Pharvaris: Deucrictibant XR cuts HAE attack rate 83%
An FDA action date is set for April 23, 2027, while CREAATE topline data are expected in 1Q2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Pharvaris N.V. reported a third-quarter 2026 net loss of €47.4 million, versus €37.1 million a year earlier, and no revenue in either quarter. Research and development expenses were €32.4 million, compared with €29.8 million; general and administrative expenses were €17.7 million, versus €9.8 million.
In the pivotal Phase 3 CHAPTER-3 study of deucrictibant XR for HAE prevention, the primary and all secondary efficacy endpoints were met; the mean monthly attack rate was reduced by 83%. The FDA is reviewing the deucrictibant IR NDA for on-demand HAE treatment, with an April 23, 2027 PDUFA action date, and the EMA is formally reviewing its MAA. Pharvaris expects CREAATE part 1 topline data in 1Q2027 and expects to submit an XR NDA in 1H2027.
Cash and cash equivalents were €282.7 million as of September 30, 2026. Nine-month net cash used in operating activities was €128.8 million, versus €99.1 million a year earlier. Management said available cash was sufficient for its operating plan for at least 12 months from issuance of the financial statements, while stating that Pharvaris remains dependent on additional financing.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointCHAPTER-3 mean monthly attack rate fell 83% in HAE participants.
Negative
- Moderate pointThird-quarter net loss increased 28% to €47.4 million.
- Moderate pointNine-month operating cash use increased 30% to €128.8 million.
Filing Explained
At September 30, 2026, 70,791,931 ordinary shares were issued, versus 65,210,590 at December 31, 2025, expanding the share base.
The company reports that its May 2026 underwritten offering closed on
An at-the-market program allows gradual sales of new shares at prevailing market prices; the company says its agreement permits sales of up to
Key Figures
Key Terms
PDUFA action date regulatory
extended-release (XR) medical
immediate-release (IR) medical
open-label extension medical
bradykinin B2 receptor antagonist medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When is the FDA action date for PHVS's deucrictibant IR NDA?
What did PHVS report from the CHAPTER-3 study?
When is PHVS expecting CREAATE part 1 results?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 November 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 November 12, 2026, Pharvaris N.V. issued a press release reporting financial results and other business updates for the three and nine months ended September 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act. Exhibits 99.2 and 99.3 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-273757, 333-277705 and 333-278650) and Form S-8 (Registration Number 333-252897) of Pharvaris N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
Exhibit No. |
|
Description |
99.1 |
|
Press Release, dated November 12, 2026, (Financial results). |
99.2 |
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations as of and for the Three and Nine Months Ended September 30, 2026 and 2025. |
99.3 |
|
Unaudited Condensed Consolidated Interim Financial Statements as of and for the Three and Nine Months Ended September 30, 2026 and 2025 and as of December 31, 2025. |
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.
|
PHARVARIS N.V. |
|
|
|
|
Date: November 12, 2026 |
By: |
/s/ Berndt Modig |
|
Name: |
Berndt Modig |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
Pharvaris Reports Third Quarter 2026 Financial Results and Provides Business Update
ZUG, Switzerland, November 12, 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 angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the third quarter ending on September 30, 2026, and provided a business update.
“The successful readout of the pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks was a major milestone for Pharvaris. If approved, deucrictibant could potentially address unmet needs across both on-demand and long-term prophylaxis of bradykinin-mediated angioedema attacks,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Results of multiple data analyses from deucrictibant studies, including from CHAPTER-3, will be presented this weekend at the ACAAI Annual Scientific Meeting, providing the Pharvaris team with an excellent opportunity to engage with the scientific community of experts in the field of allergy and immunology. Additionally, our team is preparing for our potential first commercial launch and is well on its way to building an experienced commercial team.”
Recent Business Updates
Development Pipeline
Upcoming Investor Events
Date, time: Wednesday, Dec. 2, 10:00 a.m. EST
Live audio webcasts of the presentations will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replays will be available on Pharvaris’ website for 30 days following the presentation.
Financials
Third Quarter 2026 Financial Results
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™, 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. 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,” “estimate,” “may,” “could,” “should,” “would,” “will” 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; the outcome of regulatory approvals, including the outcome of our NDA and MAA for the on-demand treatment of acute attacks of HAE; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, CHAPTER-1, and CHAPTER-3 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CREAATE; 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
Exhibit 99.2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this discussion together with our unaudited condensed consolidated interim financial statements, including the notes thereto, for the three and nine months ended September 30, 2026 and 2025 included as Exhibit 99.3 to the Report on Form 6-K to which this discussion is attached as Exhibit 99.2. We also recommend that you read “Item 4. Information on the Company”, “Item 5. Operating and Financial Review and Prospects” and our audited consolidated financial statements for fiscal year 2025, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2025 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”). In addition, we recommend that you read any public announcements made from time to time by Pharvaris N.V.
The following discussion is based on our financial information prepared in accordance with the IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”), which may differ in material respects from generally accepted accounting principles in the United States and other jurisdictions. We maintain our books and records in euros. Unless otherwise indicated, all references to currency amounts in this discussion are in euros.
The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under “Item 3. Key Information—D Risk factors” in the Annual Report and under “Risk factors” in any other periodic filings with the Securities and Exchange Commission.
Unless otherwise indicated or the context otherwise requires, all references to “Pharvaris” or the “Company,” “we,” “our,” “ours,” “us”, or similar terms refer to Pharvaris N.V. and its subsidiaries.
Overview
We are a late-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for rare diseases with significant unmet need, initially focused on angioedema and other bradykinin-mediated diseases. Our first molecule, deucrictibant (previously referred to as PHA-022121 or PHA121), is a novel, oral, small-molecule bradykinin B2 receptor antagonist under development for the prevention or treatment of attacks due to bradykinin-mediated angioedema (AE-BK), including hereditary angioedema (HAE) and acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH). Deucrictibant has the potential to address unmet medical needs by bringing improvements beyond the therapeutic profile of existing medicines and providing patients with quality of life and convenience that is superior to current standard-of-care. We believe deucrictibant has the potential to provide injectable-like efficacy™ with a well-tolerated profile and the convenience of an oral therapy for both the prophylactic and on-demand treatment of AE-BK attacks.
