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spk02: Welcome to the InVivid third quarter 2023 financial results and recent business highlights call. At this time, all participants are in a listen-only mode. After the speaker's prepared remarks, there will be a question and answer session. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Scott Young, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.
spk03: Thank you, Operator. A short while ago, we issued a press release announcing our third quarter 2023 financial results and business highlights. That press release and the slides we are using today on the webcast can be found in the investor section of the InVivid website under news and events. Today's discussion will be led by Dave Herring, InVivid's chief executive officer. He's joined by Dr. Pete Schmidt, chief medical officer, Jeremy Gowler, chief operating and commercial officer, and Bill Duke, Chief Financial Officer. During today's discussion, we will be making forward-looking statements concerning, among other things, the future of the COVID-19 landscape, our ongoing research and clinical development plans, including the timing of these plans, our regulatory and commercialization plans, strategies and opportunities, including the timing of these plans, our expected cash runway, 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 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 InVivid assumes no duty to update such data. Additional information on the risk factors that could affect InVivid's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website. I will now turn the call over to Dave.
spk00: Thanks, Scott, and thank you all for joining. As you can see on slide three, we have a full agenda for today's call. I'll begin by reviewing a few of our recent business highlights and key achievements in the third quarter. And then I'll provide some color on the current COVID-19 landscape and the very real and continued threat the disease presents to the immunocompromised and other vulnerable individuals. Pete will then discuss Canopy, our Phase III pivotal clinical trial investigating BYD222 for the prevention of symptomatic COVID-19, and review our latest in vitro data demonstrating the antibodies in vitro neutralizing activity against recent SARS-CoV-2 variants. Jeremy will then provide an update on some of the critical work that he and his team have been doing in preparation for a potential emergency use authorization, or EUA, which, if issued, could enable a commercial launch of EYD 222 in 2024. 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 lifecycle. 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 his short time within Vivid, 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 four, I am tremendously proud of the progress our team has made this year executing the plan. As referenced in today's earnings release, in September, less than six months after initiating a phase one clinical trial of BYD222, we dosed the first participant in Canopy, our phase three pivotal trial investigating BYD222 for the prevention of symptomatic COVID-19. Today, just eight 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 US as soon as practicable assuming the data we see is supportive for the requisite clinical, non-clinical, 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've trademarked Invimab. While VYD-222 is an important near-term value driver for InVivid, We believe InvaMab is the engine which holds the potential to power our success for years to come. The InvaMab platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering through our internal expertise and collaboration, such as our partnership with Atomab. While working to advance VYD222 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 InvaMab 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 vaccines. While there's 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 five, new data continue to emerge that highlight the disproportionate burden that COVID-19 has on vulnerable populations. 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 deaths, even though more than 80% of this population had received three 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 tenfold increases in risk compared to those without these conditions. Also in October, real-world evidence was published from a study referred to as the EPIC study, which looked at a sample of nearly 17 million people in a large US 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 a COVID-19 infection. Of those individuals, 24% were hospitalized with a mean stay 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 BYD 222 and future antibodies authorized and available as quickly as possible for vulnerable individuals. With that, I'll turn it over to Pete.
spk09: 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 variants, as you can see on slide six, we are pleased to report that our latest in vitro pseudovirus testing shows that DYD222 retains neutralization activity against the recent SARS-CoV-2 variants tested, such as XBB1.5, XBB1.6, and XBB1.5.10, which is an XBB variant with the same spike glycoprotein sequence as EG5, 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 seven, 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 plan to have initial primary endpoint data in late 2023 or early Q1 2024. As a reminder, Canopy has two 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 two to one 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 BYD222. 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 adentrovimab 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 practicable. 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 BYD222 satisfies. To prepare for the potential launch of BYD222, 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.
spk08: Thank you, Pete. As BYD 222 rapidly advances through the clinic and approaches a potential EUA submission, our commercial plans and preparation are featuring more prominently internally, as well as in our discussion with investors. So it was 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 eight, 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 up to give a COVID prep map based on aggregated results from a survey we conducted with specialty HCPs 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 nine, we have many activities underway to prepare for a potential BYD222 launch, if authorized. For example, go-to-market planning is underway, such as market research with HCPs 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 med 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 VYD 222 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-wise approach, we believe that we can be very effective in getting BYD 222 to key health systems and populations with a relatively small sales footprint. We have also started manufacturing a BYD 222 commercial inventory with WUSHI, 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 authorizations. and we are excited for the potential launch of BYD 222 in 2024, if authorized. While we are currently focused on launching in the U.S. by ourselves with a contract deal, of course, 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.
