Invivyd at H.C. Wainwright Conference: Expanding Beyond COVID

On Monday, 08 September 2025, Invivyd Inc. (NASDAQ:IVVD) presented at the H.C. Wainwright 27th Annual Global Investment Conference, highlighting its strategic shift from a COVID-19 focus to a broader monoclonal antibody company. While the company emphasized its growth potential with new products, it also acknowledged challenges in product delivery methods.

Key Takeaways

• Invivyd is expanding its focus beyond COVID-19 to other diseases like RSV and measles.
• The company plans to submit data for VYD-2311 to the FDA by late Q2 or early Q3 of the next year.
• Recent financials show a significant increase in net revenues, from $2.3 million to $11.8 million.
• Invivyd raised $57.5 million to support its VYD-2311 and RSV programs.
• VYD-2311 offers improved administration and potency over PEMGARDA.

Financial Results

Invivyd reported a substantial increase in net revenues, climbing from $2.3 million to $11.8 million quarter over quarter. The company recently raised $57.5 million, which will be allocated to advancing VYD-2311 and RSV programs. Invivyd is working towards reaching a cash flow breakeven point, supported by increased PEMGARDA sales and cost management strategies.

Operational Updates

PEMGARDA:

• Approved for immunocompromised individuals for COVID-19 prevention
• Requires intravenous infusion, posing convenience challenges
• Continues to show strong efficacy against tested COVID-19 variants

VYD-2311:

• Structurally 99% similar to PEMGARDA with enhanced half-life and potency
• Phase 1/2 trial showed a 76-day half-life with intramuscular dosing
• Demonstrated a 17-fold improvement in potency over PEMGARDA
• Plans to open an IND and start trial enrollment soon

RSV Program:

• Progressing towards promoting an RSV candidate

Measles Program:

• Planning to introduce a measles candidate by the end of the year

Future Outlook

Invivyd aims to submit VYD-2311 data to the FDA by late Q2 or early Q3 of the following year, targeting availability for the next respiratory season. The company is exploring head-to-head trials against vaccines to differentiate VYD-2311 further. Invivyd’s long-term vision includes becoming a leading monoclonal antibody company across multiple disease areas, expanding its focus to RSV and measles.

Q&A Highlights

VYD-2311 as Treatment:

• Discussions with the FDA about VYD-2311’s potential as a treatment option continue
• Intramuscular administration may not be suitable for immediate treatment needs

Pediatric Development:

• Considering pediatric development for RSV, aligning with existing therapies

Measles Program:

• Exploring prevention and treatment options, with clinical paths to be determined

Capital Allocation:

• Focused on VYD-2311 and RSV programs for the next year’s spending

Readers are invited to refer to the full transcript for more detailed information.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Hello everyone, and welcome back to H.C. Wainwright’s 27th Annual Global Investor Conference held on September 8th, September 10th, 2025. My name is Patrick Truchio. I’m a Senior Healthcare Analyst at H.C. Wainwright. It’s my pleasure to introduce our next company, Invivyd, a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry, designed to assess, monitor, develop, and adapt to create best-in-class antibodies. From the company, it’s my pleasure to introduce Chief Financial Officer, William Duke. William, welcome to the conference.

William Duke, Chief Financial Officer, Invivyd: Thank you very much.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: I think maybe just to start, if you can give an overview of Invivyd, the platform, the company, and how we’ve been evolving through the COVID-19 and then beyond.

William Duke, Chief Financial Officer, Invivyd: Sure. Invivyd is a commercial-stage company. We have currently been authorized, monoclonal antibody, for protection against SARS-CoV-2 in PEMGARDA. That was authorized in the spring of 2024, and we’ve now been commercial since that point in time. We are focused on prevention of COVID right now. We feel that PEMGARDA offers a unique alternative for those who are immunocompromised and for which the vaccines do not offer suitable protection. With PEMGARDA, it’s a one-hour long infused product that is delivered in an IV infusion center. We have now demonstrated the ability to provide protection to immunocompromised. We are focused on our next-generation antibody, and that is in the form of VYD-2311. We think that is going to provide a stepwise change and improvement for both patients and, possibly, a longer-acting and more durable product profile.

We think that we can actually potentially move away from the IV setting and more into intramuscular delivery. We think that’ll really open up the doors for more readily available access for patients in need.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. That’s interesting. How does your antibody engineering platform differentiate from peers, and why do you believe it can repeatedly deliver best-in-class candidates?

