Pharvaris (NasdaqGS:PHVS) FY Conference February 26, 2026 09:20 AM ET Company ParticipantsBerndt Modig - CEOMaggie Beller - Executive Director and Head of Corporate and Investor CommunicationsConference Call ParticipantsJeff Jones - Managing Director and Senior Analyst of BiotechnologyJeff JonesMorning, everyone, and welcome back to Oppenheimer's Healthcare Conference. I'm Jeff Jones, one of the analysts on the biotech team, and I'm delighted to welcome this morning, Berndt Modig, CEO of Pharvaris, as well ...

Core Insights - Pharvaris is set to present pivotal Phase 3 data from the RAPIDe-3 study of deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks at the AAAAI 2026 Annual Meeting [1][2] - The company will also share final data from the Phase 2 CHAPTER-1 study and pharmacokinetic data of the extended-release formulation of deucrictibant [2] Presentation Details - Six abstracts have been accepted for poster presentation, with three featured during a special session [1] - Key presentations include: - A novel kinin biomarker assay for bradykinin-mediated angioedema [2] - Content validity of the Angioedema symptom rating scale (AMRA) [2] - Long-term prophylactic treatment results from the Phase 2 CHAPTER-1 study [2] - Results from the Phase 3 RAPIDe-3 study on oral deucrictibant for HAE attacks [2] - Long-term safety and efficacy results from the Phase 2 CHAPTER-1 study [2] - Sustained therapeutic exposure with the once-daily oral deucrictibant extended-release tablet [2] Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for bradykinin-mediated diseases [4] - The company aims to provide therapies with injectable-like efficacy and the convenience of oral administration [4] - Pharvaris is preparing global marketing authorization applications for deucrictibant immediate-release capsules and is conducting a pivotal Phase 3 study for the extended-release tablet [4]

Core Insights - Pharvaris is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases, particularly hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][14] - The company outlined its strategic priorities for 2026, emphasizing long-term prophylaxis and on-demand treatment of HAE attacks [3][4] Clinical Development - The pivotal Phase 3 study, RAPIDe-3, demonstrated that deucrictibant significantly reduced the median time to onset of symptom relief to 1.28 hours compared to placebo (p<0.0001) [5] - Topline data from the CHAPTER-3 study, assessing deucrictibant for prophylactic treatment of HAE attacks, is expected in the third quarter of 2026 [4][5] - The NDA dossier for deucrictibant's on-demand treatment of HAE attacks is on track for filing in the first half of 2026 [4][5] Financial and Operational Updates - Pharvaris has an estimated cash runway into the first half of 2027, indicating strong financial management [4][11] - The company was added to the Nasdaq Biotechnology Index in December 2025, reflecting its compliance with market capitalization and trading volume requirements [11] Upcoming Events - Pharvaris will participate in several investor conferences and medical congresses in early 2026, showcasing its ongoing clinical studies and findings [8][10][12]

Core Insights - Pharvaris N.V. (NASDAQ:PHVS) is highlighted as a promising small-cap stock with significant upside potential, receiving a Buy rating from Morgan Stanley with a price target of $41 and an Outperform rating from Oppenheimer with a raised target of $50 from $44 [1][2]. Group 1: Clinical Study Results - The pivotal RAPIDe-3 study demonstrated positive top-line results for deucrictibant, confirming its potential for on-demand treatment of HAE attacks, with a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo [2]. - All secondary efficacy endpoints were achieved, including a median End of Progression time of 17.47 minutes and complete symptom resolution in a median of 11.95 hours, confirming the safety profile of deucrictibant across various HAE subtypes and attack severities [3]. Group 2: Future Plans - Pharvaris N.V. plans to use data from the pivotal Phase 3 study as the basis for marketing authorization applications, which are expected to be filed in the first half of 2026 [4].

