Pharvaris N.V. (PHVS) May 13, 2026 Conference Transcript

Okay. Good morning, everybody. Welcome back to the Bank of America Healthcare Conference. I'm Tazeen Ahmad. I'm one of the senior biotech analysts at the firm. It's my pleasure to have with us our next presenting company, Farveris. Up on stage with me are two members from Farveris. Thanks for making the trip, guys. We've got David Nassif, who is chief financial officer, as well as Maggie Beller, who is head of corporate and investor communications. Thanks, guys, again for flying over from Boston. So maybe we can start off with an overview of the company before we go into some specifics about updating on Catalysts.

Sure. Well, first of all, thanks for inviting us. We really appreciate it and also the opportunity to have a chat with you. Before we get into the overview, maybe for those of you that don't know, this week we priced a $132 million underwritten offering, which takes our cash runway into 2028. So now both launches, both ODT and Prophy are fully funded. Any overhang on the stock, completely lifted. So we're looking forward to future data and approvals. As to the pipeline, I guess there are basically three updates. On ODT, we are on track for the first half of 2026 filing of the NDA as it pertains to PROFI. We are still on track for top-line readout by Q3, 2026. And then on AAE, the enrollment is progressing well. So if you wanted to talk about differentiation of the products, basically our story is we are a portfolio strategy at this point where patients, payors, professionals know they can use our products for a vast array or will be able to, a vast array of indications. We have a single molecule supporting two formulations. We have once-daily dosing, we think, for the vast majority of cases. And so far, we've shown superior efficacy in ODT.

Okay, great. So maybe we can go into a little bit more detail on some of these items that you just mentioned. So on demand, can you just remind us what the takeaways from the top-line data were for the Rapid E3 study? Yeah, thanks so much, Chazine.

So we read out our Rapid 3 top-line data in December of last year. Out of that, we were pleased to hit our primary endpoint and all 11 key secondary endpoints with statistical significance in a hierarchical fashion. So that, from our biostats colleagues, is very hard to do because if you miss stat sig on one, you don't get it for any of the subsequent ones. What we are really proud of is that across the entire attack trajectory, we were able to show rapid onset of symptom relief, complete symptom resolution, and single-dose durability. So there are some key endpoints within our 12 that I just talked about, including end of progression, which is the first time somebody stops feeling worse. It's a really important psychological moment for a patient because they know their drug is working. HAE is a stress-induced disease, and so if you're able to relieve some of the stress and anxiety, that could help you come to attack resolution faster. We were able to put an end of progression at 17 and a half minutes. We are the first and only group to have done that in a pre-specified manner. So depending on how our discussions go with the FDA, that could in fact be included on our label. Next is our primary endpoint. That is time to symptom relief as measured by PGIC a little better. We were able to show that decryctoban works in about 1.28 hours for that primary endpoint. Next is substantial symptom relief. This, once again, is when people are able to kind of get back to their normal life, whether that's, you know, you're able to go to the grocery store, you're able to get your hair cut, you're able to just get back to living. We showed across two different endpoints about two and a half hours for that. And then lastly is complete symptom resolution. So that is when you are no longer experiencing any symptoms. Ducrectoband was able to do that in less than 12 hours. That's really important because that means that somebody, if they feel an attack coming on at 7 p.m. at night, they could take a single dose of ducrectoband and be completely symptom-free by the time they wake up in the morning. You can get on a plane and feel better within 12 hours, right? That is just really impactful for patients, for physicians. So we think across the board, those are really key endpoints. And lastly is our single-dose durability. 83% of people were able to achieve these efficacy findings with a single dose of 20-meg decryptoban. So all of those things, I know that's a lot of data, but we think that that really across the board differentiates us not only from standard of care, which is a cataban, but also from a recently approved oral.

Okay, so maybe can you just talk us through what the demand in on-demand is, just given that the prophy market continues to grow. There's continually, you know, new launches. You expect to be one of them over time. But maybe can you talk to us about the latest market data that you have on TAM and, you know, some important metrics, like what are the average number of breakthrough attacks patients having even if they're on a prophylactic drug?

