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PHARVARIS Pharvaris Reports Third Quarter 2021 Financial Results and Provides Business Highlights November 10 , 2021 • RAPIDe - 1 , Phase 2 on - demand study of PHVS416 for the treatment of HAE attacks , proceeding ; topline data reaffirmed for 2022 • CHAPTER - 1 , Phase 2 prophylactic study of PHVS416 for the prevention of HAE attacks , recruiting ; topline data expected in 2022 • PHVS719 Phase 1 pharmacokinetics study initiating this month • Executing from a strong financial position with cash and cash equivalents of € 218.6 million as of September 30 , 2021 ZUG , Switzerland , Nov. 10 , 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 third quarter ended September 30 , 2021 , and provided an update on recent business highlights . " This quarter we continued to execute on our robust clinical development strategy as we seek to advance novel treatments for HAE patients that offer efficacy without compromising on convenience , " said Berndt Modig , co - founder and chief executive officer of Pharvaris . " We continue enrolling patients in RAPIDe - 1 , our Phase 2 on - demand study of PHVS416 , and have begun recruiting in CHAPTER - 1 , our Phase 2 prophylactic study of PHVS416 for the prevention of HAE attacks . We expect to report top - line data , including efficacy and safety , for both studies in 2022. This month , in the PHVS719 program for HAE prophylaxis we also expect to initiate dosing in a Phase 1 pharmacokinetic study designed to assess the bioavailability of extended - release formulation . " Recent Pipeline and Business Highlights and Upcoming Milestones • Phase 2 on - demand study ( RAPIDe - 1 ) of PHVS416 proceeding toward data readout in 2022. In February 2021 , Pharvaris announced that dosing had commenced in its Phase 2 clinical study of PHVS416 for the on - demand treatment of HAE attacks . The company reaffirms guidance for reporting topline efficacy and safety data from this study in 2022 . Pharvaris is conducting RAPIDe - 1 at 33 sites in Canada , Europe , Israel , the UK , and the US . • Phase 2 prophylactic study ( HAE CHAPTER - 1 ) of PHVS416 recruiting . In addition to developing PHVS416 for the on - demand treatment of HAE attacks , the company plans to investigate the therapeutic potential of the PHVS416 formulation of PHA121 for the prophylactic prevention of HAE attacks . In April 2021 , Pharvaris announced that an IND was in effect in the US . Patient recruitment has begun and the study is expanding to Canada , Europe , Israel , and the UK . Pharvaris anticipates reporting topline safety and efficacy data from this study in 2022 . • Phase 1 pharmacokinetics study of PHVS719 initiating shortly . PHVS719 is under development as an extended- release formulation of PHA121 intended for use in the prophylactic treatment of HAE . Dosing of a Phase 1 pharmacokinetics study to assess the bioavailability of the extended - release formulation is expected to begin this month . • Expanding corporate capabilities . With Wim Souverijns joining as Chief Community Engagement and Commercial Officer to engage with patient advocacy groups , clinicians , and payers , in the third quarter the company further strengthened capabilities in Community Engagement and Commercialization , as well as CMC , Clinical , and organizational development . Third Quarter 2021 Financial Results • Liquidity position . Cash and cash equivalents were € 218.6 million as of September 30 , 2021 , compared to € 98.6 million as of December 31 , 2020 . • Research and Development ( R & D ) expenses . R & D expenses were € 9.0 million for the quarter ended September 30 , 2021 , compared to € 5.1 million for the quarter ended September 30 , 2020 . • General and Administrative ( G & A ) expenses . G & A expenses were € 4.4 million for the quarter ended September 30 , 2021 , compared to € 1.2 million for the quarter ended September 30 , 2020 . • Loss for the period . Loss for the quarter ended September 30 , 2021 was € 9.1 million , or basic and diluted loss per share of € 0.39 , for the quarter ended September 30 , 2021 , compared to loss for the quarter ended September 30 , 2020 of € 6.4 million , or basic and diluted loss per share of € 1.32 for the quarter ended September 30 , 2020 . 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 RAPIDe - 1 The RAPIDe - 1 study is a clinical research study for people who have been diagnosed with HAE . The main purpose of the study is to find out how effective three different doses of the study drug , PHVS416 , are in relieving symptoms associated with HAE attacks . Researchers developed the study drug in the form of soft capsules which are taken orally and could be a more convenient alternative to an injection into a vein or under the skin for