Invivyd, Inc. Common Stock Study result

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A short while ago, we issued a press release announcing an update on our LIBERTY phase III study and VYD2311 regulatory submission plans. That press release and the slides that are being used on today's webcast can be found in the Investors section of the Invivyd website under the Press Release and Events and Presentation sections, respectively. Today's discussion will be led by Marc Elia, Chairman and Chief Executive Officer of Invivyd. He is joined by Dr. Michael Mina, Chief Medical Officer and Chief Epidemiologist of Invivyd. During today's discussion, we will be making forward-looking statements concerning, among other things, our research and development activities, our regulatory plans, our future prospects, and other statements that are not historical facts.

These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call, and Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K and Form 10-Q, which are also available on our website. I will now turn the call over to Marc.

Good morning, and thank you all for joining us. Today marks the beginning of a new chapter for Invivyd, and we hope for vulnerable people at risk of COVID everywhere. We are very pleased today to report the top-line data from our LIBERTY phase III study and to provide you with an update on our development and regulatory plans for 2311 going forward. I'll ask Dr. Michael Mina, our Chief Medical Officer, to walk you through the highlights from LIBERTY, and then I'll discuss our next steps for VYD2311. But first, let me provide a little bit of background for today's discussion. If we can move to slide 4. As you all know, Invivyd has been in the business of making monoclonal antibodies for COVID for now six years.

We're currently commercializing the parent medicine to VYD2311, pemivibart or PEMGARDA, which is authorized under Emergency Use Authorization for the prevention of COVID among certain immunocompromised persons. PEMGARDA, you may recall, is a high dose of antibody delivered via one-hour infusion, includes a two-hour post-infusion monitoring time, carries a boxed warning for risk of anaphylaxis, requires quarterly dosing, and is overall a bit too burdensome for easy, routine access. All of that is poised to change for the better. The promise of monoclonal antibody technology in our hands was not intended to result in a burdensome medicine. The promise of our technology has been to allow most any human being, and especially the vulnerable, such as immunocompromised persons, children, and the elderly, to access immune power that is improved compared to what their own immunobiology can summon, and to do it safely, simply, and easily.

The goal of such products is to help people who choose them to stay well, and to do so without incurring some of the hardwired intrinsic downside of requiring the inflammation and antigen exposure from infection or vaccine to get an immune education that may only offer low-level short-term protection. Remember, all human beings are born immune-compromised and full of monoclonal antibodies we get from our mothers. Pharmaceutically, however, to this day, only babies have reliable access to monoclonal antibody supplementation to prevent infectious disease through nirsevimab or Beyfortus. In our view, it's time for that to change. Allowing humankind routine access to direct immune supplementation can be a revolution in the prevention of important viral diseases. While LIBERTY is the first and the smaller of our two clinical studies that are driving VYD2311 toward commercialization, it's an important first step. Next slide, please, to 5.

Today's LIBERTY data provide an important new window into the clinical profile of VYD2311, a low-dose intramuscular monoclonal antibody that is designed to prevent COVID-19. We remind everyone listening that VYD2311 previously underwent long-term first-in-human evaluation, the results of which we reported last June. That first human clinical experiment stress-tested safety and tolerability at doses far above those we believe are required to confer protective immunity, and the results were very reassuring. It also followed subjects over the long term of 180 days in order to generate a robust assessment of pharmacokinetics and estimated half-life. Today's LIBERTY data build on those initial findings and set the stage for the more definitive placebo-controlled DECLARATION data coming soon.

Before Michael discusses the LIBERTY data, I'll remind everyone what the study is and is not designed to show, as I know many listeners who are also investors may be trying to make inferences about DECLARATION or other topics from today's LIBERTY data. The LIBERTY study had a specific purpose, in part informed by questions posed to us by the U.S. FDA with joint input from CDER and CBER. First, we wanted to compare the COVID-19 vaccine safety and tolerability to VYD2311, and we are very pleased with our highly positive and statistically significant results. Note, there is no placebo arm in LIBERTY, and the study collected adverse events in a solicited manner, different than our prior studies and different than DECLARATION, which is designed similarly to the AE collection methods of our previous EVADE and CANOPY studies.

Because of LIBERTY's specific design, we do not know the adverse event profile associated with ordinary life in the study that would typically be seen in a placebo arm. However, our earlier work with 2311's similar low-dose intramuscular monoclonal grandparent molecule, adintrevimab, was very encouraging on this point, and we are looking forward to our DECLARATION data so we can all see that comparison. We are feeling very confident based on all of the data we have seen so far. Second, we and the FDA wanted to understand whether combining VYD2311 and COVID-19 vaccine would present any new safety challenge. Clearly, it does not. Indeed, by contrast, appears to drive clinical safety and tolerability outcomes in a much more favorable direction, maybe more favorable than many of us would have dared to expect, and we are very pleased with those results as well.

Third, we and the FDA wanted to understand whether the combination of VYD2311 and COVID vaccine would somehow reduce or interfere with the immunogenicity results one could achieve from vaccination alone. It does not, and as you might imagine, our highly positive results on that front are also very gratifying. What LIBERTY was not designed to do is to provide an early read-through to DECLARATION. The design of LIBERTY does not provide quite the right data, either virologically or pharmacokinetically, because of course it was built for a different purpose. Fortunately, what we do see is very encouraging, and we should have the data we want from DECLARATION very soon. A last caveat, LIBERTY also cannot be used to determine any clinical meaning about the vaccine immunogenicity results, either from the vaccine alone or the combination.

We in the field lack the necessary clinical correlates in this assay, and indeed in others, to make confident estimates of vaccine efficacy on this basis. However, it is readily apparent that however well the neutralizing antiviral titers from the COVID vaccine work clinically, adding 2311 in combination sure makes for much higher neutralizing titers. Someday, we hope both VYD2311 and the COVID vaccine can be broadly available, and either we or other groups can do the clinical research necessary to find answers to these fascinating questions about relative clinical protection or head-to-head efficacy. What we do know is that 2311 has generated what we see as an extraordinarily attractive comparative profile relative to the widely used standard of care used in millions of Americans annually, which is currently selling billions of USD in revenue.

We believe our LIBERTY data point clearly to advantages 2311 can have in helping humans at risk for COVID acquire immune supplementation via a new mechanism that operates beyond the limits of vaccinology. Finally, with these data, along with data we anticipate near-term for the DECLARATION study, we are looking forward to bringing VYD2311 to vulnerable Americans as fast as possible. To that end, we have been working hard with regulators and the federal government, including up until recently, to articulate the pathways required to move VYD2311 forward to vulnerable Americans, which I know we will discuss much more shortly. Some of these conversations and associated processes are behind the requirement to modestly delay our DECLARATION results on the order of weeks from our original guidance, and we hope you will bear with us as we move forward in our work to accelerate the program more broadly.

We are very excited to share the results of LIBERTY with the FDA and the broader scientific community. Beyond all of our interest today in the mechanics of moving VYD2311 toward approval and market, today's data underlines some of the unique and positive attributes that we think can underpin a whole new field of preventative medicine in infectious disease based on Invivyd monoclonal antibodies. With that, I will turn the call over to Dr. Michael Mina, our Chief Medical Officer, to walk you through the top-line data.