchange losses (€1.3 million). 102 Table of Contents Our net financial income was €2.8 million for the year ended December 31, 2022.
The net financial loss mainly included interests related to the PGE loans, the PPR loans and the Finance Contract, and financial interest on lease liabilities, in which €1.4 million correspond to interests related to the Finance Contract, and €0.4 million change in fair value of the EIB Tranche A Warrants, and €1.3 million loss in foreign exchange.
In connection with the LEGEND and NATiV3 clinical trials of lanifibranor, we have entered into agreements with several contract research organizations and contract manufacturing organizations. The total amount to be paid under these agreements amounted globally to €279 million as of December 31, 2023, with a repayment horizon up to 2029. These obligations represent off-balance sheet commitments.
The total amount to be paid under these agreements amounted globally to €291 million as of December 31, 2024 with €128 million already paid, and a repayment horizon up to 2029. These obligations represent off-balance sheet commitments.
The CIR (for France) for the years ended December 31, 2023, 2022, and 2021 amounted €5.3 million, €5.2 million and €3.6 million, respectively. Research and Development Expenses Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates and pre-clinical programs. We expense research and development costs as incurred.
Research and Development Expenses Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates and pre-clinical programs. We expense research and development costs as incurred.
Material cash requirements The following table discloses aggregate information about material contractual obligations and periods in which payments were due as of December 31, 2023. ​ ​ ​ ​ ​ ​ ​ (in thousands of €) 2024 Thereafter Total Bank borrowings and other loans 3,011 27,914 30,925 Lease liabilities 2,298 4,267 6,565 Purchase obligations - Obligations Under the Terms of CRO/CMO Agreements 89,959 189,099 279,058 Total 95,267 221,280 316,547 ​ The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
Material cash requirements The following table discloses aggregate information about material contractual obligations and periods in which payments were due as of December 31, 2024. ​ ​ ​ ​ ​ ​ ​ (in thousands of €) 2025 Thereafter Total Bank borrowings and other loans 3,349 46,325 49,674 Royalty Certificates ​ — ​ 29,207 (1) 29,207 Lease liabilities 2,520 2,135 4,654 Purchase obligations - Obligations Under the Terms of CRO/CMO Agreements 128,468 162,187 290,655 Total 134,336 239,853 374,190 (1) The €29.2 million relating to Royalty Certificates corresponds to debt recognized at amortized cost on the basis of the original effective interest rate. ​ The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.
On September 20, 2023, we entered into the Hepalys License Agreement with Hepalys, a new company created by Catalys Pacific, incorporated in Japan. In parallel, we entered into the Catalys Option Agreement to acquire 30% of the shares of Hepalys. On September 26, 2023, we exercised our option with an effective date on October 11, 2023.
On September 20, 2023, we also entered into an option agreement, or the Catalys Option Agreement, with Catalys Pacific Fund II, LP, or Catalys, to acquire 1,500,000 ordinary shares (then 30% of the shares) of Hepalys from Catalys. On September 26, 2023, we exercised our option with an effective date on October 11, 2023.
These estimates are based on our current business plan and exclude (i) other expenses related to the potential development of odiparcil or resulting from any potential in-licensing or acquisition of additional product candidates or technologies, or any associated development we may pursue, (ii) any potential milestone payments (other than those referenced above) that may be received or paid by us or potential financing.
These estimates are based on our current business plan, which includes the 2025 Pipeline prioritization plan under negotiation with our Worker’s Council (described in Note 29. – Events after the reporting date), but exclude any potential milestones (other than the potential milestone from CTTQ referenced above) payable to or by us and any additional expenditures related to other product candidates or resulting from any potential in-licensing or acquisition of additional product candidates or technologies, or any associated development we may pursue.
Geopolitical events such as Russia’s invasion of Ukraine or the state of war between Israel and Hamas, including with respect to some clinical trial sites in Israel for the NATiV3 trial, could further affect us, our trials and our business operations in the future.
Geopolitical events, such as Russia’s invasion of Ukraine or the conflict in the Middle East, could further affect us, our trials and our business operations in the future.
General and Administrative Expenses Our general and administrative expenses were €13.8 million in the year ended December 31, 2023, an increase of €0.9 million, or 7% compared to general and administrative expenses of €12.9 million in the year ended December 31, 2022 mainly related to the personnel costs and consulting fees due to an increase of headcount as well as granted bonuses.
General and Administrative Expenses Our general and administrative expenses were €15.8 million in the year ended December 31, 2024, an increase of €2.0 million, or 15% compared to general and administrative expenses of €13.8 million in the year ended December 31, 2023, mainly related to a €1 million increase in personnel costs, and a €0.8 million increase in consulting fees. 99 Table of Contents Marketing — Business Development Expenses Our marketing —- business development expenses were €2.0 million in the year ended December 31, 2024, an amount that remained unchanged from 2023.
The adjustments will be recognized in the consolidated financial statements as soon as we become aware of such new events or additional information.
Such estimates may be adjusted as new events occur and additional information is obtained. The adjustments will be recognized in the consolidated financial statements as soon as we become aware of such new events or additional information. Actual results may differ from the estimates and any differences may have a material impact on our consolidated financial statements.
The equity recovery loans are guaranteed predominantly by the state and feature an eight-year financing period and a four-year repayment period, €5.3 million is outstanding on December 31, 2023. - The disbursement of the first tranche of the Finance Contract, in the amount of €25 million, on December 8, 2022. 108 Table of Contents Leases represent a €6.6 million cash requirement as of December 31, 2023 with a repayment horizon up to 2027.
The equity recovery loans are guaranteed predominantly by the state and feature an eight-year financing period and a four-year repayment period, €5.2 million is outstanding on December 31, 2024. ● The disbursement of €50 million under the Finance Contract with the EIB, €25 million pursuant to the drawdown of Tranche A and €25 million pursuant to the drawdown of Tranche B (including derivatives see below).
In the first quarter of 2024, following a routine visit in our NATiV3 clinical trial of lanifibranor in NASH, a SUSAR of elevated aminotransferases in liver tests in a patient was reported. Other milder cases of elevation of aminotransferases among trial participants have also been reported.
In addition, in the first quarter of 2024, following a routine visit during our NATiV3 clinical trial of lanifibranor in MASH, an adverse event of elevated aminotransferases in liver tests in a patient enrolled in the trial was reported. This event has been assessed as a treatment-related SUSAR.
We had cash and cash equivalents of €86.6 million, €86.7 million and €26.9 million as of December 31, 2021, 2022 and 2023, respectively.
Our net losses were €54.3 million, €110.4 million and €184.2 million for the year ended December 31, 2022, 2023 and 2024, respectively. We had cash and cash equivalents of €86.7 million, €26.9 million and €96.6 million as of December 31, 2022, 2023 and 2024, respectively.
The exchange rate on the invoice date was 1.009 euros for one dollar. ​ 97 Table of Contents Other Income Our other income consists primarily of research tax credits. Research tax credits ( crédit d’impôt recherche ), or CIR, are granted by the French tax authorities to encourage technical and scientific research by French companies.
Research tax credits ( crédit d’impôt recherche ), or CIR, are granted by the French tax authorities to encourage technical and scientific research by French companies.
Accordingly, our current cash and cash equivalents and short and long-term deposits are not sufficient to cover our operating needs for at least the next 12 months. In order to cover our needs for the next 12 months, taking into account our current business plan, we estimate needing approximately an additional €100 million during this period.
Accordingly, our current cash and cash equivalents are not sufficient to cover our operating needs for at least the next 12 months. Based on our current business plan, we estimate that to cover our obligations for the next 12 months, our additional cash requirements amount to 40 to 45 million euros.
During the year ended December 31, 2022, we used €44.9 million cash in operating activities.
We also obtained the reimbursement of last year deposit of €9 million in 2024. During the year ended December 31, 2023, we used €7.7 million cash in investing activities.
In 2021, we faced a tax expense of €30 thousand related to the activity of our subsidiary Inventiva Inc. and paid €364 thousand regarding a deficit carry-back. B. Liquidity and Capital Resources As of December 31, 2021, 2022 and 2023, we had cash and cash equivalents of €86.6 million, €86.8 million and €26.9 million respectively.
The tax expenses mainly relate to the deferred tax assets allowance of €481 thousand for Inventiva Inc. 100 Table of Contents B. Liquidity and Capital Resources As of December 31, 2022, 2023 and 2024, we had cash and cash equivalents of €86.8 million, €26.9 million and €96.6 million, respectively.
During the year ended December 31, 2023, we had used $81.6 million cash in operating activities and $7.7 million cash in investing activities, and our financing activities provided $29.1 million cash.
The unfavorable impacts on the cash used in operating activities are offset by a decrease of €19.1 million in research and development expenses. During the year ended December 31, 2023, we used €81.6 million cash in operating activities.
To fund our activities until the publication of topline results from our NATiV3 trial, which is targeted for the first half of 2026, we estimate we would need approximately an additional €175 million (assuming we receive approximately €25 million in potential milestone or other payments during the period) to €200 million (assuming no potential milestone payments) (each estimate inclusive of the above referenced €100 million).These events and conditions indicate that a material uncertainty exists that may cast significant doubt on our ability to continue as a going concern and, therefore, we may be unable to realize our assets and discharge our liabilities in the normal course of business.
These events and conditions indicate that a material uncertainty exists that may cast significant doubt on our ability to continue as a going concern and, therefore, we may be unable to realize our assets and discharge our liabilities in the normal course of business.
The net financial income includes (i) the losses from the change in fair value linked to derivatives (warrants linked to the finance contract with EIB in 2022) and (ii) the foreign exchange gain generated by cash and cash equivalents denominated in U.S. dollars and the favorable exchange rate of euro against the U.S. dollar over the period.
Our net financial income was €1.8 million for the year ended December 31, 2023. The net financial income includes €1.0 million interests earned from deposit accounts and, €0.8 million foreign exchange gain generated by cash and cash equivalents denominated in U.S. dollars and the favorable exchange rate of euro against the U.S. dollar over the period.
The expenses related to research and development are partially offset by the reinvoicing to CTTQ of specific costs related to CRO expenses for clinical trials in China, for an amount of €4 million in 2023 compared to €1.5 million in 2022. 101 Table of Contents Research, pre-clinical study and clinical trial expenses are broken down by product candidate for the years ended December 31, 2022 and 2023 in the following table: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2022 2023 % change Lanifibranor ​ 40,332 ​ 85,896 ​ 113 % YAP/TEAD 991 1,207 22 % NUAK 124 — (100) % NR4A1 787 905 15 % Other 141 153 9 % Total Research, pre ‑ clinical study and clinical trial expenses 42,375 88,162 108 % ​ The increase by €45.8 million in research, pre-clinical study and clinical trial expenses is primarily related to lanifibranor, for which the related research, pre-clinical study and clinical trial expenses increased by €45.5 million mainly due to the NATiV3 Phase III clinical trial for lanifibranor in NASH.
