Welcome to H.C. Wainwright's twenty-sixth Annual Global Investment Conference. I'm Luis Santos. I'm a healthcare analyst at H.C. Wainwright, and it is my pleasure to introduce Bill Duke, CFO of Invivyd, a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from viral threats, starting with SARS-CoV-2. Welcome, Bill. It's a pleasure.
Thank you. Thank you for having us.
Can you provide us with a brief background on Invivyd and tell us about the history of the company?
Sure, so Invivyd, as you had just highlighted, is focused on delivering protection from serious viral infectious diseases, and our starting point is SARS-CoV-2, so we have most recently, in March of 2024 , received an Emergency Use Authorization for our drug, Pemgarda, and Pemgarda is our first mAb in a planned series of innovative antibody candidates, and our focus there is delivery of protection to the immunocompromised, and so these immunocompromised patients are ones that suffer from underlying afflictions and make them very susceptible, because of their immune system has been depleted, make them very susceptible to COVID, and as a result, if they were to get COVID, can often lead to hospitalizations or even worse outcomes for themselves.
Thank you for that introduction, and can you discuss Invivyd's approach to helping COVID patients, where the unmet need is right now, given the current situation?
Sure. So we look at COVID as a disease that we've kind of been dealing with for quite some time now, and we don't believe it's going anywhere. In fact, it is constantly mutating, and new variants are popping up. And as a result of that, some therapies in the past that have been useful are becoming less helpful for patients, including vaccines. So vaccines, of course, are helpful if you're a healthy, normal you know, individual, not suffering from underlying diseases, but has varying degrees of success depending upon the variant. What we are focused on is delivering of monoclonal antibodies that can help patients raise titers to actually help fight off infection. And so the immunocompromised, as we describe it, in the U.S., we're looking at approximately nine million patients that suffer and have immune comp...
are immunocompromised. We currently are focused on a subset of that, approximately 500,000 of those patients, and so again, these are people that, if they were to become infected with COVID, can lead to very serious outcomes, and as a result, right now, prior to Pemgarda coming on the market, really didn't have any opportunity for prevention.
You mentioned your antibodies and your approach. What is differentiated about your platform? Can you tell us more about that?
Sure. So we utilize a proprietary INVYMAB platform that combines state-of-the-art viral surveillance and predictive modeling, along with advanced antibody efficiencies, engineering efficiencies. So what this allows us to do is, we are constantly monitoring the variants that are in circulation, seeing how our Pemgarda product matches up against those variants, as well as a future pipeline program called 2311 , that we can talk about in a little bit. And we're constantly watching to see how those how our drug and our candidate performs against these variants. Again, the surveillance allows us to. We take information that's coming out of wastewater, et cetera, and look to see what we think are gonna be the future dominant strains and how we think that we will continue to be able to protect patients against that threat.
And on the partnership side, could you tell us more about the current partnerships you've established and how that, those may help your platform?
Yeah. So as part of our engineering development, we have an initial agreement with Adimab, which was a company in New Hampshire that allowed us to kind of piggyback off some of the things that they had discovered early on. We have since modified our approach and kind of built upon that, and that's where our INVYMAB platform that I just described comes in. As far as external commercial-oriented partnerships, that is not something that we have currently entertained just yet. It is something that we think is going in the future, that we could look at potential regional and/or pipeline programs. But for right now, we are focused with our Pemgarda in the U.S., and we are currently doing that with our own external sales force.
And on Pemgarda, touching on Pemgarda, you've announced the first shipment of the first order of Pemgarda in the U.S. that has an Emergency Use Authorization as a preventive antibody therapy for COVID. Can you tell us more about the pathway to approval? How did that go, and which population?
Sure. So we initially launched our first-in-human trial in March 2023. We were able to progress that trial through and use those results in conversation with the FDA to then set up a trial, I'll call it, that would lead to a potential authorization. So we kicked off that phase 3 trial in September 2023. We used those data and were able to file for our EUA in December of last year, and then roughly three months later, we received our EUA. So a rather rapid timeline when you think about first patient in to ultimately receiving the EUA in approximately exactly one year's time. As far as that goes for us, we were quite pleased with that progress.
We think that as we look to our next pipeline program, of course, it helps to have the benefit of that past history, and there may even be some efficiencies that we can build in.
Can you tell us more about those efficiencies?
Sure. I think that really for us, it's about trial, initial trial design. We've obviously also worked with sites that can help us enroll patients in a rapid fashion and worked with clinicians so that they're ready and able to actually do it. So think of it as the first time through you do anything, there's some learnings along the way, where we're able to utilize those learnings. The other benefit that we have is we've had constant communication with the FDA through this process, through the actual application process, and then post-issuance, constant communication with them about where we are versus certain variants, et cetera, and that leads to fact sheet adjustments.
