Pharvaris Reports Third Quarter 2022 Financial Results and Provides Business Update
December 08 2022 - 6:51AM
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 third quarter ended September 30, 2022, and
provided a business update.
“The results of the RAPIDe-1 study affirm our confidence in our
clinical development program in HAE,” said Berndt Modig, Chief
Executive Officer of Pharvaris. “Pharvaris is fully committed to
resolving the clinical holds on PHA121 in the U.S., and we
appreciate the opportunity to meet with the FDA in the recent Type
A meeting and to work with the agency on next steps. To date, the
regulatory status for our studies outside the U.S. remains
unchanged. Top-line data from CHAPTER-1, a proof-of-concept study
of PHVS416 for the prophylactic treatment of HAE, is anticipated in
the second half of 2023. Pharvaris has a strong financial position
and will continue to operate with a disciplined approach as we
aspire to bring best-in-class oral therapies to the HAE
community.”
Recent Business Updates
- Announcement of positive RAPIDe-1 data. Today
Pharvaris announced top-line Phase 2 data demonstrating
statistically significant results of PHVS416 as an oral on-demand
treatment for HAE attacks. Additional details can be found in the
news release.
- Pharvaris continues to engage with the FDA to resolve
the holds on PHA121 clinical trials in the U.S. Following
the previously announced receipt of the formal letters regarding
the holds on PHA121 clinical trials in the U.S., Pharvaris attended
a Type A meeting with the U.S. Food and Drug Administration (FDA).
During the meeting, Pharvaris proposed potential paths to resolve
the clinical holds for each of the on-demand and prophylactic
programs. The company will provide additional information following
receipt of the formal meeting minutes.
- CHAPTER-1, a global Phase 2 study of PHVS416 for the
prophylactic treatment of HAE attacks, top-line data is anticipated
2H2023. All active sites outside of the U.S. continue to
enroll participants in the CHAPTER-1 clinical study. After being
notified of the clinical holds in the U.S., Pharvaris notified
country-specific regulatory authorities in Canada, Europe, Israel,
and the UK regarding the clinical holds in the U.S. To date, the
regulatory status of the CHAPTER-1 study outside the U.S. remains
unchanged. Based on our current assumptions regarding ex-U.S.
regulatory status and enrollment, Pharvaris anticipates announcing
top-line data from the CHAPTER-1 trial in 2H2023. The study is
designed to enroll 30 patients globally with a goal of evaluating
proof of concept of PHVS416 as an oral prophylaxis against HAE
attacks. The safety and efficacy of two doses and placebo will be
evaluated by comparing the number of investigator-confirmed attacks
during participants’ 12-week treatment period. Data from this
proof-of-concept study is expected to inform design of an
anticipated Phase 3 study utilizing PHVS719, an extended-release
formulation of PHA121.
- Presentations of preclinical and clinical data
supporting development of PH121 at industry meetings. Data
detailing PHA121’s pharmacokinetic (PK), pharmacodynamic (PD) and
safety profile, as well as initial bioavailability and absorption
data for the softgel capsule formulation, PHVS416, and
extended-release tablet formulation, PHVS719, were presented at the
Bradykinin Symposium in September, the HAEi Global Leadership
Workshop in October, and the American College of Allergy, Asthma
and Immunology (ACAAI) Annual Scientific Meeting in November. In
healthy volunteer clinical studies, PHA121 was shown to be
well-tolerated with a favorable PK/PD profile up to the highest
dose tested. PHVS416 has been shown to achieve a rapid onset of
exposure in humans, which is desirable for the on-demand treatment
of HAE. PHVS719 has been shown to sustain therapeutic exposure,
which supports its use in the prophylactic treatment of HAE.
- Strengthened Executive Committee. With the
promotion of Annick Deschoolmeester to Chief Human Resources
Officer, Pharvaris continues to strengthen its Executive Committee.
Since joining Pharvaris as the Head of Human Resources in September
2021, Ms. Deschoolmeester has had a substantial impact on the
organization and has been instrumental in positioning Pharvaris for
its next stage in scale and impact.
Third Quarter 2022 Financial Results
- Liquidity Position. Cash and cash equivalents
were €198 million as of September 30, 2022, compared to €209
million as of December 31, 2021. The net cash position reflects
increased operating expenses, offset by favorable foreign exchange
effects.
- Research and Development (R&D) Expenses.
R&D expenses were €14.1 million for the quarter ended September
30, 2022, compared to €9.0 million for the quarter ended September
30, 2021.
- General and Administrative (G&A) Expenses.
G&A expenses were €8.3 million for the quarter ended September
30, 2022, compared to €4.4 million for the quarter ended September
30, 2021.
- Loss for the period. Loss for the quarter
ended September 30, 2022, was €8.5million, or basic and diluted
loss per share of €0.25, compared to €9.1 million, or basic and
diluted loss per share of €0.28, for the quarter ended September
30, 2021.
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 PHVS416PHVS416 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 rapid and reliable symptom relief, through rapid
exposure of attack-mitigating therapy in a convenient, small oral
dosage form. PHVS416 is currently in Phase 2 clinical development
outside the U.S. for the on-demand and proof-of-concept
prophylactic treatment of HAE.
About PHVS719PHVS719 is an investigational
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 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 safe, effective and
convenient alternatives to treat attacks, for 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: uncertainty in the
outcome of our interactions with regulatory authorities, including
the FDA with respect to the clinical holds 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 holds;
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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