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]

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 ...

Reduced monthly HAE attack rate maintained for at least 1.5 years in CHAPTER-1 OLE study; median proportion of days with symptoms in OLE was further reduced to zero daysAll participants in CHAPTER-1 OLE who had reached week 62 reported improved health-related quality of lifeOngoing RAPIDe-2 extension study includes efficacy data from seven upper airway, including laryngeal, attacks; median time to onset of symptom relief was 0.9 hours (N=7)In both extension studies, deucrictibant was generally well tolerate ...

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 ...

Positive long-term extension data highlighting the differentiated profile of deucrictibant for the prevention and treatment of HAE attacks presented at recent medical congressesIntend to engage in clinical development of deucrictibant for the treatment of acquired angioedema due to C1-INH deficiency (AAE-C1INH)Initiation of CHAPTER-3 global pivotal Phase 3 clinical study of deucrictibant for the prophylactic treatment of HAE using once-daily extended-release tablet expected by YE2024Operating from a strong ...

ZUG, Switzerland, Nov. 12, 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 that its management will participate in the Inaugural Guggenheim Securities Healthcare Innovation Conference, taking place from November 11-13, 2024, at the InterContinental Boston. Details are as follows: Format: Fireside ChatDate, time: Wednesday, November 13, ...

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]