Genfit FR0004163111

Genfit - 2023

1. DeZwarteRidder 3 februari 2023 13:16

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   ABOUT GENFIT
   
   GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.
   
   Its R&D pipeline covers five therapeutic areas via six independent programs which explore the potential of differentiated mechanisms of action, across a variety of development stages (Phase 1, Phase 2, Phase 3). These diseases are acute on-chronic liver failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorder (UCD)/organic acidemia disorder (OAD) and primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic franchise focused on NASH and ACLF.
   
   GENFIT has facilities in Lille and Paris, France, Zurich, Switzerland, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. www.genfit.com
2. DeZwarteRidder 3 april 2023 12:31

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   GENFIT Announces Revenues and Cash Position as of December 31, 2022
   February 28, 2023
   PDF Version
   
   Cash, cash equivalents and current financial instruments totaled €140.2 million as of December 31, 2022.
   
   Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); February 28, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced its cash position as of December 31, 2022 and revenues for 2022. 12
   
   Financials
   
   As of December 31, 2022, the Company’s cash, cash equivalents and current financial instruments amounted to €140.2 million compared with €258.8 million as of December 31, 2021. As of September 30, 2022, cash, cash equivalents and current financial instruments totaled €163.6 million.
   
   The decrease in cash, cash equivalents and current financial instruments between September 30, 2022 and December 31, 2022 notably includes the payment of CHF2.4 million (€2.4 million) representing a net cash adjustment made at year end in accordance with the Versantis AG share purchase agreement, and related acquisition costs totaling €1.7 million.
   
   The decrease in cash, cash equivalents and current financial instruments between December 31, 2021 and September 30, 2022 includes the payment of €24.0 million in January 2022 representing the VAT collected on the initial upfront payment received from Ipsen in December 2021, the disbursement of employee participation in the profits of GENFIT SA in May 2022 for a total of €0.6 million for the financial year 2021, and the initial consideration of CHF40.0 million (€41.9 million) for the acquisition of Versantis AG on September 29, 2022.
   
   Revenues
   
   Revenues for 2022 amounted to €20.2 million compared to €80.1 million for the same period in 2021.3
   
   Of the €20.2 million in revenues for 2022, €15.9 million is attributable to the partial recognition of the €40.0 million deferred income described below. €1.0 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022, which essentially outlines the scope of services to facilitate the transition of some activities related to the Phase 3 clinical trial evaluating elafibranor in Primary Biliary Cholangitis. €3.3 million was recognized as revenue in 2022 in accordance with the Inventory Purchase Agreement signed with Ipsen, pursuant to which Ipsen purchased inventory of elafibranor active pharmaceutical ingredient and drug product during the second half of 2022 with the prospect of transferring the conduct of the ELATIVETM study to Ipsen .
   
   Revenues for 2021 mainly resulted from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million was recognized as 2021 revenue, and €40 million deducted as deferred revenue. The remainder will be gradually recognized as revenue following the completion of the ELATIVE™ double-blind study, in accordance with IFRS 15 and the terms of the strategic licensing and collaboration agreement with Ipsen on December 17, 2021.
   
   Upcoming topline data readout for the Phase 3 ELATIVETM study
   
   Topline data for our Phase 3 global trial ELATIVETM evaluating elafibranor in patients with Primary Biliary Cholangitis is expected to be announced in the second quarter 2023.
   
   Upcoming financial communications
   
   The Company will release its full-year 2022 financial results on April 13, 2023. The 2022 Universal Registration Document, the 2022 Annual Financial Report (included in the 2022 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2023.
3. DeZwarteRidder 2 mei 2023 14:14

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   GENFIT Reports Full-Year 2022 Financial Results and Provides Corporate Update
   April 13, 2023
   