Deucrictibant may address unmet medical needs of people living with AE-BK by both preventing attacks from occurring, using an extended-release (XR) tablet formulation of deucrictibant (previously referred to as PHVS719), and treating the manifestations of attacks, using an immediate-release (IR) capsule formulation of deucrictibant (previously referred to as PHVS416). The XR tablet formulation is designed to maintain therapeutic levels for over 24 hours and to achieve a steady-state plasma concentration within 72 hours, supporting a once-daily dosing regimen. The IR capsule formulation is designed to rapidly reach therapeutic exposure in order to mitigate HAE attacks symptoms rapidly and completely with a single oral dose.
In addition to the differentiation of our individual products, having on-demand and prophylactic products with the same active ingredient enables patients to maintain a trusted active medicine if they change their treatment approach by moving from on-demand to prophylactic treatment (or back). This may be particularly valued by children or adolescents who typically begin therapy with on-demand only and gradually move to prophylaxis as attack severity and/or frequency increase (commonly after puberty).
We reported topline data from RAPIDe-3, a global, pivotal Phase 3, placebo-controlled study to evaluate deucrictibant IR capsule (20 mg) for the on-demand treatment of attacks in people 12 years and older with HAE, in December 2025. Deucrictibant demonstrated a clinically differentiated profile by meeting the primary and all key secondary efficacy endpoints with statistical significance and was well tolerated. A New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks is currently under review with the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. A Marketing Authorization Application (MAA) is currently under review with the European Medicines Agency (EMA).
We reported topline data from CHAPTER-3, a global, pivotal, randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet (40 mg/day) for the prophylaxis of attacks in people 12 years and older with HAE, in September 2026. Deucrictibant demonstrated a clinically differentiated profile by meeting the primary and all key secondary efficacy and quality of life endpoints with statistical significance
1
and was generally well tolerated. We plan to submit an NDA for deucrictibant XR for the prevention of AE-BK attacks with the FDA in the first half of 2027.
In October 2025, we initiated CREAATE, a global, pivotal Phase 3 study to assess the efficacy and safety of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. Enrollment in the prophylactic portion of the study, part 1, is completed and the on-demand portion of the study, part 2, is ongoing. We expect to report topline data from part 1 of this study in the first quarter of 2027. A wide variety of events beyond our control, including natural or man-made disasters, power shortages, fires, extreme weather conditions, pandemics, epidemics or outbreaks of infectious diseases, political instability or other events could disrupt our business or operations or those of our development partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future. These events may cause businesses and government agencies to be shut down, supply chains to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental restrictions. Additionally, 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 in the Annual Report.
In addition, the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries with respect to the invasion of Ukraine and the conflict in the Middle East have created global security concerns that could result in regional conflicts and also adversely affect our ability to conduct ongoing and future clinical trials of our product candidates. A further escalation of the conflicts in Ukraine or the Middle East may potentially impact our ability to complete our ongoing and planned clinical trials in these countries on a timely basis, or at all. Clinical trials in these countries could be suspended or terminated, and we may be prevented from obtaining data on patients already enrolled at affected sites. Any of the foregoing could impede the execution of our clinical development plans.
Financial Operations Overview
Revenues
We did not record any revenues during the period covered by the historical financial information included in this Report. We expect to recognize revenues from sales of deucrictibant IR in 2027, if it is approved for sale in the United States by the FDA.
Research and development expenses
Historically, we have been focused on the clinical development of deucrictibant. Since our inception, we have devoted substantially all of our resources to research and development efforts relating to the development of deucrictibant and our product candidates IR and XR. We expect that we will continue to incur significant research and development expenses as we seek to complete the clinical development of, and achieve regulatory approval for, our product candidates IR and XR, and in connection with discovery and development of any additional product candidates.
Research and development expenses consist of the following:
2
We expect our total research and development expenses to increase in 2026, driven by increases in personnel expenses plus activities supporting the continued development of our XR product candidate and our clinical study in AAE.
There is a risk that any clinical development or product discovery program may not result in commercial approval. To the extent that we fail to obtain approval to commercialize our product candidate in a timely manner, we would need to continue to conduct nonclinical studies or clinical trials over a longer period of time, and we anticipate that our research and development expenses may further increase.
Clinical development timelines and associated costs may vary significantly and FDA approval of deucrictibant IR for the treatment of on-demand attacks in 2027 is uncertain. Moreover, we cannot assure that we will be able to successfully commercialize our deucrictibant product candidate, if approved for marketing. This is due to numerous risks and uncertainties associated with developing drugs. See “ITEM 3. KEY INFORMATION: — D. Risk factors.” in our Annual Report and under “Risk factors” in any other periodic filings with the Securities and Exchange Commission for a discussion of these risks and uncertainties.
General and administrative expenses
We anticipate that we will continue to incur increasing general and administrative expenses as we advance towards potential commercialization. General and administrative expenses consist of the following:
We expect our total general and administrative expenses to increase in 2026, primarily due to the build out of our commercial organization.
Share-based compensation expenses
In 2016, we implemented an Equity Incentive Plan (the Plan), in order to advance the interests of our shareholders by enhancing our ability to attract, retain and motivate persons who are expected to make important contributions to us and by providing such persons with performance-based incentives that are intended to better align the interests of such persons with those of our shareholders. In order to incentivize our directors and employees, our Board adopted the Pharvaris N.V. 2021 Equity Incentive Plan (the 2021 Plan) for employees, consultants and directors prior to the completion of our initial public offering (IPO). The 2021 Plan became effective upon our conversion from Pharvaris B.V. into Pharvaris N.V., which occurred prior to the consummation of our IPO. The 2021 Plan provides for the grant of options, stock appreciation rights, restricted stock, RSUs, performance stock awards, other stock-based awards, performance cash awards, and substitute awards. The fair values of these instruments are recognized as personnel expenses in either research and development expenses or general and administrative expenses.
Result of operations
The financial information shown below was derived from our unaudited condensed consolidated interim financial statements for the three and nine months ended September 30, 2026 and 2025 included as Exhibit 99.3 to this
3
Report on Form 6-K. The discussion below should be read along with these unaudited condensed consolidated interim financial statements, and it is qualified in its entirety by reference to them.
