Core Insights - Pharvaris has received orphan designation from the European Commission for its investigational drug, deucrictibant, aimed at treating bradykinin-mediated angioedema [1][3] - The U.S. FDA had previously granted orphan drug designation to deucrictibant in March 2022 [2] - The company is currently executing a Phase 3 development program to evaluate the efficacy and safety of deucrictibant in hereditary angioedema (HAE) [3][5] Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address bradykinin-mediated diseases [1][5] - The company aims to provide injectable-like efficacy with the convenience of oral therapy for preventing and treating angioedema attacks [5] - Deucrictibant is being developed in two formulations: an extended-release tablet for sustained absorption and an immediate-release capsule for rapid onset of action [4] Clinical Development - Pharvaris is conducting pivotal Phase 3 studies for both the prevention of HAE attacks (CHAPTER-3) and the on-demand treatment of HAE attacks (RAPIDe-3) [5] - The company is also in discussions with regulators regarding a pivotal trial for acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [3]

Core Insights - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist aimed at treating hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][10] - Recent presentations at the AAAAI/WAO Joint Congress highlighted positive safety and efficacy data from pivotal Phase 3 studies, indicating a median of zero days with attack symptoms per month for participants on long-term prophylactic treatment [2][4] Prophylactic Program - The CHAPTER-1 Open-Label Extension study involved 30 participants receiving deucrictibant 40 mg/day for an average of 12.8 months, with a maximum exposure of 20.8 months [3] - Participants in the OLE experienced sustained protection from HAE attacks, with a median proportion of days with symptoms being zero each month [4][6] - Health-related quality of life (HRQoL) measures showed significant improvements, particularly in "functioning" and "fear/shame" domains [5][6] On-Demand Program - The RAPIDe-2 extension study evaluated the long-term safety and efficacy of deucrictibant for on-demand treatment of HAE attacks, with data from 337 attacks, including seven upper airway attacks [7] - The median time to onset of symptom relief was 0.9 hours for upper airway attacks, consistent with 1.1 hours for non-airway attacks [7][6] - Deucrictibant was well-tolerated in both extension studies, with no safety signals observed [6][7] Product Overview - Deucrictibant is being developed in two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for on-demand treatment [9][10] - The company aims to provide injectable-like efficacy with the convenience of an oral therapy for HAE attacks [10]

Company Overview - Pharvaris 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) [2] - The company aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of an oral therapy for the prevention and treatment of HAE attacks [2] Clinical Development - Pharvaris is currently evaluating the efficacy and safety of its drug, deucrictibant, in pivotal Phase 3 studies: one for the prevention of HAE attacks (CHAPTER-3) and another for the on-demand treatment of HAE attacks (RAPIDe-3) [2] Upcoming Events - Pharvaris management will participate in the Leerink Partners Global Healthcare Conference 2025, scheduled for March 10-12, 2025, in Miami, FL [1] - CEO Berndt Modig will be featured in a fireside chat on March 10 at 9:20 a.m. ET, with a live audio webcast available on the company's website [1]

Pharvaris (PHVS) FY 2025 Conference February 12, 2025 09:20 AM ET Company Participants Wim Souverijns - CCOPeng Lu - Chief Medical Officer Conference Call Participants Jeff Jones - Managing Director - Senior Analyst Jeff Jones Alright. Good morning, everyone, and welcome back to the Oppenheimer Healthcare Conference. I'm I'm Jeff Jones, one of the biotechnology analysts here on the team, and I'm joined by the team from Farvaris. Farvaris is a late clinical stage company developing, the novel oral bradykinin ...

Core Insights - Pharvaris is focused on advancing the clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist, to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema (AAE) [1][11] Strategic Priorities for 2025 - The company aims to execute two pivotal Phase 3 clinical studies for HAE, specifically RAPIDe-3 for on-demand treatment and CHAPTER-3 for prophylaxis, with topline data expected in 1Q2026 and 2H2026 respectively [2][4] - Pharvaris plans to expand its pipeline into AAE, with the initiation of a clinical study for acquired angioedema due to C1-INH deficiency anticipated in 2025 [3][6] - The company is operating from a strong financial position, with an estimated cash runway extending into 3Q2026 [3] Clinical Development Updates - RAPIDe-3 is a global Phase 3 study evaluating deucrictibant for the on-demand treatment of HAE attacks, targeting approximately 120 participants, with primary efficacy endpoints focused on symptom relief [2][5] - CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study for prophylaxis against HAE attacks, aiming to enroll about 81 participants and evaluate the efficacy of deucrictibant compared to placebo [4] - An open-label extension study, CHAPTER-4, is set to initiate in 1Q2025 to further evaluate the long-term efficacy and tolerability of deucrictibant [4] Business Updates - The company has expanded its team to support the launch of deucrictibant, with new appointments in sales, marketing, and business development [8] - Pharvaris presented data on HAE treatment experiences and unmet needs at recent medical congresses, highlighting the demand for novel oral therapies [8] - Upcoming presentations at investor conferences and medical congresses are scheduled, including participation in the J.P. Morgan Healthcare Conference [9][13]

