Invivyd, Inc.
Q2 2023 Earnings Call Transcript

Published: 12 Aug 2023

[Operator:]

Welcome to the Invivyd Second Quarter 2023 Business and Financial Results Update Call. I will now turn the call over to Gabriella Linville-Engler, Director of External Communications.

[Gabriella Linville-Engler:]

Thank you for joining us today. Before we get started, I want to tend to a few housekeeping items. I invite you to review our press release discussing our second quarter 2023 financial results and business updates, which can be found on the Investors section of the Invivyd website. I would like to remind you that during today’s discussion, we will be making several forward-looking statements. Forward-looking statements include 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, our expected cash runway and other statements that are not historical facts. Forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements, including those described under the heading Risk Factors in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K. It is now my pleasure to introduce the Invivyd management team to the call. I am joined by Dave Hering, CEO of Invivyd; and Dr. Pete Schmidt, Chief Medical Officer. I will now turn the call over to Dave.

[Dave Hering:]

Thanks, Gabriella, and thank you to everyone joining us today on our quarterly update call. In Q2, in the recent weeks, we’ve made significant progress towards our goal of commercializing VYD222 in the near-term and advancing our mission to protect vulnerable people from serious viral threats. Since our last call, we have announced positive initial safety data and robust serum neutralizing tighter data from our ongoing VYD222 Phase 1 clinical trial. We believe that the initial Phase 1 results are very encouraging and speak to the potential for VYD222 to provide vulnerable people, such as immunocompromised, with robust protection from symptomatic COVID-19. Shortly, Pete will provide additional color on the initial Phase 1 clinical trial results and our plans to rapidly initiate a 750-participant pivotal clinical trial of VYD222 for the prevention of symptomatic COVID-19 referred to as the CANOPY trial. With the compact size of CANOPY and a primary efficacy endpoint based on the analysis of serum neutralizing titers at day 28, the same biomarker used in our Phase 1 clinical trial, we believe that we can swiftly enroll the trial and generate the clinical data necessary to enable a potential emergency use authorization, or EUA submission. We look forward to initiating the CANOPY trial in the near-term and expect to have initial primary endpoint data by approximately the end of 2023. In Q2, we also announced that we reached general alignment with the FDA on a pathway to a potential EUA for VYD222 and anticipated follow-on candidates designed to prevent symptomatic COVID-19. We are very encouraged by the rapid development pathway outlined by the FDA and the opportunity it provides to leverage our previous work developing adintrevimab to accelerate the development of VYD222. We believe we are one of very few companies positioned to potentially meet the criteria that the FDA outlined for this streamlined development pathway. Importantly, with this pathway, we see a near-term opportunity to bring much needed protection from symptomatic COVID-19 to immunocompromised people. Before I hand the call over to Pete to talk about our plans for the transformational period ahead, I want to briefly underscore three important points. First, the need to protect vulnerable populations from COVID-19 remains as urgent as ever. Immunocompromised people continue to be at higher risk for severe COVID-19 related outcomes. And more broadly, COVID-19 continues to be a deadly threat. Roughly halfway through 2023, before we have even entered the fall and winter months, the CDC estimates that more than 43,000 deaths in the U.S. are attributable to COVID-19 this year. That is more than 43,000 deaths where COVID-19 was listed as the underlying cause or a contributing cause of death on the death certificate. For context, consider that RSV is estimated to cause roughly 14,000 deaths per year in the U.S. among the groups at highest risk for RSV and that pre-COVID levels for flu-related deaths have fluctuated between 23,000 and 52,000 deaths per year in the United States. COVID-19 remains a substantial driver of morbidity as well. The National Center for Health Statistics estimates that roughly 1 in 7 adults in the U.S. have experienced long COVID at some point, which adds to the unique and unacceptable burden of this disease. While many have accepted the status quo and are trying to live with COVID, we continue to argue that all are not living well, particularly vulnerable population. Second, we believe that protecting immunocompromised people from COVID-19 is a large ongoing need and opportunity. In the U.S. alone, there are an estimated 8 million to 18 million immunocompromised people who may not generate robust protection from vaccines. To our knowledge, Invivyd is one of very few companies in the clinic now with a monoclonal antibody candidate in development for the prevention of COVID-19 in this population. Consider that Evusheld alone captured $2.2 billion in total revenue in 2022 with strong growth prior to its removal from the market when it lost activity against emerging SARS-CoV-2 variance of concern. 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 for the immunocompromised patients if it were still available and relevant to circulating COVID-19 strain. In the coming periods, we look forward to sharing more insights from the market research we’ve conducted to further refine our understanding of the different immunocompromised population and the views of the clinicians who care for the different types of patients who may be chronically or temporarily immunocompromised. Third, we believe that Invivyd is uniquely positioned to rapidly and perpetually deliver mAb therapies that can keep pace with viral evolution and protect the vulnerable. Our company and our discovery platform are built on the premise that serial innovation will be required to provide vulnerable populations with continuous access to mAb therapies that protect against serious viral threats, a strategy that is similar to the approach used to periodically modify vaccines in response to viral evolution. To anticipate and quickly respond to viral evolution, we are leveraging state-of-the-art viral surveillance, predictive modeling and advanced antibody engineering techniques designed to generate a pipeline of optimized mAb candidates that could be deployed in the future. We see COVID-19 as the optimal starting point for Invivyd due to the speed with which products can be brought to the market using the EUA pathway. From there, we believe that our platform could also be applied to protect vulnerable people from other viral threats such as influenza, an area where we have an early discovery stage program. I will now pass the call to Pete Schmidt, our Chief Medical Officer, to discuss in more detail our initial Phase 1 data, pivotal clinical trial plans and regulatory pathway.