   Cash, cash equivalents and current financial assets totaled €140.2 million1 as of December 31, 2022, expected to fund operations through third quarter 2024
   Transformative milestone expected towards end of second quarter 2023, with topline data readout for Phase 3 ELATIVE® evaluating elafibranor in primary biliary cholangitis (PBC)
   Multiple events in second quarter 2023:
   1st patient screening in a Phase 2 study evaluating VS-01 in acute on-chronic liver failure (ACLF)
   1st patient screening in a Phase 1b/2 evaluating GNS561 in cholangiocarcinoma (CCA)
   Phase 1 data for NTZ in ACLF, for 2 studies in hepatic impaired and renal impaired patients (Phase 2 study initiation targeted for the second half of 2023)
   Successful acquisition of Versantis AG at end of 2022 strengthens GENFIT’s pipeline that now includes 4 clinical-stage programs and 2 preclinical-stage programs
   Conference call (English and French) on April 14, 2023 at 8am ET / 1pm GMT / 2pm CET
   
   Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); April 13, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases characterized by high unmet medical needs, today announced annual financial results for the year ended December 31, 2022. A summary of the consolidated financial statements is included further below.
   
   Pascal Prigent, CEO of GENFIT, commented:
   
   “2022 was a transformative year for GENFIT. It was marked by both the fast progression of our lead program and the expansion of our pipeline in rare and severe liver diseases, notably with the acquisition of Versantis AG. We are now approaching an inflection point: this quarter we expect to report data from our pivotal Phase 3 study in PBC. There is still an important unmet medical need in this market, and we are very encouraged by the previous Phase 2 data reported as part of this program. We believe elafibranor has significant potential, and we hope it will be demonstrated soon. Beyond this exciting milestone, we have built a rich pipeline, that now includes 3 additional phase 2-stage programs and 2 preclinical-stage programs. This pipeline, combined with a robust cash position and the near-term commercial perspectives for elafibranor, provide us with a unique opportunity to drive transformative value in 2023.”
   
   2022 Key Highlights
   
   PBC program executed according to plan
   
   Patient enrollment for the ELATIVE® Phase 3 trial evaluating elafibranor in PBC was completed mid-2022. Throughout 2022 GENFIT and Ipsen stepped up their collaboration in order to minimize the time to filing as well as prepare for the commercial launch next year, if approved.
   
   Pipeline progress
   
   Acquisition of the clinical-stage biopharmaceutical company Versantis
   
   In September 2022, GENFIT acquired clinical-stage biopharmaceutical company Versantis based in Zurich (Switzerland), significantly expanding its pipeline. This acquisition has reinforced GENFIT’s position as a leader in ACLF and other severe liver diseases. Given the unmet need related to target diseases, it is expected that the programs qualify for some of the expedited regulatory pathways provided by health authorities.
   
   Two Pipeline Days were organized in October 2022 in Paris and New York, to present these programs in detail. A replay of these events is available here: ir.genfit.com/events/event-details/ge...
   
   Assessment of Nitazoxanide (NTZ) in hepatic and renal impaired patients
   
   Two Phase 1 studies were conducted, aimed at providing insight into NTZ pharmacokinetics and safety in the setting of hepatic impairment or renal impairment, in order to prepare for the launch of a Phase 2 study in ACLF in the second half of 2023.
   
   Orphan Drug Designation granted to GNS561 for the treatment of cholangiocarcinoma
   
   In September 2022 the US Food and Drug Administration (FDA) granted Orphan Drug Designation to GNS561 (ezurpimtrostat), a novel clinical-stage autophagy/PPT1 inhibitor, for the treatment of cholangiocarcinoma (CCA).
   
   Compelling results for NIS2+TM in NASH
   
   In October 2022, GENFIT announced the development of NIS2+TM, a next-generation technology for the diagnosis of at-risk NASH, and the presentation of results on NIS2TM+’s clinical performance in three poster presentations at The Liver Meeting® 2022 organized by the AASLD2. The NIMBLE initiative of the FNIH3 highlighted in 2021 the strong and unique performance of NIS4® technology in identifying patients with at-risk NASH.
   
   II. 2023 Anticipated Milestones
   
   Topline Phase 3 data for elafibranor in PBC: towards the end of 2Q23
   
   Topline results for the ELATIVE® study are now imminent and expected to be announced towards the end of the second quarter of 2023.
   