Research, pre-clinical study and clinical trial expenses are broken down by product candidate for the years ended December 31, 2023 and 2024 in the following table: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, (in thousands of €) 2023 2024 % change Lanifibranor ​ 85,896 ​ 67,479 ​ (21) % YAP/TEAD 1,207 767 (36) % NR4A1 905 359 (60) % Other 153 (5) (103) % Total Research, pre ‑ clinical study and clinical trial expenses 88,162 68,599 (22) % ​ The decrease by €19.6 million in research, pre-clinical study and clinical trial expenses is primarily related to lanifibranor, for which the related research, pre-clinical study and clinical trial expenses decreased by €18.4 million mainly due to the temporary voluntary pause in the recruitment of patients in the NATiV3 trial following the SUSAR, to a lesser extent, due to the completion of the LEGEND trial.
The second tranche carries a 7% interest capitalized annually and repayment is due in January 2027, three years after its disbursement. In June 2022, we entered into three loan agreements with a syndicate of French banks for a total amount of €5.3 million.
Following the satisfaction of the applicable conditions precedent, we drew down Tranche A in December 2022 and Tranche B in January 2024. Tranche B carries a 7% interest rate, capitalized annually, with repayment due in January 2027, three years after disbursement.
However, at this present date, we are not aware of specific events or circumstances that would require us to update our estimates, assumptions and judgments or to revise the carrying amounts of our assets and liabilities. Such estimates may be adjusted as new events occur and additional information is obtained.
We completed randomization of the last patient in NATiV3 in April 2025 and target the publication of the topline results for the second half of 2026, and the potential NDA submission for the first half of 2027. 94 Table of Contents As of the date of this report, we are not aware of specific events or circumstances that would require us to update our estimates, assumptions and judgments or to revise the carrying amounts of our assets and liabilities.
The net financial income for both years mainly includes (i) the losses from the change in fair value linked to derivatives (warrants linked to the finance contract with EIB in 2022 and forward currency contracts in 2021) and (ii) the foreign exchange gain generated by cash and cash equivalents denominated in U.S. dollars and the favorable exchange rate of euro against the U.S. dollar over the period.
Our net financial income was €2.9 million for the year ended December 31, 2024. The net financial income includes €1.1 million interests earned from deposit accounts and €1.7 million foreign exchange gain generated by cash and cash equivalents denominated in U.S. dollars and the favorable exchange rate of euro against the U.S. dollar over the period.
Net financial income (expense) of 2022 primarily related to foreign exchange gains and losses, interest and other expense for loans and other financial debts as well as fair value loss on derivatives, offset by income received from cash and cash equivalents and short-term investments.
Net Financial Income (Expense) The net financial income (expense) of 2024 primarily related to the new shares to be issued in the second tranche of the Structured Financing, the warrants that will be attached to such new shares, interest cost, foreign exchange gains and losses as well as fair value gains and losses on forward contracts, and on EIB Warrants, partially offset by income received from deposit account and foreign exchange gains.
The decrease is primarily due to a decrease of consulting fees (€0.4 million) and a decrease of the withholding tax (€0.8 million) related to entering into the license and collaboration agreements with CTTQ, but offset by a €0.5 increase in other operating expenses related to advertisements and public relations.
They consist primarily of the withholding tax related to entering into the CTTQ License Agreement of €1.0 million, personnel costs and other operating expenses.
In particular, we may seek to raise additional funds to achieve our development goals for our research and development programs through: ● potential sales of ADSs under our existing At-The-Market program, having an aggregate offering price of $58.0 million from time to time, which has a term until August 2, 2024; ● other potential public or private securities offerings; and ● potential strategic transactions such as business development partnerships and/or royalty deals.
We will need to raise additional funds to support our business and, our research and development programs, as currently contemplated, through: ● other potential public or private securities offerings; and ● potential strategic transactions, business development partnerships and/or royalty deals.
During the year ended December 31, 2022, investing activities provided €8.9 million cash. Cash provided by investing activities mainly reflected the decrease in short-term deposit related to the unwinding of a deposit at the end of 2022 amounted to €8.8 million. 107 Table of Contents During the year ended December 31, 2021, we used €1.8 million cash in investing activities.
Investing Activities During the year ended December 31, 2024, we provided €8.7 million cash in investing activities. The cash provided is related to the subscription of a €10 million term deposit during the first quarter 2024, initially set for 2 years, and reimbursed early in July 2024.
Because of the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount or timing of product revenue. ​ ​ ​ 1 We invoiced €12.8 million on September 28, 2022 (corresponds to the initial payment of €12.1 million euros, and an additional invoicing of €0.6 million) and received on November 4, 2022, €11.5 million after deduction of withholding tax for €1.3 million.
Because of the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount or timing of product revenue. ​ 95 Table of Contents Other Income Our other income consists primarily of research tax credits.
We are currently targeting: the last patient first visit for the first half of 2024, the randomization of the last patient for the second half of 2024, the last patient last visit for the first quarter of 2026, and the publication of the topline results for the first half of 2026.
In September 2021, we initiated our NATiV3 Phase 3 clinical trial of lanifibranor in MASH. We completed randomization of the last patient in NATiV3 in April 2025 and target the publication of the topline results for the second half of 2026, and the potential NDA submission for the first half of 2027.
We requested the reimbursement of the CIR for 2020 in 2021 (fully paid in June 2021 for an amount of €4.2 million), the reimbursement of the CIR for 2021 in 2022 (fully paid in April 2022 for an amount of €3.6 million), the reimbursement of the CIR for 2022 in 2023 (fully paid April 2023 for an amount of €5.2 million).
Companies may receive cash reimbursement for any excess portion. We requested the reimbursement of the CIR for 2022 in 2023 (fully paid in April 2023), the reimbursement of the CIR for 2023 in 2024 (fully paid April 2024) and we expect to request the reimbursement of the CIR for 2024 in 2025.
Removed
Leveraging these assets and expertise, we are advancing lanifibranor for the treatment of NASH, as well as a pipeline of earlier stage programs in oncology and other diseases with significant unmet medical need. We began our operations in 2012 following the purchase of assets from Abbott.
Added
This section of our Annual Report on Form 20-F discusses our financial condition and results of operations for the fiscal years ended December 31, 2024 and 2023, and year-to-year comparisons between fiscal 2024 and fiscal 2023.
Removed
Our operations have focused on organizing and staffing our company, business planning, raising capital, entering into collaboration agreements, and conducting pre-clinical and clinical development of our product candidates. We do not have any products approved for sale and have not generated any revenue from product sales.
Added
A discussion of our financial condition and results of operations for the fiscal year ended December 31, 2022 and year-to-year comparisons between fiscal 2023 and fiscal 2022 that are not included in this Annual Report on Form 20-F can be found in “Operating and Financial Review and Prospects” in Part I, Item 5 of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with the SEC on April 3, 2024.
Removed
We received a net aggregate of €96.0 million in payments from Abbott pursuant to agreements entered into in connection with our formation, and raised €44.6 million in net proceeds from the initial public offering of our ordinary shares on Euronext Paris in February 2017, followed by €32.4 million in net proceeds from a private placement of our ordinary shares in April 2018, €8.6 million in net proceeds from two capital increases for categories of investors in September and October 2019, €14.6 million in net proceeds from a capital increase for categories of investors in February 2020.
Added
Leveraging these assets and expertise, we are advancing lanifibranor for the treatment of MASH, a progressive, chronic liver disease. MASH is believed to affect up to 12% of the United States adult population and is considered as a leading cause of cirrhosis, liver transplantation and liver cancer.
Removed
In May 2020, we entered into three credit agreements pursuant to which we received €10.0 million in the form of State Guaranteed Loans ( Prêts Garantis par l’Etat , or “PGE”), which were provided by a syndicate of French banks and are guaranteed by the French government in the context of the COVID-19 pandemic.
Added
Since our inception in 2011, we have focused on organizing and staffing our company, raising capital and performing research and development activities to advance our research, development and technology. Our ability to generate product revenue and to become profitable will depend upon our ability to successfully develop and commercialize lanifibranor and our other potential programs.
Removed
The loans were initially set to mature in May 2021, but were amended to extend the maturity date for up to an additional four years. The amendments provide for linear repayment extension over four years, beginning in July 2022 for one PGE loan, and in September 2022 for the other two PGE loans, until May 2026.
Added
Since inception, we have financed our activities through successive capital increases, borrowings, upfront and milestone payments under collaboration and license agreements with our partners, subsidies and reimbursement of CIR receivables.

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Biggest changeDirectors and Senior Management The following table sets forth information concerning our executive officers and directors as of the date hereof: Name Age Position(s) Executive Officers ​ ​ ​ ​ Frédéric Cren ​ 58 ​ Chief Executive Officer and Chairman of the Board of Directors Pierre Broqua ​ 62 ​ Deputy Chief Executive Officer, Chief Scientific Officer and Director Jean Volatier ​ 59 ​ Chief Financial Officer and Deputy General Manager Michael Cooreman ​ 66 ​ Chief Medical Officer Alice Roudot-Ketelers ​ 53 ​ Chief Operating Officer Eric Duranson ​ 50 ​ General Counsel Nathalie Harroy ​ 57 ​ Head of Human Resources Pascaline Clerc ​ 44 ​ Executive Vice President, Strategy and Corporate Affairs Non-Employee Directors ​ ​ ​ ​ Chris Buyse (1)(4)(5) ​ 59 ​ Director Lucy Lu ​ 49 ​ Director Heinz Maeusli (3) ​ 61 ​ Director Annick Schwebig (2)(3)(6) ​ 73 ​ Director Martine Zimmermann ​ 55 ​ Director (1) Chairman of the audit committee.
Biggest changeDirectors and Senior Management The following table sets forth information concerning our executive officers and directors as of the date hereof: Name Age Position(s) Executive Officers ​ ​ ​ ​ Frédéric Cren ​ 59 ​ Chief Executive Officer and Director Pierre Broqua ​ 63 ​ Deputy Chief Executive Officer and Chief Scientific Officer Pascaline Clerc ​ 45 ​ Executive Vice President, Strategy and Corporate Affairs Michael Cooreman ​ 67 ​ Chief Medical Officer Eric Duranson ​ 51 ​ General Counsel Nathalie Harroy ​ 58 ​ Head of Human Resources Kristina Meyer ​ 56 ​ Executive Vice President, Business Development & Alliance Management Alice Roudot-Ketelers ​ 54 ​ Chief Operating Officer Jean Volatier ​ 60 ​ Chief Financial Officer and Deputy General Manager Non-Employee Directors ​ ​ ​ ​ Mark Pruzanski ​ 57 ​ Chairman of the Board of Directors Srinivas Akkaraju ​ 57 ​ Director Lucy Lu ​ 50 ​ Director Heinz Maeusli (1)(3)(6) ​ 62 ​ Director Annick Schwebig (2)(3)(5) ​ 74 ​ Director Andre Turenne (4) ​ 51 ​ Director Martine Zimmermann (7) ​ 56 ​ Director (1) Chair of the audit committee.
Duranson served as the head of the legal team for Western Europe of ResMed, a medical device company, and from January 2017 to January 2020 as the head of the for Western Europe legal team for Thermo Fisher Scientific, an analytical laboratory instrument manufacturing company. Prior to that, Mr.
Duranson served as the head of the legal team for Western Europe of ResMed, a medical device company, and from January 2017 to January 2020 as the head of the Western Europe legal team for Thermo Fisher Scientific, an analytical laboratory instrument manufacturing company. Prior to that, Mr.