I think that all that knowledge compiled together actually leads us to believe that the right way to think about next gen products is that we've already set the ceiling, if you will, for the time frame, and then we'll test to see if we can kind of bring it down from there.
How often are you updating those fact sheets?
It really depends. It depends on what's happening from a virology perspective and the variants. And so from that perspective, you know, we have regular communications. You know, we're doing our own surveillance of variants. The FDA will oftentimes ask, "How are you performing against a certain variant?" Lo and behold, we've already started to assay work on that, and we'll. You know, case in point, you know, just last week, we released information with regards to KP.3, KP.3.1.1, and we actually were able to show that we had strong results against that. Now, that really, that information has been conveyed to the FDA, and we're looking forward to working with the FDA on a fact sheet revision that will include that, those.
This is, from what I understand, the antibody is targeting an epitope that has been largely conserved, even in these variants, including KP.3, which is a descendant from Omicron, but it's the most predominant right now, according to the CDC.
That's correct. Right now, KP.3.1.1 is approximately, according to the CDC, approximately 42% of the variants in circulation right now. Whether or not that continues to rise, the way that JN.1 did last winter, remains to be seen, but right now, that is the most dominant strain. Now, we are always looking at how we're performing against the most dominant strains, but also looking at strains that might be beginning to become in circulation, that we think have the ability to actually overcome some other variants and kind of take a more dominant presence. So that's one of the surveillance monitoring side of the platform technology that I was speaking about earlier.
How has the launch of Pemgarda been so far, as cases are starting to pick up here?
We've always guided that we would be a back-half-a-year revenue company in terms of slope trajectory. That being said, we launched in May. We actually had our first sale in May. In our Q2 earnings, we disclosed number of accounts that we had, and we showed a trajectory of at the start of May, we had one account that had ordered. By the end of June, we had 113 or 115 accounts that had ordered, and then we also released that in July, we closed with 208 accounts that had ordered. Now, again, that's just looking at accounts that had made at least one purchase. That's the trajectory that we're looking to continue to expand upon.
We've always looked at it and said, as people move back indoors from summer activities, as people get back to school, et cetera, that is the, quote, unquote, "peak respiratory virus disease season." And we think that, you know, while we're approaching this for immunocompromised, and their susceptibility is all year long, their care team's focus will definitely rise with this upcoming viral season. And so if we think about, you know, just how the vaccines, you know, the majority of their revenues are in that September to December timeframe, we're looking to see a bolus for ourselves during that timeframe as well.
You have guided for a yearly revenue for 2024 of $150 million-$200 million, so it seems like we're about to get some data on that.
Absolutely. Absolutely. So by the time that we actually issue our Q3 results, it will be sometime in early November. Obviously, we'll have the benefit of hindsight on Q3, but also we'll have an early-stage look into Q4. We think that the signs that we're seeing and the things that we have been doing to help lay the groundwork in preparation for this upcoming season has really started to take hold. As you know, you and I had a side conversation before. We brought on a new chief commercial officer in June. So Tim Lee joined the company from Amylyx. He's also been at Biohaven.
What we really like about Tim and what he was excited about to bring his experience was he comes from both a rare disease as well as general medicine background, had very successful launches under his belt, in both. But the rare disease was really interesting to us because COVID is not a rare disease, but we are targeting the immunocompromised, which often their underlying conditions may be rare diseases. So we are targeting stem cell and solid organ transplant patients, as well as hematological cancers patients. And so these care teams reside throughout the U.S., but their real focal point is approximately 1,200 unique centers across the country, which is... That 1,200 has allowed us to build a very reasonably sized sales force that can go and serve those centers.
Very interesting. Moving ahead, the next step would be filing an Emergency Use Authorization for treatments. What is the status of that?
So we have filed that for treatment. We were able to do so and announce that. I think we gave that update on our Q2 call. So we are in discussions with the FDA around that. You know, we were waiting on some key variant data, and we were able to release that on KP.3.1.1, and so I think that those. We look forward to having those conversations accelerate a bit with the FDA. Again, full EUA is one of those things that there's not a timetable per se that you can kind of map towards, but our past experience is that when we engage in discussions with the FDA, they pick up steam and can kind of see through to positive good conclusions. So we look forward to continuing that dialogue.
And how do you see Pemgarda fitting in the Paxlovid paradigm? Are there any advantages in immunocompromised people?
Yeah, I mean, Paxlovid has varying degrees of success, depending upon the variants that are circulating. The thing that we like most about the Pemgarda, obviously, is we've already shown that it can be very helpful for these immunocompromised patients. We released CANOPY data, again, earlier this month, that showed that the hundred and eighty day CANOPY data was extremely effective for these patients against the JN.1 wave. Everything that we've seen to date so far for the major circulating variants is that Pemgarda continues to have that activity. We think that that also can help in a treatment domain. So that's something that we, you know, once we got the EUA authorization for prevention, we had discussions with the FDA, and they, they encouraged us to, to file a treatment authorization as well. So that is what we've done.
