Inventiva , 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 that the Board of Directors called the second tranche of its previously announced¹structured financing of up to €348 million (the “Structured Financing”), for gross proceeds of €115.6 million (net proceeds of €108.5 million) (the “T2Transaction”).

Frederic Cren, Chief Executive Officer of Inventiva, stated: "We are pleased to have achieved the timely enrollment of NATiV3 and met all the conditions for the issuance of this second tranche. The quality of the investors that participated in this financing is a testimony of the strength of the clinical data generated so far with lanifibranor in patients with MASH. With enrollment of the pivotal Phase 3 completed, we are now focusing on making of lanifibranor the second oral drug for the treatment of MASH if approved. MASH is a disease for which we believe lanifibranor profile, especially in patients with advanced fibrosis and type 2 diabetes, is poised to play a key role in addressing the high unmet medical needs of patients with MASH."

The Board of Directors confirmed that all the previously disclosed conditions for the issuance of T2 Transaction have been satisfied.

The investors in the T2 Transaction were the same investors that participated in the first tranche of the Structured Financing, which was led by: New Enterprise Associates, BVF Partners LP and Samsara BioCapital, with also the participation of other 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.

Reasons for the issuance and use of the proceeds of the T2 Transaction

The Company intends to use the net proceeds from the T2 Transaction (€108.5 million), together with existing cash and cash equivalents, mainly to finance lanifibranor’s development in MASH and notably the continuation of its NATiV3 Phase 3 clinical trial.  

Working capital statement

As of December 31, 2024, cash and cash equivalents amounted to €96.6 million. Based on Company’s projected expenditures, the Company estimated that its cash and cash equivalents prior to the T2 Transaction would enable it to finance its activities until the middle of the third quarter of 2025. Accordingly, as of the date of this press release and before the closing of the T2 Transaction, the Company's current cash position is not sufficient to cover its operating needs for at least the next 12 months².

Following the closing of the T2 Transaction for expected gross proceeds of €115.6 million (€108.5 million net proceeds) and taking into account the anticipated receipt of the €8.8 million ($10 million) net milestone payment by CTTQ³ within 30 days of the closing of the T2 Transaction and the anticipated completion of the Company's pipeline prioritization plan, the Company estimates that it would have sufficient net working capital to meet its current obligations over the next 12 months, and would enable it to finance its activities until the end of the third quarter of 2026².

The Company will need to raise additional funds to achieve its long term objectives for the development and potential commercialization of lanifibranor through other potential public offerings or private placements and potential strategic options such as business development partnerships, merger and acquisition transactions and/or licensing agreements.

Main characteristics of the T2 Transaction

Pursuant to the 33^rd and 49^th resolutions of the general meeting of the shareholders held on December 11, 2024 (the “General Meeting”) in accordance with Articles L. 225-138 and seq. of the French Commercial Code (Code de commerce), the Board of Directors met on May 2, 2025, and decided to issue, without shareholders’ preferential subscription rights, (i) the ABSAs (as defined below) to the investors named in resolutions 34 to 48 of the General Meeting and (ii) the PFW-BSAs (as defined below) to the investors named in resolutions 50 to 57 of the General Meeting.

On May 2, 2025, the Company entered into subscription agreements with each of the investors participating in the Structured Financing for the issuance of the second tranche of the Structured Financing, which consists of: 

• a share capital increase without preferential subscription rights reserved to named investors (“à personne dénommée”), consisting of the issuance of:

• • 42,488,883 new shares, par value €0.01 (the "New Shares"), with one warrant attached to each New Share ("Warrants", and together with the New Shares, the "ABSAs") at a subscription price of €1.35 per ABSA; and
  • up to 38,239,990 additional new shares upon the exercise of the Warrants attached to the New Shares, at a price of €1.50 per share, if all such Warrants are exercised (the ordinary shares issued upon exercise of the Warrants, "Warrant Shares");
• the issuance of 43,437,036 pre-funded warrants (bons de souscription d’actions préfinancés) (the "Pre-Funded Warrants") to subscribe initially to one ordinary share of the Company per Pre-Funded Warrant reserved to named investors (“à personne dénommée”), with one Warrant attached to each Pre-Funded Warrant (together with the Pre-Funded Warrants, the "PFW-BSAs") at a subscription price of €1.34 per PFW-BSA.

The PFW-BSAs allows the issuance of:

• • up to 43,437,036 new shares upon the exercise of the Pre-Funded Warrants, at a price of €1.35 per share (of which €1.34 will have been prefunded on the issue date), if all the Pre-Funded Warrants are exercised (the "Pre-Funded Warrant Shares"); and
  • up to 39,093,329 additional new shares upon the exercise of the Warrants attached to the Pre-Funded Warrant, at a price of €1.50 per share, if all the Warrant Shares issued upon the exercise of each Warrant attached to the Pre-Funded Warrants are exercised.

T2 Transaction’s condition precedents

The Board of Directors confirmed that the conditions precedent to issue the second tranche of the Structured Financing are met (subject to the conditions precedent to be confirmed on the closing date). The conditions precedent were the following: (i) the adoption by the General Meeting of the resolutions regarding the issuance of the second tranche, (ii) no clinical hold recommended by the independent Data and Safety Monitoring Board of the NATiV3 clinical trial evaluating lanifibranor in MASH (“NATiV3”), (iii) the randomization of the last patient in the main cohort of NATiV3 (announced on April 1, 2025) on or before April 30, 2025, and (iv) at the time of completion of enrollment in NATiV3, the study discontinuation rate prior to week 72 was less than 30%⁴⁴.