Core Insights - Pharvaris is advancing the clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist, for the prevention and treatment of hereditary angioedema (HAE) attacks [1][9] - The company plans to initiate the pivotal Phase 3 study, CHAPTER-3, for prophylactic treatment of HAE by the end of 2024 [1][3] - Recent presentations at medical congresses highlighted positive long-term extension data for deucrictibant, reinforcing its differentiated profile and potential efficacy [2][3] Clinical Development Updates - CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study aimed at enrolling approximately 81 participants aged 12 years and older, with a primary endpoint focused on the efficacy of deucrictibant compared to placebo [3] - Enrollment in the RAPIDe-3 study, a global pivotal Phase 3 study for on-demand treatment of HAE, is progressing as planned with a target of approximately 120 participants [3] - Long-term prophylaxis data from the CHAPTER-1 OLE study showed a 93% reduction in attacks compared to baseline, while the RAPIDe-2 OLE study indicated a median onset of symptom relief in approximately 1.1 hours [3][4] Financial Position - As of September 30, 2024, the company reported cash and cash equivalents of €305 million, down from €391 million at the end of 2023 [6] - Research and Development expenses for Q3 2024 were €25.8 million, an increase from €18.5 million in Q3 2023, while General and Administrative expenses rose to €12.1 million from €7.7 million in the same period [6] - The company reported a loss of €41.7 million for Q3 2024, with a basic and diluted loss per share of €0.77, compared to a loss of €23.6 million and a loss per share of €0.58 in Q3 2023 [6] Future Plans - The company intends to expand the clinical development of deucrictibant into acquired angioedema due to C1-INH deficiency (AAE-C1INH) following promising data from an investigator-initiated trial [4] - Upcoming investor events include participation in the Evercore ISI's 7th Annual HealthCONx Conference and the Oppenheimer Movers in Rare Disease Summit [5]

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for the prevention and treatment of hereditary angioedema (HAE) attacks [2] Group 1: Company Overview - Pharvaris aims to provide effective, well-tolerated, and easy-to-administer treatment alternatives for HAE patients, both on-demand and prophylactically [2] - The company is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate another pivotal Phase 3 study for prevention by the end of 2024 [2] Group 2: Upcoming Events - Pharvaris management will participate in the Inaugural Guggenheim Securities Healthcare Innovation Conference from November 11-13, 2024, with a fireside chat scheduled for November 13 at 9:30 a.m. ET [1] - A live audio webcast of the event will be available on the Investors section of the Pharvaris website, with a replay accessible for 30 days post-presentation [1]

Core Insights - Pharvaris is hosting a virtual investor event on October 23, 2024, to discuss the unmet needs in hereditary angioedema (HAE) treatment and the potential of its drug, deucrictibant [1] - The event will feature presentations from key medical and executive personnel, followed by a live Q&A session [2] - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for HAE, with ongoing Phase 3 studies for both on-demand and prophylactic treatments [3] Company Overview - Pharvaris is developing novel, oral bradykinin B2 receptor antagonists aimed at preventing and treating HAE attacks [3] - The company aims to provide effective and well-tolerated treatment alternatives for bradykinin-mediated angioedema [3] - Positive data from Phase 2 studies has encouraged Pharvaris to advance deucrictibant, with pivotal Phase 3 studies currently enrolling [3]

Core Insights - Pharvaris is set to initiate the pivotal Phase 3 clinical study, CHAPTER-3, for deucrictibant, aimed at the prophylactic treatment of hereditary angioedema (HAE) by the end of 2024 [1][2] - The company plans to expand the clinical development of deucrictibant to include acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) as a new indication [1][3] - The CEO of Pharvaris expressed confidence in deucrictibant's potential to become a preferred therapy for HAE management, supported by new long-term extension study data [2] Clinical Development - CHAPTER-3 will evaluate the efficacy and safety of once-daily dosing of deucrictibant extended-release tablets, designed to maintain therapeutic plasma levels for over 24 hours [2][3] - The study is on track to begin by the end of 2024, with startup activities progressing as planned [2] - Data from ongoing studies indicate that deucrictibant can provide injectable-like efficacy with favorable tolerability and convenience of oral administration [3] Research Findings - A recent investigator-initiated trial at Amsterdam UMC demonstrated that deucrictibant significantly reduced mean monthly attack rates in patients with AAE-C1INH, with no severe adverse events reported [3][4] - The results from this trial support the hypothesis that deucrictibant can effectively prevent and treat AAE-C1INH, addressing an unmet medical need [4] Upcoming Events - Pharvaris will present findings at the CIIC Fall 2024 Conference, including long-term efficacy and safety data from the RAPIDe-2 and CHAPTER-1 extension studies [6] - A live conference call will be held to discuss updates and data in detail, with presentation materials available on the company's investor relations website [7] Product Overview - Deucrictibant is a novel oral bradykinin B2 receptor antagonist, developed in both extended-release and immediate-release formulations for prophylactic and on-demand treatment of HAE [8][9] - The company aims to provide effective, well-tolerated, and easy-to-administer alternatives for patients with bradykinin-mediated angioedema [9]

ZUG, Switzerland, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced a summary of data being presented at the ongoing 7th Bradykinin Symposium. Details of the presentations are outlined below: Long-Term Safety and Efficacy of Oral Deucrictibant for HAE Prophylaxis, a poster presentation by Marc A. Riedl, M.D., M.S. In the current ...