Inventiva announces financing of up to €348 million to advance the NATiV3 Phase 3 MASH study​Inventiva announces financing of up to €348 million to advance the NATiV3 Phase 3 MASH study GlobeNewswire

Inventiva secures €94.1 million of a multi-tranche equity financing of up to €348 million, subject to satisfaction of specified conditions, from both new and existing investors, and up to $30 million in milestone payments relating to equity financing pursuant to amendment to license and collaboration agreement with CTTQ.Proceeds from financing to be primarily used to advance Inventiva’s Phase 3, NATiV3 clinical trial evaluating lanifibranor in patients with MASH. More than 1,100 patients randomized in the NATiV3 study evaluating lanifibranor for the treatment of noncirrhotic MASH, with completion of enrollment projected in 1H 2025.Appointment to the Board of Directors of Mark Pruzanski, MD, as Chairman and Srinivas Akkaraju, MD, PhD, as director, subject to the next General Meeting of Shareholders’ approval. Daix (France), Long Island City (New York, United States), October 14, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases with significant unmet medical needs, today announced financing of immediately €94.1 million and up to €348 million (the “Transaction”), subject to satisfaction of specified conditions, to fund the completion of the Phase 3 NATiV3 MASH trial and preparation for the potential filing for marketing approval and commercialization of lanifibranor.

The Transaction was led by New Enterprise Associates, BVF Partners LP and Samsara BioCapital, with the participation of additional existing and new investors including Andera Partners, Deep Track Capital, Eventide Asset Management, Great Point Partners, LLC, Invus, Perceptive Advisors, Schonfeld Strategic Advisors and Sofinnova Crossover I SLP.

Pursuant to the Transaction and subject to shareholder approval at the next general meeting to be convened by December 16, 2024, the Company appointed Mark Pruzanski, MD, as Company Chairman, and Srinivas Akkaraju, MD, PhD, as a director. Up to four additional directors are to be named by each of the other four largest investors, of whom at least two will qualify as independent and would replace existing directors (excluding Frederic Cren, Mark Pruzanski and Srini Akkaraju).

Dr. Mark Pruzanski said: “I have long believed in the therapeutic potential of lanifibranor in MASH and am honored at the prospect of joining Inventiva as Chairman. Based on the previously published Phase 2b NATIVE study results, lanifibranor has a profile that positions it as a possible ‘best in category’ oral drug: its insulin sensitizing and direct antifibrotic benefits make it an ideal therapy for the large population of Type 2 diabetic patients with advanced fibrosis due to MASH who are at the greatest risk of progressing to liver failure. With the support of the equivalent of up to $410 million in funding announced today, I look forward to working with Frederic and the rest of the Board to help transition the Company to maximize its ability to deliver on lanifibranor’s promise.”

J.P. Morgan, TD Cowen, Guggenheim Securities, and LifeSci Capital are acting as placement agents for the financing, and Namsen Capital is acting as Equity Capital Markets Advisor.

Frederic Cren, Chief Executive Officer of Inventiva, stated:  “I am very pleased to announce this important financing at a critical juncture for the Company. This reflects the confidence of the participating investors and our partner CTTQ in the value of lanifibranor as a breakthrough therapy for patients suffering from MASH. The total proceeds from the financing will support the MASH program and subsequent filing for marketing approval, along with preparations for the potential commercialization of lanifibranor. I would also like to highlight the benefit Mark’s deep expertise in the MASH field brings and look forward to working with him to ensure the best chance of getting lanifibranor to patients.”

Dr. Nezam (“Nid”) Afdhal, Chief of Gastroenterology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School, said: “Investigators and clinicians remain excited about the prospect of lanifibranor in MASH due to its effect on improving both fibrosis and resolution of MASH. PPAR agonism with lanifibranor has also been demonstrated to improve the metabolic profile and cardiovascular risk factors in our patients with MASH. This dual benefit has the potential to identify lanifibranor as an optimal choice for patients with MASH, significant fibrosis, and diabetes.” 

