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PHVS

PharvarisD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-12
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Investor releaseQuarter not tagged2026-08-12

Pharvaris Reports Second Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Deucrictibant IR NDA under review by the FDA with PDUFA date of April 23, 2027; MAA validated by the EMA in July 2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Strong financial position with cash and cash equivalents of €318 million as of June 30, 2026 ZUG, Switzerland, Aug. 12, 2026 (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 angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the second quarter ending on June 30, 2026, and provided a business update. “Pharvaris continues to make strong progress advancing deucrictibant IR toward potential regulatory approval, moving closer to our goal of helping address unmet needs of people living with HAE by providing a therapy that can offer rapid and sustained attack relief and resolution with a single oral capsule. In parallel to our recent regulatory successes, our ongoing pre-commercial activities are designed to support a timely, successful U.S. launch,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Announcing pivotal data from CHAPTER-3, expected this quarter, will mark another key milestone for Pharvaris as we develop deucrictibant for both the prevention and on-demand treatment of bradykinin-mediated angioedema attacks. The financing we completed in May extends our cash runway into 2028, enabling us to properly prepare for deucrictibant’s launch and consider lifecycle management opportunities while maintaining capital discipline.” Recent Business UpdatesDevelopment Pipeline Topline data from CHAPTER-3 (NCT06669754) expected in 3Q2026. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. Eighty-five participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg/day), the intended commercial formulation…Read full document

Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Deucrictibant IR NDA under review by the FDA with PDUFA date of April 23, 2027; MAA validated by the EMA in July 2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Strong financial position with cash and cash equivalents of €318 million as of June 30, 2026 ZUG, Switzerland, Aug. 12, 2026 (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 angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the second quarter ending on June 30, 2026, and provided a business update. “Pharvaris continues to make strong progress advancing deucrictibant IR toward potential regulatory approval, moving closer to our goal of helping address unmet needs of people living with HAE by providing a therapy that can offer rapid and sustained attack relief and resolution with a single oral capsule. In parallel to our recent regulatory successes, our ongoing pre-commercial activities are designed to support a timely, successful U.S. launch,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Announcing pivotal data from CHAPTER-3, expected this quarter, will mark another key milestone for Pharvaris as we develop deucrictibant for both the prevention and on-demand treatment of bradykinin-mediated angioedema attacks. The financing we completed in May extends our cash runway into 2028, enabling us to properly prepare for deucrictibant’s launch and consider lifecycle management opportunities while maintaining capital discipline.” Recent Business UpdatesDevelopment Pipeline Topline data from CHAPTER-3 (NCT06669754) expected in 3Q2026. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. Eighty-five participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg/day), the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris expects to announce topline data from CHAPTER-3 in the third quarter of 2026. Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4 is a long-term, open-label extension study of orally administered deucrictibant XR (40 mg/day) for the prophylactic treatment of HAE attacks. The goal of the study is to evaluate the long-term safety and effectiveness of deucrictibant XR in the prophylactic treatment of HAE attacks. Review of marketing authorization applications of deucrictibant immediate-release (IR) capsule as a potential on-demand treatment of HAE attacks underway by regulatory authorities. In July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company’s New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027. In July 2026, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for deucrictibant IR and began its formal review of the MAA under the centralized procedure. Expanded Access Program (EAP) for deucrictibant IR for the on-demand treatment of HAE attacks opened in the U.S. EAPs are a potential pathway for people with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The U.S. EAP for deucrictibant IR is available to people in U.S. living with HAE meeting eligibility requirements. Healthcare professionals interested in making requests for access to deucrictibant IR through the EAP can refer to https://mytomorrows.com/pharvaris/healthcareprofessional/ and/or email Pharvaris’ Medical Affairs at [email protected]. Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a global, pivotal Phase 3 study evaluating orally administered deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. Assessment of AAE-C1INH disease burden and validation of clinical trial endpoints published in Frontiers in Immunology. Qualitative interviews provided evidence of the impact of AAE-C1INH on participants’ lives and overall well-being, and the study findings informed the clinical outcome assessment strategy for CREAATE, the first phase 3 clinical trial specifically studying AAE-C1INH. Evidence supporting bradykinin B2 receptor as a validated therapeutic target in bradykinin-mediated angioedema published in Clinical Reviews in Allergy & Immunology. This summary of the growing body of evidence explores the critical role of bradykinin B2 receptor in the pathogenesis of bradykinin-mediated angioedema and supports bradykinin B2 receptor antagonism as a therapeutic strategy for bradykinin-mediated diseases, including HAE and AAE-C1INH, as well as, potentially, other allergic and immunological conditions. Corporate Peng Lu, M.D., Ph.D., promoted to newly created role of President. Leveraging the company’s scientific rigor and reflecting the depth of Dr. Lu’s contributions, Pharvaris has brought its research, development, and commercial functions under one leadership structure by promoting Dr. Lu to President, effective June 2026, strengthening Pharvaris’ ability to deliver on its strategic priorities. Closed $132 million underwritten offering. The proceeds from the offering of $132.3 million of shares extends cash runway into 2028. Upcoming Investor Events Wells Fargo 21st Annual Healthcare Conference. Boston, MA, Sept. 8-10, 2026. 2026 Cantor Global Healthcare Conference. New York, NY, Sept. 9-11, 2026. Morgan Stanley 24th Annual Global Healthcare Conference. New York, NY, Sept. 14-16, 2026. H.C. Wainwright 28th Annual Global Investment Conference. New York, NY, Sept. 14-16, 2026. Live audio webcasts of the presentations will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replays will be available on Pharvaris’ website for 30 days following the presentation. Upcoming Medical Congress Presentations Bradykinin Symposium 2026. Berlin, September 3-4, 2026. Details for the accepted presentations at the 8th Bradykinin Symposium are as follows: FinancialsSecond Quarter 2026 Financial Results Liquidity Position. Cash and cash equivalents were €318 million as of June 30, 2026, compared to €292 million for December 31, 2025. Research and Development (R&D) Expenses. R&D expenses were €35.0 million for the quarter ended June 30, 2026, compared to €29.6 million for the quarter ended June 30, 2025. General and Administrative (G&A) Expenses. G&A expenses were €15.8 million for the quarter ended June 30, 2026, compared to €10.8 million for the quarter ended June 30, 2025. Loss for the quarter. Loss for the second quarter was €47.8 million, resulting in basic and diluted loss per share of €0.70 for the quarter ended June 30, 2026, compared to €45.5 million, or basic and diluted loss per share of €0.83, for the quarter ended June 30, 2025. Note on International Financial Reporting Standards (IFRS)Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About DeucrictibantDeucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. About PharvarisPharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. For more information, visit https://pharvaris.com/. Forward Looking StatementsThis press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “hope,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; the outcome of regulatory approvals, including the outcome of our NDA for the on-demand treatment of acute attacks of HAE; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. Contact Maggie Beller Vice President, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2026-05-13

