Okay, great. Welcome, everyone, and thanks for joining us for the fireside chat with Invivyd. I'm Evan Wang, one of our biotech senior analysts, and I'm joined by Invivyd Chief Financial Officer Bill Duke. Bill, thanks for joining us. My pleasure. Just for those unfamiliar, could you give a brief introduction on Invivyd and Pemgarda? Sure. So Invivyd is focused on delivering therapies for immunocompromised people suffering from various viral infectious diseases. Our initial focus is on COVID-19. We have been focused very much on that, and we received our EUA in March of this year for Pemgarda. Pemgarda is a monoclonal antibody that is targeted to help with the prevention for the immunocompromised population of getting COVID-19. These people are very susceptible and the consequences of them contracting COVID-19 can be quite problematic, including hospitalization or untimely death. That is where we are focused. We've been able to, in a very expeditious way, move from first in human with Pemgarda in March of 2023 to the EUA in March of 2024. So in just under 12 months, we're able to execute on that strategy. This is a strategy that we think is repeatable. Right now the company is very much focused on Pemgarda in the launch of Pemgarda and getting that into the patients that need it most. Great. So, you know, I guess since the pandemic where we had multiple antibodies, now we only have one, you guys. So I guess what drove that change and what made you guys successful? Sure, so there were other players that were in the space and have tried to get into the space. I think the biggest thing that probably led to us being the only one on the market right now is the inevitable viral evolution of COVID. What's been helpful for Pemgarda and for Invivyd is the fact that our targeted receptor binding domain has remained very much intact, and as a result of that, we are able to block the virus from attaching itself and can help patients that very much need to do so. The fact that we have a platform technology has allowed us to move expeditiously through the authorization trial and then ultimately grant authorization, and then, of course, as we said before, we're focused on COVID-19 right now, but that is something that can change in due course. Great. And you guys navigated somewhat of an uncharted path territory with development of Pemgarda and COVID antibodies in a post-pandemic setting. I think it was you guys and AstraZeneca kind of leading the way there. How, what, what does future kind of development look like? How have you kind of accelerated development here and what is support from FDA? Sure. FDA has been a partner to us and obviously navigating through the EUA process was done with great consultation from the FDA. Going forward we continue to test Pemgarda against up and coming variants. We have the platform that can actually identify what we think is going to be the next variant of concern. We are constantly looking at our own internal work to see how Pemgarda and our next generation asset VYD2311 will stack up against those variants. It is an ongoing process. I think that for us right now with Pemgarda, we are in a one hour long infusion, it's 45 milligram dose. It's something that for the patients that we are going after, the route of administration is not problematic. That being said, we feel like with a next generation we may be able to change the product profile, change the overall dose and maybe even the route of administration, which may allow even more immunocompromised people to actually get this product more rapidly. Great. Can you talk about some of the data you've generated in the pivotal trial, some of the immunogenicity data, and you've also been presenting on some pretty interesting clinical data too. What was the data, and I guess what's been the reception from the community on this data? Sure. So the nice thing about it is from a timeliness perspective, we were just recently able to get our exploratory clinical data into the fact sheet. And so we've been able to show that through six months, which is two doses day zero dose and then on day 30 dose that we've been able to show a relative risk rate of infection of 84%. And so that is a significant drop versus what people would have with placebo. I think that getting that data into the fact sheet has really been helpful. We've been able to kind of use that data in conversations with physicians prescribers out at ID Week. I think that people really appreciate the fact that that's now inclusive in the fact sheet. Of course we got to authorization using an immunobridging approach showing that demonstrated titer levels across variants that were in circulation. But now having true clinical data to point to I think has been very helpful. Great. And just to clarify, just given the concern on circulating variants, what has activity been for Pemgarda? Are there any variants of concern? Sure. So what we've been able to demonstrate and we've been able to do so and get it into our fact sheet as well is that KP.3.1.1, which is a significant variant in circulation right now and has been so since the summer months, that we've shown good activity against that. And so. So the fact that we have been able to show most recently we have 12-month data, which means that it's 6-month follow-up where people did not receive any additional doses and in months seven through 12 we've been able to show a relative risk rate of infection of 64% while not receiving any further dose. I