About the Transaction

The Transaction consists of:  

(i) the issuance , through a capital increase without preferential subscription rights reserved to a specific category of beneficiaries (“à catégorie de personnes”), of an aggregate of €94.1 million through the issuance of 34,600,507 new ordinary shares of the Company, par value €0.01 per share (the “T1 New Shares”) at a price of €1.35 per T1 New Share, and 35,399,481 prefunded warrants to purchase ordinary shares in the Company at an exercise price of €0.01 per new ordinary share, each giving the right, in the event of exercise, to one new ordinary share (the “T1 BSAs”), subject to the satisfaction of customary closing conditions;

(ii) the issuance, in a second phase, subject to the satisfaction of the T1bis Conditions Precedent (as defined below), through a new capital increase without preferential subscription rights reserved to certain identified investors (“à personne dénommée”) in accordance with article L. 225-138 of the French Commercial Code, of new ordinary shares, par value €0.01 per share or of prefunded warrants to purchase ordinary shares of the Company at an exercise price of €0.01 per new ordinary share, each giving the right, in the event of exercise, to one new ordinary share (the “T1bis New Shares”), for a total gross amount of €21.4 million;

(iii) the issuance, in a third phase, through a new capital increase without preferential subscription rights reserved to certain identified investors (“à personne dénommée”), subject to the T2 Conditions Precedent (as this term is defined below), of ordinary shares (or, in lieu of ordinary shares at the request of each investor, pre-funded warrants) to which share warrants are attached (the “ABSAs”) for a total amount of €116 million . Each ABSA will consist of a number of new ordinary shares with a par value of €0.01 (or prefunded warrants) to be determined by the Company’s Board of Directors (the “T2 New Shares”) to which will be attached a number of warrants exercisable at an exercise price of €1.50 (the “T3 BSAs”), subject to the occurrence of the T3 Triggering Event (as defined below), allowing for the subscription of a maximum aggregate amount of €116 million of new ordinary shares.

Settlement of the T1 New Shares and the T1 BSAs is expected to take place on October 17, 2024 (the “Settlement Date”), subject to satisfaction of the customary closing conditions.

Pursuant to the Amendment entered into with Chia Tai Tianqing Pharmaceutical (Guangzhou) CO., LTD. (“CTTQ”) concurrent with the Transaction, if the Company receives commitments from investors to subscribe to an equity raise, in two or three tranches, prior to December 31, 2024, for an aggregate amount of at least €180 million (the “Equity Raise”), CTTQ shall pay to the Company (i) $10 million within 30 days of settlement-delivery of the T1 New Shares and T1 BSAs in the event of the issuance of the first tranche of the Equity Raise to be paid by CTTQ, (ii) $10 million upon the completion of the second tranche of the Equity Raise and (iii) $10 million upon the publication by the Company of positive topline data announcing that any key primary endpoint or key secondary endpoint of the Phase 3 global trial, with any dosage regimen tested in the trial, have been met. Under the terms of the Amendment, the total amount of milestone payments remains unchanged, while the royalties that Inventiva is eligible to receive have been reduced to the low single digits.

Reasons for the issuance and use of the proceeds of the Transaction

The Company intends to use the net proceeds from the issuance of the T1 New Shares and T1 BSAs of €94.1 million gross, or €86.6 million net, together with available cash, as follows: approximately 85% for the clinical program evaluating lanifibranor for the treatment of MASH (“NATiV3”) and, in the event of positive NATiV3 results, for the submission of a new drug application, and the remainder, approximately 15%, for general corporate purposes. The Company has undertaken not to use these proceeds for the early redemption of its financial debt prior to its scheduled maturity or for the repurchase of securities issued as part of the Transaction, subject to the implementation of its liquidity contract with Kepler Cheuvreux.

The Company intends to use the aggregate proceeds from the issuance of the T1 New Shares and of the T1 BSAs (for a gross amount of €94.1 million and a net amount of €86.6 million), from the issuance of the T1bis New Shares (for a gross amount of €21.4 million), if this tranche is issued subject to the satisfaction of the T1bis Condition Precedent, and from the issuance of T2 New Shares (for a gross amount of €116 million) if this tranche is issued subject to the satisfaction of the T2 Conditions Precedent, i.e., a maximum gross amount of up to €232 million if these two tranches are issued, to fund the continuation of the Company’s NATiV3 Phase 3 trial as well as to initiate the compensated cirrhosis study, until the announcement of NATiV3 topline results scheduled for the second-half of 2026. Subject to the satisfaction of the applicable conditions precedent and assuming the exercise of all T3 BSAs, the Company intends to use the gross proceeds of €116 million from the exercise of the T3 BSAs to fund the Company’s pre-commercialization activities, including applications for regulatory approval for lanifibranor, if necessary.