[Pete Schmidt:]

Thank you, Dave. Excuse me. We are pleased to have recently shared positive initial data from our ongoing Phase 1 clinical trial of VYD222 which enrolled 30 healthy volunteers across three different dosing cohorts. Participants were randomized 8

[Dave Hering:]

Thank you, Pete. The details of our second quarter financials are included in the press release issued earlier today, so I won’t reiterate all of the details here. Invivyd ended the second quarter of 2023 with $298.4 million in cash, cash equivalents and marketable securities. Based on our current operating plans, we 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. As you may recall, in past quarters, we guided to the second half of 2024 on runway, but have refined our guidance now that we have finalized the size of our CANOPY trial. We believe that we are well capitalized to execute on our strategy and create value for our stakeholders. With that, operator, please open the call for questions.

[Operator:]

[Operator Instructions] Our first question comes from Maxwell Skor with Morgan Stanley. Your line is open.

[Maxwell Skor:]

Hi. Thank you for taking my questions and congrats on the updates. Just can you elaborate a bit more on the profile of Cohort B? Will these patients be vaccinated, unvaccinated, boosted? And how do you plan to evaluate clinical efficacy? Also, did the FDA provide guidance related to how long you have to follow these patients to fulfill the safety requirements? Thank you.

[Dave Hering:]

Hey Max, good question. In terms of Cohort B, this is what we call an all-comers cohort, so we really aren’t concerned with their vaccination or exposure status. And the clinical end points for that cohort will be as they were in EVADE, so symptomatic disease, anyone who gets symptomatic COVID. In terms of follow-up, we haven’t really stated. We will put those details up on clinicaltrials.gov when we initiate the trial.

[Maxwell Skor:]

Great. Thanks.

[Operator:]

One moment for our next question. Our next question comes from Evan Wang with Guggenheim. Your line is open.

[Evan Wang:]

Hey guys. Great to see all the progress from the Phase 3. I had some follow-ups on the trial design. It does seem significantly smaller compared to the SUPERNOVA trial. So – and I know there is a focus on garnering FC data from FDA. So, is this smaller trial really just driven by the platform? And if you could share more color on generating some of the FC data? Second, on enrollment and down by year-end, can you talk about what’s remaining to get the trial started, confidence enrollment and whether you need both cohorts to file for approval especially it seems like it positions you pretty well versus AstraZeneca with your data by year-end? And then third, just thoughts in terms of the commercial opportunity of this immunocompromised and all-comers. I know the focus there has been on immunocompromised, you are seeing. So, just wondered if you have updated thoughts on some of the all-comers commercial opportunity. Thanks.

