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Pharvaris Announces Annual Meeting of Shareholders
GlobeNewswire News Room· 2024-06-11 10:50
Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing novel, oral bradykinin B2 receptor antagonists aimed at treating and preventing hereditary angioedema (HAE) attacks [4] - The company aims to provide efficacious, safe, and easy-to-administer treatment alternatives for all sub-types of HAE, both on-demand and prophylactically [4] Upcoming Events - The annual general meeting of shareholders is scheduled for June 28, 2024, at 15:00 CEST (9:00 a.m. EDT) [1] - Relevant documents and information regarding the annual general meeting will be available in the "Investors" section of Pharvaris' website and on the SEC's website [3]
Pharvaris Highlights Properties of Deucrictibant in Data Presentations at Recent Congresses
GlobeNewswire News Room· 2024-06-04 10:50
Core Insights - Pharvaris presented data on deucrictibant, an oral bradykinin B2 receptor antagonist, demonstrating its effectiveness in treating hereditary angioedema (HAE) attacks, with 78.6% of participants experiencing substantial symptom resolution within 24 hours [1][2] Group 1: Clinical Efficacy - Deucrictibant achieved substantial symptom resolution in 78.6% of participants within 24 hours after a single dose, compared to 22.4% for placebo [2] - The Treatment Outcome Score (TOS) questionnaire indicated that the majority of HAE attacks treated with deucrictibant resulted in significant symptom improvement [2] - The effectiveness of deucrictibant was found to be comparable to high-efficacy injectable therapies, with higher satisfaction scores than other oral prophylactic treatments [4] Group 2: Safety and Satisfaction - The treatment satisfaction questionnaire showed that participants reported higher satisfaction with deucrictibant's effectiveness compared to placebo, driven by favorable scores across all measured subdomains [4] - The side effects and convenience scores were consistent between deucrictibant and placebo, indicating a favorable safety profile [4] Group 3: Future Developments - Pharvaris plans to publish data from ongoing open-label extensions to further establish the long-term safety and efficacy of deucrictibant [2] - The company is exploring additional indications and pipeline expansion opportunities to address unmet needs in the HAE community [2][5] Group 4: Product Information - Deucrictibant is being developed in two formulations: an immediate-release capsule for acute treatment and an extended-release tablet for prophylactic use [6] - The company aims to provide effective, safe, and easy-to-administer alternatives for all sub-types of HAE [7]
Pharvaris Highlights Properties of Deucrictibant in Data Presentations at Recent Congresses
Newsfilter· 2024-06-04 10:50
In addition to these findings, Pharvaris continues to evaluate the ever-changing treatment landscape in HAE to best address the unmet need of people living with HAE through presentation of real-world evidence of treatment behaviors. Evaluation of Treatment Satisfaction Questionnaire for Medication (TSQM) in participants in the Phase 2 CHAPTER-1 clinical study showed satisfaction with the effectiveness of deucrictibant is higher to placebo and is in-line with separate observations of high-efficacy injectable ...
Pharvaris to Present Clinical and Nonclinical Data at Upcoming Congresses
Newsfilter· 2024-05-13 10:50
ZUG, Switzerland, May 13, 2024 (GLOBE NEWSWIRE) -- Pharvaris (NASDAQ:PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the acceptance of abstracts for presentation at three upcoming congresses: the 20th Annual Congress of International Drug Discovery Science and Technology (IDDST); the 2024 Eastern Allergy Conference (EAC); and the European Academy of Allergy and Clinical Immunolog ...
Pharvaris N.V.(PHVS) - 2023 Q4 - Annual Report
2024-04-10 20:12
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...
Pharvaris N.V.(PHVS) - 2023 Q4 - Annual Report
2024-04-10 20:11
Recent Business Updates and Highlights Development Pipeline Exhibit 99.1 Pharvaris Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Zug, Switzerland, April 10, 2024 – Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update. "20 ...
