Invivyd at H.C. Wainwright Conference: Strategic Moves in Antibodies

On Tuesday, 20 May 2025, Invivyd Inc. (NASDAQ:IVVD) participated in the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025, offering a strategic overview of its antibody platform. Led by HC Wainwright’s Patrick Trucchio, the session featured insights from Invivyd’s senior executives on their commercial launch, new sales strategy, and future pipeline. Despite facing initial challenges, the company remains optimistic about its growth prospects and market positioning.

Key Takeaways

• Invivyd has internalized its sales force, expecting a return to growth after initial challenges.
• Pembarka, their COVID-19 prophylaxis, showed significant sales growth from Q2 to Q4 2024.
• The company is focusing on developing next-generation antibodies like DYD-2311.
• Engagement with the FDA is ongoing for treatment indications of new antibodies.
• Invivyd is exploring partnerships with governments and organizations.

Financial Results

Invivyd reported robust sales growth for Pembarka, with figures rising from $2.3 million in Q2 2024 to $13.8 million in Q4. However, Q1 2025 sales dipped to $11.3 million due to the transition to an internal sales force. The company anticipates renewed growth as the sales team becomes more effective.

Operational Updates

• Sales Force Transition: The internalization of the sales force was completed by the end of Q1 2025, with most new hires onboarded in January and February. This strategic shift is expected to yield positive returns.
• Payer Engagement: Pembarka is covered by Medicare and Medicaid, with favorable outcomes from commercial payers like United, Aetna, and Cigna.
• Market Position: The focus is on larger academic institutions, and Emgarda has been recognized as a standard of care in specific guidelines. A digital marketing campaign is planned for summer to leverage the typical COVID-19 surge.

Future Outlook

• DYD-2311 Development: Resources are being concentrated on DYD-2311, with data on its half-life and safety expected later this quarter.
• Regulatory Strategy: Invivyd is actively engaging with the FDA to align monoclonal antibody expectations with vaccine standards.
• Pipeline Expansion: The company is developing antibodies for RSV and measles, with updates anticipated by the end of 2025.
• Business Development: Invivyd remains open to partnerships with governmental and organizational bodies to bolster its programs.

Q&A Highlights

• EUA Framework: Invivyd is optimistic about the new administration’s stance on antibodies under the EUA framework.
• Variant Surveillance: The company employs a residue plasticity index for monitoring SARS-CoV-2 variants.
• Measles Program: There is concern about potential increases in measles cases due to fluctuating vaccination rates.

In conclusion, Invivyd’s presentation at the H.C. Wainwright Conference highlighted its strategic initiatives in the antibody market. For a detailed understanding, readers are encouraged to refer to the full transcript.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Not ready. Okay. Hello, everyone, and welcome to the third annual, HC Wainwright BioConnect Conference. I’m Patrick Trucchio, a senior health parent at HC Wainwright. It’s my pleasure to, introduce you to the management of InVivid.

I’m Katie Falzoni, senior vice president of finance and Robert Allen, CSO. So first, I think it’d be good to start out with, some background on Invivid platform and on the validation of this antibody platform.

Katie Falzoni, Senior Vice President of Finance, InVivid: Great. So, yeah, Invivid is a monoclonal antibody company here, our our infectious disease company. Right now, we have a product on the market under emergency use authorization. You’re authorized March of twenty twenty four and launched in April. And, our product in the market is for the pre exposure prophylaxis of COVID nineteen.

And Ravi will speak a little bit about the platform.

Robert Allen, CSO, InVivid: Yeah. So we have an antibody discovery platform that lends itself very well to establishment of an antibody relationship with a target and then optimization of that target over time, with a dynamic target such as we’ve seen with, SARS CoV two. We also have now applied that to other virus pathogens that we consider to be, you know, not quite as dynamic as SARS CoV two, but, are dynamic in their own right, that being RSV and measles. And then we have it in Vivid, basically been able to move all the way from discovery through to commercialization under the same roof, utilizing outside resources, of course, but demonstrated that on a number of occasions with completion of clinical trials and, completion of commercial scale manufacturing on a number of antibodies to date. Yeah.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Great. So maybe just on Pembarka, maybe you can provide some background here on Pembarka, the the road to approval, and then, kind of the latest on the commercial, launch.

