Invivyd, Inc. (NASDAQ:IVVD) Q2 2023 Earnings Call Transcript

Dave Hering: Yes. The only thing I would add, Evan is, as it relates to the commercial opportunity, I mean we are focused on the vulnerable population, which could be argued to be just about all of us given the current state of protection and where we are with variants. With that said, our initial focus has always been on this immunocompromised group, folks who have been contraindicated against vaccines, etcetera, those who are at highest risk for severe outcomes from COVID-19.

Pete Schmidt: And in terms of activities necessary to initiate CANOPY, it’s largely just the box checking stuff that you have to do before you start a trial. I think we have passed all the major hurdles. We haven’t provided specific guidance on when we are going to start, but you can see that we did say we will release some preliminary primary efficacy endpoints data by the end of – by around the end of 2023.

Operator: Thank you. One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

Unidentified Analyst: Hi. Good evening. Thanks for taking our questions. This is Jenna on for Mike. We have two questions, if we may. First question is at this upcoming year-end readout of initial pivotal data, what are you looking to show? And what is the bar? Are you looking to replicate the Phase 1 results, which was already great, or are you looking to show even higher titer levels? And then second question is, from that point forward, what are the key milestones afterwards? And how soon could you expect to be on the market? Thank you.

Dave Hering: Yes. So, yes, so from the preliminary data that we are talking about around year-end, it would be similar to what we saw in the Phase 1, the titer values. That said, it will be based on an analysis for day 28. So, it’s slightly different than the day seven Phase 1 data that we provided there, but similar in terms of we are looking for high titer values. They don’t have to be equivalent to the Phase 1, but based on everything we saw from Phase 1, it’s repeating that in this Cohort A and getting some of that preliminary data. And so that would confirm what we have seen in Phase 1 and what we are expecting to see in CANOPY. Key milestones after, right, for an EUA submission, you need the clinical data. You need a preclinical set of activity, CMC, etcetera.

We believe we can assemble all of that quite rapidly. And certainly, we will provide more information and guidance as we get closer to this clinical information, etcetera. But certainly, it’s something that we are looking to do as quickly as possible especially as we are starting to see an uptick in COVID cases, an increase in hospitalizations, etcetera, even prior to the fall and winter season. And so certainly, it’s not lost on us that time is of the essence and in a situation where there are no mAbs on the market, one that we are looking to rectify as quickly as we can.

Unidentified Analyst: Great. Thank you so much.

Operator: One moment for our next question. The next question comes from Patrick Trucchio with H.C. Wainwright. Your line is open.

Patrick Trucchio: Thanks and good afternoon, and congrats on the progress. I have a couple of follow-up questions. The first is just I am wondering if you can talk about the new COVID variant, EG.5. What have we seen so far with these cases of COVID-19? How different or similar is this variant to XBB.1.5? And would you expect VYD222 to retain activity against this variant?