Pharvaris Reports First Quarter 2023 Financial Results and Provides Business Update
May 08 2023 - 5:50AM
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 first quarter ended March 31, 2023 and provided a
business update.
“The Pharvaris team has made strong progress advancing our key
studies and initiatives toward meaningful year-end milestones,
including the anticipated reporting of topline CHAPTER-1 data and
the submission of newly generated non-clinical toxicology data to
the FDA to address the clinical holds in the U.S.,” said Berndt
Modig, Chief Executive Officer of Pharvaris. “The data presented at
the C1-inhibitor Deficiency and Angioedema Workshop provide
additional insights into the therapeutic profile of deucrictibant
as potential treatment for HAE and other bradykinin-mediated
diseases.”
Recent Business Updates
- Top-line data from CHAPTER-1, a global Phase 2 study of
PHVS416 (immediate-release deucrictibant capsules) for the
prophylactic treatment of HAE attacks, anticipated by
YE2023. CHAPTER-1 is currently on hold in the U.S. All
CHAPTER-1 sites outside of the U.S. continue to recruit
participants in the study. Based on the Company’s current
assessment of the ex-U.S. regulatory status and enrollment rates,
Pharvaris anticipates announcing top-line data by the end of
2023.
- Non-clinical toxicology study ongoing. A
26-week rodent toxicology study, which is intended to provide
additional data to address the clinical holds in the U.S., is
ongoing; the results from which Pharvaris anticipates submitting to
the U.S. Food and Drug Administration (FDA) by the end of
2023.
- Clinical and non-clinical deucrictibant data presented
at a recent medical meeting supports ongoing clinical
development. Pharvaris presented data from clinical and
non-clinical studies in two oral and three poster presentations at
the 13th C1-inhibitor Deficiency and Angioedema Workshop, which was
held from May 4-7, 2023, in Budapest, Hungary. Details of the
presentations were included in a recent press release. The posters
and slides from the oral presentations are available on the
Investors section of the Pharvaris website.
First Quarter 2023 Financial Results
- Liquidity Position. Cash and cash equivalents
were €135 million as of March 31, 2023, compared to €162 million
for December 31, 2022.
- Research and Development (R&D) Expenses.
R&D expenses were €13.7 million for the quarter ended March 31,
2023, compared to €13.5 million for the quarter ended March 31,
2022.
- General and Administrative (G&A) Expenses.
G&A expenses were €7.3 million for the quarter ended March 31,
2023, compared to €5.9 million for the quarter ended March 31,
2022.
- Loss for the year. Loss for the first quarter
was €22.6 million, resulting in basic and diluted loss per share of
€0.67, for the quarter ended March 31, 2023, compared to €16.0
million, or basic and diluted loss per share of €0.48, for the
quarter ended March 31, 2022.
Upcoming EventsBofA Securities 2023
Healthcare Conference. Las Vegas, May 9-11, 2023. Morgan
Conn, Ph.D., Chief Business Officer, and Wim Souverijns, Ph.D.,
Chief Community Engagement and Commercial Officer, will present a
corporate overview on Wednesday, May 10, at 4:35 p.m. PDT
(Thursday, May 11, at 1:35 a.m. CEST). 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 90 days following the
presentation.
European Academy of Allergy & Clinical Immunology
(EAACI) Hybrid Congress 2023. Hamburg, Germany, June 9-11,
2023. Two abstracts have been accepted for presentation during the
“flash talks on angioedema” Flash Talks:
- Title: Treatment with Oral Administered
Bradykinin B2 Receptor Inhibitor PHVS416 Improves Hereditary
Angioedema Attack SymptomsAbstract Number:
001557Date/Time: Sunday, June 11, 14:10 CEST (8:10
a.m. EDT)Presenter: Emel Aygören-Pürsün, M.D.,
University Hospital Frankfurt
- Title: Efficacy and Safety of Oral
Administered Bradykinin B2 Receptor Inhibitor PHVS416 in Treatment
of Hereditary Angioedema Attacks: Topline Results of RAPIDe-1 Phase
2 TrialAbstract Number:
001510Date/Time: Sunday, June 11, 14:30 CEST (8:30
a.m. EDT)Presenter: Marcus Maurer, M.D., Charité
Universitätsmedizin Berlin
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 PHVS416 (immediate-release deucrictibant
capsules)PHVS416 (immediate-release deucrictibant
capsules) is an investigational medicine intended to treat acute
attacks of hereditary angioedema (HAE) containing deucrictibant, 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 PHVS719 (extended-release deucrictibant
tablets)PHVS719 (extended-release deucrictibant tablets)
is an investigational medicine intended to prevent attacks of
hereditary angioedema (HAE) containing deucrictibant, a highly
potent, specific, and orally bioavailable competitive antagonist of
the bradykinin B2 receptor. Pharvaris is developing this
formulation to provide 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 PharvarisBuilding on its deep-seated
roots in HAE, Pharvaris is a clinical-stage company developing
novel, oral bradykinin-B2-receptor antagonists to treat and prevent
HAE attacks. 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, 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 relating to our future plans, studies and
trials, and any 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 deucrictibant
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 arising from epidemic diseases, such as the COVID-19
pandemic, which may adversely impact our business, nonclinical
studies, and clinical trials; the expected timing and results of
the rodent toxicology study; 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 weaknesses
in our internal control over financial reporting and to maintain an
effective system of internal control over financial reporting;
changes and uncertainty in general market, political and economic
conditions, including as a result of inflation and 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.
Contact
Maggie Beller
Head of Public Relations and Communications
maggie.beller@pharvaris.com
Pharvaris NV (NASDAQ:PHVS)
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