Thank you, Nadia. Welcome to the top line data announcement of RAPIDe-1, a phase II clinical study of PHVS416 for the on-demand treatment of hereditary angioedema. My name is Maryann Cimino, Director of Corporate Relations at Pharvaris. Please note that today's webcast is being recorded, and the slides will be uploaded onto the investor section of our corporate website immediately following this call. Please note that the statements of our guests today are their own, and not those of Pharvaris. While the company believes these statements to be reliable as of the date of this presentation, it has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of the information in their comments. In addition, our presentation today will include forward-looking statements, including, but not limited to, statements regarding our future plans, product candidates and clinical studies. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. For additional information regarding the various factors that could cause such differences, please see the section entitled Risk Factors in our annual report on Form 20-F and our other filings available on the SEC's website. Any forward-looking statements represent the company's expectations only as of today. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so unless required by law. During our call, Pharvaris's Chief Executive Officer, Berndt Modig, will speak to our mission and vision to improve the standard of care for people living with HAE. Pharvaris's Chief Medical Officer, Dr. Peng Lu, will go through the top line efficacy and safety findings from RAPIDe-1. We are also joined by Professor Marcus Maurer, the principal investigator in the RAPIDe-1 clinical study, who will share his perspective as a treating physician on these data. Thank you, Professor Maurer, for joining us. Additionally, Pharvaris's Chief Community Engagement and Commercial Officer, Wim Souverijns, and Chief Business Officer, Morgan Conn, are available for the Q&A portion of the call. I will now turn it over to Berndt. Thank you, Maryann, and thank you all for joining our call. Today marks an important milestone for Pharvaris as we will be sharing for the first time clinical data in people living with HAE from our phase II on-demand RAPIDe-1 study. In the last two decades, substantial progress has been made in treating HAE attacks. Despite this progress, people with HAE have significant unmet need. Today, the standard of care for on-demand treatment requires a painful injection, which often requires redosing and can be very burdensome. Many attacks go untreated or treatment is delayed, counter to the international clinical guideline recommendations for treating all attacks early. When we asked patients what they expected from a new therapy to treat their HAE attacks, they were crystal clear. They are looking for a treatment that provides rapid onset of symptom relief and attack resolution with one single dose and in the form of an oral medicine. Targeting bradykinin, the ultimate cause of the signs and symptoms of HAE attacks, has the potential to deliver on their hopes. At Pharvaris, we discovered and developed the first orally bioavailable bradykinin B2 receptor antagonist. The dose and exposure level, as determined through the bradykinin challenge in healthy volunteers, provided the foundation for the design of our RAPID-1 trial that we will look at in a few minutes. I will now hand it over to our Chief Medical Officer, Dr. Lu, to walk through the RAPID-1 data. Peng. Thank you, Berndt. I'm very happy to share the top-line results of the RAPIDe-1 study today. RAPIDe-1 is a phase II study to assess the efficacy and the safety of 416 for the on-demand treatment of HAE attack. The RAPIDe-1 study has two parts. In part 1, all the patients are randomized, receive a single dose of 416, either 10, 20, or 30 mg for PK and the safety assessment. In part 2, patients treated three attacks at home setting, two with active and one with placebo. Altogether, in RAPIDe-1 study, 74 patients were enrolled from 13 countries. The primary endpoint of RAPIDe-1 study was a change in composite VAS-3 score from pre-treatment to four hour post-treatment. Five key secondary endpoints were planned to assess time to onset of symptom relief and symptom resolution. In this primary analysis, for either primary or key secondary endpoints, multiple comparison procedure was applied in testing the medium and high doses. Safety, PK, and use of rescue medication data will also be shared today. In the primary analysis of RAPIDe-1 study, 156 attacks were included for safety assessment. 