He previously served on the as a director and chairman of the audit committee of Progenics Pharmaceuticals from November 2019 to June 2020. Prior to joining our board, he served from 2003 to 2018 as the Chief Financial Officer of Advanced Accelerator Applications, a biopharmaceutical company operating in the field of nuclear medicine. Mr.
He previously served as a director and chairman of the audit committee of Progenics Pharmaceuticals from November 2019 to June 2020. Prior to joining our board, he served from 2003 to 2018 as the Chief Financial Officer of Advanced Accelerator Applications, a biopharmaceutical company operating in the field of nuclear medicine. Mr.
Nathalie Harroy has served as our Head of Human Resources since Inventiva’s inception in 2012. Prior to joining Inventiva, from 2010 to 2012 Ms. Harroy worked in human resources at Abbott Laboratories. Before its acquisition by Abbott Laboratories in 2010, she held various human resource-related roles within Solvay Pharmaceuticals. Ms.
Nathalie Harroy has served as our Head of Human Resources since our inception in 2012. Prior to joining Inventiva, Ms. Harroy worked in human resources at Abbott Laboratories from 2010 to 2012. Before its acquisition by Abbott Laboratories in 2010, she held various human resource-related roles within Solvay Pharmaceuticals. Ms.
Volatier was a senior consultant for I Care Environnement, a consulting company from January 2011 to October 2011, the interim Chief Financial Officer of the NAOS Group, a skin care company, from April 2010 to November 2010, and the Chief Financial Officer of the Soufflet Group, an agro-industry company from January 2007 to October 2008.
Volatier was a senior consultant for I Care Environnement, a consulting company from January 2011 to October 2011, the interim Chief Financial Officer of the NAOS Group, a skin care company, from April 2010 to November 2010, and the Chief Financial Officer of the Soufflet Group, an agro-industry company from January 2007 to October 2008. Mr.
She also received a bachelor’s degree from the University of Tennessee’s College of Arts and Sciences. Heinz Maeusli has served as a member of our Board of Directors since May 2019. Mr. Maeusli also serves as director and member of the audit committee and nominating & corporate governance committee of Lantheus since 2020.
She also received a bachelor’s degree from the University of Tennessee’s College of Arts and Sciences. Heinz Maeusli has served as a member of our Board of Directors since May 2019. Mr. Maeusli also serves as director and member of the audit committee and nominating & corporate governance committee of Lantheus, a radiopharmaceuticals company, since 2020.
Schwebig has held senior positions in the pharmaceutical industry, including Vice President Medical Affairs France and Vice President Research and Development Europe at Bristol-Myers Squibb, a global biopharmaceutical company, from 1983 to 2000. Ms. Schwebig has been a member of the Board of Directors of Cellectis S.A., a biotechnology company, between 2011 and June 2023. Ms.
Schwebig has held senior positions in the pharmaceutical industry, including Vice President Medical Affairs France and Vice President Research and Development Europe at Bristol-Myers Squibb, a global biopharmaceutical company, from 1983 to 2000. Ms. Schwebig served as a member of the Board of Directors of Cellectis S.A., a biotechnology company, between 2011 and June 2023. Ms.
Pierre Broqua has served as our Chief Scientific Officer since co-founding Inventiva in 2011, and as our Deputy Chief Executive Officer and a member of our Board of Directors since May 2016. Previously, Dr. Broqua served as a Head of Research for Abbott Laboratories from 2010 until 2012.
Pierre Broqua has served as our Chief Scientific Officer since co-founding Inventiva in 2011, and as our Deputy Chief Executive Officer since May 2016, and as a member of our Board of Directors between May 2016 and December 2024. Previously, Dr. Broqua served as a Head of Research for Abbott Laboratories from 2010 until 2012.
Prior to that, Dr. Lu was the Chief Executive Officer and a member of the Board of Directors of Avenue Therapeutics, Inc., a public biotechnology company, since its inception in 2015 until March 2022, and Executive Vice President and Chief Financial Officer of Fortress Biotech, Inc. from 2012 to 2017. Dr.
Lu was the Chief Executive Officer and a member of the Board of Directors of Avenue Therapeutics, a biotechnology company, since its inception in 2015 until March 2022, and Executive Vice President and Chief Financial Officer of Fortress Biotech from 2012 to 2017. Dr.
(2) For fiscal year 2023, variable compensation has been determined based on the achievement of targets set at the beginning of the year by the Board of Directors in view of Compensation and Appointments Committee recommendations.
(4) For fiscal year 2024, variable compensation has been determined based on the achievement of targets set at the beginning of the year by the Board of Directors in view of Compensation and Appointments Committee recommendations.
Cooreman was Vice President, Science and Medicine, in charge of global research and development in gastroenterology and hepatology at Ferring Pharmaceuticals. From 2015 to 2017, Dr. Cooreman served as Chief Medical Officer at ImmusanT, a biotechnology company located in the United States.
Michael Cooreman has served as our Chief Medical Officer since October 2020. From 2017 to 2020, Dr. Cooreman was Vice President, Science and Medicine, in charge of global research and development in gastroenterology and hepatology at Ferring Pharmaceuticals. From 2015 to 2017, Dr. Cooreman served as Chief Medical Officer at ImmusanT, a biotechnology company located in the United States.
Maeusli holds master’s degrees in business from Columbia Business School in New York and from the University of St. Gallen. Annick Schwebig has served as a member of our Board of Directors since February 2017.
Maeusli holds master’s degrees in business from Columbia Business School and from the University of St. Gallen. 108 Table of Contents Annick Schwebig has served as a member of our Board of Directors since February 2017.
Lu serves as a board member of Veru Inc., a public biopharmaceutical company, since 2021. Dr. Lu holds a doctor of medicine degree from the New York University School of Medicine and a master’s degree in business administration from the Leonard N. Stern School of Business at New York University.
Lu serves as a member of the board of Fortress Biotech, a biopharmaceutical company, since December 2022 and of Veru, a biopharmaceutical company, since 2021. Dr. Lu holds a doctor of medicine degree from the New York University School of Medicine and a master’s degree in business administration from the Leonard N. Stern School of Business at New York University.
Compensation 114 Table of Contents Compensation of Directors and Executive Officers The aggregate compensation paid and benefits in kind granted by us to our current executive officers and directors, including share-based compensation, for the year ended December 31, 2023 was €3.3 million.
Compensation Compensation of Directors and Executive Officers The aggregate compensation paid and benefits in kind granted by us to our current executive officers and directors, including share-based compensation, for the year ended December 31, 2024 was €3.5 million.
For the year ended December 31, 2023, the total amount to be set aside or accrued to provide pension, retirement or similar benefits to our directors or our executive officers was €0.5 million. Non-Employee Director Compensation The total annual compensation amount is set by the Annual General Meeting.
For the year ended December 31, 2024, the total amount to be set aside or accrued to provide pension, retirement or similar benefits to our directors or our executive officers was €0.6 million. Non-Employee Director Compensation The Annual General Meeting sets the total annual compensation amount.
Harroy worked in R&D and the Scientific Affairs Division of Fournier Laboratories prior to its acquisition by Solvay Pharmaceuticals. She holds a DESE degree in Human Resources Management from Conservatoire National des Arts et Métiers (CNAM), Dijon. Pascaline Clerc has served as our Executive Vice President, Strategy and Corporate Affairs since October 2023.
Harroy worked in R&D and the Scientific Affairs Division of Fournier Laboratories prior to its acquisition by Solvay Pharmaceuticals. She holds a DESE degree in Human Resources Management from Conservatoire National des Arts et Métiers (CNAM), Dijon. Kristina Meyer has served as our Executive Vice President, Business Development & Alliance Management since April 2024.
The performance criteria, which are qualitative in nature, are related to product development, clinical studies results, regulatory approval for certain products, as well as the marketing strategy and financial visibility. (3) Reflects valuation of 515,000 share warrants, and 600,000 performance warrants granted during fiscal year 2023. (4) Represents housing, car allowances and social guarantees for company managers and executives (GSC).
The performance criteria, which are qualitative in nature, are related to product development, clinical studies results, regulatory approval for certain products, as well as the marketing strategy and financial visibility. (5) Reflects valuation of 477,239 share warrants, and 50,484 performance warrants granted during fiscal year 2024. (6) Represents housing, car allowances and social guarantees for company managers and executives (GSC).
(2) Chairman of the compensation and appointments committee. (3) Member of the audit committee. (4) Member of the compensation and appointments committee. (5) As representative of Sofia BV, the legal entity that holds this board seat. (6) As representative of Cell+, the legal entity that holds this board seat.
(2) Chair of the compensation and appointments committee. (3) Member of the audit committee. (4) Member of the compensation and appointments committee. (5) As representative of Cell+, the legal entity that holds this board seat. (6) Member of the Corporate Social Responsibility Committee.
In 2000, she founded Actelion Pharmaceuticals France SAS, a pharmaceuticals company specializing in developing drugs for orphan diseases, and was its Chairman and Chief Executive Officer from 2000 to 2015. Ms.
In 2000, she founded Actelion Pharmaceuticals France, a pharmaceuticals company specializing in developing drugs for orphan diseases, and served as Chairperson and Chief Executive Officer from 2000 to 2015. Ms.
The compensation our non-employee directors received for the financial year 2023 is set out in the table below. ​ ​ ​ ​ ​ ​ ​ ​ ​ Gross Fees ​ Warrants ​ ​ Name Earned (€)(1) (€)(2) Total (€) Sofia BV, represented by Chris Buyse ​ 61,200 ​ — ​ 61,200 Lucy Lu (3) ​ 43,200 ​ — ​ 43,200 CELL+, represented by Annick Schwebig ​ 61,200 ​ — ​ 61,200 Heinz Maeusli 49,200 — 49,200 Martine Zimmermann 21,600 — 21,600 (1) Includes out-of-pocket expenses paid by us.
The compensation of our non-employee directors received for the financial year 2024 is set out in the table below. ​ ​ ​ ​ ​ ​ ​ ​ ​ Gross Fees ​ Warrants ​ ​ Name Earned (€)(1) (€)(2) Total (€) Mark Pruzanski(3) ​ — ​ — ​ — Srinivas Akkaraju(3) ​ — ​ — ​ — Lucy Lu(3) ​ 60,000 ​ — ​ 60,000 CELL+, represented by Annick Schwebig 84,000 — 84,000 Heinz Maeusli ​ 68,400 ​ — ​ 68,400 Martine Zimmermann ​ 60,000 ​ — ​ 60,000 Andre Turenne(3) ​ 60,000 ​ — ​ 60,000 Sofia BV, represented by Chris Buyse (4) 84,000 — 84,000 (1) Includes out-of-pocket expenses paid by us.
From June 2014 to July 2021, Ms. Roudot-Ketelers served as Vice President Clinical Development at Genfit, a French biopharmaceutical company dedicated metabolic and liver-related diseases, where she was in charge of all drug development programs and oversaw cross-functional teams in Chemistry, Manufacturing and Controls, non-clinical and clinical development up to Phase III trials.
Roudot-Ketelers served as Vice President Clinical Development at Genfit, where she was in charge of all drug development programs and oversaw cross-functional teams in Chemistry, Manufacturing and Controls, non-clinical and clinical development up to Phase 3 trials.
