Invivyd, Inc. (NASDAQ:IVVD) Q3 2023 Earnings Call Transcript

Dave Hering: Yes. So the first part of the question is in terms of the gating items. So we’re very excited to have fully enrolled the study. We’re collecting that data to move forward. And as we stated, what we’re looking for is that preliminary primary endpoint data by the end of this year or early Q1 next year. And so for us, the gating components are collecting that information and assuming it’s positive, combining that with the rest of the data package that I’ve mentioned, including CMC, nonclinical, et cetera. And given the continued unmet need and the lack of products available, our goal continues to be to put that submission together as soon as practicable and we feel that the agency would be quite interested in receiving that submission given the current state of where we are. As it relates to your question about — what was the second?

Jeremy Gowler: Titers.

Dave Hering: Titers. Yes, and whether the FDA — so we had talked to the FDA previously about using titer values. That’s what led to this immunobridging and as we have stated earlier in our press release. We have reached general alignment with the FDA on that as a surrogate endpoint being able to use that titer value as calculated from PK concentration and bridging it back to the original EVADE trial from adintrevimab. And so we are very confident that using that as an endpoint with something that the FDA was aligned on for an EUA submission, again, assuming that the data supports the outcome.

Operator: Our next question will come from the line of Maxwell Skor from Morgan Stanley.

Maxwell Skor: Congrats on the progress. So with regards to your EUA data package, how often are you required to update your in vitro neutralization assay to include currently circulating variance? And also given the design of your CANOPY trial, would you expect to be authorized in both the pre and post exposure setting? Thank you.

Dave Hering: Yes, I’ll let Pete answer. You can take both those questions, if you like.

Peter Schmidt: Yes. So in terms of how frequently we update neutralization against circulating variance, it’s as quickly as possible in real time. There is no set schedule that we’ve received that demands on a certain schedule. As you know, this is a kind of a collaborative approach with the FDA and the CDC and all the other monitoring authorities. So we updated in real-time as soon as we get the data. And in terms of PrEP versus PEP, we are pursuing the PrEP indication only. So we won’t be generating any PEP data or post-exposure prophylaxis data.

Operator: And our last question for today will come from the line of Evan Wang from Guggenheim Securities.

Evan Wang: I had a follow-up in terms of some of the pre-commercial planning ongoing. Can you provide a sense of at least initial thoughts on the size of the sales force needed for that targeted population approach?

Dave Hering: Sure, Jeremy, I’ll let you take that one.

Jeremy Gowler: Sure. Thanks, Evan. So we’re still in that size and exercise. But as we said, it’s a very relatively concentrated market, so we believe it will be a relatively small commercial footprint that we would need to ultimately capitalize on the market that we would enter into with this immunocompromised in most at-risk group. But we will give a little more detail as we get closer to launch.

Dave Hering: Yes. And the only thing I’d add there, Evan, is we’ve talked about this being able to utilize more of a sort of key account type model to go and call on these various systems and accounts. And as Jeremy said, focusing in that upper right quadrant, you can really go after a lot of these different individuals in a targeted way given the sort of concentrated nature of where they are and where they receive care from their various HCPs.