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]

Core Viewpoint - Pharvaris is advancing its late-stage development of deucrictibant, a novel oral bradykinin B2 receptor antagonist, aimed at addressing unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][2] Recent Business Updates - Pharvaris plans to host an R&D-focused update on June 4, 2025, to discuss the pathophysiology of bradykinin-mediated angioedema and the company's approach to addressing unmet needs [3] - The company is currently enrolling participants in two pivotal Phase 3 studies: CHAPTER-3 for prophylaxis against HAE attacks and RAPIDe-3 for on-demand treatment of HAE attacks [5][6] - Pharvaris has received TQT study waivers from the FDA for both the extended-release and immediate-release formulations of deucrictibant, indicating no evident effect on cardiovascular parameters [6] Financials - As of March 31, 2025, the company reported cash and cash equivalents of €236 million, down from €281 million at the end of 2024 [13] - Research and Development (R&D) expenses for Q1 2025 were €30.9 million, compared to €18.5 million in Q1 2024, while General and Administrative (G&A) expenses increased to €11.3 million from €9.8 million [13] - The loss for the first quarter of 2025 was €46.3 million, resulting in a basic and diluted loss per share of €0.85, compared to a loss of €28.0 million or €0.52 per share in Q1 2024 [13] Upcoming Events - Pharvaris will participate in the 46th Annual Goldman Sachs Global Healthcare Conference from June 9-11, 2025, with a fireside chat scheduled for June 11 at 4:00 p.m. ET [7]

Core Insights - Pharvaris is expanding the potential treatment applications of deucrictibant for individuals with bradykinin-mediated angioedema, including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency [1][2] - The company will host a virtual R&D call to discuss the pathophysiology, prevalence, current treatment paradigms, unmet needs, and the potential of deucrictibant [2] - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through an oral therapy for bradykinin-mediated angioedema attacks [3] Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address various types of bradykinin-mediated angioedema [3] - The company is currently conducting pivotal Phase 3 studies to evaluate the efficacy and safety of deucrictibant for both the prevention and on-demand treatment of HAE attacks [3] Event Details - The virtual event titled "Deucrictibant: Beyond HAE Type 1/2" is scheduled for June 4, 2025, at 8:00 a.m. ET/14:00 CET [1][2] - Registration for the live webcast is available on the company's website, with an archived replay accessible for at least 30 days post-event [2]

Summary of Pharvaris (PHVS) Conference Call - May 08, 2025 Company Overview - **Company**: Pharvaris - **Focus**: Development of treatments for hereditary angioedema (HAE) with a unique mechanism targeting the bradykinin pathway Key Points Industry Context - **Market Dynamics**: The hereditary angioedema treatment market is highly competitive, with a significant focus on prophylactic treatments. Currently, 62% of the U.S. market is prophylactic, with expectations for growth to 70-80% [13][14][46]. Product Differentiation - **Ducritoban**: Pharvaris's lead product, a B2 receptor antagonist, offers two formulations: immediate release for rapid onset and extended release for 24-hour coverage. This positions it uniquely compared to existing plasma kallikrein inhibitors [5][6][10]. - **Patient Coverage**: Ducritoban can potentially treat a broader patient population, including type 3 HAE patients, which are often overlooked by current treatments [6][7]. Efficacy and Safety - **Phase II Results**: Ducritoban demonstrated an 85% reduction in overall attacks and over 92% reduction in moderate to severe attacks in placebo-controlled trials [53]. The drug was well tolerated over two years with no treatment-related signals observed [11]. - **On-Demand Treatment**: The time to symptom relief was approximately 1.1 hours, with complete resolution within 12 hours, showcasing its efficacy compared to existing treatments [20][21]. Phase III Trials - **Ongoing Studies**: The Phase III trial for on-demand treatment is expected to report top-line results in the first half of 2026, with a focus on symptom relief onset and overall attack management [35][69]. - **Prophylaxis Study Design**: The prophylaxis trial will involve a six-month placebo-controlled study with a 2:1 active placebo ratio, targeting 81 patients [55]. Market Opportunities - **On-Demand vs. Prophylactic**: While the on-demand market is smaller (21% of value), there is significant opportunity as 30-40% of attacks go untreated. The introduction of effective oral therapies could change treatment dynamics [46][48]. - **Patient Preferences**: There is a growing preference for oral treatments, with 70% of patients now favoring oral over injectable options, indicating a shift in market dynamics [63][64]. Financial Position - **Cash Reserves**: As of December 2024, Pharvaris had €280 million in cash, providing a strong financial position to support ongoing and future studies [68]. Future Directions - **Acquired Angioedema Study**: Pharvaris plans to initiate a pivotal study for acquired angioedema by the end of 2025, expanding its target population beyond HAE [69][70]. Additional Insights - **Long-Term Safety Confidence**: The company has built confidence in the long-term safety of bradykinin antagonism based on historical data from similar treatments [8][10]. - **Patient Treatment Burden**: The oral formulation reduces treatment burden compared to injectables, which require more complex administration [32][33]. This summary encapsulates the key insights from the Pharvaris conference call, highlighting the company's strategic positioning, product differentiation, and market opportunities within the hereditary angioedema treatment landscape.

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address unmet medical needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][2] Business Updates - The company has achieved target enrollment in the RAPIDe-3 pivotal Phase 3 study for the on-demand treatment of HAE attacks, which strengthens confidence in clinical timelines [3][4] - Enrollment is ongoing in the CHAPTER-3 pivotal Phase 3 study for prophylaxis against HAE attacks, with topline data expected in the second half of 2026 [3][4] - Deucrictibant has received orphan medicinal product designation in Europe, reinforcing its potential to address unmet medical needs in HAE and other bradykinin-mediated angioedema diseases [3][5] Clinical Data - Recent data presentations at various congresses highlight the long-term efficacy of deucrictibant, showing a maintained reduced attack rate in long-term prophylaxis and rapid treatment of HAE attacks [3][4] - In the ongoing RAPIDe-2 extension study, the median time to onset of symptom relief for upper airway attacks was reported as 0.9 hours [4] Financial Performance - As of December 31, 2024, the company reported cash and cash equivalents of €281 million, a decrease from €391 million as of December 31, 2023 [13] - Research and Development (R&D) expenses for Q4 2024 were €31.2 million, compared to €18.6 million in Q4 2023, while full-year R&D expenses were €98.6 million versus €65.6 million in 2023 [13] - General and Administrative (G&A) expenses for Q4 2024 were €13.9 million, up from €8.6 million in Q4 2023, with full-year G&A expenses totaling €47.1 million compared to €31.3 million in 2023 [13] - The company reported a loss of €34.8 million for Q4 2024, resulting in a basic and diluted loss per share of €0.64, and a full-year loss of €134 million, with a basic and diluted loss per share of €2.48 [13]

Development Pipeline Corporate • Orphan designation granted to deucrictibant for the treatment of bradykinin-mediated angioedema. On March 28, 2025, the European Commission (EC) granted orphan designation to • Target enrollment achieved in RAPIDe-3 (NCT06343779). RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), has reached its target enrollment and continues to assess ...