William Duke, Chief Financial Officer, Invivyd: Yeah, the great thing about PEMGARDA is that it’s actually shown tremendous activity through various strains of COVID. Where others had fallen away, when you look at AstraZeneca’s product, it has lost its activity against the dominant strains. PEMGARDA has been able to continue strong activity. It really has to do with its binding site. We are able to, regardless to date of the actual variant, show strong efficacy and strong activity in protection against SARS-CoV-2. What we like about our technology is that this is our third, VYD-2311 will be our third antibody, protection against COVID. It is a very small stepwise change, but what we like about VYD-2311 is that we think we can really improve on our product profile, moving away from intravenous delivery, moving to intramuscular administration. We’ve demonstrated a longer half-life, which means that we may be able to do better on dosing, improve dosing.

We think that that’ll really help patients as opposed to having to go to an infusion center. This is something that would be able to get administered at a pharmacy.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Clearly a significant advantage. How do you see the current political environment expanding the market opportunity for PEMGARDA and VYD-2311?

William Duke, Chief Financial Officer, Invivyd: Yeah, I mean, we all know that there’s been a change in administration. You know, the latest election and the change in both the administration, but also in the senior leadership at the FDA. We have had very good relations with the FDA, improved relations with the FDA. We had a type C meeting on our next monoclonal antibody with VYD-2311. We feel like we are going to be able to move in an expeditious manner, towards a full, a fully licensed approval as opposed to emergency use authorization. It’s something that we’ve really been able to work well with the agency and excited on the next steps of development with them as we move that into the clinic for what we think it will be the pivotal trial.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: For those less familiar, maybe we can start with PEMGARDA, and you can kind of talk about its mechanism, the current EUA label, and the target patient population.

William Duke, Chief Financial Officer, Invivyd: Yeah, so we are currently approved for immunocompromised for prevention of COVID. Those for which the vaccines do not offer suitable protection. If you think about the way that the vaccines operate, you need to have an active immune system. For many of the immunocompromised, they have an ablated immune system, which means that the vaccines don’t have something to adhere to and actually utilize. Monoclonal antibodies, it’s the closest thing to a natural antibody, and your body is able to actually build up a mechanism which it can actually fight off the virus. From that perspective, I think that monoclonal antibodies are widely understood. I think it’s becoming more and more prevalent that they can provide strong protection against COVID, but also that they have places in other disease states. That’s things that we’re exploring in RSV.

We’ve also announced that we have a measles program as well that we’re looking to generate an antibody for.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. Maybe you can talk about the commercial reception to date and how you see uptake trending into this upcoming respiratory season.

William Duke, Chief Financial Officer, Invivyd: Yeah, so our last quarter we had $11.8 million in net revenues. That’s a substantial uptake from $2.3 million in the prior year, quarter over quarter. We feel like there’s still a lot of ground to be made with regards to PEMGARDA. The thing about PEMGARDA, it is not our best product that we think that we can develop. When I say that, the product profile is difficult. The fact that people have to get into an IV infusion center to actually have administered a one-hour long infusion with a two-hour follow-up, there’s obstacles there. That being said, PEMGARDA is a very resilient drug. You know, since we’ve developed it over three and a half years ago, it has continued to show strong efficacy and strong activity against all variants that have emerged that we have tested against. We very much are appreciative of that and love that about it.

That being said, we want to make this easier for patients. We want to make it easier for prescribers. We want to make it so that this is an easy product that they can receive. That’s why we’re looking at that stepwise change with VYD-2311.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. How important is inclusion in guidelines such as IDSA and NCCN to drive, you know, physician adoption and payer engagement?

William Duke, Chief Financial Officer, Invivyd: I mean, it’s pivotal, right? When you’re talking to an oncologist and you’re actually seeing that they can look at it and they can say, you know, we have a plethora of patients that can really benefit from this. The last thing that you want your patient, when they’re going through their other forms of therapy, is that a COVID infection to actually mean that they can’t get into hospital to actually get their standard of care. They look at this and they say these guidelines are paramount because it’s making it so that prescribers can easily adopt. The fact that we also have strong reimbursement obviously helps significantly as well. We feel like we have that well-rounded. Again, we’re definitely looking to grow PEMGARDA. We think that with the upcoming respiratory disease season, COVID is on the rise.

You can look in the news and you can see that it’s heating up in California. It’s also heating up in New York. You can see more people being masked. For us sitting here, if you’re not immunocompromised, you may not be as concerned. If you are immunocompromised, you’re significantly concerned. That goes to the elderly, but also those who are, as I said, severely immunocompromised. We feel like we are very well situated to help there.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. Moving on to VYD-2311, talked a little bit about this compound. How is it different from, or how does it improve upon PEMGARDA? You know, mentioned intramuscular administration. Maybe you could talk a little bit more about its design and how it improves.

