Pharvaris N.V.(PHVS) - 2022 Q4 - Annual Report

Executive Summary & Business Highlights Pharvaris, a clinical-stage company, highlights its focus on HAE treatments, recent positive clinical data, and upcoming development milestones Introduction to Pharvaris Pharvaris is a clinical-stage company focused on developing novel, oral bradykinin-B2-receptor antagonists for treating and preventing hereditary angioedema (HAE) attacks - Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks[3] Strategic Vision & Key Milestones The company achieved a significant milestone with positive RAPIDe-1 clinical study data in December 2022, demonstrating PHVS416's potential for on-demand HAE treatment. Pharvaris anticipates further milestones in 2023, including top-line Phase 2 CHAPTER-1 data, activation of ex-U.S. Phase 3 sites, and submission of non-clinical toxicology data to the FDA - The positive outcome of the RAPIDe-1 clinical study, announced in December 2022, demonstrates the potential of PHVS416 to offer meaningful improvement over the standard of care for on-demand treatment of HAE attacks[4] - Anticipated milestones for 2023 include the announcement of top-line Phase 2 CHAPTER-1 data, activation of first ex-U.S. clinical sites for a Phase 3 on-demand study, and submission of non-clinical toxicology data to the FDA[4] Recent Business Updates Key updates include the anticipated top-line data from the CHAPTER-1 prophylactic treatment study in 2H2023 (ex-U.S. sites), initiation of a 26-week non-clinical toxicology study to address U.S. clinical holds, completion of the RAPIDe-1 on-demand study with positive data, and preparatory activities for the RAPIDe-3 Phase 3 study. The global nonproprietary name 'deucrictibant' was also adopted for PHA121 - Top-line data from CHAPTER-1, a global Phase 2 study for prophylactic treatment of HAE attacks, is anticipated in 2H2023, with ex-U.S. sites continuing recruitment[5][6] - A 26-week non-clinical toxicology study, intended to address U.S. clinical holds, has been initiated with results anticipated by year-end 2023[6][8] - RAPIDe-1, a placebo-controlled evaluation of on-demand attacks, has completed its last patient's last visit, with positive top-line data announced in December 2022[8] - Preparatory activities for RAPIDe-3, a Phase 3 study for on-demand treatment of HAE, are underway[8] - Deucrictibant has been adopted as the approved global nonproprietary name for PHA121 by WHO and USAN[6][8] Product Pipeline Overview This section details Pharvaris's investigational product pipeline, including PHVS416 for on-demand and prophylactic HAE treatment and PHVS719 for prophylactic use PHVS416 (Deucrictibant Softgel Capsule) PHVS416 is an investigational softgel capsule formulation of deucrictibant, designed for rapid and reliable symptom relief in HAE attacks. It is currently in Phase 2 clinical development outside the U.S. for on-demand and proof-of-concept prophylactic treatment - PHVS416 is an investigational softgel capsule formulation containing deucrictibant (PHA121), a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor[10] - Pharvaris aims to develop this formulation to provide rapid and reliable symptom relief through rapid exposure of attack-mitigating therapy in a convenient, small oral dosage form[10] - PHVS416 is currently in Phase 2 clinical development outside the U.S. for the on-demand and proof-of-concept prophylactic treatment of HAE[10] PHVS719 (Deucrictibant Extended-Release Tablet) PHVS719 is an investigational extended-release tablet formulation of deucrictibant, aimed at preventing HAE attacks with sustained exposure. It is in Phase 1 clinical development, showing a well-tolerated, once-daily dosing profile in healthy volunteers - PHVS719 is an investigational extended-release tablet formulation containing deucrictibant (PHA121), a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor[11] - Pharvaris is developing this formulation to provide an easy way to prevent attacks with sustained exposure of attack-preventing medicine in a convenient, small oral dosage form[11] - PHVS719 is currently in Phase 1 clinical development for the prophylactic treatment of HAE, with a single dose showing a well-tolerated, extended-release profile supporting once-daily dosing in healthy volunteers[11] Financial Performance (Q4 & FY 2022) This section reviews Pharvaris's financial results for Q4 and full year 2022, highlighting liquidity, increased operating expenses, and a higher net loss Liquidity Position Pharvaris reported cash and cash equivalents of €162 million as of December 31, 2022, a decrease from €209 million at the end of 2021 | Metric | As of Dec 31, 2022 | As of Dec 31, 2021 | | :----- | :----------------- | :----------------- | | Cash and Cash Equivalents | €162 million | €209 million | Operating Expenses Research and Development (R&D) expenses significantly increased to €57.4 million for the full year 2022 from €35.8 million in 2021. General and Administrative (G&A) expenses also rose to €29.3 million for the full year 2022 from €18.3 million in 2021 | Expense Category | Q4 2022 | Q4 2021 | FY 2022 | FY 2021 | | :--------------- | :------ | :------ | :------ | :------ | | R&D Expenses | €15.7 million | €10.7 million | €57.4 million | €35.8 million | | G&A Expenses | €7.8 million | €5.5 million | €29.3 million | €18.3 million | Net Loss The company reported a net loss of €76.3 million for the full year 2022, resulting in a basic and diluted loss per share of €2.27, compared to a loss of €42.7 million (€1.40 per share) in 2021 | Metric | Q4 2022 | Q4 2021 | FY 2022 | FY 2021 | | :----- | :------ | :------ | :------ | :------ | | Loss for the period | €39.2 million | €12.3 million | €76.3 million | €42.7 million | | Basic and Diluted Loss per Share | €1.16 | €0.37 | €2.27 | €1.40 | IFRS Reporting Standard Pharvaris, as a Foreign Private Issuer, prepares its consolidated financial statements and information in accordance with IFRS, as issued by the International Accounting Standards Board, and maintains its books and records in Euro currency - 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[9] - Pharvaris maintains its books and records in the Euro currency[9] Corporate Information This section provides an overview of Pharvaris's corporate mission, outlines forward-looking statements and associated risks, and includes contact information About Pharvaris Pharvaris is a clinical-stage company deeply rooted in HAE, developing oral bradykinin-B2-receptor antagonists. The company aims to provide safe, effective, and convenient on-demand and prophylactic treatment alternatives for all HAE subtypes by targeting a clinically proven therapeutic pathway - Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks, building on its deep-seated roots in HAE[12] - The company aspires to offer people with all sub-types of HAE safe, effective, and convenient alternatives to treat attacks, both on-demand and prophylactically[13] Forward-Looking Statements & Risks This section contains forward-looking statements based on management's current expectations, which involve substantial risks and uncertainties. Key risks include regulatory outcomes (especially regarding U.S. clinical holds), timing and success of clinical programs, regulatory approvals, ability to raise capital, intellectual property protection, and general market conditions - This press release contains certain forward-looking statements that involve substantial risks and uncertainties, based on management's current expectations[14] - Such risks include uncertainty in the outcome of interactions with regulatory authorities (e.g., FDA clinical holds), expected timing, progress, or success of clinical development programs (PHVS416 and PHVS719), and the timing of regulatory approvals[14] - Additional risks encompass the ability to establish commercial capabilities, compete in the pharmaceutical industry, raise capital, protect intellectual property, manage regulatory changes, and maintain effective internal control over financial reporting[14] Contact Information For public relations inquiries, Maggie Beller can be contacted via email or phone - Contact for Public Relations and Communications: Maggie Beller[17] - Email: maggie.beller@pharvaris.com, Phone: +1-914-960-2092[17]