Working capital statement

As of the date of this press release, the Company believes that prior to the Transaction, its net working capital is not sufficient to meet its obligations over the next 12 months. As of June 30, 2024, the Company had cash and cash equivalents of €10.1 million, compared with cash and cash equivalents of €26.9 million and €9.0 million of long-term deposit1 at December 31, 2023.

In July 2024, Inventiva issued royalty certificates for an amount of approximately €20.1 million (the “2024 Royalty Certificates”). Taking into account its current cost structure and expected expenses, and taking into account the proceeds from the issuance of the 2024 Royalty Certificates and the short-term cash preservation measures put in place by the Company, but excluding any proceeds from the Transaction, the Company estimates that its cash, cash equivalents and deposits would enable it to finance its operations until mid-October 2024. Prior to the Transaction, the Company is therefore unable to meet its current obligations over the next 12 months.

To cover its obligations until the beginning of October 2025, based on its current business plan, the Company estimates that its additional cash requirements will amount to between €130 million and €135 million.

The Company also estimates that, prior to the Transaction, it would need approximately €250 million to finance its activities until the topline results from its NATiV3 trial, targeted for the second half of 2026. This estimate includes the estimated €130 to €135 million needed to finance the Company’s activities over the next 12 months mentioned above.

Following the issuance of the T1 New Shares and of the T1 BSAs (and excluding the issuance of the T1bis New Shares, the ABSAs and the exercise of the T3 BSAs) for gross proceeds of €94.1 million, or estimated net proceeds of €86.6 million, the Company will not have sufficient net working capital to meet its current obligations over the next 12 months, and will see its financial visibility extended, taking into account the €8.6 million ($10 million) net payment to be made by CTTQ within 30 days of the settlement and delivery of the T1 New Shares and the T1 BSAs, to the end of the second quarter of 2025. The Company estimates that, following the issuance of the T1 New Shares and of the T1 BSAs and taking into account the payment to be made by CTTQ within 30 days of the settlement and delivery of the T1 New Shares and the T1 BSAs, but excluding the issuance of the ABSAs and the exercise of the T3 BSAs, its additional cash requirements in order to meet its current obligations over the next 12 months will amount to €40 million.

If the T1bis Shares (representing a gross amount of €21.4 million) and the ABSAs (representing a gross amount of €116 million) are issued, subject to T1bis Conditions Precedent and T2 Conditions Precedent, as applicable, the Company could extend its financial visibility beyond 12 months.

To the extent the T1bis Conditions Precedent and/or the T2 Conditions Precedent are not satisfied and/or the T3 Triggering Event does not occur and therefore the T1bis Shares and the ABSAs are not issued and the Company does not receive any of the contemplated gross proceeds from the issuance of the T1bis Shares or ABSAs or exercise of the T3 BSAs, the Company will need to raise additional funds to support is business and its research and development programs as currently contemplated through:

other potential public offerings or private placements of equity or debt instruments; or potential strategic options such as business development partnerships and/or licensing agreements. Main characteristics of the Transaction

The Company’s Board of Directors, by virtue of the powers granted to it by the 25th resolution of the shareholders’ general meeting of June 20, 2024 (capital increase without preferential subscription rights in favor of specific categories of beneficiaries2) and in accordance with Articles L. 225-138 et seq. of the French Commercial Code (Code de commerce) has decided on October 11, 2024 to proceed with the issuance of T1 New Shares and of T1 BSAs and has determined the final number of T1 New Shares and of the T1 BSAs and their subscription price and exercise price.

