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Inventiva (IVA) Loses -17.66% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2024-10-01 14:36
A downtrend has been apparent in Inventiva S.A. Sponsored ADR (IVA) lately with too much selling pressure. The stock has declined 17.7% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical ...
Inventiva provides a corporate update and reports its unaudited 2024 first-half financial results
GlobeNewswire News Room· 2024-09-25 20:00
Recruitment in NATiV3 clinical trial progresses with over 85% of the targeted number of patients enrolled in the main cohort and a statistical powering of the study expected to be superior to 95% for both doses evaluated in the trial. Baseline characteristics of patients randomized in the main cohort of NATiV3 remain consistent with the characteristics of patients enrolled in the completed Phase IIb, NATIVE, clinical trial. Blinded analyses of patients in NATiV3 suggest a positive evolution of key biomarker ...
Half-Year Review of Inventiva's Liquidity Contract with Kepler Cheuvreux
GlobeNewswire News Room· 2024-07-19 15:30
Cash: € 285,764.46 Number of shares: 129,659 Number of executions on buy side on semester: 1,886 Number of executions on sell side on semester: 1,610 Traded volume on buy side on semester: 322,578 shares for € 1,074,534.26 Traded volume on sell side on semester: 276,147 shares for € 938,985.90 When the contract was initially implemented, the following resources were included in the liquidity account: | --- | --- | --- | --- | --- | --- | |-----------------|--------|-----------|-------|-------|-----------| | ...
Inventiva announces a €20.1 million issuance of royalty certificates
GlobeNewswire News Room· 2024-07-18 06:30
The Company intends to use approximately 95% of the net proceeds from the Transaction to continue the NATiV3 Phase III trial of lanifibranor in MASH/ NASH ("NATiV3") and the remainder for general corporate purposes. The Royalty Certificates are being issued pursuant to a decision of Board of Directors on July 16, 2024, in accordance with the provisions of Article L. 228-36-A of the French Commercial Code (Code de commerce) to one new investor and existing shareholders. The holders of Royalty Certificates ar ...
Down -27.95% in 4 Weeks, Here's Why You Should You Buy the Dip in Inventiva (IVA)
ZACKS· 2024-06-18 14:35
Group 1 - The stock of Inventiva S.A. Sponsored ADR (IVA) has experienced a significant downtrend, declining 28% over the past four weeks due to excessive selling pressure [1] - The stock is currently in oversold territory, indicated by an RSI reading of 28.42, suggesting a potential trend reversal [2][3] - Analysts have raised earnings estimates for IVA by 0.5% over the last 30 days, indicating a consensus that the company may report better earnings than previously predicted [3] Group 2 - The Zacks Rank for IVA is 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [3]
Inventiva announces two scientific presentations at the EASL International Liver Congress™ 2024
globenewswire.com· 2024-05-22 20:00
Daix (France), Long Island City (New York, United States), May 22, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non- alcoholic steatohepatitis ("NASH"), and other diseases with significant unmet medical needs, today announced that two scientific abstracts have been selected for poster presentation at the upc ...
Inventiva reports 2024 First Quarter Financial Information¹ and provides a corporate update
globenewswire.com· 2024-05-21 20:00
Core Viewpoint - Inventiva, a clinical-stage biopharmaceutical company, reported its financial results for Q1 2024, highlighting significant cash usage in operations and R&D, while also providing updates on its clinical trials and corporate governance [1][7]. Financial Results - As of March 31, 2024, the company's cash and cash equivalents were €11.0 million, down from €26.9 million at the end of 2023. Short-term deposits were €0.1 million, and long-term deposits were €19.0 million [2][10]. - Net cash used in operating activities for Q1 2024 was (€29.4) million, an increase from (€20.4) million in Q1 2023. R&D expenses rose by 82% year-over-year, driven by costs related to the NATiV3 Phase III clinical trial [3]. - Net cash used in investing activities was (€10.3) million in Q1 2024, compared to (€8.4) million in Q1 2023, primarily due to changes in deposits [4]. - The company generated €23.7 million in financing activities during Q1 2024, a significant increase from (€1.2) million in Q1 2023, attributed to a €25 million loan from the European Investment Bank [5]. Corporate Update - The company appointed Andre Turenne to its Board of Directors, pending shareholder ratification [9][11]. - The NATiV3 Phase III clinical trial for lanifibranor continues without protocol modifications, with 280 sites in 15 countries resuming patient screening [10][20]. - The anticipated last patient first visit for the NATiV3 trial is targeted for the first half of 2024 [12]. Research and Development - Inventiva's lead product candidate, lanifibranor, is in a pivotal Phase III trial for MASH/NASH, a chronic liver disease with no approved therapies [17]. - The company has suspended clinical efforts for odiparcil to focus on lanifibranor and is reviewing options for its further development [18]. - The company has a robust scientific team and an extensive library of approximately 240,000 pharmacologically relevant molecules [19].
Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH
globenewswire.com· 2024-05-16 20:00
Core Viewpoint - The Data Monitoring Committee (DMC) has recommended the continuation of the NATiV3 Phase III clinical trial for lanifibranor without modifications, confirming its good safety profile based on a review of safety data from over 900 patients [1][2][3]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH/NASH) and other diseases with significant unmet medical needs [2][8]. - The company is advancing its lead product candidate, lanifibranor, which is a pan-PPAR agonist designed to target all three PPAR isoforms, contributing to its favorable tolerability profile observed in clinical trials [4][9]. Clinical Trial Details - The NATiV3 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of lanifibranor in adult patients with biopsy-proven non-cirrhotic MASH/NASH and F2/F3 liver fibrosis, involving approximately 900 patients over a 72-week period [5][6]. - The DMC's review included safety data from more than 900 patients, with over 360 treated for more than 48 weeks and 80 for more than 72 weeks, supporting the trial's continuation [3][5]. Regulatory Status - Lanifibranor has received Breakthrough Therapy and Fast Track designations from the FDA for the treatment of MASH/NASH, which may expedite its development and review process [4][8].
Inventiva(IVA) - 2023 Q4 - Annual Report
2024-04-03 10:11
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, 2023 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) - 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].