Pharvaris (PHVS) Update / Briefing June 04, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Farvaris event. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded, and a replay will be made available on the Farvaris website following the conclusion of the event. I'd now like to turn the call over to Maggie Beller, Head Head of Corporate and Investor Communications at Farvaris. Please go ...

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]

ZUG, Switzerland, May 19, 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 abstracts for presentation at three upcoming congresses: the 14th C1-Inhibitor Deficiency and Angioedema Workshop, to be h ...

Pharvaris (PHVS) 2025 Conference May 14, 2025 11:40 AM ET Speaker0 My name is Jeremiah Lorenz. I'm one of the Equity Research Analysts here at Bank of America. It's my pleasure to introduce our next presenting company, Farveris. Today, we'll be joined by CEO, Bernd Modig. Bernd, take it away. Speaker1 Yes. Thank you, and welcome and good morning to Farveris. And I'm going show you a brief presentation. It's only fifteen minutes. So if you have questions or want to follow-up, we invite you to reach out to us ...

Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026Attack dataset continues to accumulate in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelinesTQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant immediate-release formulationPharvaris Management to host R&D call on June 4 at 8:00 ...

Expansion of potential treatment applications of deucrictibant in people living with bradykinin-mediated angioedemaZUG, Switzerland, May 12, 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), including HAE with normal C1 inhibitor and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), t ...

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 ...

