Valneva SE (NASDAQ:VALN) Q3 2023 Earnings Call Transcript

With regards to other regulatory bodies, other recommendation bodies, I mean, first of all, you know that every single regulatory authority is taking a slightly different stance when it comes to interpretation of data. So therefore, I think the basis for potential recommendations may be different in different geographies. On top of that, we have learned and I personally have learned this through my more than 30 years in the vaccine industry that also different recommendation bodies take very different approaches. So it’s very difficult to predict at this point in time how other regulatory bodies, be it in Canada or be it in Europe or even be it in other territories will position chikungunya. We continue to believe that chikungunya is representing a major unmet medical need.

And therefore, we see a benefit to provide a vaccine solution.

Boran Wang: Great. And as a follow-up in terms of the hMPV asset. I know you guys are seeking a partner there. We’re seeing a pretty robust initial launch in RSV. So it seems like hMPV could be a very interesting program. Can you help us think about how you’re thinking about partnering discussions and what’s the scope and type of agreements you’re looking at?

Thomas Lingelbach: Yes. This is also, of course, a very good question. I think — as you have rightly pointed out, I think the RSV market is expected to transition towards an RSV, hMPV combination market when it comes to vaccination strategies and vaccination solutions, vaccine solutions. And therefore, we decided not to develop hMPV as a stand-alone clinical asset. Right now, we are looking at different partnership opportunities. And this spans across a pure straight out-licensing all the way into potential other sets of joint development structures and the like. But it is too early at this point in time to guide really what it’s going to be. What we can say is, we have multiple parties under CDA and we have — and we are exploring opportunities here.

Operator: Our next question comes from the line of Simon Scholes of First Berlin.

Simon Scholes: Congratulations on the strong numbers. I was just wondering if you could let me know which of your planned future chikungunya trials will generate 15-day onset of immunity data for inclusion on the label subject to approval and how soon you might be able to get that data onto the label?

Thomas Lingelbach: So right now, I mean, as you know, the — when we started the development of chikungunya we had agreed a standard endpoint, meaning 1 month after vaccination. Of course, we had and we have already published data that show an early onset. However, this data was generated from earlier studies. And therefore, as soon as we’re going to start the next study and the next study is probably going to be a study in immunocompromised. And we will include earlier immunological end point, in order to verify what we have seen already in prior studies, namely, that we got to have an immunogenicity level above the anticipated protective threshold, somewhere in between day 8 and day 14. And we will, of course, include that so that we can use this data from a well-controlled Phase III study in order to amend the label as soon as possible.

Operator: Our next question comes from the line of Samir Devani from Rx Securities.

Samir Devani: Congrats on a good quarter. And congrats on the ACIP draft recommendation. I’ve got a few questions. I’ll probably kick off on that first. One of the bullet highlights is that it’s recommended for somebody traveling to a territory where there is a chikungunya outbreak. And I’m just wondering, as we see today, which territory would you say is the most important that’s currently exhibiting a chikungunya outbreak. So I guess that’s the first question.