Pharvaris Reports First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Timeline for submission of NDA of deucrictibant IR for the on-demand treatment of HAE attacks remains on-track in 1H2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Cash and cash equivalents of €247 million as of March 31, 2026; subsequent closing of $132 million underwritten offering extends cash runway into 2028 ZUG, Switzerland, May 12, 2026 (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 financial results for the first quarter ended in March 31, 2026, and provided a business update. “In 2026, Pharvaris remains focused on execution across our late-stage programs, including reporting CHAPTER-3 data in the third quarter and enrolling in CREAATE, and on establishing our commercial infrastructure in preparation for the potential launch of deucrictibant IR,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The growing published scientific evidence of deucrictibant’s potential as an end-to-end portfolio solution for bradykinin-mediated angioedema care supports our clinical, regulatory, and commercial strategies. Supported by the upsized and oversubscribed raise of approximately $132 million, our team is maintaining a disciplined approach to capital allocation that prioritizes the success of deucrictibant.” Recent Business Updated Development Pipeline Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. Approximately 81 participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data from CHAPTER-3 in the third quarter of 2026. Enrollment in CHAPTER-4 (…Read full document

Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Timeline for submission of NDA of deucrictibant IR for the on-demand treatment of HAE attacks remains on-track in 1H2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Cash and cash equivalents of €247 million as of March 31, 2026; subsequent closing of $132 million underwritten offering extends cash runway into 2028 ZUG, Switzerland, May 12, 2026 (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 financial results for the first quarter ended in March 31, 2026, and provided a business update. “In 2026, Pharvaris remains focused on execution across our late-stage programs, including reporting CHAPTER-3 data in the third quarter and enrolling in CREAATE, and on establishing our commercial infrastructure in preparation for the potential launch of deucrictibant IR,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The growing published scientific evidence of deucrictibant’s potential as an end-to-end portfolio solution for bradykinin-mediated angioedema care supports our clinical, regulatory, and commercial strategies. Supported by the upsized and oversubscribed raise of approximately $132 million, our team is maintaining a disciplined approach to capital allocation that prioritizes the success of deucrictibant.” Recent Business Updated Development Pipeline Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. Approximately 81 participants were enrolled and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data from CHAPTER-3 in the third quarter of 2026. Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4 is a long-term, open-label extension study of orally administered deucrictibant XR for the prophylactic treatment of HAE attacks. The goal of the study is to evaluate the long-term safety and effectiveness of deucrictibant XR in the prophylactic treatment of HAE attacks. Submission of New Drug Application (NDA) of deucrictibant immediate release (IR) capsule for the on-demand treatment of HAE attacks remains on-track for 1H2026. Data from the pivotal, randomized, placebo-controlled Phase 3 study, RAPIDe-3, and the long-term extension study, RAPIDe-2, will serve as the basis for the NDA of deucrictibant IR, which is on-track for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2026. Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a global, pivotal Phase 3 study evaluating orally administered deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. Recent data publications and presentations report evidence on the potential for combined use of bradykinin B2 receptor antagonism for both prophylactic and on-demand treatment of HAE attacks. Evidence supporting the use of deucrictibant IR as an on-demand treatment in the event of a breakthrough attack in combination with deucrictibant XR as a prophylactic treatment were recently presented at the CIIC Spring 2026 Conference. Results from the Phase 2 randomized, placebo-controlled clinical studies CHAPTER-1 and RAPIDe-1 provided evidence of bradykinin B2 receptor antagonism as both prophylactic and on-demand treatment options, respectively, for those living with HAE, supporting further development of deucrictibant for both indications in Phase 3 studies, and were also recently published back-to-back in The Lancet Heamatology. Corporate Closing of $132 million underwritten offering extends cash runway. The proceeds from the offering of $132.3 million of shares will be used to fund research and development expenses for Pharvaris’ late-stage clinical programs, the expansion of a sales and marketing team in the U.S., and related commercialization expenses, as well as for working capital and general corporate purposes. Pharvaris remains diligent in its operational management and expects to have a cash runway into 2028. Upcoming Investor Events BofA Securities Health Care Conference 2026. Las Vegas, NV, May 12-14, 2026. Format: Fireside Chat Date, time: Wednesday, May 13, 8:40 a.m. PDT (11:40 a.m. EDT) 2026 RBC Capital Markets Global Healthcare Conference. New York, NY, May 19-20, 2026. Format: Fireside Chat Date, time: Wednesday, May 20, 11:00 a.m. EDT Financials First Quarter 2026 Financial Results Liquidity Position. Cash and cash equivalents were €247 million as of March 31, 2026, compared to €292 million for December 31, 2025. Research and Development (R&D) Expenses. R&D expenses were €29.9 million for the quarter ended March 31, 2026, compared to €30.9 million for the quarter ended March 31, 2025. General and Administrative (G&A) Expenses. G&A expenses were €14.0 million for the quarter ended March 31, 2026, compared to €11.3 million for the quarter ended March 31, 2025. Loss for the quarter. Loss for the first quarter was €38.8 million, resulting in basic and diluted loss per share of €0.59 for the quarter ended March 31, 2026, compared to €46.3 million, or basic and diluted loss per share of €0.85, for the quarter ended March 31, 2025. Note on International Financial Reporting Standards (IFRS) Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “hope,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; the timing and outcome of regulatory approvals, including the timing and outcome of our planned submission of an NDA with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Vice President, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2026-04-06

