Pharvaris N.V. Ordinary Shares H.C. Wainwright 28th Annual Global Investment Conference

Thanks. Pleasure to be here.

Sure. Pharvaris has been around 11 years, and it was founded by the founders of the icatibant molecule, even a decade before that. We are obviously publicly held with a 2.5, nearly $3 billion market cap. Our goal ultimately, by the time we have our major products approved, is to have a label that says we are all about bradykinin-mediated disorders. We're starting with Type 1 and 2 HAE, but as you'll hear in this conversation, there will also be normal C1 brought into the mix, there'll be acquired angioedema brought into the mix, and then we're looking at peripheral bradykinin-mediated disorders early on in the pipeline, possible SNDA candidates. We will have ultimately, if all goes well, the broadest label in this industry.

Hereditary angioedema is a genetic disorder in which people have a mutation in their SERPING1 gene that results in either dysfunction or disorder of the C1 inhibitor. This is within the contact pathway in the kallikrein system, resulting in excess bradykinin. When that bradykinin binds with the B2 receptor, it causes vasodilation or leakage of fluid into the intracellular space. You end up resulting in swelling attacks that are unpredictable, they are extremely painful. They can be throughout the body, so in the hands, the face, the GI tract, sometimes in the throat, which results in swelling that can lead to asphyxiation and potentially death. These are unpredictable, painful, potentially fatal swelling events that occur in the U.S., it is in about 8,000 people, so it is a rare disorder.

Our drug, deucrictibant, is an antagonist of the B2 receptor, so that means that it blocks bradykinin from binding with the B2 receptor, thereby stopping the cascade of excess bradykinin at the very bottom of the cascade. We essentially plug the sink at the bottom of the cascade. As David alluded to, this enables us to not only address excess bradykinin from the kallikrein system that I talked about before, but also address other sources of excess bradykinin, including through mutations outside SERPING1, such as plasminogen, kininogen, factor XII. There are about eight common other genetic mutations that lead to excess bradykinin. That is where our drug acts, and we have, as you mentioned before, we have two settings for deucrictibant. We have an immediate release capsule that enables rapid uptick of the therapeutic exposure that is best suited for treating acute attacks.

If and when somebody is experiencing an HAE attack, they are able to take a single pill, and that rapidly and completely treats their attacks. In that setting, we are under review by the FDA.

Our MAA is also validated in Europe, and we hope to have that approved potentially on the market in April of next year. In a second setting, we have an extended release tablet that is best suited for a slower, more progressive uptake, so it's extended release. deucrictibant is absorbed in the gut. That is best for a once-daily prophylactic treatment, so we prevent attacks from happening. We reported phase III results of that just last week, and I think we're going to talk about that a little bit more in the future.

Great question. We've been answering questions. We've also been hosting various inspections, and a mid-cycle review is coming up, which we won't be giving guidance on as to when that is, but things are going well.

For our setup in the commercial side of things, we are building out our team. We expect to have about 70 to 80 people in total in the commercial function. By the end of the year, we will have about 95% of that workforce hired. Within that, we are going to have about 30 to 40 sales reps. That is in line with other HAE companies that launch drugs here. We are in line with that. We are expecting our manufacturing to be ready for launch. Hopefully, the day that we get approval, we should be able to launch the drug. We are well set up and well capitalized to be able to successfully launch deucrictibant IR potentially in April of next year upon approval.