   Phase 2 results showed a statistically significant improvement on both the primary and composite biochemical evaluation criteria, the latter now being the primary endpoint of the pivotal Phase 3 trial to support accelerated approval. In addition, the results showed a positive trend on the improvement of pruritus, while preserving a favorable safety and tolerability profile. These positive conclusions were published in the Journal of Hepatology in 2021.4 Safety data derived from more than 1,000 patients in the biopsy-based Phase 3 RESOLVE-IT® trial of elafibranor in NASH also supported further development in PBC.
   
   Under the agreement with Ipsen, GENFIT is eligible to receive regulatory, commercial, and sales-based milestone payments up to €360 million, with a potential first significant milestone payment as early as 2023 and an additional potential milestone payment in 2024, if ELATIVE® is successful. In addition, GENFIT is eligible for double-digit royalties of up to 20%. In the case of a positive trial outcome, the well-established global commercial footprint of Ipsen will be an important driver of commercial success. By 2024, if approved, elafibranor could potentially become a new therapeutic option for PBC patients not responding to UDCA5, and become the first alternative to currently approved second line treatment in a market estimated at $1.5bn in the coming years, and $3.1 billion in the US and in the five main European countries by 2030.6
4. Pjotr 30 juni 2023 07:19

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   twitter.com/genfit_pharma/status/1674...
5. DeZwarteRidder 30 juni 2023 07:29

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   Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE® trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease
   June 30, 2023
   PDF Version
   Trial met primary endpoint with a statistically significant higher percentage of patients achieving a clinically meaningful cholestasis response compared to placebo
   Elafibranor was well tolerated with a safety profile consistent with previous studies
   Results position elafibranor as a potentially important new treatment option, where there is still high unmet need
   Ipsen intends to submit regulatory applications for elafibranor following discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
   GENFIT conference call (English and French) on June 30 at 8am ET / 1pm GMT / 2pm CET
   
   Paris (France); June 30, 2023 - Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE® Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual a,d PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).
   
   The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving a cholestasis response compared with 4% on placebo (p<0.0001). Cholestasis response is defined in the trial as alkaline phosphatase (ALP) <1.67 x upper limit of normal (ULN), an ALP decrease = 15 percent and total bilirubin (TB) = ULN at 52 weeks. ALP and bilirubin are important predictors of disease progression. Reductions in levels of both can indicate reduced cholestatic injury and improved liver function.
   
   The first secondary endpoint, normalization of ALP at Week 52, was also met with statistically significant improvements for investigational elafibranor compared with placebo. For the other secondary endpoint, a trend for pruritus improvement was observed with a greater decrease from baseline in the PBC Worst Itch NRS score for patients on elafibranor compared to placebo, which did not reach statistical significance. In the study, elafibranor was generally well tolerated with a safety profile consistent with that observed in previously reported studies.
   
   “These are encouraging results that suggest elafibranor could be an effective treatment to prevent progression of PBC in patients who have received UDCA. It has a good safety profile and was well- tolerated, and could provide an important new therapeutic option for long-term treatment of patients with this debilitating condition,” said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. “PBC is a serious condition which, if not treated properly, can lead to progression of liver disease and ultimately liver failure. We are excited about the potential of this investigational treatment and Ipsen now intends to discuss these results with regulatory agencies and plans to move forward with regulatory submissions to the U.S. Food and Drug Administration and the European Medicines Agency.”
   