She holds a master’s degree in Pharmacy from the University of Lyon, and a Doctor of Pharmacy degree from the University of Lille. Eric Duranson has served as our General Counsel since July 2021. From February 2020 to June 2021, Mr.
He holds a Doctor of Medicine degree from the University of Louvain, Belgium, and a doctor degree from the Heinrich Heine University in Düsseldorf, Germany. Eric Duranson has served as our General Counsel since July 2021. From February 2020 to June 2021, Mr.
He holds a master’s degree in management from Paris IX Dauphine University, PSL University, an executive specialized master’s degree in corporate social responsibility from MINES-ParisTech, PSL University, and the diplome d’etudes superieures comptables et financieres.
He holds a master’s degree in management from Paris IX Dauphine University, PSL University, an executive specialized master’s degree in corporate social responsibility from MINES-ParisTech, PSL University, and the diplome d’etudes superieures comptables et financieres . Non-Employee Directors Mark Pruzanski has served as chairman of our Board of Directors since December 2024. Dr.
She serves as the Chief Executive Officer of Microbial Machines, a biotech company focused on synthetically engineered bacteria to detect and treat diseases of the alimentary track since March 2023, and served as the Chief Operations Officer of Innovative Cellular Therapeutics, Inc., a development-stage biotech company focused on CAR T therapy for solid tumors, between April 2022 and February 2024.
She serves as the Chief Executive Officer of Prescryptive Bio, a biotech company focused on a novel treatment for metastatic colorectal cancer since March 2023, and served as the Chief Operations Officer of Innovative Cellular Therapeutics, a development-stage biotech company focused on CAR T therapy for solid tumors, between April 2022 and February 2024. Prior to that, Dr.
The compensation of our non-employee directors takes their attendance at meetings of the Board of Directors and its committees into account as follows: ● For attending at least 80% of the meetings of the Board of Directors held during the financial year: 50,000 euros per year per member; ● For attending less than 80% of the meetings of the Board of Directors held during the financial year: a prorated amount based on 50,000 euros per year for 100% attendance; ● For chairing a committee of our Board of Directors: a maximum of €13,000 per year; and ● For membership of a committee of our Board of Directors (other than as chairperson): a maximum of €7,000 per year.
Broqua until his resignation as director in December 2024), are directors did not receive any additional compensation for their services as directors. 109 Table of Contents The compensation of our non-employee directors takes their attendance at meetings (virtual or in person) of the Board of Directors and its committees into account as follows: ● For attending at least 80% of the meetings of the Board of Directors held during the financial year: €50,000 per year per member (the Chairman of the Board of Directors and the Chief Executive Officer receive no remuneration in this respect); ● For attending less than 80% of the meetings of the Board of Directors held during the financial year: a prorated amount based on €50,000 per year for 100% attendance; ● For chairing a committee of our Board of Directors: a maximum of €13,000 per year; and ● For membership of a committee of our Board of Directors (other than as chairperson): a maximum of €7,000 per year.
The most recent decision was made on May 28, 2018, setting this amount at €250,000 with effect from 2018. The following table sets forth information regarding the compensation earned by our non-employee directors for service on our Board of Directors during the year ended December 31, 2023. Mr. Cren, who is our Chief Executive Officer, and Dr.
The following table sets forth information regarding the compensation earned by our non-employee directors for service on our Board of Directors during the year ended December 31, 2024. Dr. Pruzanski, who is the Chairman of our Board of Directors, Mr. Cren, who is our Chief Executive Officer, and Dr.
He has a doctor of philosophy degree in pharmacology from the University of Paris Descartes and a master’s degree in chemistry and biochemistry from Université Pierre et Marie Curie, Paris. 111 Table of Contents Jean Volatier has served as our Chief Financial Officer since August 2012, and as our Deputy General Manager since January 26, 2024. Previously, Mr.
She holds a master’s degree in Pharmacy from the University of Lyon, and a Doctor of Pharmacy degree from the University of Lille. 107 Table of Contents Jean Volatier has served as our Chief Financial Officer since August 2012, and as our Deputy General Manager since January 2024. Previously, Mr.
He received a master’s degree in business administration from INSEAD, a master’s degree in international relations from Johns Hopkins University and a bachelor’s degree in economics from Paris IX Dauphine University.
Previously, he served as the General Manager, Research of Abbott Laboratories, a pharmaceutical company, from 2010 until 2012. He received a master’s degree in business administration from INSEAD, a master’s degree in international relations from Johns Hopkins University and a bachelor’s degree in economics from Paris IX Dauphine University.
Throughout her career, she has acquired extensive expertise as Regulatory Affairs Executive in both small and large pharmaceutical groups, holding senior roles in the United States, Europe and Asia-Pacific. Ms. Zimmermann has worked across all phases of drug development within several therapeutic areas, interacting with relevant regulatory authorities in key markets, including the U.S.
Throughout her career, she has acquired extensive expertise as Regulatory Affairs Executive in both small and large pharmaceutical groups, holding senior roles in the United States, Europe and Asia-Pacific. Ms.
Schwebig is a graduate of the Paris Faculty of Medicine. Martine Zimmermann has served as a member of our Board of Directors since April 2021. Ms. Zimmermann has been the Senior Vice President and Head of Regulatory Affairs and R&D Quality of Ipsen Biopharmaceuticals, a global biopharmaceuticals company, since January 2023.
Turenne holds a B.A. from Kalamazoo College and an M.B.A. from the Tuck School of Business at Dartmouth. Martine Zimmermann has served as a member of our Board of Directors since April 2021. Ms. Zimmermann has been the Senior Vice President and Head of Regulatory Affairs of Ipsen Biopharmaceuticals, a global biopharmaceuticals company, since January 2023.
Family Arrangements and Selection Arrangements There are no family relationships among any of our executive officers or directors. B.
Ms. Zimmerman holds a Doctor of Pharmacy degree from the University of Strasbourg. Family Arrangements and Selection Arrangements There are no family relationships among any of our executive officers or directors.
(2) This column represents the full grant date fair value of share warrants ( bons de souscription d’actions ) granted during the year as measured pursuant to the Black-Scholes option-pricing model. (3) The Board of Directors, in its meeting on November 9, 2022, appointed Dr. Lucy Lu as a new director. Dr.
(2) This column represents the full grant date fair value of share warrants ( bons de souscription d’actions ) granted during the year as measured pursuant to the Black-Scholes option-pricing model. (3) Mr. Turenne was appointed at the general shareholders’ meeting that took place on June 20, 2024. Dr. Pruzanski and Mr.
He holds a Doctor of Medicine degree from the University of Louvain, Belgium, and a doctor degree from the Heinrich Heine University in Düsseldorf, Germany. Alice Roudot-Ketelers has served as our has served as our Chief Operating Officer since February 2023 after having served as Vice President Pharmaceutical & Clinical Development from August 2021 to January 2023.
Alice Roudot-Ketelers has served as our Chief Operating Officer since February 2023 after having served as Vice President Pharmaceutical & Clinical Development from August 2021 to January 2023. From June 2014 to July 2021, Ms.
Executive officers Frédéric Cren has served as our Chief Executive Officer since co-founding Inventiva in 2011, and as the chairman of our Board of Directors since May 2016. Previously, he served as the General Manager, Research of Abbott Laboratories, a pharmaceutical company, from 2010 until 2012.
(7) Chair of the Corporate Social Responsibility Committee. 106 Table of Contents Executive officers Frédéric Cren has served as our Chief Executive Officer since co-founding Inventiva in 2011, and as the chairman of our Board of Directors between May 2016 and December 2024.
The 80% rule set out in the first two bullets above does not apply to compensation committees of our Board of Directors. The maximum compensation for attending committee meetings explained in the last two bullets assumes attendance of 100% of the meetings of such committees during the financial year.
The maximum compensation for attending committee meetings explained in the last two bullets assumes attendance of 100% of the meetings of such committees during the financial year. In the event of absence from a committee meeting, the compensation will be prorated.
Food and Drug Administration, the European Medicines agency and the Japanese Pharmaceuticals and Medical Devices Agency. Ms. Zimmerman also serves as director of Ligand Pharmaceuticals since 2023 and previously served as director of Caelum Biosciences between 2018 and 2019. Ms.
Zimmermann has worked across all phases of drug development within several therapeutic areas, interacting with relevant regulatory authorities in key markets, including the FDA, the EMA and the Japanese Pharmaceuticals and Medical Devices Agency. Ms. Zimmerman also serves as director of Ligand Pharmaceuticals, a biopharmaceutical company, since 2023 and previously served as director of Caelum Biosciences between 2018 and 2019.
Lu was ratified by the shareholders during the general shareholders meeting that took place on January 25, 2023. 115 Table of Contents Executive Director Compensation The following table sets forth information regarding compensation earned by Frédéric Cren, our Chairman of the Board and Chief Executive Officer, and by Pierre Broqua, our Deputy Chief Executive Officer, Chief Scientific Officer and Director, during the year ended December 31, 2023. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Equity ​ All Other ​ Paid ​ Incentive ​ ​ ​ ​ Salary ​ Bonus ​ awards ​ Compensation ​ leave ​ payments ​ Total Name and principal position (€) (€) (€) (€) (€) (€) (€) Frédéric Cren ​ 305,006 (1) ​ 148,690 (2) ​ 524,969 (3) ​ 25,034 (4) ​ — ​ — ​ 1,003,699 Chief Executive Officer and Chairman of the Board ​ ​ ​ ​ ​ ​ ​ ​ ​ Pierre Broqua 244,816 (1) ​ 100,987 (2) ​ 524,969 (3) ​ 17,653 (4) ​ — 50,000 (5) ​ 938,425 Deputy Chief Executive Officer, Chief Scientific Officer and Director ​ (1) Reflects gross compensation before taxes.
(4) Sofia BV, represented by Chris Buyse, resigned as director on December 10, 2024. 110 Table of Contents Executive Officers and Employee Director Compensation The following table sets forth information regarding compensation earned by Frédéric Cren, our Chairman of the Board and Chief Executive Officer, and by Pierre Broqua, our Deputy Chief Executive Officer, Chief Scientific Officer and Director, during the year ended December 31, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Equity ​ All Other ​ Paid ​ Incentive ​ ​ ​ ​ Salary ​ Bonus ​ awards ​ Compensation ​ leave ​ payments ​ Total Name and principal position (€) (3) (€) (4) (€) (5) (€) (6) (€) (€) (€) Frédéric Cren ​ 311,116 ​ 148,690 ​ 263,861 ​ 26,007 ​ 10,555 ​ — ​ 760,229 Chief Executive Officer and Director (1) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Pierre Broqua 249,717 ​ 102,487 ​ 263,861 ​ 16,522 ​ — ​ — (7) ​ 632,587 Deputy Chief Executive Officer and Chief Scientific Officer (2) ​ ​ (1) Mr.
Broqua, who is our Deputy Chief Executive Officer and Chief Scientific Officer, are directors but do not receive any additional compensation for their services as directors.
Broqua, who is our Deputy Chief Executive Officer and Chief Scientific Officer (Dr.
He serves as board member, audit committee president and member of the corporate social responsibility committee of MaaT Pharma, a biotech company listed on Euronext since December 2021. Michael Cooreman has served as our Chief Medical Officer since October 2020. From 2017 to 2020, Dr.