Pharvaris' Deucrictibant Could Be a Game Changer Pending Phase III Results, RBC Says

MT Newswires

Pharvaris (PHVS) remains well positioned with its lead drug candidate, deucrictibant, supported by u

Investor releaseQuarter not tagged2026-04-02

Pharvaris Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

GlobeNewswire
Enrollment completed in CHAPTER-3, a pivotal study of deucrictibant XR for prophylactic treatment of HAE attacks; topline data anticipated in 3Q2026 Timeline for submission of NDA dossier of deucrictibant IR for on-demand treatment of HAE attacks remains on-track in 1H2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Cash and cash equivalents of €292 million as of December 31, 2025 ZUG, Switzerland, April 02, 2026 (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 financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “The positive readout of our first pivotal Phase 3 study, RAPIDe-3, at the end of 2025 was a crucial moment for Pharvaris. With the momentum of this important milestone, we continue to execute in 2026 through the anticipated NDA submission of deucrictibant IR for the on-demand treatment of HAE attacks, topline data readout of CHAPTER-3, and enrollment in CREAATE,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Across all our programs, Pharvaris remains committed to helping to improve standard of care for those living with bradykinin-mediated angioedema. In addition to potentially bringing deucrictibant to those with HAE type 1 and type 2, we hope to also address unmet needs of those with HAE with normal C1 inhibitor and acquired angioedema with C1 inhibitor deficiency. Our team will continue to operate in a financially disciplined manner through these key inflection points.” Recent Business Updates Development Pipeline Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. Target enrollment was achieved in CHAPTER-3, a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study enrolled approximately 81 participants randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or p…Read full document

Enrollment completed in CHAPTER-3, a pivotal study of deucrictibant XR for prophylactic treatment of HAE attacks; topline data anticipated in 3Q2026 Timeline for submission of NDA dossier of deucrictibant IR for on-demand treatment of HAE attacks remains on-track in 1H2026 Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Cash and cash equivalents of €292 million as of December 31, 2025 ZUG, Switzerland, April 02, 2026 (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 financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “The positive readout of our first pivotal Phase 3 study, RAPIDe-3, at the end of 2025 was a crucial moment for Pharvaris. With the momentum of this important milestone, we continue to execute in 2026 through the anticipated NDA submission of deucrictibant IR for the on-demand treatment of HAE attacks, topline data readout of CHAPTER-3, and enrollment in CREAATE,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Across all our programs, Pharvaris remains committed to helping to improve standard of care for those living with bradykinin-mediated angioedema. In addition to potentially bringing deucrictibant to those with HAE type 1 and type 2, we hope to also address unmet needs of those with HAE with normal C1 inhibitor and acquired angioedema with C1 inhibitor deficiency. Our team will continue to operate in a financially disciplined manner through these key inflection points.” Recent Business Updates Development Pipeline Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. Target enrollment was achieved in CHAPTER-3, a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study enrolled approximately 81 participants randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the third quarter of 2026. Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4 is a long-term, open-label extension study of orally administered deucrictibant XR tablet (40 mg/day) for the prophylactic treatment of HAE attacks. The goal of the study is to evaluate the long-term safety and effectiveness of deucrictibant XR tablet in the prophylactic treatment of HAE attacks. Submission of U.S. New Drug Application (NDA) of deucrictibant IR for the on-demand treatment of HAE attacks anticipated 1H2026. Data from RAPIDe-3 and RAPIDe-2 will serve as the basis for the NDA of deucrictibant, which is on-track to be submitted in the first half of 2026. Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a global, pivotal Phase 3 study evaluating orally administered deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. In part 1 of CREAATE, participants receive either deucrictibant XR (40 mg) or placebo once daily for the prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants treat two attacks in a crossover fashion, one attack with deucrictibant IR (20 mg) and one with placebo according to a randomized treatment sequence, for the on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study assessing the long-term safety and effectiveness of deucrictibant IR (20 mg) for on-demand treatment of AAE-C1INH attacks. Data from RAPIDe-3 support the potentially differentiated profile of deucrictibant for the on-demand treatment of HAE attacks. Data from the pivotal global Phase 3 study (NCT06343779) were presented in a featured posted at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting. RAPIDe-3 met the primary and all 11 secondary efficacy endpoints with high statistical significance with deucrictibant achieving onset of symptom relief in 1.28 hours and complete symptom resolution in 11.95 hours (median times), confirming its potentially differentiated profile for the treatment of HAE attacks versus placebo. Upcoming Participation at Investor Conferences BofA Securities Health Care Conference 2026. Las Vegas, NV, May 12-14, 2026. Format: Fireside Chat Date, time: Wednesday, May 13, 8:40 a.m. PDT (11:40 a.m. EDT) 2026 RBC Capital Markets Global Healthcare Conference. New York, NY, May 19-20, 2026. Format: Fireside Chat Date, time: Wednesday, May 20, 11:00 a.m. EDT Financials Fourth Quarter and Full Year 2025 Financial Results Liquidity Position. Cash and cash equivalents were €292 million as of December 31, 2025, compared to €281 million for December 31, 2024. Research and Development (R&D) Expenses. R&D expenses were €34.1 million for the fourth quarter and €124 million for the full year of 2025, compared to €31.2 million for the fourth quarter and €98.6 million for the full year of 2024. General and Administrative (G&A) Expenses. G&A expenses were €13.5 million for the fourth quarter and €45.3 million for the full year of 2025, compared to €13.9 million for the fourth quarter and €47.1 million for the full year of 2024. Loss for the year. Loss for the fourth quarter of 2025 was €46.7 million, resulting in basic and diluted loss per share of €0.72. For the full year of 2025, loss was €176 million, resulting in basic and diluted loss per share of €2.97 per share. This compares to €34.8 million, or basic and diluted loss per share of €0.64 for the fourth quarter of 2024, and €134 million, or basic and diluted loss per share of €2.48, for the full year of 2024. About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “hope,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; the timing and outcome of regulatory approvals, including the timing and outcome of our planned submission of an NDA with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Vice President, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2025-11-12

