Earnings release
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PHARVARIS Pharvaris Reports First Quarter 2021 Financial Results and Provides Business Highlights May 26 , 2021 • RAPIDE - 1 , Phase 2 on - demand study of PHVS416 for the treatment of HAE attacks proceeding • HAE CHAPTER - 1 , Phase 2 prophylactic study of PHVS416 for prevention of HAE attacks , on - track to initiate in 2021 • Viviane Monges nominated to Board of Directors and as Chair of the Audit Committee • Strong financial position with cash and cash equivalents of € 238.3 million as of March 31 , 2021 ZUG , Switzerland , May 26 , 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 first quarter ended March 31 , 2021 , and provided an update on recent business highlights . " We continue to execute on a development strategy which we believe provides value to shareholders and patients , as demonstrated by the successful completion of our IPO in the first quarter of the year and the continued enrollment of our Phase 2 on - demand study of PHVS416 , from which we plan to report data next year , " said Berndt Modig , co - founder and chief executive officer of Pharvaris . " In order to meet the unmet need of many HAE patients demanding oral alternative therapies , we plan to initiate our HAE CHAPTER - 1 Phase 2 prophylactic study of PHVS416 this year . Pharvaris remains committed to providing access to medicines for patients in need , and the recent appointment of Wim Souverijns to the executive team will guide our clinical development and enable us to prepare for the commercialization of our B2 - receptor antagonists . Additionally , we have nominated Viviane Monges to join our board of directors as the chair of the audit committee , bringing diverse global financial experience to our team . " Recent Business Highlights and Upcoming Milestones Pipeline • Phase 2 on - demand study ( RAPIDe - 1 ) of PHVS416 proceeding . 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 . • 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 is active in the US with the FDA 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 . Corporate • Leadership team expansion . In May 2021 , the company announced the expansion of their leadership team through the appointment of Wim Souverijns , Ph.D. , as chief community engagement & commercial officer . 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 . • Board of Directors nomination . In May 2021 , the company nominated Viviane Monges as a new member of the Board of Directors and Chair of the Audit Committee . Ms. Monges currently serves on the board of multiple pharmaceutical , biotechnology , and financial companies , including DBV Technologies , UCB , and Novo Holdings , and brings over 30 years of financial management experience from within the pharmaceutical industry and across several continents . Her appointment to the Board is expected to be formally confirmed at an upcoming general meeting of shareholders . • Preclinical data accepted for presentation at C1 - Inhibitor Deficiency Angioedema Workshop . The company will present preclinical data for PHA121 at the 12th C1 - Inhibitor Deficiency Angioedema Workshop , to be held virtually from June 3-6 , 2021. The abstract , titled " PHA - 022121 : Efficacy in a monkey bradykinin challenge model translated to human , " has been accepted for oral presentation by Anne Lesage , Ph.D. , chief early development officer of Pharvaris , in Session 1 , Basic Research and Diagnostics , on June 4 at 9:45 a.m. CEST . • Completed initial public offering ( IPO ) . In February 2021 , Pharvaris completed its IPO of 9,511,075 shares of common stock at a public offering price of $ 20.00 per share , generating gross proceeds of $ 190.2 million before deducting underwriting discounts and commissions and estimated offering expenses . First Quarter 2021 Financial Results • Liquidity Position . Cash and cash equivalents were € 238.3 million for the quarter ended March 31 , 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 March 31 , 2021 ,