[Dave Hering:]

So, I will take the first part of this, and then, Pete, you can tag on. So, as it relates to the size of the study versus SUPERNOVA, I mean I can’t comment specifically on why their trial is the size that it is, not knowing that. But I think what’s key is we have started and had these conversations since that December FDA meeting where they had a joint FDA/EMA session talking specifically about how to accelerate mAb development in – against COVID-19. And that’s where they first started bringing up this prototype concept. And then certainly, as we are into our Phase 1 study, we got further detail, which we put forward in a press release talking about this immunobridging concept and being able to utilize specific data from adintrevimab. I think SUPERNOVA has gone through a variety of iterations and clinical trial design, which may have impacted that. I don’t really know. But specifically, when we look at this, Cohort A allows you to get this titer level data quickly in a small subset of the overall trial. And then Cohort B gets you the necessary safety end that you need to pull together – to put together a package for a potential EUA. You can talk a little bit, Pete, about starting and enrollment, some of the other pieces that Evan asked about.

[Pete Schmidt:]

Yes. And to clarify in Cohort B, it’s exactly what Dave said. I don’t think there is necessarily an intent to pursue a commercial opportunity there. That’s really just to provide the supportive safety database as it’s – as you can imagine, it’s easier to enroll all-comers than specifically the immunecompromised. And in terms of recruitment and what we expect, I think it goes to what I was saying about this registry we created. So, every individual in that registry has identified as immune compromise and has expressed interest in an interventional trial. So, we are very pleased to have that ready database of over 1,000 individuals, and we think that a large proportion of them will be very interested enrolling quickly.

[Dave Hering:]

Yes. The only thing I would add, Evan is, as it relates to the commercial opportunity, I mean we are focused on the vulnerable population, which could be argued to be just about all of us given the current state of protection and where we are with variants. With that said, our initial focus has always been on this immunocompromised group, folks who have been contraindicated against vaccines, etcetera, those who are at highest risk for severe outcomes from COVID-19.

[Pete Schmidt:]

And in terms of activities necessary to initiate CANOPY, it’s largely just the box checking stuff that you have to do before you start a trial. I think we have passed all the major hurdles. We haven’t provided specific guidance on when we are going to start, but you can see that we did say we will release some preliminary primary efficacy endpoints data by the end of – by around the end of 2023.

[Operator:]

Thank you. One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

[Unidentified Analyst:]

Hi. Good evening. Thanks for taking our questions. This is Jenna on for Mike. We have two questions, if we may. First question is at this upcoming year-end readout of initial pivotal data, what are you looking to show? And what is the bar? Are you looking to replicate the Phase 1 results, which was already great, or are you looking to show even higher titer levels? And then second question is, from that point forward, what are the key milestones afterwards? And how soon could you expect to be on the market? Thank you.

[Dave Hering:]

Yes. So, yes, so from the preliminary data that we are talking about around year-end, it would be similar to what we saw in the Phase 1, the titer values. That said, it will be based on an analysis for day 28. So, it’s slightly different than the day seven Phase 1 data that we provided there, but similar in terms of we are looking for high titer values. They don’t have to be equivalent to the Phase 1, but based on everything we saw from Phase 1, it’s repeating that in this Cohort A and getting some of that preliminary data. And so that would confirm what we have seen in Phase 1 and what we are expecting to see in CANOPY. Key milestones after, right, for an EUA submission, you need the clinical data. You need a preclinical set of activity, CMC, etcetera. We believe we can assemble all of that quite rapidly. And certainly, we will provide more information and guidance as we get closer to this clinical information, etcetera. But certainly, it’s something that we are looking to do as quickly as possible especially as we are starting to see an uptick in COVID cases, an increase in hospitalizations, etcetera, even prior to the fall and winter season. And so certainly, it’s not lost on us that time is of the essence and in a situation where there are no mAbs on the market, one that we are looking to rectify as quickly as we can.

[Unidentified Analyst:]

Great. Thank you so much.

[Operator:]

One moment for our next question. The next question comes from Patrick Trucchio with H.C. Wainwright. Your line is open.

[Patrick Trucchio:]

Thanks and good afternoon, and congrats on the progress. I have a couple of follow-up questions. The first is just I am wondering if you can talk about the new COVID variant, EG.5. What have we seen so far with these cases of COVID-19? How different or similar is this variant to XBB.1.5? And would you expect VYD222 to retain activity against this variant?