Volatier serves as a member of the Board of Directors, as chairperson of the audit committee and as member of the corporate social responsibility committee of MaaT Pharma, a biotechnology company.
Buyse holds a master’s degree in applied economic sciences from the University of Antwerp and a master’s degree in business administration from the Vlerick School of Management in Ghent. 112 Table of Contents Lucy Lu has served as a member of our Board of Directors since May 2018.
Akkaraju received his M.D. and a Ph.D. in Immunology from Stanford University and his undergraduate degrees in Biochemistry and Computer Science from Rice University. Lucy Lu has served as a member of our Board of Directors since May 2018.
Removed
Non-Employee Directors Chris Buyse has served as a member of our Board of Directors since February 2017. Chris Buyse is currently the managing partner of Fund+, which is a life sciences investment fund that he co-founded in 2015. Previously, Mr. Buyse was Chief Financial Officer at ThromboGenics NV, a public biotechnology company, from 2006 to 2014.
Added
He has a Ph.D. in pharmacology from the University of Paris Descartes and a master’s degree in chemistry and biochemistry from Université Pierre et Marie Curie, Paris. Pascaline Clerc has served as our Executive Vice President, Strategy and Corporate Affairs since October 2023.
Removed
He is currently also serving as a director of Hyloris Pharmaceuticals NV, since December 2020, and IPA Therapeutics Inc., since August 2023. Mr. Buyse previously served as director of EYE-D Pharma SA, between March 2019 and March 2023.
Added
Prior to that, she served as our Head of Business Development between February 2015 and April 2024. Before joining Inventiva, from September 2013 to January 2015, Dr. Meyer served as Vice President of Business Development of Oxford BioTherapeutics Ltd. Dr.
Removed
As director of Bone Therapeutics SA from 2008 to 2018, as director of Keyware Technologies NV from 2006 to 2019, and as director of Celyad SA from 2008 to 2022. Mr.
Added
Meyer also served as Vice President of Business Development of Evotec (UK) Ltd. between January 2005 to August 2013, and Director Business Development of Sertanty from November 2002 to November 2004. She holds an undergraduate degree and a Ph.D. in chemistry from Goethe University Frankfurt.
Removed
Zimmerman holds a Doctor of Pharmacy degree from the University of Strasbourg. ​ 113 Table of Contents Diversity of the Board of Directors Board Diversity Matrix (As of the date of this Report) Country of Principal Executive Offices France Foreign Private Issuer Yes Disclosure Prohibited under Home Country Law No Total Number of Directors 7 Female Male Non-Binary Did Not Disclose Gender Part I: Gender Identity Directors 3 4 0 0 Part II: Demographic Background Underrepresented Individual in Home Country Jurisdiction 1 LGBTQ+ 0 Did Not Disclose Demographic Background 2 ​ The information regarding the diversity of our Board of Directors for the year ended December 31, 2022 is available in our Annual Report on Form 20-F for the year ended December 31, 2022.
Added
Pruzanski has been a member of the board of directors of Equillium, a clinical-stage biotechnology company, since September 2018. Prior to joining Inventiva, Dr.
Removed
In the event of absence from a committee meeting, the compensation will be prorated.
Added
Pruzanski served as a member of the Board of Directors from September 2021 to August 2023, and as Chief Executive Officer from April 2022 to September 2023 of Versanis Bio, a clinical-stage biotechnology company, where he spearheaded the development of novel therapies for obesity and other cardiometabolic diseases until the company’s acquisition in 2023 by Eli Lilly and Company. Dr.
Removed
Lu had previously been Sofinnova Partners’ representative at Inventiva’s Board of Directors since January 2020. The nomination of Dr.
Added
Pruzanski was also a co-founder and member of the Board of Directors of Intercept Pharmaceuticals, a biopharmaceutical company, where he served as President and Chief Executive Officer from 2002 until January 2021. Prior to co-founding Intercept, Dr.
Removed
(5) On December 20, 2023, we entered into an agreement for the transfer and communication of know-how with Mr. Pierre Broqua (the “Regulated Agreement”) to secure the transfer of Mr. Broqua’s intellectual property rights in the research and development work he carried out up to December 31, 2022 (the “Work Rights”).
Added
Pruzanski was a venture partner at Apple Tree Partners, an early-stage life sciences venture capital firm that he co-founded, and an entrepreneur-in-residence at Oak Investment Partners, a venture capital firm. Dr.
Removed
In consideration for the assignment of Work Rights, we will pay Mr. Broqua (i) €50,000 euros and (ii) a further €50,000 subject to the granting of a marketing authorization or the conclusion of a licensing agreement with a third party relating to the patents associated with the assignment of Work Rights (the “Assignment Remuneration”).
Added
Pruzanski received his M.D. from McMaster University, a M.A. degree in International Affairs from the Johns Hopkins University School of Advanced International Studies, and a bachelor’s degree from McGill University. Srinivas Akkaraju has served as a member of our Board of Directors since December 2024. Dr. Akkaraju is a Founder and Managing General Partner at Samsara BioCapital.
Removed
The Board of Directors intends to propose a change to the remuneration policy for Mr. Broqua in respect of the 2023 financial year to provide for the allocation of the Assignment Remuneration at the 2024 Annual General Meeting.
Added
Previously, from April 2013 to February 2016, he served as a General Partner of Sofinnova Ventures. From January 2009 until April 2013, he served as Managing Director of New Leaf Venture Partners. He also previously served as a Managing Director at Panorama Capital, LLC, a private equity firm. Prior to co-founding Panorama Capital, he was with J.P.
Removed
The foregoing payments of the Assignment Remuneration is subject to the approval by the 2024 Annual General Meeting of the resolution relating to the approval of the amendment to the remuneration policy for the Chief Executive Officer in respect of the 2023 financial year.
Added
Morgan Partners, which he joined in 2001 and of which he became a Partner in 2005. From October 1998 to April 2001, he was in Business and Corporate Development at Genentech (now a wholly owned member of The Roche Group), a biotechnology company, most recently as Senior Manager. Dr.
Removed
Following the entry in force of the Sapin 2 Law (French law No. 2016-1691 of December 9, 2016), the payment of the elements of variable compensation and, as appropriate, exceptional compensation attributed for a financial year to the Chairman of the Board, the Chief Executive Officer and the Deputy Chief Executive Officer, is conditional on approval by the next ordinary general meeting of their elements of compensation, paid or attributed during the said financial year (ex post vote).
Added
Akkaraju is a member of the Board of Directors for Scholar Rock since July 2022, Mineralys Therapeutics since April 2021, vTv Therapeutics since March 2024, and Syros Pharmaceuticals since June 2017. Dr.
Removed
The payments of the above variable compensation are subject to approval by our shareholders at the extraordinary shareholder meeting to be held on May 23, 2024. 116 Table of Contents Limitations on Liability and Indemnification Matters Under French law, provisions of bylaws that limit the liability of directors are ineffective.
Added
Akkaraju previously served as director of Chinook Therapeutics from July 2019 to September 2023, Intercept Pharmaceuticals from October 2012 to November 2023, Jiya Acquisition Corp. from November 2020 to November 2022, Seattle Genetics (now, Seagen) from July 2003 to September 2020, Aravive from July 2012 to April 2020 and Principia Biopharma from February 2011 to June 2019. Dr.
Removed
However, French law allows sociétés anonymes to contract for and maintain liability insurance against civil liabilities incurred by any of their directors and officers involved in a third-party action, provided that they acted in good faith and within their capacities as directors or officers of the company.
Added
Schwebig is a graduate of the Paris Faculty of Medicine. Andre Turenne has served as a member of our Board of Directors since May 2024. Mr. Turenne currently serves as President and Chief Executive Officer of Matchpoint Therapeutics since October 2021, and as advisor to Atlas Venture since 2021. Prior to joining Matchpoint, Mr.
Removed
Criminal liability cannot be indemnified under French law, whether directly by the company or through liability insurance. We have liability insurance for our directors and officers, including insurance against liability under the Securities Act. We also may enter into agreements with our directors and executive officers to provide contractual indemnification.
Added
Turenne served as President and Chief Executive Officer of Voyager Therapeutics between July 2018 and June 2021. He previously held senior leadership positions at Sanofi, including Senior Vice President and Global Head of Business Development & Licensing, responsible for strategic transactions across therapeutic areas, modalities, and geographies. Mr.
Removed
With certain exceptions and subject to limitations on indemnification under French law, these agreements will provide for indemnification for damages and expenses including, among other things, attorneys’ fees, judgments and settlement amounts incurred by any of these individuals in any action or proceeding arising out of his or her actions in that capacity.
Added
Subject to shareholder approval, which approval was obtained at the general shareholders’ meeting of December 11, 2024, we appointed Mark Pruzanski and Srinivas Akkaraju as members of the Board, and Mark Pruzanski as Chairman of the Board, pursuant to the subscription agreements we entered into on October 11, 2024 in connection with the Structured Financing.
Removed
Certain of our non-employee directors may also, through their relationships with their employers or partnerships, be insured against certain liabilities in their capacity as members of our Board of Directors. These arrangements may discourage shareholders from bringing a lawsuit against our directors and executive officers for breach of their duty.
Added
We have further agreed in the subscription agreements to nominate up to four additional persons for approval as members of the Board at a general meeting of shareholders, upon the proposal of certain of the Investors. Such additional members of the Board would replace existing members of the Board (other than Frédéric Cren, Dr. Pruzanski and Dr. Akkaraju). B.
Removed
These provisions also may have the effect of reducing the likelihood of derivative litigation against directors and executive officers, even though such an action, if successful, might otherwise benefit us and our shareholders.
Added
The most recent decision was made on June 20, 2024, setting this amount at €500,000 with effect from 2024.
Removed
Furthermore, a shareholder’s investment may be adversely affected to the extent we pay any costs of settlement and damage awards against directors and officers pursuant to any insurance arrangements.
Added
In order to offer competitive compensation packages to directors resident in North America, we will propose to our shareholders at the next shareholders’ general meeting, to be held on May 22, 2025, to increase the aggregate annual compensation package to be allocated among all our directors to €900,000 starting for the 2025 financial year.
Removed
Equity Incentives We believe our ability to grant equity incentives is a valuable and necessary compensation tool that allows us to attract and retain the best available personnel for positions of substantial responsibility, provides additional incentives to employees and promotes the success of our business.
Added
We will propose to our shareholders at the next shareholders’ general meeting that, subject to the approval of the new aggregate compensation package above, the amounts shown in the first two bullets be increased to €100,000.
Removed
Due to French corporate law and tax considerations, we have historically granted or may grant in the future several different equity incentive instruments to our directors, executive officers, employees and other service providers, including: ● founder’s share warrants ( bons de souscription de parts de créateur d’entreprise, or BSPCE ), which are granted to our officers and employees; ● share warrants ( bons de souscription d’actions, or BSA ), which have historically only been granted to non-employee directors and a consultant of the company; ● restricted, or free, shares ( actions gratuites, or AGA ); and ● stock options ( options de souscription et/ou d’achats d’actions ). ● performance units ( plan d’attribution gratuite d’unités de performance, or PAGUP ) Our Board of Directors’ authority to grant these equity incentive instruments and the aggregate amount authorized to be granted under these instruments must be approved by a two-thirds majority of the votes held by our shareholders present, represented or voting by authorized means, at the relevant extraordinary shareholders’ meeting.