147 attacks were included in the efficacy analysis. Demographics and the baseline features of patients in this study are generally well balanced. Female to male patient ratio is about two to one. Among the patients, there are around 90% Type I HAE patients and 10% Type II patients. Here are the PK profile from subset of HAE patients in RAPIDe-1 study. Consistent with observations in healthy volunteers, this PK data shows that all three doses of PHVS416 achieved therapeutic level within 30 minutes. The plasma concentration are maintained above EC85 for approximately eight hours for the 10 and the 20 mg dose, and for more than 10 hours for the 30 mg dose level. All this data indicate all three doses would be effective to treat HAE attacks. For the primary endpoint, all three doses of 416 significantly reduced attack symptom by VAS-3 at four hours post-treatment. Compared to placebo, the dotted gray line, the treatment of the effect of active doses can be noted after about one and a half an hour. The difference in the treatment effect reached about 15 to 13 points at four hours and sustained through 24 hours. For the case century endpoint, all three doses of 416 significant shortened time to onset of symptom relief, defined by 30% reduction in VAS-3. The median time to onset of symptom relief about two and a half hours for active doses, compared to about eight hours for placebo. Consistently, PHVS416 also significantly reduced time to 50% reduction in VAS-3. The median time to 50% reduction in VAS-3 score was about four hours for active doses, compared to 23 hours for placebo. Regarding to the almost complete or complete symptom relief, it is defined that all individual VAS score less than 10. From the data and graph, we can tell that PHVS416 significantly reduced time to symptom resolution. Median time is about seven and a half hours for PHVS416, compared to about 42 hours for placebo. For the efficacy analysis, RAPIDe-1 study also includes MSCS and the TOS assessment. MSCS, Mean Symptom Complex Severity, is a patient-reported outcome measure for HAE patients to capture symptom severity of attacks. At four hour post-dose, the severity score was greatly reduced for all three doses. The MSCS reduction for PHVS416 is about -0.9, compared to -0.29 for placebo group. TOS, Treatment Outcome Score, is a measure of the symptom response to HAE treatment. As shown in the graph, PHVS416 significantly improved response scores compared to the flat line of placebo. The treatment effect start to be onset from one hour, and the mean difference between PHVS416 and the placebo reached over six days at a four hour post-dose. In addition to the symptom and the response evaluation, another important secondary endpoint is to assess the use of the rescue medication. As shown in the graph and the bar chart, within 12 hours post-treatment, about 61 placebo patients used the rescue medication, while only 19% for 10 mg, 11% for 20 milligram, and 6.5% for 30 mg patients in active arm used rescue medication. This data demonstrate PHVS416 substantially reduced the rescue medication use in a dose-dependent manner, which is consistent with the effective exposure duration across the three dose levels we presented by PK profiles. The 61 rescue medication used for placebo patients is also consistent with the real world acute treatment rate for HAE attacks. While using TOS to assess the response to HAE treatment, it captured the symptoms of HAE attacks in five complex: internal, external head/neck, cutaneous, GI, and genitourinary. At each time point, the symptom change from treatment is reported by patients with five scales as shown in the slides. Within 48 hours assessment, approximately 90% attacks treated with 416 achieved a little better for all five symptom complex. The median time to achieving a little better is about two hours for active doses, compare about eight hours for placebo. Over 80% attacks achieved a lot of better or resolved for all five symptom complex. The median time to a lot better or resolved is about five hours for 416, compared to 23 hours for placebo. Time to symptom relief by COGS PRO further demonstrate consistent efficacy across all doses. From the safety perspective, 416 is also well-tolerated across all three doses. No treatment-related serious Adverse Events or severe events were reported. No Adverse Events led to treatment discontinuation. No treatment-related abnormalities were observed for lab, vital sign, or ECGs. There are a few treatment-related AEs reported within 48 hours after drug administration. From the table, we can tell in the non-attack visit, one nausea and one headache were reported for 10 mg and 20-mg cohort. During the home setting period, for one attack treated with 30 mg, vomiting, nausea, and fatigue for one attack were reported. For one attack treated with placebo, one blister event were observed. Overall, we are very pleased to report for RAPIDe-1 study, it met all primary and secondary endpoints. 416 showed consistent and clear efficacy across all endpoints. Together with its well-tolerated safety profile, it positions 416 well for the next step in our clinical development program. Thank you all. Dr. Maurer, I will hand it over to you. Thank you very much. Hi, this is Marcus Maurer, joining you live from Berlin. I'm a dermatologist, allergist, and run an angioedema clinic here in Berlin, one of the biggest in the country. I was involved from the very beginning with this program, and I'm very happy to say that this is a great day for us as the angioedema treating community and a wonderful day for HAE patients everywhere. Look, a lot of things have been said, but I think a couple of them need to be said really loud and again. Hereditary angioedema is an unpredictable disease. You always have to be ready for the worst, and that's an attack that could lead to suffocation or extreme pain. This is so for patients who do not have treatment, this is so for patients who are on prophylactic treatment wherever they are. It is essential that all patients with hereditary angioedema have on-demand treatment. We have on-demand treatment that is best applied in all settings of attacks. Meaning we should have patients treat their attack that occurs as early as possible. Any burden, any hurdle to fast treatment is a hurdle to fast response. The best thing that we can advise our patients to do is to take a pill and stop the attack as early as possible within the first 10 minutes, within the first half hour. Is that possible today? No, it is not. Patients need to find a quiet place to do an IV infusions or a Sub-Q injection. This is not very comfortable or possible in many places. We need to see that the convenience that an oral on-demand treatment will provide will also result in better clinical responses, less burden, and less impact of attacks in routine clinical life. I think from the data presented, there's no doubt that this works. It's a very effective, very fast treatment, and it's safe. It is a milestone in the development of novel solutions for patients with hereditary angioedema. No question. I'll tell you what was most convincing to me when I saw the data. These people with angioedema in this clinical trial, they didn't know whether they were getting the real drug or placebo. To see these dramatic differences in the use of rescue medication in a setting where you do not know is this the real drug or not, is super convincing. You saw that there's a dose response. You saw that there is a huge difference in the rate of patients on the real treatment groups versus placebo when it comes to the use of rescue medication, when it comes to thinking, this is not working, this is not getting better, or at least it's not getting worse. This shows to me that patients do know that this treatment helps them, that they do refrain from taking other medication, rescue medication, that this is something that they will use and like in real life. Well done. Congratulations. And I'm very much looking forward to be working with this drug in my clinical practice. Thank you. Thank you, Professor Maurer, for your kind words and great insights from a treatment perspective of HAE. We're excited with the data that we shared today. The RAPIDe-1 has met its primary as well as all its secondary endpoints, providing the foundation for the further development of PHVS416 as a potential on-demand treatment of HAE attacks. As some of you may recall, our product strategy is to develop two formulations with the same active ingredient. The dose and exposure levels as determined through the bradykinin challenge in healthy volunteers provided the foundation for the design of our RAPIDe-1 trial. We applied the same principle to the design of our proof-of-concept prophylactic study, CHAPTER-1, which we anticipate announcing top line data from in the second half of 2023. Back over to you, Maryann. Thank you, Berndt. Now, Nadia, if we can please open this up for the Q&A, as this concludes our presentation section. Thank you very much. As a reminder, to ask a question, you need to press star one one on your telephone keypad and wait for a name to be announced. Please stand by while we compile the Q&A roster. This will take a few moments. Now we're going to take the first question. Yes. Please stand by. The first question comes to line of Joseph Schwartz from SVB Securities. Your line is open. Please ask your question. Hi. Thanks so much, and congrats on the data. I was wondering if you noticed any differences in baseline characteristics or response for patients in RAPIDe-1 who were enrolled outside the U.S. versus inside the U.S.? How do the patients outside of the U.S. who are enrolled in CHAPTER-1 compare to those in the U.S.? If they follow the same pattern as what you saw in RAPIDe-1, how would that be expected to influence the results in CHAPTER-1 if you need to rely on just enrolling patients outside the U.S. for that trial? Thank you. Yeah. Thanks, Joe. Thanks for joining the call. We don't believe that there are any differences there that we have in our patient structure. I'll also let Peng Lu, our Chief Medical Officer, comment. Yeah. Thanks, Berndt. Thanks for the question. Indeed, in RAPIDe-1 study, we include both U.S. patients and ex-U.S. patients. So far, we only present top-line data. We did not go to the detail to compare the patient features across different regions. In the future, we would expect to share more information. Okay, thanks. Thanks a lot. Peng. If I could just ask one more. I saw that, you know, you had your Type A meeting with the FDA. Are there any features in particular which are more or less clearly in alignment on that you're waiting for the minutes to confirm? How do you feel about the likelihood of gaining alignment after the one meeting that you had versus requiring more interactions? Kind of related to that, how is it going securing the necessary resources required to undertake an additional tox study? Assuming you gain alignment with the FDA, how quickly can you get that up and running? Yeah. Yes, we said we had a Type A meeting with the FDA, and we will provide the more fulsome update on that once we have received the formal minutes. It's hard to comment on that right at this moment, but once we have the formal minutes, we will be able to provide you more information on that. And in terms of resources, as you have seen, the FDA has requested of us to do a non-clinical study in rats, and that is of course costs money, but it's not significantly material in terms of the cost. It's the time is of course the more important aspect of that. As I said, we will provide more information once we have the formal minutes. Okay. We'll stand by. Thanks and congrats. Thanks. Thank you. Now we are going to take our next question. Please stand by. The next question comes to line of Jonathan Wolleben from JMP Securities. Your line is open. Please ask your question. Hey, good morning. Congrats on the data, and thanks for taking the questions. A couple from me. Just wondering, when we're looking at the primary endpoint graph, is anything going on with the placebo patients at four hours that they seem to be pretty steady, but then, you know, then they start having the slant downwards similar to drug at that time point? Did you see anything, as far as baseline characteristics, whether it's severity of attack, that showed, you know, better responses, on drug? Yeah. I'll hand over to Peng Lu, to answer the question. Yeah. Yeah. Thanks for the great question. Actually, we want to give a little bit more details regarding the study design for the RAPIDe-1 because before, you know, that waiting four hours post-treatment, we recommend the patients that don't use the rescue medication if possible. From four hours, if, you know, the patients need a rescue medication, typically, you know, the patients in the study will start using rescue medication. As we showed in the slide deck for rescue medication part, around 50%- 60% placebo patients used rescue medication within 12 hours. All this patient data has been censored and removed from the top-line graph. Therefore, all the data showed that post four hours here is maybe that potentially is more mild attack or attack who don't need rescue medication. So far, we don't have more detailed data, but in the future, we will do further analysis. Therefore, we expect the drop of the line there is highly possible is due to the natural resolution of the attack. As mentioned, we will do further analysis in the future. Thank you, Peng. Was there anything that in the baseline characteristics that, you know, portended a better response on 416? That's also excellent question. As mentioned, so far we only have top-line data, but we indeed in the future will include that analysis based on the baseline severity for the attacks, and we will provide the more analysis in the future conference. One more if I may before I jump back in the queue. Mm-hmm. Sure. What is FDA's current thinking on, you know, a primary endpoint for a registrational trial for acute treatment? Is it you think sticking with the VAS 30 at four hours or is there a different endpoint? Obviously, you have good data across all the endpoints here, but how are you thinking about the path forward? I'll jump back in the queue. Thanks. That's excellent question. I will start first, maybe I will hand it off to Dr. Maurer. In the RAPIDe-1 study, we used that, you know, composite of VAS-3 and MSCS scores because they were recommended by FDA companion published in June 2021. I think all these endpoints acknowledged by the agency. For the future, that is the phase III trial, we will further work with agency and consider more about our data to make the final decision about our future pivotal study. Dr. Maurer, would you like to comment for this question? Sure. Sure, Peng. I'll be happy to comment. Look, To me, these are 17 ways of looking at the same thing. Either the drug works or it doesn't. Whether you look at a total composite score, a single score, the dominant, symptom, the time to response, the use of... You know, you could go through the entire list of outcomes that have been used as primary or secondary in all the previous on-demand trials, and in the end, you will see whether a drug works or not. I'm very happy to see so many outcomes being looked at in this trial, including a little better, which I like a lot because in my clinical practice, the first thing that I want to hear from a patient using on-demand treatment is it's not getting worse because that's when I know that I can expect the patient to survive in case of a laryngeal attack and to get a little better because, you know, it never gets a little better and then worse again. You know. There's a dynamic to things and to see that this occurs so early here I think is very meaningful. That's not to take away from the other outcomes that were measured, including, as I said, for me, most importantly, the use of rescue medication. Thank you. Excuse me, Jon, do you have any other questions? No, that's perfect and very helpful. Thanks, and congrats again. Thank you so much. Thank you. Now we're going to take our next question. Please stand by. The next question comes to line of Jacob Mekhael from Van Lanschot Kempen. Your line is open. Please ask your question. Hi there, thanks for taking my question. Also congrats on these results. My first one is, we can see that the biggest VAS improvement was seen in the 10 mg dose, and also on the time to almost complete onset of symptom relief, it was also shown the best at the 10-mg dose. Are you able to comment on that? Are there any reasons for that? Also perhaps maybe if you can tell us what dose would you go with in a future trial. One other question that I had is, with the data set now in hand, what are the next steps for the program in the on-demand setting? Is there a plan to progress with the phase III outside of the U.S. first and then add U.S. later on? Do you want to resolve, you know, the hold issue and start with a global trial straight away? Yeah. Thanks. Thanks for that, Jacob. I hand over to Peng here, but I just to say that in all three doses, we reached the above the therapeutic exposure levels very quickly in all doses and the differentiation between the doses is really in the duration of effect. I'll let Peng also comment further on that. I have to say, great question. Thanks for the questions here. I would answer maybe one by one here. Regarding for the 10 mg, that's mainly due to that for this study, that as a pre-specified, you know, multiple test procedures, we, you know, have the testing for the 20 and the 30 mg, and it's supported by nominal statistical analysis for 10 mg. From all the graph and from the data, it demonstrated 10 mg is also effective. It's from our pre-specified multiple test schema there. The second question regarding for the time to the almost complete or complete resolution, we think that may be mainly due to the two factors. First factor is that, currently we also do further analysis to see the location of attacks across the different dose group. Each dose group, we only have a limited attack. We try to see whether data for the 10 mg, whether maybe potentially more abdominal attack than peripheral attack or such kind of data. Since we only have top-line results, it's not available yet. Second, we also acknowledge that for this trial, the design is mainly to assess the time to onset of the symptom relief. We have more intense assessment up to six hours and a very sparse sample collected post six hours. For example, we only have eight hours, 24 hours and 48 hours try to reduce the patient burden. In the future, we will try to optimize the sample collection and maybe it more accurately captured the time to the almost complete and complete resolution. Even with the sparse data here, we can tell that the time to complete or almost complete resolution for active dose is much more shortened compared to placebo. If we put all tasks treated here together with a larger pool here, we can tell that the time is about seven to eight hours for active doses. Yeah. Also Jacob on this parent, on the question on plan going forward. As you mentioned, we had the FDA meeting and Type A meeting and in that meeting, we discussed and proposed paths forward and to resolve the hold, and that also included proposals for the on-demand indication and the prophylactic indication. As I said earlier, once we have the minutes from that meeting and provide more updates and more clarity on the next step in our development for 416. Okay. Thank you very much. Thank you. Now we're going to take our next question. Please stand by. The next question comes to line of Seongwoo Yoo from Oppenheimer. Your line is open. Please ask your question. Hi, thanks. Thanks for taking my question and congrats on the data. I have two questions. The first one is, with the results currently available, does the team have a strong sense of what they anticipate would constitute the late-stage design of an on-demand trial with 416, including any direct comparison to currently available on-demand therapies? My second question is, can you talk a little bit on the expectations for timing of data from CHAPTER-1, whether these are influenced by the ongoing efforts to remove the FDA clinical hold? Thank you. Yeah, thanks for those questions. I'll start with the second one, then I'll hand over to Peng. We have, as you've seen, guided now for a readout on CHAPTER-1 in second half of next year. Also, as we said before, I mean, to date, no regulatory agency outside of the U.S. has put a hold on any of our sites outside the U.S. This CHAPTER-1 study continues to enroll patients. Based on that, we've updated our guidance to second half of next year. Thanks, thanks, Berndt. Regarding for your first question, that currently we are indeed very dedicatedly working on the study design for the pivotal study and also based on the exciting data here. Regarding for your question to compare the current standard of care on-demand treatment, it will be challenged to have head-to-head comparison because all the current standard of care treatment is injection by injection. It's almost impossible to blind the trial. We expect it will be still placebo-controlled trial. Thank you very much. Thank you. Now we're going to take our next question. Please stand by. The next question comes through line of Tazeen Ahmad from Bank of America. Your line is open. Please ask your question. Yeah. Hi, this is Avi from Tazeen's team. Congratulations on the data. I think most of my questions are already answered, but maybe, if you can comment on how do we think about this data, in comparison to Firazyr? I think if they had shown time to 50% symptom relief of two hours, and I understand that, you know, there's a convenience involved here, which also plays a role. Like if you have to talk about the unmet need and like if you have to do some comparison, like how do we interpret that? Maybe also, like a follow-up to the, your plan to meet with the FDA, if you are able to share anything about your strategy there, now that you have this data in hand, like how you're planning to, you know, have discussions with them. What do you plan to discuss? Yeah. I'll answer again the second question first, and then I hand it over to Peng. As I said earlier, we had our Type A meeting, and we proposed plans to resolve the hold and also for on-demand and prophylaxis separately. That's, as I said earlier, we have to wait for the minutes and then we can provide more information about the plan. As the data that we've seen today, of course, is also important in that context. That's all I can say right now. We look forward to providing more information once we have the minutes. Yes, thanks, Berndt. For the first question, I will try to address, then I will hand it over to the Dr. Maurer to share, you know, for him to share the experience. Basically that, for the comparison, it's very hard to compare to icatibant head-to-head because the trial setting is completely different. When the Firazyr, they are all a clinical trial was conducted 10 years ago, is in the clinical setting. Around that time, the baseline severity of attack is much higher than the RAPIDe-1 trial. Around that time, there's a 50% that VAS reduction is around from 40-20 there. With the current setting, you can tell for RAPIDe-1, the baseline severity attack is only around 25-27. A lot of patients, if we still apply 50% VAS reduction for the onset of symptom relief, is already falling under 10. It's almost complete of the attack resolution. Therefore, after discussing with Dr. Maurer and other KOLs, we feel it's more appropriate to use 30% of VAS reduction as a definition to define the onset of symptom relief. Therefore, from the data, we can tell time to onset of symptom relief is about two hours with a VAS-3, 30% reduction. Dr. Maurer, would you mind to share your thoughts? No, absolutely not. Peng, you're right. speed of onset is important and also, and that's equally important, but features into this, how fast patients can treat. Firazyr is a great drug. It made a huge difference when we got it for our patients because they could use it much faster than an IV infusion, which was standard of care then. Yet we see that it still takes time for patients to give themselves the Sub-Q injection. Not because they don't know that this is an attack, simply because of practical reasons. You know, finding time and space in order to give yourself that injection. Mind you, most of my patients anyway, have their injection with them 'cause that's what they use today. sometimes they forget and then they're stuck. That's not the fault of the syringe, you know. What we expect will happen with a drug that is biologically very similar to Firazyr, don't forget they both act on the same target, bradykinin B2 receptor, and both have very similar kinetics in their biological function. It will make a huge difference, or probably the biggest difference, how fast people can use a tablet versus a Sub-Q injection. That in turn will have a huge impact on the time that patients will have an attack, time to complete resolution, time to response, because again, the earlier you hit an attack, the more effective you're going to be, and every minute counts. That's why I have high hope that the practicability of having oral medication that is basically oral Firazyr, if you want, oral icatibant, will play out in higher efficacy and lower burden of patients who experience an attack. All right. Thank you. Maybe a quick follow-up on the FDA part. You had your Type A meeting. Do you have any update? I know you will share your update after you get your minutes, what is the timing of that? You got 30 days, right? Do you think we will hear something back in January or this month? What is the estimated time? We haven't talked publicly about the exact date when we had the meeting, but you're correct that FDA typically have it as a 30-day period there, that I can give you some indication. We haven't specified a date. It will be coming up soon, as I said. We look forward to providing that update when it comes here. Okay. Thank you so much, and congratulations again for your data. Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad. Dear speakers, there are no further questions at this time. I would now like to hand the conference over to our main speaker today, to Maryann Cimino, for closing remarks. Thank you, Nadia, and thank you everyone for joining our call. Have a great day.