Invivyd, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Thank you. It's a pleasure to be here.

Happy to. Okay. Why don't we start then in the biggest picture? When most of us think about preventing an infection, especially from a virus, we will commonly think about vaccines. Indeed, America is in possession of a great number of vaccines. Some of them are extraordinary. Some of them are maybe more marginal in terms of their overall quality, say how well they protect you, for how long, and with what safety profile, so on and so forth. You'll notice that even though monoclonal antibody technology is inspired by human immunology, we actually have precious few monoclonal antibodies to prevent similar diseases. The ones that have been around the longest, and indeed some of the most economically and medically important, remain just in pediatric RSV or neonatal RSV.

Well, COVID came around, and it looked to many of us at the time, and I think was well demonstrated to be a virus that would be highly responsive to a monoclonal antibody. I think that's something to do with the match between what kind of neutralizing power a good company can put into the human serum and the requirement of that virus to essentially access cells in the epithelial tissues of your let's call it mouth, nose, and eyes, but then also your endothelial tissues, which are central to cardiovascular function, but where COVID likes to live and work. Invivyd began as a company devoted to monoclonals for COVID, and we've done that, and we're doing that. That is the main basis of our work daily, and I'll get into how we do it.

I would just point out, we exist as a company to start to right-size some of that relative dependency as it goes to American infectious disease medicine. We believe there's a lot of places where a monoclonal can play beautifully out past the limit of vaccinology. In COVID, many of you may remember from the height of the pandemic, Regeneron, which famously saved President Trump's life, or Evusheld, which was an AstraZeneca product for immunocompromised persons. Well, now the world is down to the work of Invivyd. We today make and sell Pemgarda, pemivibart, which is a preventative monoclonal antibody for use by moderately to severely immunocompromised persons. But more importantly, it makes a point. We built an entire company and an entire tech platform to deal with the particulars of this and perhaps other viruses, those things that move around a little bit.

We believe we are experts at finding pieces of those viruses that don't move, that are highly druggable, and we built a tech platform to exert that. Pemgarda, pemivibart, was kind of our warm-up act. I mean no shade. It's a beautiful antibody from the point of view of demonstrating longitudinal control over a virus that has escaped pretty much every other, in fact, actually every other pharmaceutical company. It has not escaped us. What's particularly compelling about that from an Invivyd standpoint, we think, is that we ourselves are aiming to replace Pemgarda, pemivibart, with something much more scalable. Because of the particulars of pemivibart, it's an infused product. It requires an hour-long infusion with a 2-hour monitoring, which is about the most burdensome vaccine ever invented by a good amount. Then we do you one better. It is only available under EUA.

It has a box warning for anaphylaxis. This is a highly imperfect medicine. Like I say, though, it expresses a really important fundamental point and allows us to iterate ever so slightly to make VYD2311, which is the molecule we are currently wrapping up pivotal on right now. That medicine we would expect to essentially embody the same properties, very strong ability to disrupt infection at a level way past what a vaccine can conjure, we believe these days. Likely to last much longer than a vaccine, we believe, and likely, we believe also to be safer and more tolerable.

That's a pretty good setup for a company like ours, we think, because, again, go back to the beginning, our observation has been consistently, this is a virus that will respond well to a monoclonal, and we're in the business of taking our technology and now making a medicine that we hope will be scalable to much larger populations. The way we've designed VYD2311 is to essentially make it functionally interchangeable with a vaccine. They will both be IM. We would hope over time we would acquire equal standing in terms of ability to get dosed at a pharmacy or at a minute clinic or any setting where you might otherwise think to get a vaccine. In sum, and then I'll pause, we see deploying our technology as offering a better way to do business with this particular virus and then perhaps others going forward.

Sure. We were inspired by the American REVOLUTION, given a lot of the, let's call it socio-medical churn happening around COVID-19. And so yes, our REVOLUTION program includes DECLARATION, which is our placebo-controlled two active arm pivotal study, which asks the question, does the Invivyd antibody VYD2311 reduce the incidence of PCR positive symptomatic COVID compared to placebo? This is essentially our third time running a similar study with a functionally identical antibody. Our first one adintrevimab was long ago in seronegative people, about a 71% reduction. Pemivibart, PEMGARDA, put up about an 84% to 94% reduction compared to placebo in modern populations against Omicron viruses. That brings us to 2311. We'll see how we do.

What we've said about it is we were desirous and have spent the last year running that study, and when one does infectious disease prophylaxis studies, the major unmodifiable risk is your so-called attack rate. Do you see enough disease in the study to give yourself statistical power that would substantiate your treatment effect at better than P of 05, because that is the typical intellectual framework we operate in. We upsized our study back in April and were able to disclose at the time that we had acquired some good statistical power for the upper end.

All we have been facing over the last few weeks is, it is safe to think, for those of you that are following our story, and we don't disclose the particulars, but I think it's safe for you to conclude the bottom end of our target VE may not be super well covered by the statistical power we've acquired so far. We have some decisions to make in the very near term, and we've been working very hard over the last year to provide pathways forward we think will allow us to operate well even in that setting.

We will either in the coming weeks, make the decision to fully unblind the study and file the drug on a normal pathway, traditional approval pathway, or we will make the decision to partially unblind, meaning safety, pharmacokinetics that allow us to measure the antiviral activity of the medicine and file for accelerated approval. That is, I think something that would be new in COVID antibodies, okay? But I would say we are inspired by and have been working closely with the federal government because today, or at least very soon, there will be XFG vaccines in your pharmacies that are either mRNA or protein encoded. You will know nothing about those vaccines from any kind of formal testing. You won't know how well they work. You won't know how long they'll last. You won't even know how safe they are.