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Inventiva receives $10 million milestone payment from CTTQ
Globenewswire· 2025-07-07 20:00
Core Viewpoint - Inventiva has received a $10 million milestone payment from Chia Tai-Tianqing Pharmaceutical Group Co., Ltd (CTTQ) as part of their collaboration to develop lanifibranor for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [1][3] Group 1: Financial Developments - The milestone payment follows the successful settlement of the second tranche of €115.6 million in gross proceeds from a structured financing deal of up to €348 million [2] - Under the CTTQ License Agreement, Inventiva is eligible to receive up to an additional $265 million in milestone payments and royalties on annual net sales of lanifibranor if approved [3] Group 2: Clinical Development - Lanifibranor has received Breakthrough Therapy Designation for MASH from both the U.S. FDA and the Chinese NMPA, which may expedite its development and regulatory review [4] - CTTQ is participating in the ongoing NATiV3 pivotal Phase 3 clinical trial for lanifibranor, which includes over 60 sites across mainland China [4] - A Phase I bridging study by CTTQ confirmed no significant ethnic differences, facilitating the regulatory approval process in China based on NATiV3 trial results [4] Group 3: Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for MASH, with lanifibranor being a novel pan-PPAR agonist currently evaluated in the NATiV3 Phase 3 clinical trial [5]
Inventiva announces the publication in Journal of Hepatology Reports on results of lanifibranor treatment on liver sinusoidal endothelial cells in patients with MASLD/MASH and in preclinical models of the disease
Globenewswire· 2025-07-02 20:00
Core Insights - Inventiva, a clinical-stage biopharmaceutical company, announced the publication of results from the Phase 2b NATIVE clinical trial and preclinical study on lanifibranor for treating metabolic dysfunction-associated steatohepatitis (MASH) [1][10] Group 1: Clinical Trial Results - The Phase 2b NATIVE trial demonstrated that lanifibranor can reduce liver sinusoidal endothelial cell (LSEC) capillarization, which is associated with fibrosis and inflammation in patients with MASH [2][3] - CD34 staining in liver biopsies indicated a higher density in patients with MASLD or MASH compared to those without, and treatment with lanifibranor for 24 weeks resulted in a dose-dependent reduction in CD34 staining [3][6] - Histological evaluations showed that LSEC capillarization occurs early in the disease, suggesting that lanifibranor may help prevent progression to cirrhosis [6][7] Group 2: Mechanism of Action - Lanifibranor acts as a pan-PPAR agonist, targeting all three PPAR isoforms, which may contribute to its anti-fibrotic and anti-inflammatory effects [9] - Preclinical models indicated that lanifibranor not only reverses capillarization but also normalizes intrahepatic vascular resistance and portal vein pressure, outperforming single PPAR agonists [4][7] Group 3: Company Overview - Inventiva is focused on developing oral therapies for MASH and is currently evaluating lanifibranor in the pivotal Phase 3 NATiV3 clinical trial [10] - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, highlighting its potential in treating MASH [9]
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Globenewswire· 2025-06-10 20:00
Core Insights - Inventiva, a clinical-stage biopharmaceutical company, has appointed Renée Aguiar-Lucander to its Board of Directors, a decision approved by shareholders at the recent Annual General Meeting [1][2] - The company is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently in the final stages of clinical development for its drug lanifibranor [1][3] Company Overview - Inventiva specializes in the research and development of oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Leadership Background - Renée Aguiar-Lucander, the newly appointed board member, has a strong background in the biopharmaceutical industry, having served as CEO of Hansa Biopharma and Calliditas Therapeutics, where she led the latter to a $1.1 billion acquisition by Asahi Kasei in 2024 [2] - Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy and successfully launched the product in the U.S. [2] Strategic Importance - The appointment of Aguiar-Lucander is seen as pivotal for Inventiva as it prepares for the potential approval and launch of lanifibranor [2] - The NATiV3 Phase 3 trial is fully enrolled, indicating progress towards bringing lanifibranor to patients with MASH [2]
Inventiva (IVA) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2025-06-03 17:01
Core Viewpoint - Inventiva S.A. Sponsored ADR (IVA) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Inventiva indicates that for the fiscal year ending December 2025, the company is expected to earn -$1.30 per share, reflecting a 61% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Inventiva has increased by 20.7%, indicating a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks rating system is based on changes in a company's earnings picture, which is crucial for predicting near-term stock price movements [2][4]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) stocks generating an average annual return of +25% since 1988, showcasing its effectiveness [7]. - The upgrade of Inventiva to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for higher stock movement in the near term [10].