think that's been very helpful for people to see and so that data has been extremely helpful. I think that that is also going to. We just announced that we had a preprint that was initiated. It's not yet available, but the submission has occurred that CANOPY data is part of that preprint. And then there will be another preprint that shows our own internal methodology where we can surveil antibody against new novel variants. In that methodology gave us an early look to show that we expected to have good activity against KP.3.1.1 and now it is showing that we expect to have activity against XEC variant which is a rising variant in circulation. Now that's still pending our external in vitro neutralization assay data which is conducted by Monogram/L abcorp and we should have that in weeks to come. Great. And as you've been launching this year, you've built the management team to support that. Can you talk about the hires there and how have you kind of prepared for launch? Sure, so we launched in the spring of this year and we did so with an external sales force and we have been making some shifts along the way to internalize some of those sales resources. The fact is, you know, we did not necessarily know the timing of the EUA grant, so the external sales force concept made it so that we could have something available at a moment's notice, and that really worked out quite well early on. Now that we actually have more traction and more evidence of what is needed in the space, we've been able to target bringing certain people in house and that's really worked out well. We hired a Chief Commercial Officer this summer, Tim Lee. Tim has been a great add to the team, really working well with the sales force as well as the marketing team to make sure that we can get out in the forefront for prescribing physicians as well as the patient communities. Great. So on the launch the indication is for moderate to severe immunocompromised. How large is that population? I guess how large of a sales force do you need to target that effectively? And I guess what is the market opportunity here? Sure. So that concept, the overall U.S. population is greater than nine million. Of course, we are targeting right now cancer patients, stem cell transplant patients, organ transplant patients. And that patient profile kind of brings down the population to roughly 500,000. Now, we will be expanding that as time goes on. But that initial 500,000 can be really well serviced. And you can strike a very large percentage of that by adhering to some of the large healthcare centers. And there's about 1,200 of those across the U.S. so because of that size population, we feel like we are able to do so with a reasonable size sales force. And so we are pleased about the uptake that we're having. Also by bringing these sales people internal as opposed to external, we feel like we're going to be able to get the best and brightest and move forward in a productive way. Great. I guess. How well penetrated are you now into some of these sites? I know you've been pretty active at medical meetings too. What's been the feedback or why have they joined or why haven't they joined or, you know? Sure. I think the biggest thing to understand is that this does take some time. Part of it is getting through formulary committees and et cetera at some of these larger institutions. We've made some good progress on those fronts. We're looking forward to making a real strong push to get even more centers on board. And part of the reason that we're augmenting our sales force is to really kind of push forward that strategy. I think that one of the benefits that we are now seeing is that again, as opposed to on the f act sheet, that purely speaks to the immunobridging. Having real clinical efficacy data in there is very helpful. And of course, it was exploratory data. But now having that in the four corners of the fact sheet means that we can actually speak to that with the prescribing physicians and at the infusion center level. Great. I do want to touch on, you know, the kind of label amendments that happened recently and concerns on variants of resistance. I know that's been resolved now, but you've commented that that's, you know, impacted the launch a little bit. Are we beyond that now? I guess. How has reception been after that? Sure. I mean, we feel like we're beyond it right now. It was unfortunate and we feel like it could have been avoided. But what ultimately happened is that included in our fact sheet. The FDA had included some non peer reviewed third party non-promising activity data that would suggest that Pemgarda would not be active against circulating variants including KP.3.1.1. Very shortly thereafter we had our own third party data from Monogram in vitro assay data that actually showed that we retained activity against KP. 3.1.1 as well as other relevant variants that were in circulation at that time. There was about a one month time frame between where that information was. The third party data was included in our fact sheet that has since been resolved. It was resolved at the end of September and to be honest, we're pleased where the fact sheet resides right now. But that did, you know, we definitely faced some headwinds because of that. The good news is that as I mentioned before, IDWeek came at a really good time. It was early October. Our revised fact sheet was done at the end of September, gave us some real pertinent information to get in front of