Comparison of the three months ended September 30, 2026 and September 30, 2025.
|
|
For the three months ended |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Research and development expenses |
|
|
(32,419,747 |
) |
|
|
(29,814,908 |
) |
|
|
(2,604,839 |
) |
|
|
9 |
% |
General and administrative expenses |
|
|
(17,662,504 |
) |
|
|
(9,849,591 |
) |
|
|
(7,812,913 |
) |
|
|
79 |
% |
Total operating expenses |
|
|
(50,082,251 |
) |
|
|
(39,664,499 |
) |
|
|
(10,417,752 |
) |
|
|
26 |
% |
Operating loss |
|
|
(50,082,251 |
) |
|
|
(39,664,499 |
) |
|
|
(10,417,752 |
) |
|
|
26 |
% |
Finance income / (expense) |
|
|
2,883,782 |
|
|
|
2,345,995 |
|
|
|
537,787 |
|
|
|
23 |
% |
Loss before tax |
|
|
(47,198,469 |
) |
|
|
(37,318,504 |
) |
|
|
(9,879,965 |
) |
|
|
26 |
% |
Income taxes |
|
|
(214,524 |
) |
|
|
181,469 |
|
|
|
(395,993 |
) |
|
|
(218 |
)% |
Loss for the period |
|
|
(47,412,993 |
) |
|
|
(37,137,035 |
) |
|
|
(10,275,958 |
) |
|
|
28 |
% |
Revenues
We did not generate any revenues for the three months ended September 30, 2026 and September 30, 2025.
Research and development expenses
|
|
For the three months ended |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Personnel |
|
|
(11,324,489 |
) |
|
|
(9,019,095 |
) |
|
|
(2,305,394 |
) |
|
|
26 |
% |
Clinical |
|
|
(17,058,384 |
) |
|
|
(16,501,843 |
) |
|
|
(556,541 |
) |
|
|
3 |
% |
Manufacturing |
|
|
(2,952,041 |
) |
|
|
(2,747,027 |
) |
|
|
(205,014 |
) |
|
|
7 |
% |
Nonclinical |
|
|
(945,383 |
) |
|
|
(1,433,314 |
) |
|
|
487,931 |
|
|
|
(34 |
)% |
Intellectual Property |
|
|
(139,450 |
) |
|
|
(113,629 |
) |
|
|
(25,821 |
) |
|
|
23 |
% |
Total research and development |
|
|
(32,419,747 |
) |
|
|
(29,814,908 |
) |
|
|
(2,604,839 |
) |
|
|
9 |
% |
Research and development expenses increased from €29.8 million for the three months ended September 30, 2025 to €32.4 million for the three months ended September 30, 2026. The increase primarily relates to increased personnel, clinical, and manufacturing expenses, offset by a decrease in nonclinical expenses.
For the three months ended September 30, 2026 and 2025, personnel expenses were €11.3 million and €9.0 million, respectively, an increase of €2.3 million. The increase in personnel expenses is primarily driven by the hiring of additional employees to support analytical, medical affairs and supply chain activities in preparation for the potential launch of the IR product. Personnel expenses include €3.0 million of share-based compensation versus €2.5 million in the prior-year period.
For the three months ended September 30, 2026 and 2025, clinical expenses were €17.1 million and €16.5 million, respectively. This represents an increase of €0.6 million, primarily due to higher spending on the development of the XR program, the CREAATE (AAE) clinical study, and medical affairs activities to support the potential launch of the IR product offset by decreasing IR clinical development expenses.
4
The following table summarizes our research and development expenses by project for the three months ended September 30, 2026 and 2025:
|
|
Three months ended September 30, |
|
||||||||||
|
|
2026 |
|
2025 |
|
Change |
|
% |
|
||||
Project-Specific Expenses |
|
€ |
|
€ |
|
€ |
|
|
|
||||
On-Demand (IR) |
|
|
(5,755,775 |
) |
|
(6,506,551 |
) |
|
750,776 |
|
|
(12 |
)% |
Prophylaxis (XR) |
|
|
(7,918,316 |
) |
|
(6,932,362 |
) |
|
(985,954 |
) |
|
14 |
% |
AAE |
|
|
(3,609,272 |
) |
|
(3,005,282 |
) |
|
(603,990 |
) |
|
20 |
% |
Unallocated Expenses |
|
|
|
|
|
|
|
|
|
||||
Personnel |
|
|
(11,324,489 |
) |
|
(9,019,095 |
) |
|
(2,305,394 |
) |
|
26 |
% |
Other |
|
|
(3,811,895 |
) |
|
(4,351,618 |
) |
|
539,723 |
|
|
(12 |
)% |
Total research and development expenses |
|
|
(32,419,747 |
) |
|
(29,814,908 |
) |
|
(2,604,839 |
) |
|
9 |
% |
The On-Demand (IR) project-specific expenses decrease of €0.8 million versus the prior year period is primarily due to decreasing IR clinical development expenses related to completion of the Phase 3 program.
The Prophylaxis (XR) project-specific expenses increase of €1.0 million versus the prior year period is primarily due to an increase in the pediatric trial implementation plus the XR long-term, open-label clinical study offset by the completion and wind down of Phase 1 through Phase 3 XR clinical trials and a decrease in manufacturing expenses.
The AAE project-specific expenses increase of €0.6 million versus the prior year period is primarily due to the commencement and progress in the CREAATE trial (a global, pivotal Phase 3 study), including work towards completion of enrollment in part 1, patient rollover into part 2 and enrollment of new patients directly into part 2.
