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- Inventiva secures €21.4 million leading to completion of the first tranche of the financing for c. €116 million, part of the multi-tranche equity financing of up to €348 million announced on October 14, 2024.
- Proceeds from the completed first tranche to be primarily used to advance Inventiva's Phase III, NATiV3 clinical trial evaluating lanifibranor in patients with MASH.
- Appointment of Mark Pruzanski as new Chairman of the Board of Directors and Srinivas Akkaraju as new member of the Board of Directors.
Frédéric Cren, Chief Executive Officer of Inventiva, stated: "We are pleased to announce that we secured €21.4 million successfully completing the first tranche of the financing announced in October. The multi-tranche equity raise of up to €348 million has been instrumental to keep Inventiva on track with recruitment for our pivotal Phase III clinical trial of our asset lanifibranor. We believe that lanifibranor holds significant potential to address unmet medical needs, and we are encouraged by the intensification of trial activities, with a completion of our recruitment expected in the first half of 2025. I am also delighted to welcome Mark and Srinivas to our Board of Directors. Their expertise and strategic insights will be invaluable as we advance our clinical program and prepare for a potential NDA filing for lanifibranor."
On October 14, 20241 the Company announced the Multi-Tranche Financing and the completion of a capital increase 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 the issuance of 35,399,481 prefunded warrants to purchase up to 35,399,481 ordinary shares at an exercise price of €0.01 per new ordinary share (the "T1 BSAs”) at a subscription price of €1.34 per T1 BSA, subject to the satisfaction of customary closing conditions. Settlement and delivery of the T1 New Shares and the T1 BSAs, took place on October 17, 2024.
Following issuance of the T1 New Shares and T1 BSAs, and the subsequent adoption by shareholders of the appropriate resolutions by the General Meeting, the Board of Directors decided on December 13, 2024 to use the delegations granted by the General Meeting to proceed with the T1 bis Transaction, consisting of 7,872,064 new ordinary shares (the "T1 bis Shares”) at a subscription price of €1.35 per T1 bis Share and 8,053,847 pre-funded warrants to purchase up to 8,053,847 ordinary shares at an exercise price of €0.01 per new ordinary share (the "T1 bis BSAs”) at a subscription price of €1.34 per T1 bis BSA, for aggregate gross proceeds of €21,419,441.38.
Reasons for the issuance and use of the proceeds of the T1 bis Transaction
The Company intends to use the net proceeds of €20.1 million from the T1 bis Transaction, 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 T1 bis Transaction, subject to the implementation of its liquidity contract with Kepler Cheuvreux.
Working capital statement
As of the date of this press release, the Company believes that its net working capital would not be sufficient to meet its obligations over the next 12 months. As of September 30, 2024, 2024, the Company had cash and cash equivalents of €13.9 million, compared with cash and cash equivalents of €26.9 million and €9.0 million of long-term deposit2 at December 31, 2023.
Taking into account its current cost structure and expected expenses and taking into account the (i) the receipt of €94.1 million in gross proceeds from the issuance of the T1 New Shares and the T1 BSAs, (ii) the anticipated receipt of €21.4 million in gross proceeds from the T1 bis Transaction, and (iii) the first milestone of $10 million (gross proceeds) received under the amendment to the licensing agreement with Chia Tai Tianqing Pharmaceutical (Guangzhou) CO., LTD. ("CTTQ”), the Company estimates that its cash, cash equivalents and deposits would enable it to finance its operations until the middle of the third quarter of 20253. Accordingly, the Company will not have sufficient net working capital to meet its current obligations over the next 12 months from the date of this press release.
Based on its current business plan, the Company estimates that to cover its obligations until mid-December 2025 its additional cash requirements amount to between €120 million and €130 million.
Subject to satisfaction of the applicable conditions precedent, if the second tranche of the Multi-Tranche Financing is completed for anticipated gross proceeds of €116 million, the Company could extend its financial visibility beyond 12 months.
To the extent the applicable conditions precedent for the issuance of the second tranche of the Multi-Tranche Financing are not satisfied and/or the T3 Triggering Event (as defined in the press release published on October 14, 2024) does not occur and, therefore, the Company does not receive any of the contemplated gross proceeds from the issuance of the ABSAs or exercise of the T3 BSAs (each as defined in the press release published on October 14, 2024), the Company will need to raise additional funds to support its 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.
