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PHARVARIS Pharvaris Reports Second Quarter 2026 Financial Results and Provides Business Update August 12 , 2026 • 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 Updates Development 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/healthcare professional / and / or email Pharvaris ' Medical Affairs at expandedaccess@pharvaris.com . • 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