General and administrative expenses
|
|
For the three months ended September 30, |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Personnel |
|
|
(8,484,610 |
) |
|
|
(5,345,074 |
) |
|
|
(3,139,536 |
) |
|
|
59 |
% |
Professional |
|
|
(4,487,309 |
) |
|
|
(1,627,647 |
) |
|
|
(2,859,662 |
) |
|
|
176 |
% |
Insurance, facilities and office |
|
|
(1,673,971 |
) |
|
|
(1,276,944 |
) |
|
|
(397,027 |
) |
|
|
31 |
% |
Travel |
|
|
(574,524 |
) |
|
|
(252,162 |
) |
|
|
(322,362 |
) |
|
|
128 |
% |
Accounting, tax and auditing fees |
|
|
(669,978 |
) |
|
|
(566,839 |
) |
|
|
(103,139 |
) |
|
|
18 |
% |
Other |
|
|
(1,772,112 |
) |
|
|
(780,925 |
) |
|
|
(991,187 |
) |
|
|
127 |
% |
Total general and administrative |
|
|
(17,662,504 |
) |
|
|
(9,849,591 |
) |
|
|
(7,812,913 |
) |
|
|
79 |
% |
General and administrative expenses increased from €9.8 million for the three months ended September 30, 2025 to €17.7 million for the three months ended September 30, 2026. The increase in general and administrative expenses is primarily due to increases in commercial personnel, professional, and other expenses, supporting a potential launch of IR in 2027.
For the three months ended September 30, 2026 and 2025, personnel expenses were €8.5 million and €5.3 million, respectively. The €3.1 million increase in personnel expenses is primarily driven by the hiring of commercial employees to support the potential launch of the IR product in 2027. Personnel expenses include an amount of €3.7 million of share-based compensation versus €2.4 million in the prior-year period.
For the three months ended September 30, 2026 and 2025, professional fees were €4.5 million and €1.6 million, respectively. This represents an increase of €2.9 million, primarily due to commercial expenses supporting a potential launch of IR in 2027.
For the three months ended September 30, 2026 and 2025, other expenses were €1.8 million and €0.8 million, respectively, an increase of €1.0 million. The increase is primarily due to HAE market data expenses supporting the potential launch of IR in 2027.
5
Finance income / (expense) - net
Finance income (expense) for the three months ended September 30, 2026 and 2025 was €2.9 million and €2.3 million, respectively. The €0.6 million year-over-year variance was primarily attributable to continued foreign exchange appreciation in the USD during 2026.
Income taxes
Income taxes are accounted for in accordance with IAS 34. The interim period is considered part of a larger financial year, where the income tax is recognized in each interim period based on the best estimate of the weighted average annual income tax rate expected for the full financial year. The estimated tax expenses are determined based on a full-year basis and subsequently allocated using the expected full-year effective tax rate. The one-off items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/income.
The tax expense over the three months ended September 30, 2026 relates to the Company's U.S. and Dutch fiscal unity.
Comparison of the nine months ended September 30, 2026 and September 30, 2025
|
|
For the nine months ended |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Research and development expenses |
|
|
(97,581,077 |
) |
|
|
(90,337,209 |
) |
|
|
(7,243,868 |
) |
|
|
8 |
% |
General and administrative expenses |
|
|
(47,561,462 |
) |
|
|
(31,886,698 |
) |
|
|
(15,674,764 |
) |
|
|
49 |
% |
Total operating expenses |
|
|
(145,142,539 |
) |
|
|
(122,223,907 |
) |
|
|
(22,918,632 |
) |
|
|
19 |
% |
Operating loss |
|
|
(145,142,539 |
) |
|
|
(122,223,907 |
) |
|
|
(22,918,632 |
) |
|
|
19 |
% |
Finance income / (expense) |
|
|
11,775,975 |
|
|
|
(6,410,657 |
) |
|
|
18,186,632 |
|
|
|
(284 |
)% |
Loss before tax |
|
|
(133,366,564 |
) |
|
|
(128,634,564 |
) |
|
|
(4,732,000 |
) |
|
|
4 |
% |
Income taxes |
|
|
(1,089,831 |
) |
|
|
(323,980 |
) |
|
|
(765,851 |
) |
|
|
236 |
% |
Loss for the period |
|
|
(134,456,395 |
) |
|
|
(128,958,544 |
) |
|
|
(5,497,851 |
) |
|
|
4 |
% |
Revenues
We did not generate any revenues for the nine months ended September 30, 2026 and September 30, 2025
.
6
Research and development expenses
|
|
For the nine months ended |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Personnel |
|
|
(32,075,450 |
) |
|
|
(26,796,193 |
) |
|
|
(5,279,257 |
) |
|
|
20 |
% |
Clinical |
|
|
(52,460,272 |
) |
|
|
(48,551,185 |
) |
|
|
(3,909,087 |
) |
|
|
8 |
% |
Manufacturing |
|
|
(8,397,899 |
) |
|
|
(8,546,654 |
) |
|
|
148,755 |
|
|
|
(2 |
)% |
Nonclinical |
|
|
(3,167,244 |
) |
|
|
(6,141,579 |
) |
|
|
2,974,335 |
|
|
|
(48 |
)% |
License fees |
|
|
(1,000,000 |
) |
|
|
— |
|
|
|
(1,000,000 |
) |
|
|
100 |
% |
Intellectual Property |
|
|
(480,212 |
) |
|
|
(301,598 |
) |
|
|
(178,614 |
) |
|
|
59 |
% |
Total research and development |
|
|
(97,581,077 |
) |
|
|
(90,337,209 |
) |
|
|
(7,243,868 |
) |
|
|
8 |
% |
Research and development expenses increased from €90.3 million for the nine months ended September 30, 2025, to €97.6 million for the nine months ended September 30, 2026. The increase primarily relates to increased personnel and clinical expenses, offset by a decrease in nonclinical expenses.
For the nine months ended September 30, 2026 and 2025, personnel expenses were €32.1 million and €26.8 million, respectively, an increase of €5.3 million. The increase in personnel expenses is primarily driven by the hiring of employees to support increased regulatory, medical affairs, and supply chain activities relating to the potential approval and launch of the IR product in 2027. Personnel expenses include €8.1 million of share-based compensation versus €7.5 million in the prior-year period.
For the nine months ended September 30, 2026 and 2025, clinical expenses were €52.5 million and €48.6 million, respectively. This represents an increase of €3.9 million primarily due to higher spending on the conduct of the CREAATE (AAE), the XR long-term, open-label, and the IR extension clinical studies plus additional activities to support the potential approval and launch of the IR product offset by completion of the RAPIDe-3 (IR) Phase 3 clinical trial.
