This is the first time Jeremy has joined an earnings call. So by way of quick introduction, he has served as our Chief Operating and Commercial Officer since December of 2022. Jeremy has more than 20 years of commercial leadership experience across all stages of product life cycle. He joined us from Sandoz, where he served as the Global Commercial Head of the Biopharma business and had responsibility for the launches of their late-stage pipeline assets as well as the established commercial portfolio. Before we open the call for Q&A, Bill Duke will review our third quarter financial performance and share our latest cash runway guidance. Bill joined us in September as Chief Financial Officer, and it is a pleasure to have him with us today. Bill brings more than 25 years of experience, including more than a decade of senior leadership experience in the biotechnology industry.

During a short time with Invivyd, he has already proven himself to be a tremendous addition to our executive team and his knowledge and leadership will be invaluable to us as we prepare for a potential transition to a revenue-generating commercial company. Moving to Slide 4. I am tremendously proud of the progress our team has made this year executing to plan. As referenced in today's earnings release in September, less than 6 months after initiating a Phase 1 clinical trial of VYD222, we dosed the first participant in CANOPY, our Phase 3 pivotal trial investigating VYD222 for the prevention of symptomatic COVID-19. Today, just 8 weeks later, we are pleased to announce that we have completed enrollment in the CANOPY trial with approximately 750 participants enrolled, including approximately 300 immunocompromised individuals.

With CANOPY advancing swiftly, we continue to anticipate having initial primary endpoint data from this study in late 2023 or early Q1 2024. Given the pressing unmet medical need, our goal remains to apply for an EUA in the U.S. as soon as practicable, assuming the data we see is supportive for the requisite clinical, nonclinical and CMC data packages. The speed and efficiency of our progress are a testament to the dedication and focus of the outstanding team we have assembled and speak clearly to the fact that COVID-19 remains a significant health concern, particularly for immunocompromised individuals in the U.S. who currently have no authorized monoclonal antibodies available for them for pre-exposure prophylaxis or prep of COVID-19. This large unmet medical need is yet another consequence of the virus's relentless ability to mutate and over time render therapeutics ineffective.

That's precisely why we have strategically positioned ourselves to keep pace with viral evolution through our proprietary platform approach, which we trademarked INVYMAB. While VYD222 is an important near-term value driver for Invivyd, we believe INVYMAB is the engine which holds the potential to power our success for years to come. The INVYMAB platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering through our internal expertise and collaborations, such as our partnership with Adimab. While working to advance VYV222 through to a potential EUA submission, in parallel, we have also been working to identify and optimize mAb candidates that can be deployed in response to ongoing SARS-CoV-2 evolution.

We also continue to engage in constructive dialogue with the FDA regarding potential pathways that would enable us to fully leverage our INVYMAB platform approach to rapidly and perpetually deliver monoclonal antibody candidates. We are pursuing an approach that would, in some respects, mirror the process used to authorize the annual flu and COVID vaccine. While there is much work ahead of us, we are very pleased with our progress to date and look forward to sharing more details in the quarters ahead. Before I turn the call over to Pete, I would just make a few points about the current state of COVID and the clear and urgent need for new monoclonal antibodies. While many people with healthy immune systems have learned to live with COVID and accept it as a part of the new normal, that simply isn't an option for the immunocompromised.

They face distinct risks and challenges, which remain as acute today as they did during the height of the pandemic. As you can see on Slide 5, new data continue to emerge that highlight the disproportionate burden that COVID-19 has on vulnerable population. In October, real-world evidence was published from the INFORM study, which looked at the impact of COVID-19 in 2022, using data from a sample of nearly 12 million people in England. Results show that immunocompromised individuals accounted for only 3.9% of the overall study population, but roughly 25% of all COVID-19 hospitalizations, ICU admissions and death, even though more than 80% of this population had received 3 or more COVID vaccines. Furthermore, certain immunocompromised populations such as solid organ and stem cell transplant recipients and those recently treated for blood cancers had greater than 10-fold increases in risk compared to those without these conditions.