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. So the road to approval, as I mentioned, was through emergency use authorization. We our first quarter, was q two of last year. We had sales of about 2,300,000. In q three, it was 9,300,000.0.

And then in q four, ’13 point ’8 million. We did at the end of last year decide make the decision to internalize the Salesforce. With all transitions, there is a learning curve there. We did anticipate that there would be some headwind in q one. We did have sales of 11,300,000.0, but we’re really excited about what we’re seeing with the Salesforce that’s now in place.

Most of them are onboarded in January, February of ’20 ’20 ’5 and then fully trained up and out in the field by the end of the quarter. We’re really pleased with sort of the return on investment we’re seeing today in our return to growth. We really took the long term view here, really thinking that internalizing the Salesforce would really position us for a rapid acceleration.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Are there some specific metrics you can point to within Salesforce that are giving you this confidence?

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. I mean, of course, we get really excited when we see new accounts ordering, when we see accounts that are, existing accounts that we continue to order. During our q one earnings call, we also presented some other metrics, including highlighting certain interactions with HCPs, the amount of calls we have with them, etcetera. All of those are trending really nicely from January to April. And as I mentioned, q two to date, we’re really pleased with what we’ve seen.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Can you talk a little bit about the, engagement with payers, payer reimbursement, what we’re seeing on that side of things?

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. So, thankfully, under EUA, CMS is statutorily obligated to, reimburse for Medicare and Medicaid. So we are covered by both Medicare and Medicaid, and then the commercial payers did follow. I’m pleased to report that we’ve also had really positive outcomes with, some of the larger plans, including, United, Aetna, Cigna, and certain regional Blue Cross Blue Shield plans as well.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And is there an opportunity to sort of streamline or expand access and infusion, you know, expand the infusion capabilities in various geographies?

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. So right now, our Salesforce is geography based, and really focusing on some of the larger academic institutions and then also sort of the other networks, you know, HCPs, etcetera, that are associated with those those hospitals. In addition, just to sort of think about the COVID nineteen market in general, last year, the, therapy market was about over $9,000,000,000. Right now, we, from a patient, from a market share standpoint, are still, you know, reaching in the thousands, not sort of the hundreds of thousands of of patients that are potentially eligible eligible for Chemgarta. But we feel that there is definitely a big opportunity for our sales force to sort of educate health care providers.

And so we look forward to that. And we also sort of feel that there is a great momentum that we have right now, just with Hemgarda being recognized as a standard of care. We were recently added to the NCCN guidelines for certain B cell lymphomas. That’s in addition to the IDSA guidelines that we were added to in the fall. And so we’re really happy with the momentum and especially heading into the summer months with the summer surge.

Typically, there is a surge during the summer months, especially as people start to travel, go inside in air conditioning. And so we’ll have sort of a digital marketing campaign that will be kicking off related to that.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Can you talk a little bit more about that market and just sort of your you mentioned your your market share and and sort of how how should we think about this, you know, the COVID treatment and COVID prevention market?

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. So the COVID prevention market is sort of the market that that I was just speaking about. And then for COVID treatment, you know, that is not something that we’re currently indicated for. And we’ll but we, you know, have we do think that there is potentially a role for, monoclonal antibodies in the treatment of COVID nineteen. And we do think that especially for in the immunocompromised population where maybe they have more limited, they don’t have the same response to a vaccine that somebody who is not immunocompromised would have.

There’s definitely patients that are in need.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: So maybe we can talk a little about the regulatory and UA framework. And I’m just wondering, I guess, just sort of what’s the, latest, on FDA’s response to PEMGARDA treatment UA request, and are there additional data submissions planned?

Robert Allen, CSO, InVivid: Yeah. So the treatment the treatment request was denied by the the FDA for PIMGARDA. We now have a new FDA, and we have a new opportunity for conversations around treatment for PIMGARDA. But, also, more importantly, I think the feedback that we did have on PIMGARDA guides us a bit in terms of how we would approach with next gen antibodies of VYD two three one one, how we would approach a treatment indication with that antibody. That antibody is attractive in many ways because of its potency.