Conditions precedent to the issuance and subscription of the T1bis New Shares

The issuance by the Company of the T1bis New Shares is subject to the approval by the shareholders’ meeting to be held no later than December 16, 2024 of the resolutions and decisions of the Board of Directors allowing the issuance of such T1bis New Shares and that no material adverse change (defined as any event, breach or circumstance, individually or in the aggregate, that has had or could reasonably be expected to have a material adverse effect on the clinical development stages of lanifibranor, or on the manufacture of the new drug in preparation for commercial launch, or with respect to the company’s ability to successfully complete the NATiV3 trial and obtain the necessary Food and Drug Administration (FDA) approvals (a “Material Adverse Change”)) between the issuance of the T1 New Shares and T1 BSA and the settlement and delivery of the T1bis New Shares (together, the “T1bis Conditions Precedent”). The adoption of the necessary resolutions by the shareholders at the general meeting to be held no later than December 16, 2024 will be the subject of a press release, in line with the Company’s information obligations. The issuance of the T1bis New Shares will also be the subject of a press release on the day of the meeting of the Board of Directors or the Chief Executive Officer acting by delegation of the Board of Directors of the Company deciding on this issuance.

Conditions precedent to the issuance and subscription of the ABSAs

The issuance by the Company of the ABSAs and their subscription by each investor is subject to the following conditions : (i) no Material Adverse Change between issuance of T1bis New Shares and the settlement and delivery of the ABSAs, (ii) the DMC, an independent group of experts responsible for monitoring the safety of patients enrolled in the NATiV3 study, which is usually set up for certain clinical trials, does not recommend suspending the NATiV3 study, (iii) the last patient in the NATiV3 main cohort has been randomized (the latter should happen no later than April 30, 2025), (iv) the study drop-out rate before week 72 is less than 30% (the “T2 Triggering Event”), (v) the subscription and payment by investors of all the T2 New Shares upon settlement-delivery of the T2 New Shares, (vi) the approval by the shareholders at the general meeting to be held no later than December 16, 2024 of the resolutions and decisions of the Board of Directors allowing the issuance of the T2 New Shares and the attached T3 BSAs (and allowing the implementation of the new governance of the Company if it has not already been implemented by that date) and (vii) the customary settlement-delivery conditions (conditions (i) to (vii) collectively, the “T2 Conditions Precedent”). Conditions (i) through (iv) may be waived with the consent of investors representing 60% of the aggregate of all ABSAs to be subscribed. The issuance of the ABSAs will be the subject of a press release on the day of the meeting of the Board of Directors or the Chief Executive Officer acting by delegation of the Board of Directors of the Company noting the completion of the T2 Triggering Event and deciding on this issue.

Conditions precedent to the exercise of the T3 BSAs:

Subject to satisfaction of the T2 Conditions Precedent and the issuance of the ABSAs, the exercise of the T3 BSAs is further subject to the release by the Company of topline data announcing that any key primary endpoint or key secondary endpoint of NATiV3 (resolution of NASH without worsening fibrosis and improvement of liver fibrosis without worsening NASH), with any dosage regimen tested in the trial, have been met no later than June 15, 2027 (the “T3 Triggering Event”). The exercise of the T3 BSAs must take place no later than July 30, 2027 (the “T3 BSA Maturity Date”).

Upon the occurrence of a Transforming Event (as defined below), satisfaction of the T3 Triggering Event as a condition to exercise may be waived with the prior consent of the holders representing 60% of all the T3 BSAs. A Transforming Event shall occur upon any of the following cases: (i) a person, alone or in concert, acquires control of the Company (control having the meaning set out in Article L. 233-3 of the French Commercial Code) 233-3 of the French Commercial Code), (ii) the announcement or the filing of a takeover bid, public exchange offer, alternative offer or mixed offer, (iii) a merger in which the where the holdings of shareholders of the Company are diluted by 30% or more, or (iv) the transfer of significant rights in lanifibranor to an entity in which the Company holds less than 51% of the capital or voting rights, or (v) an agreement relating to lanifibranor having or that may reasonably have a significant effect on the Company’s business, financial position or prospects (a “Transforming Event”). The exercise of the T3 BSAs will be the subject of a press release on the day of the meeting of the Board of Directors or the Chief Executive Officer acting by delegation of the Board of Directors of the Company recording the occurrence of the T3 Triggering Event or the waiver by investors of this condition.

