Inventiva(IVA)

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Inventiva(IVA) - 2023 Q2 - Earnings Call Transcript
2023-09-29 18:58
Ed Arce - H.C. Wainwright Lucy Codrington - Jefferies & Co. Evan Wang - Guggenheim Securities Jacob Mekhael - KBC Securities So let me turn to the highlights. It's been a very busy first half, and I would say, very exciting for Inventiva. And I'll start by going over some of the key highlights regarding our key program lanifibranor, including an update on the global Phase 3 NATiV3, our Phase 2 combo study with lani and empagliflozin. And of course come back on the investigator initiated study in patients wi ...
Inventiva(IVA) - 2023 Q2 - Quarterly Report
2023-09-28 21:26
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 $58.3 million until August 2, 2024[61]. - The company has estimated it can finance its activities until the beginning of the second quarter of 2024, based on its current business plan[118]. - As of June 30, 2023, the company had €31.2 million in available cash and cash equivalents, which is expected to finance activities until the beginning of Q2 2024[187]. - The company incurred operating losses and negative cash flows from operations since inception, with no expected revenue from product sales in the near future[186]. Collaborations and Agreements - The license and collaboration agreement with Chia Tai Tianqing Pharmaceutical Group includes two short-term milestone payments totaling $5 million, with the first payment of $2 million received on July 19, 2023[16]. - The second potential milestone payment under the agreement with CTTQ for $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 $10 million upfront payment and potential milestone payments of up to $231 million[42][44]. - The Company invoiced CTTQ for $2.1 million following IND approval in China, with an additional milestone payment of $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 S.A. (IVA) 2022 Full Year Results Earnings Call Transcript
2023-03-30 17:19
Inventiva S.A. (NASDAQ:IVA) 2022 Full Year Results Earnings Conference Call March 30, 2023 8:00 AM ET Company Participants Frédéric Cren – Chief Executive Officer Jean Volatier – Chief Financial Officer Michael Cooreman – Chief Medical Officer Conference Call Participants Seamus Fernandez – Guggenheim Securities Annabel Samimy – Stifel Ed Arce – H.C. Wainwright Frédéric Gomez – Pharmium Securities Operator Good day and thank you for standing by. Welcome to the Inventiva 2022 Full Year Results Call and Webca ...
Inventiva(IVA) - 2022 Q4 - Annual Report
2023-03-30 10:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Inventiva (IVA) Investor Presentation - Slideshow
2023-03-07 19:04
Developing innovative therapies in NASH NasdagListed This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this presentation are forward-looking statements. These statements include, but are not limited to, forecasts, targets and estimates with respect to Inventiva's pre-clinical programs and clinical trials, including recruitment, ...
Inventiva(IVA) - 2022 Q2 - Earnings Call Transcript
2022-09-22 20:36
Inventiva S.A. (NASDAQ:IVA) Q2 2022 Earnings Conference Call September 22, 2022 8:00 AM ET Company Participants Frédéric Cren - Co-Founder and CEO Pierre Broqua - Co-Founder and CSO Michael Cooreman - Chief Medical Officer Jean Volatier - Chief Financial Officer Philip Duong - Head, Investment Conference Call Participants Ed Arce - H.C. Wainwright Jeroen Van den Bossche - KBC Securities Alex Cogut - Bryan, Garnier Delphine Le Louët - Société Générale Operator Good day and thank you for standing by. Welcome ...
Inventiva (IVA) Investor Presentation - Slideshow
2022-06-13 09:22
inventiva | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-----------|-------|------------------------|-------|-------|------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | Developing innovative therapies in | | | | | NASH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Corporate Presentation | | | | | | | | June 2022 | | | | | | | | | | | | | | | | | | | EURONEXT DISCLAIMER This presentation contains fo ...
Inventiva(IVA) - 2021 Q4 - Annual Report
2022-03-11 22:03
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Inventiva(IVA) - 2021 Q4 - Earnings Call Transcript
2022-03-08 19:35
Inventiva S.A. (NASDAQ:IVA) Q4 2021 Earnings Conference Call March 8, 2022 8:00 AM ET Company Participants Frédéric Cren - Chairman, Chief Executive Officer & Co-Founder Pierre Broqua - Chief Scientific Officer & Co-Founder Michael Cooreman - Chief Medical Officer Jean Volatier - Chief Financial Officer Conference Call Participants Lucy Codrington - Jefferies Jeroen Van den Bossche - KBC Securities Jean-Jacques Le Fur - Bryan, Garnier Ivan Wang - Guggenheim Securities Delphine Le Louët - Société Générale Op ...
Inventiva(IVA) - 2021 Q2 - Earnings Call Transcript
2021-09-21 20:20
Inventiva S.A. (NASDAQ:IVA) Q2 2021 Results Conference Call September 21, 2021 8:00 AM ET Â Company Participants Frédéric Cren - Chairman, CEO and Co-Founder Pierre Broqua - CSO and Co-Founder Michael Cooreman - CMO Jean Volatier - CFO Conference Call Participants Lucy Codrington - Jefferies Lenny Van Steenhuyse - KBC Securities Ed Arce - H.C. Wainwright Zegbeh Jallah - Roth Capital Partners Delphine Le Louët - Société Générale Operator Good day and thank you for standing by. Welcome to InventivaÂ's First H ...