Financial Performance and Funding - The company has generated no revenues to date and has incurred significant losses since inception, with expectations of continued losses over the next several years[42]. - The company may need to raise substantial additional funding to continue operations, which could lead to dilution of existing shareholders[49]. - The market price of the company's ordinary shares is likely to be highly volatile, and there is no current intention to pay dividends[42]. - Significant shareholders beneficially owned approximately 56.41% of the outstanding ordinary shares as of April 1, 2025[229]. - The company does not currently intend to pay cash dividends on its ordinary shares in the foreseeable future[231]. - An active trading market for the company's ordinary shares may not be sustainable, potentially impairing future capital raising efforts[228]. Product Development and Clinical Trials - The company is heavily dependent on the success of its product candidates, specifically the extended-release and immediate-release formulations of deucrictibant, which are in late-stage development[42]. - Topline data from the RAPIDe-1 study demonstrated efficacy in the Phase 2 clinical trial for treatment of HAE attacks on demand using deucrictibant IR[42]. - The company has established proof-of-concept for deucrictibant in Phase 2 trials for both treatment and prophylaxis of HAE attacks, but future clinical trials may not replicate these results[63]. - The FDA lifted clinical holds on deucrictibant for on-demand and prophylactic treatment of HAE in June 2023 and January 2024, respectively, but future challenges may arise[64]. - The company has completed Phase 2 trials for on-demand and prophylactic settings, providing critical data for late-phase clinical trials[86]. - The company is developing an extended-release formulation for deucrictibant, with plans for multiple dose studies to assess pharmacokinetics and safety[79]. - The company has not yet received regulatory approval for any drugs and may face significant delays in the commercialization of its product candidates[71]. - The company has not submitted any marketing authorization applications for its product candidates, which must include extensive nonclinical and clinical data to establish safety and effectiveness[72]. - The company faces risks in clinical trials, including failure to obtain necessary approvals and potential negative results, which could lead to additional trials or abandonment of product development[73]. - The company may experience setbacks in clinical trials, including delays in commencing or completing trials, which could materially affect its business[42]. Regulatory and Compliance Risks - The company identified material weaknesses in its internal control over financial reporting as of December 31, 2023, which were concluded to be remediated by December 31, 2024[52]. - The company is subject to taxation in multiple jurisdictions, including the Netherlands, Switzerland, and the United States, which may lead to variable effective income tax rates[57]. - The OECD's Global Anti-Base Erosion Model Rules aim to impose a global minimum tax of 15% on multinational enterprises with revenue exceeding €750 million, which could impact the company if revenue thresholds change[60]. - The EU Pillar II Directive, adopted on December 15, 2022, requires member states to implement minimum tax measures starting from fiscal years beginning on or after December 31, 2023[61]. - The company is subject to extensive regulations for clinical trials and marketing, requiring authorization from appropriate regulatory authorities[89]. - Regulatory disruptions at agencies like the FDA and EMA could hinder the approval process for new products[78]. - The company acknowledges that clinical trials may not uncover all possible adverse effects, leading to potential safety concerns post-approval[83]. - The company may face significant delays in obtaining marketing approvals in the United Kingdom due to Brexit, which could restrict revenue generation and profitability[94]. - The company faces challenges in conducting animal testing due to regulatory and public pressures, potentially impacting research and development activities[88]. - The company may experience delays in patient enrollment for clinical trials, which could increase development costs and delay regulatory approvals[81]. Manufacturing and Supply Chain Risks - The company does not own manufacturing facilities and relies on third-party CDMOs, which may affect its ability to supply sufficient product candidates[110]. - The company currently relies on a small number of CDMOs for production, which poses risks to manufacturing operations and could adversely affect business and financial results[111]. - Manufacturing process changes may require repeating trials or conducting additional trials, potentially delaying marketing approval[112]. - Development of in-house manufacturing facilities could enhance control over material supply, but the company lacks experience in this area[113]. - Dependence on third-party manufacturers may adversely affect future profit margins and timely commercialization of products[114]. - Manufacturing challenges may arise during scale-up, leading to increased costs or delays in regulatory approval[115]. - The company relies on third-party manufacturers who are also subject to environmental and safety regulations, which could impact business operations[221]. Competition and Market Risks - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may hinder its ability to commercialize its product candidates successfully[137]. - The commercial success of the company's product candidates will depend significantly on market acceptance among physicians, patients, and healthcare payors[135]. - Market opportunities for product candidates may be smaller than anticipated, potentially lowering revenue projections[130]. - The company anticipates pricing pressures due to the increasing availability of generic products and cost-containment initiatives by insurers[138]. - The insurance coverage and reimbursement status for newly approved products remains uncertain, which could limit the company's ability to generate revenue[145]. - Governments and pricing authorities, especially in the European Union, impose strict price controls that may adversely affect future profitability[143]. Intellectual Property Risks - The company is exposed to risks related to the enforcement of its intellectual property rights, which could lead to potential litigation and impact its ability to protect its technologies[172]. - The patent protection for the company's products may not be sufficiently broad, which could allow competitors to develop similar products and adversely affect the company's market position[170]. - The company may not be able to secure necessary patent rights or maintain existing patents, which could limit its ability to compete effectively in the market[175]. - The duration of patent protection is limited, with U.S. patents generally expiring 20 years after the effective filing date, which could impact the company's long-term competitive advantage[178]. - The company faces risks related to the expiration of patents for product candidates, which may leave it vulnerable to competition from biosimilars or generics[181]. - Future patents may be challenged in court, potentially leading to loss of exclusivity or invalidation, which could adversely affect the company's competitive position[182]. - The company may not be able to protect its intellectual property rights in all jurisdictions, limiting its ability to prevent third parties from using its inventions[184]. - Changes in patent laws, such as those introduced by the America Invents Act, could weaken the company's ability to obtain and enforce patent protection[189]. - The company may face significant costs and distractions from potential litigation regarding intellectual property rights, which could impact its financial condition[197]. - There is a risk of infringing third-party intellectual property rights, which could result in costly litigation and affect the company's ability to commercialize its product candidates[194]. Operational and Management Risks - The company may encounter ownership disputes related to intellectual property, which could result in litigation and loss of valuable rights[196]. - The company faces challenges in attracting and retaining qualified management and scientific personnel, which is crucial for the successful development and commercialization of its product candidates[162]. - The company may struggle to enter into or maintain strategic alliances necessary for the commercialization of its product candidates, facing competition from other companies and institutions[167]. - The company may face significant product liability claims, which could result in substantial financial liabilities[151]. - The company’s business operations may be subject to significant costs associated with compliance with health care laws, which could lead to penalties and impact financial results[213]. - Rapid technological changes in the pharmaceutical industry could render the company’s product candidates obsolete, adversely affecting financial condition and prospects[215]. - The company’s international operations are subject to various economic, political, and regulatory risks, including differing drug approval requirements and intellectual property protections[216]. - Failure to achieve projected development goals may delay product commercialization, potentially leading to a decline in stock price[219]. Environmental and Legal Risks - The company is subject to extensive environmental, health, and safety laws and regulations, which may lead to significant compliance costs and liabilities[222]. - Misconduct by employees or third parties could result in significant administrative, civil, and criminal fines, adversely affecting the company's reputation and financial condition[224]. - The company may face increased restrictions and compliance costs related to changing legal or regulatory requirements, impacting production and development efforts[222]. - There is no certainty that all employees and collaborators will comply with applicable laws, potentially leading to significant legal and financial repercussions[227]. - The company faces risks related to the handling of sensitive patient data, which is subject to stringent privacy laws[121]. - Non-compliance with GDPR could result in fines up to €20 million or 4% of total worldwide annual turnover, whichever is higher[124].