Added
If one of our directors is appointed or leaves during a financial year, such director’s compensation is calculated by weighting the above-mentioned sum of €50,000 (or €100,000) in proportion to the effective term of office over the financial year and in accordance with the rules set out in the first two bullets.

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Item 7. Management's Discussion & Analysis

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

27 edited+172 added−8 removed14 unchanged
Biggest change(7) ​ 3,845,676 ​ 7.4 % Directors and Executive Officers: ​ ​ ​ Frédéric Cren (2) 5,827,224 11.1 % Pierre Broqua (6) 4,097,500 7.8 % Jean Volatier (8) 171,300 * ​ Michael Cooreman (9) 36,500 * ​ Alice Roudot-Ketelers (10) 36,500 * ​ Eric Duranson (11) 36,500 * ​ Nathalie Harroy (12) 80,033 * ​ Pascaline Clerc (13) ​ 18,250 ​ * ​ Sofia BV, represented by Chris Buyse (14) 30,000 * ​ Lucy Lu — — ​ CELL+ represented by Annick Schwebig (15) 33,076 * ​ Heinz Maeusli — — ​ Martine Zimmermann — — ​ All directors and executive officers as a group (13 persons) 10,366,883 19.7 % * Represents beneficial ownership of less than 1%.
Biggest change(5) 6,331,195 6.6 % Andera Partners (6) ​ 6,148,147 ​ 6.4 % Frédéric Cren (7) ​ 5,827,224 ​ 6.1 % Perceptive Advisors (8) 5,555,555 5.8 % Qatar Holding LLC (9) 5,157,233 5.4 % Eventide (10) 5,059,258 5.3 % Executive Officers: ​ ​ ​ Frédéric Cren (7) 5,827,224 6.1 % Pierre Broqua (11) 4,097,500 4.3 % Pascaline Clerc (12) 18,250 * ​ Michael Cooreman (13) 36,500 * ​ Eric Duranson (14) ​ 66,500 ​ * ​ Nathalie Harroy (15) 120,033 * ​ Kristina Meyer (16) 32,519 * ​ Alice Roudot-Ketelers (17) 66,500 * ​ Jean Volatier (18) 231,300 * ​ Directors: ​ ​ ​ Mark Pruzanski ​ — ​ — ​ Srinivas Akkaraju (19) ​ 4,930,067 ​ 4.9 % Lucy Lu ​ — ​ — ​ Heinz Maeusli ​ — ​ — ​ CELL+ represented by Annick Schwebig (20) ​ 33,076 ​ * ​ Andre Turenne ​ — ​ — ​ Martine Zimmermann ​ — ​ — ​ All directors and executive officers as a group (16 persons) ​ 15,459,469 ​ 15.6 % * Represents beneficial ownership of less than 1%.
However, such transactions, when entered into in the ordinary course of business (“ opérations courantes ”), at arms’ length (“ conclues à des conditions normales ”) (the “Ordinary Transactions Conducted under Normal Conditions”) or entered into between a fully-owned company and its holding company and not exceeding US$120,000, are deemed not to create or involve a material interest on the part of the related person and are not to be reviewed, nor will they require approval or ratification, under our policy.
However, such transactions, when entered into in the ordinary course of business ( opérations courantes ), at arms’ length ( conclues à des conditions normales ) (the “Ordinary Transactions Conducted under Normal Conditions”) or entered into between a fully-owned company and its holding company and not exceeding US$120,000, are deemed not to create or involve a material interest on the part of the related person and are not to be reviewed, nor will they require approval or ratification, under our policy.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of March 1, 2024 and options and warrants that are currently exercisable or exercisable within 60 days of March 1, 2024.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including free shares that vest within 60 days of March 1, 2025 and options and warrants that are currently exercisable or exercisable within 60 days of March 1, 2024.
Shares subject to free shares that vest within 60 days of March 1, 2024 and shares subject to warrants currently exercisable or exercisable within 60 days of March 1, 2024 are deemed to be outstanding for computing the percentage ownership of the person holding these free shares and 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.
Shares subject to free shares that vest within 60 days of March 1, 2025 and shares subject to warrants currently exercisable or exercisable within 60 days of March 1, 2025 are deemed to be outstanding for computing the percentage ownership of the person holding these free shares and 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.
Related Party Transactions Since January 1, 2023, we have engaged in the following transactions with our directors, executive officers and holders of more than 5% of our outstanding voting securities and their affiliates, which we refer to as our related parties.
Related Party Transactions Since January 1, 2024, we have engaged in the following transactions with our directors, executive officers and holders of more than 5% of our outstanding voting securities and their affiliates, which we refer to as our related parties.
The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees. This number of holders of record also does not include holders whose shares may be held in trust by other entities. 130 Table of Contents B.
The actual number of holders is greater than these numbers of record holders, and includes beneficial owners whose ordinary shares or ADSs are held in street name by brokers and other nominees. This number of holders of record also does not include holders whose shares may be held in trust by other entities. B.
All of the transactions described above were entered into prior to the adoption of the written policy, but all were approved by our board of directors to the extent required by, and in compliance with, French law. C . Interests of Experts and Counsel Not applicable.
All of the transactions described above were entered into prior to the adoption of the written policy, but all were approved by our board of directors to the extent required by, and in compliance with, French law. C . Interests of Experts and Counsel Not applicable. ​ 131 Table of Contents
Major Shareholders The following table and accompanying footnotes sets forth, as of March 1, 2024, information regarding beneficial ownership of our ordinary shares by: ● each person, or group of affiliated persons, known by us to beneficially own more than 5% of our ordinary shares; ● each of our executive officers; ● each of our directors; and ● all of our executive officers and directors as a group.
Major Shareholders The following table and accompanying footnotes set forth, as of March 1, 2025, information regarding beneficial ownership of our ordinary shares by: ● each person, or group of affiliated persons, known by us to beneficially own more than 5% of our ordinary shares; ● each of our executive officers; ● each of our directors; and ● all of our executive officers and directors as a group.
(1) The information shown is based upon disclosures on a Schedule 13D/A filed with the SEC on September 25, 2023 by BVF Partners L.P. (“BVF Partners”) on behalf of itself and Biotechnology Value Fund, L.P. (“BVF”), BVF I GP LLC (“BVF GP”), Biotechnology Value Fund II, L.P.
(1) The information shown is based upon disclosures on a Schedule 13D/A filed with the SEC on December 23, 2024 by BVF Partners L.P./IL (“BVF Partners”) on behalf of itself and Biotechnology Value Fund, L.P. (“BVF”), BVF I GP LLC (“BVF GP”), Biotechnology Value Fund II, L.P.
Our calculation of the percentage of beneficial ownership is based on 52,115,807 of our ordinary shares outstanding as of March 1, 2024. 128 Table of Contents Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Inventiva S.A., 50 rue de Dijon, 21121 Daix, France. ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Percentage of ​ ​ shares ​ shares ​ ​ beneficially ​ beneficially Name of beneficial owner owner owned 5% Shareholders: ​ BVF Partners L.P.
Our calculation of the percentage of beneficial ownership is based on 95,662,391 of our ordinary shares outstanding as of March 1, 2025. ​ 123 Table of Contents Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Inventiva S.A., 50 rue de Dijon, 21121 Daix, France. ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Percentage of ​ ​ shares ​ shares ​ ​ beneficially ​ beneficially Name of beneficial owner owned owned 5% Shareholders: ​ BVF Partners L.P.
This agreement was executed on December 20, 2023. Related Person Transaction Policy We comply with French law regarding approval of transactions with related parties. We have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions.
Related Person Transaction Policy We comply with French law regarding approval of transactions with related parties. We have adopted a related person transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related person transactions.
Any related person transaction, if not initially identified as a related person transaction prior to consummation, shall be submitted to the Board for review and ratification in accordance with the approval policies set forth above as soon as reasonably practicable. The Board shall consider whether to ratify and continue, amend and ratify, or terminate or rescind such related person transaction.
Any related person transaction, if not initially identified as a related person transaction prior to consummation, shall be submitted to the Board for review and ratification in accordance with the approval policies set forth above as soon as reasonably practicable.
(5) The information shown is based upon disclosures on a Schedule 13G filed with the SEC on February 9, 2024 by Sofinnova Crossover I SLP (“SC”), Sofinnova Partners SAS (“SP SAS”), and Antoine Papiernik (“Papiernik”), Cédric Moreau (“Moreau”), Kinam Hong (“Hong”), Joseph Anderson (“Anderson”) and Jacques Theurillat (“Theurillat”), the members of the investment committee of SC.
(4) The information shown is based upon disclosures on a Schedule 13G filed with the SEC on February 14, 2025 by Sofinnova Crossover I SLP (“SC”), Sofinnova Partners SAS (“SP SAS”), and Antoine Papiernik, Cédric Moreau, Kinam Hong, Joseph Anderson and Jacques Theurillat, the members of the investment committee of SC. SP SAS is the management company of SC.
Schwebig in her own name. Significant Changes in Percentage Ownership According to its filings with the Securities and Exchange Commission, Yiheng Capital Management L.P. purchased 982,679 ordinary shares or ADSs in the second quarter of 2022, increasing its position by approximately 59%, to approximately 6.5%.
(20) Consists of 3,076 ordinary shares and 30,000 ordinary shares underlying the BSA 2017. Significant Changes in Percentage Ownership According to its filings with the Securities and Exchange Commission, Yiheng Capital Management L.P. purchased 982,679 ordinary shares or ADSs in the second quarter of 2022, increasing its position by approximately 59%, to approximately 6.5%.
Shareholders in the United States As of December 31, 2023, to the best of our knowledge 21,291,980 of our outstanding ordinary shares (including ordinary shares in the form of ADSs) were held by 12 shareholders of record in the United States.
Shareholders in the United States As of December 31, 2024, to the best of our knowledge 45,685,186 of our outstanding ordinary shares (including ordinary shares in the form of ADSs) were held by 14 shareholders of record in the United States.
Voting Rights A double voting right is attached to each registered share which is held in the name of the same shareholder for at least two years. Any of our principal shareholders who have held our ordinary shares in registered form for at least two years have this double voting right.
Any of our principal shareholders who have held our ordinary shares in registered form for at least two years have this double voting right.
Our management must present information regarding the related person transaction to our board of directors, for review, consideration and approval or ratification.
The Board shall consider whether to ratify and continue, amend and ratify, or terminate or rescind such related person transaction. ​ 130 Table of Contents Our management must present information regarding the related person transaction to our board of directors, for review, consideration and approval or ratification.
The principal business address for New Enterprise Associates is 1954 Greenspring Drive, Suite 600, Timonium, Maryland 21093, United States. (4) The information shown is based upon disclosures on a Schedule 13G filed with the SEC on September 5, 2023 by Qatar Investment Authority on behalf of itself and Qatar Holding LLC. Consists of 5,157,233 ordinary shares.
(9) The information shown is based upon disclosures on a Schedule 13G filed with the SEC on September 5, 2023 by Qatar Investment Authority on behalf of itself and Qatar Holding LLC. Consists of 5,157,233 ordinary shares.
