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]

Summary of Pharvaris (PHVS) FY Conference Call - June 11, 2025 Company Overview - Pharvaris is a publicly traded company focused on hereditary angioedema (HAE), a disease characterized by unpredictable and painful swelling attacks that can be fatal if they affect the throat [2][3] Core Product and Development - The company is developing an oral Bradykinin B2 receptor antagonist called ducryptoban, currently in phase three trials for both on-demand and prophylactic treatment [3][4] - Phase two data showed an 85% attack reduction compared to placebo for the prophylactic use, with open-label extension data indicating a 93% attack reduction [10][11] Competitive Landscape - The market includes various treatment modalities, including long-acting injectables and oral therapies. Pharvaris aims to provide a product that combines injectable-like efficacy with oral convenience [4][5][6] - Current leading prophylactic therapy is Tekxiro, an injectable used every two weeks, while Orlodayo has shown strong market performance despite lower efficacy [7][8] Phase III Study Design - The phase three study will include a broader patient population (81 participants) and utilize an extended-release formulation for improved pharmacokinetics [13][14] - The study design includes a two-to-one randomization to increase the likelihood of participants receiving the active drug [17] Key Endpoints and Expectations - The primary endpoint for the phase three study has shifted to patient-reported outcomes (PGIC) to align with regulatory expectations, which is considered a lower bar than previous endpoints [35] - The company aims to reproduce or improve upon the 85% attack reduction seen in phase two to remain competitive in the market [20][39] Market Strategy - Pharvaris is targeting multiple patient segments, including new patients, those dissatisfied with current oral therapies, and patients currently on injectables [24][25][27] - The prophylaxis market is expected to grow, with the company positioned to capture both oral and injectable segments [41][43] Expansion Plans - Pharvaris is exploring expansion into treating patients with normal C1 inhibitor levels and acquired angioedema, representing a significant unmet medical need [49][50] - The company has orphan drug designation for bradykinin-mediated angioedema in both the US and EU, enhancing its commercial potential [51] Financial Outlook - As of the end of Q1 2025, Pharvaris had €236 million in cash, providing a runway through Q3 2026, covering the upcoming phase three data readouts [59] - The company is actively building its commercial team and infrastructure to prepare for market entry [46][47] Investment Considerations - Pharvaris emphasizes its experienced management team, strong intellectual property portfolio, and the differentiated profile of ducryptoban as compelling reasons for investment [61][63] - The company believes it is currently undervalued and presents an interesting opportunity for investors with upcoming milestones [63]

Summary of Farvaris Conference Call Company and Industry Overview - **Company**: Farvaris - **Industry**: Pharmaceutical, specifically focusing on treatments for bradykinin mediated angioedema (HAE) Key Points and Arguments 1. **Introduction of Ducryptoban**: Farvaris is developing ducryptoban, an oral therapy aimed at treating bradykinin mediated angioedema, including types beyond hereditary angioedema (HAE) types one and two [2][4][16] 2. **Unmet Medical Needs**: There is a significant unmet need for effective treatments for patients with bradykinin mediated angioedema, particularly those with normal C1 inhibitor levels, which represent an additional 15-25% of patients [17][36] 3. **Clinical Trials**: Two pivotal Phase III studies are ongoing to evaluate the efficacy and safety of ducryptoban for both prophylactic and on-demand treatment of HAE attacks [17][33] 4. **Biomarker Development**: A novel biomarker assay has been developed to identify individuals with bradykinin mediated angioedema, which could enhance diagnosis and treatment management [24][31] 5. **Current Treatment Landscape**: The current treatment options for bradykinin mediated angioedema are limited, with many patients relying on off-label treatments that do not adequately address their needs [36][45] Additional Important Content 1. **Types of Angioedema**: The call discussed various types of bradykinin mediated angioedema, including hereditary angioedema due to C1 inhibitor deficiency and acquired forms, emphasizing the need for accurate diagnosis and tailored treatment approaches [8][10][12] 2. **Challenges in Diagnosis**: Diagnosing bradykinin mediated angioedema, especially in patients with normal C1 inhibitor levels, is challenging due to the lack of measurable biomarkers [11][23] 3. **Regulatory Support**: Farvaris has received orphan drug designation from both US and EU regulatory authorities for ducryptoban, highlighting the potential for this treatment to address significant unmet medical needs [45] 4. **Community Engagement**: Farvaris is collaborating with patient organizations and experts to better understand the needs of those living with bradykinin mediated angioedema [16][36] 5. **Future Directions**: The company aims to expand treatment options for patients with bradykinin mediated angioedema beyond HAE types one and two, with ongoing studies expected to provide critical data for regulatory filings [45][44] This summary encapsulates the key discussions and insights from the Farvaris conference call, focusing on the company's initiatives and the broader context of bradykinin mediated angioedema treatment.

