Earnings release
Page 1
PHARVARIS Pharvaris Reports Second Quarter 2021 Financial Results and Provides Business Highlights July 30 , 2021 • RAPIDe - 1 , Phase 2 on - demand study of PHVS416 for the treatment of HAE attacks expanding to US , expected to report data in 2022 • CHAPTER - 1 , Phase 2 prophylactic study of PHVS416 for the prevention of HAE attacks , and PHVS719 Phase 1 PK study expected to initiate in 2021 • Executing from a strong financial position with cash and cash equivalents of € 224.3 million as of June 30 , 2021 ZUG , Switzerland , July 30 , 2021 ( GLOBE NEWSWIRE ) -- Pharvaris ( Nasdaq : PHVS ) , a clinical - stage company focused on the development and commercialization of novel oral bradykinin - B2 - receptor antagonists for the treatment of hereditary angioedema ( HAE ) and other bradykinin- B2 - receptor - mediated indications , today reported financial results for the second quarter ended June 30 , 2021 , and provided an update on recent business highlights . " We made significant clinical advancements this quarter as we seek to offer novel treatments to HAE patients that are both convenient and efficacious . The data presented recently at two medical meetings continue to demonstrate the compelling PK / PD and safety profiles of PHA121 , which is the active ingredient in PHVS416 and PHVS719 . Regarding RAPIDe - 1 , our Phase 2 on - demand study of PHVS416 , we are encouraged by positive feedback from clinical sites and look forward to expanding this study to provide the opportunity for US patients to participate . We also expect to initiate our prophylactic study this year and report topline data for both patient studies in 2022 , " said Berndt Modig , co - founder and chief executive officer of Pharvaris . " We are very happy to have our newly appointed chief community engagement & commercial officer , Wim Souverijns , on board . He has immediately started laying the foundations of our global commercial and market access strategy and engaging broadly with stakeholders . " Recent Pipeline and Business Highlights and Upcoming Milestones Pipeline • Phase 2 on - demand study ( RAPIDe - 1 ) of PHVS416 proceeding toward data readout in 2022. In February 2021 , Pharvaris announced that enrollment had commenced in its Phase 2 clinical study of PHVS416 for the on - demand treatment of HAE attacks . An IND for the on - demand RAPIDe - 1 study is in effect , expanding enrollment into the United States . Data from this trial is expected to be reported in 2022 . • Phase 2 prophylactic study ( HAE CHAPTER - 1 ) of PHVS416 to begin in 2021. In addition to developing PHVS416 for the on - demand treatment of HAE attacks , the company plans to investigate the therapeutic potential of PHVS416 for the prophylactic prevention of HAE attacks . In April 2021 , Pharvaris announced that an IND was in effect in the US and expects to initiate the study in 2021 . • Phase 1 pharmacokinetics study of PHVS719 to begin by the end of 2021. PHVS719 is an extended - release formulation of PHA121 intended for use in the prophylactic treatment of HAE . The company expects to initiate a Phase 1 pharmacokinetics study by the end of 2021 . • Presentations of clinical data of PHA121 at medical meetings . Data detailing PHA121's pharmacokinetic ( PK ) , pharmacodynamic ( PD ) , and safety profiles were presented at the 12th C1 Inhibitor Deficiency and Angioedema Workshop in June 2021 and at the European Academy of Allergy and Clinical Immunology ( EAACI ) Annual Congress in July 2021 . PHA121 , the active ingredient in PHVS416 and PHVS719 , was well - tolerated and showed a favorable PK profile up to the highest dose tested . Corporate • Held Annual Meeting of Shareholders and appointed Viviane Monges to Board of Directors . On June 29 , 2021 , the company held an Annual Meeting of Shareholders at which all the proposals were approved . On June 29 , 2021 , the Company's general meeting of shareholders appointed Ms. Viviane Monges as Non - Executive Director . On June 30 , 2021 , the Board of Directors elected Ms. Monges as chair of the Audit Committee . • Establishment of Community Engagement and Commercial Function with appointment of Wim Souverijns to leadership team . Effective July 1 , 2021 , Wim Souverijns , Ph.D. , joined Pharvaris ' executive team . In this newly created role , Wim is responsible for engagement of key stakeholders across HAE as the company sets its regulatory , commercial , and market - access strategies . Second Quarter 2021 Financial Results • Liquidity Position . Cash and cash equivalents were € 224.3 million for the quarter ended June 30 , 2021 , compared to € 98.6 million for the year ended December 31 , 2020 . • Research and Development ( R & D ) Expenses . R & D expenses were € 8.1 million for the quarter ended June 30 , 2021 , compared to € 4.3 million for the quarter ended June 30 , 2020 .