physicians and speak to. So the reception on that has been positive. Great. And so that's been building awareness after that. I'd really help, I guess. How else are you physicians getting information on this EUA. You know, a lot. Of feet on the street and getting out in front of them as much as possible. There's been some social media campaigns, et cetera, that have actually been targeted. But to be quite honest, it's really the job of our sales team and our marketing efforts to kind of get in front of the prescribers in the infusion centers, letting them know that there's an antibody that's out there and available and actually has shown great activity against the circulating variants. And I think the key to note is that everything that we've tested against to date. We've remained active. Now we will have the third-party data on the XEC variant in the coming weeks, but at least our internal assessment in our internal process to date has shown that we expect to remain active. Great. And so I think when we look at your site availability, we see over 400-450 sites available. I think that might, you know, you've come with that might actually underreport, I guess. How has uptake been at these sites? What are we seeing in terms of orders, reorders? Are there any kind of color you can provide there? Yeah, I mean what I will say is as we entered August we were seeing very good ramp. We actually faced those headwinds that we just talked about with the fact sheet that took a little bit of time to kind of overcome. The revised fact sheet came in at the end of September, so we saw a flattening. Now that we have what we call a properly stated fact sheet, we feel like we have good momentum heading into the holiday seasons where people are going to want to be indoors with family. We are the only monoclonal antibody on the market for prevention. We think that we provide a good level of protection, a very strong level of protection, especially in comparison to vaccines alone, where for the immunocompromised they don't necessarily work oftentimes because they have a completely ablated immune system. And you need a healthy immune system for the vaccines to take hold. So an antibody therapy is one that can really help these patients. And we believe that we're in position now to kind of capitalize on that and help patients that are really in need. Got it. And I know it might still be early, but in terms of patients and their, I guess, habits with Pemgarda, are they redosing, are they kind of continuing protection on or is this kind of focused on this kind of fall vaccination season? Are they just going for one dose? Yeah, I think it's very early to kind of comment on that. That being said, what I will say about this targeted population is that they are very adamant about making sure that they remain protected. So I think that when you talk about them, if you're able to get them on therapy and they're actually able to get the dose and see that the dose is working, these are people who we expect to come back and come back regularly. They know the impact that COVID can have on their underlying disease states. And so as a result they're very vigilant. Great. Should we be thinking about this in sort of like the typical seasonal flu vaccine season where we see some of this peaking already and kind of declining? Or is this something that could be a little bit different? Yeah, I think it could be a little bit different in that for prevention they're concerned about it 12 months a year. And so when I say they, I mean the immunocompromised. And so whether it's the summer months or if it's the winter months, I think that they're constantly looking for protection. And so for that I definitely think that, you know, the fall and winter seasons, you know, for the non immunocompromised, it's definitely more. Their awareness is much more heightened and they may be a little bit more taking notice. That being said, you know, this is a great time for us to be actually in the midst of a launch because, you know, COVID is still very much out there in the press. You know, we're sitting here in 2024 and there's someone dying from COVID every, you know, every eight hours. We're looking at things and saying, you know, we really can help these patients that are very much in need. Right now there is no other point of therapy from an antibody perspective that's available. Great. So it sounds like it's a pretty motivated population, I guess. What are some reasons why maybe someone with immunocompromise might like not to receive Pemgarda? I guess, what's been some of the feedback that you've received? I think that one of the big things for us is making sure that it was reimbursable, and so early on we were able to receive our HCPCS codes, which actually allowed for the purchase of the drug and the administration to be fully covered under Medicare, so that was a very big win in our column because that addresses approximately 50% of our target population. With regards to commercial payers, we've seen very good uptake. We've seen demonstrated reimbursement across the major health plans as well as regional health plans, so I think that that obstacle has very much kind of been alleviated. I think that having more infusion centers on the map, so to speak, for where they can actually receive the therapy has definitely been of great help. Earlier on, people were having difficulty maybe finding infusion centers. I think that has been largely alleviated in significant