ABSAs subscription period:

Subject to approval of the necessary resolutions by the shareholders at the general meeting to be held no later than December 16, 2024, the ABSAs will be issued and subscribed subject to a decision by the Company’s Board of Directors, which must be taken within a period between March 31, 2025 (excluded) and May 31, 2025, with at least fifteen business days’ prior notice.

Exercise period of the T3 BSAs:

Each investor will be able to exercise the T3 BSAs owned by it, in whole or in part, for cash, at the earliest between (x) the 45th calendar day following the occurrence of the T3 Triggering Event and (y) the third business day (inclusive) preceding the T3 BSAs Maturity Date in the event of the occurrence of the T3 Triggering Event (the “T3 BSA Exercise Period”) and, if the occurrence of the T3 Triggering Event is waived as described above, during the period starting from (inclusive) the date on which such waiver is granted and ending on the third Business Day (inclusive) prior to the T3 BSA Maturity Date.

If the T3 Triggering Event is not fulfilled or does not occur within the defined time period, the T3 BSAs will automatically lapse on the third business day following the T3 BSA Exercise Period.

Subscription price of the T1 New Shares, the T1 BSAs, the ABSAs and exercise price of the T3 BSAs:

On October 11, 2024, the Board of Directors set the subscription price of the T1 New Shares at €1.35 (the “T1 Subscription Price”) (€0,01 nominal value and €1.34 premium).

Given the specific characteristics of T1 BSAs, the subscription price of each T1 BSAs is equal to €1.34 and corresponds to the T1 Subscription Price (i.e. €1.35) reduced by the nominal value of an ordinary share (€0.01).

In accordance with the price limits set forth in the 25th resolution of the general meeting held on June 20, 2024, the T1 Subscription Price (i.e. €1.35) represents a discount of 10% to €1.5048, which is the volume weighted average price of the Company’s shares on the regulated market of Euronext in Paris during the last 5 trading sessions preceding pricing of the T1 New Shares (the “Reference Price”).

Subject to satisfaction of the T1bis Conditions Precedent, the subscription price of the T1bis New Shares will be equal to the T1 Subscription Price (i.e. €1.35).

Subject to satisfaction of the T2 Conditions Precedent, the subscription price of the ABSAs will correspond to the lower of (i) the T1 Subscription Price (i.e. €1.35) and (ii) the volume-weighted average of the Company’s share price on the regulated market of Euronext Paris during the 5 trading sessions preceding pricing of the ABSAs (it being specified that no discount will be applied to this average).

Subject to the completion of T3 Triggering Event or the Transforming Event, the T3 BSA Exercise Price corresponds to the Reference Price (it being specified that no discount will be applied to this average), i.e. €1.50 (the “T3 BSA Exercise Price”).

Allocation of the Transaction and undertakings of the Company:

The number of T1bis New Shares, T2 New Shares and T3 BSAs will be subscribed by each investor pro rata to the number of T1 New Shares and T1 BSAs subscribed for by this investor. In the event of failure by an investor to subscribe for the ABSAs, the Company undertakes to offer the other investors the right to subscribe for a number of additional ABSAs not subscribed for by the defaulting investor, which will be allocated pro rata to the number of T1 New Shares subscribed and of T1 BSAs subscribed for by each investor and wishing to subscribe for these ABSAs.

Governance Rights:

As part of the Transaction, the Company has undertaken, subject to settlement of the T1 New Shares and T1 BSAs to propose the appointment of Mark Pruzanski and Srinivas Akkaraju as members of the Board of Directors at the general meeting to be held no later than December 16, 2024.

In addition, up to four additional directors may be appointed or co-opted to replace existing directors (other than Frédéric Cren, Mark Pruzanski and Srinivas Akkaraju), it being specified that one director will be appointed or co-opted on the proposal of BVF Partners LP (“BVF”) and three directors upon proposal by each of the three largest investors in the Transaction, subject to settlement-delivery of the T1 New Shares and T1 BSAs and shareholder approval of the resolutions relating to the issuance of the ABSAs by the general meeting to be held no later than December 16, 2024.