Pharvaris Reports Third Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Topline data for RAPIDe-3, a pivotal Phase 3 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, expected in 4Q2025 Enrollment in CHAPTER-3, a pivotal Phase 3 study of deucrictibant extended-release tablet for prophylaxis of HAE attacks, is progressing as planned; topline data anticipated in 2H2026 Initiated CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Data presented at recent medical congresses, including final outcomes from the completed open-label extension phase of the Phase 2 CHAPTER-1 study, reinforce the potential of deucrictibant to differentiate through its efficacy and safety profile Strong financial position with cash and cash equivalents of €329 million as of September 30, 2025 ZUG, Switzerland, Nov. 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) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “We remain on track to report data from the pivotal Phase 3 trial, RAPIDe-3, in the fourth quarter of 2025,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The achievement of this data readout, combined with the anticipated readout of CHAPTER-3 in the second half of next year, and the future outcome of the recently initiated CREAATE study, demonstrate our continued execution and commitment to develop new and innovative therapies for people with bradykinin-mediated diseases. Pharvaris is also financed well into the first half of 2027, providing us with cash runway through these key inflection points.” Recent Business Updates and Highlights Development Pipeline Topline data from RAPIDe-3 (NCT06343779) expected in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating orally administered deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment of approximately 120 participants in March 2025. Pharvaris expects to announce top-line data in the fourth quarter of 2025. Enrollment in CHAP…Read full document

Topline data for RAPIDe-3, a pivotal Phase 3 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, expected in 4Q2025 Enrollment in CHAPTER-3, a pivotal Phase 3 study of deucrictibant extended-release tablet for prophylaxis of HAE attacks, is progressing as planned; topline data anticipated in 2H2026 Initiated CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks Data presented at recent medical congresses, including final outcomes from the completed open-label extension phase of the Phase 2 CHAPTER-1 study, reinforce the potential of deucrictibant to differentiate through its efficacy and safety profile Strong financial position with cash and cash equivalents of €329 million as of September 30, 2025 ZUG, Switzerland, Nov. 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) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “We remain on track to report data from the pivotal Phase 3 trial, RAPIDe-3, in the fourth quarter of 2025,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The achievement of this data readout, combined with the anticipated readout of CHAPTER-3 in the second half of next year, and the future outcome of the recently initiated CREAATE study, demonstrate our continued execution and commitment to develop new and innovative therapies for people with bradykinin-mediated diseases. Pharvaris is also financed well into the first half of 2027, providing us with cash runway through these key inflection points.” Recent Business Updates and Highlights Development Pipeline Topline data from RAPIDe-3 (NCT06343779) expected in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating orally administered deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment of approximately 120 participants in March 2025. Pharvaris expects to announce top-line data in the fourth quarter of 2025. Enrollment in CHAPTER-3 (NCT06669754) progressing as planned. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026. Initiated CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. CREAATE assesses the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants receive either deucrictibant extended-release tablet (40 mg) or placebo once daily for the prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants treat two attacks in a cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo, for the on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study assessing the long-term safety and efficacy of deucrictibant immediate-release capsule (20 mg) for on-demand treatment. Final data from the completed Phase 2 CHAPTER-1 OLE study provide further evidence on the long-term safety and efficacy of deucrictibant for the prevention of HAE attacks. Recent data shared in an oral presentation by Dr. Marc A. Riedl at the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting reported the final outcomes of the CHAPTER-1 study (NCT05047185), in which deucrictibant was generally well tolerated. Results from the randomized portion and the open-label portion demonstrated that the mean rate of HAE attacks was reduced by deucrictibant within the first week of treatment and remained low for up to 34 months, with an overall on-treatment attack rate of 0.12 throughout the open-label portion. Corporate Closed $201 million public offering. The proceeds from the public offering of with cash proceeds of approximately $201 million extends the cash runway well into the first half of 2027. Financials Third Quarter 2025 Financial Results Liquidity Position. Cash and cash equivalents were €329 million as of September 30, 2025, compared to €281 million for December 31, 2024. Research and Development (R&D) Expenses. R&D expenses were €29.8 million for the quarter ended September 30, 2025, compared to €25.8 million for the quarter ended September 30, 2024. General and Administrative (G&A) Expenses. G&A expenses were €9.8 million for the quarter ended September 30, 2025, compared to €12.1 million for the quarter ended September 30, 2024. Loss for the year. Loss for the third quarter was €37.1 million, resulting in basic and diluted loss per share of €0.60 for the quarter ended September 30, 2025, compared to €41.7 million, or basic and diluted loss per share of €0.77, for the quarter ended September 30, 2024. Note on International Financial Reporting Standards (IFRS) Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, Swissmedic, and the European Commission. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as RAPIDe-3, CHAPTER-3, and CREAATE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2025-08-13

