Inventiva S.A. (NASDAQ:IVA) Q4 2022 Earnings Call Transcript

Ed Arce: Okay. Great. And as a follow-up, I just wanted to ask for the, I think you mentioned at the beginning of your remarks some work that’s been done more recently on speeding up biopsies. I wondered if you could expand upon those activities and what you’ve done and how that’s helped the study. And then lastly, I just wanted to ask about the financials. I think you said cash right now is runway to the end of the year. If you could confirm that and also what’s the remaining amount on the ATM? Thanks so much.

Frédéric Cren: Okay. So on the biopsy process so has been many activities going on and improving that process that helped in the €“ in improving the screening process. So by spinning up, I meant that the process between making a biopsy in a site and the time it takes for the reviewer to give their appraisal, it’s a long process. So I think we have now speed up and optimize that process. And then secondly, the big change we made is that, you know that we follow say the FDA guidelines to have a biopsy reviewed by three pathologists with a tiebreaker. We starting the trial with two pathologists involved, and if one of these two pathologists is agreed or did not evaluate in the same way as the other one, the biopsy, the patient would be excluded.

And now we have introduced a tiebreaker also for the baseline. And so now when there is a disagreement between the two biologists, there is a tiebreaker that the pathologist that have the tiebreaker. So that that also has been introduced, and all along the way, also we have introduced training, alignment training between these three pathologies so that they really work as a team. That’s also something that has taken us some time and we see now good alignment between these three pathologists. Then on cash, on all of that I led to Jean answer about the ATM and the cash.

Jean Volatier: Sure. So ATM, as we seen in the end of 2023, and very important without considering the second tranche of the EIB which present the €“ they say cartridge of €25 million. And we have still US$58-plus million on the shelf for the other market program.

Ed Arce: Great. Thanks so much.

Operator: We are now going to proceed with our next question. And the question come from line of Frédéric Gomez from Pharmium Securities. Please ask your question.

Frédéric Gomez: Thanks for taking my questions.

Operator: Frédéric Gomez your line is open.

Frédéric Gomez: Thanks for taking the question. One of the NATiV3, yes, can you hear me?

Frédéric Cren: Yes.

Jean Volatier: Yes.

Frédéric Gomez: Yes. Can you hear me?

Frédéric Cren: Hello. We hear you very well.

Frédéric Gomez: Can you hear me?

Frédéric Cren: Yes. Yes.

Frédéric Gomez: Okay, perfect. Yes, perfect. So the first question is on the LEGEND study, the primary will be the HbA1c. Can you maybe clarify a little bit the statistical analysis plan or you will perform the analysis between the combo arm and the lani arm? Just yes, I’m just wondering how you will say that the study is positive because we should expect an effect on the primary if there are any around versus the placebo? And just to follow-up a little bit on this analysis of biopsies and the change in the number of pathologists that will have a look at the biopsies you started at two, now it’s says three pathologist. Does it €“ I’m curious to hear you about the potential impact on the outcome and also the baseline data because this shift may have an impact of the role on the trial itself, if more patients have been looked by three pathologists versus two. Can you maybe elaborate a little bit more on the potential impact of this change?

Frédéric Cren: Sure. So for the LEGEND we can start with that, and maybe even for the tiebreaker, maybe Michael you can address that.