Pharvaris (Nasdaq: PHVS), a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
HAE attacks, building on its deep-seated roots in hereditary
angioedema (HAE), today reported financial results for the first
quarter ended March 31, 2022, and provided an update on recent
business highlights.
"We met our operational goals for PHVS416 for the on-demand
treatment of HAE attacks and have reached our target patient
enrollment in the RAPIDe-1 Phase 2 study,” said Berndt Modig, chief
executive officer of Pharvaris. “We sincerely thank the HAE
patients and HAE community, investigators, and site staff across
the globe who are participating in this trial, as well as our
outstanding team. Pharvaris is also enrolling patients in
CHAPTER-1, a proof-of-concept Phase 2 clinical trial using PHVS416
for the prophylactic treatment of HAE attacks. We continue to
collaborate with the HAE community to further understand how our
clinical research can address remaining unmet needs in HAE."
Recent Business Highlights and Updates
- Target enrollment achieved for Phase 2 on-demand study
(RAPIDe-1) of PHVS416. RAPIDe-1, a Phase 2 clinical study
of PHVS416 for the on-demand treatment of HAE attacks, has reached
its target enrollment and continues to assess HAE attacks across 33
clinical sites in Canada, Europe, Israel, the UK and the U.S.
Top-line data from the study is anticipated to be available in the
fourth quarter of 2022.
- Enrollment ongoing in Phase 2 prophylactic study (HAE
CHAPTER-1) of PHVS416. HAE CHAPTER-1, a proof-of-concept
Phase 2 clinical trial using PHVS416 for the prophylactic treatment
of HAE attacks, is enrolling across clinical sites in Canada,
Europe, Israel, the UK and the U.S. Top-line data from the study
are anticipated in the fourth quarter of 2022.
- RAPIDe-2 expected to initiate in 2022.
RAPIDe-2, a long-term extension study evaluating PHVS416 for the
on-demand treatment of people with HAE, is expected to initiate in
the second half of 2022.
First Quarter 2022 Financial Results
- Liquidity Position. Cash and cash equivalents
were €194.8 million as of March 31, 2022, compared to €209.4
million as of December 31, 2021.
- Research and Development (R&D) Expenses.
R&D expenses were €13.5 million for the quarter ended March 31,
2022, compared to €8.1 million for the quarter ended March 31,
2021.
- General and Administrative (G&A) Expenses.
G&A expenses were €5.9 million for the quarter ended March 31,
2022, compared to €3.8 million for the quarter ended March 31,
2021.
- Loss for the period. Loss for the quarter
ended March 31, 2022 was €16.0 million, or basic and diluted loss
per share of €0.48, for the quarter ended March 31, 2022 compared
to loss for the quarter ended March 31, 2021 of €6.0 million, or
basic and diluted loss per share of €0.66 for the quarter ended
March 31, 2021.
Upcoming Events
- BofA 2022 Healthcare Conference, presentation at 10:00 am
PDT/1:00 pm EDT on May 12, 2022 in Las Vegas, NV
- Kinin2022 Conference, symposium (“Tailored drug development for
patients living with HAE”) with Anne Lesage, Ph.D., Chief Early
Development Officer, on June 7, 2022
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.
About RAPIDe-1The 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 softgel 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-1The 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 softgel
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 PHVS416PHVS416 is a softgel capsule
formulation containing PHA121, a highly potent, specific, and
orally bioavailable competitive antagonist of the bradykinin B2
receptor. Pharvaris is developing this formulation to provide fast
and reliable symptom relief when patients want, through rapid
exposure of attack-mitigating medicine 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.
About PHVS719PHVS719 is an extended-release
tablet formulation containing PHA121, a highly potent, specific,
and orally bioavailable competitive antagonist of the bradykinin B2
receptor. 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.
PHVS719 is currently in Phase 1 clinical development for the
prophylactic treatment of HAE. In healthy volunteers, a single dose
of PHVS719 was well tolerated with an extended-release profile
supporting once-daily dosing.
About PHA121PHA121 (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. 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. PHA121 has been observed to be
well-tolerated at all doses studied to date.
About PharvarisPharvaris 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 more 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 StatementsThis 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 mid-stage clinical
trials; 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.
ContactMaryann CiminoDirector of Corporate
Relationsmaryann.cimino@pharvaris.com+1-617-710-7305
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