A biopharmaceutical company developing oral pills for hereditary angioedema, a rare genetic disorder that causes sudden, painful swelling attacks. Its lead drug candidate, deucrictibant, aims to offer patients a pill instead of the injections they currently use. The company was founded in 2015 in Leiden, the Netherlands, when chemist Jochen Knolle—inventor of the injectable HAE drug icatibant—teamed up with colleagues to create an oral version of the same idea. The name blends "pharma" with a made-up suffix.
20-F · Fiscal year ended Dec 31, 2025 · SEC filing ↗
Pharvaris' pivotal on-demand Phase 3 trial met all endpoints, clearing a path to its first NDA submission, while the net loss widened to €175.7M.
Deucrictibant's Phase 3 on-demand trial succeeded, giving Pharvaris a clear shot at its first regulatory filing. The net loss widened to €175.7M as R&D spending rose 26% to €124.5M, driven by three concurrent pivotal studies, while a €160.3M equity raise left year-end cash at €291.7M. The company is now transitioning from a pure development story to one with a tangible commercial catalyst.
Key takeaways
The RAPIDe-3 Phase 3 trial of deucrictibant immediate-release for on-demand HAE treatment met all primary and key secondary endpoints, showing faster symptom relief versus placebo, and the company plans to submit a New Drug Application in the first half of 2026.
R&D expenses rose 26% to €124.5M, with clinical costs up 21% to €67.7M and personnel costs up 29% to €35.8M, as the company ran three pivotal studies: the now-completed RAPIDe-3, the ongoing CHAPTER-3 prophylaxis trial, and the newly initiated CREAATE study in acquired angioedema.
General and administrative expenses fell 4% to €45.3M, as reductions in consulting and legal costs offset a €4.3M increase in personnel expenses tied to pre-commercial build-out.
Finance income swung to a €3.9M net expense from €13.3M in income the prior year, driven by a €19.1M foreign exchange loss as the U.S. dollar depreciated against the euro.
Cash and equivalents stood at €291.7M at year-end, supported by a €160.3M equity offering in July 2025; management stated this is sufficient to fund operations for at least twelve months.
The company recorded no and stated it does not expect any until a product is commercialized.
What changed
The prior year flagged the RAPIDe-3 Phase 3 on-demand trial as a key watch item; the trial read out positively, meeting all primary and secondary endpoints, and an NDA submission is now planned for the first half of 2026.
The prior year flagged cash burn against the $291.6M position; the company raised €160.3M in a July 2025 equity offering, and year-end cash stood at €291.7M, extending the runway through the NDA submission.
The prior year flagged progress on building U.S. commercial infrastructure; G&A personnel costs rose €4.3M, reflecting pre-launch activities, though total G&A fell 4% as other administrative spending declined.
What to watch
Acceptance and review timeline for the deucrictibant immediate-release NDA, expected to be submitted in the first half of 2026.
Topline data from the CHAPTER-3 Phase 3 prophylaxis trial of deucrictibant extended-release, which will determine the scope of the product's label.
Quarterly cash burn rate against the €291.7M year-end position, particularly as the company funds two ongoing pivotal trials and prepares for a potential commercial launch.
Section summaries
Quantitative and Qualitative Disclosures About Market Risk
We are exposed to a variety of risks in the ordinary course of our business, including, but not limited to, foreign currency risk and interest rate risk. We regularly assess each of these risks to minimize any adverse effects on our business as a result of those factors. For a d…
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We are exposed to a variety of risks in the ordinary course of our business, including, but not limited to, foreign currency risk and interest rate risk. We regularly assess each of these risks to minimize any adverse effects on our business as a result of those factors. For a detailed discussion, see Note 17 to our consolidated financial statements included elsewhere in this Annual Report.
A pre-revenue biotech faces material risks from heavy reliance on deucrictibant clinical success, substantial future funding needs, and regulatory hurdles.
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The prior year flagged remediation of material weaknesses in internal control over financial reporting; the filing does not report that these have been fully remediated, indicating they persist.
Any update on the remediation of the material weaknesses in internal control over financial reporting, which have been flagged for multiple years.
The company's future is heavily dependent on the success of its sole late-stage product candidates, deucrictibant IR and XR, for treating HAE, with no assurance of trial success, regulatory approval, or market differentiation.
Substantial additional funding is required to continue operations; failure to raise capital could force program delays, reductions, or insolvency, and raising capital may dilute existing shareholders.
Clinical development setbacks are a key risk, including potential failure to replicate prior positive trial results, past FDA clinical holds, and the inherent uncertainty of demonstrating safety and efficacy in ongoing pivotal Phase 3 trials.
Regulatory and pricing pressures, particularly U.S. healthcare reforms like the Inflation Reduction Act and proposed most-favored-nation pricing models, could severely limit the commercial potential and profitability of any approved products.
The company is heavily reliant on third parties for clinical trials, manufacturing, and core intellectual property, where failure or disputes—especially a breach of the BRAIN Biotech AG agreement—could terminate its core development program.
Intellectual property risks are significant, including the possibility that patents may not be obtained, may be invalidated, or may not prevent competitors from developing similar products, alongside challenges in protecting trade secrets.
Pharvaris is a late-stage biopharma developing oral bradykinin B2 receptor antagonist deucrictibant for rare angioedema diseases.
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The company's sole product candidate, deucrictibant, is being developed in two formulations: an immediate-release (IR) capsule for on-demand treatment and an extended-release (XR) tablet for of HAE attacks.
Pivotal Phase 3 data (RAPIDe-3) for the on-demand IR capsule met all primary and key secondary endpoints, showing faster symptom relief versus placebo, with an NDA submission planned for H1 2026.
A pivotal Phase 3 prophylactic study (CHAPTER-3) for the once-daily XR tablet is ongoing, supported by positive Phase 2 data showing an 84.5% reduction in monthly attack rate.
The company is expanding its target indications beyond HAE, initiating a pivotal Phase 3 study (CREAATE) for acquired angioedema (AAE-C1INH) and exploring other bradykinin-mediated diseases.
Pharvaris intends to build its own U.S. commercial infrastructure for the HAE market, which had estimated global sales of $2.7 billion in 2024, while evaluating partnerships ex-U.S.
The company owns worldwide intellectual property for deucrictibant, with patents expiring in 2038 or later, and relies on third-party CDMOs for API and drug product manufacturing.
Pharvaris reported a €175.7M net loss in FY2025, driven by a 26% increase in R&D expenses to advance deucrictibant Phase 3 trials.
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Total operating expenses rose 17% to €169.8M, primarily due to a €25.9M increase in R&D spending for the deucrictibant Phase 3 programs.
R&D expenses reached €124.5M, with clinical costs up 21% to €67.7M and personnel costs up 29% to €35.8M, supporting three pivotal studies.
Project-specific R&D spending shifted: On-Demand (IR) costs fell 8% to €28.2M after the RAPIDe-3 study readout, while Prophylaxis (XR) costs rose 19% to €32.1M and AAE costs surged to €6.9M.
General and administrative expenses decreased 4% to €45.3M, as a €4.3M increase in personnel costs was offset by reductions in consulting, legal, and other administrative expenses.
Finance income swung to a €3.9M net expense from €13.3M income, mainly due to a €19.1M foreign exchange loss from U.S. dollar against the euro.
Cash and equivalents stood at €291.7M at year-end, bolstered by a €160.3M equity offering in July 2025; management believes this is sufficient to fund operations for at least twelve months.