   “We are pleased by these results because PBC remains a disease where significant unmet medical needs exist”, added Pascal Prigent, Chief Executive Officer of GENFIT. “This long-awaited trial outcome is therefore good news for patients and for healthcare professionals who need more options to improve the clinical management of patients with PBC. It is also a gratifying recognition of the quality of our team’s work and of GENFIT’s ability to innovate and deliver tangible results.”
6. DeZwarteRidder 30 juni 2023 19:52

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   Cymabay soars as Genfit hits an itch hitch
   
   Elizabeth Cairns
   
   The topline hit in the pivotal Elative study of Genfit’s elafibranor in primary biliary cholangitis means the company has salvaged something from the agent, which failed disastrously in Nash three years ago. It also validates Ipsen’s move to license the PPARa/d agonist 18 months later. But the real winner might in fact be neither of these companies but Cymabay, developer of a similarly-acting agent. Cymabay’s stock opened up 40% today whereas Genfit’s shares sank 5% and Ipsen’s barely shifted, since the Elative data provide an opening for Cymabay’s seladelpar. Elative met its primary endpoint with a statistically significant difference in composite responders at one year – 51% versus 4% with placebo – but missed on the vital secondary of pruritus improvement, only mustering a favourable trend. It appears investors believe seladelpar can do better on the itch measure when its pivotal trial, Response, reports data in the coming quarter. And with reason: in seladelpar’s other phase 3 in primary biliary cholangitis, Enhance, 78% of patients on the 10mg dose achieved the composite response versus 13% on placebo at three months. Enhance also hit on pruritis, showing a significant 1.59-point improvement with the 10mg dose among those with moderate to severe itch at baseline.
7. Speculatie 7 september 2023 13:38

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   • Speculatie

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   Nou DZR, verwacht jij ook wat ik verwacht binnenkort?
8. DeZwarteRidder 7 september 2023 13:40

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   • DeZwarteRidder

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   quote:

   Speculatie schreef op 7 september 2023 13:38:

   Nou DZR, verwacht jij ook wat ik verwacht binnenkort?
   

   Misschien.
9. Speculatie 7 september 2023 14:06

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   als dat zo zou zijn
10. DeZwarteRidder 8 september 2023 17:26

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    Er lijkt een grote koper bezig te zijn.
    
    Op 20 september komt er nieuws.
11. Pjotr 13 november 2023 22:35

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    www.nejm.org/doi/full/10.1056/NEJMoa2...
12. DeZwarteRidder 12 december 2023 10:09

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    GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings in Primary Biliary Cholangitis (PBC)
    
    GENFIT S.A.
    Fri, December 8, 2023 at 1:55 AM EST·10 min read
    In this article:
    
    US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor.
    
    Acceptance triggers a first milestone payment. Further milestones are expected upon US and European launches which could now happen in 2Q24 in the US (FDA PDUFA1 action date: June 10, 2024) and 2H24 in Europe. These milestones total approximately 89M€.
    
    Launches in the US and Europe will also make GENFIT eligible for royalty payments.
    
    Revenues will fund the development of GENFIT’s pipeline, now mainly focused on Acute On-Chronic Liver Failure (ACLF) with 5 differentiated assets.
    
    Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 8, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces its revised outlook for 2024 and reflects on recent progress.
    
    Elafibranor in PBC
    
    Ipsen has made significant progress since the announcement of positive interim data of ELATIVE® pivotal Phase 3 trial in June 2023:
    
    Strong leadership presence at AASLD The Liver Meeting® and additional results from ELATIVE® presented as late breaker, including data showing statistically significant improvement (nominal p-value < 0.05) on multidimensional measures of pruritus (PBC-40 and 5D-itch scores)
    
    Publication of ELATIVE® Phase 3 data in the New England Journal of Medicine
    
    Regulatory filing acceptance obtained in the US, Europe and United Kingdom2 in less than 6 months after topline Phase 3 data, and Priority Review granted for NDA by the US FDA with PDUFA target action date on June 10, 2024
    
    During its Capital Market Day on December 7, Ipsen reiterated its confidence in elafibranor as its profile could be very beneficial for patients suffering from PBC. In the ELATIVE® Phase 3 trial, significant treatment benefit in the primary composite endpoint was achieved with elafibranor, with a high responder rate, and a low placebo effect3. The key secondary endpoint on ALP normalization was achieved – despite a high baseline ALP level – with high statistical significance, the pruritus improvements on PBC-40 and 5D-itch scores were also statistically significant4 and elafibranor was generally well-tolerated with a well-documented safety profile consistent with previous trials.