On July 28, 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 June 30, 2022, and its revenues for the first half of 2022 (Press release, Inventiva Pharma, JUL 28, 2022, View Source [SID1234617078]).
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Cash Position
As of June 30, 2022, Inventiva’s cash position was €87.2 million compared to €80.5 million as of March 31, 2022 and €95.4 million as of December 31, 2021.
Net cash used in operating activities amounted to €26.1 million in the first half of 2022 compared to €19.8 million for the same period in 2021. R&D expenses for the first half of 2022, mainly driven by the development of lanifibranor in NASH, were up 53% compared to the first half of 2021. This significant increase in R&D expenses was driven by the costs associated with the NATiV3 Phase III clinical trial of lanifibranor in NASH and, to a lesser extent, with the Legend Phase IIa combination trial with lanifibranor and empagliflozin in patients with NASH and type 2 diabetes . In January 2022, the Company received a €4 million milestone payment from AbbVie following the inclusion of the first patient in the ongoing Phase IIb clinical trial with cedirogant (previously ABBV-157) in adult patients with moderate to severe chronic plaque psoriasis, and the 2021 R&D tax credit ("CIR") for €3.6 million was received in May 2022.
Net cash generated from investing activities for the first half of 2022 amounted to €0.8 million, compared to -€1.2 million for the same period in 2021.
Net cash from financing activities for the first half of 2022 amounted to €13.96 million compared to no net cash generated from financing activities over the first half of 2021. This increase is mainly driven by the equity raised through the Company’s At-The-Market Program for approximately €9.3 million (gross proceeds) on June 15, 2022, and three loan agreements with French banks for a total amount of
€5.3 million. One of the loans has been contracted as part of a state-guaranteed PGE loan facility ("Prêt Garanti par l’Etat") with Bpifrance and the two others from a stimulus economic plan ("Prêts Participatifs Relance") granted by Crédit Agricole Champagne-Bourgogne and Société Générale.
Over the first half of 2022, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.2 million versus €1.5 million for the first half of 2021, due to the strengthening of USD versus Euro.
Furthermore, the Company also finalized the documentation requirement under the credit facility for up to $50 million with the European Investment Bank (the "EIB") announced on May 16, 2022, by signing a warrant agreement with the EIB on July 1, 2022. The Company plans to use the proceeds from the EIB facility, when received, towards its clinical studies and preclinical pipeline, including to help fund a portion of its NATiV3 Phase III clinical trial of lanifibranor in patients with NASH3.
Considering its current R&D and clinical development programs and excluding any proceeds from the EIB credit facility and any potential additional financial resources, the Company estimates that its existing cash, cash equivalents and short-term deposits should allow the Company to fund its operations through the end of the second quarter 20234.
Revenues
The Company’s revenues for the first half of 2022 amounted to €0.1 million, as compared to €0.2 million for the same period in 2021.
Next key milestones expected
Strategy update on the potential development of odiparcil – anticipated by end of 2022
Publication of the results of the investigator-initiated study with lanifibranor in patients with NAFLD and T2D – previously planned for second half of 2022 is now expected in the first quarter of 2023
Last Patient First Visit of the NATiV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for first half of 2023
Study completion of phase IIb trial of cedirogant in patient with psoriasis conducted by AbbVie – planned for first half of 2023
Topline results of Phase IIa LEGEND of lanifibranor in combination with empagliflozin in patients with NASH and T2D– planned for second half of 2023
Upcoming investor conference participation
H.C. Wainwright 24th Annual Global Investment Conference – September 12-14, New York City
KBC Life Sciences Conferences – September 15-16, Virtual
Lyon Pôle Bourse- September 28, Lyon
HealthTech Innovation Days – October 12-14, Paris
Portzamparc BNP Paribas Biotech & Santé – October 4, Virtual
Jefferies 2022 London Healthcare Conference – November 15-17, London
Upcoming scientific conference participation
Paris Nash Meeting – September 8-9, Paris
91èmes Journées Scientifiques de l’AFEF – October 5-8, Dijon
AASLD – The Liver Meeting – November 4-8, Washington, DC
6th Obesity and NASH Drug Development Summit – November 29 through December 1st, Boston
Next financial results publication
Financial results for the first half of 2022: Wednesday, September 21, 2022 (after U.S. market close)