ways and we continue to make further progress on that front. Great. You've also submitted an EUA for the treatment setting. Can you talk about some of the opportunity there? I think everyone's familiar with some of the Paxlovid numbers that we've seen, but I guess where is your niche there? Yeah. So again, targeting the immunocompromised is where we're going. We're looking for a potential EUA amendment, which would mean that we would be available for both prevention as well as treatment if granted. We look at the opportunity as upside to ourselves because there's significant demand out there. I think everyone was surprised by the Paxlovid numbers that were shown for Q3. $2.7 billion in top line revenues. COVID is out there in the market for COVID is immense. Between treatment and prevention, you're looking at over $10 billion annually. So we look at it and say that we are a very good alternative to Paxlovid. Paxlovid has some drug-drug interactions difficulties there and then there's also the reasonable likelihood for rebound. So with our point of therapy, we think that we offer a differentiated approach and that we could really help immunocompromised individuals. Great. Then you're also in development for VYD2311. I think that's just drilling down now. So I guess what are next steps there? How are you thinking about development of that antibody? Sure. So VYD2311 is currently in a Phase 1 trial in Australia. We're looking at a similar pathway that we've experienced for EUA with regards to Pemgarda. I think the key thing there is that early stage signals show that this is an antibody that has greater potency, which means that could lead to an improved product profile. So this potential to either lower the dose with a shorter IV or change the route of administration to IM or SubQ. In either case, we think that could lead to a stronger product profile and could mean that we may be able to expand to a larger percentage of those immunocompromised population. Great. So how are you approaching development there? I guess there's some considerations where you could maybe target the treatment setting first or going prevention first. How are you planning, I guess on developing it with two potential avenues there? I think that we want to see how things work out with the current EUA submission on treatment. That being said, I think that this early Phase 1 data will help inform that decision. We do look at this and say it has both possibilities for both prevention and treatment and having that lower dose and having that, that stronger product profile can kind of make that even increase the likelihood of that coming to fruition. So we're excited about the potential of VYD2311. That being said, right now we are really focused on Pemgarda launch and really focus on making sure that we can help patients in need today. Great. And then as you think about the pipeline, you mentioned that the company's focus on broader infectious disease, where could Invivyd go? Yeah, I mean we are definitely focused on COVID right now, first and foremost. That being said, we'd look across various diseases and see that you could make play in influenza RSV. There's a number of different potentials. That being said, where we're capitalized today, where we are devoting our resources today, is definitely on COVID. Got it. And then I guess with that, can you comment on your cash position and runway? I think you updated some guidance there recently. We did. So, we pre-announced that we expected to end Q4 with, excuse me, Q3 with roughly $107 million of cash and cash equivalents. And then we further went on to guide that we expect to end the year with at least $65 million in cash and cash equivalents. The other side of that guidance that we did say is that we are on a march towards profitability, and we are looking at, we feel like we can, with the continued growth rate on the top line and utilization of our existing cash, that we feel like we can march towards profitability in the first half of the year. Great. Can you kind of walk through some of the assumptions there in terms of what needs to happen, I guess for the remainder of the year, early next year to kind of meet profitability? I think it's continued modest growth on the top line. That being said, we're shooting for much more than that. That being, you know, that being said, from an expense side of things, one of the important things to consider is the fact that we made a very heavy investment in our manufacturing, and so if you think about the way that the EUA construct is, you need to have product available in order to actually get authorized and it's commercial grade product available, so the heavy investment was made in that a lot of that inventory was expensed even before EUA. And the fact that we are sitting on inventory right now for Pemgarda and don't think that we're going to need to do much more manufacturing at least in the coming, you know, in the coming periods, that should lower our expense profile going forward for, certainly for this year. And then of course when you look at the fact that we've also started manufacturing and done a lot of manufacturing on VYD2311 within 2024, I think that also helps the fact that those expenses shouldn't necessarily repeat themselves in 2025. Great. Well, I think you guys are announcing earnings or full year and 3Q earnings tomorrow morning. So I'm sure we'll get more color on some of the KPIs. But looking forward to the call tomorrow and thank