Yeah, that's a great question. So as we look at the on-demand market, I think we can say holistically, we think that the entry of an oral should actually grow the number of attacks that are treated because the treatment barrier is so much lower when you have an oral. Before there was this recently approved oral, people would need to excuse themselves, inject themselves. It's very painful. There's all sorts of stigma associated with injections. And we believe by removing the challenges around discretion, around portability, an oral should allow people to treat more attacks. So before the summer of last year, about 70% of attacks were treated. That leaves 30% that are untreated. So we think that there could be more attacks treated. However, as you said, there have been recent entries in the LTP space that are really putting up great efficacy numbers. You know, you've got 80 to 90 percent attack reduction. Based off of our open label extension data, we think that DecryptoBank could have less than one breakthrough attack a year. So there could be a bit of an increase and then a decrease as you think about more attacks treated. In 2025, there were about 87,000 doses given, and that's an important distinction because some people require multiple doses to be able to completely address their attacks. So some standard of care takes two to three vials. We know that the oral takes about 38% of people have to take a second dose. So we believe that the total attacks treated is probably a little bit less than the number of doses taken. But once again, that's a flexing number right now as we think that there could be more attacks treated in the future.

Now, can you talk about the heterogeneity of HAE and, you know, the type of attacks patients have? If they tend to have one type of attack, is that what they tend to get most of the time? or can it be any variety of, you know, parts of the body that are impacted by an attack?

That's a great question. So when we think about an HAE patient, a person can have changes in their HAE throughout their lifetime, right? It tends to be stress-induced, as I said. Hormonal changes can cause either more frequent attacks or more severe attacks. So somebody who, you know, even for me, you can have one attack that is a mild attack. Maybe it's a peripheral hand swell. And then the very next attack could be a laryngeal attack, which is potentially life-threatening. So as you go throughout your life, that can change over time. That's one of the benefits of Ducryctoban is this ability to be able to address attacks depending on how a person and their physician decide to treat their HAE. At some point, there may be a situation where people don't want to be on long-term prophy all the time. And so you're able to quickly come off of Ducryctiband XR and switch to maybe just treating on demand. It's also important for women of childbearing age or who are breastfeeding. You shouldn't be on an HA medication if you're pregnant or breastfeeding. And so the ability to come on and off therapy is a unique selling point of Ducryctiband. Okay.

And then in terms of types of attacks, are there ones that patients feel like, you know, I don't need anything for this. If my pinky is swollen, you know, I can deal with it. And if that's their current way of thinking, do you think that having an option like Ducre could change their mind?

That's a great point is that we, in fact, our goal right now is to change treatment expectations. Right now, somebody may, as you said, get a peripheral hand swell. It could be their left hand I'm right-handed you know what I'm just gonna deal with this because I'd rather save my medication for my next attack which could be an abdominal attack which is super painful laryngeal attack or something that impacts my life more as we said with the decrease in treatment burden of an oral therapy we believe that those decisions that people have to make when they forego treatment could be lessened if you're able to have something that's discreet, that's portable, that's easy to take, easy to swallow, and like I said, what we believe outperforms standard of care, though no head-to-head studies have been conducted.

So you do have a comp in the market, a recently launched comp of an oral for on-demand. You know, I'm sure you guys have been following that. What are you learning from that, and where do you think Ducree can potentially perform That's a great question.

We believe Ectorly's launch has gone really well. It confirms what we and the sponsor of Ectorly had said beforehand, which is that there is a severe unmet need for oral therapies in on-demand. We think that they've done a great job being able to capture that market. For us, we view the on-demand commercial opportunity in three main segments. ones. One is the people who are on a cataband right now, decryctoband and a cataband utilize the same mechanism of action. However, decryctoband is more potent than a cataband. That means and it has a longer half-life. That means that as I was saying before some people who take two to three vials of a cataband to fully treat their attack could now do that with just a single pill. So if people have been using a cataband since it was launched in the U.S. in 2011, they've built a trust in the mechanism, and now we can go to them and say, this is the same mechanism, it works for you because this is at the bottom of the HAE cascade, however, it works in a single pill and it's oral. So that's sort of that first segment that we think we can go after. The second segment is people who are on a C1 replacement right now. The way that people are utilizing C1 replacement is to address patients with normal C1. So mechanistically, this shouldn't work, right? If you have normal C1, you add more C1. It doesn't really work. However, that is an infusion that's done with a healthcare practitioner. So if there is a risk of an attack progressing to a laryngeal attack, which could cause asphyxiation, at least there's a healthcare provider on site. We believe that with the mechanism of decryctibant, our data in normal C1, which showed equivalent efficacy from normal C1 to type 1 and type 2, that that whole 20% of the HEE market that's currently unserved could work well with decryctibant. And then lastly, as you said, ectorly is the oral that's on the market right now. we believe that although not head-to-head studies we believe we have a differentiated profile there we approach that market in providing people with a risk-free trial of treating their on-demand attack either with decreto band or if they're using actorly you can just say try it once and see how you are how your attack progresses we've heard anecdotally that for physicians and patients who have participated in both the Phase III study for Confident and our Phase III study, Repeat III, that there is a marked difference between these two drugs. We want people to experience the 17.5 end of progression, the less than 12 hours complete symptom resolution, the single-dose durability, and we think that with this differentiated profile that that's how we're going to capture those oral switches as well.

