Group 1 - Pharvaris is developing deucrictibant, a promising molecule for Hereditary Angioedema (HAE) [2] - The presentation features key executives from Pharvaris, including CCO Wim Souverijns and CMO Peng Lu [1] - The session aims to provide insights into the current state of affairs at Pharvaris and engage in a Q&A format [2]

Financial Data and Key Metrics Changes - The company is in a late-stage pre-commercial phase, gearing up for data readouts in Q4 of this year and filing next year, with another Phase III readout expected in the second half of next year [5][29][30] Business Line Data and Key Metrics Changes - The company is developing ducryptobant for both treatment and prevention of bradykinin-mediated attacks, with a focus on oral therapies that meet community demands for efficacy and tolerability [4][10][11] - The Phase II results showed injectable-like efficacy for prophylaxis, which if confirmed in Phase III, could position the product as a leading option in the market [10][11] Market Data and Key Metrics Changes - The oral market for hereditary angioedema (HAE) treatments has shown resilience to new entrants, with a clear demand for effective oral options [12][13] - The company anticipates that oral products will dominate the prophylaxis market in the future, potentially capturing a significant share of new patients [46] Company Strategy and Development Direction - The company aims to launch ducryptobant in the U.S. first, with plans for global expansion through partnerships due to varying pricing challenges outside the U.S. [33][34] - The strategy includes targeting multiple patient segments, including those dissatisfied with current oral options and those on injectable therapies [45][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III trial results, expecting to confirm the efficacy and safety profile established in Phase II [21][22] - There is a strong belief that the combination of on-demand and prophylactic oral therapies will significantly change the treatment landscape for HAE patients [52][53] Other Important Information - The company is preparing for a commercial launch by building relationships within the HAE community, emphasizing the importance of connections in this therapeutic area [31][32] - The CREATE study will target acquired angioedema patients, expanding the potential market for ducryptobant [60][62] Q&A Session Summary Question: What type of product profile is expected in the Phase III on-demand trial? - The company aims to demonstrate injectable-like efficacy, placebo-like safety, and great convenience for both on-demand and prophylactic use [21][22] Question: How does the extended release formulation impact safety and efficacy? - The extended release formulation is expected to optimize pharmacokinetics, potentially reducing safety concerns and boosting efficacy [37][38] Question: How will ducryptobant fit within the various patient segments? - The company plans to target patients currently on injectable prophylaxis, those dissatisfied with Orlodea, and new patients, anticipating that oral products will become the first-line therapy [45][46] Question: What is the strategy for differentiating the product label? - The company aims to target both hereditary and acquired angioedema, leveraging its unique mechanism of action to differentiate from competitors [60][61]

Core Insights - Pharvaris is making significant progress in addressing unmet needs for patients with bradykinin-mediated angioedema, with key clinical trials and financial updates indicating a strong operational focus [2][3][4] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of €200 million, a decrease from €281 million at the end of 2024 [11] - The company incurred a loss of €45.5 million for the second quarter of 2025, resulting in a basic and diluted loss per share of €0.83, compared to a loss of €29.7 million or €0.55 per share in the same quarter of 2024 [16] Development Pipeline - Topline results for the pivotal Phase 3 study RAPIDe-3, evaluating deucrictibant for on-demand treatment of HAE attacks, are expected in the fourth quarter of 2025 [3][4] - Enrollment is ongoing for CHAPTER-3, another pivotal Phase 3 study for prophylaxis against HAE attacks, with topline results anticipated in the second half of 2026 [3][4] - The CREAATE study, focusing on prophylactic and on-demand treatment of AAE-C1INH attacks, is on track to initiate by the end of 2025 [3][4] Recent Business Updates - The company successfully closed a public offering raising approximately $201 million in July 2025, which will extend its cash runway into the first half of 2027 [6] - Recent presentations at medical congresses highlighted clinical data supporting deucrictibant's potential to meet the needs of patients with bradykinin-mediated angioedema [5] Corporate Strategy - Pharvaris aims to maintain financial discipline while conducting multiple global Phase 3 studies, which is crucial for the successful development of deucrictibant [2][3] - The company is exploring the potential expansion of treatment applications for bradykinin B2 receptor antagonism, indicating a strategic focus on addressing broader unmet medical needs [3]

Company Overview - Pharvaris N.V. is a late-stage biopharmaceutical company focused on developing novel, oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][5] - The company aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies for the prevention and treatment of bradykinin-mediated angioedema attacks [5] Recent Financial Activity - Pharvaris announced the closing of an upsized underwritten public offering of 9,562,500 ordinary shares, which includes the full exercise of an option by underwriters to purchase an additional 1,312,500 ordinary shares, along with pre-funded warrants to purchase 500,000 ordinary shares [1] - The gross proceeds from this offering amounted to approximately $201.2 million before deducting underwriting discounts, commissions, and other offering expenses [1] Clinical Development - Pharvaris is currently evaluating the efficacy and safety of its drug, deucrictibant, in pivotal Phase 3 studies for both the prevention of HAE attacks (CHAPTER-3) and the on-demand treatment of HAE attacks (RAPIDe-3) [5]

