Genfit (AO) | Buy | GNS561: another positive step for Genfits upside story

Research evidence excerpt

Genfit (AO) | Buy | GNS561: another positive step for Genfits upside story

with potential

relevance beyond the initial CCA setting, and could make the asset more visible to potential partners.

GNS561 is not included in our valuation and therefore represents pure upside to our investment case. This comes on top of recent

positive progress in MASH diagnostics, also outside our valuation framework for the moment, with a potential Medicare/Medicaid

reimbursement decision expected soon and, in our view, the ability to generate several tens of millions of euros of annual

royalties for Genfit over time if adoption materialises.

Early, but clearly supportive

The data should be interpreted in the right context: this is not yet a pivotal efficacy readout, but it is exactly the type of signal

needed at this stage to justify moving forward. In a small Phase Ib trial, favourable safety, no DLTs and early disease control in a

heavily pretreated population are enough to support continued development.

Genfit will now expand the Phase Ib study with additional higher-dose cohorts, while keeping the planned transition to Phase II

on track for H2 2026. The recommended Phase II dose and study design are expected to be finalised over the summer, and

investors will likely look for more granular efficacy and dose-level data as the programme advances, making this asset a near-

term pipeline newsflow item rather than a distant optionality.

The consistency of the signal as additional patients were treated is also worth highlighting. While the dataset remains limited,

stable disease in around half of patients at Week 6, including one durable case up to Week 30, suggests that the combination may

be biologically active in a difficult-to-treat population.

Another upside layer outside valuation