-- Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR
for the prophylaxis of HAE attacks, expected in 3Q2026
-- Timeline for submission of NDA of deucrictibant IR for the on-demand
treatment of HAE attacks remains on-track in 1H2026
-- Enrollment ongoing in CREAATE, a pivotal study of deucrictibant for the
prophylactic and on-demand treatment of AAE-C1INH attacks
-- Cash and cash equivalents of EUR247 million as of March 31, 2026;
subsequent closing of $132 million underwritten offering extends cash
runway into 2028
ZUG, Switzerland, May 12, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema $(HAE)$ and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the first quarter ended in March 31, 2026, and provided a business update.
"In 2026, Pharvaris remains focused on execution across our late-stage programs, including reporting CHAPTER-3 data in the third quarter and enrolling in CREAATE, and on establishing our commercial infrastructure in preparation for the potential launch of deucrictibant IR," said Berndt Modig, Chief Executive Officer of Pharvaris. "The growing published scientific evidence of deucrictibant's potential as an end-to-end portfolio solution for bradykinin-mediated angioedema care supports our clinical, regulatory, and commercial strategies. Supported by the upsized and oversubscribed raise of approximately $132 million, our team is maintaining a disciplined approach to capital allocation that prioritizes the success of deucrictibant."
Recent Business Updated
Development Pipeline
-- Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. CHAPTER-3
is a randomized, double-blind, placebo-controlled Phase 3 study of orally
administered deucrictibant extended-release (XR) tablet for the
prophylaxis against angioedema attacks in adults and adolescents (12
years and older) with HAE. Approximately 81 participants were enrolled
and randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which
is the intended commercial formulation, or placebo, once daily for 24
weeks. Pharvaris anticipates announcing topline data from CHAPTER-3 in
the third quarter of 2026.
-- Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4
is a long-term, open-label extension study of orally administered
deucrictibant XR for the prophylactic treatment of HAE attacks. The goal
of the study is to evaluate the long-term safety and effectiveness of
deucrictibant XR in the prophylactic treatment of HAE attacks.
-- Submission of New Drug Application (NDA) of deucrictibant immediate
release $(IR)$ capsule for the on-demand treatment of HAE attacks remains
on-track for 1H2026. Data from the pivotal, randomized,
placebo-controlled Phase 3 study, RAPIDe-3, and the long-term extension
study, RAPIDe-2, will serve as the basis for the NDA of deucrictibant IR,
which is on-track for submission to the U.S. Food and Drug Administration
(FDA) in the first half of 2026.
-- Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a
global, pivotal Phase 3 study evaluating orally administered
deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH
attacks.
-- Recent data publications and presentations report evidence on the
potential for combined use of bradykinin B2 receptor antagonism for both
prophylactic and on-demand treatment of HAE attacks. Evidence supporting
the use of deucrictibant IR as an on-demand treatment in the event of a
breakthrough attack in combination with deucrictibant XR as a
prophylactic treatment were recently presented at the CIIC Spring 2026
Conference. Results from the Phase 2 randomized, placebo-controlled
clinical studies CHAPTER-1 and RAPIDe-1 provided evidence of bradykinin
B2 receptor antagonism as both prophylactic and on-demand treatment
options, respectively, for those living with HAE, supporting further
development of deucrictibant for both indications in Phase 3 studies, and
were also recently published back-to-back in The Lancet Heamatology.
Corporate
-- Closing of $132 million underwritten offering extends cash runway. The
proceeds from the offering of $132.3 million of shares will be used to
fund research and development expenses for Pharvaris' late-stage clinical
programs, the expansion of a sales and marketing team in the U.S., and
related commercialization expenses, as well as for working capital and
general corporate purposes. Pharvaris remains diligent in its operational
management and expects to have a cash runway into 2028.
Upcoming Investor Events
-- BofA Securities Health Care Conference 2026. Las Vegas, NV, May 12-14,
2026.
-- Format: Fireside ChatDate, time: Wednesday, May 13, 8:40 a.m. PDT
(11:40 a.m. EDT)
-- 2026 RBC Capital Markets Global Healthcare Conference. New York, NY, May
19-20, 2026.
-- Format: Fireside ChatDate, time: Wednesday, May 20, 11:00 a.m. EDT
Financials
First Quarter 2026 Financial Results
-- Liquidity Position. Cash and cash equivalents were EUR247 million as of March 31, 2026, compared to EUR292 million for December 31, 2025. -- Research and Development (R&D) Expenses. R&D expenses were EUR29.9 million for the quarter ended March 31, 2026, compared to EUR30.9 million for the quarter ended March 31, 2025. -- General and Administrative (G&A) Expenses. G&A expenses were EUR14.0 million for the quarter ended March 31, 2026, compared to EUR11.3 million for the quarter ended March 31, 2025. -- Loss for the quarter. Loss for the first quarter was EUR38.8 million, resulting in basic and diluted loss per share of EUR0.59 for the quarter ended March 31, 2026, compared to EUR46.3 million, or basic and diluted loss per share of EUR0.85, for the quarter ended March 31, 2025.
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 Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic.
About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris' aspiration is to offer therapies with injectable-like efficacy$(TM)$, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit https://pharvaris.com/.
Forward Looking Statements
This 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, " "hope," "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; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in
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