William Duke, Chief Financial Officer, Invivyd: The thing about it, it’s structurally very similar to PEMGARDA. It’s, you know, 99% similar. That being said, the subtle changes that we have made have been able to increase its half-life, which means that the amount of time that’ll stay in the body. It also is much more potent, which means that we think we can bring the dose down and really that active form of being able to change the route of administration. That’s the most pivotal that we look at. To be able to move away from an IV and delivery by intramuscular, we really think that that’s going to be a game changer for both patients and, you know, prescribers as well.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. The Phase 1/2 trial showed a 76-day half-life for IM dosing and a very good safety profile across all routes. Why is this durability so important clinically?

William Duke, Chief Financial Officer, Invivyd: The biggest thing is that being able to show what, let’s show in comparison. PEMGARDA, it’s an improved upon half-life from PEMGARDA, which means that PEMGARDA right now is approved for quarterly administration. We think that there’s potential to change to longer dosing intervals. That being said, when you look at what it has been able to show from protecting people against the COVID versus vaccines, that 76% to 90%, depends upon the period of time that you look at, is very strong activity. Right now, if you look at what’s going on with the COVID vaccines, they simply aren’t working for patients. As a result of that, we feel like we’re very well situated.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: In terms of potency, I think VYD-2311 demonstrated approximate 17-fold improvement over PEMGARDA across dominant variants. How do you interpret that, you know, in the sort of the real-world protection?

William Duke, Chief Financial Officer, Invivyd: Yeah, I mean, again, we think PEMGARDA shows very strong protection. We’re very pleased about that. The biggest thing that we see is that against every variant that PEMGARDA has worked, VYD-2311 has also worked and shown stronger durability if you look at it from that perspective and stronger efficacy. That being said, we think it’s an improvement. The biggest thing that we want to hammer home for those and the real improvement that we want to make is that route of administration and potentially dosing intervals. We think that that’s where the real, where the rubber hits the road for us.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Following the type C meeting with the FDA, can you tell us about the registrational plan and why a single pivotal Phase 2/3 trial is sufficient for BLA?

William Duke, Chief Financial Officer, Invivyd: Yeah, because VYD-2311 is so similar to PEMGARDA and the fact that we have actually shown with three, now this will be our third antibody that we have been able to develop and show strong activity against. They have looked at our past history and then they’ve looked at what our plan going forward is, and they’ve commented to us that our canopy design, they think that we don’t have to deviate very far from that. There may be some things that we want to do, such as potential head-to-head versus vaccine, things that the agency hasn’t yet commented on, but we may look to do that to make it really kind of simpler for prescribers, but also for reimbursement. We think that there’s some real things that we can do to help differentiate and put ourselves in a real strong position.

What we’re looking for next is to formalize the study design, get alignment on the actual, the actual study design and open that IMD and kick off the trial as soon as possible.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Is there a potential to conduct sort of a head-to-head safety evaluation compared to vaccines? If you were to do something like this, what would you hope to show and how important would that be for a positioning?

William Duke, Chief Financial Officer, Invivyd: To be honest, we want this to be vaccine-like in terms of the experience that someone has going into a pharmacy or your doctor’s office to receive. We want to make that very similar. That being said, where we differentiate ourselves is monoclonal antibodies work and they work and offer strong routes of protection. I think that what we are looking for is to show that it is quite, it is very, monoclonal antibodies are very safe. Our current, PEMGARDA has a box warning, the hour-long infusion. We think that by moving to intramuscular dosing, we can actually move off of that and we can reduce what may be any potential adverse events that patients might have.

We think that the only thing that we’re really looking at is at the point of injection, there may be some soreness for a very short period of time, not that different from getting your flu shot or getting your COVID vaccines. We think that we’re in a very good position from that perspective and we’re excited to move forward.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Is there a potential to move VYD-2311 into treatment?

William Duke, Chief Financial Officer, Invivyd: That is something that we’re going to continue to talk to the agency about. We think that there is. We think the fact that we can kind of deliver that strong protection. Now the route of administration may or may not be the same for treatment versus prevention because if you think about it, when you’re looking for treatment, you want it immediate. Obviously, the benefit of an IV therapy is that it is immediately into your bloodstream. That is something that we will continue to look at. That being said, we very much feel like treatment is an option for this. We’re initially focused on prevention, but I think any study design that we look at will also have an element that may be able to lend itself to treatment.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Are you thinking about pediatric development, and what parallels do you see to prophylactic antibodies and RSV?

William Duke, Chief Financial Officer, Invivyd: Yeah, RSV is a very, you know, we feel like we have the potential to have a best-in-class monoclonal antibody for RSV. That’s why we got into this. We feel like we can help differentiate ourselves. Our platform technology lends itself to this. With regards to pediatrics, obviously, you know, the approved therapies are definitely geared towards pediatrics, but we think that it’s also very important for elders. We think of it a little bit more broadly, but we will definitely be taking all that into consideration when we move forward with, you know, when we announce our RSV candidate.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: With the commercial profile for VYD-2311, if it’s approved, maybe you could talk more about, you know, just in terms of cost, convenience, scale relative to vaccines, and then also relative to PEMGARDA.

