Thank you for standing by. And welcome to Invivyd’s First Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the call over to Katie Falzone, SVP, Finance. Please, go ahead.

Thank you, Operator. A short while ago, we issued a press release announcing our Q1 2025 financial results and business highlights. That press release and the slides that are being used on today’s webcast can be found in the Investor section of the Invivyd website under the Press Release and Events and Presentation sections, respectively. Today’s discussion will be led by Marc Elia, Chairman of the Invivyd Board of Directors. He is joined by Tim Lee, Chief Commercial Officer; Bill Duke, Chief Financial Officer; Dr. Robert Allen, Chief Scientific Officer; and Dr. Mark Wingertzahn, Senior Vice President of Clinical Development. During today’s discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our regulatory plans, certain financial expectations, our future prospects 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 change over time and 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 Invivyd assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd’s business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K and 10-Q, which are also available on our website. I will now turn the call over to Marc.

Good morning and thank you all for joining us. Turning to Slide 4, the first quarter and our early second quarter has been a very busy and productive time marked by transition. Our commercial organization is now wholly internalized, new in the field and reflects an intentional bet by this management team that our new internal team will drive broader adoption of PEMGARDA with associated commercial results. While it is early, our leading indicators are promising and we remain targeting near-term breakeven with continued revenue growth and operating expense management. Scientifically, we’re very pleased with what we see in the evolutionary journey of SARS-CoV-2 relative to the epitope we are exploiting with pemivibart, and as now, we see no obstacle to long-term growth in our commercial PEMGARDA business. We have secured access to additional non-dilutive capital to grow if certain conditions and milestones are met, and we are expanding our pipeline to multiple disease areas in which we believe our scientific approach can add value to patients in need. Specifically, we have added discovery programs against new viral targets with the potential for identifying best in-class medicines for diseases outside of COVID-19. Our previous work in influenza continues at a low intensity, but bird flu with pandemic potential has not meaningfully emerged, and in the very recent short time, we have actually seen more U.S. deaths from measles outbreaks than we have seen from avian influenza over the past year or so. At this point, it is reasonable to expect that trend to continue and our focus has shifted accordingly toward early measles discovery. Last year, we initiated a new discovery program for an RSV monoclonal antibody that Robbie Allen, our CSO, will describe in a bit more detail. RSV presents a very clear, high-value competitive landscape and some molecular…

Thank you, Marc, and good morning all. Turning to Slide 6, the first quarter cemented our transition from a contracted, largely outsourced model designed to hit a short seasonal window to a best-in-class commercial footprint to drive consistent growth via an in-house team. We did not have a fourth quarter call, so it’s been six months since I’ve had the opportunity to speak with the broad investor community. And it’s worth sharing a few general observations from the fall and winter before we walk through key indicators. Marc and the team asked me to create a best-in-class commercial effort to put behind PEMGARDA and our future molecules. I’m pleased with what we’ve done so far, but in many ways, we are just getting started. First, we spent an enormous amount of time with healthcare providers and health systems simply re-educating on the existence of monoclonal antibodies as an alternative therapy available today. What began as a commercial interest, largely driven by those who knew and anticipated PEMGARDA, we’re now beginning to see institutional orders that are just beginning to reflect the underlying medical needs. Protocols, pathways, real-world experience and word of mouth in the clinical community are still in the early innings, and we expect real growth to follow as this familiarity rises. Second, healthcare providers began with real skepticism on the ability of PEMGARDA to navigate virus evolution, particularly following the FDA’s misguided and harmful insertion of inaccurate third-party virology data into the PEMGARDA fact sheet last fall. The combination of our communication of the underlying science and long -- along with the empirical reality of the attractive continuing activity is now gaining notice and belief. Third, the understanding of COVID-19 of the community has undergone a notable evolution. Most healthcare providers are now moving beyond the pandemic era…