(“BVF2”), BVF II GP, LLC (“BVF2 GP”), Biotechnology Value Trading Fund OS LP (“Trading Fund OS”), BVF Partners OS Ltd. (“Partners OS”), BVF GP Holdings LLC (“BVF GPH”), BVF Inc., and Mark N. Lampert.
(“BVF2”), BVF II GP, LLC (“BVF2 GP”), Biotechnology Value Trading Fund OS LP (“Trading Fund OS”), BVF Partners OS Ltd. (“Partners OS”), BVF GP Holdings LLC (“BVF GPH”), BVF Inc./IL, and Mark N. Lampert. BVF directly owns 4,630,461 ordinary shares, including 451,003 ordinary shares underlying ADSs held by it.
Arrangements with Our Directors and Executive Officers Director and Executive Officer Compensation We are parties to employment agreements and other compensation arrangements, including equity compensation arrangements, with our directors and executive officers in the ordinary course of business.
Arrangements with Our Directors and Executive Officers Director and Executive Officer Compensation We are parties to employment agreements and other compensation arrangements, including equity compensation arrangements, with our directors and executive officers in the ordinary course of business. 127 Table of Contents Agreement with Pierre Broqua On December 11, 2024, we entered into an agreement with Pierre Broqua, our Deputy Chief Executive Officer and Chief Scientific Officer.
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 us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. 131 Table of Contents Under the policy, we will collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant shareholder to enable us to identify any existing or potential related-person transactions and to effectuate the terms of the policy.
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 us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally.
(11) Consists of 15,000 ordinary shares and 21,500 free shares granted under the AGA 2021 Plan that vested on March 25, 2024. (12) Consists of 65,700 ordinary shares and 14,333 free shares granted under the AGA 2021 Plan that vested on March 25, 2024.
(11) Consists of 3,882,500 ordinary shares and 215,000 founder share warrants granted under the BSPCE 2021 Plan that vested on March 25, 2024. (12) Consists of 18,250 ordinary shares. (13) Consists of 36,500 ordinary shares. (14) Consists of 66,500 ordinary shares. (15) Consists of 120,033 ordinary shares.
The principal business address for Qatar Investment Authority is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, P.O. Box 23224, Qatar.
The principal business address for Qatar Investment Authority is Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, P.O. Box 23224, Qatar. (10) Consists of 5,059,258 ordinary shares held directly by Eventide Healthcare Innovation Fund I LP (“Eventide LP”). Eventide Healthcare Innovation GP LLC (“Eventide GP”) is the general partner of Eventide LP.
BVF beneficially owned 4,630,461 shares, including 451,003 shares underlying ADSs held by it, (ii) BVF2 beneficially owned 3,321,861 shares, including 234,997 Shares underlying ADSs held by it, (iii) Trading Fund OS beneficially owned 397,086 shares, including 40 Shares underlying ADSs held by it, and (iv) 196,091 Shares were held by BVF, BVF2, Trading Fund OS and a certain managed accounts.
BVF2 directly owns 3,321,861 ordinary shares, including 234,997 ordinary shares underlying ADSs. Trading Fund OS directly owns 397,086 ordinary shares, including 40 ordinary shares underlying ADSs. 196,091 ordinary shares are held in a certain managed account (“Partners Managed Account”).
(1) 8,545,499 16.4 % Frédéric Cren (2) 5,827,224 11.1 % New Enterprise Associates (3) 5,572,953 10.7 % Qatar Holding LLC (4) 5,157,233 9.9 % Sofinnova Crossover I SLP (5) 5,070,266 9.7 % Pierre Broqua (6) ​ 4,097,500 ​ 7.8 % Entities affiliated with Yiheng Capital Management, L.P.
(1) 8,545,499 8.9 % Invus Public Equities (2) 8,470,274 8.8 % New Enterprise Associates (3) 8,350,730 8.7 % Sofinnova Crossover I SLP (4) 6,751,746 7.0 % Entities affiliated with Yiheng Capital Management, L.P.
SP SAS is the management company of SC. Consists of 5,070,266 ordinary shares, including ordinary shares represented by ADSs held by Sofinnova Crossover I SLP.
Consists of 6,751,746 ordinary shares, including ordinary shares represented by ADSs held by Sofinnova Crossover I SLP. The principal business address of each is 7-11, boulevard Haussmann 75009 Paris, France.
Yiheng Capital Management, LP (the “Investment Manager”) serves as investment manager to the Partnership. Mr. Yuanshan Guo is the managing member of the Investment Manager. In such capacity, Mr. Guo and the Investment Manager may be deemed to have voting and dispositive power with respect to the shares held for the Partnership.
(5) The information shown is partially based upon disclosures on a Schedule 13G filed with the SEC on November 13, 2024 by Yiheng Capital Management, LP (the “Investment Manager”) who serves as investment manager to Yiheng Capital Partners, L.P. (the “Partnership”). Mr. Yuanshan Guo is the managing member of the Investment Manager. In such capacity, Mr.
Removed
Item 7. Major Shareholders and Related Party Transactions. A.
Added
Item 7.B Major Shareholders and Related Party Transactions—Related Party Transactions—Agreement with Pierre Broqua. ” This agreement is subject to the approval by the 2025 Annual General Meeting.
Removed
The principal business address for BVF Partners L.P. is 44 Montgomery Street 40th Floor, San Francisco, CA 94104. (2) Consists of 5,612,224 ordinary shares and 215,000 founder share warrants granted under the BSPCE 2021 Plan that vested on March 25, 2024. (3) Consists of 4,110,367 ordinary shares and 1,462,586 ADSs.
Added
Following the entry in force of the Sapin 2 Law (French law No. 2016-1691 of December 9, 2016), the payment of the elements of variable compensation and, as appropriate, exceptional compensation attributed for a financial year to the Chairman of the Board, the Chief Executive Officer and the Deputy Chief Executive Officer, is conditional on approval by the next ordinary general meeting of their elements of compensation, paid or attributed during the said financial year (ex post vote).
Removed
The principal business address of each is 7-11, boulevard Haussmann 75009 Paris, France. 129 Table of Contents (6) Consists of 3,882,500 ordinary shares and 215,000 founder share warrants granted under the BSPCE 2021 Plan that vested on March 25, 2024. (7) Consists of 3,845,676 ordinary shares held for the account of Yiheng Capital Partners, L.P. (the “Partnership”).
Added
The payments of the above variable compensation are subject to approval by our shareholders at the extraordinary shareholder meeting to be held on May 22, 2025. 111 Table of Contents Limitations on Liability and Indemnification Matters Under French law, provisions of bylaws that limit the liability of directors are ineffective.
Removed
Each disclaims beneficial ownership of the securities reported herein except to the extent of that person’s pecuniary interest therein. The principal office of each is 101 California Street, Suite 2880, San Francisco, CA 94111. (8) Consists of 149,800 ordinary shares and 21,500 free shares granted under the AGA 2021 Plan that vested on March 25, 2024.
Added
However, French law allows sociétés anonymes to contract for and maintain liability insurance against civil liabilities incurred by any of their directors and officers involved in a third-party action, provided that they acted in good faith and within their capacities as directors or officers of the company.
Removed
(9) Consists of 15,000 ordinary shares and 21,500 free shares granted under the AGA 2021 Plan that vested on March 25, 2024. (10) Consists of 15,000 ordinary shares and 21,500 free shares granted under the AGA 2021 Plan that vested on March 25, 2024.
Added
Criminal liability cannot be indemnified under French law, whether directly by the company or through liability insurance. We have liability insurance for our directors and officers, including insurance against liability under the Securities Act. We also may enter into agreements with our directors and executive officers to provide contractual indemnification.
Removed
(13) Consists of 7,500 ordinary shares and 10,750 free shares granted under the AGA 2021 Plan that vested on March 25, 2024. (14) Consists of 30,000 ordinary shares issuable upon the exercise of share warrants (BSA). (15) Consists of 30,000 ordinary shares issuable upon the exercise of share warrants (BSA) and 3,076 shares held by Dr.
Added
With certain exceptions and subject to limitations on indemnification under French law, these agreements will provide for indemnification for damages and expenses including, among other things, attorneys’ fees, judgments and settlement amounts incurred by any of these individuals in any action or proceeding arising out of his or her actions in that capacity.
Removed
Agreement with Pierre Broqua On December 15, 2023, the Board of Directors authorized the Company to enter into an agreement with Pierre Broqua, Deputy Chief Executive Officer, Chief Scientific Officer and director of the Company.
Added
Certain of our non-employee directors may also, through their relationships with their employers or partnerships, be insured against certain liabilities in their capacity as members of our Board of Directors. These arrangements may discourage shareholders from bringing a lawsuit against our directors and executive officers for breach of their duty.
Removed
In this agreement, Pierre Broqua transferred certain of his intellectual property rights related to patents to us in consideration of a payment of €50,000 (net of taxes) and an additional one-time milestone payment of €50,000 (net of taxes) conditioned upon the occurrence of (i) regulatory approval for lanifibranor in the U.S. or the EU, or (ii) Inventiva entering into a license agreement covering the U.S. or EU market.
Added
These provisions also may have the effect of reducing the likelihood of derivative litigation against directors and executive officers, even though such an action, if successful, might otherwise benefit us and our shareholders.
Added
Furthermore, a shareholder’s investment may be adversely affected to the extent we pay any costs of settlement and damage awards against directors and officers pursuant to any insurance arrangements.
Added
Equity Incentives We believe our ability to grant equity incentives is a valuable and necessary compensation tool that allows us to attract and retain the best available personnel for positions of substantial responsibility, provides additional incentives to employees and promotes the success of our business.
Added
Due to French corporate law and tax considerations, we have historically granted or may grant in the future several different equity incentive instruments to our directors, executive officers, employees and other service providers, including: ● founder’s share warrants ( bons de souscription de parts de créateur d’entreprise, or BSPCE ), which are granted to our officers and employees; ● share warrants ( bons de souscription d’actions, or BSA ), which have historically only been granted to non-employee directors and a consultant of the company; ● restricted, or free, shares ( actions gratuites, or AGA ); ● stock options ( options de souscription et/ou d’achats d’actions ); and ● performance units ( plan d’attribution gratuite d’unités de performance, or PAGUP ) Our Board of Directors’ authority to grant these equity incentive instruments and the aggregate amount authorized to be granted under these instruments must be approved by a two-thirds majority of the votes held by our shareholders present, represented or voting by authorized means, at the relevant extraordinary shareholders’ meeting.
Added
Once approved by our shareholders, our Board of Directors can grant founder’s share warrants and share warrants for up to 18 months, and free shares and stock options for up to 38 months from the date of the applicable shareholders’ approval.
Added
The authority of our Board of Directors to grant equity incentives may be extended or increased only by extraordinary shareholders’ meetings. As a result, we typically request that our shareholders authorize new pools of equity incentive instruments at every annual shareholders’ meeting.
Added
We had nineteen share-based compensation plans in force in 2024 for our executive officers, non-employee directors, employees and service providers, the BSPCE 2021 Plan, AGA 2021-1, AGA 2021 bis, AGA 2023-1, AGA 2023-2, AGA 2024-1, AGA 2024-2, AGA 2024-3 and AGA 2024-4 Plans, the BSA 2017, BSA 2018, BSA 2019, BSA 2019 bis, BSA 2019 ter, and BSA 2021, BSA 2023-1 and BSA 2023-2 Plans, the SO 2024-1 and SO 2024-2 Plans.
