Full Press Release Details
Pharvaris Reports Second Quarter 2022 Financial Results and Provides Business Update
Zug, Switzerland, September 12, 2022 Pharvaris (Nasdaq: PHVS), a
clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial
results for the second quarter ended June 30, 2022, and provided a business update.
Pharvaris is dedicated to bringing therapeutic
alternatives to people living with HAE and we maintain our belief in the potential of PHA121. Our team is committed to working with the FDA to resolve the hold on clinical trials involving PHA121 in the U.S. and we deeply appreciate the patience of
the HAE community during this time, said Berndt Modig, Chief Executive Officer of Pharvaris. Having evaluated the impact of the clinical hold, we anticipate announcing top-line Phase 2 data for RAPIDe-1 in the fourth quarter of this
year. As we work to address the FDA s concerns and continue interactions with other regulatory authorities, we maintain a disciplined operational approach with our strong cash position expected to provide runway through the first quarter of
Recent Business Updates
Second Quarter 2022 Financial Results
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.
PHVS416 is an investigational softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the
bradykinin B2 receptor. Pharvaris aims to develop this formulation to provide fast and reliable symptom relief, through rapid exposure of attack-mitigating therapy in a convenient, small oral dosage form. In healthy volunteers, a single dose of
PHVS416 showed rapid exposure exceeding predicted therapeutically efficacious levels within 15 minutes. PHVS416 is currently in Phase 2 clinical development for the on-demand treatment of HAE.
PHA121 (PHA-022121) is a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2
receptor that has completed Phase 1 clinical development. PHA121 utilizes the same mechanism as icatibant, the leading therapy for on-demand treatment of HAE. Pharvaris is developing this novel small molecule
for on-demand and prophylactic treatment of HAE and other bradykinin-mediated diseases through formulations optimized for each setting. Data from single- and multiple-ascending-dose Phase 1 studies in healthy
volunteers demonstrate rapid exposure and linear pharmacokinetics at doses up to 50 mg. In a bradykinin-challenge study in healthy volunteers, PHA121 showed significant inhibition of bradykinin-induced hemodynamic changes with an average composite
EC50 of 2.4 ng/mL and EC85 of 13.8 ng/mL, approximately four-fold more potent than historical data for icatibant. Quantitative modeling
indicates that single oral doses of PHA121 will maintain pharmacological effectiveness for a substantially longer time than 30 mg of subcutaneous icatibant. In clinical studies, PHA121 has been observed to be well-tolerated at all doses studied to
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. By directly targeting this
clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE effective and convenient alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.
Forward-Looking Statements
This press release contains
certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without
limitation, statements containing the words believe, anticipate, expect, estimate, may, could, should, would, will, intend and
similar expressions. These forward-looking statements are based on management s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other
important factors that may cause Pharvaris actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking
statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA with respect to the clinical hold on PHA121 clinical trials in the U.S.; the expected
timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the
clinical hold; risks associated with the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the timing of regulatory approvals; the value of our ordinary
shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidate that we may develop in the future; our ability to establish commercial
capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry and with competitive generic products; our ability to market, commercialize and
achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual
property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable
laws and regulations, including tax laws, our ability to successfully remediate the material weakness in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes in
general market, political and economic conditions, including as a result of the current conflict between Russia and Ukraine; and the other factors described under the headings Cautionary Statement Regarding Forward-Looking Statements and
Item 3. Key Information D. Risk Factors in our Annual Report on Form 20-F and other periodic filings with the Securities and Exchange Commission.
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While
Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon
as representing Pharvaris views as of any date subsequent to the date of this press release.
Director of Corporate Relations