Okay. So the three subgroups that you just mentioned to me, which are the ones that you think will be the fastest to onboard?

Based off of the mechanism, we believe that the Catabant switches and the Rukinus switches are going to be the fastest. It will take more effort to be able to get in front of people who have already tried Ectorly. So that's probably the largest opportunity, but also maybe the more difficult to switch.

Okay, got it. Now, as you think about what type of commercial organization you'll need, assuming that it'll be this launches first and then prophy after, how big of a footprint do you think you're going to be needing?

So I'll take that one. We believe that by the end of this year, we'll have 70 people in commercial, ready to launch on demand sometime in 27. And then we think that we're going to need another 20 by the end of 27 to fully address the profi market. So 90 people ultimately over the course of two years.

And have you started the process of identifying people?

Oh, yes.

When would you start to hire people?

The sales force will come call it Q3, Q4. Some of the more senior people, we've probably already hired three or four this year, and there are another three or four in the mix. So it's happening.

Got it. And then from the time you get approved, let's say your Padufa is on a Tuesday, would you be able to launch on the Wednesday?

Well, the goal is to launch as soon as possible thereafter, which is why we want to make sure everyone's been hired and trained and product is available and we're ready to go. So we're hoping that it's virtually instantaneous, we'll see.

So maybe let's move on to prophylaxis. So maybe give us an update on the timing for the top-line data that you're expecting to show us. Is it this summer? Third quarter. Third quarter. Remind us the design of the study and what would be good data, or clinically meaningful data, rather.

Absolutely. So our phase three study is a global study. We enrolled approximately 81 people in a two-to-one fashion. So that helped us with approaching people. There was a higher likelihood that they would be on active drug. Our global footprint included the U.S., Europe, APAC, LATAM. We included type 1, type 2, and normal C1 participants, as well as adolescents, so 12 and up. the, like I said, guided towards data in the third quarter. Now, leading into our chapter one, our phase two study, we had done some market research of what would be a meaningful efficacy number for us to be able to own the oral segment. Our market research indicated that we would need to put up at least 70% efficacy for percentage of a tax reduction monthly. When we flipped over the Chapter 1 data, we were happy to see 85%. That put us squarely within the other injectables in this space. Right now, those injectable numbers are between 80 and 90%. Our goal would be to replicate that phase 2 data. So if we could be between 80 and 85, we think that that not only significantly gives us ownership of the oral segment, but also enables us to to compete with injectables. And then I can sort of talk about maybe our four segments that we have in the LTP space as well. So we know that 80% of physicians will start naive patients on an oral therapy if all things are equivalent, efficacy, safety. So in the U.S., there are about 200 to 250 new HAE patients each year. If we're able to capture 80% of that, you know, 200, and keep them on therapy then each year that's 20 that's 200 stacking on top of one another now of course we're not going to keep a hundred percent of every new patient but unlike another approved oral which has about a 60% retention rate we think we can be closer to 90% if we're able to put up our 80 to 85% efficacy so that ends up just being a pancake effect over time the next segment is people who have tried an oral but come off of it. Based off of those retention numbers I was just stating, if 40% of people each year drop out, we believe by the time we could potentially get to market, there are 1,000 people who have tried an oral and come back off of it. So that's 1,000 people who have indicated they want an oral, but for whatever reason, efficacy, tolerability, they've moved back to their injectable that if we're able to go to those people and present an equivalent efficacy and tolerability profile we believe that we could capture some of that market the third segment is people who are on the oral right now who maybe are foregoing efficacy and tolerability because they prefer their oral so much whether it's they don't like injection or there's some sort of anti-drug antibody with other therapies, they're foregoing their efficacy. So if we're able to say, you like your daily oral at 44% reduction, here's an 80 to 85% daily oral, we may be able to switch those patients there. We know from data that's put out by another sponsor that those orals are still having about one to two breakthrough attacks a month. As I mentioned earlier, Our open label extension data indicates that we could be at less than one attack a year So we're really excited about that opportunity to provide a potentially better efficacy and tolerability oral for people And then the last segment is people who are staying on injectables right now because they don't want to forego their efficacy and tolerability We had done some market research questioning people on when they would prefer a daily oral to a a long-acting injectable at the different injection rates right now so once every two weeks four weeks two months three months and then six months it's only when we get to daily oral verse once every six months that people tend to prefer about 50 50 so let's assume that another sponsor can put up a six-month injectable that once again has the same efficacy and tolerability that we're seeing of these others that profi market which is about a four point seven billion market right now, splits evenly between 50% orals, 50% injectables. We believe with an efficacy profile that we could dominate orals. And then within the injection space, that tends to be a little bit of a crowded market, right? You've got about nine injectables that are all going to be competing for that other 50%. So although we don't believe that 100% of the market it will go to orals, we do think that we can have a strong market leadership for the prophylactic space.

