When we talk about building a company to meet the challenges of SARS-CoV-2, what we mean is that we believe we are pioneering a still brand-new approach to antibody prophylactics and therapeutics. Engineered antibodies represent the promise of conferring to vulnerable populations, the immune response to viral threats that we all wish we could have following vaccination or infection, an immune response that may be necessary for staying safe and well rather than the immune response that keeps us alive but at continuous risk. Obviously, the risk of SARS-CoV-2 is highest for immunocompromised population who today benefit least from vaccination and represent a high disproportionate share of ongoing hospitalizations and deaths. We're starting our journey serving their needs but see the possibility of serving broader populations as we advance our technology and strategy.

Broadly, our strategy is to combine the potential for high efficacy and attractive safety of modern monoclonal antibodies or mAbs directed against the SARS-CoV-2 spike protein with the opportunity for product evolution, one commonly sees in the vaccine industry. We set out on this mission because to us, it so far represents the only viable approach for bringing high-value medical options to populations in need. At this point, we see an attractive commercial opportunity for PEMGARDA in the near term, a rapid compact, capital-efficient pathway to generating novel options for 2 distinct use cases prep and potentially treatment and a scientific engine devoted to repeatable, reliable, best-in-class molecule generation. Of course, major questions have surrounded this strategy for now almost 2 years, in large part, regulatory and operational.

We're thrilled that over the last year, we have started to answer those questions more definitively in partnership with a highly motivated and thoughtful regulator in the U.S. Food and Drug Administration. The recent emergency use authorization for PEMGARDA for PrEP of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise. And now the opportunity to file an application for EUA for treatment of mild to moderate symptomatic COVID-19 in a similar immunocompromised population, both represent the growing alignment between the core of our strategy and the posture of the major U.S. medical authority. Our aim is to build on and expand these early successes now by innovating to improve our products on all dimensions, the resistance to evasion that can be built into them, the potency of our antibodies and accompanying improvements in dose therapeutic index and form factor they might offer and the clinical data that we hope can substantiate broad use of antibody products in the future.

Our agenda today is unique for a regular quarterly call. While we will review certain elements of our recent business progress, we will also provide context for the scientific and clinical thinking that underpins our corporate and commercial strategy and our enthusiasm for the future of Invivyd. Because this is not an R&D day, we will move relatively quickly through some concepts and hope that as you reflect on what you hear and read, you can engage with us on a follow-up basis if it is a further use following today's call. We have heard clearly from many of you that there are gaps in your understanding of our technologies, and we would like to take this opportunity to fill in those gaps so you can understand our company better moving forward through the launch.

We believe that Invivyd's bespoke, proprietary and fully integrated discovery technologies, combined with potential rapid development pathways, represent an impressive competitive advantage designed to keep Invivyd serving vulnerable populations with high-value commercial products engineered to treat and protect from serious viral threats in perpetuity. We see the technological core of this engine as substantiating the economic vision for our firm, which is to advance high-value novel medicines with high speed, high capital efficiency and high confidence to ensure that shareholders also benefit from the substantial medical value we aim to create for vulnerable populations. A few final notes before we move on with our agenda. We are well engaged in a search for a permanent CEO, but we will not comment further at this time.

Also, Jeremy Gowler will comment on multiple elements of the early PEMGARDA launch, but we will not be disclosing any more granular detail than that which he will walk through in his prepared remarks nor will we comment on any early sales trends other than to say that at this point, we are pleased with the organic demand we believe we're observing in the field. We have been moving quickly to establish the mechanical infrastructure, the institutional knowledge and the experience base that will allow appropriate vulnerable populations, their HCPs and broad health systems to access PEMGARDA routinely. I'll now turn the call over to Bill Duke, the CFO of Invivyd, to discuss our financial results and guidance.

