(Boursier.com) — inventive a biopharmaceutical company specializing in the clinical development of orally administered small molecules for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with unmet medical need, today reports its cash position as of June 30, 2022 and its revenue for the first half of 2022.
As of June 30, 2022, Inventiva’s cash position amounted to €87.2 million, compared to €80.5 million as of March 31, 2022 and €95.4 million as of December 31, 2021.
Net cash flow used by operating activities amounted to €26.1 million in the first half of 2022, compared to €19.8 million over the same period in 2021. Research and development expenses for the first half of 2022, mainly related to the development of lanifibranor in NASH, showed a 53% increase compared to the first half of 2021. This significant increase in ‘R&D’ expenses is linked to the costs associated with the Phase III clinical study NATiV3 with lanifibranor in NASH and to a lesser extent, in the Phase IIa Legend clinical study combining lanifibranor and empagliflozin in patients with NASH and type 2 diabetes. In January 2022, the Company received a payment from €4 million milestone from AbbVie following enrollment of first patient in ongoing Phase IIb clinical trial with cedirogant (formerly ABBV-157) in adult patients with moderate to severe chronic plaque psoriasis, and the 2021 R&D tax credit (“CIR”) of €3.6 million was received in May 2022.
Net cash flow generated by investing activities amounted to €0.8 million in the first half of 2022, compared to -€1.2 million over the same period in 2021.
Cash flow generated by financing activities in the first half of 2022 was high
to 13.9 million euros while no cash flow was generated by financing activities in the first half of 2021. This increase is notably linked to the raising of an amount of 9.3 million euros (gross proceeds) on June 15, 2022 under Inventiva’s At-The-Market (ATM) program set up on August 2, 2021, and upon the signature of three loan agreements with French banks for a total amount of 5.3 million euros. One of the loans was concluded in the form of a loan guaranteed by the State (PGE) with Bpifrance and the two others in the form of Participative Recovery Loans concluded with Crédit Agricole Champagne-Bourgogne and Société Générale.
In the first half of 2022, the Company recorded a positive foreign exchange effect on its cash and cash equivalents of €3.2 million versus €1.5 million in the first half of 2021, due to the strengthening of the USD compared to the euro.
In addition, the Company has also finalized the documentation required under the financing agreement of up to $50 million with the European Investment Bank (the “EIB”), announced on May 16, 2022, by signing an agreement for the issuance of warrant agreements with the EIB on July 1, 2022. The Company plans to use the financing granted by the EIB, when received, for its clinical studies and its preclinical pipeline , in particular to finance part of its NATiV3 Phase III clinical trial on lanifibranor in patients with NASH3.
Considering its current ‘R&D’ and clinical development programs, and excluding any future proceeds from the Financing Agreement with the EIB and any potential additional financial resources, the Company estimates that its cash, cash equivalents cash and short-term deposits should allow it to finance its activities until the end of the second quarter of 20234.
The Company’s revenue for the first half of 2022 amounted to €0.1 million, compared to €0.2 million for the same period in 2021.
Expected next milestones
Update on odiparcil’s development strategy – expected by the end of 2022
Publication of results from the investigator-initiated clinical study evaluating lanifibranor in patients with type 2 diabetes and NAFLD – previously scheduled for the second half of 2022 is now expected for the first quarter of 2023
Last patient first visit of the NATIV3 Phase III clinical study evaluating lanifibranor in NASH – now scheduled for the first half of 2023
Completion of Phase IIb clinical study conducted by AbbVie evaluating cedirogant in adult patients with psoriasis – expected in the first half of 2023
Publication of the results of the Phase IIa LEGEND study combining lanifibranor and empagliflozin in patients with NASH and type 2 diabetes – planned for the second half of 2023
Upcoming participation in investor conferences
HC Wainwright 24th Annual Global Investment Conference, September 12-14 – New York City
KBC Life Sciences Conference, September 15-16 – Virtual
Lyon Pôle Bourse, September 28 – Lyon
HealthTech Innovation Days, October 12-14 – Paris
Portzamparc BNP Paribas Biotech & Health, October 4 – Virtual
Jefferies 2022 London Healthcare Conference, November 15-17; London
Upcoming participations in scientific conferences
Paris NASH Meeting, September 8-9 – Paris
91st AFEF Scientific Days, October 5-8 – Dijon
AASLD The Liver Meeting, November 4-8 – Washington, DC
6th Obesity and NASH Drug Development Summit, November 29 to December 1 – Boston
Next financial meeting
Financial results for the first half of 2022: Wednesday, September 21, 2022 (after market close in the United States)