For the nine months ended September 30, 2026 and 2025, nonclinical expenses were €3.2 million and €6.1 million, respectively. This represents a decrease of €3.0 million which primarily relates to a decline in nonclinical discovery research.
The following table summarizes our research and development expenses by project for the nine months ended September 30, 2026 and 2025:
|
|
Nine months ended September 30, |
|
||||||||||
|
|
2026 |
|
2025 |
|
Change |
|
% |
|
||||
Project-Specific Expenses |
|
€ |
|
€ |
|
€ |
|
|
|
||||
On-Demand (IR) |
|
|
(17,027,742 |
) |
|
(20,690,919 |
) |
|
3,663,177 |
|
|
(18 |
)% |
Prophylaxis (XR) |
|
|
(24,796,287 |
) |
|
(23,017,480 |
) |
|
(1,778,807 |
) |
|
8 |
% |
AAE |
|
|
(8,153,997 |
) |
|
(3,706,023 |
) |
|
(4,447,974 |
) |
|
120 |
% |
Unallocated Expenses |
|
|
|
|
|
|
|
|
|
||||
Personnel |
|
|
(32,075,450 |
) |
|
(26,796,193 |
) |
|
(5,279,257 |
) |
|
20 |
% |
Other |
|
|
(15,527,601 |
) |
|
(16,126,594 |
) |
|
598,993 |
|
|
(4 |
)% |
Total research and development expenses |
|
|
(97,581,077 |
) |
|
(90,337,209 |
) |
|
(7,243,868 |
) |
|
8 |
% |
The On-Demand (IR) project-specific expenses decrease of €3.7 million versus the prior year period is primarily due to completion of the RAPIDe-3 (IR) Phase 3 clinical trial and lower spending on the conduct of the IR extension clinical study offset by activities to support the regulatory filing, potential approval and launch of the IR product.
The Prophylaxis (XR) project-specific expenses increase of €1.8 million versus the prior year period is primarily due to increases in the XR long-term, open-label clinical study and the pediatric program offset by the completion and wind down of Phase 1 through Phase 3 XR clinical trials and decreases in manufacturing and nonclinical development activities.
The AAE project-specific expenses increase of €4.4 million versus the prior year period is primarily due to the
7
commencement and progress of the CREAATE trial (a global, pivotal Phase 3 study), including work towards completion of enrollment in part 1, patient rollover into part 2 and enrollment of new patients directly into part 2.
General and administrative expenses
|
|
For the nine months ended |
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
||||
Personnel |
|
|
(22,235,450 |
) |
|
|
(16,149,932 |
) |
|
|
(6,085,518 |
) |
|
|
38 |
% |
Professional fees |
|
|
(11,342,672 |
) |
|
|
(5,994,632 |
) |
|
|
(5,348,040 |
) |
|
|
89 |
% |
Insurance, facilities and office |
|
|
(4,699,440 |
) |
|
|
(4,017,027 |
) |
|
|
(682,413 |
) |
|
|
17 |
% |
Travel |
|
|
(1,301,082 |
) |
|
|
(851,363 |
) |
|
|
(449,719 |
) |
|
|
53 |
% |
Accounting, tax and auditing fees |
|
|
(1,791,951 |
) |
|
|
(1,928,068 |
) |
|
|
136,117 |
|
|
|
(7 |
)% |
Other |
|
|
(6,190,867 |
) |
|
|
(2,945,676 |
) |
|
|
(3,245,191 |
) |
|
|
110 |
% |
Total general and administrative |
|
|
(47,561,462 |
) |
|
|
(31,886,698 |
) |
|
|
(15,674,764 |
) |
|
|
49 |
% |
General and administrative expenses increased from €31.9 million nine months ended September 30, 2025, to €47.6 million for the nine months ended September 30, 2026. The increase in general and administrative expenses is primarily due to increases in commercial personnel, professional fees, and other expenses, in support of the potential launch of the IR product in 2027.
For the nine months ended September 30, 2026 and 2025, personnel expenses were €22.2 million and €16.1 million, respectively. The €6.1 million increase in personnel expenses is primarily driven by share-based compensation and the hiring of commercial employees to support the potential launch of the IR product in 2027. Personnel expenses include €10.2 million of share-based compensation versus €7.0 million in the prior-year period.
For the nine months ended September 30, 2026 and 2025, professional fees were €11.3 million and €6.0 million, respectively. This represents an increase of €5.3 million, primarily due to commercial and IT expenses supporting the potential launch of the IR product in 2027.
For the nine months ended September 30, 2026 and 2025, other expenses were €6.2 million and €2.9 million, respectively, an increase of €3.2 million. The increase is primarily due to conference and HAE market data expenses supporting the potential launch of the IR product in 2027.
Finance (expense) / income - net
Finance (expense) / income - net, for the nine months ended September 30, 2026 and 2025 was €11.8 million and (€6.4) million, respectively. The significant change from expense to income in the current year results from a stronger USD/Euro exchange rate in the current period versus a weaker USD/Euro exchange rate in the prior year period. Interest income represents €1.5 million, resulting from a higher amount of invested cash in the current year period.
Income taxes
Income taxes are accounted for in accordance with IAS 34. The interim period is considered part of a larger financial year, where the income tax is recognized in each interim period based on the best estimate of the weighted average annual income tax rate expected for the full financial year. The estimated tax expenses are determined based on a full-year basis and subsequently allocated using the expected full-year effective tax rate. The one-off items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/income.
Liquidity and Capital Resources
Since inception, we have incurred significant operating losses. For the nine months ended September 30, 2026 and 2025, we incurred losses of €134.5 million and €129.0 million, respectively. Since inception, we have not generated any revenues or net cash flows from sales. We will not receive any revenues from sales until deucrictibant
8
IR is approved by the FDA and launched in the United States. We expect to recognize revenues from sales in 2027, if deucrictibant IR is approved for sale by the FDA then. There is no assurance that it will be approved or successfully launched.
To date, we have relied on the issuance of equity securities to finance our operations and internal growth in the form of ordinary shares and pre-funded warrants sold pursuant to underwritten offerings, private placements and at-the-market sales programs. In July 2025, we conducted an underwritten offering of ordinary shares and pre-funded warrants to purchase ordinary shares that generated net proceeds of approximately €160.9 million ($189 million). In May 2026, we conducted an underwritten offering of ordinary shares that generated net proceeds of approximately $124.3 million.