spk04: Thank you, Jeremy. I'm excited to have joined the InVivid team at such a potentially transformative period for the company. I've been very impressed by the InVivid team's ability to execute, to plan, and by the nimble, highly motivated teams that are driving InVivid's work forward at a remarkable pace. I see great potential in InVivid's strategy and platform-based approach and believe that InVivid 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 map 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. InVivid 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 BYD 222, 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 BYD 222, 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.
spk02: Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from Patrick Truccio from HC Wainwright. Your line is open.
spk06: Thanks. Good evening and congrats on all the progress. Just the first question is just on the enrollment completion and the canopy phase three trial. Can you remind us what we need to see in terms of day 28 serum neutralizing titers and at each dose that would give confidence in the VID222 EUA submission? And then just on the EUA submission, a clarification, it sounds like you can submit following the primary endpoint data from cohort A. Is that accurate? And separately, what role, if any, would the month three redosing data in cohort A and data from cohort B have in terms of gaining or maintaining the EUA?
spk00: Yeah, thanks, Patrick. I'll let Pete answer the first part of the question. I can tackle the one about as we're preparing for a potential EUA submission.
spk09: Yeah, the primary endpoint at day 28 is that immunobridging endpoint, or serum neutralizing titers, as compared to historical data from the added travel map trial.
spk00: Right. And as we've talked about, the EUA submission package that we're working on is a combination of clinical, non-clinical, and CMC. The pivotal data from Canopy is one element of that, and is certainly one of the components that we're looking at in pulling this together. And then, in parallel, we're working on the additional supportive data from the other elements as we work towards this potential EUA submission.
spk06: Got it. That's helpful. And then, if I could, just a few on the commercial launch and the preparations, follow up on that in greater detail, you know, specifically with regard to the scale of the manufacturing and tire discussions. Are there any particular reimbursement codes or other aspects of the launch that are unique for this type of launch, particularly with regard to payer coverage? And then just as it regards slide eight, this is a broad group of patients who could benefit from BYD222. So I'm wondering if you can discuss the expected launch trajectory, you know, how you're, you know, kind of deciding how to manufacture at this stage. And if there's, you know, any particular immunocompromised patients, that would be the focus or Would this be a broader effort for the launch if CYD222 receives authorization?
spk00: Yeah, I'll let Jeremy talk to the first question about payers, and I can help a little bit more with the focus for the launch.
spk08: Yeah, thanks, Patrick. There's several steps we're taking to ensure that we have the appropriate market access plan in place, which includes coding, et cetera. And we don't At this time, it's premature for us to really give specifics on that, but we are working to be ready when it comes to launch, given we're still pre-EUA.
spk00: Yeah, and just as it regards to slide eight, so we've now, through our own market research, really cataloged this 9 million of immune compromised as the population. We've talked about this as really a subset of vulnerable, which can include people who are contraindicated for vaccines, etc., But where we really are planning the focus of the initial launch is in that upper right quadrant, that 485,000 people. And as it lists here, folks who are stem cell transplant recipients, solid organ transplants, and the variety of blood cancer patients in those areas. And as Jeremy mentioned, partly that's because these are the people who are the highest risk, and certainly are also the ones who are expected to have the highest uptake. And then it also represents an efficient way for us to bring the product to market looking at contract sales forces, et cetera, given the relatively consolidated group of people that these folks are that we could look to target.
spk06: Right. That's great. Thank you very much.
spk02: One moment for our next question. And our next question comes from the line of Michael E. from Jefferies. Your line is open.
spk01: Hi. Good evening. This is Jenna from Mike. Thanks for taking our questions. We wanted to get your take. What do you think are the gating factors for submission given that 28 days is either really soon or we've actually passed 28 days since the end of Q3? So how should we think about when you'll be able to put everything together to submit and then the next step from there and ultimately how confident you are that FDA will approve just based on titers? Thank you.
spk00: Yeah, so the first part of the question is in terms of the gating items, too. We're very excited to have fully enrolled the study. We're collecting that data. to move forward. And as we stated, what we're looking for is that preliminary primary endpoint data by the end of this year or early Q1 next year. And so for us, the gating components are collecting that information and assuming it's positive, combining that with the rest of the data package that I've mentioned, including, you know, CMC nonclinical, et cetera. And given the continued unmet need and the lack of products available, Our goal continues to be to put that submission together as soon as practicable, and we feel that the agency would be quite interested in receiving that submission given the current state of where we are. As it relates to your question about, what was the second? Titers. Titers. Oh, yeah, and whether the FDA. We had talked to the FDA previously about using titer values. That's what led to this immunobridging. And as we had stated earlier in a press release, we had reached general alignment with the FDA on that as a surrogate endpoint, being able to use that titer value as calculated from PK concentrations and bridging it back to the original AVAID trial from intravimab. And so we are very confident that using that as an endpoint was something that the FDA was aligned on for an EUA submission, again, assuming that the data supports the outcome.