The Board of Directors has, on October 11, 2024, irrevocably decided, on the pending condition of the appointment of Mark Pruzanski as director of the Company by the general meeting to be held no later than December 16, 2024, to dissociate the functions of président du conseil d’administration (chairman of the board) and directeur général (CEO), Frédéric Cren being currently président directeur général of the Company, and to appoint Mark Pruzanski as président du conseil d’administration and Frédéric Cren as directeur général, as of the date of the next board meeting held after such general meeting.

Form of the T1 New Shares and the T1 BSAs:

The T1 New Shares shall be registered in pure registered form (au nominatif pur) under French law until the earlier of (x) the date of settlement-delivery of T2 New Shares or (y) May 20, 2025. Thereafter, the T1 New Shares will be held at the option of the holder either in registered form (au nominatif) or in bearer form (au porteur).  

The T1 BSAs will be securities giving access to the capital within the meaning of Article L. 228-91 of the French Commercial Code. They will be issued in dematerialized form and held in pure registered form (au nominatif pur) until the expiration of the lock-up (described below) in the securities account opened in the name of the investor in the books of the Company’s account keeper. No physical document evidencing ownership of the T1 BSAs will be issued. The T1 BSAs will not be listed but will be admitted to Euroclear.

The shares issued upon the exercise of T1 BSAs (the “T1 Warrant Shares”) will be held in pure registered form (au nominatif pur) until expiration of the lock-up and thereafter at the option of the holder, in registered form (au nominatif) or in bearer form (au porteur).

As soon as they are issued, the T1 New Shares, the T2 New Shares, the T1 Warrant Shares and the shares issued upon the exercise of T3 BSAs (the “T3 Warrant Shares”), if any, will be automatically assimilated to the Company’s ordinary shares and will be admitted to trading on the regulated market of Euronext Paris under ISIN number FR0013233012.

Form of the T1bis New Shares, the T2 New Shares and the T3 BSAs:

The T1bis New Shares will be registered under the same conditions as the T1 New Shares.

The T2 New Shares will be held, from their issuance and at the holder’s option, in registered form (au nominatif) or in bearer form (au porteur) and will be freely transferable.

The T3 BSAs will be securities giving access to the share capital within the meaning of article L. 228-91 of the French Commercial Code. They will be issued in dematerialized form and held in registered form (au nominatif) in a securities account opened in the name of the investor in the books of the Company’s account keeper. No physical document evidencing ownership of the T3 BSAs will be issued. The T3 BSAs will not be listed or admitted to Euroclear.

The shares issued upon exercise of the T3 BSAs (the “T3 Warrant Shares”) will be held, upon issuance and at the option of the holder, in registered form (au nominatif) or in bearer form (au porteur).

Adjustment of exercise ratio and the T3 BSA Exercise Price:

The T3 BSA Exercise Price and/or the number of T3 Warrant Shares will be subject to adjustment from time to time according to mandatory legal requirements imposed by the French Commercial Code and French market standards.

In case of a capital increase, absorption, merger, spin-off or issuance of new shares or securities giving access to the share capital, or any other financial transaction involving a preferential subscription right or reserving a priority subscription period for the benefit of the Company’s shareholders, the Company will be entitled to suspend the exercise of the T3 BSAs for a period that may not exceed three months or any other period set by the applicable regulations.

Lock-up on T1 New Shares, on T1 BSAs and on T1bis New Shares:

Investors participating in the Transaction have agreed to a lock-up on the T1 New Shares and the T1 BSAs and the T1 Warrant Shares until the earlier of (x) the issuance date of the ABSAs or (y) May 20, 2025, subject to certain exceptions (including transfers to an affiliate to the investor, to another investor, or, subject to the agreement of the Company in its sole discretion, to any third party who makes the same lock-up commitment on the T1 New Shares and on the T1 BSAs and T1 Warrant Shares).

The T1bis New Shares will be held by investors under the same conditions as the T1 New Shares in the event of their issuance.