Bill Duke: Thank you, Marc. Turning to Slide 5. We ended Q1 2024 with cash and cash equivalents of $189.4 million. We did not record any PEMGARDA revenue in the first quarter as orders and shipments began in April. In April 2024, we announced that following a comprehensive strategic review, the company is improving its projected 2024 year-end cash position by approximately $20 million to $25 million. Our updated cash guidance improvement was built to include the anticipated spend on 2024 incremental clinical commitments associated with our potential treatment EUA. The improvements were realized through comprehensive resource realignment, ensuring robust investment in the commercial launch of PEMGARDA in the discovery of novel monoclonal antibodies.

We have recently undertaken a commitment to filing a second EUA application for PEMGARDA, focusing on the treatment of mild to moderate symptomatic COVID-19 for certain immunocompromised people. This is a potentially transformational opportunity for Invivyd near term as we move into the summer and fall, and we consider this route as a future cornerstone for rapid development of innovative molecules. We will not, however, alter our year-end cash and top line revenue guidance even if we achieve EUA treatment. At this point, we feel very comfortable with our near-term economic opportunity and look forward to updating our estimates in the fall at the earliest. Finally, as Marc mentioned, we look forward to continuing to innovate and introduce additional novel antibodies.

We have studied the time and costs associated with generating the PEMGARDA clinical package that support PrEP and potential treatment. Going forward, we believe we can significantly reduce our clinical development time and costs, and we will look forward to sharing more detail soon. As you have seen from our prior descriptions of the target population and our recently disclosed commercial pricing, these use cases represent a total addressable market measured in billions of annual revenue when considering the roughly 500,000 people in the U.S. who are the most vulnerable and our initial focus. We are working to realize that potential and aim to expand the populations we can serve as our technology and strategy allow. With that, I'll turn the call over to Jeremy to update you on our launch.

Jeremy Gowler: Thanks, Bill. Moving to Slide 6. PEMGARDA is a high-value medicine for moderately to severely immunocompromised individuals who are in urgent need of protection from COVID-19. It fills a critical need not otherwise addressed in the marketplace today. Overall, we are very pleased with the strong interest we've seen thus far from patients and providers. Since authorization, we have so far received a surprising and gratifying level of unsolicited inquiries into our call center. Our field teams are having many positive interactions with our customers and are experiencing a high degree of interest in PEMGARDA. Now we are going through the logistics phase of the launch, where we are managing the processes around institution and payer access to ensure that PEMGARDA is broadly and conveniently available to those whom it is authorized.

We are moving to ensure that PEMGARDA awareness and logistical support are in place prior to the broadest activation of HCP and patient interest in the coming months. Of note, PEMGARDA represents our first-generation technology. And as we will discuss later on in the call, we already have a follow-up map in VYD2311, which we believe holds the potential to have an improved product profile. The work we are doing today with PEMGARDA, we believe will pave the way for VYD2311 to seamlessly slot in behind it and build on PEMGARDA's anticipated success. Turning to Slide 7. We are a little more than 6 weeks post authorization and the commercial organization and functions supporting it have been hard at work to execute on the PEMGARDA launch. Our manufacturing colleagues worked very quickly to have product available within a week of authorization.

In parallel, we contracted with 3 major distributors to ensure that our customers could procure PEMGARDA via their preferred procurement partner and subsequently shipped our first order. As of late, our focus has been on securing reimbursement and access. In mid-April, we announced that the U.S. Centers for Medicare and Medicaid Services, or CMS, published 2 healthcare common procedure coding system codes or HCPCS codes, a Q-code covering product reimbursement for PEMGARDA and a product-specific M-code covering the administration. This is critical because CMS provides coverage for nearly half of the moderately to severely immunocompromised people at higher risk for severe COVID-19, whom we are targeting. In parallel, our national account management team has been working to secure commercial reimbursement for PEMGARDA as well with private payers to ensure that the other half of the moderately to severely immunocompromised people who are eligible for PEMGARDA can access it.

Our team of key account managers recently hit the ground running after completing extensive training, and they are now all fully deployed and calling on our roughly 1,150 targeted accounts to build awareness for the product and drive uptake. The early focus is on securing inclusion of PEMGARDA on institutional formularies as needed. We have had positive engagement and we see institutions taking it through the formulary committee processes already and some have already ordered product. With respect to the patient experience and access, we are putting an even greater focus on building out logistical support to assist moderate to severe immunocompromised people who are seeking PEMGARDA. This work includes the creation of an online infusion site finder to help those people trying to access PEMGARDA.

This new tool, which will be accessible in the future on pemgarda.com, is under active development. And in parallel, we are engaging with infusion providers outside of traditional institutions to support patient access to the product. And finally, we are excited about the potential to submit and receive an additional EUA for PEMGARDA focused on the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised people should it be granted by the FDA. Since the commercial pathway and infrastructure already exists for the antivirals like Veklury, we are excited to have this additional use case for the product beyond PrEP as another potential way to capitalize on the work done to bring PEMGARDA to market. We will look forward to updating you more on our sales and relevant trends as the launch progresses.

I will now turn the call over to Mark Wingertzahn, SVP of Clinical Development and Medical Affairs. Over to you, Mark.

Mark Wingertzahn: Thanks, Jeremy. It's been great to join in Invivyd at a fascinating time for the company and patients in need. Turning to Slide 8. As a reminder, our EUA for PrEP for COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise is based upon the ongoing Canopy Phase III clinical trial that includes 2 cohorts. First, we have a single-arm open-label cohort in immunocompromised subjects, the so-called Cohort A. Second, there is a randomized double-blind safety cohort in people at risk of SARS-CoV-2 infection from regular face-to-face meetings with exploratory clinical event endpoints, the so-called Cohort B. We have collected exploratory information on COVID events in both arms on an ongoing basis.

Although obviously, the lack of a placebo arm renders the interpretation of events in the cohort A, a bit more opaque. Moving to Slide 9. As a reminder, in order to meet the immunobridging endpoint agreed to with FDA, we dosed to very high titers and then allowed the titers to decay with ordinary antibody PK subject to the half-life of VYD222, now PEMGARDA. You can well imagine that a redose will produce another major boost to titers, which we then expect will fall at a similar rate. As every dose involves a phase with very high titers, which then descent to lower levels, we look forward to seeing how we accrue any events we collect after our day 90 calculation in trough titers. Perhaps prior to a second dose, a time period that may give us information that could help us calibrate dose optimization going forward.

Turning to Slide 10. As a reminder, we began the CANOPY clinical trial going into and then through the fall/winter 2023-20224 JN.1 wave. As a result, we saw a relatively robust attack rate in our study of about 3% to 5%. Although CANOPY was not prospectively designed or powered to demonstrate protection from symptomatic COVID-19, and that analysis of exploratory endpoints of symptomatic COVID-19 events in CANOPY were unrelated to FDA's review of our EUA application, we note the events have exploratory value as we consider the titers that may be associated with various levels of protection and think about dose and product profile going forward. We have previously disclosed that in Cohort B, our double-blind placebo-controlled cohort, we observed protection of 100% through day 67, a period that overlap with very high sVNA titers.

Through day 90, we saw one breakthrough infection in the Pemivibart arm compared to 8 in the Placebo arm, yielding a relative risk reduction of approximately 94%. As highlighted on the previous slide, while we are aware that additional cases of COVID-19 have occurred in Cohort A and Cohort B post day 90, we are awaiting the upcoming analysis of the second dose blinded 90-day interval that will add additional resolution to our thinking. We look forward to sharing these data later this summer. Turning to Slide 11. Importantly, we recently announced our intention to submit an EUA request for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people. As described in our press release, we view this as a logical and welcome complement to our overall serial monotherapy bridging paradigm and a reassuring reminder of the intellectual alignment between Invivyd and the U.S. FDA.

The anticipated treatment EUA submission will leverage already existing data sets from our STAMP and CANOPY clinical trials. In parallel to the anticipated submission of the EUA request, we plan to design and initiate a compact clinical trial focused on generating confirmatory safety, pharmacokinetic and clinical virology data. Importantly, treatment of mild-to-moderate symptomatic COVID-19 and certain immunocompromised people is a second use case for PEMGARDA and possibly follow-up molecules with shorter-term endpoints than PrEP, which may substantiate rapid innovation moving forward. Turning to Slide 12. This additional use case is important because even with vaccination, immunocompromised people are disproportionately impacted by severe COVID-19 outcomes and remain a major driver of ongoing hospitalization and death in the U.S. despite current small molecule treatment options.

Moving to Slide 13. If authorized, PEMGARDA could be a welcome addition to the therapeutic armamentarium and a valuable potential option for certain people with moderate to severe immune compromise when alternative COVID-19 treatment options were not clinically appropriate or accessible. At present, there is no authorized antibody treatment of COVID-19 and among existing options, some are complicated by drug-drug interactions and others are mainly deployed in a hospital setting requiring burdensome repeat intravenous infusions on consecutive days. Turning to Slide 14. As we have seen since the beginning of COVID therapies, treatment option utilization ebbs and flows with overall viral presence. Nonetheless, in year 5 of the pandemic, COVID treatments remain heavily utilized.

We are moving with considerable urgency as we believe that immunobridging provides us with a more rapid and efficient pathway to deliver an important COVID-19 treatment option, complementing our efforts with PrEP. I am now pleased to turn the call to Robbie to discuss our analytics and Discovery Technologies.

Robert Allen: Thank you, Mark. Good afternoon. Many of you have expressed interest in hearing more about our work on virus evolution and the confidence we have in the quality and durability of PEMGARDA and our pipeline molecules. To start on Slide 15, I want to introduce VivydTools, which is our in-house proprietary software that tracks virus variation across our COV-2 from multiple sources, including clinical sample sequence data and the sequencing data collected from wastewater. As a general rule, variants that become clinically relevant are detected in wastewater well in advance of their broad emergence. Wastewater data also includes sequences of viruses that do not ultimately rise to high prevalence in the clinic. But these data provide a broad view of the mutational space that has been explored by the virus over time.

We use this tool for 2 purposes: firstly, in furtherance of activity prediction and monitoring, but also, as you will see increasingly to power highly proprietary discovery approaches that we think give us a unique advantage in the field. On slide, as you can see on the left side of the panel on Slide 16, at Invivyd, we log and analyze variation observed across the spike protein down to very low frequency polymorphic explorations. In this small excerpt, you're seeing graphs which depict the various changes on the amino acid by amino acid basis across positions 403 to 432. While this view of the data allows you to appreciate multiple data sets simultaneously, the sharp eye among you may notice that some of these graphs do not have a lot of color and noise on them, whereas others do.

That reflects the degree to which less or more polymorphic exploration has taken place at a given residue as the virus has evolved. By evaluating epitopic sites for our antibodies, including VYD222, we can assess how mutable or polymorphic our epitope is. We got finally in the areas we track as part of the assigned epitope of VYD222, we have observed polymorphic stability since the emergence of Omicron through to the present day. Turning to Slide 17. Of course, once we pick an antibody to develop it, we cannot change it. And so monitoring and analysis of variation gets much more valuable when we can incorporate it into the design of our screens and the selection of our antibody candidates. In a moment, I'm going to describe how this practice has been integrated into our pipeline.

But for now, I will simply note the following. When we look at the variation across Spike and RBD, the area we want to contact with the mAb, we see evolution, sometimes saltation or large structural shares. And then we see reconvergence along previously documented exploratory pathways. In simplest terms, while we cannot expressly predict variation, we are beginning to better understand the nature of SARS-CoV-2 evolution. If we can create some level of data-driven intelligence in predicting future potential changes, we can identify future theoretical or synthetics by proteins that may not even exist yet as variance, but which represent probabilistic futures for which we want to prepare. And if we can do that, we can deploy our proprietary discovery technology that takes advantage of the high-throughput yeast-based mAb optimization platform from Adimab, directing it to perform operations that would be practically impossible with less advanced technology.

Turning to Slide 18. What that means is that armed with information about viruses that have circulated are now circulating and then armed with synthetic depictions about what might circulate, we can execute boolean or logic-driven discovery screens in which we direct the platform to identify predefined antibodies, all based on the original framework of adintrevimab and now Pemivibart, which, for example, neutralize XBB and JN.1 and so on, but which do not interact with the residues we may worry about from our probabilistic work. We can then select those candidate antibodies and indeed confirm the activity we believe we wish them to have, both against current virus, but also, which embrace the anticipation of single or multiple future convergently evolved variants.

Moving to Slide 19. We are looking for antibodies that are not limited by Mammalian immune suite such as we might see in convalescent serum or a mouse, we are seeking novel molecules that can go through rapid highly efficient development path and in each generation of molecule, we are looking to increase our design level confidence in resistance to variation and improve the overall pharmaceutical properties of our products. In practice, this approach started with adintrevimab, which was made early as the maturation of a SARS-CoV-1 antibody against Wuhan than its virus. The critical product attribute at that time was thought to have been achieved through conservation of H2 access, although the Omicron shift taught us and other sponsors that there were sufficient permissiveness in H2 access to make immune evasion a second critical dimension of the discovery process.

Then we go to Pemivibart which is adintrevimab optimized against BA.2, but leaving as a criterion backwards-looking neutralization of ancestral pre-Omicron lineages, that constraint appears to be driving so far a highly encouraging conservation of the Pemivibart epitope across evolution, but impose at least a modest potency penalty on recent circulating viruses. Our next anticipated clinical candidate VYD2311, takes Pemivibart and optimizes it further for increased potency and assessed variation resistance. We will look forward to introducing you to 2311 more fully soon, but the early profile is very encouraging as it goes to improvement over Pemivibart in terms of possible dose, therapeutic index and route of administration. A bit earlier, still in Discovery, we are now integrating our forward-looking synthetic antigens to create antibodies that we believe have some in-built anticipatory intelligence, a process we expect to monitor and refine as we go.

In these, we are now operating out past the frontier of what is, and we are actually discovering and qualifying molecules that are designed on multiple dimensions to address what we believe is likely in the future, a very unique approach in biopharmaceuticals as far as we are aware. Next, I'd like to turn it back over to Marc for some closing thoughts before we move to Q&A.

Marc Elia: Thanks, Robbie. In summary, as shown on Slide 20, we're constantly tracking, analyzing and considering variation. We do it both to monitor the probable activity of our current drug Pemivibart, to monitor the stability of epitopes for candidate drugs, including 2311 and others and now also to generate analytic findings that allow us to build antibodies, which anticipate probable changes and clearly retain activity. You will have and will, in the future, see various results of neutralization assays on our and other antibodies. We would encourage you to interpret those data with caution. Our colleagues at AstraZeneca on the EVUSHELD Fact Sheet characterized changes in neutralizing potency of less than 5 fold as "no change" which speaks to the variable nature of these assays and the tenuous uncertain relationship between those precise assay results and overall clinical activity.

Worse, when and if an assay has changed or our laboratory is switched as a vendor, comparability becomes more fraud. As a consequence, while we at Invivyd will continue monitoring neutralization carefully, we will not update you all on an ad hoc basis. Rather, we will communicate our findings with the FDA and update our product fact sheet when applicable. The sum of all this work is that we believe we have excellent and growing evolutionary intelligence on SARS-CoV-2 and a unique ability to operationalize that intelligence. Our work can never be perfect as we are up against Mother Nature, and she always has tricks upper her sleeve. However, we are highly encouraged by our recent progress in our basic science, our clinical development, our growing regulatory alignment and our commercial efforts.

Our goal with innovation over time will be to substantially expand the population to whom we can offer COVID-19 protection and treatment, to improve the profile of our products and thereby to substantially increase the medical value of our products for patients and providers and therefore, are value creation for shareholders. I'd like to ask the operator to open the line for questions.

Operator: [Operator Instructions] Our first question comes from the line of Maxwell Skor of Morgan Stanley.

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