Also, in October, real-world evidence was published from the study referred to as the EPIC study, which looked at a sample of nearly 17 million people in a large U.S. commercial health insurance plan and COVID-19 infections between early 2020 and early 2022. In this study, immunocompromised individuals accounted for 2.7% of the population. Unsurprisingly, EPIC found that people who were immunocompromised were more likely to get COVID-19 than people who were not with about 14% of the immunocompromised people being diagnosed with the COVID-19 infection. Of those individuals, 24% were hospitalized with a means day of 15 days and a mean cost of $64,000 per patient. These data underscore the heavy human and financial toll that COVID-19 takes on this population and serve as a powerful motivation for us to get VYD222 and future antibodies authorized and available as quickly as possible for vulnerable individuals.

With that, I'll turn it over to Pete.

Peter Schmidt: Thank you, Dave. As Dave mentioned, mutation is an expected and inherent characteristic of SARS-CoV-2 as it continues to circulate. With regards to the recent variant, as you can see on Slide 6, we are pleased to report that our latest in vitro pseudovirus testing shows that VYD222 retains neutralization activity against the recent SARS-CoV-2 variance tested, such as XBB.1.5, XBB.1.6 and XBB.1.5.10, which is an XBB variant with the same spike glycoprotein sequence as EG.5 including the F456L mutation in the spike. Based on the now cast estimates provided by the CDC, we estimate that approximately 80% of the current CDC tracked variants are now XBB lineage variants with the F456L mutation. Moving to Slide 7. I'm very proud of the impressive progress that our team and our study partners have made this quarter to advance our CANOPY trial.

As Dave mentioned, we recently completed enrollment in our CANOPY trial and continue on plans to have initial primary endpoint data in late 2023 or early Q1 2024. As a reminder, CANOPY has 2 cohorts. In Cohort A, we enrolled approximately 300 individuals who are significantly immune compromised. All participants in Cohort A received VYD222. For Cohort A, the co-primary endpoints are safety and tolerability and serum neutralizing titers at Day 28 against relevant SARS-CoV-2 variants, which will be calculated based on the pharmacokinetic concentration of VYD222 from the immunocompromised participants and the IC50 value for VYD222 against relevant SARS-CoV-2 variants. In Cohort B, we enrolled approximately 450 individuals who are at risk for exposure to SARS-CoV-2, which is essentially anyone who has regular unmasked interactions with others.

Participants in Cohort B were randomized 2-to-1 to receive VYD222 or placebo. The primary endpoint for Cohort B is safety and tolerability, and the primary purpose of this cohort is to build out the safety database for VYD222. The primary efficacy analysis for CANOPY will use an immunobridging approach, comparing data obtained from the immunocompromised cohort to certain historical data from our previous clinical trial of adintrevimab for the prevention of symptomatic COVID-19 in which serum neutralizing titers correlated with observed clinical efficacy. Our team is laser-focused on executing the CANOPY trial and preparing for a potential EUA submission as soon as practical. As we've anticipated, the FDA continues to utilize the EUA pathway to authorize new products, including the latest mRNA vaccines for certain age groups.

Furthermore, the design of our CANOPY trial reflects the input we've received from the FDA on an immunobridging pathway to a potential EUA for new mAb candidates that meet certain criteria, which we believe VYD222 satisfies. To prepare for the potential launch of VYD222, our teams have also been engaging in appropriate scientific exchange with the medical community and key opinion leaders, and we are raising awareness of monoclonal antibodies for COVID-19 with various patient groups. To date, we've engaged with more than 35 different patient organizations, many that advocate for populations that may have a reduced immune response to vaccines. With that, I will now pass the call to Jeremy.

