Workflow
Pharvaris N.V.(PHVS)
icon
Search documents
Pharvaris N.V. (PHVS) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-10 17:07
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 ...
Pharvaris (NasdaqGS:PHVS) FY Conference Transcript
2025-09-10 13:32
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]
Pharvaris (NasdaqGS:PHVS) FY Conference Transcript
2025-09-09 13:00
Pharvaris (NasdaqGS:PHVS) FY Conference September 09, 2025 08:00 AM ET Company ParticipantsMaggie Beller - Head of IROperatorEveryone, and thank you for joining the H.C. Wainwright 27th Annual Global Investment Conference. My name is Arabella, and I'm an associate on the Equity Research team at H.C. Wainwright. We hope you have a productive day of one-on-one meetings, company presentations, and panels. With that said, it's my pleasure to introduce Pharvaris. Pharvaris is a late-stage biopharmaceutical compa ...
Pharvaris N.V. (PHVS) Presents at Wells Fargo 20th Annual Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-05 05:04
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]
Pharvaris N.V.(PHVS) - 2025 FY - Earnings Call Transcript
2025-09-04 20:45
Pharvaris (PHVS) FY 2025 Conference September 04, 2025 03:45 PM ET Speaker0All right, perfect. My name is Tiago Fauci. I'm a biotech analyst here at Wells Fargo, joined today by the Pharvaris team. I appreciate you guys joining us today for our healthcare conference. We're going to do a fireside chat and run through some questions. Usually, I like to start by giving you some room to just do intro remarks, where the company is today, next upcoming catalyst, and then we'll dive into the more nitty-gritty ques ...
Pharvaris N.V. (PHVS) Presents At Cantor Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-04 09:25
PresentationSteven SeedhouseMD & Biotechnology Analyst 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 for me to introduce our next presenting company, Pharvaris. I'm joined on stage by CCO, Wim Souverijns; and the CMO, Peng Lu. I'm really looking forward to the conversation. Obviously, Pharvaris is developing deucrictibant. It's a very exciting molecule for HAE. And in lieu of me saying more, I woul ...
Pharvaris (PHVS) 2025 Conference Transcript
2025-09-03 16:32
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 ...
Pharvaris Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 20:05
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]
Pharvaris Announces Closing of $201.2 Million Upsized Public Offering of Ordinary Shares and Pre-Funded Warrants and Full Exercise of Underwriters’ Option to Purchase Additional Shares
Globenewswire· 2025-07-24 20:05
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]
Pharvaris Announces Pricing of Upsized $175 Million Public Offering of Ordinary Shares and Pre-Funded Warrants
GlobeNewswire News Room· 2025-07-23 01:22
Core Viewpoint - Pharvaris N.V. has announced the pricing of an underwritten offering of 8,250,000 ordinary shares at $20.00 per share and pre-funded warrants to purchase 500,000 ordinary shares at $19.99 each, aiming to raise approximately $175 million before expenses [1]. Group 1: Offering Details - The offering includes 8,250,000 ordinary shares priced at $20.00 each and pre-funded warrants for 500,000 shares at $19.99 each, with the total gross proceeds expected to be around $175 million [1]. - Pharvaris has granted underwriters a 30-day option to purchase an additional 1,312,500 ordinary shares at the public offering price [1]. - The offering is expected to close on or about July 24, 2025, subject to customary closing conditions [1]. Group 2: Company Background - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating bradykinin-mediated diseases, including hereditary angioedema (HAE) [5]. - The company aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies for preventing and treating angioedema attacks [5]. - Pharvaris is currently conducting pivotal Phase 3 studies for the prevention and on-demand treatment of HAE attacks [5]. Group 3: Underwriters - Morgan Stanley, Leerink Partners, Cantor, Oppenheimer & Co., and Van Lanschot Kempen are acting as joint book-running managers for the offering [2]. - The shares and pre-funded warrants are being offered under an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission [2].