Signing and closing of the T2 Transaction:

On May 2, 2025, each investor participating in the Structured Financing entered into a subscription agreement for a pro rata amount based on their participation in the first tranche of the Structured Financing, as announced on October 14, 2024. The closing of the T2 Transaction is expected to occur on or around May 7, 2025 and remains subject to the conditions that (i) no clinical hold is recommended by the Data and Safety Monitoring Board of NATiV3, and (ii) no material adverse change occurs prior to the settlement and delivery of the ABSAs and the PFW-BSAs and other customary closing conditions.

Subscription price of the ABSAs, the PFW-BSAs and exercise price of the Pre-Funded Warrants and the Warrants:

On May 2, 2025, the Board of Directors set the subscription price per ABSA at €1.35 (i.e., €0.01 nominal value and €1.34 premium) and the subscription price per PFW-BSA at €1.34.

The payment of €1.34 per Pre-Funded Warrant is final and irrevocable, regardless whether the Pre-Funded Warrant is exercised.

The Pre-Funded Warrants are exercisable for a period of 10 years from the date of their issuance.

Subject to the conditions described below, each Warrant is initially exercisable for 0.9 Warrant Shares (subject to adjustment from time to time) for a price per Warrant Share equal to €1.50 (which equals to an exercise price per Warrant of €1.35).

Conditions precedent to the exercise of the Warrants and exercise period:

The exercise of the Warrants, which will be the third tranche of the Structured Financing, is subject to the release by the Company of topline data announcing that any key primary endpoint or key secondary endpoint of NATiV3 (resolution of MASH without worsening fibrosis and improvement of liver fibrosis without worsening MASH), 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 Warrants must take place no later than July 30, 2027.

For more information on the Warrants, please see the press release issued on October 14, 2024.

Form and method of registration of the New Shares, the Pre-Funded Warrants, the Warrants, the Warrant Shares and the Pre-Funded Warrant Shares:

The New Shares, the Warrant Shares, the Pre-Funded Warrants and the Pre-Funded Warrant Shares may be held in pure registered form (au nominatif pur) or in administered registered form (au nominatif administré) or in bearer form (au porteur), at the purchasers' option. The Warrants will be held in pure registered form only.

As soon as they are issued, the New Shares, the Warrant Shares and the Pre-Funded 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.

The Warrants will not be admitted to trading or admitted to Euroclear.

Adjustment of exercise ratio of the Pre-Funded Warrants and the Warrants:

The number of Warrants Shares and Pre-Funded 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.

Representation of Pre-Funded Warrants holders and Warrants holders:

The holders of the Pre-Funded Warrants and of the Warrants will each and respectively 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.

Prospectus exemption:

The T2 Transaction is not subject to a prospectus requiring an approval of the French Financial Markets Authority (Autorité des Marchés Financiers) (the “AMF”). In accordance with Article 1(5) (ba) of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the “Prospectus Regulation”), the Company has filed with the AMF a document containing the information set out in Annex IX of the Prospectus Regulation (the “Information Document”) considering that the T2 Transaction represents a dilution above 30% of the current share capital of the Company. A copy of the Information Document is available on the Company’s website (www.inventivapharma.com). 

Governance:

In the subscription agreements executed on October 11, 2024, the Company undertook to submit to the General Meeting or at a later general meeting of shareholders, up to four additional new members of the Board of Directors, in order to replace existing members of the Board of Directors (other than Frédéric Cren, Mark Pruzanski and Srinivas Akkaraju), one of which upon proposal of BVF Partners LP (which has proposed to appoint a director at the next general meeting), and three of which upon proposal of each of the three largest investors in the Structured Financing.

Impact of the T2 Transaction on the share capital:

Following the settlement and delivery, the Company’s share capital will be €1,391,512.74 divided into 139,151,274 shares.

For illustration purposes, the impact of the issuance of the New Shares, the Pre-Funded Warrants, the Warrants, the Pre-Funded Warrant Shares (assuming full exercise of the Pre-Funded Warrants), the Warrant Shares (assuming full exercise of the Warrants) on the ownership of a shareholder holding 1% of the Company’s share capital prior to the T2 Transaction and not subscribing to it, is as follows (calculation made on the basis of the Company's share capital as of April 30, 2025):

1. The calculations are based on the assumption of the exercise of all Pre-Funded Warrants and Warrants to be issued in the T2 Transaction, and all outstanding 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) and stock-options (options d’achat d’actions) will vest, as of the date of this press release, giving access to a maximum of 73,042,652 shares.

Impact of the T2 Transaction on shareholders' equity

For illustration purposes, the impact of the issuance of New Shares, the Pre-Funded Warrants, the Warrants, the Pre-Funded Warrant Shares (assuming full exercise of the Pre-Funded Warrants), the Warrant Shares (assuming full exercise of the Warrants) on the Company's equity per share (calculation made on the basis of the Company's equity at December 31, 2024 is as follows:

1. The calculations are based on the assumption of the exercise of all Pre-Funded -Warrants and Warrants to be issued in the T2 Transaction, 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) and stock-options (options d’achat d’actions) will vest, as of the date of this press release, giving access to a maximum of 73,042,652 shares.

Evolution of the shareholding structure in connection with the T2 Transaction

The shareholding structure of the Company prior to the T2 Transaction is set forth below: