6-K 1 tm2325230d1_6k.htm FORM 6-K

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of August 2023

 

Commission File Number: 001-39374

 

 

 

Inventiva S.A.

(Translation of registrant’s name into English)

 

 

 

50 rue de Dijon

21121 Daix France

+33 3 80 44 75 00
(Address of principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

x Form 20-F ¨ Form 40-F

 

 

 

 

 

 

On August 30, 2023, Inventiva S.A. (the “Registrant”) entered into subscription agreements (the “New Share Subscription Agreements”) with certain investors, pursuant to which the Registrant agreed to issue and sell, and such investors agreed to purchase and acquire, an aggregate of 9,618,638 of the Registrant’s ordinary shares, nominal value €0.01 per share (the “New Shares”), in a transaction exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”).

 

The subscription price of the New Shares is €3.18 per ordinary share. Settlement and delivery of the New Shares is expected to occur on or about September 5, 2023, subject to the satisfaction of customary closing conditions. In connection with the entry into the New Share Subscription Agreements, the investors party thereto have agreed not to sell, transfer or otherwise dispose of the New Shares for a period of six months following the date of closing, subject to certain specified exceptions.

 

The foregoing description of the New Share Subscription Agreements is qualified in its entirety by reference to the form of New Share Subscription Agreement, a copy of which is filed as Exhibit 99.1 to this Report of Foreign Private Issuer on Form 6-K and is incorporated by reference herein.

 

Concurrently with the entry into the New Share Subscription Agreement, on August 30, 2023, the Registrant entered into subscription agreements (the “Royalty Certificate Subscription Agreements”) with certain investors, pursuant to which the Registrant agreed to issue and sell, and such investors agreed to purchase and acquire, an aggregate of 51 royalty certificates (the “ Royalty Certificates”), in a transaction exempt from registration under the Securities Act (collectively with the sale of the New Shares, the “Transactions”).

 

The Royalty Certificates will provide the holders thereof with the right to an annual payment of royalties (“Royalties”) equal to 2% of the future net sales, if any, of the Registrant’s product candidate lanifibranor beginning on the fiscal year following the start of the sales of lanifibranor following the granting of the market authorization for lanifibranor in (i) the United States, (ii) the countries of the European Union or (iii) the United Kingdom, whichever occurs the first, if at all.

 

The Royalty Certificates will have a term of 15 years following the date of issue and do not provide for an accelerated repayment in case of change of control. The Registrant may at any time repurchase in full the Royalty Certificates by paying an amount equal to (i) the global cap of €92.1 million minus any Royalties paid prior to such repurchase or (ii) a price to be agreed between the Registrant and the holders of the Royalty Certificates. The Registrant has a preemptive right on any transfer of Royalty Certificates.

 

The subscription price of the Royalty Certificate is €100,000 per certificate. Settlement and delivery of the Royalty Certificates is expected to occur on or about September 5, 2023, subject to the satisfaction of customary closing conditions. In connection with the entry into the Royalty Certificate Subscription Agreements, the investors party thereto have agreed not to sell, transfer or otherwise dispose of the Royalty Certificates for a period of six months following the date of closing, subject to certain specified exceptions.

 

The foregoing description of the Royalty Certificate Subscription Agreements and the terms and conditions of the Royalty Certificates are qualified in their entirety by reference to the form of Royalty Certificate Subscription Agreement, a copy of which is filed as Exhibits 99.2 to this Report of Foreign Private Issuer on Form 6-K and is incorporated by reference herein.

 

The Registrant expects to receive aggregate gross proceeds from the Transactions of approximately €35.7 million. The Registrant expects to use approximately 95% of the net proceeds from the Transactions to support its ongoing NATiV3 Phase III clinical trial of lanifibranor for patients suffering from NASH, with the remainder to support its other clinical and preclinical programs, as well as for general corporate purposes.

 

A copy of the press release issued on August 31, 2022 in connection with the Transactions is attached hereto as Exhibit 99.3.

 

 

 

 

Forward-Looking Statements

 

This report on Form 6-K contains “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 Form 6-K are forward-looking statements. These statements include, but are not limited to, the timing and completion of the Transactions, the commercialization of lanifibranor and achievement of any sales related thereto, payment of royalties, the Registrant’s anticipated future performance and the expected use of proceeds from the Transactions. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond the Registrant’s control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by the Registrant or its partners will be reached on their expected timeline, or at all. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that the Registrant is a clinical-stage company with no approved products and no historical product revenues, the Registrant has incurred significant losses since inception, the Registrant has a limited operating history and has never generated any revenue from product sales, the Registrant will require additional capital to finance its operations, in the absence of which, the Registrant may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, the Registrant’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of the Registrant’s clinical trials may not support the Registrant’s product candidate claims, the Registrant’s expectations with respect to the changes to the clinical development plan for lanifibranor for the treatment of NASH may not be realized and may not support the approval of a New Drug Application, the Registrant may encounter substantial delays in its clinical trials or the Registrant may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of the Registrant to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside the Registrant’s control, the Registrant’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, the Registrant faces substantial competition and the Registrant’s business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by geopolitical events, such as the conflict between Russia and Ukraine, related sanctions and related impacts and potential impacts on the initiation, enrollment and completion of the Registrant’s clinical trials on anticipated timelines, health epidemics, and macroeconomic conditions, including global inflation, rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this report on Form 6-K. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

 

Please refer to the Universal Registration Document for the year ended December 31, 2022 filed with the Autorité des Marchés Financiers on March 30, 2023, and the Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 30, 2023 for other risks and uncertainties affecting the Registrant, including those described from time to time under the caption “Risk Factors”. Other risks and uncertainties of which the Registrant is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.

 

All information in this report on Form 6-K is as of the date of the report. Except as required by law, the Registrant has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, the Registrant accepts no liability for any consequences arising from the use of any of the above statements.

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Form of New Share Subscription Agreement
99.2   Form of Royalty Certificate Subscription Agreement
99.3   Press Release, dated August 31, 2023

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Inventiva S.A.
     
Date: August 31, 2023 By: /s/ Frédéric Cren
    Name Frédéric Cren
    Title: Chief Executive Officer