It’s around 15 fold more potent than DYD two twenty two or Pembarka and opens up the door to other parenteral routes, including something like an immuno you know, sort of an I’m route or sub q route. So with all of those things in hand, we look to engage the FDA very soon with documentation around these issues of treatment. We also have, you know, a general desire to look for alignment on the FDA’s part between the expectations with respect to monoclonal antibodies as they relate to the expectations for vaccine. And so we’ve had a citizen’s petition recently that, argues for that parity. So all of that points in the direction to the future that we feel pretty strongly that we have a a good plan and a good opportunity to engage with the agency around treatment.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Is there any, indication with this new administration how they’re going to, I guess, sort of view antibodies with this EUA framework?

Robert Allen, CSO, InVivid: So I think that, that in general, we’ve had, you know, very good responses from the agency around antibodies in general. Like, I think that, right now, we would not anticipate that on the basis of this being a monoclonal antibody that there would be any need to to adjust course. Right?

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Right. I

Katie Falzoni, Senior Vice President of Finance, InVivid: think we will find out more. I think that in terms of the vaccines, I think later today, sort of the the FDA is going to be unveiling sort of the new plan for vaccines. And as Ravi mentioned, with the citizens petition, we think that will, sort of help inform the path forward. But what we anticipate is that we’ll probably align very much with what we’ve already done for, Emgarda, which is we conducted a, you know, a placebo controlled, clinical trial as part of Canopy.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Right. And so do you anticipate submitting a full BLA for Pembarda in prevention, or or would you shift to DUID twenty three eleven?

Katie Falzoni, Senior Vice President of Finance, InVivid: At this time, I think we’re focusing our resources really on twenty three eleven, going forward, of course, maintaining all of our requirements for for PEMGARDA. But for any kind of, you know, treatment indication or potentially pursuit of a BLA, that would be for the next generation twenty three eleven candidate.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And then for, twenty three eleven, you have the phase one readout expected this quarter. What do you what do you need to I mean, presumably, it’s it’s a similar platform, so we would expect safety data and tolerability data to look similar. But what are you looking for there? Is there anything that you’d wanna see there, as far as gating factors moving forward phase two?

Katie Falzoni, Senior Vice President of Finance, InVivid: Yeah. So we’re anticipating we we did already, release an early preview of some of the the data in early February. We would expect that, hopefully, it’s not too much of an update coming, as when we release the updated data, except we’ll have be more informed on sort of the half life as we have not yet reached a half life, when we initially report that data. And in addition to that, we will also be reporting safety data.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And so how are you thinking about dosing and route of administration? I think you mentioned, possibility for intramuscular.

Robert Allen, CSO, InVivid: Yeah. The the half life and the potency together go into the consideration of what we call the titer, right, which is how much antibody is is onboard at the time when a given variant is encountered. And the potency of twenty three eleven along with the half life and the overall PK is very attractive when it comes to intramuscular routes and subcu routes, which we think are gonna be sort of well received by the immunocompromised population over that consideration that we have with d one e two two two. Right? So that’s kind of the the direction that we’d like to go, and, we have no reason to think that we can’t pursue that direction based on the physical chemical properties of the antibody.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And is this still the expectation to target the immunocompromised population, or what might you look to sort of expand?

Robert Allen, CSO, InVivid: Well, I think that immunocompromised is, a place that we’ve come to know through this commercialization effort, and we think that there is still a lot of space in that population to to introduce antibodies for COVID. But there’s also other at risk populations that go beyond

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: the

Robert Allen, CSO, InVivid: immunocompromised. And those could be people that are, health care workers that are facing COVID on a regular basis. But people that are at risk are is a population that we’d like to basically explore with the agency, as a potential second consideration beyond the immunocompromised.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: To what extent can the data from the pericardial program support, 02/2011 as you look to advance this?

