Genfit SA (NASDAQ:GNFT) Q2 2020 Earnings Conference Call - Final Transcript

Sep 30, 2020 • 04:30 pm ET

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Genfit SA (NASDAQ:GNFT) Q2 2020 Earnings Conference Call - Final Transcript

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Executive
Pascal Prigent

in the NASH space are large long and very expensive. Considering the evolving NASH landscape and the results of the analysis from more complete data set. We did some means at the cost to probability of success ratio was not acceptable to continue development of Elafibranor in NASH and officially terminated resolve it in line with earlier guidance in July.

Therefore, we are also studying all clinical investigations related to the development and lifecycle of Elafibranor in NASH this includes combination studies pediatric studies and the study on lipid composition now let's talk about our new corporate strategy we are choosing to concentrate on 2 programs that both address a significant unmet medical need represents a significant business opportunity and have a favorable risk profile, the clinical development of elafibranor as a second-line treatment in PBC and the development of our diagnostic franchise let's start with PBC on September 24 a few days ago, we announced the first patient visit relative Phase III trial evaluating Elafibranor in PBC this milestone is now behind us and we are recruiting patients. We have made the necessary adjustments in collaboration with our CRO to successfully execute in this new covey dwelled PBC prevents exciting opportunities that are meaningful for patients and for corporate strategy.

Today in the PBC market, there is only one therapeutic option for second line for after uDTA and that market is nearly $300 million every year with double-digit growth. The reason we're so excited by this opportunity in PBC is that according to our market research. The second line PBC market could be over $1 billion in a few years, there is only one approved product in second line PBC and significant unmet medical needs remain, we feel that elafibranor if approved, could be an exciting alternative for patients and if care professional have you done from a Phase II trial, give us confidence going into a reality of Phase III trial indeed a Phase II after 12 weeks he efficacy.

We've had a few on the composite endpoint was well above what has been the required to get an approval in this indication, a positive trend was also 7 providers reinforcing of potential for differentiation, if you can see, it looks really good, but what about safety, well, there are always surprises in clinical development. But we have thousands of patients with years of to add a few. By now, and it has consistently demonstrated a very clean profile. Finally, the commercial certainty is much higher for PBC but in overlever in metabolic diseases patients are easily identifiable with standard lab Seth.

It is a clear treatment regimen and the cost of the Gold these established allowing us a more streamlined pricing and commercialization strategy in summary, we see a significant business opportunity in PBC. We are confident that we can have a successful Phase III based on our Phase 2 trial evidence and we relatives first stations is it complete and factoring in the constraints of the