spk01: Got it. Okay. Thank you.
spk02: One moment for our next question. And our next question will come from the line of Maxwell Score from Morgan Stanley. Your line is open.
spk05: Great, thanks, and congrats on the progress. So in regards to your EUA data package, how often are you required to update your in vitro neutralization assay to include currently circulating variants? And also, given the design of your canopy trial, would you expect to be authorized in both the pre- and post-exposure setting? Thank you.
spk00: Yeah, I'll let Pete answer. You can take both those questions if you like. Yep.
spk09: So in terms of how frequently we update neutralization against circulating variants, it's as quickly as possible in real time. There's no set schedule that we've received that demands them on a certain schedule. As you know, this is a kind of a collaborative approach with the FDA and the CDC and all the other monitoring authorities. So we update in real time as soon as we get the data. And in terms of PrEP versus PEP, we are pursuing the PrEP indication only, so we won't be generating any PEP data or post-exposure prophylaxis data.
spk06: Great. Thanks.
spk02: Thank you. One moment for our next question. And our last question for today will come from the line of Evan Wang from Guggenheim Securities. Your line is open.
spk07: Great. Had a follow-up in terms of some of the pre-commercial planning ongoing. Can you provide a sense of, you know, or at least initial thoughts on the size of the Salesforce needed for that targeted population approach?
spk00: Sure, Jeremy. I'll let you tackle that one.
spk08: Sure. Thanks, Evan. So we're still in that sizing exercise, but as we said, it's a very relatively concentrated market, so we believe it will be a relatively small commercial footprint that we would need to ultimately capitalize on the market that we would enter into if it's immunocompromised, the most at risk group. But we will give a little more detail as we get closer to launch.
spk00: Yeah, and the only thing I'd add there, Evan, is we've talked about this being able to utilize more of a sort of key account type model to go and call on these various systems and accounts. And as Jeremy said, focusing in that upper right quadrant, you can really go after a lot of these different individuals in a targeted way, given the sort of concentrated nature of where they are and where they receive care from their various HCPs. Great.
spk07: And then in terms of some of the pre-commercial manufacturing ramps, Can you provide any color in terms of some estimates or how extensively you plan to build that inventory? And I have two more follow-ups.
spk00: Yeah, so on the inventory side, we've begun to prepare and have a variety of commercial material at risk. What we continue to balance is both making sure that we're being as cost-effective as we can with the cash in our balance sheet, but also making sure that we have doses available. What we're really looking to do is use a gated approach. So as we move forward, continuing to ramp that up as we start to see data or get to a point of a potential EUA submission and or then launch, we have a great partner in WUSHI and we continue to look at ways that we can really optimize when those doses would be available and how we commit to them. So that's really the plan and approach now is start to prime the pump and have some of those doses available for a potential launch and then continue to add to that as we see more information and track further in the process.
spk07: Got it. And in terms of some of the, you know, phase one data, I think you guys are tracking that over time. So, just wondering how, you know, the chemics are looking over there and if there's any implications or kind of thoughts on, you know, I guess, how redosing could look in the future.
spk09: Pete, you want to take that one? Yeah, no new recent updates from the phase one data. We'll look at the totality of data coming out of that study and, of course, Canopy to make our conclusions and recommendations about redosing.
spk07: Got it. And last one from May. You know, great to see all the market research. I'm just wondering how, you know, I guess payers And, you know, KOLs are looking at, you know, how much do they value clinical data versus the surrogate? Is there kind of acceptance of this surrogate beyond FDA? Thanks.
spk00: Jeremy, you want to look at that one?
spk08: I think it's a good question. For MAVS, it certainly is a new concept, but it's not a new concept in infectious disease with vaccines using surrogate endpoints. So, we believe that there will be acceptability of this data beyond just FDA with practitioners and payers.
spk05: Great, thank you.
spk02: Thank you. I'd like to turn the conference back to Dave for closing remarks.
spk00: Thank you all for joining the call today. This is a very exciting time for Unvivid as we approach a potential EUA submission and authorization of VYD222 for the prevention of symptomatic COVID-19. which would represent a significant achievement for InVivid, but more importantly, it would be a major advancement for the immunocompromised people we serve. We thank you for your continued support and interest in InVivid, and we look forward to sharing additional updates with you soon. Thank you very much, and have a good evening.
spk02: And this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.
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