As of September 30, 2026 we held cash and cash equivalents of €282.7 million. Of the cash on hand, €0.1 million relates to guarantees. We do not expect positive operating cash flows in the foreseeable future and remain dependent on additional financing to fund our research and development expenses, general and administrative expenses and financing costs. We believe that the available cash balances are sufficient to fund the cash needs of our operating plan for at least twelve months from the issuance date of these consolidated financial statements. Accordingly, the consolidated financial statements have been prepared on a going concern basis.
Our future viability is dependent on our ability to raise additional capital to finance operations. We will need to finance our operations through public or private securities offerings, debt financings or other sources, which may include licensing, collaborations or other strategic transactions or arrangements. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining such additional financing on terms acceptable to us, if at all. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.
Our contractual obligations and commitments as of September 30, 2026 amounted to €123 million primarily related to research and development contracts.
Cash Flows
Comparison for the nine months ended September 30, 2026 and 2025.
The following table sets forth our primary sources and uses of our cash and cash equivalents for each of the periods set forth below:
|
For the nine months ended |
|
||||||||||||
|
2026 |
|
|
2025 |
|
Change |
|
|
% |
|
||||
|
€ |
|
|
€ |
|
€ |
|
|
|
|
||||
Net cash flows used in operating activities |
|
(128,787,013 |
) |
|
|
(99,120,876 |
) |
|
(29,666,137 |
) |
|
|
30 |
% |
Net cash flows used in investing activities |
|
(79,004 |
) |
|
|
(163,081 |
) |
|
84,077 |
|
|
|
(52 |
)% |
Net cash flows provided by financing activities |
|
111,945,400 |
|
|
|
160,335,728 |
|
|
(48,390,328 |
) |
|
|
(30 |
)% |
Net (decrease) increase in cash and cash equivalents |
|
(16,920,617 |
) |
|
|
61,051,771 |
|
|
(77,972,388 |
) |
|
|
(128 |
)% |
Cash and cash equivalents at the beginning of the period |
|
291,678,888 |
|
|
|
280,728,037 |
|
|
10,950,851 |
|
|
|
4 |
% |
Effect of exchange rate changes |
|
7,974,547 |
|
|
|
(12,494,179 |
) |
|
20,468,726 |
|
|
|
(164 |
)% |
Cash and cash equivalents at the end of the period |
|
282,732,818 |
|
|
|
329,285,629 |
|
|
(46,552,811 |
) |
|
|
(14 |
)% |
Operating activities
Net cash used in operating activities was €128.8 million for the nine months ended September 30, 2026 and primarily consisted of a net loss before taxes of €133.4 million adjusted for share-based compensation of €18.3 million, net foreign exchange gain of €8.8 million and finance costs of €0.2 million, an increase in other current assets of €1.8 million and decreases in trade and other payables of €0.9 million and increase in accrued liabilities of €0.6 million as well as other changes in net working capital.
Net cash used in operating activities was €99.1 million for the nine months ended September 30, 2025 and primarily consisted of a net loss before taxes of €128.63 million adjusted for share-based compensation of €14.5 million, net foreign exchange losses of €12.0 million and finance income of €0.4 million, an increase in other current assets of €1.5 million and increase in accrued liabilities of €5.1 million and other changes in net working capital.
9
Financing activities
During May, 2026, we entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners LLC as representatives of the underwriters named therein, pursuant to which we agreed to issue and sell in an underwritten offering 4,455,863 ordinary shares, par value €0.12 per share (which includes the exercise in full by the underwriters of their option to purchase up to an additional 581,199 ordinary shares). The offering closed on May 11, 2026, and we generated net proceeds of approximately €105.7 million ($124.3 million), after deducting bank fees of approximately €6.7 million ($7.9 million).
Off-Balance Sheet Arrangements
As of September 30, 2026, we did not have any off-balance sheet arrangements other than the disclosed commitments.
Quantitative and Qualitative Disclosures About Market Risk
During the nine months ended September 30, 2026, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Item 11. Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report.
Critical Accounting Estimates and Judgments
There have been no material changes to the significant accounting policies and estimates described in Note 2.19 to our consolidated financial statements in the Annual Report.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this management’s discussion and analysis are or may be forward-looking statements with respect to us, our industry and our business that involve substantial risks and uncertainties. All statements other than statements of historical fact contained in this management’s discussion and analysis, including statements regarding our future financial condition, results of operations and/or business achievements, including, without limitation, statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions are forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Such forward-looking statements involve unknown risks, uncertainties and other factors which may cause our actual results, financial condition, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Factors that might cause such a difference include, but are not limited to:
10
You should refer to “ITEM 3. Key information—D. Risk factors.” section of our Annual Report and under “Risk factors” in any other periodic filings with the Securities and Exchange Commission for a discussion of important
11
factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this management’s discussion and analysis will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.
In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.
We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
In addition, statements that “we believe” and other similar statements reflect our belief and opinions on the relevant subject. These statements are based upon information available to us as of the date of this management’s discussion and analysis, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
12
Exhibit 99.3
Pharvaris N.V.
