ZUG, Switzerland, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced the acceptance of two abstracts for oral presentation and six for poster presentation at the American College of Allergy, Asthma, and Immun ...

Question-and-Answer SessionSo just to kick things off, could you set the stage by walking us through deucrictibant's value proposition across both acute and prophylactic treatment of hereditary angioedema.Berndt A. ModigCo-Founder, CEO & Executive Director Yes. Thanks, Max, and great to be here again. So deucrictibant being an oral therapy option is -- fulfills a very specific unmet need in this space that we've seen over the years. And so that's a key feature, of course, the oral aspect of it. And you expe ...

Summary of Conference Call on Pharvaris and Deucrictibant Company and Industry Overview - **Company**: Pharvaris - **Industry**: Hereditary Angioedema (HAE) Treatment Key Points and Arguments 1. **Deucrictibant's Value Proposition**: Deucrictibant is an oral therapy that addresses a significant unmet need in HAE treatment, combining oral convenience with high efficacy comparable to injectable therapies [1][2] 2. **Treatment Segments**: The prophylactic treatment segment has grown to approximately 67% of the population and 80% of the market value, while the on-demand segment remains viable due to its flexibility [3][4] 3. **Patient-Centric Approach**: The choice between prophylactic and on-demand treatment is highly individualized, influenced by patient preferences and anxiety levels regarding attacks [5][6] 4. **Mechanism of Action**: Deucrictibant is unique as it is the only therapy with formulations for both prophylactic and on-demand use, acting as a bradykinin B2 receptor antagonist [9][10] 5. **Phase 3 Trials**: The timeline for the RAPIDe-3 Phase 3 trial has been moved up to Q4 2025, with expectations of strong efficacy and safety data based on Phase 2 results [11][17] 6. **Efficacy Metrics**: In Phase 2 trials, deucrictibant showed an 87% reduction in attacks compared to placebo, with 49% of patients experiencing zero attacks [21][22] 7. **Market Opportunity**: There are approximately 150 to 300 new HAE patients diagnosed annually, with a significant portion expressing dissatisfaction with current treatments, indicating a strong market opportunity for deucrictibant [25][26] 8. **Regulatory Milestones**: The FDA has accepted TQT waivers for both formulations of deucrictibant, which will streamline the regulatory process and reduce costs [30][32] 9. **Financial Position**: Pharvaris reported around $200 million in cash, extending its runway to the first half of 2027, with plans for a U.S. sales and marketing infrastructure [40][41] 10. **Future Developments**: Pharvaris plans to initiate trials for acquired angioedema and aims for a broad label for deucrictibant, targeting not just type 1 and 2 angioedema [36][37] Additional Important Insights - **Patient Satisfaction**: A survey indicated that 67% of patients are not satisfied with their current treatment, highlighting the demand for more effective options [25] - **Competitive Landscape**: The company is closely monitoring competitors and the evolving market dynamics, particularly in the context of pricing and payer expectations [28][29] - **AI Utilization**: Pharvaris is exploring the use of AI for data analysis and medical writing, indicating a forward-looking approach to technology integration [43] - **Regulatory Interactions**: Positive interactions with the FDA have been reported, with no major concerns regarding tariffs or regulatory changes impacting the company [45][46]

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]

Pharvaris (PHVS) 2025 Conference September 03, 2025 11:30 AM ET Company ParticipantsWim Souverijns - CCOSteve Seedhouse - Biotechnology Equity ResearchPeng Lu - Chief Medical OfficerWim SouverijnsI told her.Steve SeedhouseYeah.That wasn't me. That was that was the conference, organizers. Great. Great. Okay.Well, thanks so much everyone and welcome to the next session. I'm Steve Seedhouse from the biotech team here at Cantor. And it's really a privilege of me to introduce our next presenting company, Varveri ...

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]