you so much for joining us. Excellent. Thank you. Great. Welcome everyone and thanks for joining us for the fireside chat with Invivyd. I'm Evan Wang, one of our biotech senior analysts and I'm joined by Invivyd Chief Financial Officer Bill Duke. Bill, thanks for joining us. My pleasure. Just for those unfamiliar, could you give a brief introduction on Invivyd and Pemgarda? Sure. So Invivyd is focused on delivering therapies for immunocompromised people suffering from various viral infectious diseases. Our initial focus is on COVID-19. We have been focused very much on that. And we received our EUA in March of this year for Pemgarda. Pemgarda is a monoclonal antibody that is targeted to help with the prevention for the immunocompromised population of getting COVID-19. These people are very susceptible and the consequences of them contracting COVID-19 can be quite problematic, including hospitalization or untimely death. That is where we are focused. We've been able to, in a very expeditious way, move from first in human with Pemgarda in March of 2023 to the EUA in March of 2024. So in just under 12 months, we're able to execute on that strategy. This is a strategy that we think is repeatable. Right now the company is very much focused on Pemgarda and the launch of Pemgarda and getting that into the patients that need it most. Great. So I guess since the pandemic where we had multiple antibodies, now we only have one, you guys. So I guess what drove that change and what made you guys successful? Sure. So there were other players that were in the space and have tried to get into the space. I think the biggest thing that probably led to us being the only one on the market right now is the inevitable viral evolution of COVID-19. What’s been helpful for Pemgarda and for Invivyd is the fact that our targeted receptor binding domain has remained very much intact. And as a result of that, we are able to block the virus from attaching itself and can help patients that very much need to do so. The fact that we have a platform technology has allowed us to move expeditiously through the authorization trial and then ultimately grant authorization. And then, of course, as we said before, we’re focused on COVID-19 right now, but that is something that can change in due course. Great. You guys navigated somewhat of an uncharted territory with development of Pemgarda and COVID antibodies in a post pandemic setting. I think it was you guys and AstraZeneca kind of leading the way there. What does future development look like? How have you accelerated development here and what is support from FDA? Sure. So FDA has been a partner to us and obviously navigating through the EUA process was done with great consultation from the FDA. So going forward, we continue to test Pemgarda against up and coming variants. We have the platform that can actually identify what we think is going to be the next variant of concern. And we are constantly looking at our own internal work to see how Pemgarda and our next generation asset VYD2311 will stack up against those variants. So it is an ongoing process. I think that for us right now with Pemgarda, you know, we are in a one-hour-long infusion, it's 45-milligram dose. It's something that, you know, for our, the patients that we are going after, the route of administration is not problematic. That being said, we feel like with a next generation we may be able to change the product profile, change the overall dose and maybe even the route of administration, which may allow even more immunocompromised people to actually get this product more rapidly. Great. Can you talk about some of the data you've generated in the pivotal trial, some of the immunogenicity data and you've also been presenting on some pretty interesting clinical data too? What was the data and I guess what's been the reception from the community on this data? Sure. So the nice thing about it is from a timeless perspective, we were just recently able to get our exploratory clinical data into the fact sheet. And so we've been able to show that through six months, which is two doses, day zero dose and then day 30 dose, that we've been able to show a relative risk rate of infection of 84%. And so that is a significant drop versus what people would have with placebo. I think that getting that data into the fact sheet has really been helpful. We've been able to kind of use that data in conversations with physician prescribers out at IDWeek. I think that people really appreciate the fact that that's now included in the fact sheet. Of course we got authorization using an immunobridging approach showing that demonstrated titer levels across variants that were in circulation. But now having true clinical data to point to, I think, has been very helpful. Great. And just to clarify, just given the concern on circulating variants, what has activity been for Pemgarda? Are there any variants of concern? Sure. So what we've been able to demonstrate, and we've been able to do so and get it into our fact sheet as well, is that KP.3.1.1, which is a significant variant in circulation right now and has been so since the summer months that we've shown good activity against that. So the fact that we have been able to show most recently we have 12-month data, which means that it's six-month follow-up where people did not receive any additional doses. In months seven through 12 we've been able to show a relative risk rate of infection of 64% while not receiving