William Duke, Chief Financial Officer, Invivyd: Yeah, so the nice thing is that we have ample quantity of products currently. Because we had already gone through the EUA process, when you’re going through an EUA process, you need to have commercially available product on hand. Not knowing exactly how the discussions would land with the FDA, we were preparing to potentially have to go to EUA, right? Now we’re looking at things very much more in a full BLA license, but having that product available is very helpful to us. The fact that we think we can dramatically reduce the dose also lends itself to the cost, right? We think of ourselves as, you know, hundreds of dollars as opposed to thousands of dollars per dose. That being said, from a cost perspective, we think that we can have, you know, strong margins.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Right. Great. Any questions from the audience? I wanted to ask about the measles program. Maybe you can tell us why you chose measles and how you envision a clinical, sort of development path forward.

William Duke, Chief Financial Officer, Invivyd: Yeah, so we’ve announced a discovery program for measles monoclonal antibody. Part of the reason is we were getting asked an awful lot, can your platform apply to measles? Listen, the measles vaccine historically has been one of the better vaccines out there and has shown strong protection. That being said, there’s a segment of the population that does not want to and is opposed to taking vaccines. A monoclonal antibody is not a vaccine. We’re not an anti-vaccine company. That being said, we want to create alternatives for patients who need them. We think that we’re well positioned to be able to do that. The benefit of having a platform technology is that you can kind of, we can churn out monoclonal antibodies at a rapid pace.

That being said, we think that measles is one of those disease areas where we can create an impact, and even look at potentially treatment as well as prevention. Of course, we’re going to explore all of this. With regards to the study design and what it looks like, that’s going to have to be, we’re really going to need to sit with the agency and discuss that. That being said, it’s a program that’s earlier on, but it’s something that we’re very much looking forward to.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: What is your timeline for updates for these various programs for VYD-2311, for RSV, and for measles? When should we expect the next updates on each?

William Duke, Chief Financial Officer, Invivyd: Sure. For 2311, our next step is opening an IND, getting that trial design agreed to with the agency, and starting to enroll. We think that is something that we can do in the coming quarters. We’re not talking years, we’re talking quarters. Our goal would be to be able to put data in front of the agency at the end of the first half of next year, in early Q3, so late Q2, early Q3, so that they have something to contemplate. That being said, in an ideal world, we’d be ready for next respiratory disease season in the fall of next year. Of course, the biggest thing that we can control is getting that trial started and getting the data turned over to the agency. That’s something that we’re very much looking forward to. With regards to our RSV program, we are getting close on promoting a candidate.

I think that the next step for us is identifying and formalizing what that candidate is going to be and then looking at that Phase 1/2 trial. With regards to measles, a little bit later, we think that that’s probably more the end of this year when we’ll probably have a candidate that we can actually promote to the clinic.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: In terms of capital allocation decisions, you know, you have the commercialization ongoing. You have some of these earlier stage pipeline programs. How should we think about capital allocation, cash runway?

William Duke, Chief Financial Officer, Invivyd: Yeah, we just completed a raise. We actually just raised $57.5 million via what we think is a very good offering for the company. What that does is gives us some longer-term stability. We think that we are still running very lean as a company, and we’re looking to continue to do so. We think that we can kind of get to that cash flow breakeven point with increased PEMGARDA sales and cost mitigation strategies. That being said, we’re really looking to move forward on VYD-2311. VYD-2311 is where we think that the bolus of, when I think about the new spend for next year, it’ll very much be focused on VYD-2311 and then what we choose to do with RSV. I think those are the first two things that we’re going to be allocating funds to. That being said, we’re very excited about the position that we’re in.

We were able to bring on some very strong investors. We think that they’re very supportive of the company, understanding of the mission, and they’re looking forward to seeing what we can accomplish together.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: If we look a little further out, what’s the long-term vision for Invivyd, and where do you see this company positioned in five years from now?

William Duke, Chief Financial Officer, Invivyd: Yeah, I think that we’re going to be, we are a monoclonal antibody company. We are not a COVID company. COVID is the first disease that we chose to go into, and we chose to go into it because we could do so in a very rapid fashion. That being said, I think that we are looking at other disease states like RSV that we think we can have strong impact. I think that when you think about where we’ll be going forward in five years out, I think that we’re going to be playing in multiple disease states, and we look forward to being, you know, not a single, commercial product company.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Terrific. Thank you so much, Bill, and thank you so much to Invivyd and everyone for attending. Have a great rest of your day and conference.

William Duke, Chief Financial Officer, Invivyd: Great. Thank you so much.

Patrick Truchio, Senior Healthcare Analyst, H.C. Wainwright: Thank you.

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