Thanks, Tim. It’s an exciting time to be in infectious disease prevention and treatment as the central authorities in the United States reconsider the state of the world for COVID-19 and beyond. I’ll begin on Slide 14 by commenting on our now multiyear work with antibodies directed against the receptor binding domain or RBD of the SARS-CoV-2 spike protein. This is obviously a validated target and has been targeted repeatedly by our colleagues and competitors and other companies who would like to produce highly effective treatments and preventatives for COVID-19. The challenge they and we faced and that we believe we are overcoming is evolutionary. Invivyd proprietary technologies are designed to yield antibody medicines that target special real estate on a biological target in motion such as SARS-CoV-2. So far, pemivibart has been a total success on that front. When we back of the envelope calculate the sheer number of mammalian SARS-CoV-2 infections and consider the quantitative dynamics of infections, the fidelity of the SARS-CoV-2 polymerase, et cetera, we begin to estimate that the virus has explored quadrillions of molecular variants over the past years. And throughout the epitope, that defines the pemivibart binding site has remained structurally intact. Accordingly, the product potency has assessed in best-in-class industrial systems has remained accordingly stable. Reassuringly, of course, for our pipeline molecule 2311, VYD2311, the same is true only EC50 values are holding more stable at much more potent levels. In fact, neither the measured potency nor any change for VYD2311 would be visible if we placed our neutralization data onto the chart at the bottom of Slide 14. Why? Slide 15 shows a graphical depiction of the SARS-CoV-2 spike protein with a blue area shaded indicating the pemivibart epitope. The genetic and structural change observed over time at each amino acid…

Thanks, Robbie. Good morning, everyone. In early February, we re-reported our initial progress with VYD2311, our next-generation antibody designed to improve upon pemivibart. As a reminder on Slide 19, all Invivyd COVID-19 antibodies share identical scaffolding and generally, our discovery process works such that each successive monoclonal antibody is a minor but essential tweak from the last. This process results in molecules that are near identical in terms of amino acid sequence, in fact, change -- generally change about to a similar or even lesser extent than, let’s say, mRNA COVID vaccines from one generation to the next. With VYD2311, we are not trying to solve a problem related to variation or some threat to pemivibart activity. Rather, we are trying to engineer more medically and commercially attractive features into our medicines. Slide 20 quickly outlines our first in human dose and route of administration ranging clinical trial designed to provide maximum forward flexibility for our go-to markets and regulatory conversations. You can see the cohorts on the slide and the concepts behind assessing them initially. We will be wrapping up the study soon and will be pleased to provide an update in the next weeks on our progress. Turning to Slide 21, it reminds us very quickly the properties of VYD2311 relative to pemivibart and what we think those properties allow for. It is our belief that 2311 can be a major step forward for people sick with COVID-19 and people highly vulnerable to COVID-19, whether immunocompromised or not. VYD2311 represents a potential step change in accessibility and scalability for protection compared to PEMGARDA and may present the opportunity to also create a highly efficient and effective treatment. With that, I would like to turn the call back to Marc Elia who will discuss a regulatory experience with our COVID-19 treatment EUA request and some next steps. Marc?

Thank you, Mark. As previously mentioned, we have been watching evolution at HHS and FDA with great interest. One of the key messages new HHS and FDA leadership has sent has been a desire for greater transparency, especially as it relates to communication between FDA and industrial sponsors. At this time, we have not seen any convention emerge on this front among our colleagues in industry, nor do we have any guidance on this topic from the agency. However, we are aligned with the notion that transparency is a generally good thing for regulators, patients, sponsors and citizens. With that in mind, and given the sheer volume of correspondence companies like ours have with FDA, we are today beginning by providing direct excerpts and data from one recent correspondence back in February, specifically the declination by the legacy Biden FDA of our application for expansion of our EUA to include treatment of active mild-to-moderate COVID in immunocompromised persons with no treatment options. This action generated many questions to our company from HCPs and patients, and we hope that today’s presentation provides some answers. Importantly, we believe our presentation today reflects both the core of scientific review by the agency and the bulk of their communication to us on the topic, and would resemble in some ways the major points the agency might render to, for example, an advisory committee if that were an operative forum. We are including our rebuttals to those points, which ultimately will build to our intended next steps. Importantly, at Invivyd, we are Americans and taxpayers, and some of us are patients too, in addition to industrial sponsors, and so we view our partnership with FDA as fundamentally collaborative on behalf of patients in need. Slide 22 describes the operative background. Immunobridging of antibodies for COVID-19…