any further dose. I think that's been very helpful for people to see and so that data has been extremely helpful. I think that is also going to. We just announced that we had a preprint that was initiated. It's not yet available, but the submission has occurred. That CANOPY data is part of that preprint, and then there will be another preprint that shows our own internal methodology where we can surveil antibody against new novel variants. That variant, that methodology gave us an early look to show that we expected to have good activity against KP.3.1.1, and now it is showing that we expect to have activity against XEC variant, which is a rising variant in circulation. Now that's still pending our external in vitro neutralization assay data, which is conducted by Monogram/ Labcorp, and we should have that in weeks to come. Great. And as you've been launching this year, you've built the management team to support that. Can you talk about the hires there and how you've kind of prepared for launch? Sure. So we launched in the spring of this year and we did so with an external sales force and we have been making some shifts along the way to internalize some of those sales resources. The fact is we did not necessarily know the timing of the EUA grant. So the external sales force concept made it so that we could have something available at a moment's notice. And that really worked out quite well early on. Now that we've actually have more traction and more evidence of what is needed in the space, we've been able to target bringing certain people in house and that's really worked out well. We hired a Chief Commercial Officer this summer, Tim Lee. Tim has been a great add to the team, really working well with the sales force as well as the marketing team to make sure that we can get out in the forefront for prescribing physicians as well as the patient communities. Great. So on the launch the indication is for moderate to severe immunocompromised. How large is that population? I guess how large is sales force? Do you need to target that effectively? And I guess what is the market opportunity here? Sure. So the overall that concept, the overall U.S. population is greater than nine million. Of course we are targeting right now cancer patients, stem cell transplant patients, organ transplant patients and those that patient profile kind of brings down the population to roughly 500,000. Now we will be expanding that as time goes on, but that initial 500,000 can be really well serviced and you can strike a very large percentage of that by adhering to some of the large health care centers and there's about 1,200 of those across the U.S. so because of that size population, we feel like we are able to do so with a reasonable size sales force. And so we are pleased about the uptake that we're having. Also, by bringing these sales people internal as opposed to external, we feel like we're going to be able to get the best and brightest and move forward in a productive way. Great. I guess. How well penetrated are you now into some of these sites? I know you've been pretty active at medical meetings too. What's been the feedback or why have they joined or why haven't they joined or you know? Sure. I think the biggest thing to understand is that, you know, this does take some time. Part of it is getting through formulary committees and et cetera at some of these larger institutions. We made some good progress on those fronts. We're looking forward to making, you know, a real strong push to get even more centers on board. And part of the reason that we're augmenting our sales force is to really kind of push forward that strategy. I think that one of the benefits that we are now seeing is that again, as opposed to on the fact sheet, that purely speaks to the immunobridging, having real clinical efficacy data in there is very helpful and of course it was exploratory data. But now having that in the four corners of the fact sheet means that we can actually speak to that with the prescribing physicians and at the infusion center levels. Great. And I do want to touch on the kind of label amendments that happened recently and concerns on variants of resistance. I know that's been resolved now, but you've commented that that's, you know, impacted the launch a little bit. Are we beyond that now? I guess. How has reception been after that? Sure. I mean we feel like we're beyond it right now. It was unfortunate and we feel like it could have been avoided. But what ultimately happened is that included in our fact sheet the FDA had included some non-peer-reviewed third-party non-primary viral activity data that would suggest that Pemgarda would not be active against circulating variants including KP.3.1.1. Very shortly thereafter we had our own third-party data from Monogram in vitro assay data that actually showed that we retained activity against KP.3.1.1 as well as other relevant variants that were in circulation at that time. There was about a one-month timeframe between where that information was the third-party data was included in our fact sheet that has since been resolved. It was resolved at the end of September, and to be honest, we're pleased where the fact sheet resides right now. But that did, you know, we definitely faced some headwinds because of that. The good news is that, as I mentioned before, IDWeek came at a really good time. It was early October. Our revised fact sheet was done at the end of September, gave us some