As far as the advantages go, again, it's really about the susceptibility to variants, and the lowering of their immunocompromised state. So we feel like Pemgarda offers a unique alternative there.
That's great. And between the PrEP indication and treatment, what is the proportion of revenues that you estimate?
Yeah, yeah, we haven't gone that far in with any public realm. The other thing is, because we don't have control over the timing of when the treatment EUA could come to fruition, our revenue guidance right now is based off of Pemgarda sales in from prevention. I think if anything were to happen during the season, you know, for treatment, it could potentially be a bonus to us. That being said, treatment is also something that we're looking at with our next gen product, and I know that we're gonna hopefully talk a little bit about that as well.
That's a great segue for your other program, VYD-2311.
Yes.
Can you tell us more about that program and how, what are the next steps for that program?
Sure. So we just launched our first-in-human trial that is being done in Australia. The same sites that we actually utilized when we took Pemgarda through that route. So there's some efficiencies there, and we're pleased to be working with the teams in Australia. With regards to what we like about 2311, we like the fact that it's it. Early signs are that it has a high degree of potency, and for what that could translate to, it could translate to a lower IV dose, it could transfer to a change in administration, potentially IM. And then further down the line, you know, we could explore subcutaneous. That being said, you know, we still have to conduct these trials, so we're excited about the potency.
We're also excited about the fact that, as Pemgarda has shown, that it's very active against variants that emerge. We've seen the same type of thing with VYD-2311 in early stage pseudovirus assays.
Do you plan to launch it or to pursue the PrEP indication or treatment first for this program?
We have not disclosed that yet, but I can tell you that we like the pathway that we've established so far with the FDA. So again, this first-in-human trial results. We believe that we can have those later this year. We will then have discussions with the FDA about what that translates to in terms of a registration study or an authorization study, because we're still looking to follow that EUA pathway. And as a result of those discussions, that would then be part of whether or not we are looking at solely prevention or prevention slash treatment.
That makes sense, and for that, I guess, your cash position plays a role.
Absolutely
... and it's going to be evolving. Again, more data to come in the next couple of months. I think, so what will you be focusing your resources for the next coming months?
Yeah. So what we've disclosed is that at the end of Q2, we had approximately $150 million, just under $150 million of cash and cash equivalents. You know, right now, our key focus is on two things. We're focused on, very much on the Pemgarda launch and also the next gen product, 2311, clinical advancement. In terms of an allocation of resources, right now, so much of those resources is being pushed into the commercial launch, but at the same point in time, we are also developing. We've already developed clinical material for 2311, and we're in the early stage of commercial development because in order to ultimately file an EUA, you have to have commercial-ready inventory available. And so because of the manufacturing process, you need to start that in advance. So we're excited about the prospects here.
We're excited about where we are in development, as well as what we're seeing in the early stages of the launch. You know, when it comes time to. We're continuing to consume cash through these various processes, especially advancing VYD-2311. That being said, we're really excited about what we're seeing early on in stages of the commercial launch. We look at selling a product as the best and most efficient way for us to raise, you know, raise our cash balance. That being said, we're always looking at additional opportunities. If we see good momentum, there may be an opportunity to actually bring money in the door to accelerate certain other activities that we would choose to do. But for all intents and purposes right now, focusing really on those launch activities and the pipeline.
That makes sense. Looking beyond COVID, what's the status of your discovery engine for influenza?
I mean, we continue to have influenza in our pipeline charts. The vast majority of our funds are definitely dedicated right now to COVID-19 and for treatment and prevention, and we think that right now that is a very large potential total addressable market between those populations. And I think that as we continue to see success, that's when we will kind of look towards other pipeline activities and other program activities.
I'm just curious, if you did pursue the influenza pipeline, would that be in immunocompromised people as well? Or-
To be seen.
Very well. And can you just tell us what investors are missing about Invivyd story?
I think the fact that COVID isn't going anywhere. You know, we're all sitting here in an open forum today, and we do so taking comfort from the fact that if we were able to get-- if we did get COVID, we would deal with it a few rough days and be able to go on with our activities. There's a subset of the population that that's not the case for, and it's that subset that we're really targeting and looking to help. I can tell you, by working with patient advocacy groups, they're really pleased to, quote, unquote, "Not be left out in the cold on this," and so they're pleased to have a therapy that they can take and feel good about.
Great. Thank you so much. Bill Duke, CFO of Invivyd, thank you very much for attending.
Thank you.