Pursuant to the 5th to 32nd resolutions of the General Meeting and in accordance with Articles L. 225-138 and seq. of the French Commercial Code (Code de commerce), the Board of Directors held on December 13, 2024 has decided to issue, without shareholders' preferential subscription rights, the T1 bis Shares to the investors named in resolutions 6 to 22 of the General Meeting and the T1 bis BSAs to the investors named in resolutions 24 to 32 of the General Meeting.
Conditions precedent to the issuance and subscription of the T1 bis Shares and T1 bis BSAs
The issuance by the Company of the T1 bis Shares and T1 bis BSAs was subject to the approval of the General Meeting no later than December 16, 2024 and the absence of a "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 approvals) between October 17, 2024 and the settlement and delivery of the T1 bis Shares and T1 bis BSAs.
Subscription price of the T1 bis Shares and the T1 bis BSAs
On December 11, 2024, the General Meeting set the subscription price (i) of each T1 bis Share to €1.35 (i.e., €0.01 nominal value and €1.34 premium) (the "T1 bis Subscription Price”) and (ii) of each T1 bis BSAs to €1.34, which corresponds to the T1 bis Subscription Price (i.e., €1.35) reduced by the nominal value of an ordinary share (€0.01).
Allocation of the T1 bis Transaction
The number of T1 bis Shares and T1 bis BSAs were subscribed by each investor pro rata to the number of T1 New Shares and T1 BSAs subscribed for by such investor.
Form of the T1 bis Shares and the T1 bis BSAs
The T1 bis 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 (as defined in the press release published on October 14, 2024) or (y) May 20, 2025. Thereafter, the T1 bis Shares will be held at the option of the holder either in registered form (au nominatif) or in bearer form (au porteur).
The T1 bis 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 bis BSAs will be issued. The T1 bis BSAs will not be listed but will be admitted to Euroclear.
The shares issued upon the exercise of T1 bis BSAs (the "T1 bis 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 bis Shares and T1 bis Warrant Shares 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.
Lock-up on T1 bis Shares, T1 bis BSAs and T1 bis Warrant Shares
Investors participating in the T1 bis Transaction have agreed to a lock-up on the T1 bis Shares, the T1 bis BSAs and the T1 bis 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 bis Shares and on the T1 bis BSAs and T1 bis Warrant Shares).
Representation of T1 bis BSAs
The T1 bis 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.
T1 bis Transaction participants
BVF Partners LP ("BVF”), which holds approximately 9.8% of the share capital and approximately 8.6% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 1,872,668 T1 bis BSAs for an amount of approximately €2.5 million. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, BVF will hold approximately 9.0% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
New Enterprise Associates ("NEA”), which holds approximately 9% of the share capital and approximately 7.8% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 514,846 T1 bis Shares for an amount of approximately €700,000 and to 2,917,464 T1 bis BSAs for an amount of approximately €3.9 million. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, NEA will hold approximately 8.8% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Sofinnova Crossover I SLP ("Sofinnova”), which holds approximately 7.4% of the share capital and approximately 7.5% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 311,654 T1 bis Shares for an amount of approximately €420,000. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, Sofinnova will hold approximately 7.1% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Yiheng Capital Management, L.P., ("Yiheng”), which holds approximately 6.3% of the share capital and approximately 5.5% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 370,689 T1 bis Shares for an amount of approximately €500,000. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, Yiheng will hold approximately 6.2% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Invus Public Equities, ("Invus”), which holds approximately 8.7% of the share capital and approximately 7.6% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 1,372,924 T1 bis Shares for an amount of approximately €1.8 million. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, Yiheng will hold approximately 9.5% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Andera Partners, ("Andera”), which holds approximately 5.8% of the share capital and approximately 5.0% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 1,139,527 T1 bis Shares for an amount of approximately €1.5 million. Assuming the issuance of the T1 bis Shares and the T1 BSAs, Andera will hold approximately 6.5% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Perceptive Advisors, ("Perceptive”), which holds approximately 5.2% of the share capital and approximately 4.5% of the voting rights of the Company as of the date hereof and not taking into account the T1 bis Transaction, subscribed to 1,029,693 T1 bis Shares for an amount of approximately €1.3 million and to 343,321 T1 bis BSAs for an amount of approximately €460,000. Assuming the issuance of the T1 bis Shares and the T1 bis BSAs, Perceptive will hold approximately 5.8% of the share capital of the Company, on a non-diluted basis immediately following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs.