real pertinent information to get in front of physicians and speak to. So the reception on that has been positive. Great, and so that's been building awareness after that IDWeek helped, I guess. How else are physicians getting information on? This EUA. You know, a lot of feet on the street and getting out in front of them as much as possible. There's been some social media campaigns, etc., that have actually been targeted. But to be quite honest, it's really the job of our sales team in our marketing efforts to kind of get in front of the prescribers in the infusion centers, letting them know that there's an antibody that's out there and available and actually has shown great activity against the circulating variants. And I think the key to note is that everything that we've tested against to date we've remained active. Now we will have the third party data on the XEC variant in the coming weeks, but at least our internal assessment and our internal process to date has shown that we expect to remain active. Great. And so I think when we look at your site availability we see over 400, 450 sites available. I think that might, you know, that might actually under report, I guess. How has uptake been at these sites? What are we seeing in terms of orders, reorders? Are there any kind of color you can provide there? Yeah, I mean, what I will say is, as we entered August, we were seeing very good ramp. We actually faced those headwinds that we just talked about with the fact sheet that took a little bit of time to kind of overcome. The revised fact s heet came in at the end of September. So we saw a flattening, and now that we have what we call a properly stated f act sheet, we feel like we have good momentum heading into the holiday seasons where people are going to want to be indoors with family. We are the only monoclonal antibody on the market for prevention, and we think that we provide a good level of protection, a very strong level of protection, especially in comparison to vaccines alone, where for the immunocompromised, they don't necessarily work oftentimes because they have a completely ablated immune system, and you need a healthy immune system for the vaccines to take hold, so an antibody therapy is one that can really help these patients, and we believe that we're in position now to capitalize on that and help patients that are really in need. Got it. And I know it might still be early, but in terms of patients and their, I guess, habits with Pemgarda, are they redosing, are they kind of continuing protection on or is this kind of focused on this kind of fall vaccination season? Are they just going for one dose? Yeah, I think it's very early to kind of comment on that. That being said, what I will say about this targeted population is that they are very, very adamant about making sure that they remain protected, so I think that when you think about them, if you're able to get them on therapy and they're actually able to get the dose and see that the dose is working, these are people who we expect to come back and come back regularly. They know the impact that COVID can have on their underlying disease states, and so as a result, they're very vigilant. Great. So should we be thinking about this in sort of like the typical seasonal flu vaccine season where we see some of this peaking already and kind of declining, or is this something that could be a little bit different? Yeah, I think it could be a little bit different in that for prevention, they're concerned about it 12 months a year. And so when I say they, I mean the immunocompromised. And so whether it's the summer months or if it's the winter months, I think that they're constantly looking for protection. And so for that, I definitely think that the fall and winter seasons for the non-immunocompromised, it's definitely more. Their awareness is much more heightened and they may be a little bit more taking notice. That being said, this is a great time for us to be actually in the midst of a launch because COVID is still very much out there in the press. We're sitting here in 2024 and there's someone dying from COVID every eight hours. We're looking at things and saying we really can help these patients that are very much in need. Right now there is no other point of therapy from an antibody perspective that's available. Great, so it sounds like it's a pretty motivated population. I guess. What are some reasons why maybe one of these immune, someone with immune compromise might like not to receive Pemgarda? I guess what's been some of the feedback that you've received. I think that one of the big things for us is making sure that it was reimbursable, and so early on we were able to receive our HCPCS codes, which actually allowed for the purchase of the drug and the administration to be fully covered under Medicare, so that was a very big win in our column because that addresses approximately 50% of our target population. With regards to commercial payers, we've seen very good uptake. We've seen demonstrated reimbursement across the major health plans as well as regional health plans, so I think that obstacle has very much kind of been alleviated. I think that having more infusion centers on the map, so to speak, for where they can actually receive the therapy has definitely been of great help. Earlier on, people were having difficulty maybe finding infusion centers. I think that has been largely in significant ways largely alleviated, and we continue