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 fourth
quarter and year ended December 31, 2021 and provided recent
business highlights.
“The time since our initial public offering in February 2021 has
been transformational for Pharvaris, enabling us to reach clinical
development milestones, including initiation and continued progress
of our Phase 2 RAPIDe-1 on-demand study of PHVS416, the initiation
and enrollment of our Phase 2 CHAPTER-1 prophylactic study of
PHVS416, and the completion of our Phase 1 pharmacokinetics study
for PHVS719,” said Berndt Modig, chief executive officer of
Pharvaris. “We look forward to our next milestones, including
announcing top-line data from our Phase 2 trials, RAPIDe-1 and
CHAPTER-1. We will continue to execute our strategy efficiently in
2022 supporting our mission to provide individual choice for
managing HAE through potent and convenient oral on-demand and
prophylactic therapies.”
Recent Business Highlights and
UpdatesPipeline
- 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 randomized five-period crossover
single-dose study to assess bioavailability of two different
extended-release formulations with and without food, in comparison
to a single dose of PHVS416 without food. The pharmacokinetics of a
single dose of PHVS719 (40 mg) under fasted conditions yielded
exposure above 13.8 ng/mL (the EC85 determined in a Phase 1
bradykinin challenge in healthy volunteers) by the two-hour
timepoint and maintained this exposure for at least an additional
28 hours. The overall exposure was not affected by food. The
24-hour area-under-the-curve (AUC24h) exposure of PHA121 using
PHVS719 (40 mg) is similar to that observed in Phase 1 studies with
PHVS416 softgel capsules dosed 20 mg twice a day with food (one of
the doses used in the CHAPTER-1 prophylactic proof-of-concept
study). The study showed that PHVS416 and PHVS719 were well
tolerated. During the study, there were no severe adverse events
(SAEs) or severe treatment-emergent adverse events (TEAEs)
reported.“We are thrilled to have achieved with the PHVS719
extended-release formulation for the first time the possibility of
a once-daily oral bradykinin receptor antagonist for prevention of
hereditary angioedema attacks,” said Jochen Knolle, CSO of
Pharvaris. “The versatile properties of PHA121, in this case the
ability to be absorbed through the colon, combined with the
appropriate slow-release technologies, has enabled a release
profile well-suited to all-day exposure of compound. This
single-dose study showed that PHVS719 (40 mg) maintained PHA121
exposure for a full day above the levels that prevented the effects
of a surge of bradykinin as shown in our mechanistic study in
healthy volunteers. We look forward to confirming these results in
an upcoming multi-dose PK study, to support use of PHVS719 in a
future pivotal clinical study when combined with the anticipated
results of our CHAPTER-1 proof-of-concept study.”
- Orphan Drug Designation granted by FDA. On
March 18, 2022, the FDA granted orphan drug designation to PHA121,
the active ingredient in our PHVS416 and PHVS719 product
candidates, for treatment of bradykinin-mediated angioedema.
- Phase 2 on-demand study (RAPIDe-1) of PHVS416
ongoing. RAPIDe-1, a Phase 2 clinical study of PHVS416 for
the on-demand treatment of HAE attacks, continues enrollment and
attack surveillance 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.
- Phase 2 prophylactic study (HAE CHAPTER-1) of PHVS416
enrollment ongoing. CHAPTER-1, a Phase 2 clinical trial of
PHVS416 for the prophylactic treatment of HAE attacks, is enrolling
patients across 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.
- RAPIDe-2 expected to initiate in 2022.
RAPIDe-2, an open-label extension study evaluating PHVS416 for the
on-demand treatment of people with HAE, is expected to initiate in
the second half of 2022.
- Preclinical data of PHA121 published in
International Immunopharmacology. In March 2022,
Pharvaris announced the publication of preclinical data in
International Immunopharmacology demonstrating the specificity and
potency of PHA121, the active ingredient in our PHVS416 and PHVS719
product candidates.
Corporate
- Board of Directors. In December 2021,
Pharvaris announced the appointments of Elisabeth Björk, M.D., and
Anne Marie de Jonge Schuermans, Ph.D., to the board of directors
with expected confirmation at the company’s upcoming 2022 annual
general meeting of shareholders. Dr. Björk and Dr. de Jonge
Schuermans have replaced Martijn Kleijwegt and Rémi Droller, both
of whom stepped down from the board in December 2021 to focus on
new investments.
Year End 2021 Financial Results
- Liquidity Position. Cash and cash equivalents
were €209.4 million as of December 31, 2021, compared to €98.6
million for December 31, 2020.
- Research and Development (R&D) Expenses.
R&D expenses were €10.7 million for the fourth quarter and
€35.8 million for the full year of 2021, compared to €7.7 million
for the fourth quarter and €19.5 million for the full year of
2020.
- General and Administrative (G&A) Expenses.
G&A expenses were €5.5 million for the fourth quarter and €18.3
million for the full year of 2021, compared to €2.1 million for the
fourth quarter and €5.5 million for the full year of 2020.
- Loss for the year. Loss for the fourth quarter
was €12.3 million, resulting in basic and diluted loss per share of
€0.41. For the full year, loss was €42.7 million, resulting in
basic and diluted loss per share of €1.40 per share. This compares
to €10.6 million, or basic and diluted loss per share of €2.18, for
the fourth quarter and €26.0 million, or basic and diluted loss per
share of €5.36, for the full year of 2020.
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. 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.
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 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 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.
ContactsPharvarisMaryann
CiminoDirector of Corporate
Relations+1-617-710-7305maryann.cimino@pharvaris.com
InvestorsSarah
McCabesarah.mccabe@sternir.com+1-212-362-1200
Media Maggie Beller, Russo Partners,
LLCmaggie.beller@russopartnersllc.com +1-646-942-5631
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pharvaris NV (NASDAQ:PHVS)
Historical Stock Chart
From Apr 2023 to Apr 2024