On November 10, 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 needs, reported its cash position as of September 30, 2021 and its revenues for the first nine months of 2021 (Press release, Inventiva Pharma, NOV 10, 2021, View Source [SID1234595106]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cash Position

As of September 30, 2021, Inventiva’s cash and cash equivalents stood at €105.7 million, compared to €93.6 million as of June 30, 2021 and €105.72 million as of December 31, 2020.

Net cash used in operating activities amounted to €31.6 million for the first nine months of 2021 compared to (€19.4) million for the same period in 2020. R&D expenses for the first nine months of 2021 were up by 88% compared to the same period in 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH, and to a lesser extent, by the increase of general and administrative expenses (G&A) expenses (+ 51%) resulting from Inventiva’s dual listing status.

Net cash generated from financing activities for the first nine months of 2021 amounted to €23.9 million, mainly due to the sale of $30 million in gross proceeds of the Company’s ordinary shares in the form American Depositary Shares ("ADS") on September 23, 2021. The sale was made through the Company’s At-The-Market (ATM) program established on August 2, 2021, to existing and new specialized institutional investors. For the same period in 2020, net cash generated from financing activities amounted to €111.6 million, driven by: the issuance of €15 million (gross proceeds) of ordinary shares to certain existing investors in the Company, the entry into €10 million in French state-guaranteed credit agreements with a syndicate of French banks, and the receipt of €94.9 million3 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020.

Over the third quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million.

Considering its current R&D and clinical development programs and excluding additional financial resources that may originate from funding activities, Inventiva’s cash runway will allow the Company to fund its operations through the first quarter of 2023.

Revenues

The Company’s revenues for the first nine months of 2021 amounted to €0.2 million, as compared to €0.3 million for the same period in 2020. As part of its collaboration with AbbVie in auto-immune diseases, 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 planned before the end of 2021.

Update on the Phase II clinical trial with lanifibranor in patients with NAFLD and T2D

The Phase II investigator-initiated clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2D) is progressing and Professor Cusi is recruiting the last patients of the trial. However, given the current status of recruitment, the publication of the results is now expected for the second half of 2022, rather than the first half of 2022 as previously communicated.

Next key milestones expected

Webcast with Key Opinion Leaders from the AASLD The Liver Meeting 2021 hosted by Inventiva – scheduled on November 19, 2021
Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for November 2021
Activation of first clinical sites for Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and T2D – planned for the first half of 2022
Last Patient First Visit of the NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the second half of 2022
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of NAFLD in patients with T2D – planned for the second half of 2022
Strategy update on the development of odiparcil – planned for 2022
Upcoming investor conference participation

Stifel Healthcare Conference 2021 – November 16-17, 2021
Jefferies 2021 London Healthcare Conference – November 16-18, 2021
J.P. Morgan Healthcare Conference 2022 – January 10-13, 2021
Upcoming scientific conference presentations

AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

Full-Year 2021 Revenues and cash position: Monday, February 14, 2022 (after U.S. market close)