Okay. Thanks for all of that color. And also the split between on-demand versus prophylaxis, right? So you're going to further be differentiated in that you're going to offer patients in both segments treatment.

So what's your concern about cannibalization if you have a really strong prophylactic oral as you describe with the outcome that you're hopeful for with the 80% plus reduction in attacks kind of how do you think about what the on-demand opportunity would be for that same product yep so right now 38% of the US market is on on-demand only we believe that that will get smaller over time as more people add on prophylaxis to their to their treatment regimen however every HAE patient is an on-demand patient because there you should still carry rescue medication with you in case you get a breakthrough attack sure now for us we believe that we can really address both aspects of that right so it's not we're not as concerned of oh well what happens if 80% of the market becomes pro fee okay we're good with that we have a pro fee what happens if on-demand takes over okay we also believe that we have a dominant profile there and one of the things that we're working towards building a highlight level of data around is what if somebody was on decreto band XR and then if and when they had a breakthrough attack they could treat with decreto band IR so we've pulled together some initial efficacy findings around mechanism on mechanism so people from chapter one who had breakthrough attacks treated with a catabat same mechanism of decreto band and had equivalent efficacy findings as people from placebo who treated with a catabat we most recently put out some interesting safety margin data around people if somebody was modeled around if somebody was on XR daily and then they treated not only with one IR tablet but a second IR tablet right away. Those safety margins were well within what we would expect of a NOEL. So we're thrilled with that.

Okay. So as you think about timelines for the data readout, what should we expect to see in 3Q when you top line the data?

We will be, of course, showing numbers around our percentage attack reduction, safety profile as well. I think one of the things that we've been seeing from other people and what is shifting in expectations on Prophy is some data around either number of days that are attack-free, percentage of patients that are attack-free, The bar is being raised as the efficacy improves from all of our peers. And so I think the attack-free percentage and numbers will be important for us as well.

Now, that 80% plus that you have the goal of achieving, as you expand from a phase one slash two to a pivotal study, the population is quite heterogeneous. So how do you get comfortable that with more patients enrolled in this pivotal study that you could do a similar number to what you had in that impressive smaller study? Thank you.

So one of the items that we've implemented in the phase three to be able to protect against this phase two to phase three efficacy degradation is we're switching our formulation from a twice daily immediate release capsule. So that has a very swift uptake of therapeutic exposure, and then it sort of drifts until about hour 12, and then you take a second one. Now, at around hour 12 and 24 in our Chapter 1 study, we believe that some patients could have been vulnerable to breakthrough attacks because there's an opportunity to drop below that therapeutic threshold of EC85, about 13.8 nanograms. we have modeled our pk around the xr formulation which is the the formulation we're using in chapter three as well as our intended commercial formulation and put out recent pk variability data which indicates that even from patient to patient there the pk and therapeutic exposure is about two to four times higher than that minimum EC85 where you're blocking 85% of the B2 receptor because the PK profile is much softer and you're not having these drastic peaks and troughs we believe that that is an optimized formulation for a once daily prophylactic okay got it so if you want to go back to comparing versus Orlodeo, which would be your oral competitor in the space.

You know, historically, the HAE market has tended to be sticky, which means if something is working for you, whatever it might be, even Synrise, which is an old drug, some people are still on it, you tend to stay on it. If it's not working for you, you know, our feedback from physicians is that you tend to switch to something else pretty quickly. So what portion of the population are you really, you know, looking to have patients switch from? Because it's our understanding that for Olodeo, if it's not working for you, you've already moved on to something else. So would it be from the injectable population, at least initially, that you would expect to see most of your uptake?

We believe, and I think we're in complete agreement, there is some brand loyalty that people have. However, I think that your point is very well taken, which is if it's working for you, they will stay on it. As I mentioned before, people on Orly-Dea are still experiencing one to two breakthrough attacks a month. Based off of what we're seeing from the other injectables, that actually isn't working well for them, right? Like that is not the expectation that patients have when they take an injectable. So we believe that people are accepting a lower efficacy because they prefer an oral so much. So we actually really do think that good is not good enough, right? Just because you are on an oral right now and putting up with breakthrough attacks doesn't mean that that's what you should be experiencing. So, you know, Oral-A-Day was able to capture about 25% of the market in five years with a maybe not as compelling profile. So as much as people say that it's a sticky market, it's not that sticky if they're able to get 25% of the market in five years. We believe that people will switch to the better product for them.

And then maybe one more question about your point on switching. So it is true that if it's not that different, you know, it's hard to get patients to switch unless they feel like something is really different. So going from an injectable to an oral would be, you know, one of those things where, hey, this is different enough. I want to try it. But what about the flip side of injectables?

There's, there's now a bunch of trying to dominate 100% of the market. There are, each patient and physician has a, has the opportunity to choose what's best for them. There are benefits to being on a, on a long-acting injectable, and then there are trade-offs as well, right? We see that at the end of those long injection frequencies, there tend to be more breakthrough attacks, as, or sometimes triggered by stress right you know that your next injection is coming up the longer people have in between injections the more likelihood that you're going to miss an injection right you can't remember if you took it in the first week of July or the second week of July and then lastly the control that you forego by just taking an injection and then you know having to wait for your next injection could actually be quite a deterrent for people. You know, if somebody, for example, like I said, for people who want to get pregnant, if you are on a six-month injection, that means that you need to start family planning multiple half-lives before that. So you start to family plan a year and a half to two years before you can actually begin that process. So we believe that the control around being able to say, each day I wake up and I'm able to control my HAE by taking a daily oral is going to be really appealing to people as well. Like I said, not 100% in the market. There are going to be people who prefer to just get an injection every six months and not worry about it. That's okay. We're trying to provide patient choice.

Okay. All right. So when the top line comes out, assuming that it's positive? What are the next steps with FDA?

So in addition to having our efficacy and safety from the randomized clinical trial portion, there's an open label extension that's running where we need to be able to have enough people who were on de-correctivant for a full year. So we need to pull together that safety database. And then the other thing, as David mentioned, is our ongoing and CREATE study. This is an acquired angioedema. Part one of that study is a 12-week prophylactic study that if the timing allows with the setup of 24 patients in that group, we could actually take the efficacy and safety from AAE, add it on to chapter three plus the chapter four safety database and submit that for a broader submission on AEBK, which is bradykine-mediated angioedema.

Okay. And when would that happen, do you think?

We haven't guided towards when that data is going to be, but once we get enough visibility into that, we'll provide a disclosure on it. Okay. Perfect.

It's also true, I think, given that there are no approved AAE therapies, that if we are able to put the two together in one filing that we could get priority review.

With that, we're out of time. So thank you guys for spending the last 30 minutes with me. Thanks, everyone, for joining as well. Thanks.