Thank you, Marc. Turning to Slide 35, prior to today’s call, we released our Q1 2025 results, including PEMGARDA net product revenue of $11.3 million, and March ending cash and cash equivalents of approximately $48 million. As previously mentioned, to drive long-term topline growth, we made a strategic decision to internalize our sales force at the beginning of 2025. Although this shift created a short-term headwind reflected in PEMGARDA net product revenue during Q1, we are now seeing positive momentum with a return to growth and early signs of acceleration in Q2. We are pleased with the continued execution of financial discipline, reporting a continued reduction of operating expenses. We recorded $27.4 million in operating expenses in Q1 2025, compared to $32.3 million in Q4 2024, a 15% reduction of quarter-over-quarter. This was after a decrease from Q3 to Q4 of over 50%. We anticipating -- we anticipate operating expenses will continue to decrease in the second quarter as we have manufactured sufficient supply of PEMGARDA and VYD2311, and do not plan for a significant further manufacturing expense in the near-term. Backed by a strong cash position and potential to access up to $30 million in non-dilutive funding through our term loan facility with SVB secured in April, we remain focused on growing PEMGARDA at topline revenue, continued financial discipline and continue to target profitability by the end of the first half of 2025. I’ll now turn the call over to the Operator to open the call for questions.

Thank you. [Operator Instructions] Our first question comes from the line of Michael Yee of Jefferies. Please go ahead, Michael.

Yeah. Good morning, guys. Thanks for taking our questions. This is Kyle Yang from Michael Yee. Just a few from us. The first one is could you please characterize your recent interaction and/or experience with the new agency, particularly on EUA, including maintaining your EUA for COVID prevention and use of EUA for future applications, including for treatment and also use of surrogate endpoints such as virus titers for approval? The second one real quick is on Q1 sales, could you please characterize your -- the headwinds that you encountered in Q1? I understand your team briefly discussed it. Could you please expand on that and tell us how you addressed these areas of improvements in the second quarter and just help us think about your sales in Q2 and how do you and your confidence, what gives you confidence that you’re going to see the momentum continue in the second quarter? Thank you.

Great. Thanks so much. Let me start and then I’ll ask Tim to answer the second part. So regarding EUA, you asked a couple of different things, but with respect to maintenance of EUA, it is actually our preference to move with the FDA beyond that construct. Indeed, it’s generally understood that EUAs are designed to effectively convert at some pace and subject to some mechanism. We’ve not actually had that conversation with the new FDA, which as you may or may not know is effectively recently seated, but we’re looking forward to it very much. Critically, our current EUA for the prevention of COVID-19 in certain immunocompromised persons, yes, was generated on the basis of immunobridging, but of course carries with it the results of a randomized clinical study interrogating both safety and exploratory clinical efficacy. So in our minds, those data are unique in the field. This is the point we’ve raised in a few different domains, particularly our recent Citizen Petition. So unlike any other company we’re aware of that has an authorized preventative or approved preventative, we actually have contemporary efficacy data and so would seek to leverage that in one form or another subject to discussion with the FDA of moving toward BLA. That would be our preference and it would certainly be our preference going forward. So I don’t think any of that is either of nerve wracking nor surprising. It’s in fact embedded into the very nature of a granted EUA and we’re really looking forward to talking with them about that. On a go forward basis, I think what we see is a pretty clear scientific, and I mean, sort of academic and clinical understanding, that sVNA titers are a highly useful validated surrogate endpoint. And you can see that embedded into, of course, the work that we’ve done with FDA to-date, and in fact, the evolution of our product fact sheet, which alludes to some of the meta-analytics describing these relationships. So we see the endemic virus situation as an opportunity to normalize all of this away from EUA into a landscape akin to an accelerated approval with a post-market conversion study, which I think not coincidentally, perhaps, appears to be the direction of travel for COVID-19 vaccines. All of that is to us highly welcome and embedded into all of our plans for both pemivibart and our molecules going forward. You have to remember that an EUA does not carry an express obligation to generate randomized clinical data on the other side of it, but of course, accelerated approvals do. So we would look forward to that paradigm and it’s going to be a major feature of what we believe will be our upcoming discussions with the agency. So I hope that’s clear. If it’s not, please, please get back into the queue. But meanwhile, I’ll ask Tim to expand on our Q1 changes and our confidence going forward.