Pharvaris Reports Second Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Topline results for RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, expected in 4Q2025 Enrollment continues in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline results expected in 2H2026 Startup activities for CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, on track; study is expected to initiate by YE2025 Strong financial position with cash and cash equivalents of €200 million as of June 30, 2025; subsequent closing of $201 million public offering extends cash runway into 1H2027 ZUG, Switzerland, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to 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 reported financial results for the second quarter ended June 30, 2025, and provided a business update. “Halfway through 2025, an important executional year for the company, Pharvaris is making meaningful progress in our ambition to address unmet needs of people living with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The readout of RAPIDe-3 topline results, which is estimated to be in the fourth quarter of this year, is anticipated to be an important inflection point for our stakeholders. CHAPTER-3 continues to progress with topline results expected in the second half of 2026, and we are on track to initiate CREAATE in 2025. Our ability to conduct multiple global Phase 3 studies, deliver and present data supporting deucrictibant’s potentially differentiated profile in bradykinin-mediated angioedema diligently and on-time, and maintain financial discipline, supported the oversubscribed raise of approximately $200 million, which we expect will extend our cash runway beyond the estimated topline data readout date for the prophylactic program.” Recent Business Updates and Highlights Development Pipeline Topline results from RAPIDe-3 (NCT06343779) anticipated in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg, which is the intended commercial dosage) for the on-demand treatment…Read full document

Topline results for RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, expected in 4Q2025 Enrollment continues in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline results expected in 2H2026 Startup activities for CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, on track; study is expected to initiate by YE2025 Strong financial position with cash and cash equivalents of €200 million as of June 30, 2025; subsequent closing of $201 million public offering extends cash runway into 1H2027 ZUG, Switzerland, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to 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 reported financial results for the second quarter ended June 30, 2025, and provided a business update. “Halfway through 2025, an important executional year for the company, Pharvaris is making meaningful progress in our ambition to address unmet needs of people living with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The readout of RAPIDe-3 topline results, which is estimated to be in the fourth quarter of this year, is anticipated to be an important inflection point for our stakeholders. CHAPTER-3 continues to progress with topline results expected in the second half of 2026, and we are on track to initiate CREAATE in 2025. Our ability to conduct multiple global Phase 3 studies, deliver and present data supporting deucrictibant’s potentially differentiated profile in bradykinin-mediated angioedema diligently and on-time, and maintain financial discipline, supported the oversubscribed raise of approximately $200 million, which we expect will extend our cash runway beyond the estimated topline data readout date for the prophylactic program.” Recent Business Updates and Highlights Development Pipeline Topline results from RAPIDe-3 (NCT06343779) anticipated in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg, which is the intended commercial dosage) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment in March 2025; the study continues to assess HAE attacks in enrolled participants. Given the current dataset of evaluable attacks, Pharvaris anticipates announcing topline results in the fourth quarter of 2025. Enrollment continues in CHAPTER-3 (NCT06669754). CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg, which is the intended commercial dosage), or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline results of CHAPTER-3 in the second half of 2026. CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, is expected to initiate by year end 2025. CREAATE will assess the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants will receive either deucrictibant extended-release tablet (40 mg), or placebo, once daily to assess deucrictibant as a prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants will treat two attacks in a double-blinded cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo, to assess deucrictibant as an on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study that will assess the long-term safety and efficacy of deucrictibant immediate-release capsule (20 mg) as an on-demand treatment. R&D Call explored the potential expansion of treatment applications for bradykinin B2 receptor antagonism. Pharvaris management hosted a call in which they explored the pathophysiology and prevalence of bradykinin-mediated angioedema, the current treatment paradigm and unmet needs of those living with bradykinin-mediated angioedema, such as HAE with normal C1 inhibitor and AAE-C1INH, the potential of deucrictibant to address those unmet needs, and Pharvaris’ biomarker approach to aid in the identification of those living with bradykinin-mediated angioedema and other diseases. Presentations at recent medical congresses highlight clinical and non-clinical deucrictibant data. Data providing further evidence for deucrictibant’s potential to address unmet needs of people living with bradykinin-mediated angioedema were presented at recent medical congresses, such as the 14th C1-Inhibitor Deficiency and Angioedema Workshop, European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, U.S. Hereditary Angioedema Association (HAEA) 2025 National Summit, CIIC 2025 Spring Conference, ISPOR 2025, and 2025 Eastern Allergy Conference (EAC). Corporate Closing of approximately $201 million public offering in July 2025 extends cash runway. The proceeds from the public offering with cash proceeds of approximately $201 million shares will be used to fund research and development expenses for late-stage clinical programs, the hiring of a sales and marketing team in the U.S. and related commercialization expenses and for working capital and general corporate purposes. Pharvaris remains diligent in its operational management and expects to have a cash runway into the first half of 2027. Upcoming Investor Conference Presentations Pharvaris management will participate in the following upcoming investor conferences in September: Cantor Global Healthcare Conference 2025. New York, NY, September 3-5, 2025. Format: Fireside Chat Date, time: Wednesday, September 3, 2025, 11:30 a.m. ET (17:30 CEST) 2025 Wells Fargo Healthcare Conference. Boston, MA, September 3-5, 2025. Format: Fireside Chat Date, time: Thursday, September 4, 2025, 3:45 p.m. ET (21:45 CEST) H.C. Wainwright 27th Annual Global Investment Conference. New York, NY, September 8-10, 2025. Format: Fireside Chat Date, time: Tuesday, September 9, 2025, 8:00 a.m. ET (14:00 CEST) Morgan Stanley 23rd Annual Global Healthcare Conference. New York, NY, September 8-10, 2025. Format: Fireside Chat Date, time: Wednesday, September 10, 2025, 8:30 a.m. ET (14:30 CEST) A live audio webcast of the fireside chat will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replay will be available on Pharvaris’ website for 30 days following the presentation. Upcoming Medical Congress Presentations European Academy of Allergy & Clinical Immunology (EAACI) 2025 Hong Kong Allergy School 2025. Hong Kong, August 27-29, 2025. Details for the accepted oral presentations at EAACI Hong Kong Allergy School 2025 are as follows: Title: Efficacy and Safety of Oral Deucrictibant for Prophylactic (CHAPTER-3) and for On-Demand Treatment (RAPIDe-3) of Hereditary Angioedema Attacks in Adolescents and Adults: Two Phase 3 Trial Designs Presenter: Philip H. Li, M.D., FRCP Date, time: Thursday, August 28, 2025, 15:45-15:55 HKT (3:45-3:55 a.m. ET, 9:45-9:55 CEST) Title: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylactic and On-Demand Treatment of Hereditary Angioedema Attacks: Results of the CHAPTER-1 and RAPIDe-2 Extension Trials Presenter: Ramon Lleonart, M.D. Date, time: Friday, August 29, 2025, 16:05-16:15 HKT (4:05-4:15 a.m. ET, 10:05-10:15 CEST) Financials Second Quarter 2025 Financial Results Liquidity Position. Cash and cash equivalents were €200 million as of June 30, 2025, compared to €281 million for December 31, 2024. Research and Development (R&D) Expenses. R&D expenses were €29.6 million for the quarter ended June 30, 2025, compared to €23.1 million for the quarter ended June 30, 2024. General and Administrative (G&A) Expenses. G&A expenses were €10.8 million for the quarter ended June 30, 2025, compared to €11.3 million for the quarter ended June 30, 2024. Loss for the year. Loss for the second quarter was €45.5 million, resulting in basic and diluted loss per share of €0.83 for the quarter ended June 30, 2025, compared to €29.7 million, or basic and diluted loss per share of €0.55, for the quarter ended June 30, 2024. Note on International Financial Reporting Standards (IFRS) Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration and orphan designation by the European Commission. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2025-07-10

