Clinical Trials and Development - The Company has initiated the pivotal Phase III clinical trial of lanifibranor in NASH ("NATiV3") in the second half of 2021, with the last patient first visit targeted by the end of the second half of 2023[15]. - The investigator-initiated Phase II clinical trial of lanifibranor in patients with T2D and NAFLD demonstrated a 44% reduction of hepatic fat after 24 weeks of treatment[17]. - The Company aims to expand the addressable patient population for lanifibranor beyond patients with F2 and F3 fibrosis to include those with NASH and compensated cirrhosis through an additional Phase III trial[25]. - The treatment with lanifibranor 800mg/once daily for 24 weeks was well tolerated, with no safety concerns reported[18]. - The Company faced slower than predicted site activation and enrollment due to the COVID-19 pandemic, particularly affecting sites in Ukraine and Russia[19]. - A significant proportion of patients achieved over 30% liver triglyceride reduction and NAFLD resolution with lanifibranor compared to placebo[31]. - The Company has activated 409 clinical sites for the NATiV3 trial, with topline results publication now targeted for the second half of 2025[19]. - The NATiV3 trial design has been revised to limit the duration to 120 weeks and reduce biopsies from three to two, improving patient enrollment rates which have doubled in sites with the new design[153]. - The revised NATiV3 trial design has been approved in 16 countries, with approximately 70% of activated sites operating under this new design[153]. - The Company has amended the NATiV3 protocol to potentially accelerate enrollment due to previous delays caused by COVID-19 and geopolitical issues[147]. - The last patient first visit for NATiV3 is targeted for the end of H2 2023, with topline results expected in the second half of 2025[147]. Financial Performance - The company reported total revenue of €6.622 million for the first half of 2023, a significant increase of 95% compared to €3.392 million in the first half of 2022[66]. - The company recorded a net loss of €55.3 million in the first half of 2023, which is an increase of €25.8 million compared to a net loss of €29.5 million in the first half of 2022[86]. - Research and development expenses rose to €54.062 million in the first half of 2023, reflecting an increase of €24.196 million or 81% compared to €29.866 million in the same period of 2022[71]. - Other income increased by €1.4 million, or 42%, compared to the first half of 2022, primarily due to higher French Research tax credits[68]. - The company reported a total comprehensive loss of €55,179,000 for the first half of 2023, compared to €29,172,000 in the same period of 2022, an increase of approximately 89.5%[140]. - The net loss for the first half of 2023 was €55.3 million, compared to a net loss of €29.5 million in the first half of 2022, representing an increase of €25.8 million[112]. - The basic and diluted loss per share for the first half of 2023 was €(1.31), compared to €(0.72) in the same period of 2022, reflecting a deterioration in per-share performance[139]. Cash and Liquidity - As of June 30, 2023, the Company had cash and cash equivalents of €31.2 million, down from €86.7 million at the end of 2022[55]. - The company’s cash position is insufficient to cover operating needs for at least the next 12 months, indicating material uncertainty regarding its ability to continue as a going concern[58]. - The company anticipates that global macroeconomic conditions and geopolitical events may impact its ability to secure new financing[61]. - The company expects to raise additional financing, including potential sales of ADSs under the At-The-Market program for up to 5 million, with the first payment of 3 million is due upon enrollment of the first patient in the registrational study in mainland China[29]. - An exclusive licensing agreement with Hepalys Pharma for lanifibranor in Japan and South Korea includes a 231 million[42][44]. - The Company invoiced CTTQ for 3 million expected upon the first patient enrollment in the registrational study[158][160]. - The company has a milestone payment of €1.7 million net under the license and collaboration agreement with CTTQ related to the achievement of the first milestone[188]. Assets and Liabilities - Non-current assets increased by €8.8 million (92%) to €18.4 million as of June 30, 2023, primarily due to a €8.6 million rise in other non-current assets[87]. - Current assets decreased by €54.0 million (51%) to €52.4 million, mainly driven by a €55.5 million (64%) decline in cash and cash equivalents[88]. - Shareholders' equity fell by €53.1 million (117%) to €(7.7) million, largely due to the appropriation of the 2022 net loss[91]. - Current liabilities rose by €7.1 million (23%) to €37.8 million, primarily due to a €9.3 million increase in trade payables related to R&D expenses[94]. - Total assets decreased to €70,819,000 as of June 30, 2023, compared to €116,004,000 at the end of 2022, a reduction of approximately 39.0%[138]. - The company has incurred a long-term financial debt of €8.253 million as of June 30, 2023, down from €9.876 million at the end of 2022[181]. - The company’s long-term debt increased to €31,014,000 as of June 30, 2023, compared to €28,663,000 at the end of 2022, an increase of approximately 4.7%[138]. Future Outlook - The Company plans to submit an NDA for accelerated approval in the U.S. and a conditional marketing authorization in the EU if the NATiV3 study is successful[41]. - The company anticipates relying on additional funding through equity issuances, debt financings, and strategic partnerships to achieve its development goals[122]. - The company is pursuing a potential €25 million EIB Financing, contingent on meeting specific conditions, including achieving at least €70 million in funding[122]. - The company expects to receive potential milestone payments totaling €1.7 million under the collaboration agreement with CTTQ by the end of 2023[119].
Inventiva(IVA) - 2023 Q2 - Quarterly Report