Yeah. Of course. Thank you, Marc. I think we -- I brushed over it pretty quickly, but when I look back at what we were able to do in Q1, it was pretty remarkable. We decoupled from the contract sales organization and built our own best-in-class sales team, trained them and deployed them by partnering with our human resource team to make all of this happen in weeks. And so we did see a disruption in field activity, but with that, we were really thoughtful in how we made that approach and amplified some of the air cover that we can do with digital marketing and others to fill a little bit of that void. I think what we’re pleased with seeing right now, and I shared it on the key launch metrics slide, is that when you look from January 1 through the end of April 30th, we’re seeing a really nice increase in breadth, depth, as well as unique accounts that the team is calling on. So we’ve really refocused around what we’re calling a core four specialist, including rheumatology, where we’ve seen a high degree of acceptance and adoption and it’s been a really good area of focus for us. I also look at where PEMGARDA is available. When I had my first call about a year ago with you, we had about 120 sites. Right now, if you go to our infusion finder, we have over 880 sites. So we continue to drive access to PEMGARDA really broadly through multiple channels and are starting to see that. And as alluded to, we’re seeing some of our -- we are seeing some really strong numbers into Q1 right now and are excited about that.

Thanks so much.

Thank you. Our next question comes from the line of Patrick Trucchio of H.C. Wainwright. Go ahead, Patrick. Patrick, your line is open. Please make sure your line isn’t muted. If you’re on a speakerphone, lift your handset.

Hi. Good morning. I’m sorry I was on mute. This is Luis in for Patrick. Thank you for taking our questions. And again, we understand that these are challenging times, but we appreciate all the team’s work and progress so far. So on a follow-up question a little bit to what was discussed earlier, can you discuss a little bit more in detail the measles program, if you plan to pivot to measles? And if you -- whatever details you can share on the expected clinical trial development path and potential market size? And how -- and in the context of your current cash position and the non-diluted loan facility, how you’re planning to prioritize? Thank you.

Yeah. Let me start. This is Mark, and I’ll see, maybe Robbie can add some color. But when we’re discussing our discovery programs, that is spending that is essentially in all of our standing budgets and it doesn’t represent a particularly incremental draw from our forecasted cash balances. It is a matter of priority. So, yes, we’re adding a program, for example, in measles, but I want to say you might have used the word pivot, which is not something that I would agree with. We’re not pivoting any more than when we leave, English class and go to math class, we’re pivoting and deciding to just focus on math. We’re adding something that we think could be potentially important and that could create a lot of value for patients in need and shareholders over time. So doing these early discovery programs provides us with a basis for considering clinical development under the right circumstances. And again, as stewards of capital, we are always going to try to be disciplined about spending shareholder money only on those projects that we see having a very, very attractive near term return profile. Now, in the case of measles, there may well be some interest in the even the national level and we will look forward to exploring that potential. But I don’t think you can consider any of it as a change or a particular draw on our capabilities or interests elsewhere. It is all about adding optionality and setting into place the ability to grow over the long-term, both in terms of the scale of our business, but more importantly, growing the scale of our anticipated medical impact. Is that clear?

Yes. That’s helpful. Thank you so much.

Thank you. I would now like to turn the conference back over to the company for any closing remarks.

Okay. Well, thank you very much all for joining us this morning and we will look forward to any further questions in follow-up later today. Thanks all. Bye-bye.

This concludes today’s conference call. Thank you for participating. You may now disconnect.