Added
In general, founder’s share warrants and share warrants no longer continue to vest following termination of the employment, office or service of the holder and all vested shares must be exercised within post-termination exercise periods set forth in the grant documents.
Added
In the event of certain changes in our 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 shares issuable and/or the exercise price of the outstanding warrants. 112 Table of Contents Founder’s Share Warrants (bons de souscription de parts de créateur d’entreprise) Founder’s share warrants have traditionally been granted to certain of our employees who were French tax residents because the warrants carry favorable tax and social security treatment for French tax residents.
Added
Similar to options, founder’s share warrants entitle a holder to exercise the warrant for the underlying vested shares at an exercise price per share determined by our Board of Directors and at least equal to the fair market value of an ordinary share on the date of grant.
Added
However, unlike options, the exercise price per share is fixed as of the date of implementation of the plans pursuant to which the warrants may be granted, rather than as of the date of grant of the individual warrants.
Added
Our shareholders, or pursuant to delegations granted by our shareholders, our Board of Directors, determines the recipients of the warrants, the dates of grant, the number and exercise price of the founder’s share warrants to be granted, the number of shares issuable upon exercise and certain other terms and conditions of the founder’s share warrants, including the period of their exercisability and their vesting schedule.
Added
In 2024, we had one founder’s share warrants plan in effect: BSPCE 2021 (2021) Plan On April 16, 2021, the Board of Directors approved the allocation of 600,000 founder share warrants (BSPCE 2021) to Mr. Frédéric Cren and Mr.
Added
Pierre Broqua as corporate officers of the Company. ​ ​ ​ ​ ​ ​ BSPCE 2021 Plan title (2021) plan Decision of issuance by the Board of Directors 04/16/2021 ​ Grant date 04/16/2021 ​ Beneficiaries Frédéric Cren and Pierre Broqua (1) Number of BSPCE granted 600,000 ​ Expiration date 03/31/2034 ​ Number of shares per BSPCE 1 ​ Subscription price (€) 0 ​ Exercise price (€) 11.74 ​ Performance condition Partially (2) Valuation method used Monte Carlo ​ Fair value at grant date (€) 5.4 – 5.7 ​ (1) Mr.
Added
Cren and Mr. Broqua each received a grant of 300,000 founder share warrants.
Added
(2) The vesting of the BSPCE 2021 occurred as follows: (i) 50% of the BSPCE 2021 vested if the holder is employed by us at the date of the Board of Directors meeting voting on the financial statements for the fiscal year ending December 31, 2023 and (ii) 50% of the BSPCE 2021 vest if (i) the abovementioned presence condition is met, and (ii) certain performance conditions are met.
Added
The performance conditions were as follows: (i) sufficient cash flow for the next 12 months (10%), (ii) recruitment of new patients in the NATiV3 study (20%) and total shareholder return (20%).
Added
At its meeting on March 25, 2024, the Board of Directors acknowledged that of the 50% of BSPCE 2021 subject to performance conditions, 72% had become exercisable and 28% had lapsed. 113 Table of Contents Share Warrants (bons de souscription d’actions) Share warrants have historically been granted to our non-employee directors and consultants that regularly work in partnership with us.
Added
Similar to options, share warrants entitle a holder to exercise the warrant for the underlying vested shares at an exercise price per share determined by our Board of Directors and at least equal to the fair market value of an ordinary share on the date of grant.
Added
However, unlike options, the exercise price per share is fixed as of the date of implementation of the plans pursuant to which the warrants may be granted, rather than as of the date of grant of the individual warrants.
Added
As of December 31, 2024, we had issued eight types of share warrants as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ BSA ​ BSA ​ BSA ​ BSA ​ BSA ​ BSA BSA ​ BSA Plan title 2017 plan 2018 plan 2019 plan ​ 2019 bis plan 2019 ter plan 2021 plan 2023 plan 2023-2 Plan Meeting date May 29, 2017 ​ May 28, 2018 ​ May 27, 2019 ​ May 27, 2019 ​ May 27, 2019 ​ April 16, 2021 ​ May 25, 2023 ​ December 15, 2023 Decision of issuance by the Board of Directors ​ May 29, 2017 ​ December 14, 2018 ​ June 28, 2019 ​ March 9, 2020 ​ March 9, 2020 ​ April 16, 2021 ​ May 25, 2023 ​ December 15, 2023 Total number of BSAs authorized (General meeting) ​ 600,000 ​ 600,000 ​ 600,000 (1) 600,000 (1) 600,000 (1) 50,000 ​ 10,000 ​ 20,000 Total number of BSAs authorized (Board of Directors) ​ 195,000 (2) 126,000 (3) 10,000 ​ 10,000 ​ 36,000 ​ 50,000 ​ 10,000 ​ 20,000 Total number of BSA subscribed ​ 195,000 ​ 126,000 ​ 10,000 ​ 10,000 ​ 36,000 ​ 16,000 ​ — ​ — Start date for the exercise of the BSAs ​ (2) ​ (3) ​ (4) ​ (5) ​ (6) ​ (8) ​ (9) ​ (9) BSA expiration date ​ May 29, 2027 ​ December 14, 2028 ​ June 28, 2029 ​ March 9, 2030 ​ March 9, 2030 ​ March 31, 2034 ​ March 31, 2036 ​ March 31, 2036 BSA exercise price per share ​ €6.675 ​ €6.067 ​ €2.20 ​ €3.68 ​ €3.68 ​ €11.74 ​ €2.51 ​ €3.91 Number of shares subscribed as of December 31, 2024 ​ — ​ — ​ — ​ — ​ — ​ — ​ — ​ — Total number of shares available for subscription as of December 31, 2024 ​ 130,000 ​ 116,000 ​ 10,000 ​ 10,000 ​ 36,000 ​ 14,333 ​ 10,000 ​ 20,000 Maximum number of new shares that can be issued ​ 130,000 ​ 116,000 ​ 10,000 ​ 10,000 (7) 36,000 (7) 14,333 ​ 10,000 ​ 20,000 (1) Total number of BSAs authorized for all 2019 plans is 600,000.
Added
(2) All rights granted under this plan have fully vested. 10,000 BSA 2017 were exercised and 55,000 BSA 2017 were cancelled or have lapsed. (3) All rights granted under this plan have fully vested. 10,000 BSA 2018 were cancelled or have lapsed. (4) All rights granted under this plan have fully vested.
Added
(5) All rights granted under this plan have fully vested. (6) All rights granted under this plan have fully vested. (7) On March 9, 2020, our Board of Directors granted 10,000 BSA 2019 bis and 36,000 BSA 2019 ter all of which have been subscribed by the beneficiaries.
Added
(8) The BSA 2021 share warrants vested on March 25, 2024, when the Board of Directors confirmed the partial satisfaction of the vesting conditions. 30,000 BSA granted under this plan were cancelled in June 2021 and 4,000 were cancelled in 2022. The BSA 2021 share warrants will expire ten years after vesting.
Added
(9) Estimated date: the BSA 2023 and BSA 2023-2 may be exercised from the date of the Board of Directors’ meeting called to approve our financial statements for the financial year ending December 31, 2025, and until the end of a period of ten (10) years from that date.
Added
Our shareholders, or pursuant to delegations granted by our shareholders, our Board of Directors, determines the recipients of the warrants, the dates of grant, the number and exercise price of the share warrants to be granted, the number of shares issuable upon exercise and certain other terms and conditions of the share warrants, including the period of their exercisability and their vesting schedule.
Added
Free Shares (actions gratuites) Our Free Share Plans were adopted by our Board of Directors on: ● April 16, 2021 for the 2021 Free Share Plan, 114 Table of Contents ● December 8, 2021 for the 2021 bis Free Share Plan, ● May 25, 2023 for the 2023-1 Free Share Plan, ● December 15, 2023 for the 2023-2 Free Share Plan, and ● December 13, 2024 for the 2024-1, 2024-2, 2024-3 and 2024-4 Free Share Plans.
Added
Free shares may be granted to any individual employed by us or by any affiliated company. Free shares may also be granted to our Chairman, our Chief Executive Officer and our Deputy Chief Executive Officer.
Added
However, no free share may be granted to a beneficiary holding more than 10% of our share capital or to a beneficiary who would hold more than 10% of our share capital as a result of such grant. Shares held by the shareholder for 7 years or longer are excluded for the purposes of calculating this 10% threshold.
Added
In addition, under French law, the maximum number of shares that may be granted shall not exceed 10% of the share capital as at the date of grant of the free shares (30% if the allocation benefits all employees).
Added
The conditions for the allocation of free shares as decided by the Board of Directors at its meetings of April 16, 2021 and December 8, 2022, May 25, 2023, December 15, 2023 and December 11, 2024 are set out below.
Added
None of the interested parties holds more than 10% of the share capital, no allocation will result in one of the interested parties holding more than 10% of the share capital and no corporate officer has benefited from said allocations. 2021-1 Free Share Plan On April 16, 2021, the Board of Directors adopted a plan to allocate 466,000 shares, or AGA 2021-1, to 93 employees.
Added
Rights granted under the AGA 2021-1 plan vested on March 25, 2024, when the Board of Directors confirmed the partial satisfaction of the vesting conditions. 50% of the shares was allocated subject to compliance by the beneficiary with a condition of presence and the remaining 50% of the shares was allocated subject to (i) the fulfillment by the beneficiary of a condition of presence and (ii) the achievement of certain performance conditions.
Added
Since their issuance, 296,166 AGA 2021-1 were acquired by the beneficiaries and 169,834 lapsed. As of December 31, 2024 no AGA 2021-1 are outstanding. 2021 bis Free Share Plan On December 8, 2022, the Board of Directors adopted a plan to allocate 123,000 shares, or AGA 2021 bis, to 13 employees.
Added
Rights granted under the AGA 2021 bis plan vested on March 25, 2024, when the Board of Directors confirmed the partial satisfaction of the vesting conditions. 50% of the shares was allocated subject to compliance by the beneficiary with a condition of presence and the remaining 50% of the shares was allocated subject to (i) the fulfillment by the beneficiary of a condition of presence and (ii) the achievement of certain performance conditions.
Added
Since their issuance, 65,215 AGA 2021-2 were acquired by the beneficiaries and 57,785 lapsed. As of December 31, 2024 no AGA 2021-2 are outstanding. 2023 Free Share Plans On May 25, 2023, the Board of Directors adopted a plan to allocate 300,000 free shares, or AGA 2023-1, to Pierre Broqua.
Added
Rights granted under the AGA 2023-1 plan will vest on the date of the meeting of the Board of Directors held after closing the financial statements for the financial year ending December 31, 2026. 75% of the shares was allocated subject to compliance by the beneficiary with a condition of presence and the remaining 25% of the shares was allocated subject to the achievement of certain performance conditions.
Added
Since the beginning of the plan, 75,000 AGA 2023-1 lapsed. 115 Table of Contents In May 2023, Frédéric Cren was not eligible for an allotment of free shares under Article L. 225-197-1 II of the French Commercial Code, as he was holding more than 10% of our share capital.

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