Inventiva to Participate in the Upcoming Jefferies Global Healthcare Conference and UBS Spring Biotech Conference
GlobeNewswire News Room· 2025-05-27 20:00
Group 1 - The core focus of Inventiva is the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [4] - Inventiva will participate in two investor conferences in June 2025, including the Jefferies Global Healthcare Conference and the UBS Spring Biotech Conference [2][3] - Frédéric Cren, CEO of Inventiva, will present a corporate overview during a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [2] Group 2 - Inventiva is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [4] - The company is publicly listed on Euronext Paris and NASDAQ, with the ticker symbol IVA [5]
Inventiva reports 2025 First Quarter Financial Information¹
Globenewswire· 2025-05-23 06:30
Core Insights - Inventiva reported a decrease in cash and cash equivalents to €67.9 million as of March 31, 2025, down from €96.6 million at the end of 2024, primarily due to cash used in operating activities for the lanifibranor development program [2][3] - The company anticipates that its current cash resources, along with gross proceeds of €115.6 million from structured financing and a $10 million milestone payment from Chia Tai Tianqing Pharmaceutical Group, will fund operations until the end of Q3 2026 [3] - Inventiva did not recognize any revenues in Q1 2025, consistent with Q1 2024 [5] Financial Results - Cash and cash equivalents as of March 31, 2025: €67.9 million, a decrease of €28.7 million from €96.6 million on December 31, 2024 [2] - Gross proceeds from structured financing: €115.6 million, with net proceeds of €108.5 million [3] - Anticipated milestone payment from CTTQ: $10 million [3] Research and Development Updates - The company completed enrollment for its pivotal Phase 3 clinical trial, NATiV3, evaluating lanifibranor in patients with MASH [10] - The company initiated a clinical development program for lanifibranor in Japan with the first participant dosed in a Phase 1 trial [10] - Recent publications include findings on non-invasive biomarker signatures and improvements in portal hypertension with lanifibranor treatment [10] Future Outlook - The company plans to raise additional funds for the long-term development and commercialization of lanifibranor through public offerings, private placements, and strategic partnerships [4] - Topline results from the NATiV3 trial are expected in the second half of 2026 [8]
Results of the Votes of the Combined Shareholders' General Meeting of May 22, 2025
GlobeNewswire News Room· 2025-05-23 06:00
Core Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and announced the results of its Combined Shareholders' Meeting [1][12] - The meeting took place on May 22, 2025, in Paris, chaired by CEO Frédéric Cren [2] - All resolutions were adopted except for the 33rd resolution, which was negatively recommended by the Board of Directors [3] Voting Results - The shareholders present included 245 participants, representing a total of 90,772,892 shares and 102,984,957 votes, achieving a quorum of 65.264% [5] - Ordinary resolutions were overwhelmingly adopted, with the first resolution receiving 99.98% approval [6][10] - The 33rd resolution, which would have allowed the Board to decide on share capital increases for a company savings plan, was rejected with 90.58% against [10][11] Company Overview - Inventiva is publicly listed on Euronext Paris and Nasdaq, focusing on the research and development of oral small molecule therapies for MASH and other unmet medical needs [12][13] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial for MASH treatment [12]
Results of the Votes of the Combined Shareholders’ General Meeting of May 22, 2025
Globenewswire· 2025-05-23 06:00
Core Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1][11] - The Combined Shareholders' Meeting took place on May 22, 2025, where all resolutions were adopted except for one [2][3] - The compensation policy for corporate officers was approved as presented in the 2024 Universal Registration Document [4] Voting Results - A total of 245 shareholders participated in the voting, representing 90,772,892 shares, which is 65.264% of the voting rights [5][7] - The majority of ordinary resolutions were adopted with over 99% approval, while the only rejected resolution was the 33rd, which aimed to empower the Board of Directors for share capital increases [3][10] - The voting results showed a high level of shareholder engagement, with a quorum of 65.264% achieved [5][10] Company Overview - Inventiva is publicly listed on Euronext Paris and Nasdaq, focusing on unmet medical needs in liver diseases [11][12] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial for MASH [11]
Description of the Share Repurchase Program Covered by the Liquidity Agreement with Kepler Chevreux
Globenewswire· 2025-05-22 12:00
Core Viewpoint - The company Inventiva has approved a share repurchase program aimed at enhancing market liquidity, with a maximum purchase limit of 10% of its capital over the next 18 months [1][4]. Group 1: Share Repurchase Program - The share repurchase program was approved during the Ordinary General Meeting on May 22, 2025, with the primary objective of animating the market under a liquidity agreement [1][2]. - The maximum number of shares that can be acquired is 13,869,673, considering the 45,454 shares already held in treasury as of May 19, 2025 [4]. - The maximum price per share for the repurchase is set at 40 euros [4]. Group 2: Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [2]. - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the pivotal Phase 3 clinical trial for treating adult patients with MASH [2]. Group 3: Market Information - Inventiva is publicly listed on Euronext Paris (ticker: IVA) and the Nasdaq Global Market in the United States [3]. - The company has a total of 13,915,127 shares in its capital structure as of May 19, 2025 [4].
Inventiva secures the €116 million second tranche of its structured financing of up to €348 million
Globenewswire· 2025-05-05 06:30
Core Viewpoint - Inventiva has successfully completed the enrollment of the Phase 3 NATiV3 study for lanifibranor in MASH and has initiated the second tranche of its structured financing, raising €115.6 million in gross proceeds to support the drug's development [1][2][4]. Financing Details - The second tranche of structured financing amounts to €115.6 million gross (net proceeds of €108.5 million) [1][4]. - The financing was led by existing investors from the first tranche, including New Enterprise Associates, BVF Partners LP, and Samsara BioCapital [3]. Use of Proceeds - The net proceeds from the T2 Transaction will primarily be used to finance the development of lanifibranor in MASH, particularly the continuation of the NATiV3 Phase 3 clinical trial [4]. Financial Position - As of December 31, 2024, the company's cash and cash equivalents were €96.6 million, which was projected to cover operational needs until mid-Q3 2025 [5]. - Following the T2 Transaction, the company estimates sufficient net working capital to meet obligations for the next 12 months, extending financing capabilities until the end of Q3 2026 [6]. Future Funding Needs - The company will require additional funding to achieve long-term objectives for lanifibranor's development and potential commercialization through public offerings, private placements, or strategic partnerships [7]. Transaction Characteristics - The T2 Transaction involves the issuance of 42,488,883 new shares at a subscription price of €1.35 per share, with attached warrants [9][12]. - The Board confirmed that all conditions for the issuance of the second tranche have been satisfied, including the completion of enrollment in the NATiV3 study [10][11]. Shareholder Impact - The issuance of new shares and warrants will dilute existing shareholders, with significant changes in ownership percentages expected post-transaction [23][25][29].