Unaudited Condensed Consolidated Interim Financial Statements
For the nine months ended September 30, 2026
Contents
Unaudited condensed consolidated statement of loss and other comprehensive loss |
3 |
|
|
Unaudited condensed consolidated statement of financial position |
4 |
|
|
Unaudited condensed consolidated statement of changes in equity |
5 |
|
|
Unaudited condensed consolidated statement of cash flows |
6 |
|
|
Notes to the unaudited condensed consolidated interim financial statements |
7 |
|
|
2
Unaudited condensed consolidated statement of loss and other comprehensive loss
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|||||||||
|
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
|||||
|
Notes |
|
€ |
|
€ |
|
€ |
|
€ |
|
|||||
Research and development expenses |
|
3 |
|
|
(32,419,747 |
) |
|
(29,814,908 |
) |
|
(97,581,077 |
) |
|
(90,337,209 |
) |
General and administrative expenses |
|
4 |
|
|
(17,662,504 |
) |
|
(9,849,591 |
) |
|
(47,561,462 |
) |
|
(31,886,698 |
) |
Total operating expenses |
|
|
|
(50,082,251 |
) |
|
(39,664,499 |
) |
|
(145,142,539 |
) |
|
(122,223,907 |
) |
|
Finance income/ (expense) |
|
6 |
|
|
2,883,782 |
|
|
2,345,995 |
|
|
11,775,975 |
|
|
(6,410,657 |
) |
Loss before income tax |
|
|
|
(47,198,469 |
) |
|
(37,318,504 |
) |
|
(133,366,564 |
) |
|
(128,634,564 |
) |
|
Income taxes |
|
7 |
|
|
(214,524 |
) |
|
181,469 |
|
|
(1,089,831 |
) |
|
(323,980 |
) |
Net Loss |
|
|
|
(47,412,993 |
) |
|
(37,137,035 |
) |
|
(134,456,395 |
) |
|
(128,958,544 |
) |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|||||
Items that may be reclassified to profit or loss: |
|
|
|
|
|
|
|
|
|
|
|||||
Exchange (losses) gains arising on translation of foreign operations |
|
|
|
(525,801 |
) |
|
(10,062 |
) |
|
213,142 |
|
|
(399,979 |
) |
|
Total comprehensive loss attributable to: |
|
|
|
|
|
|
|
|
|
|
|||||
Equity holders of the Company |
|
|
|
(47,938,794 |
) |
|
(37,147,097 |
) |
|
(134,243,253 |
) |
|
(129,358,523 |
) |
|
Loss per share attributable to the equity holders of the Company during the periods |
|
|
|
|
|
|
|
|
|
|
|||||
Basic and diluted loss per share: |
19 |
|
|
(0.67 |
) |
|
(0.60 |
) |
|
(1.98 |
) |
|
(2.26 |
) |
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
3
Unaudited condensed consolidated statement of financial position
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|||
|
|
Notes |
|
|
€ |
|
|
€ |
|
|||
Assets |
|
|
|
|
|
|
|
|
|
|||
Non-current assets |
|
|
|
|
|
|
|
|
|
|||
Property, plant and equipment |
|
|
8 |
|
|
|
496,263 |
|
|
|
642,470 |
|
Right of use assets |
|
|
9 |
|
|
|
614,189 |
|
|
|
756,951 |
|
Deferred tax assets |
|
|
7 |
|
|
|
746,063 |
|
|
|
887,352 |
|
Current assets |
|
|
|
|
|
|
|
|
|
|||
Receivables |
|
|
10 |
|
|
|
1,367,904 |
|
|
|
556,739 |
|
Other current assets |
|
|
11 |
|
|
|
4,490,654 |
|
|
|
2,938,215 |
|
Cash and cash equivalents |
|
|
12 |
|
|
|
282,732,818 |
|
|
|
291,678,888 |
|
Current tax receivable |
|
|
10 |
|
|
|
4,615,830 |
|
|
|
3,994,384 |
|
Total assets |
|
|
|
|
|
295,063,721 |
|
|
|
301,454,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|||
Equity and liabilities |
|
|
|
|
|
|
|
|
|
|||
Equity |
|
|
|
|
|
|
|
|
|
|||
Share capital |
|
|
13 |
|
|
|
8,495,377 |
|
|
|
7,825,271 |
|
Share premium |
|
|
|
|
|
916,066,727 |
|
|
|
792,549,401 |
|
|
Other reserves |
|
|
|
|
|
57,045,111 |
|
|
|
50,766,138 |
|
|
Currency translation reserve |
|
|
|
|
|
(57,027 |
) |
|
|
(270,169 |
) |
|
Accumulated loss |
|
|
|
|
|
(716,575,955 |
) |
|
|
(579,596,307 |
) |
|
Total equity |
|
|
|
|
|
264,974,233 |
|
|
|
271,274,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|||
Long term liabilities |
|
|
|
|
|
|
|
|
|
|||
Non-current lease liability |
|
|
9 |
|
|
|
430,277 |
|
|
|
576,585 |
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|||
Trade and other payables |
|
|
14 |
|
|
|
5,304,404 |
|
|
|
5,114,186 |
|
Accrued liabilities |
|
|
15 |
|
|
|
24,181,149 |
|
|
|
23,348,472 |
|
Current lease liability |
|
|
9 |
|
|
|
173,658 |
|
|
|
200,213 |
|
Current tax payable |
|
|
|
|
|
— |
|
|
|
941,209 |
|
|
Total liabilities |
|
|
|
|
|
30,089,488 |
|
|
|
30,180,665 |
|
|
Total equity and liabilities |
|
|
|
|
|
295,063,721 |
|
|
|
301,454,999 |
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
4
Unaudited condensed consolidated statement of changes in equity
For the nine months ended September 30, 2026 and September 30, 2025
|
|
|
|
|
Share |
|
|
Share |
|
|
|
Other |
|
|
Currency |
|
|
Accumulated |
|
|
Total |
|
||||||||
|
|
Notes |
|
|
€ |
|
|
€ |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
||||||||
Balance at January 1, 2025 |
|
|
|
|
|
6,525,539 |
|
|
|
623,641,380 |
|
|
|
|
39,711,103 |
|
|
|
137,726 |
|
|
|
(402,255,007 |
) |
|
|
267,760,741 |
|
||
Net Loss |
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
(128,958,544 |
) |
|
|
(128,958,544 |
) |
||||||
Issue of share capital |
|
|
|
|
|
1,207,500 |
|
|
|
170,029,468 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
171,236,968 |
|
|
Transaction costs on issue of shares |
|
|
|
|
|
— |
|
|
|
(10,888,679 |
) |
|
|
— |
|
|
— |
|
|
— |
|
|
|
(10,888,679 |
) |
|||||
Currency translation reserve |
