Summary of Pharvaris Conference Call Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating hereditary angioedema (HAE) and other bradykinin-mediated diseases [4][5] Key Points Clinical Development - Pharvaris is conducting two pivotal Phase 3 studies, with results expected in the next 12 months [4] - The on-demand program for deucrictibant is anticipated to read out in Q4 2025, while the prophylactic program is expected to provide top-line data in the second half of 2026 [4][10] - An acquired angioedema Phase 3 pivotal study is planned to be initiated this year [4][14] Market Potential - The HAE market is projected to reach approximately $4.7 billion by 2036 [4] - Pharvaris aims to broaden the indication for deucrictibant beyond hereditary angioedema to include other bradykinin-mediated angioedema [4][15] Product Differentiation - Deucrictibant operates at the bottom of the angioedema pathway, contrasting with other treatments that act higher up in the kallikrein system [5] - The product features two formulations: an extended-release formulation for prophylactic use and an immediate-release capsule for on-demand treatment [6][10] Clinical Efficacy - In Phase II studies, deucrictibant demonstrated: - End of progression in 25-26 minutes [8] - Onset of symptom relief in 1.1 hours, compared to 2.4 hours for standard care [9] - Complete symptom resolution in 10.6 hours [9] - 85% reduction in overall attacks at injectable levels [11] - 93% attack reduction in open-label extension data [11] Safety Profile - Deucrictibant has shown placebo-like tolerability and received a QT waiver, indicating a favorable safety profile [9][11] Strategic Positioning - Pharvaris intends to launch the on-demand program first, followed by the prophylactic program, leveraging the dual portfolio to expand beyond hereditary angioedema [18] - The company has orphan drug designation in Europe and the U.S. for bradykinin-mediated angioedema, which may facilitate priority review discussions with regulators [15] Competitive Landscape - The company believes that the best product can become a market leader, emphasizing the importance of patient services and marketing in the HAE space [16][17] - There is a significant unmet need for effective oral therapies in the HAE market, as evidenced by the uptake of existing oral treatments [16] Future Opportunities - Pharvaris estimates that the population with normal C1 could represent an additional 20% of the current HAE types I and II population, indicating potential for market expansion [25] Additional Insights - The ability to use both on-demand and prophylactic therapies in concert is seen as a differentiator for payer and physician adoption [23] - The company is exploring opportunities for identifying patients with acquired angioedema and HAE of unknown mutations through a biomarker [25]

Company Overview - Pharvaris is a late-stage pre-commercial biotech company currently in Phase III clinical trials for two products targeting HAE (Hereditary Angioedema) attacks [2] - The two products include deucrictibant IR (immediate-release) for on-demand treatment and an extended-release formulation for prevention [2] Upcoming Catalysts - The company anticipates reading out results from its first Phase III trial for on-demand treatment by the end of the year [3] - A filing for the immediate-release product is expected in the first half of 2026 [3] - The readout for the second Phase III trial focused on prophylaxis is scheduled for the second half of the year [3]

Financial Data and Key Metrics Changes - The company is in phase 3 for two products, with the first phase 3 readout expected by the end of the year and the second in the first half of 2026 [2] - The prophylaxis market is anticipated to grow significantly, with 60% of patients currently on prophylaxis representing 80% of the market value [4][5] Business Line Data and Key Metrics Changes - The on-demand market is expected to grow due to the introduction of oral products, which could lead to more attacks being treated [4] - The prophylaxis market is viewed as a blue ocean for oral treatments, with the company aiming to capture a significant share of new patients transitioning from injectables [5][6] Market Data and Key Metrics Changes - The U.S. market currently has about 150 to 250 new HAE patients each year, with a significant portion expected to transition to prophylaxis [5] - The company expects the overall prophylactic market to grow to 70% to 80% over time, which may impact the on-demand market [35] Company Strategy and Development Direction - The company aims to position its oral product as a leading option in the prophylaxis market, leveraging its efficacy and tolerability compared to injectables [20][21] - The strategy includes building relationships within the HAE community to facilitate product adoption and trust [51][52] Management's Comments on Operating Environment and Future Outlook - Management noted that 65% of patients on prophylaxis are dissatisfied with their current treatment, indicating a potential market opportunity for their oral product [10] - The company is optimistic about the upcoming phase 3 data and believes it will confirm the efficacy seen in phase 2 trials [12][19] Other Important Information - The company is exploring opportunities in the acquired angioedema segment, which could unlock additional patient populations [36][39] - The management is focused on building a strong organizational infrastructure in preparation for product launches [52] Q&A Session Summary Question: How likely is the company to translate phase 2 data into competitive phase 3 results? - Management expressed confidence in the consistency of trial designs and endpoints, suggesting that the phase 3 results should align with phase 2 findings [13][19] Question: What drives the stickiness of current treatments among patients? - Management indicated that patient satisfaction and the availability of alternatives are key factors, with many patients expressing a desire for better options [9][10] Question: How does the company plan to differentiate its on-demand product? - The company believes that the rapid onset of symptom relief and the ability to achieve complete resolution with a single dose will set its product apart [28][29] Question: What is the expected impact of payers on market share? - Currently, payers have not significantly influenced the prophylaxis market, but a broader label could lead to preferential treatment from payers [25][26] Question: How does the company plan to prepare for the launch of its products? - The company is focused on hiring experienced personnel and building relationships within the HAE community to support the launch [51][52]

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]