Pharvaris Updates Timing of Topline Data Announcement for RAPIDe-3 Pivotal Phase 3 Study to the Fourth Quarter of 2025

GlobeNewswire
Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026 ZUG, Switzerland, July 10, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to 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), updated the guidance for the disclosure of topline data from the ongoing RAPIDe-3 pivotal Phase 3 study evaluating deucrictibant immediate-release (IR) capsule for the on-demand treatment of HAE attacks. Pharvaris anticipates announcing topline data from RAPIDe-3 in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026. “The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth quarter of this year,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Our phase 3 data may provide evidence of deucrictibant IR’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy—from rapid end of progression to fast and complete resolution—and a favorable safety profile, with the convenience of a single-capsule oral dose.” Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, added, “We aim to confirm the findings from our Phase 2 studies in a larger Phase 3 trial, RAPIDe-3. Importantly, this study is assessing the effects of deucrictibant for people with high unmet need beyond adults with HAE type 1 and 2, such as participants with HAE with normal C1 inhibitor and adolescents between 12 and 17 years and will be evaluating the effects of deucrictibant in treating laryngeal attacks. We want to thank the clinical trial participants, the investigators and their study site collaborators for their ongoing commitment to this important trial.” RAPIDe-3 (NCT06343779) is a global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of angioedema attacks in approximately 120 adult and adolescent (12 years and older) participants with HAE, including form…Read full document

Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026 ZUG, Switzerland, July 10, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to 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), updated the guidance for the disclosure of topline data from the ongoing RAPIDe-3 pivotal Phase 3 study evaluating deucrictibant immediate-release (IR) capsule for the on-demand treatment of HAE attacks. Pharvaris anticipates announcing topline data from RAPIDe-3 in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026. “The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth quarter of this year,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Our phase 3 data may provide evidence of deucrictibant IR’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy—from rapid end of progression to fast and complete resolution—and a favorable safety profile, with the convenience of a single-capsule oral dose.” Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, added, “We aim to confirm the findings from our Phase 2 studies in a larger Phase 3 trial, RAPIDe-3. Importantly, this study is assessing the effects of deucrictibant for people with high unmet need beyond adults with HAE type 1 and 2, such as participants with HAE with normal C1 inhibitor and adolescents between 12 and 17 years and will be evaluating the effects of deucrictibant in treating laryngeal attacks. We want to thank the clinical trial participants, the investigators and their study site collaborators for their ongoing commitment to this important trial.” RAPIDe-3 (NCT06343779) is a global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of angioedema attacks in approximately 120 adult and adolescent (12 years and older) participants with HAE, including forms with C1 inhibitor deficiency and forms with normal C1INH. The primary endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least “a little better.” Other endpoints include time to End of Progression (EoP) in attack symptoms, substantial symptom relief, complete symptom resolution and proportion of complete symptom resolution achieved with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S), PGI-C, and by Angioedema Symptom Rating Scale (AMRA), and incidence of treatment-emergent adverse events (TEAEs). About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration and orphan designation by the European Commission. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, , which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; political conditions, such as the current war between Russia and Ukraine; economic conditions, including continuing inflation concerns; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2025-05-14