Jeremy Gowler: Thank you, Pete. s VYD222 rapidly advances through the clinic and approaches a potential EUA submission, our commercial plan in preparation are featuring more prominently internally as well as in our discussion with investors. So it's a pleasure to join today's call to share a bit more color about the market opportunity and the many activities we are undertaking as we gear up for a potential launch. Turning to Slide 8. Based on our extensive market research, we believe there is a significant market opportunity with more than 9 million immunocompromised people at risk for severe COVID-19 in the U.S. Looking at the chart on the left, the x-axis shows the risk of severe COVID-19 and the Y-axis is expected uptake of a COVID PrEP MAb based on aggregated results from a survey we conducted with specialty HCP in the U.S. Importantly, this market is comprised of different subgroups with varying degrees of risk and expected uptake.

At the top far right of the chart, you can see that there are approximately 485,000 people who are at the highest risk and have the highest expected uptake based on our market research. We can further refine the population into several key subgroups, including approximately 67,000 stem cell transplant recipients, 86,000 solid organ transplant recipients and 332,000 people with hematologic or lymphatic cancer. We see a clear opportunity to impactfully enter the market, utilizing an efficient sales footprint to target certain subgroups of patients and providers initially and expand to additional groups over time. Turning to Slide 9. We have many activities underway to prepare for a potential VYD222 launch if authorized. For example, go-to-market planning is underway such as market research with HCP, market sizing and segmentation, brand strategy and field force sizing work.

With regards to our market research in a recent survey we conducted with nearly 200 U.S. physicians who treat different types of immunocompromised patients. 76% of respondents said they would be extremely likely or somewhat likely to use Evusheld, a previously authorized PrEP mAb for COVID-19 for their immunocompromised patients if it were still available and relevant to circulating COVID-19 strains. We believe that this result underscores the ongoing market opportunity. With regard to market access, if authorized, we expect to commercialize VYD222 under the traditional sales model rather than through the large government purchases and stockpiling as we saw with COVID-19 products in the past. In anticipation of launch, we have payer and pricing work underway and are preparing our distribution models and channels.

With a step wide approach, we believe that we can be very effective in getting VYD222 to key health systems and populations with a relatively small sales option. We have also started manufacturing of VYD222 commercial inventory with WuXi, and they continue to be an outstanding partner to us as we make excellent progress preparing for the CMC package that will be part of our anticipated EUA submission. With respect to the caliber of our commercial organization, from the top, we have Dave, who played a pivotal role in the launch of the first COVID-19 vaccine as the global mRNA business and franchise lead for Pfizer, and we have brought on board experienced leaders to head up our market access, sales and marketing functions. This seasoned team has collectively launched multiple successful products to address infectious disease.

Our team has been working diligently, and I'm very pleased with all the progress we've made to prepare for the potential emergency use authorization, and we are excited for the potential launch of VYD222 in 2024, if authorized. While we are currently focused on launching in the U.S. by ourselves with the contract field force, we are actively exploring potential partnerships and collaborations. With that, I will now turn it over to Bill to provide an overview of our financials.

Bill Duke: Thank you, Jeremy. I'm excited to have joined the Invivyd team at such a potentially transformative period for the company. I've been very impressed by the Invivyd team's ability to execute to plan and by the nimble, highly motivated teams that are driving Invivyd's work forward at a remarkable pace. I see great potential in Invivyd's strategy and platform-based approach and believe that Invivyd is poised to make a meaningful difference in the lives of thousands of vulnerable people in the United States who have been without access to a mAb for COVID-19 prevention for far too long. Turning to the financials on Slide 10. The details of our third quarter financials are included in the press release we issued earlier today.

So I won't reiterate all the numbers here. Invivyd ended the third quarter of 2023 with approximately $265 million in cash, cash equivalents and marketable securities. Based on the current operating plans, we continue to expect that our cash, excluding any potential revenue associated with VYD222 will enable us to fund our operating expenses into the fourth quarter of 2024. Regarding our efforts and resources, as you have heard today, we are actively preparing for the potential authorization and launch of VYD222, including the manufacturing of an additional commercial supply. We will continue to deliberately manage our expenses as we rapidly advance our work on timelines that are significantly compressed compared to traditional biotech programs.

With that, operator, please open the call for questions.

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