Robert Allen, CSO, InVivid: Yeah. I think that remains to be seen. That really is gonna require a conversation around assumptions with the agency. We have a number of readouts from the CANOPY trial that really speak to the potency of this approach as it relates to protection against, the complications from COVID. But that conversation is going to decide how that data can be used, going forward with 02/03/2011.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And just as far as, you know, with SARS CoV two kind of continuing to evolve, I guess, I guess what gives you confidence that your the epitope targeted by Emgard and BUID twenty three eleven will will remain relevant? So we’ve spent a whole lot of

Robert Allen, CSO, InVivid: time looking at, variant monitoring and surveillance. We look both in the wastewater as well as in clinical sequencing data. And everything that we know about where MGARDA binds to the target, tells us that that particular epitope has been very quiet in the wake of the Omicron shift, and that’s now been three years where we see quiescence at that epitope. That also is something that we can look at with respect to all the changes that have occurred in the target and make what we call synthetic antigens or synthetic pseudoviruses to future proof against those changes that we have seen that are fall outside of our epitope as well. So all of those together have created an empirical approach that gives us a great deal of confidence in the quiescence that we see at the epitope and the fact that if we don’t see changes within that epitope, we have reason to believe that this is going to result in basically continuity of the neutralization activity that we’ve demonstrated today, all of which has been clinically meaningful as held in light of the CANOPY trial.

Right?

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And so how has your surveillance capability evolved, you know, whether it’s, you know, wastewater sequence monitoring? How does this sort of inform your discovery and prioritization?

Robert Allen, CSO, InVivid: Right. I think the first thing that everybody started out with was variant level data that allowed them to say, this is the variant, and this is the change of the amino acid. What we’ve gone back and looked at is all changes that have occurred across every amino acid in the target. Right? So looking at the RBD equally waiting change.

And so we have developed what’s called a residue plasticity index that looks at plasticity over time as an accumulated factor, but also in any particular time period, how much change is occurring. And then we then can map that based on cryo EM and X-ray crystallography onto the target, we can see that our epitope with regard to this plasticity has remained sort of aplastic. Right? Whereas other aspects of the target have been very plastic. And based on the distance between our epitope and those regions of plasticity that is now informed by a constantly updated database of sequence, we can, you know, have confidence that these types of changes, however distant they are from our epitope, are not going to result in changes in our binding capacity.

Right? We then come back to that. Like I said, we can reprove that with pseudovirus data, and we use a sort of industry standard pseudovirus for all of our outgoing data with a third party. And then we can also look at binding, with synthetic antigens that enjoy all of that space independent of whether or not it’s actually come out as a variant in the past or will come out in the future. So that future proofing is something that is relatively new based on our analysis of plasticity at the target.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: So earlier brought up RSV. So I’m I’m just curious. Can you talk about, you know, RSV, where the where you see the unmet need and, sort of how your program is progressing?

Robert Allen, CSO, InVivid: So like SARS CoV two, RSV has demonstrated in the past in clinical trials, some degree of plasticity. And so you’ve seen escape in some of those trials from antibodies that were used in that setting. We’ve now taken all of that data with respect to escape from other known actives and built that into our screening process for an antibody that’s going to address, hopefully, those needs. We’re still in the midst of the discovery process, and we would look to get more close to the the preclinical candidate by the end of this year. But the same approach to, understanding plasticity is what’s driving our desire to move into that space.

We think that, you know, from a patient perspective, there’s still a a large unmet medical need that any one antibody is not going to be sufficient to meet. So be that in the neonate population or in other immunocompromised populations, we think we’re gonna, you know, have an antibody that’s unique and differentiated with respect to its breadth of protection and a neutralization. And then with measles, we’re sort of going in the same direction. The claims of measles are you know, this is something that’s been well understood for a while. There are a few variants within the measles populations, especially if you look across North America.

So we will take that same approach, and we will be looking in, the past for sequences, but also looking in the present at the sequencing and the wastewater for signals related to each of these pathogens that help us to understand the underlying rate of change and how our which epitopes are best to sit within that change, you know, rate and also the geography of that change.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Right. So the measles program, there’s no idea now. So I’m just curious, the decision to go forward perhaps with measles program over something like, you know, pandemic flu threats.