Governance
As previously announced, Mark Pruzanski and Srinivas Akkaraju have been appointed as directors by the shareholders, replacing Pierre Broqua and Sofia BVBA, represented by Chris Buyse, during the General Meeting for a term expiring at the end of the annual general meeting to be held in 2027 to approve the financial statements for the year ending December 31, 2026.
The General Meeting also approved (i) a remuneration policy for the Chairperson of the Board of Directors and for the Chief Executive Officer applicable in respect of the current year from the date of separation of the functions of the Chairperson of the Board of Directors and the Chief Executive Officer, (ii) an amendment to the remuneration policy of the Deputy Chief Executive Officer and (ii) an amendment to the remuneration policy of the directors.
On December 13, 2024, the Board of Directors acknowledged the separation of the roles of the Chairperson of the Board of Directors and the Chief Executive Officer as well as the appointment of Mark Pruzanski as Chairperson of the Board of Directors and Frédéric Cren as Chief Executive Officer.
Up to four new members of the Board of Directors may be appointed or co-opted, during the next general meeting and at the latest, during the general meeting of shareholders convened to approve the financial statements for the year ending December 31, 2025, (other than Frédéric Cren, Mark Pruzanski and Srinivas Akkaraju), one of which upon the proposal of BVF, and three of which upon the proposal of each of the three largest subscribers.
Exemption of a French Listing Prospectus
The Company, for the purpose of listing the T1 bis Shares and the T1 bis Warrant Shares issuable upon exercise of the T1 bis BSAs on the regulated market of Euronext Paris, is exempt from the requirement to file with the Autorité des marchés financiers a French-language listing prospectus, as these securities are fungible with securities already admitted to trading on the same regulated market, and represent, over a twelve-month period, less than 30% of the number of securities already admitted to trading on the same regulated market in accordance with Article 1(5)(a) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended by Regulation (EU) 2024/2809 of 23 October 2024.
Impact of the T1 bis Transaction on the share capital
Following the settlement and delivery of the T1 bis Shares and the T1 bis BSAs, the Company's share capital will be €949,497.59, divided into 94,949,759 shares.
For illustration purposes, the impact of the issuance of the T1 bis Shares and the T1 bis Warrant Shares (assuming full exercise) on the ownership of a shareholder holding 1% of the Company's share capital prior to the T1 bis Transaction and not subscribing to it, is as follows (calculation made on the basis of the Company's share capital as of October 30, 2024):
| Percentage of capital | ||
| Non-diluted basis | Diluted basis(1) | |
| Before issuance of the T1 bis Shares and T1 bis BSAs | 1% | 0.65% |
| After issuance of the T1 bis Shares and the T1 bis BSAs | 0.92 % | 0.62 % |
| After issuance of the T1 bis Shares and Warrant Shares upon exercise of the T1 bis BSAs | 0.85 % | 0.58 % |
Impact of the T1 bis Transaction on shareholders' equity
For illustration purposes, the impact of the issuance of the T1 bis Shares and the T1 bis Warrant Shares (assuming full exercise) on the Company's equity per share (calculation made on the basis of the Company's equity at October 30, 2024) is as follows:
| Equity per share in euros | ||
| Non-diluted basis | Diluted basis(1) | |
| Before issuance of the T1 bis Shares and T1 bis BSAs | € - 0.21 | € -0.14 |
| After issuance of the T1 bis Shares and the T1 bis BSAs | € - 0.08 | € - 0.06 |
| After issuance of the T1 bis Shares and Warrant Shares upon exercise of the T1 bis BSAs | € 0.03 | € 0.02 |
(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.