Core Viewpoint - Pharvaris N.V. has announced the pricing of an underwritten offering of 8,250,000 ordinary shares at $20.00 per share and pre-funded warrants to purchase 500,000 ordinary shares at $19.99 each, aiming to raise approximately $175 million before expenses [1]. Group 1: Offering Details - The offering includes 8,250,000 ordinary shares priced at $20.00 each and pre-funded warrants for 500,000 shares at $19.99 each, with the total gross proceeds expected to be around $175 million [1]. - Pharvaris has granted underwriters a 30-day option to purchase an additional 1,312,500 ordinary shares at the public offering price [1]. - The offering is expected to close on or about July 24, 2025, subject to customary closing conditions [1]. Group 2: Company Background - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating bradykinin-mediated diseases, including hereditary angioedema (HAE) [5]. - The company aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies for preventing and treating angioedema attacks [5]. - Pharvaris is currently conducting pivotal Phase 3 studies for the prevention and on-demand treatment of HAE attacks [5]. Group 3: Underwriters - Morgan Stanley, Leerink Partners, Cantor, Oppenheimer & Co., and Van Lanschot Kempen are acting as joint book-running managers for the offering [2]. - The shares and pre-funded warrants are being offered under an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission [2].

Core Viewpoint - Pharvaris N.V. is planning to offer and sell $150 million of ordinary shares to fund research and development, hiring a sales and marketing team in the U.S., and for general corporate purposes [1] Group 1: Offering Details - Pharvaris intends to grant underwriters a 30-day option to purchase an additional $22.5 million of ordinary shares [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1] - The shares are being offered under an effective shelf registration statement filed with the U.S. SEC [3] Group 2: Use of Proceeds - The net proceeds from the offering will primarily fund late-stage clinical programs, sales and marketing team hiring, and working capital [1] Group 3: Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases [6] - The company aims to provide injectable-like efficacy and placebo-like tolerability with oral therapies for treating hereditary angioedema (HAE) [6] - Pharvaris is currently conducting pivotal Phase 3 studies for the prevention and on-demand treatment of HAE attacks [6]

Group 1 - Pharvaris (NASDAQ: PHVS) is set to release topline results for its Phase 3 trial, Rapide-3, for immediate-release deucrictibant in Q4 2025 [1] - Analysis of clinical trial data and medical literature suggests a favorable chance of success for Pharvaris [1] Group 2 - The author has a background in medicine and statistics, which led to an interest in biotech investing [1]

Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, targeting unmet needs in bradykinin-mediated diseases, with topline data from the RAPIDe-3 Phase 3 study expected in Q4 2025 and a potential NDA submission in H1 2026 [1][2][4] Group 1: Study and Data - The RAPIDe-3 study has achieved target enrollment, and the topline data announcement is now anticipated in the fourth quarter of 2025 [2] - The study evaluates deucrictibant immediate-release capsules (20 mg) for on-demand treatment of angioedema attacks in approximately 120 participants aged 12 and older, including those with C1 inhibitor deficiency [2][3] - Primary endpoints include time to onset of symptom relief and other measures of symptom resolution and safety [2][3] Group 2: Drug Development - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for rapid treatment [3][4] - The drug has received orphan drug designation from the FDA and the European Commission for treating bradykinin-mediated angioedema [3] Group 3: Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for bradykinin-mediated angioedema [4] - The company is conducting multiple pivotal Phase 3 studies, including CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment of HAE attacks [4]

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][3] Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies for the prevention and treatment of bradykinin-mediated angioedema attacks [3] - The company is currently evaluating the efficacy and safety of its lead candidate, deucrictibant, in pivotal Phase 3 studies for both prophylaxis and on-demand treatment of HAE attacks [3] Upcoming Presentations - Pharvaris announced the acceptance of abstracts for presentation at the US Hereditary Angioedema Association's 2025 National Summit, scheduled for July 10-13, 2025, in Baltimore, Maryland [1] - Multiple poster presentations will be held on July 11, 2025, featuring various studies related to deucrictibant, including long-term safety and efficacy, disease control, and health-related quality of life improvements in HAE patients [2][4]

Core Insights - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, aimed at treating bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][14] - The company presented data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, highlighting the efficacy and safety of deucrictibant in both prophylactic and on-demand treatment settings [2][5] Prophylaxis - The CHAPTER-1 open-label extension study demonstrated long-term safety and efficacy of oral deucrictibant for prophylaxis in HAE, with participants experiencing sustained attack reduction and improved health-related quality of life (HRQoL) [5][6] - All participants reported clinically meaningful improvements in HRQoL, maintained up to week 62 of the study [5] - The ongoing CHAPTER-3 Phase 3 study is designed to evaluate the efficacy and safety of a once-daily, oral deucrictibant extended-release tablet for HAE prophylaxis [5][4] On-Demand Treatment - The RAPIDe-2 extension study provided evidence of the long-term safety and efficacy of oral deucrictibant for treating HAE attacks, with a median time to onset of symptom relief of 1.1 hours and 97.8% of attacks achieving symptom relief within 12 hours [10][7] - Deucrictibant was well tolerated, with no treatment-related adverse events reported, and 89.2% of attacks that achieved symptom resolution at 24 hours were treated with a single dose [10][8] - The RAPIDe-3 study is the first Phase 3 on-demand study to explore 'end-of-progression' as a new pre-specified endpoint, which is significant for HAE patients [2][5] Expansion Beyond HAE - Pharvaris is exploring the potential of deucrictibant beyond HAE, with ongoing studies validating a novel kinin biomarker assay for characterizing bradykinin-mediated pathologies [9][16] - A real-world survey indicated that patients prescribed long-term prophylaxis (LTP) experienced more mild attacks and better HRQoL compared to those on on-demand treatment (ODT) alone, supporting the importance of both treatment modalities in HAE management [10]