Pharvaris Reports First Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire
Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Attack 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 timelines TQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant immediate-release formulation Pharvaris Management to host R&D call on June 4 at 8:00 a.m. ET (14.00 CET) ZUG, Switzerland, May 13, 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 financial results for the first quarter ended March 31, 2025, and provided a business update. “Our interactions with the HAE community combined with the regulatory receipt of orphan drug designation for deucrictibant in both the U.S. and EU, strengthen our belief that deucrictibant has the potential to address unmet needs of people living with all types of bradykinin-mediated angioedema, including those with HAE with normal C1 inhibitor and with AAE-C1INH,” said Berndt Modig, Chief Executive Officer of Pharvaris. “We will detail our plans to expand the potential treatment opportunities of deucrictibant beyond people with HAE type 1/2 during an R&D call in June. We are diligently working to achieve our clinical, regulatory, and pre-commercial aspirations for 2025 and bring deucrictibant to people living with bradykinin-mediated angioedema, while maintaining our financial discipline.” Recent Business Updates Development Pipeline RAPIDe-3 (NCT06343779) attack dataset continues to accumulate. 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), reached target enrollment in March 2025; the study continues to assess HAE attacks in approximately 120 participants. Enrollment in CHAPTER-3 (NCT06669754) progressing as planned. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extende…Read full document

Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Attack 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 timelines TQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant immediate-release formulation Pharvaris Management to host R&D call on June 4 at 8:00 a.m. ET (14.00 CET) ZUG, Switzerland, May 13, 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 financial results for the first quarter ended March 31, 2025, and provided a business update. “Our interactions with the HAE community combined with the regulatory receipt of orphan drug designation for deucrictibant in both the U.S. and EU, strengthen our belief that deucrictibant has the potential to address unmet needs of people living with all types of bradykinin-mediated angioedema, including those with HAE with normal C1 inhibitor and with AAE-C1INH,” said Berndt Modig, Chief Executive Officer of Pharvaris. “We will detail our plans to expand the potential treatment opportunities of deucrictibant beyond people with HAE type 1/2 during an R&D call in June. We are diligently working to achieve our clinical, regulatory, and pre-commercial aspirations for 2025 and bring deucrictibant to people living with bradykinin-mediated angioedema, while maintaining our financial discipline.” Recent Business Updates Development Pipeline RAPIDe-3 (NCT06343779) attack dataset continues to accumulate. 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), reached target enrollment in March 2025; the study continues to assess HAE attacks in approximately 120 participants. Enrollment in CHAPTER-3 (NCT06669754) progressing as planned. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026. Data from a recent food effect study, which further supports that the extended-release tablet can be administered with or without food, will be presented at an upcoming medical congress. Receipt of TQT (thorough QT) waivers. Following review of preclinical and clinical data, the U.S. Food and Drug Administration (FDA) has accepted Pharvaris’ TQT study waiver requests. These waivers apply to the prophylactic program (IND153097) for deucrictibant extended-release formulation and the on-demand program (IND155872) for deucrictibant immediate-release formulation. Previously, Pharvaris has presented clinical and nonclinical data demonstrating that deucrictibant has no evident effect on cardiovascular parameters. Corporate Company hosting R&D-focused update on June 4. Pharvaris executives will be joined by key medical expert, Danny M. Cohn, M.D., Ph.D., to discuss the pathophysiology of bradykinin-mediated angioedema, the prevalence and unmet needs of those living with these conditions, Pharvaris’ approach to addressing these unmet needs, and Pharvaris’ biomarker approach to identification of those living with bradykinin-mediated angioedema and other diseases. To register, click here. Upcoming Investor Events Deucrictibant: Beyond HAE Type 1/2, Pharvaris-hosted R&D Call Format: Management Call Date, time: Wednesday, June 4, 8:00 a.m. ET (14.00 CET) 46th Annual Goldman Sachs Global Healthcare Conference, Loews Miami Beach Hotel, Miami Beach, FL, June 9-11, 2025 Format: Fireside chat Date, time: Wednesday, June 11, 4:00 p.m. ET (22.00 CET) A live audio webcast of the fireside chat will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replay will be available on Pharvaris’ website for 30 days following the presentation. Financials First Quarter 2025 Financial Results Liquidity Position. Cash and cash equivalents were €236 million as of March 31, 2025, compared to €281 million for December 31, 2024. Research and Development (R&D) Expenses. R&D expenses were €30.9 million for the quarter ended March 31, 2025, compared to €18.5 million for the quarter ended March 31, 2024. General and Administrative (G&A) Expenses. G&A expenses were €11.3 million for the quarter ended March 31, 2025, compared to €9.8 million for the quarter ended March 31, 2024. Loss for the year. Loss for the first quarter was €46.3 million, resulting in basic and diluted loss per share of €0.85 for the quarter ended March 31, 2025, compared to €28.0 million, or basic and diluted loss per share of €0.52, for the quarter ended March 31, 2024. Note on International Financial Reporting Standards (IFRS) Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation by the U.S. Food and Drug Administration and orphan designation by the European Commission. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of an oral therapy to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, , which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; political conditions, such as the current war between Russia and Ukraine; economic conditions, including continuing inflation concerns; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications [email protected]

