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91250002119400054083000P3Y54083000
A joint-stock company (soci t anonyme) with a share capital of 524,771.88 euros
Registered office: 50, rue de Dijon, 21121 Daix, France
Dijon Trade and Companies Register 537 530 255
INTERIM FINANCIAL REPORT
FOR THE SIX MONTHS ENDED JUNE 30, 2024
| 1. | Interim Financial Report | 3 |
| 1.1. | General overview of activities | 3 |
| 1.2. | Significant events in the first half of 2024 | 5 |
| 1.3. | Recent events and prospects | 8 |
| 1.4. | Risk factors | 9 |
| 1.5. | Earnings analysis | 11 |
| 1.6. | Analysis of the financial situation | 16 |
| 2. | Cash flow and equity | 19 |
| 2.1. | Cash and cash equivalents | 19 |
| 2.2. | Cash flow analysis | 21 |
| 2.3. | Anticipated sources of funds | 22 |
| 3. | Unaudited interim condensed consolidated financial statements | 24 |
| 3.1. | Statutory Auditors' Review Report on the Half-yearly Financial Information | 24 |
| 3.2. | Interim Condensed Consolidated financial statement | 25 |
| 4. | Other information | 62 |
| 4.1. | Table of delegations | 62 |
In this half-yearly report (the "Interim Financial Report"), and unless otherwise specified, the terms Inventiva or the Company are taken to mean the company Inventiva S.A. with its registered office at 50, rue de Dijon, 21121 Daix, France, and which is listed with the Dijon Trade and Companies Register under number 537 530 255 and its subsidiary, 100% owned, Inventiva Inc. with its registered office at 10-34 44th Dr, Long Island City, 11101 New York, USA, created in January 2021.
Certain terms used in this Interim Financial Report are defined in the Company's annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 3, 2024 ("the Annual Report").
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management's beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this document, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this document, the words "anticipate," "believe," "can," "continue", "could," "estimate," "expect," "goal", "intend," "is designed to," "may," "might," "plan," "will," "would," "potential," "predict," "objective," "should," "target", or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
We encourage you to read and carefully consider all of the risk factors disclosed in "Item 3.D-Risk Factors" of our Annual Report and Section 1.4 hereof, for a discussion of the risks and uncertainties material to our business, including important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this document will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. These forward-looking statements represent our plans, objectives, estimates, expectations and intentions only as of the date of this filing. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
You should read this document and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
Market and competitive position
This Interim Financial Report also contains information about the Company's activities and the markets on which it operates. This information comes from studies or surveys carried out internally or externally. Other information contained in this Interim Financial Report is available to the general public. The Company considers that all of this information is reliable, but it has not been verified by an independent expert. The Company cannot guarantee that a third party using different methods to gather, analyze or calculate market data would obtain the same results.
Certain figures (including data expressed in thousands or millions of euros or dollars) and the percentages presented in this Interim Financial Report have been rounded up or down. Accordingly, totals given may vary slightly from those obtained by adding the exact (unrounded) values of those same figures.
Certain figures are given in thousands or millions of euros and are indicated as thousand or million respectively in this Interim Financial Report.
1.Interim Financial Report
1.1. General overview of activities
Inventiva S.A. is a public limited company registered and domiciled in France. Its head office is located at 50 rue de Dijon, 21121 Daix. The consolidated nancial statements of the company Inventiva include Inventiva S.A. and its subsidiary Inventiva Inc., created in January 2021.
Inventiva's ordinary shares have been listed on compartment B of Euronext Paris regulated market since February 2017 and Inventiva's American Depositary Shares ("ADSs"), each representing one ordinary share, have been listed on the Nasdaq Global Market since July 2020.
Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical need.
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing lanifibranor for the treatment of MASH/NASH, as well as a pipeline of earlier stage programs in oncology discovery.
Lanifibranor, its lead product candidate, is being developed for the treatment of patients with MASH/NASH, a chronic and progressive liver disease. In 2020, the Company announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with MASH/NASH and announced that the U.S. Food and Drug Administration ("FDA") had granted the Company the status of Breakthrough Therapy and Fast Track designation. The Company initiated the pivotal Phase III trial of lanifibranor in MASH/NASH ("NATiV3") in the second half of 2021. In March 2024, the Company announced positive results from its Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and Type 2 Diabetes ("DT2") ("LEGEND").
In the first half of 2022, the Company faced delays in its NATiV3 trial that were primarily due to a higher than originally projected screen failure rate resulting in slower than anticipated enrollment rate. In addition, the Company experienced slower than predicted site activation, screening and enrollment due to negative impacts from the COVID-19 pandemic, mainly during the years 2020 and 2021, and the Company was unable to conduct clinical trial activities at sites originally located in Ukraine due to the war between Ukraine and Russia and made the decision to put recruitment for its NATiV3 trial in Ukraine on hold and close all sites in Russia. Global geopolitical events that continue to impact the markets (including Russia's invasion of Ukraine or the state of war between Israel and Hamas) could affect the Company.
In January 2023, the Company amended the protocol for the NATiV3 trial in part to potentially accelerate enrollment and identified additional sites to help compensate for the inability to use sites in Ukraine and Russia. The revised study design limits the planned duration of the trial to 120 weeks instead of up to seven years, reduces the number of biopsies from three to two and included a 48-week active treatment extension study. The Company expects that the changes to the clinical development plan of lanifibranor, including plans for a new Phase III trial in patients with MASH/NASH and compensated cirrhosis, will be beneficial to the lanifibranor clinical program by reducing the number of biopsies and the trial duration, eventually offering all patients in the trial access to treatment and potentially expanding the addressable patient population beyond patients with F2 and F3 fibrosis to patients with NASH and compensated cirrhosis.
INTERIM FINANCIAL REPORT FOR THE SIX MONTHS ENDED JUNE 30, 2024 ||
In September 2022, the Company entered into a license and collaboration agreement with Chia Tai Tianqing Pharmaceutical (Guangzhou), Co., LTD ("CTTQ"), a Sino Biopharm group company, to develop and commercialize, subject to regulatory approval, lanifibranor for the treatment of MASH/NASH and other metabolic diseases in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan ("CTTQ Territory"). In May 2023, the Company announced that CTTQ had received the Investigational New Drug ("IND") approval from the Chinese National Medicine Products Administration ("NMPA") allowing CTTQ to initiate the clinical development of lanifibranor in MASH/NASH in mainland China. CTTQ is participating in the ongoing NATiV3 Phase III trial and is conducting a Phase I clinical pharmacology study. In the framework of its participation in the Company's NATiV3 Phase III global clinical trials, pursuant to the terms of the agreement, CTTQ bears all costs associated with these trials conducted in the CTTQ Territory.
On September 20, 2023, the Company and Hepalys Pharma, Inc. ("Hepalys") announced an exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea (the "Hepalys License Agreement"). Hepalys is a new company created by Catalys Pacific Fund II, LP ("Catalys"). Under the Hepalys License Agreement, the Company received a $10 million upfront payment (equal to 9.5 million) on October 18, 2023, and is eligible to receive up to $231 million if certain clinical, regulatory and commercial conditions are met; in addition to tiered royalties from mid double digits to low twenties based on net sales of lanifibranor in Japan and South Korea, subject to regulatory approval. In parallel with the Hepalys License Agreement, the Company entered into an option agreement with Catalys to acquire 30% of the shares of Hepalys (the "Catalys Option Agreement"). The Company exercised that option on September 26, 2023, with an effective date of October 11, 2023, at an aggregate exercise price of 300 (equal to 1.90). Also on September 20, 2023, the Company entered into a shareholders agreement with Catalys and Hepalys (the "Catalys Shareholders Agreement"). Pursuant to the Catalys Shareholders Agreement, the Company has the option to acquire all outstanding shares of Hepalys at a pre-agreed multiple of post-money valuation and the Company has a right of first refusal if Hepalys receives an offer for the license or rights related to lanifibranor.
In the first quarter of 2024, following a routine visit during Company's NATiV3 clinical trial of lanifibranor in MASH/NASH, a Suspected Unexpected Serious Adverse Reaction ("SUSAR") was reported in a patient. As a result of this SUSAR, the Company 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 Committee1 ("DMC").
On March 7, 2024, the Company announced that screening activities had resumed in American sites under central Institutional Review Board ("IRB"). The impact of the pause on the overall timeline of the trial remains unclear, as new exclusion criteria were added, which may increase the screen failure rate, and the SUSAR, new exclusion criteria and increased liver monitoring may discourage potential trial participants.
On March 18, 2024, the Company announced positive results from its LEGEND proof-of-concept study combining lanifibranor with empagliflozin in patients with MASH /NASH and DT2.
The Company expects the first visit of the last patient to be in the fourth quarter of 2024 (versus the first quarter of 2024 as previously announced) and to complete randomization in the first half of 2025. Due to a delay of around 3 to 5 months in recruitment, the Company is currently targeting the topline results for the second half of 2026 (versus the beginning of the second half of 2026 as previously announced).
If the results of the trial confirm sufficient clinical benefit and a continued good safety profile, the Company plans to file an application for accelerated approval in the United States and conditional authorization in the European Union for the marketing of lanifibranor.
The Company's pipeline also includes odiparcil, which it was previously developing for the treatment of patients with mucopolysaccharidosis type VI ("MPS VI"), a group of rare genetic diseases. As announced in 2020, the Company decided to focus its clinical efforts on the development of lanifibranor. Based on feedback from the FDA, the Company believes there is potential for an efficient development pathway for odiparcil for the treatment of MPS VI and it continues to review potential options to further develop odiparcil for the treatment of MPS VI, which may include pursuing or creating a partnership, license or other transaction.
1 A DMC is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
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1.2. Significant events in the first half of 2024
1.2.1.Operations and product portfolio
Treatment-related Suspected Unexpected Serious Adverse Reaction in the first quarter of 2024
On February 15, 2024, the Company announced that an adverse event of elevated aminotransferases in liver tests was reported in a patient enrolled in the NATiV3 trial following a scheduled visit. The patient had been without clinical symptoms throughout the period of observation. This event has been assessed as a treatment-related SUSAR. Other milder cases of elevation of aminotransferases among trial participants have also been reported in the trial. The Company 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 in the first quarter of 2024. Patients already enrolled in the Phase III NATiV3 trial continued to receive treatment under the new liver monitoring schedule recommended by the DMC. This SUSAR is the first reported in all clinical trials with lanifibranor.
On March 7, 2024, the Company received approval from the central IRB overseeing clinical research in the United States to resume screening activities in its sites. This was an important milestone as 152 sites of the NATiV3 clinical trial sites are operating under central IRB and have so far randomized over 60% of the patients in the main cohort.
Due to a delay of around 3 to 5 months in recruitment, the Company is currently targeting the first visit of the last patient for the fourth quarter of 2024, completion of randomization in the first half of 2025 and the main results are expected for the second half of 2026 (versus the beginning of the second half of 2026 as previously disclosed).
The Company presented the results of LEGEND Phase IIa combination trial with lanifibranor and empagliflozin in patients with MASH/NASH and T2D
On March 18, 2024, the Company announced positive results from its LEGEND proof-of-concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and type 2 diabetes.
The LEGEND trial was designed as 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 MASH/NASH and T2D. 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/NASH was based on historic histology evaluation or a combination of non-invasive methods including diagnostic methods including imaging. 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.
The study achieved the primary efficacy endpoint with an absolute reduction in Hemoglobin A1c (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.
The study also demonstrated a statistically significant reduction in hepatic steatosis measured by MRI-PDFF, in patients treated with lanifibranor alone and in combination with empagliflozin, -47% and -38% respectively, compared to placebo (0%). 83% and 67% of patients treated with lanifibranor alone or in combination with empagliflozin respectively, showed a reduction greater or equal to 30% of their hepatic fat, compared to 0% in the placebo arm. In addition, the study demonstrated a statistically significant effect on several secondary and exploratory endpoints, including liver enzymes (alanine aminotransferase ("ALT") and aspartate aminotransferase ("AST")), insulin resistance (HOMA-IR), HDL, and adiponectin. Markers of liver inflammation and fibrosis (corrected T1 relaxation time (cT1) assessed by LiverMultiScan ) were assessed for the first time with lanifibranor and showed a significant effect with lanifibranor alone and in combination with empagliflozin.
The study also demonstrated that patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that can be observed in some patients treated
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with lanifibranor alone. Furthermore, these results demonstrated a significant relative reduction in the VAT/SAT ratio (visceral and subcutaneous adipose tissue) in patients treated with lanifibranor alone or in combination with empagliflozin, -5% and -17% respectively, compared to an increase of 11% in patients under placebo. This result reflects a shift from pro-inflammatory visceral fat towards metabolically healthy adipose tissue.
The treatment with lanifibranor 800mg/daily alone and in combination with empagliflozin 10mg/daily for 24 weeks appears to be well tolerated, with no safety concerns reported.
Given that the primary endpoint of LEGEND was met, and statistically significant results were achieved on several key additional markers, the Company has decided to stop the recruitment as defined per protocol. More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.
Additional results from NATIVE Phase IIb clinical trial
On May 13, 2024, the Company announced the publication in Nature Communications of additional results from NATIVE Phase IIb clinical trial demonstrating improvement of markers of cardiometabolic health in patients with MASH/NASH treated with lanifibranor.
Improvements were observed for insulin resistance (insulin levels, HOMA-IR), lipid metabolism (triglycerides, HDL-cholesterol, apolipoproteins), control of glycemia (HbA1c, fasting glucose (FG) levels), systemic inflammation (hs-CRP, ferritin), hepatic steatosis and diastolic blood pressure.
Recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH
On May 16, 2024, the Company announced the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH.
The DMC recommended to continue the clinical trial without further modification of the protocol, as amended immediately after learning about the SUSAR based on the pre-planned review of safety data.
The recommendation was based on the unblinded review by the DMC of safety data from more than 900 patients randomized in the main and exploratory cohorts, including more than 360 and 80 patients that have been treated for more than 48 and 72 weeks, respectively.
The patient who experienced the adverse event of increased liver test results, which was reported as a SUSAR, had been without clinical symptoms throughout the period of observation and has fully recovered.
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The Company issued 3,144,654 warrants to EIB in connection with the drawdown of Tranche B
On January 4, 2024, the Company issued 3,144,654 additional warrants to the European Investment Bank ("EIB") and such warrants (the "EIB Tranche B Warrants"), in accordance with the terms of the 6th resolution of the combined general meeting of shareholders of January 25, 2023 and Article L.225-138 of the French Commercial Code, as a condition to the drawdown of the second tranche of 25.0 million ("Tranche B") under the finance contract between the Company and EIB ("Finance Contract"). The 3,144,654 shares underlying the EIB Tranche B Warrants represented approximately 6.07% of the Company's then-outstanding share capital. If all the warrants issued to the EIB in connection with drawdown of the first tranche of 25.0 million ("Tranche A") under the Finance Contract (the "EIB Tranche A Warrants" and, together with the EIB Tranche B Warrants, the "EIB Warrants") and the EIB Tranche B Warrants were exercised, the EIB would hold approximately 11.3% of the Company's share capital as of June 30, 2024.
The exercise price of the EIB Tranche B Warrants is equal to 3.95 and corresponds to 95% of the volume-weighted average price of the Company's shares on the regulated market of Euronext Paris during the last trading session preceding the decision to issue the warrants (i.e. January 3, 2024).
The EIB Tranche B Warrants have a maturity of twelve years and shall be exercisable following the earliest to occur of (i) the maturity date of Tranche A (i.e., on December 8, 2026), (ii) a change of control event, (iii) an event of default under the Finance Contract, or (iv) a repayment demand by EIB under the Finance Contract. The EIB Warrants will automatically be deemed null and void if not exercised within the twelve-year period.
EIB has a put option which may require the Company to repurchase all or part of the unexercised EIB Tranche B Warrants then exercisable at their intrinsic value (subject to a cap equal to the amount drawn under the Finance Contract) under certain circumstances (for example, in the event of a change of control or on the maturity date of Tranche A or in the event of default). The Company (or a substitute third party) has a call option to require EIB to sell all shares and other securities of the Company, including the EIB Warrants, to the Company, subject to certain terms and conditions. In addition, the Company has a right of first refusal to buy-back all EIB Tranche B Warrants offered for sale to a third party, subject to certain terms and conditions.
On the basis of the 3,144,654 new shares of the Company issuable upon exercise of all the EIB Tranche B Warrants at a price of 3.95 per new share, the Company could potentially receive gross proceeds of up to 12,421,383. There is no assurance that EIB will exercise any or all of the EIB Warrants or that the Company will receive any proceeds from the exercise of the warrants.
The exercise ratio of EIB Tranche A Warrants has been adjusted following the issue of EIB Tranche B Warrants. As of the date of authorization of the issuance of these financial statements, one EIB Tranche A Warrant entitles its holder to subscribe for 1.27 ordinary shares in the Company.
The Company drew down Tranche B of 25 million under Finance Contract with EIB
On January 18, 2024, the Company drew down Tranche B under the Finance Contract for an amount of 25 million.
After the drawdown of Tranche A in December 2022, the Company had an option to access further 25 million tranche, Tranche B, subject to the achievement of certain conditions precedent. Following the achievement of those conditions, the Company decided to draw on Tranche B. The Company intends to use the proceeds to fund part of NATiV3.
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Tranche B carries a 7% interest capitalized annually and repayment in fine. The repayment is due in January 2027, three years after its disbursement. The disbursement of Tranche B was subject to, among other conditions, (i) the full drawdown of Tranche A, (ii) the receipt by the Company from the date of the Finance Contract of an aggregate amount of at least 70 million (inclusive of the 18 million that was a condition for the disbursement of Tranche A), paid either in exchange for shares of the Company, or through upfront or milestone payments, (iii) an out-licensing, partnership or royalty transaction with an upfront payment of at least 10 million, (iv) operational criteria based on patient enrollment and number of sites activated in the Company's NATiV3 Phase III clinical trial of lanifibranor in patients with MASH/NASH and (v) the Company issuing EIB Tranche B Warrants (see above - The Company issued 3,144,654 warrants to European Investment Bank in connection with the drawdown of Tranche B) in accordance with the terms and conditions of the warrant agreement entered into on July 1, 2022.
Tranche B of 25 million was recognized as financial debt at amortized cost, which takes into account the fair value of the derivative instrument (warrants) at inception and the borrowing costs.
On June 12, 2024, the Company and EIB amended the warrant to modify the rules for adjusting the exercise ratios of the EIB Warrants.
1.3. Recent events and prospects
1.3.1.Operations and product portfolio
Update on NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH.
On July 5, 2024, the Company provided an update on its NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH. Recruitment in NATiV3 clinical trial continues in both cohorts with over 80% of the targeted number of patients enrolled in the main cohort and 100% in the exploratory cohort of NATiV3.
The first visit of the last patient of NATiV3 is anticipated to occur during the fourth quarter of 2024, and topline results are expected in the second half of 2026. The Company strengthened its patent portfolio with a new patent in Japan that provides intellectual property rights on the potential use of lanifibranor for the treatment of patients with cirrhosis until 2039, excluding any potential patent term adjustments or extensions that may provide additional protection until 2043.
Issuance of royalty certificates
On July 18, 2024, the Company announced the issuance of 201 royalty certificates ("2024 Royalty Certificates") for aggregate gross proceeds of approximately 20.1 million. Royalties amount to 3% on future net sales of lanifibranor in the United States of America, the European Union and the United Kingdom over a 14-year term.
Approving of patent application
On July 25, 2024 the Company announces that the Japan Patent Office ("JPO") approved Inventiva's patent application No. JP 2019-203498, protecting the use of lanifibranor for the treatment of patients with cirrhosis. This new patent will be valid until November 8, 2039, excluding any potential patent term adjustments or extensions that may provide additional protection.
Financing in three tranches for a maximum amount of 348 million
The Company announced the following financing on 14 October 2024 structured in three tranches:
(i) the issuance , through a capital increase without preferential subscription rights reserved to a specific category of beneficiaries (" cat gorie de personnes"), of new ordinary shares at a gross value, including issuance premium, of 94.1 million through the issuance of 34,600,507 new ordinary shares, par value 0.01 per share (each, a "T1 New Shares"), and 35,399,481 prefunded warrants to subscribe for shares in the Company at a price outstanding of 0.01 per new ordinary share, each giving the right, in the event of exercise, to one new ordinary share (the "T1 BSAs");
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(ii) the issuance, in a second phase, as part of a new capital increase without preferential subscription rights reserved to certain identified investors (" personne d nomm e"), of new ordinary shares, par value 0.01 per share or of prefunded warrants to subscribe for ordinary shares of the Company (each, a "T1bis New Shares"), for a total amount of 21.4 million (excluding exercise of pre-funded warrants);
(iii) the issuance, in a third phase, as part of a new capital increase without preferential subscription rights reserved to certain identified investors (" personne d nomm e") subject to operational conditions to be met and the adoption of the necessary resolutions by the Shareholders' Meeting to be held before December 16, 2024, (or prefunded warrants) to which share warrants (the "ABSAs") are attached for a total amount of 116,000,000. Each ABSA will consist of a number of new ordinary shares with a par value of 0.01 (or pre-funded warrants) to be determined by the Company's Board of Directors (each, a "T2 New Share") to which will be attached a number warrants exercisable at an exercise price of 1.50 (each, a "T3 BSA") allowing the subscription of a number of new ordinary shares of the Company for a maximum total amount of 116,000,000.
The subscription agreements for the T1 New Shares and the T1 BSA were signed on October 11, 2024, and the settlement-delivery of the T1 New Shares and the T1 BSA is expected to take place on October 17, 2024, subject to the absence of any material adverse event between the signing of the agreements and the settlement-delivery of the T1 New Shares and the T1 BSA.
Amendment to the exclusive license and collaboration agreement with CTTQ
On October 11, 2024, the Company has entered into an amendment (the "Amendment") to the exclusive license and collaboration agreement with Chia Tai Tianqing Pharmaceutical Group, Co., Ltd ("CTTQ"), dated September 21, 2022, as amended. Under the Amendment, if the Company receives subscription commitments, before December 31, 2024, from investors to subscribe to a fundraising, in two or three tranches, for a total gross amount of at least 180,000,000 (the "Fund Raising"), CTTQ shall pay to the Company (i) $10,000,000 within 30 days of settlement-delivery of the T1 New Shares and T1 Warrants in the event of the issuance of the first tranche of the Fund Raising to be paid by CTTQ, (ii) $10,000,000 in the event of the issuance of the second tranche of the Fund Raising, and (iii) $10,000,000 upon publication by the Company of the pivotal data announcing that the primary endpoint or one of the two key secondary endpoints of NATiV3, with one of the dosing regimens tested in the trial, have been met. Under the terms of the Amendment, the total amount of potential clinical, regulatory and commercial milestone payments remains unchanged, while the royalties that Inventiva is likely to receive have been reduced to a low figure.
The Company's business faces significant risks. You should carefully consider all of the information set forth in this document and in the Company's other filings with the United States Securities and Exchange Commission, or the SEC, including the risk factors which the Company faces and which are faced by the Company's industry described in Chapter 2 of the Company's 2023 Universal Registration Document Part I, Item 1A. " Risk Factors" of the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2023, in addition to the following risk factors. Our business, financial condition or results of operations could be materially adversely affected by any of these risks.
Please refer to chapter 2.1 of the 2023 Universal Registration Document and as amended in Section 5 of the amendment to the universal document as filed with the AMF under number D.24-0227-A01 on October 14, 2024 (the "Amendment to the 2023 Universal Registration Document "), which are incorporated herein by reference.
The risk factor in the 2023 Universal Registration Document amended in the context of the Amendment to the 2023 Universal Registration Document is as follows:
Liquidity risk: the Company believes that it will be able to finance its activities until the end of the second half of 2025, and there is doubt regarding our ability to continue as a going concern.
As of 30 June 2024, the Company had cash and cash equivalents of 10.1 million, compared to 26.9 million, and 9.0 million of long-term deposit2 as of December 31, 2023.
2 The long-term deposit had a two year-term, were accessible prior to the expiration of the term with a notice period of 31 days and were considered as liquid by the Company.