Evolution of the shareholding structure in connection with the T1 bis Transaction
The shareholding structure of the Company prior to the T1 bis Transaction is set forth below:
| Shareholding prior to the T1 bis 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 | 6.45% | 11,224,448 | 11.23% |
| Pierre Broqua | 3,882,500 | 4.56% | 7,765,000 | 7.77% |
| Sub-total - Concert | 9,494,724 | 10.91% | 18,989,448 | 19.0% |
| BVF Partners L.P. | 8,545,499 | 9.81% | 8,545,499 | 8.55% |
| New Enterprise Associates (NEA) | 7,835,884 | 9.00% | 7,835,884 | 7.84% |
| Invus | 7,606,810 | 8.74% | 7,606,810 | 7.61% |
| Sofinnova | 6,440,093 | 7.40% | 7,480,654 | 7.49% |
| Yiheng | 5,474,986 | 6.29% | 5,474,986 | 5.48% |
| Qatar Holding LLC | 5,157,233 | 5.92% | 5,157,233 | 5.16% |
| Andera Partners | 5,008,620 | 5.75% | 5,008,620 | 5.01% |
| Perceptive | 4,525,862 | 5.20% | 4,525,862 | 4.53% |
| Employees | 1,338,127 | 1.54% | 2,282,563 | 2.28% |
| ISLS Consulting | 111,000 | 0.13% | 222,000 | 0.22% |
| Treasury shares | 106,115 | 0.12% | - | 0.00% |
| Directors (non-executive) | 10,000 | 0.01% | 10,000 | 0.01% |
| Free floats | 25,422,742 | 29.20% | 26,799,821 | 26.81% |
| Total | 87,077,695 | 100.00% | 99,939,380 | 100.00% |
| Shareholding following the issuance of the T1 bis Shares and the T1 bis BSAs | ||||
| On a non-diluted basis | ||||
| Shareholders | Number of Shares | % of share capital | Number of voting rights | % of voting rights |
| Frédéric Cren (Family) | 5,612,224 | 5.91% | 11,224,448 | 10.41% |
| Pierre Broqua | 3,882,500 | 4.09% | 7,765,000 | 7.20% |
| Sub-total - Concert | 9,494,724 | 10.00% | 18,989,448 | 17.61% |
| Invus | 8,979,734 | 9.46% | 8,979,734 | 8.33% |
| BVF Partners L.P. | 8,545,499 | 9.00% | 8,545,499 | 7.93% |
| New Enterprise Associates (NEA) | 8,350,730 | 8.79% | 8,350,730 | 7.75% |
| Sofinnova | 6,751,746 | 7.11% | 7,792,307 | 7.23% |
| Andera Partners | 6,148,147 | 6.48% | 6,148,147 | 5.70% |
| Yiheng | 5,845,675 | 6.16% | 5,848,675 | 5.42% |
| Perceptive | 5,555,555 | 5.85% | 5,555,555 | 5.15% |
| Qatar Holding LLC | 5,157,233 | 5.43% | 5,157,233 | 4.78% |
| Eventide | 5,059,258 | 5.33% | 5,059,258 | 4.69% |
| Employees | 1,338,127 | 1.41% | 2,282,563 | 2.12% |
| ISLS Consulting | 111,000 | 0.12% | 222,000 | 0.21% |
| Treasury shares | 106,115 | 0.11% | 0 | 0.00% |
| Directors (non-executive) | 10,000 | 0.01% | 10,000 | 0.01% |
| Free float | 23,496,216 | 24.75% | 24,873,295 | 23.07% |
| Total | 94,949,759 | 100.00% | 107,811,444 | 100.00% |
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the field of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH, a common and progressive chronic liver disease.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva's decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA).
Contacts
| Inventiva Pascaline Clerc EVP of Global External Affairs +1 202 499 8937 | Brunswick Group Tristan Roquet Montegon / Aude Lepreux / Julia Cailleteau Media relations +33 1 53 96 83 83 | Westwicke, an ICR Company Patricia L. Bank Investor relations +1 415 513-1284 |
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This press release contains certain "forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva's cash resources, the anticipated proceeds from the T1 bis Transaction and Inventiva's expected use of such proceeds, satisfaction of the closing conditions and timing of closing, settlement and delivery of the T1 bis Transaction, Inventiva's cash position following the closing of the T1 bis Transaction, the satisfaction in part or full of the T2 Conditions Precedent, the occurrence of the T3 Triggering Event, the anticipated proceeds from Tranche 2 of the Multi-Tranche Financing and the exercise by the investors of the warrants and pre-funded warrants issued or to be issued in connection with the Multi-Tranche Financing, Inventiva's expectations with respect to ownership in its share capital by certain investors, forecasts and estimates with respect to Inventiva's pre-clinical programs and clinical trials, including design, protocol, duration, timing, recruitment, costs, screening and enrollment for those trials, including the ongoing NATiV3 Phase III clinical trial of lanifibranor in MASH, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, potential regulatory submissions, approvals and commercialization, Inventiva's pipeline and preclinical and clinical development plans, the clinical development of and regulatory plans and pathway for lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes”, "anticipates”, "expects”, "intends