On July 28, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported its cash position as of June 30, 2021 and its revenues for the first half of 20211 (Press release, Inventiva Pharma, JUL 28, 2021, View Source [SID1234585338]).

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Cash Position

As of June 30, 2021, Inventiva’s cash and cash equivalents stood at €93.6 million compared to €107.8 million as of March 31, 2021 and €113.02 million as of December 31, 2020.

Net cash used in operating activities amounted to €19.8 million in the first half of 2021 compared to €7.2 million for the same period in 2020. R&D expenses for the first half of 2021 were up 56% compared to the first half of 2020, mainly driven by the development of lanifibranor in NASH and costs linked to the preparation for the initiation of NATiV3, the Company’s Phase III clinical trial evaluating lanifibranor in NASH. This amount includes the payment received on June 30, 2021 of €8.0 million of Research Tax Credit (CIR – Crédit Impôt Recherche) (€3.8 million related to complementary filings following the 2020 Conseil d’État judgement covering prior years, and €4.2 million related to the 2020 Research Tax Credit), while the first half of 2020 had been positively impacted by the receipt of a €4.2 million non-recurrent late payment of the 2018 Research Tax Credit and a €4.2 million payment in respect of the 2019 Research Tax Credit.

Net cash used from investing activities amounted to €1.2 million in the first half of 2021 compared to 1.0 million for the same period in 2020.

No net cash from financing activities was generated over the first half of 2021 while Inventiva recorded
€24.6 million of net cash from financing activities for the same period in 2020, notably related to the issuance of €15 million (gross proceeds) of ordinary shares in February 2020 and the entry into a €10.0 million State-guaranteed loan, with a syndicate of French banks in May 2020.

Over the first semester of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalent of €1.2 million.

Considering its current R&D and clinical development programs, and excluding additional financial resources, Inventiva’s cash runway will allow to fund its operating activities through the third quarter of 2022.

Revenues

The Company’s revenues for the first half of 2021 amounted to €0.2 million, as compared to €0.1 million for the same period in 2020.

As part of its collaboration with Abbvie in auto-immune diseases3, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant before the end of 2021.

Next key milestones expected

First patient first visit of NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the third quarter of 2021
Initiation by AbbVie of a Phase IIb clinical trial with cedirogant – expected in the second half of 2021
Strategy update on the development of odiparcil – planned for the second half of 2021
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2DM) – planned for the first half of 2022
Upcoming investor conference participation

Citi’s 16th Annual BioPharma Conference 2021, September 8-9, 2021
KBC Virtual Life Science Conference, September 7-9, 2021
H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021
Lyon Pôle Bourse Forum, September 27-28, 2021
HealthTech Innovation Days 2021, October 4-5, 2021
Portzamparc Health Biotech Seminar 2021, October 6, 2021
Guggenheim CV&M Disease Day, October 7, 2021
H.C. Wainwright 5th Annual NASH Investor Conference, October 11, 2021
Stifel Healthcare Conference 2021, November 16-17, 2021
Jefferies 2021 London Healthcare Conference, November 16-18, 2021
Upcoming scientific conference participation

Paris NASH Meeting, October 22-23, 2021
AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

H1 2021 Financial results: Monday, September 20, 2021 (after U.S. market close)