[Dave Hering:]

Yes. On the first piece, right, I mean we continue to see viral evolution. That’s I guess one of the most critical components of the Invivyd strategy, right, which is we expect the virus to continue to evolve, which is why we see serial innovation as the answer, continuing to update antibodies, etcetera. As it relates to EG.5, we are looking to pull in and get in vitro data on it. But based on what we have seen so far, our belief is that it wouldn’t cause a significant activity reduction to VYD222. And so we will take a look at that now that it’s the predominant variant and do some additional confirmatory test, etcetera. I do think we have seen a progression from the summer into now, which is, like I have said, not unexpected. We continue to do a variety of surveillance and predictive modeling on our side and look at mutation specifically, so even before they become specifically designated variants. And so that’s how we continue to look at what do we see coming, which ones would we like to start to test against, how we start to bring in assays against those and prepare for different eventualities. So, that’s really, like I have said, embedded into how Invivyd is structured in our strategy and looking to assess and then respond to the different variants as they emerge.

[Patrick Trucchio:]

Great. And then just a clarification question. Is the expectation to have primary endpoint data from both Cohorts A and B at the end of 2023? And can you talk to us about the potential for government contracts for VYD222, or would this be primarily be commercialized through sort of traditional channels and methods? And then just lastly, can you talk about advantages of VYD222 compared to some of these other antibodies in development for COVID-19? And what are some of the advantages perhaps of the dosing schedule or others that you can point to relative to those approaches? Thank you very much.

[Dave Hering:]

I can take government contracts. You want to take first the preliminary data we are expecting from the primary endpoint at around the end of the year?

[Pete Schmidt:]

Yes, that’s a good question. So, our understanding and plan is actually that we don’t need the serum neutralizing titer data from Cohort B. There, that group just serves to increase the safety database, the exposure needed for an EUA. So, the preliminary data you will see will just be from the immune compromised cohort, which is Cohort A.

[Dave Hering:]

Yes. And then related to your question about government contracts, based on the current environment and transition, we are not anticipating government contracts as the primary source for really putting much in terms of our commercial readiness related to government contracts. We are preparing for a traditional market, your activities related to reimbursement in payers and market access, etcetera. And so that’s really the focus of the team now as we are preparing for a potential launch and being ready for that in a traditional market. That said, a variety of the different acts that Congress took during the pandemic do provide different reimbursements and things of coverage for Medicare, etcetera. And so we continue to look at all of those. So, even without government contracts, as we saw during the pandemic, there still is a variety of support that has been put in place for COVID-related products. As it relates to advantages of VYD222, one of the things that we have been saying for quite a while is 222 is a reengineered version of our original antibody ADG20. And we did this through an affinity maturation process and did it looking at the BA1, BA2 backbone of Omicron. And so with a set of slight changes, a, amino acids, we were able to reestablish binding where ADG20 has lost. ADG20 came from a SARS-CoV-1 survivor. And so we continue to see that 222 has broad neutralizing activity and is one that we really see as an antibody that, to-date, has not occurred in a natural setting. And so we feel that it provides us a higher probability of duration of activity. And so that’s what we continue to look at and test, but we think that’s probably the most critical advantage, which is being able to have prolonged activity as our hypothesis for 222. Beyond that, we continue to see that by utilizing the adintrevimab, the ADG20 data, that allows this platform as well to be quite a significant advantage. As we said, we see that Invivyd is one of a few companies who could utilize existing data that was done previously. And that’s quite an advantage as it relates to pursuing EUAs in a much faster fashion than running full clinical endpoint studies, especially given the current environment and looking to recruit patients.

[Patrick Trucchio:]

Okay. Thank you so much.

[Operator:]

And I am not showing any further questions at this time. I would like to turn the call back over to Dave for any closing remarks.

[Dave Hering:]

Thank you all for joining the call today. It’s a very exciting time for Invivyd as we get closer to milestones that we believe would be quite impactful for patients, our organization and shareholders. We thank you for your continued support and interest in Invivyd, and we will look forward to catching up with any of you individually over the coming days. Thank you so much.

[Operator:]

Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.