Core Insights - Saturn V Capital Management has initiated a new position in Pharvaris N.V. (PHVS), acquiring 886,332 shares valued at approximately $22.1 million during the third quarter, indicating strong interest from a major hedge fund in the biotech sector [1][2]. Company Overview - Pharvaris N.V. is a clinical-stage biotechnology company focused on developing novel oral therapies for hereditary angioedema (HAE), a rare genetic disorder [6][9]. - The company has three pivotal programs underway: PHA121 (Phase II), PHVS416 (Phase II), and PHVS719 (Phase I), targeting both acute and prophylactic treatment needs [9][10]. - As of market close on the reporting date, Pharvaris shares were priced at $25.35, reflecting a 33% increase over the past year, outperforming the S&P 500, which rose by 12% in the same period [3][4]. Financial Metrics - Pharvaris has a market capitalization of $1.6 billion and reported a net income of -$163.7 million for the trailing twelve months (TTM) [4]. - The company had €329 million in cash on hand as of September 30, which is expected to finance operations into the first half of 2027, covering major data readouts [10]. Investment Implications - Saturn V's stake in Pharvaris represents about 4.9% of its 13F assets, aligning with the fund's focus on biotech investments and high-conviction clinical risks [3][11]. - Recent positive topline data from the RAPIDe-3 Phase 3 trial showed a median time to onset of symptom relief of 1.3 hours, highlighting the potential for future growth despite the company being pre-revenue [11][12].

Core Insights - Pharvaris (PHVS) shares increased nearly 22% following positive results from the phase III RAPIDe-3 study for its drug deucrictibant, aimed at treating hereditary angioedema (HAE) attacks in adults and adolescents aged 12 and older [2][8] Study Results - The RAPIDe-3 study achieved its primary endpoint, with patients experiencing symptom relief within 1.28 hours after taking deucrictibant, compared to over 12 hours with placebo [3] - All secondary endpoints were met, including a median time to substantial symptom relief of under 3 hours with deucrictibant versus over 12 hours with placebo, and complete symptom resolution in 11.95 hours compared to more than 24 hours for placebo [3] - 83% of HAE attacks were managed with a single dose of deucrictibant, and over 93% of attacks were treated without the need for backup treatment [4] Regulatory Plans - Pharvaris plans to submit a regulatory filing for deucrictibant in the first half of 2026, which could position it as the second oral on-demand therapy for HAE after KalVista Pharmaceuticals' Ekterly [5] Competitive Landscape - Comparisons between deucrictibant and KalVista's Ekterly highlight potential advantages for deucrictibant, as it showed faster symptom relief in the RAPIDe-3 study compared to the KONFIDENT study supporting Ekterly's approval [6] - Year-to-date, Pharvaris stock has risen 53%, outperforming the industry growth of 20% [7] Product Development - Pharvaris is developing two formulations of deucrictibant: an immediate-release capsule for acute treatment and an extended-release tablet for prophylactic treatment [10] - The extended-release tablet is being evaluated in the phase III CHAPTER-3 study for HAE prophylaxis, with top-line data expected in the second half of 2026 [11] - Additionally, the extended-release formulation is under evaluation in the CREAATE study for treating acquired angioedema with C1-inhibitor deficiency [12] Market Positioning - If approved, deucrictibant will compete in the on-demand treatment space against KalVista's Ekterly, with advantages over older injectable treatments like Firazyr and Kalbitor due to its oral administration [14] - In the prophylactic treatment segment, competitors include BioCryst Pharmaceuticals and Ionis Pharmaceuticals, with BioCryst's Orladeyo and Ionis' Dawnzera being notable products [15]

