The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Yeah. Great to have you. Dave, just to set the stage for those unfamiliar, can you just give a brief introduction on Invivyd and help frame the unmet
need with COVID.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. To starting up the platform, you just mentioned the serial platform approach. I think we're all familiar with how the virus has evolved over
time. So how does your platform seek to address this?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. So you talked about this feedback from FDA. How are they looking at this platform or serial approach to antibodies? I guess, what's included
in that clearance?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. The VYD222, you're in Phase 3 now, but you report Phase 1 [last] year -- later this year. Can you just walk us through what we saw there? Was
that consistent with your expectations?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. I know you guys have done a lot of modeling around these titers. So based just on that high-dose Phase 1 data, do you have a good sense
of what the profile will look like?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. So CANOPY is now underway. You have two cohorts that you're looking at. Can you walk us through -- can you describe the two cohorts
you're looking at and when we could see data?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Right, and that Cohort A population is pretty similar to what you have done in the Phase 1, is that correct?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Is there any reason to see any differences?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And so data around year end or early next, how quickly can you move from data to EUA filing?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And how much can you leverage from, I guess, your prior experience with filing and roadmap?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And just given that COVID continues to change, so how has to do to against the most recent variants?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. So assuming this is positive, and you proceed EUA, I guess, longer term, what does the next trial look like? When a variant eventually does
appear, how do you guys thinking about ways to get that new antibody to people faster?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: And it has been once a year.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Now turning to commercial. Lots of news over the last few weeks on COVID market, more on the vaccine side. But how are you thinking about the
commercial opportunity for an antibody?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: So what are the current prevention options that immunocompromised use? I know vaccination remains [recommendations] given the lack of
choice.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. I know one of the things you're looking at in the Phase 3, is redosing and durability.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: So can you walk us through how you're thinking about that? What data may emerge over time? And we've seen that with RSV on the product side
(inaudible) as being important for pricing. So just how are you thinking about some of those?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: And understanding the FDA's given the clearance on the surrogate titer value. Just how are payers, physicians, patients looking at this endpoint?
Are they kind of understanding?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And every show, they had a $2 billion contract.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And does the EUA impact how you can market this product? I know we started to see some ads from one of your peers (multiple speakers).
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NOVEMBER 07, 2023 / 8:50PM, IVVD.OQ - Invivyd Inc at Guggenheim Securities Inflammation & Immunology
Conference
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And as looking at your antibody, you have some peers that are also looking at their own, including AstraZeneca who's in Phase 3. Talks have
been on the market around year end. So how are you thinking about the market opportunity with coexisting with some of the peers?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. And as we're thinking about commercial market, is this a market where we'll see some seasonality in terms like fall treatment for the
immunocompromised? Or is it a little bit different in immunocompromised population?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. Can you talk about some of the capital needed to support this platform I'm talking about? I guess, where is it now? Where do you see this?
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consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 07, 2023 / 8:50PM, IVVD.OQ - Invivyd Inc at Guggenheim Securities Inflammation & Immunology
Conference
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. I guess with commercial again, I'm talking about going about that plan seasonality. Assuming EUA maybe the first half of the year, should
we think about some of the revenue contribution being more in that fall time point? Or how quickly can we see interest in this?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. With these surrogate endpoints, I know there are some international markets that have also expressed interest and support, like an early
authorization under that kind of design.
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Can you talk about how you're thinking about maybe the international market?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: I remember FDA and EMA were both interested in how the workshop in accelerate development. Are there any updates?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Got it. And then last question for me. As you're looking beyond 222, I guess, how is your research engine operate? And I guess, maybe what's next?
Question: Evan Wang - Guggenheim Securities LLC - Analyst
: Great. Thank you so much, Dave.
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