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GENFIT : Corporate presentation: Petit résumé généré par l IA

15 nov. 2024 09:59

GENFIT, a late-stage biopharmaceutical company focused on rare and life-threatening liver diseases, provided a corporate update on November 13, 2024, ahead of The Liver Meeting 2024®. Here are the key points from their presentation:
Primary Biliary Cholangitis (PBC) Program

Ipsen, GENFIT's partner, is making progress with elafibranor (Iqirvo®) on both commercial and regulatory fronts in the U.S. and Europe1
2
.
This progress is expected to enhance GENFIT's financial outlook for the rest of 2024 and beyond1
2
.

Acute on-Chronic Liver Failure (ACLF) Program

GENFIT plans to initiate multiple clinical studies in 20251
2
.
The company updated the Phase 2 UNVEIL-IT® study protocol to improve trial enrollment and address logistical challenges2
.
Four clinical trial data readouts are anticipated by the end of 2025, including:
Data from three new clinical trials to be launched in the first half of 2025
Phase 2 UNVEIL-IT® data from the VS-01 program1
2

Upcoming Events
GENFIT will lead three key events on ACLF:

ACLF KOL Advisory Board (November 14, 2024)
ACLF Satellite Symposium (November 15, 2024)
ACLF Booth Talks (November 15-17, 2024)1
2

R&D Portfolio
GENFIT's ACLF franchise includes five assets under development:

VS-01
NTZ
SRT-015
CLM-022
VS-02-HE

These assets are based on complementary mechanisms of action using different routes of administration1
. The company also has other assets targeting serious diseases such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA)1
. GENFIT's update demonstrates its continued focus on advancing its ACLF program and leveraging its partnership with Ipsen for the PBC program, positioning the company for potential growth in the coming years.

6 réponses

  • 15 novembre 2024 10:00

    Based on the corporate update provided by GENFIT, here are the key points regarding the expected data for GNS561:
    GNS561 in KRAS-mutated cholangiocarcinoma

    A phase 1b/2a clinical trial for GNS561 is currently ongoing1
    .
    Preliminary data from the Phase 1b portion of this trial is targeted to be available by the end of 20241
    2
    .
    Final data from the full phase 1b/2a study is expected by the end of 20251
    2
    .

    This timeline indicates that GENFIT is making progress with the clinical development of GNS561 for cholangiocarcinoma (bile duct cancer) with KRAS mutations. The company plans to have initial results from the early phase study within about a year, with more comprehensive data following approximately a year later. These upcoming readouts will provide important insights into the safety and potential efficacy of GNS561 in this specific type of cancer.


  • 15 novembre 2024 10:02

    Based on the information provided in the search results, we can estimate the cost of studies led by GENFIT as follows:
    Research and Development Expenses
    GENFIT is currently conducting several research and development programs, which include:

    UNVEIL-IT™, a Phase 2 clinical trial evaluating VS-01 in Acute-on-Chronic Liver Failure (ACLF)
    The cholangiocarcinoma program evaluating GNS561
    The ACLF program evaluating NTZ
    Non-clinical trial of SRT-015 in ACLF
    ELATIVE®, specifically the portion of the Phase 3 clinical trial evaluating elafibranor in PBC not yet transferred to Ipsen

    Financial Outlook
    GENFIT expects that their existing cash and cash equivalents will enable them to fund their operating expenses and capital expenditure requirements until approximately the fourth quarter of 20251
    2
    . As of December 31, 2023, the company's cash and cash equivalents amounted to €77.8 million1
    .
    Upcoming Clinical Trials
    GENFIT plans to initiate multiple clinical studies in 2025, including:

    Two new proof-of-concept studies evaluating VS-01 and NTZ
    A First-in-Human study for SRT-015 with GENFIT's formulation
    Continuation of the Phase 2 UNVEIL-IT trial

    These trials are expected to launch in the first half of 2025, with data readouts expected by year-end4
    .
    Estimated Costs
    While specific costs for each study are not provided, we can infer that the total cost for all studies is significant, given that it accounts for a substantial portion of the company's cash burn rate. The fact that GENFIT expects their current cash position to fund operations until Q4 2025, including these new and ongoing studies, suggests that the total cost for all studies is likely in the tens of millions of euros. It's important to note that this is an estimation based on the available information. The actual costs may vary depending on factors such as the duration and complexity of each study, the number of patients enrolled, and any unforeseen challenges that may arise during the clinical trial process.


  • 15 novembre 2024 10:07

    Attention!


  • 15 novembre 2024 10:49

    ah oui on a tout compris !!


  • 15 novembre 2024 12:01

    Quelqu'un sait nous faire un résumé avec transcription ? 😂


  • 15 novembre 2024 12:23

    GENFIT montre une stratégie claire : partenariat solide avec Ipsen pour la PBC, pipeline diversifié en ACLF et CCA, et trésorerie maîtrisée jusqu'à 2025. Les prochains readouts seront décisifs pour confirmer cette dynamique


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