Core Insights - Pharvaris is a biopharmaceutical company focused on developing oral treatments for hereditary angioedema (HAE) using a bradykinin B2 antagonist approach, addressing both on-demand and preventive needs for patients [1][6] Stock Performance - As of December 3, 2025, Pharvaris (PHVS) stock was priced at $29.37, reflecting a 21.75% increase from the previous session, with fluctuations between $23.80 and $29.68 on that day [4] - The stock has experienced a yearly high of $29.67 and a low of $11.51, indicating its volatile nature [4] Market Analysis - Morgan Stanley set a price target of $41 for PHVS, suggesting a potential increase of approximately 39.62% based on the company's promising late-stage pipeline and anticipated phase 3 data by the end of 2025 [2][6] - Pharvaris has a market capitalization of approximately $1.91 billion, indicating a substantial presence in the biopharmaceutical sector [5] Clinical Development - The company has received a buy rating with a target price of $40, driven by strong phase 2 results and regulatory precedents [3][6] - The mechanism of Deucrictibant, a key component of their treatment, has been validated, with an estimated probability of success for the upcoming phase 3 readout exceeding 90% [3]

Core Insights - Pharvaris N.V. is focused on developing treatments for rare diseases, particularly Hereditary Angioedema (HAE) [1][6] - Morgan Stanley has an "Overweight" rating for Pharvaris, raising the price target from $37 to $41, with the current stock price at $29.37 [1][6] Study Results - The RAPIDe-3 Phase III study of Deucrictibant showed a median time to symptom relief of 1.28 hours, significantly faster than placebo [2][3][6] - The study involved 134 participants aged 12 and older, demonstrating the efficacy of Deucrictibant in treating HAE attacks [2] - 83% of attacks were treated with a single capsule, and 93.2% of participants did not require rescue medication within 12 hours [3] Future Plans - Pharvaris plans to use the RAPIDe-3 study data for marketing authorization applications, expected to be submitted in the first half of 2026 [3][6] - The positive results from the study have contributed to an increase in PHVS stock value by 21.75% [6] Market Performance - Pharvaris' current stock price is $29.37, reflecting a change of $5.25, with a market capitalization of approximately $1.91 billion [5][6] - The stock has fluctuated between $23.80 and $29.68 today, with a 52-week high of $29.67 and a low of $11.51 [5]

Core Insights - The announcement pertains to the topline data from the RAPIDe-3 Phase III clinical study of deucrictibant, which is an immediate-release capsule designed for the on-demand treatment of hereditary angioedema attacks [2]. Company Overview - Pharvaris is leading the communication regarding the RAPIDe-3 study and its implications for the treatment of hereditary angioedema [2]. - The webcast is part of Pharvaris's efforts to keep investors informed about the progress and potential of their clinical studies [2]. Clinical Study Details - The RAPIDe-3 study is a Phase III clinical trial, indicating it is in the later stages of testing before potential regulatory approval [2]. - The focus of the study is on the efficacy of deucrictibant in treating hereditary angioedema attacks on an on-demand basis [2].

Core Insights - Pharvaris N.V. announced topline data from the RAPIDe-3 Phase 3 trial of deucrictibant for treating hereditary angioedema (HAE) attacks, indicating positive results for the on-demand treatment [1][3] Study Results - The RAPIDe-3 trial enrolled 134 participants aged 12 years and older, evaluating the oral deucrictibant immediate-release (IR) capsule for HAE attacks [2] - Deucrictibant showed a faster median time to treatment response compared to placebo, with shorter median times for substantial symptom relief and complete symptom resolution [3] - The data indicated fewer attacks required a second dose or rescue medication within 12 hours [4] - 83.0% of attacks were treated with a single capsule of deucrictibant IR, and 93.2% of treated attacks did not require rescue medication [9] Safety and Tolerability - Deucrictibant was well tolerated, with no serious treatment-related adverse events reported, and no participants discontinued treatment due to adverse events [5] Future Plans - The data from the RAPIDe-3 study will support marketing authorization applications planned for submission in the first half of 2026 [3] Competitive Landscape - The FDA approved Ionis Pharmaceuticals' Dawnzera for HAE prophylaxis, which significantly reduced the monthly attack rate by 81% compared to placebo over 24 weeks [6] - KalVista Pharmaceuticals' Ekterly was also approved for acute HAE attacks, being the first oral on-demand treatment for HAE [7] Market Reaction - Pharvaris shares increased by 12.32% to $27.09 following the announcement of the trial results [7]