Inventiva S.A. (NASDAQ:IVA) Q4 2023 Earnings Call Transcript

Frederic Cren : The second question is easy. We have met all the requirement of EIB and that allowed us to draw the second tranche of €25 million. And then if we want to put in place a new loan with EIB, we need to, you know, to discuss that with them. I think they’re not close to it, but they’re open to do such a thing, but we have not started discussing on that. And then to when we plan to open ex-U.S., site, so Canada, there are site and the central IRD, so those we plan to open those soon. And then the other countries will start opening then starting from April with a focus for us on Europe. What I mentioned in my introductory that most of our patients come from the U.S. or North America close to 70% and an additional 21% come from EU. They are really a focus from our team to focus our effort in these two geographic areas.

Rami Katkhuda: I know it’s a bit early, but would you look to partner lani in Europe as well? Would that partnership come before or after the NATiV3 readout?

Frederic Cren : Our strategy concerning lani is that we see that there are two strategic regions for NASH that are Europe and the U.S. We want to keep those, right, I would say bundled together as one. And so, we would more looking at partnering Europe and the U.S. together rather than splitting those. We think that an appropriate moment will be post Phase 3, because we’re confident in the data we will generate post Phase 3 and the ability to get approval on based on the NATiV3 data.

Rami Katkhuda: Got it. Thanks so much.

Operator: We will now take the next question from the line of Lucy Codrington from Jefferies. Please go ahead.

Lucy Codrington : I didn’t quite catch in the prepared remarks. Could you just repeat the state of random, the kind of randomization post the screening resuming and also just whether you had a set amount already in screening when the recruitment was halted, has that number changed within that screening pool? Given the kind of safety concerns is probably overstating it, but since that incident and then the required additional monitoring that the trial will entail, has that meant you have lost any patients within screening? And then just on the partnership kind of commentary, I guess I was going to ask if you are in any active discussions with potential partners and whether interest had increased since your recent data and the approval.

I guess your comment just then suggesting you’d prefer to wait till after Phase 3 might suggest that no, but I guess can you afford to wait till after Phase 3 given the cash constraints that you have? And could you explore other kind of routes in terms of a potential option agreement? Are this type of things being considered in order to get you to that data which seems to be the most important thing. And then I guess related to that, you mentioned about potentially another AIB loan. How long do those loans take to negotiate? Just cognizant, we have only got a limited amount of time before the cash runway expires. Thank you.

Frederic Cren : Yes. So, I’ll take the first two question about the state of the trial and the partnering and let Jean answer the question about the European Investment Bank and how long does that takes on screening? What I said is that we have more than 75% of the patient needed in the, for the main cohort that are randomized, and that we have more than 350 patients in screening. The pool of patients in screening is diminishing, but it’s not due to pushback or a change of attitude of the sites towards Lanifibranor to the contrary, as I said, we have had the meetings call, webinars a face-to-face meeting with the site. And the excitement remains, especially after the legend data, the patient in screening are diminishing. It’s just because at a certain moment there is a date of, let’s call it a date of validity for the lab test and for the biopsy, and for at a certain moment, we lose those patients.

And then also I mentioned, give some data about where this current and what is important is that the countries? Which we will reopen first as really those countries that matter, which is North America and in Europe. And when I say that matters is that they’re providing, they are the most the country providing more patients in the trial. Now, concerning our cash runway, yes, we have a contrast runway until early Q3. Luckily for us, we are in a, I would say in a good moment with positive data in the NASH field due to the medical approval, which has lifted the regulatory hurdle, the need that patient do not need to go under biopsy. [technical difficulty] all options are on the table. It could be as you mentioned, working with a big pharma, or it could be to go back to the capital market.

We have, I think a strong share debate that has been supportive for the past 12 years. And so, we think we are in a positive in a positive trend. So maybe I’ll let Jean ask, answer your question about the timing of the EIB.

Jean Volatier : We have continuous discussion with the EIB. By the way, they have asked to come visit us on the site in a couple of weeks. There are two ways, one way the short circuit would be below 10 million. This could be managed within the existing loans. And generally, it could be within two or three months. And the second option is a greater tranche, which would be managed through a new finance agreement. Obviously, both would go with cash injections — was talking about potential capital increase. So, this would be managed together with this operation, and for the second options, I guess, that within six months to one year, this could be possible to discuss a sub tranche. But again, everything is depending on future cache injection on which we are working actively.