to make further progress on that front. Great. You've also submitted an EUA for the treatment setting. Can you talk about some of the opportunity there? I think everyone's familiar with some of the Paxlovid numbers that we've seen, but I guess where is your niche there? Yeah. So again, targeting the immunocompromised is where we're going. We're looking for a potential EUA amendment, which would mean that we would be available for both prevention as well as treatment. If granted, we look at the opportunity as upside to ourselves because there's significant demand out there. I think everyone was surprised by the Paxlovid numbers that were shown for Q3. $2.7 billion in top line revenues. COVID is out there and the market for COVID is immense. B etween treatment and prevention, you're looking at over $10 billion annually. So we look at it and say that we are a very good alternative to Paxlovid. Paxlovid has some drug-drug interaction difficulties there and then there's also the reasonable likelihood for rebound. So with our point of therapy, we think that we offer a differentiated approach and that we could really help immunocompromised individuals. Great. Then you're also in development for VYD2311. It's growing now. So I guess what are next steps there? How are you thinking about development of that antibody? Sure. So VYD2311 is currently in a Phase 1 trial in Australia. We're looking at a similar pathway that we've experienced for EUA with regards to Pemgarda. I think the key thing there is that early stage signals show that this is an antibody that has greater potency, which means that could lead to an improved product profile. So this potential to either lower the dose with a shorter IV or change the route of administration to IM or SubQ. In either case, we think that could lead to a stronger product profile and could mean that we may be able to expand to a larger percentage of those immunocompromised population. Great. So how are you approaching development there? I guess there's some considerations where you could maybe target the treatment setting first or going prevention first. How are you planning, I guess on developing it? With two potential avenues there. I think that we want to see how things work out with the current EUA submission on treatment. That being said, I think that this early Phase 1 data will help inform that decision. We do look at this and say it has both possibilities for both prophylaxis, prevention and treatment, and having that lower dose and having that stronger product profile can kind of make that even increase the likelihood of that coming to fruition, so we're excited about the potential of VYD2311. That being said, right now we are really focused on Pemgarda launch and really focus on making sure that we can help patients in need today. Great. And then you know, as you think about the pipeline, you mentioned that the company's focus on broader infectious disease, where could Invivyd go? Yeah, I mean we are definitely focused on COVID right now first and foremost. That being said, we'd look across various diseases and see that you could make a play in influenza, RSV. There's a number of different potentials. That being said, where we're capitalized today, where we are devoting our resources today is definitely on COVID. Got it. And then I guess with that, can you comment on your cash position and runway? I think you updated some guidance there recently. We did. So we pre-announced that we expected to end Q4 with, excuse me, Q3 with roughly $107 million of cash and cash equivalents. And then we further went on to guide that. We expect to end the year with at least $65 million in cash and cash equivalents. The other side of that guidance that we did say is that we are on a march towards profitability and we are looking at, you know, we feel like we can, with the continued growth rate on the top line and utilization of our existing cash that we feel like we can march towards profitability in the first half of the year. Great. Can you kind of walk through some of the assumptions there in terms of what needs to happen? I guess for the remainder of the year, early next year to kind of meet profitability? I think it's continued modest growth on the top line. That being said, we're shooting for much more than that. That being said, from an expense side of things, one of the important things to consider is the fact that we made a very heavy investment in our manufacturing. And so if you think about the way that the EUA construct is, you need to have product available in order to actually get authorized in its commercial grade product, product available. So the heavy investment was made in that a lot of that inventory was expensed even before our EUA. And the fact that we are sitting on inventory right now for Pemgarda and don't think that we're going to need to do much more manufacturing, at least in the coming periods, that should lower our expense profile going forward certainly for this year. Then of course, when you look at the fact that we've also started manufacturing and done a lot of manufacturing on VYD2311 within 2024, I think that also helps the fact that those expenses shouldn't necessarily repeat themselves in 2025. Great. Well, you know, I think you guys are announcing earnings or full 3Q earnings tomorrow morning, so I'm sure we'll get some more color on some of the KPIs, but looking forward to the call tomorrow, and thank you so much for joining us. Excellent. Thank you.