Investor releaseQuarter not tagged2025-04-07

Pharvaris Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

GlobeNewswire
Target enrollment achieved in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelines Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Orphan medicinal product designation granted to deucrictibant in Europe for the treatment of bradykinin-mediated angioedema Data presented at recent congresses reinforces the value of deucrictibant by highlighting its ability to maintain a reduced attack rate in long-term prophylaxis, and potential to rapidly and completely treat HAE attacks, including in participants experiencing upper-airway attacks Strong financial position with cash and cash equivalents of €281 million as of December 31, 2024 ZUG, Switzerland, April 07, 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 financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “Pharvaris is focused on the development of deucrictibant to address unmet needs for people living with bradykinin-mediated angioedema; our priority remains generating robust clinical data to support this goal. We are pleased to have met our aggressive enrollment timelines for RAPIDe-3; we believe this was driven by high engagement from the HAE community, reinforcing the excitement about the clinical data and the potential impact of deucrictibant for those with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “To our knowledge, deucrictibant is the only orally-administered bradykinin B2 receptor antagonist in development for both the prophylactic and on-demand treatment of bradykinin-mediated angioedema. Consistent with the U.S. Food and Drug Administration, the European Commission’s granting of orphan designation to deucrictibant reiterates its potential to address unmet medical needs in HAE, as well as other bradykinin-mediated angioedema diseases.” Recent Business Updates Development Pipeline Target enrollment achieved in RAPIDe-3 (NCT063437…Read full document

Target enrollment achieved in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelines Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Orphan medicinal product designation granted to deucrictibant in Europe for the treatment of bradykinin-mediated angioedema Data presented at recent congresses reinforces the value of deucrictibant by highlighting its ability to maintain a reduced attack rate in long-term prophylaxis, and potential to rapidly and completely treat HAE attacks, including in participants experiencing upper-airway attacks Strong financial position with cash and cash equivalents of €281 million as of December 31, 2024 ZUG, Switzerland, April 07, 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 financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “Pharvaris is focused on the development of deucrictibant to address unmet needs for people living with bradykinin-mediated angioedema; our priority remains generating robust clinical data to support this goal. We are pleased to have met our aggressive enrollment timelines for RAPIDe-3; we believe this was driven by high engagement from the HAE community, reinforcing the excitement about the clinical data and the potential impact of deucrictibant for those with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “To our knowledge, deucrictibant is the only orally-administered bradykinin B2 receptor antagonist in development for both the prophylactic and on-demand treatment of bradykinin-mediated angioedema. Consistent with the U.S. Food and Drug Administration, the European Commission’s granting of orphan designation to deucrictibant reiterates its potential to address unmet medical needs in HAE, as well as other bradykinin-mediated angioedema diseases.” Recent Business Updates Development Pipeline 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 HAE attacks in approximately 120 participants. Enrollment in CHAPTER-3 (NCT06669754) progressing as planned. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026. Open-label extensions of deucrictibant in both prophylaxis (CHAPTER-4, NCT06679881) and on-demand (RAPIDe-2, NCT05396105) are ongoing. Participants who have completed the randomized clinical trials for the prophylactic or on-demand treatment of HAE attacks with deucrictibant are eligible to continue deucrictibant therapy through open-label extension studies. The intention of the studies is to evaluate the long-term safety and efficacy of deucrictibant for the prevention or treatment of HAE attacks. Data presentations at recent congresses highlight long-term clinical data of deucrictibant. Recent presentations at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting, the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress, and the 2025 HAE International (HAEi) Regional Conference APAC, support Pharvaris’ deucrictibant product strategy. Long-term extension data from the open-label extension (OLE) part of CHAPTER-1 study showed that deucrictibant maintained the reduced monthly HAE attack rate for at least a year and a half, and the median proportion of days with symptoms during the OLE was further reduced to zero days. The ongoing RAPIDe-2 extension study includes efficacy data from seven upper airway, including laryngeal, attacks, in which the median time to onset of symptom relief was 0.9 hours (N=7). 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 deucrictibant for the treatment of bradykinin-mediated angioedema in the European Union. The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to deucrictibant for the treatment of bradykinin-mediated angioedema in March 2022. Upcoming Investor Events The Citizens JMP Life Sciences Conference, New York, New York, May 7-8, 2025 Format: Fireside Chat Date, time: Thursday, May 8, 12:30 p.m. ET Bank of America Global Healthcare Conference, Las Vegas, Nevada, May 13-15, 2025 Format: Company Presentation Date, time: 8:40-8:55 a.m. PT (11:40-11:55 a.m. ET) Live audio webcasts will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replays will be available on Pharvaris’ website for 30 days following the events. Financials Fourth Quarter and Full Year 2024 Financial Results Liquidity Position. Cash and cash equivalents were €281 million as of December 31, 2024, compared to €391 million for December 31, 2023. Research and Development (R&D) Expenses. R&D expenses were €31.2 million for the fourth quarter and €98.6 million for the full year of 2024, compared to €18.6 million for the fourth quarter and €65.6 million for the full year of 2023. General and Administrative (G&A) Expenses. G&A expenses were €13.9 million for the fourth quarter and €47.1 million for the full year of 2024, compared to €8.6 million for the fourth quarter and €31.3 million for the full year of 2023. Loss for the year. Loss for the fourth quarter of 2024 was €34.8 million, resulting in basic and diluted loss per share of €0.64. For the full year of 2024, loss was €134 million, resulting in basic and diluted loss per share of €2.48 per share. This compares to €32.7 million, or basic and diluted loss per share of €0.95, for the fourth quarter of 2023 and €100.9 million, or basic and diluted loss per share of €2.63, for the full year of 2023. Note on International Financial Reporting Standards (IFRS) Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency. About Deucrictibant Deucrictibant is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist currently in clinical development. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation by the U.S. Food and Drug Administration and orphan designation by the European Commission. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of an oral therapy to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/. Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, , which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. CONTACT: Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook