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 ...

Pharvaris (PHVS) Conference May 08, 2025 12:30 PM ET Speaker0 Try and keep running out schedule here. Good afternoon, everybody. Thanks for joining us for a session with Barbarus. My name is John Wallovan, senior analyst here at Citizens Life Sciences at our twenty twenty five conference. We have Pong Lu and Wim Sovian. Speaker1 Good. Good enough. Speaker0 Head of head of, medical and head of commercial. So it's a perfect time to to jump in that hereditary angioedema. Cat's out of the bag, but tell us what ...

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].

ZUG, Switzerland, April 01, 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 that the European Commission (EC) has granted orphan designation to its investigational drug, deucrictibant, for the treatment of bradykini ...

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]

ZUG, Switzerland, March 03, 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 that its management will participate in the Leerink Partners Global Healthcare Conference 2025, taking place from March 10-12, 2025, at th ...

Initiated CHAPTER-3, the pivotal Phase 3 study of deucrictibant for prophylaxis against hereditary angioedema (HAE) attacks in 2024; topline data anticipated in 2H2026Enrollment in RAPIDe-3, the pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, continuing as planned; topline data anticipated in 1Q2026Study initiation of deucrictibant for the treatment of acquired angioedema due to C1-INH deficiency (AAE-C1INH) anticipated in 2025Operating from a strong financial position wit ...