Pharvaris (PHVS) deepens 2025 loss while pivotal HAE trials hit key milestones
Rhea-AI Filing Summary
Pharvaris reported a larger 2025 loss while advancing its late-stage HAE pipeline. Cash and cash equivalents were €291.7 million as of December 31, 2025, up from €281 million a year earlier, supporting ongoing Phase 3 programs.
R&D expenses rose to €34.1 million in the fourth quarter and €124.5 million for 2025, reflecting investment in pivotal studies, while G&A expenses were €13.5 million in the quarter and €45.3 million for the year. The company reported a fourth-quarter loss of €46.7 million and a full-year loss of €175.7 million, with basic and diluted loss per share of €0.72 and €2.97, respectively.
Pharvaris completed enrollment in CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for prophylactic treatment of hereditary angioedema (HAE), with topline data anticipated in the third quarter of 2026, and plans to submit a U.S. NDA for deucrictibant IR for on-demand HAE treatment in the first half of 2026.
Positive
- RAPIDe-3 success and differentiated efficacy profile: The pivotal RAPIDe-3 Phase 3 trial of deucrictibant for on-demand HAE treatment met its primary and all 11 secondary endpoints, with median symptom relief at 1.28 hours and complete resolution at 11.95 hours, supporting a potentially strong competitive profile versus placebo.
- Late-stage pipeline and clear near-term milestones: Enrollment is complete in CHAPTER-3 with topline data anticipated in 3Q2026, while a U.S. NDA submission for deucrictibant IR for on-demand HAE treatment is anticipated in 1H2026, providing defined late-stage regulatory and clinical catalysts.
- Robust liquidity to fund development: Cash and cash equivalents of €291.7 million as of December 31, 2025, up from €281 million a year earlier, give the company resources to continue pivotal trials and regulatory preparations.
Negative
- Widening net loss driven by higher R&D: Full-year 2025 loss increased to €175.7 million from €134.2 million in 2024, with basic and diluted loss per share rising to €2.97 from €2.48, reflecting heavier investment and ongoing absence of product revenue.
Insights
Pivotal HAE data and upcoming NDA submission offset higher losses.
Pharvaris highlighted late-stage momentum in deucrictibant. RAPIDe-3 met its primary and 11 secondary endpoints, with median onset of symptom relief in 1.28 hours and complete resolution in 11.95 hours versus placebo, supporting a potentially differentiated on-demand HAE profile.
Pipeline risk remains, but visibility is improving. Enrollment is complete in CHAPTER-3, with topline results expected in Q3 2026, and the company anticipates submitting a U.S. NDA for deucrictibant IR in the first half of 2026. Additional programs like CHAPTER-4 and CREAATE broaden potential indications across hereditary and acquired angioedema.
The company ended 2025 with €291.7 million in cash and cash equivalents, providing funding for these late-stage studies despite a full-year loss of €175.7 million. Actual outcomes will depend on Phase 3 readouts and regulatory decisions disclosed in future updates.
Cash increased modestly, but losses widened with heavier R&D spending.
Operating trends show a classic late-stage biotech profile. R&D expenses rose to €34.1 million in Q4 and €124.5 million for 2025, up from €98.6 million in 2024, reflecting intensified pivotal development. G&A was stable to slightly lower year over year.
The full-year loss expanded to €175.7 million, with basic and diluted loss per share of €2.97. Still, cash and cash equivalents increased to €291.7 million as of December 31, 2025, indicating recent financings or cash management supported the balance sheet while the company advances toward potential regulatory milestones.
Key Figures
Key Terms
hereditary angioedema medical
acquired angioedema due to C1 inhibitor deficiency medical
bradykinin B2 receptor antagonist medical
extended-release tablet technical
New Drug Application (NDA) regulatory
orphan drug designation regulatory
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2026
Commission File Number: 001-40010
Pharvaris N.V.
(Translation of registrant’s name into English)
Emmy Noetherweg 2
2333 BK Leiden
The Netherlands
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
PHARVARIS N.V.
On April 2, 2026, Pharvaris N.V. (the “Company”) reported its financial results for the fourth quarter and fiscal year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
EXHIBIT INDEX
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99.1 |
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Press Release, dated April 2, 2026. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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PHARVARIS N.V. |
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Date: April 2, 2026 |
By: |
/s/ Berndt Modig |
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Name: |
Berndt Modig |
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Title: |
Chief Executive Officer |
Exhibit 99.1
Pharvaris Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
ZUG, Switzerland, April 2, 2026 – 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 fourth quarter and full year ended December 31, 2025, and provided a business update.
“The positive readout of our first pivotal Phase 3 study, RAPIDe-3, at the end of 2025 was a crucial moment for Pharvaris. With the momentum of this important milestone, we continue to execute in 2026 through the anticipated NDA submission of deucrictibant IR for the on-demand treatment of HAE attacks, topline data readout of CHAPTER-3, and enrollment in CREAATE,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Across all our programs, Pharvaris remains committed to helping to improve standard of care for those living with bradykinin-mediated angioedema. In addition to potentially bringing deucrictibant to those with HAE type 1 and type 2, we hope to also address unmet needs of those with HAE with normal C1 inhibitor and acquired angioedema with C1 inhibitor deficiency. Our team will continue to operate in a financially disciplined manner through these key inflection points.”
Recent Business Updates
Development Pipeline
Upcoming Participation at Investor Conferences
Date, time: Wednesday, May 13, 8:40 a.m. PDT (11:40 a.m. EDT)
Date, time: Wednesday, May 20, 11:00 a.m. EDT
Financials
Fourth Quarter and Full Year 2025 Financial Results
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™, 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 the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; the timing and outcome of regulatory approvals, including the timing and outcome of our planned submission of an NDA with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, 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, including with respect to existing therapies, emerging potentially competitive therapies and with competitive
generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; 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 (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; 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 U.S. 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
Vice President, Head of Corporate and Investor Communications
maggie.beller@pharvaris.com