Pharvaris N.V.(PHVS) - 2022 Q4 - Annual Report
2023-04-05 10:53
[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) Pharvaris, a clinical-stage company, highlights its focus on HAE treatments, recent positive clinical data, and upcoming development milestones [Introduction to Pharvaris](index=1&type=section&id=Introduction%20to%20Pharvaris) 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](index=3&type=chunk) [Strategic Vision & Key Milestones](index=1&type=section&id=Strategic%20Vision%20%26%20Key%20Milestones) 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](index=4&type=chunk) - 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](index=4&type=chunk) [Recent Business Updates](index=1&type=section&id=Recent%20Business%20Updates) 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](index=5&type=chunk)[6](index=6&type=chunk) - 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](index=6&type=chunk)[8](index=8&type=chunk) - **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](index=8&type=chunk) - Preparatory activities for **RAPIDe-3**, a Phase 3 study for on-demand treatment of HAE, are underway[8](index=8&type=chunk) - **Deucrictibant** has been adopted as the approved global nonproprietary name for PHA121 by WHO and USAN[6](index=6&type=chunk)[8](index=8&type=chunk) [Product Pipeline Overview](index=3&type=section&id=Product%20Pipeline%20Overview) 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)](index=3&type=section&id=PHVS416%20(Deucrictibant%20Softgel%20Capsule)) 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](index=10&type=chunk) - 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](index=10&type=chunk) - **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](index=10&type=chunk) [PHVS719 (Deucrictibant Extended-Release Tablet)](index=3&type=section&id=PHVS719%20(Deucrictibant%20Extended-Release%20Tablet)) 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](index=11&type=chunk) - 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](index=11&type=chunk) - **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](index=11&type=chunk) [Financial Performance (Q4 & FY 2022)](index=2&type=section&id=Financial%20Performance%20(Q4%20%26%20FY%202022)) 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](index=2&type=section&id=Liquidity%20Position) 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](index=3&type=section&id=Operating%20Expenses) 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](index=3&type=section&id=Net%20Loss) 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](index=3&type=section&id=IFRS%20Reporting%20Standard) 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](index=9&type=chunk) - Pharvaris maintains its books and records in the **Euro currency**[9](index=9&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) This section provides an overview of Pharvaris's corporate mission, outlines forward-looking statements and associated risks, and includes contact information [About Pharvaris](index=3&type=section&id=About%20Pharvaris) 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](index=12&type=chunk) - 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](index=13&type=chunk) [Forward-Looking Statements & Risks](index=4&type=section&id=Forward-Looking%20Statements%20%26%20Risks) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) [Contact Information](index=5&type=section&id=Contact%20Information) For public relations inquiries, Maggie Beller can be contacted via email or phone - Contact for Public Relations and Communications: **Maggie Beller**[17](index=17&type=chunk) - Email: **maggie.beller@pharvaris.com**, Phone: **+1-914-960-2092**[17](index=17&type=chunk)
Pharvaris N.V.(PHVS) - 2022 Q4 - Annual Report
2023-04-05 10:51
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR ...
Pharvaris N.V.(PHVS) - 2021 Q4 - Annual Report
2022-03-29 12:10
Pipeline • Top-line Phase 1 data demonstrate extended-release PHVS719 suitable for once-daily dosing. The Phase 1 pharmacokinetics (PK) study of PHVS719 included 8 healthy volunteers dosed in an open-label • Phase 1 pharmacokinetics study demonstrates PHVS719 well tolerated with extended-release profile supporting once-daily dosing • Orphan Drug Designation for PHA121 granted by FDA • RAPIDe-1, Phase 2 on-demand study of PHVS416 for the treatment of HAE attacks ongoing; top-line data anticipated in 4Q22 • C ...
Pharvaris N.V.(PHVS) - 2021 Q4 - Annual Report
2022-03-29 12:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . OR ☐ SHELL COMPANY REPORT PURSUANT TO SE ...