Inventiva: H1 2021 Half-Year Financial Report

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INVENTIVA SA

  1. seal reservebusiness (anonimous society) with a capital of 386,593.61 euros Headquarters: 50, rue de Dijon, 21121 Daix, France
    RCS Dijon 537 530 255

INTERIM FINANCIAL REPORT

FOR THE SIX MONTHS ENDED JUNE 30, 2021

Contents
1. Interim financial report ……………………………………… ….. ……………………………. 2
1.1. General presentation of activities ………………………………………. ……………….. ………………………… ………. 2
1.2. Significant events of the first half of 2021 …………………………………….. …… ……………………………. 2
1.3. Recent events and outlook ………………………………………. …. ………………………………………. ………. 5
1.4. Risk factors ……………………………………….. . …………………………………………. …………….. ……………. 8
1.5. Income Analysis ……………………………………….. ……………… ………………………….. ……………………………. ……. 9
1.6. Analysis of the financial situation ……………………………………… ………. ……………………………. 15
2. Cash flow and equity …………………………………… ….. …………………………………. 18
2.1. Cash and cash equivalents ……………………………………… . ……………………………………….. 18
2.2. Cash flow analysis ……………………………………… ….. ……………………………………… ………………… …. 21
2.3. Planned sources of funding ………………………………………. …. …………………………………. 23
3. Interim condensed consolidated financial statements ………………………. 24
Note 1. Company Information …………………………………… ……. ……………………………………. ……. 29
Note 2. Basis of preparation of the consolidated accounts ……………………………. 32
Note 3. Accounting principles ………………………………………… ……………………………………….. 34
Note 4. Notes on the consolidated balance sheet ……………………………………… ………….. …………………… 36
Note 5. Notes to the income statement …………………………………….. ……….. ………………………………. 49
Note 6. Other financial information ……………………………………….. ……………. ……………………………. …… 56

Definitions

In this half-yearly report (the Interim financial report), and unless otherwise indicated, the conditions inventive or the Society means the company Inventiva SA whose head office is located at 50, rue de Dijon, 21121 Daix, France, and which is registered in the Dijon Trade and Companies Register under number 537 530 255 and its subsidiary, wholly owned , Inventiva Inc. with its head office at 10-34 44e Dr, Long Island, 11101 New York, USA, created January 2021.

A glossary defining certain terms used in this half-year financial report can be found in the Universal Registration Document 2020 (the Universal Registration Document 2020).

Forward-looking information

This half-year financial report contains information on the objectives and development priorities of the Company. This information is sometimes identified by the use of the future, the conditional, or terms such as “consider”, “anticipate”, “think”, “aim”, “expect”, “understand”, “should”, ” seek “,” estimate “,” believe “,” wish “,” power “or, where appropriate, the negative form of these same terms, or any other variant or similar terminology. The reader’s attention is drawn to the fact that these development goals and priorities depend on circumstances or facts which are uncertain whether they will occur or materialize. These development goals and priorities are not historical data and should not be interpreted as a guarantee that facts or data will occur, that assumptions will be verified or that goals will be achieved. By their nature, these objectives may not be achieved and any statement or information given in this interim financial report may turn out to be inaccurate. The Company has no obligation to update this information, subject to applicable regulations and in particular the general regulations of the Autorité des marchés financiers (Financial Markets Authority – AMF).

Market and competitive position

This half-year financial report also contains information on the Company’s activities and the markets in which it operates. This information comes from studies or surveys carried out internally or externally. The other information contained in this interim financial report is accessible to the general public. The Company considers that all of this information is reliable but has not been verified by an independent expert. The Company cannot guarantee that a third party using different methods to collect, analyze or calculate market data would obtain the same results.

Rounding of numbers

Certain figures (including data expressed in thousands or millions of euros or dollars) and percentages presented in this half-year financial report have been rounded up or down. Therefore, the totals shown may vary slightly from those obtained by adding the exact (unrounded) values ​​of these same figures.

Abbreviations

Certain figures are given in thousands or millions of euros and are indicated respectively in thousands of euros or millions of euros.

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1. Interim financial report

1.1. General overview of activities

Since the creation of the Company, most of its resources have been devoted to research and development (R&D), in particular to develop:

  • the lanifibranor clinical program in a Phase III NATIVE clinical study for patients with non-alcoholic steatohepatitis (“NASH”), for which positive Phase IIb results were announced in June 2020 and Breakthrough Therapy and Fast Track designations have been granted by the United States Food and drug administration (“FDA”) in October 2020 and September 2019, respectively;
  • the odiparcil clinical program, for which the positive results of the Phase IIa clinical study in the treatment of type VI mucopolysaccharidosis, or MPS VI, were announced in December 2019 and the “Fast Track” designation was granted by the FDA in October 2020;
  • to a lesser extent, the Company portfolio of preclinical products, particularly in the field of oncology.

In November 2020, the Company decided to focus its clinical activities on the development of lanifibranor for the treatment of NASH. As part of this decision, the Company is examining all available options to optimize the development of odiparcil for the treatment of MPS VI and, during this period, has suspended all research and development activities related to MPS.

These research and development activities are presented in more detail in Chapter 1 Commercial activities and markets of the 2020 Universal Registration Document.

The evolution of research and development costs is detailed in paragraph 1.5.2 “Operating Expenses” below.

1.2. Highlights of the first half of 2021

1.2.1. Operations and product portfolio

The 2020 Universal Registration Document describes the main clinical and preclinical programs of the Company. The significant events related to the programs that took place in the first half of 2021 are as follows:

Lanifibranor

Design of its Phase III clinical study with lanifibranor in NASH

On January 5, 2021, the Company announced details of the Phase III clinical trial with its lead drug candidate lanifibranor for the treatment of NASH following the end of phase II meeting with the FDA and receipt of the letter. scientific opinion of the European Medicines Agency (“EMA”). The phase III trial design and clinical strategy have been discussed with both regulatory authorities and the following key points can be confirmed:

  • Request for expedited US approval and EU conditional approval for lanifibranor based on a Histological analysis at 72 weeks;
  • Use of a composite primary endpoint combining resolution of NASH and improvement of fibrosis;
  • Adequacy of long-term use to be established after 72 weeks.

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Disclaimer

Inventiva SA published this content on September 20, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on September 20, 2021 08:11:08 PM UTC.


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