On November 10, 2022 Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis ("NASH") and other diseases with significant unmet medical needs, reported its cash position as of September 30, 2022 and its revenues for the first nine months of 2022 (Press release, Inventiva Pharma, NOV 10, 2022, View Source [SID1234623728]).

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Cash Position

As of September 30, 2022, Inventiva’s cash position stood at €72.6 million, compared to €87.2 million as
of June 30, 2022 and €95.4 million as of December 31, 2021.

Net cash used in operating activities amounted to €40.0 million for the first nine months of 2022 compared to
€31.6 million for the same period in 2021. R&D expenses, mainly driven by the development of lanifibranor in NASH, were up 27% compared to the same period in 2021. This significant increase was driven mostly by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH including a full nine months of operation for the U.S. affiliate and, to a lesser extent, with the Legend Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes.

Cash flow from operating activities was also positively impacted in the first half of 2022 by the €4 million milestone payment from AbbVie in January 2022 following the inclusion of the first patient in the Phase IIb clinical trial with cedirogant (formerly ABBV-157) in adult patients with moderate to severe chronic plaque psoriasis, though this trial has since been discontinued by AbbVie3 as previously disclosed, and the 2021 French Research tax credit ("CIR") for €3.6 million received in April 2022.

Net cash generated from investing activities for the first nine months of 2022 amounted to €0,7 million, compared to (€1.2) million net cash consumed for the same period in 2021.

Net cash generated from financing activities for the first nine months of 2022 amounted to €13.1 million compared to €23.9 million in the same period in 2021, mainly driven by the proceeds of €9.3 million (gross proceeds) raised through the Company’s At-The-Market Program on June 15, 2022, and three loan agreements with a syndicate of French banks for a total amount of €5.3 million. One of the loans was contracted as part of a French state-guaranteed loan facility ("Prêt Garanti par l’Etat" or "PGE") with Bpifrance, and the two others obtained as part of a French state stimulus economic plan ("Prêts Participatifs Relance" or "PPR") granted by Crédit Agricole Champagne-Bourgogne and Société Générale.

In the third quarter of 2022, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.5 million for the nine-month period ending September 30, 2022, versus €1.5 million for the same period in 2021, due to the strengthening of USD versus Euro.

Considering its current R&D and clinical development programs, and additional financial resources that may originate from funding activities, the Company estimates that its existing cash, cash equivalents and short-term deposits including the $12,6 million received from Sino Biopharm on November 4th and the €25 million from the EIB credit first tranche facility4 should allow the Company to fund its operations through Q4 2023.

Revenues

The Company’s revenues for the first nine months of 2022 amounted to €0.1 million, as compared to €0.2 million for the same period in 2021. The Company’s development agreement with Sino Biopharm was executed on September 21, 2022 as previously announced and the $12.6 million upfront payment was received on November 4, 2022.

Next expected key milestones

Publication of the topline results of the investigator-initiated study with lanifibranor in patients with Non-Alcoholic Fatty Liver Disease ("NAFLD") and T2D – planned for the first quarter of 2023
Publication of the topline results of the Phase IIa LEGEND of lanifibranor in combination with empagliflozin in patients with NASH and T2D – planned for the second half of 2023
Last Patient First Visit of the Phase III NATiV3 clinical trial evaluating lanifibranor in NASH – targeted for the second half of 2023
Upcoming investor conference participation

Jefferies 2022 London Healthcare Conference – November 15-17 – London
B Riley’s Cardiometabolic Health Mini Symposium – November 28 – Virtual
Degroof Petercam’s Healthcare Conference 2023 – January 24-27 – Virtual
Guggenheim Health Altitudes Summit 2023 – March 13-16 – Telluride, Colorado
Upcoming scientific conference participation

6th Obesity and NASH Drug Development Summit – November 29 through December 1, Boston, MA
MOSAIC Conference – December 5-6, Washington, DC
Next financial results publication

Full-Year 2022 Revenues and cash position: Tuesday, February 14, 2022 (after U.S. market close).