- 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
“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
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 inCanada ,Europe ,Israel , theUK , 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 toCanada ,Europe ,Israel , and theUK .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 ofDecember 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 endedSeptember 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 endedSeptember 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 endedSeptember 30, 2021 , compared to loss for the quarter endedSeptember 30, 2020 of €6.4 million, or basic and diluted loss per share of €1.32 for the quarter endedSeptember 30, 2020 .
Note on International Financial Reporting Standards (IFRS)
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 resolving HAE attacks. For more information, visit https://hae-rapide.com/, https://hae-rapide.us/, or https://clinicaltrials.gov/ct2/show/NCT04618211.
About HAE CHAPTER-1
The HAE CHAPTER-1 study is a clinical research study for people who have been diagnosed with HAE. The main purpose of the study is to evaluate two different doses of the study drug, PHVS416, in preventing 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 preventing HAE attacks. For more information, visit https://haechapter-1.com or https://clinicaltrials.gov/show/NCT05047185.
About PHVS416
PHVS416 is a softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor.
About PHVS719
PHVS719 is an extended-release tablet formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor.
About PHA121
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 for the treatment of HAE. PHA121 utilizes the same mechanism as icatibant, the leading therapy for on-demand treatment of HAE.
About
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: the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in early-stage clinical trials; risks associated with the COVID-19 pandemic, which may adversely impact our business, preclinical 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
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
Contacts
Director of Corporate Relations
+1-617-710-7305
maryann.cimino@pharvaris.com
Investors
sarah.mccabe@sternir.com
+1-212-362-1200
Media
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+1-646-942-5631
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