Pharvaris Reports Second Quarter 2022 Financial Results and Provides Business Update
September 12 2022 - 6:50AM
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 2024.”
Recent Business Updates
- Pharvaris announced that it has received formal clinical hold
letters from the U.S. Food and Drug Administration (FDA). This
follows the previously announced verbal notification of a hold on
the clinical trials of PHA121 in the U.S. under Investigational New
Drug (IND) applications for the on-demand and prophylactic
treatment of HAE attacks. The FDA requested that Pharvaris conduct
an additional long-term rodent toxicology study and update the
Investigator’s Brochure. The letters stated that the nonclinical
observations are unlikely due to B2 receptor antagonism. Pharvaris
plans to request a Type A meeting to discuss on-demand and
prophylactic proposals to address the clinical holds.
- RAPIDe-1, a global Phase 2 study of PHVS416 for the
on-demand treatment of HAE, continues evaluating enrolled patients
outside the U.S. with top-line data anticipated in 4Q22.
The previously announced target enrollment of 72 people with HAE
across 33 sites in Canada, Europe, Israel, the UK, and the U.S. was
achieved. Subsequent to the clinical hold, the company continues to
evaluate PHVS416 for HAE attacks in patients enrolled outside the
U.S. The goal of RAPIDe-1 is to assess PHVS416 as an oral acute
treatment of HAE attacks by comparing safety and symptom relief
(skin pain, skin swelling, and abdominal pain) during HAE attacks
across three doses and placebo. The primary endpoint of RAPIDe-1 is
the change of the composite of the three measured symptoms (skin
pain, skin swelling and abdominal pain) using a visual analogue
scale (VAS-3) four hours after treatment. One of the measured
symptoms must have a VAS score of 30 before treatment to be
considered a qualified HAE attack. Other key secondary endpoints
include the time to onset of symptom relief, as well as safety and
tolerability. Given the current dataset of evaluable attacks,
Pharvaris anticipates announcing top-line data in the fourth
quarter of 2022.
- Working with country-specific regulatory authorities
regarding ongoing CHAPTER-1 Phase 2 study of PHVS416 for the
prophylactic treatment of HAE attacks. Pharvaris has
notified country-specific regulatory authorities in Canada, Europe,
Israel, and the UK of the clinical hold in the U.S. When the
company has more clarity regarding the impact of the U.S. clinical
hold and additional feedback from global regulatory authorities,
Pharvaris will provide guidance on the timing of announcing
top-line data for the CHAPTER-1 trial. The study is designed to
enroll 30 patients globally in CHAPTER-1 with a goal of evaluating
proof of concept of PHVS416 for 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 study
is expected to inform design of an anticipated Phase 3 study
utilizing PHVS719, an extended-release formulation of PHA121.
- Strengthened executive team. With the
appointment of Joan Schmidt, J.D., as Chief Legal Officer,
effective June 2022, the company further strengthened its
capabilities in legal, compliance, and governance.
- Held Annual Meeting of Shareholders and appointed
Elisabeth Björk, M.D., and Anne Marie de Jonge Schuermans, Ph.D.,
to the Board of Directors. On June 29, 2022, the company
held an Annual Meeting of Shareholders at which all proposals were
approved. Dr. Björk and Dr. de Jonge Schuermans were appointed as
Non-Executive Directors.
Upcoming Events
- Pharvaris will attend the upcoming Morgan Stanley 20th Annual
Global Healthcare Conference, which is being held in New York from
September 12-14, 2022. Mr. Modig and Morgan Conn, Ph.D., Chief
Business Officer, will participate in a fireside chat on Monday,
September 12, at 4:15 p.m. ET. A live audio webcast will be
available on the Investors section of the Pharvaris website at
https://ir.pharvaris.com/news-events/events-presentations. A replay
will be available on Pharvaris’ website for 30 days following the
fireside chat.
Second Quarter 2022 Financial Results
- Liquidity Position. Cash and cash equivalents
were €201 million as of June 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 €13.7 million for the quarter ended June 30,
2022, compared to €8.1 million for the quarter ended June 30,
2021.
- General and Administrative (G&A) Expenses.
G&A expenses were €7.7 million for the quarter ended June 30,
2022, compared to €4.7 million for the quarter ended June 30,
2021.
- Loss for the period. Loss for the quarter
ended June 30, 2022 was €12.6 million, or basic and diluted loss
per share of €0.38, compared to €15.2 million, or basic and diluted
loss per share of €0.46, for the quarter ended June 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 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.
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. 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 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 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: 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.
ContactsPharvarisMaryann
CiminoDirector of Corporate
Relations+1-617-710-7305maryann.cimino@pharvaris.com
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