Robert Allen, CSO, InVivid: Right now, the burden of disease with measles looks like it has, a potential rate of increase that’s a little bit different than h five in one looks. We know that there’s twenty million Americans that are not vaccinated, for measles. We don’t expect that number to go down. We expect that number to go up. We’ve seen cases that are at, in recent past, you know, remarkable levels of cases that are occurring across North America.

So we also would expect that as vaccination rates, fail to go down, that case numbers would not, you know, not change or maybe even increase. The whole point here is to keep the disease burden down as low as possible. And, ultimately, you know, like, as a virologist, I look at this as an opportunity to eradicate a pathogen. Right? So if we’re going to eradicate, then we’re going to need vaccines, and we’re going to need monoclonal antibodies in order to achieve that.

And so that’s sort of where we sit with measles in in terms of how it compares to h five n one. It’s still a very important pathogen. We have the ability to address that pathogen at the at a certain time when the time is right, but right now, the the time is right for measles for us.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And so how will you define success in the measles program? Is it, you know, as an acute therapeutic, prophylactic, or sort of a stockpile ready agent for outbreak control?

Robert Allen, CSO, InVivid: So go ahead.

Katie Falzoni, Senior Vice President of Finance, InVivid: Well, I think from a you know, we are open to to various options, and it sort of depends. Once we actually identify the candidate, we will determine sort of what next steps would look like. In terms of government stockpiling, that would be something that potentially, you know, would be up to the government to sort of out of our control. That would be, of course, something that we would be open to, having conversations about. And, yeah, hopefully, you know, within in the future, maybe we’ll be talking about potentially commercializing, one of these, know, either RSV or measles.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And and with RSV and measles, what sort of the cadence of, you know, next milestones for these programs? What should we expect, you know, sort of the candidates and the clinical?

Katie Falzoni, Senior Vice President of Finance, InVivid: So we’ve publicly stated that we anticipate to have updates on both RSV and measles by the end of twenty twenty five.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And possibly have candidates named by, you know, the end of the year or by next year?

Katie Falzoni, Senior Vice President of Finance, InVivid: By the end of twenty twenty five.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: End of ’20

Katie Falzoni, Senior Vice President of Finance, InVivid: ’20 ’5. The timing. Yeah. Okay.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And then, I guess, just have you started or have you had any discussions with HHS, ARNA, any of these other agencies around, measles or, you know, sort of pandemic threats or any other viral threats?

Robert Allen, CSO, InVivid: Yeah. I think those conversations are best had when you’ve got that antibody in hand. So we, you know, we look forward to that. But, right now, we’re focused on discovery.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And as far as, I guess, the the strategy around business development,

Robert Allen, CSO, InVivid: how

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: should we think about that? Are these all of these programs, would you intend to keep, you know, in house or just for out licensing opportunities?

Katie Falzoni, Senior Vice President of Finance, InVivid: I think that currently, we would be sort of open to conversations. Whether they were with the government or whether they were with potential other partners, we would be open to those conversations.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: And so as we think about over the next twelve months, the key kind of milestones that investors can look forward to. It’s more just sort of the continued ramp up in PEMGARDA. Yes. You know, we’ll have a few additional it sounds like a few additional candidates perhaps by the end of the year. And then possibly in ’20 you know, next year, we’ll we should start to see maybe some additional clinical data as well.

Katie Falzoni, Senior Vice President of Finance, InVivid: Exactly. And then also the 2,311 data that we anticipate later this quarter.

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Right. So what what do you think investors are missing?

Katie Falzoni, Senior Vice President of Finance, InVivid: I think that right now COVID is something that people don’t wanna think about necessarily. You know? And I think, it’s been five years, and I think there’s also sort of this time will tell of what the political environment, will look like as well. We feel as though COVID’s here to stay. We see us being active in the COVID nineteen market, hopefully, in both prevention and treatment at some point and hopefully with a maybe more favorable product profile with twenty three eleven.

But, yeah, we think it’s exciting times for. So

Patrick Trucchio, Senior Health Parent at HC Wainwright, HC Wainwright: Great. Any other questions? Thank you so much. Always a pleasure to catch up. Thanks, Katie.

Katie Falzoni, Senior Vice President of Finance, InVivid: Thank you.

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