Voting undertakings:

The investors have undertaken to subscribe for the T1bis New Shares and the ABSAs and to vote in favor of the resolutions of the general meeting to be held no later than December 16, 2024 relating to the issuance of the T1bis New Shares and the ABSAs (with the exception of the resolution relating to this investor’s own investment) and relating to changes in the governance of the Company.

Mr. Frédéric Cren and Mr. Pierre Broqua have undertaken to vote in favor of the resolutions of the general meeting to be held no later than December 16, 2024.

Representation of T1 BSAs and T3 BSAs holders:

The T1 BSAs holders and the T3 BSAs holders will each be grouped automatically for the defense of their common interests in a masse. The masses will act, in part, through a representative and, in part, through collective decisions of the relevant holders.

Transaction participants:

BVF, which holds approximately 16.4% of the share capital and approximately 13.1% of the voting rights of the Company as of the date hereof and not taking into account the Transaction, subscribed to 8,231,034 T1 BSAs for an amount of approximately €11 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, BVF will hold approximately 9.8% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

New Enterprise Associates (“NEA”), which holds approximately 10.7% of the share capital and approximately 8.5% of the voting rights of the Company as of the date hereof and not taking into account the Transaction, subscribed to 2,262,931 T1 New Shares for an amount of approximately €3 million and to 12,823,276 T1 BSAs for an amount of approximately €17 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, NEA will hold approximately 9.0% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Sofinnova Crossover I SLP (“Sofinnova”), which holds approximately 9.7% of the share capital and approximately 9.4% of the voting rights of the Company as of the date hereof and not taking into account the Transaction, subscribed to 1,369,827 Tranche 1 New Shares for an amount of approximately €1.8 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, Sofinnova will hold approximately 7.4% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Yiheng Capital Management, L.P., (“Yiheng”), which holds approximately 7.4% of the share capital and approximately 5.9% of the voting rights of the Company as of the date hereof and not taking into account the Transaction, subscribed to 1,629,310 T1 New Shares for an amount of approximately €2.2 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, Yiheng will hold approximately 6.3% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Invus Public Equities, (“Invus”), subscribed to 6,034,482 T1 New Shares for an amount of approximately €8.1 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, Invus will hold approximately 8.7% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Andera Partners, (“Andera”), subscribed to 5,008,620 T1 New Shares for an amount of approximately €6.7 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, Andera will hold approximately 5.8% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Perceptive Advisors, (“Perceptive”), subscribed to 4,525,862 T1 New Shares for an amount of approximately €6.1 million and 1,508,620 T1 BSAs for €2.0 million. Assuming the issuance of the T1 New Shares and the T1 BSAs, Perceptive will hold approximately 5.2% of the share capital of the Company, on a non-diluted basis immediately following the closing of the first tranche of the Transaction.

Impact of the Transaction on the share capital

Following the Settlement Date, the Company’s share capital will be €870,776.95 million divided into 87,077,695 shares.

For illustration purposes, the impact of the issuance of the T1 New Shares, the T1 Warrant Shares (assuming full exercise), the T1bis New Shares, the T2 New Shares and the T3 Warrant Shares (assuming full exercise) on the ownership of a shareholder holding 1% of the Company’s share capital prior to the Transaction and not subscribing to it, is as follows (calculation made on the basis of the Company’s share capital as of September 30, 2024):

  Percentage of capital Non-diluted basis Diluted basis(1) Before issuance of the T1 New Shares 1% 0.87% After issuance of the T1 New Shares and T1 BSA 0.60% 0.45% After issuance of the T1 New Shares, the T1 Warrant Shares and the T1bis New Shares 0.55% 0.41% After issuance of the T1 New Shares, the T1 Warrant Shares, the T1bis New Shares and the T2 New Shares* 0.29% 0.26% After issuance of the T1 New Shares, the T1 Warrant Shares, the T1bis New Shares, the T2 New Shares*, and the T3 Warrant Shares 0.20% 0.19% (1) Calculations are based on the assumption that all share subscription warrants (BSA) and warrants for the subscription of business creators’ shares (BSPCE) will be exercised and that all allocated free shares (actions gratuites) will vest.

*Calculations are based on the assumptions that (i) all the conditions for the issue of the New T1bis Shares and New T2 Shares have been met, (ii) the T2 New Shares will only be issued in ordinary shares and (iii) the subscription price of the ABSAs is equivalent to the Subscription Price of the New T1 Shares (i.e. a number of 85,925,919 New T2 Shares).

Impact of the Transaction on shareholders’ equity

For illustration purposes, the impact of the issuance of the of the T1 New Shares, the T1 Warrant Shares (assuming full exercise), the T2 New Shares and the T3 Warrant Shares (assuming full exercise) on the Company’s equity per share (calculation made on the basis of the Company’s equity at June 30, 2024) is as follows:

  Equity per share in euros Non-diluted basis Diluted basis(1) Before issuance of the T1 New Shares -€1.88 -€1.04 After issuance of the T1 New Shares and T1 BSA -€0.14 €0.18 After issuance of the T1 New Shares, the T1 Warrant Shares and the T1bis New Shares €0.10 €0.30 After issuance of the T1 New Shares, the T1 Warrant Shares, the T1bis New Shares and the T2 New Shares* €0.54 €0.56 After issuance of the T1 New Shares, all the T1 Warrant Shares, the T1bis New Shares, the T2 New Shares*, and the T3 Warrant Shares €0.83 €0.80 (1) Calculations are based on the assumption that all share subscription warrants (BSA) and warrants for the subscription of business creators’ shares (BSPCE) will be exercised and that all allocated free shares (actions gratuites) will vest.

*Calculations are based on the assumptions that (i) all the conditions for the issue of the New T1bis Shares and New T2 Shares have been met, (ii) the T2 New Shares will only be issued in ordinary shares and (iii) the subscription price of the ABSAs is equivalent to the Subscription Price of the New T1 Shares (i.e. a number of 85,925,919 New T2 Shares).

Evolution of the shareholding structure in connection with the Transaction

The shareholding structure of the Company prior to the Transaction is set forth below:

  Shareholding prior to the Transaction   On a non-diluted basis Shareholders Number of Shares % of share capital Number of voting rights % of voting rights Frédéric Cren 5,612,224 10.8% 11,224,448 17.2% Pierre Broqua 3,882,500 7.4% 7,765,000 11.9% Sous-total – Concert 9,494,724 18.2% 18,989,448 29.1% BVF Partners L.P. 8,545,499 16.4% 8,545,499 13.1% New Enterprise Associates (NEA) 5,572,953 10.7% 5,572,953 8.5% Sofinnova 5,070,266 9.7% 6,110,827 9.4% Qatar Holding LLC 5,157,233 9.9% 5,157,233 7.9% Yiheng 3,845,676 7.4% 3,845,676 5.9% ISLS Consulting 111,000 0.2% 222,000 0.3% David Nikodem – – – – M. J GOLDBERG – – – – Directors (non-executifs) 10,000 0.02% 10,000 0.02% Employees 1,338,127 2.6% 2,282,563 3.5% Treasury shares 106,115 0.2% – – Free float 13,225,595 24.7% 14,602,674 22.2% Total 52,477,188 100.0% 65,338,873 100.0% The issuance of T1 New Shares and the T1 BSA will have the following impact on the allocation of the share capital and the voting rights of the Company:

  Shareholder following the issuance of T1 New Shares and the T1 BSA   On a non-diluted basis Shareholders Number of Shares % of share capital Number of voting rights % of voting rights Frédéric Cren 5,612,224 6.4% 11,224,448 11.2% Pierre Broqua 3,882,500 4.5% 7,765,000 7.8% Sous-total – Concert 9,494,724 10.9% 18,989,448 19.0% BVF Partners L.P. 8,545,499 9.8% 8,545,499 8.6% New Enterprise Associates (NEA) 7,835,884 9.0% 7,835,884 7.8% Sofinnova 6,440,093 7.4% 7,480,654 7.5% Qatar Holding LLC 5,157,233 5.9% 5,157,233 5.2% Yiheng 5,474,986 6.3% 5,474,986 5.5% Perceptive 4,525,862 5.2% 4,525,862 4.5% Andera Partners 5,008,620 5.8% 5,008,620 5.0% Invus 7,606,810

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