Core Insights - Pharvaris is advancing its late-stage clinical development of deucrictibant, a novel 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][18] - The company plans to present pivotal data readouts for deucrictibant in the next 18 months, highlighting its commitment to addressing unmet medical needs in this area [2][4] Prophylaxis - The ongoing Phase 2 CHAPTER-1 open-label extension study shows that oral deucrictibant maintains a low attack rate for over a year and a half, regardless of baseline attack rates [3] - Participants in the CHAPTER-1 study reported significant improvements in health-related quality of life (HRQoL) and treatment satisfaction, with all participants indicating well-controlled HAE [4] - A pharmacokinetics study demonstrated that the extended-release (XR) formulation of deucrictibant supports once-daily dosing, showing a four-fold higher mean plasma concentration than the therapeutic threshold at 24 hours [5][7] On-Demand Treatment - A post-hoc analysis of the RAPIDe-1 and RAPIDe-2 trials indicated that 95-100% of HAE attacks treated with a single dose of deucrictibant achieved symptom relief without recurrence [9] - The median time to onset of symptom relief was reported as 1.1 hours, with 97.8% of attacks achieving relief within 12 hours [10][11] - Deucrictibant was well tolerated across various attack types, including upper airway attacks, with no treatment-related adverse events reported [11] Expansion Beyond HAE - Pharvaris is exploring a novel biomarker assay for diagnosing bradykinin-mediated angioedema, which could enhance the identification and management of related conditions [12] - The company is also assessing the patient experience and outcome measures for AAE-C1INH, aiming to develop a conceptual model to support clinical assessments [14] - A systematic literature review estimated the prevalence of HAE-C1INH in the EU and UK to be between 0.05-0.33 per 10,000 individuals, indicating a significant need for effective treatments [15]

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][8] - The company announced the acceptance of abstracts for presentation at three upcoming congresses, highlighting its ongoing research and development efforts [1] Upcoming Presentations - At the C1-Inhibitor Deficiency and Angioedema Workshop in Budapest, several presentations will focus on the clinical validation of biomarker assays, long-term prophylactic treatment with oral Deucrictibant, and patient experiences related to acquired angioedema [2] - The 2025 Eastern Allergy Conference and the EAACI Congress 2025 will also feature presentations on the long-term safety and efficacy of oral Deucrictibant for both prophylaxis and treatment of hereditary angioedema attacks [4][5] Research Focus - The presentations will cover various aspects of bradykinin-mediated angioedema, including clinical validation of novel biomarker assays, health-related quality of life improvements, and pharmacokinetics studies [2][3] - Pharvaris is currently evaluating the efficacy and safety of Deucrictibant in pivotal Phase 3 studies for both the prevention and on-demand treatment of HAE attacks [8]

Summary of Pharvaris (PHVS) Conference Call Company Overview - Pharvaris is focused on bradykinin-mediated angioedema, particularly hereditary angioedema (HAE) [3][4] - The company is pioneering science for patient choice in therapy options [3] - Pharvaris has two late-stage programs in Phase III for its molecule, Cryptevant, which serves both as prophylaxis and on-demand treatment [3][4] Market Insights - The global market for HAE is projected to grow to approximately $5.2 billion by 2036 [4] - There remains a significant unmet need in the HAE market, with no sustainable first-mover advantage for new entrants [4][5] - HAE is a genetic condition that significantly impacts the quality of life, with unpredictable attacks of swelling [5][6] Clinical Data and Pipeline - The prevalence of HAE is estimated to be between 1 in 10,000 to 1 in 80,000 individuals globally [7] - Patients typically experience around 12 to 24 attacks per year, influencing their treatment choices [8] - Cryptevant is a B2 receptor antagonist and the first and only small molecule orally available for this indication [9][10] - The company has two Phase III studies ongoing: RAPID E3 for on-demand treatment and Chapter III for prophylaxis, with top-line data expected in Q1 2026 and the second half of 2026, respectively [13][14] Efficacy and Safety - In Phase II studies, Cryptevant showed an 84.5% reduction in attacks at a 40 mg/day dosage compared to placebo [16][17] - The open-label extension study indicated a further 93% attack reduction compared to baseline [17] - The Phase III study for prophylaxis is designed to compare confirmed attacks against a placebo, with a focus on safety and efficacy [18][22] Future Plans and Regulatory Status - Pharvaris is planning a pivotal trial for acquired angioedema, with orphan drug status granted in Europe and the U.S. for both on-demand and prophylactic treatments [15] - The company aims to become a leader in the bradykinin-mediated angioedema space and is committed to engaging with the HAE community [23][24] Key Takeaways - Pharvaris is well-funded and has a strong R&D team with extensive experience in the therapeutic area [5] - The company is positioned to potentially become the standard of care in oral therapies for HAE, pending successful clinical trials and regulatory approvals [23][24]