|
|
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(399,979 |
) |
|
— |
|
|
|
(399,979 |
) |
||||||
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
|
— |
|
|
|
|
14,512,568 |
|
|
— |
|
|
|
— |
|
|
|
14,512,568 |
|
||
Settlement of share-based payments |
|
|
|
|
|
62,095 |
|
|
|
6,732,044 |
|
|
|
|
(6,654,004 |
) |
|
|
— |
|
|
|
(1,162,570 |
) |
|
|
(1,022,435 |
) |
||
Balance at September 30, 2025 |
|
|
|
|
|
7,795,134 |
|
|
|
789,514,213 |
|
|
|
|
47,569,667 |
|
|
|
(262,253 |
) |
|
|
(532,376,121 |
) |
|
|
312,240,640 |
|
||
Balance at January 1, 2026 |
|
|
|
|
|
7,825,271 |
|
|
|
792,549,401 |
|
|
|
|
50,766,138 |
|
|
|
(270,169 |
) |
|
|
(579,596,307 |
) |
|
|
271,274,334 |
|
||
Net Loss |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
(134,456,395 |
) |
|
|
(134,456,395 |
) |
||
Issue of share capital |
|
|
13 |
|
|
|
534,704 |
|
|
|
111,874,998 |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
112,409,702 |
|
|
Transaction costs on issue of shares |
|
|
|
|
|
— |
|
|
|
(7,219,999 |
) |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,219,999 |
) |
||
Currency translation reserve |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
213,142 |
|
|
|
— |
|
|
|
213,142 |
|
||
Settlement of share-based payments |
|
|
|
|
|
135,402 |
|
|
|
18,862,327 |
|
|
|
|
(12,055,593 |
) |
|
|
— |
|
|
|
(2,523,253 |
) |
|
|
4,418,883 |
|
||
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
|
— |
|
|
|
|
18,334,566 |
|
|
|
— |
|
|
|
— |
|
|
|
18,334,566 |
|
|
Balance at September 30, 2026 |
|
|
|
|
|
8,495,377 |
|
|
|
916,066,727 |
|
|
|
|
57,045,111 |
|
|
|
(57,027 |
) |
|
|
(716,575,955 |
) |
|
|
264,974,233 |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
5
Unaudited condensed consolidated statement of cash flows
For the nine months ended September 30, 2026 and 2025
|
|
|
|
2026 |
|
|
2025 |
|
||
|
|
Notes |
|
€ |
|
|
€ |
|
||
Operating activities |
|
|
|
|
|
|
|
|
||
Loss before tax |
|
|
|
|
(133,366,564 |
) |
|
|
(128,634,564 |
) |
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
|
|
|
|
|
|
|
|
||
Share-based payment expense |
|
18 |
|
|
18,334,566 |
|
|
|
14,512,568 |
|
Depreciation expense |
|
4 |
|
|
376,415 |
|
|
|
313,485 |
|
Net foreign exchange (gain) loss |
|
|
|
|
(8,818,926 |
) |
|
|
11,981,990 |
|
Finance costs (income) |
|
|
|
|
236,465 |
|
|
|
(410,470 |
) |
|
|
|
|
|
|
|
|
|
||
Changes in working capital: |
|
|
|
|
|
|
|
|
||
(Increase) decrease in receivables |
|
|
|
|
(814,056 |
) |
|
|
57,822 |
|
(Increase) decrease in other current assets |
|
|
|
|
(1,780,427 |
) |
|
|
1,543,852 |
|
(Decrease) in trade and other payables |
|
|
|
|
(921,030 |
) |
|
|
(3,938,399 |
) |
Increase in accrued liabilities |
|
|
|
|
646,315 |
|
|
|
5,089,500 |
|
|
|
|
|
|
|
|
|
|
||
Income taxes paid |
|
|
|
|
(2,547,412 |
) |
|
|
(80,522 |
) |
(Paid) received interest |
|
|
|
|
(132,359 |
) |
|
|
443,862 |
|
Net cash flows used in operating activities |
|
|
|
|
(128,787,013 |
) |
|
|
(99,120,876 |
) |
|
|
|
|
|
|
|
|
|
||
Investing activities |
|
|
|
|
|
|
|
|
||
Purchase of property, plant and equipment |
|
8 |
|
|
(79,004 |
) |
|
|
(163,081 |
) |
Net cash flows used in investing activities |
|
|
|
|
(79,004 |
) |
|
|
(163,081 |
) |
|
|
|
|
|
|
|
|
|
||
Financing activities |
|
|
|
|
|
|
|
|
||
Proceeds from issue of shares |
|
13 |
|
|
119,351,386 |
|
|
|
171,400,309 |
|
Transaction costs on issue of shares |
|
|
|
|
(7,219,999 |
) |
|
|
(10,911,884 |
) |
Payment of principal portion of lease liabilities |
|
9 |
|
|
(185,987 |
) |
|
|
(152,697 |
) |
Net cash flows provided by financing activities |
|
|
|
|
111,945,400 |
|
|
|
160,335,728 |
|
|
|
|
|
|
|
|
|
|
||
Net increase (decrease) in cash and cash equivalents |
|
|
|
|
(16,920,617 |
) |
|
|
61,051,771 |
|
Cash and cash equivalents at the beginning of the period |
|
|
|
|
291,678,888 |
|
|
|
280,728,037 |
|
Effect of exchange rate changes |
|
|
|
|
7,974,547 |
|
|
|
(12,494,179 |
) |
Cash and cash equivalents at the end of the period |
|
12 |
|
|
282,732,818 |
|
|
|
329,285,629 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
6
Notes to the unaudited condensed consolidated interim financial statements
1. Corporate and Group information
This section provides general corporate and group information about Pharvaris N.V. and its subsidiaries.
1.1 Corporate information
Pharvaris N.V. was incorporated on September 30, 2015 and is based in Leiden, the Netherlands.
The Company’s registered office is located at Emmy Noetherweg 2, Leiden. The Company is registered at the Chamber of Commerce under file number 64239411.
Pharvaris is a late-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for rare diseases with significant unmet need, initially focused on angioedema and other bradykinin-mediated diseases.
The unaudited condensed consolidated interim financial statements of Pharvaris N.V. (the “Company” or “Pharvaris”) and its subsidiaries (collectively, “The Group”) as of September 30, 2026, and December 31, 2025, and for the three and nine months ended September 30, 2026 and 2025 were authorized for issue in accordance with a resolution of the directors on November 12, 2026.
1.2 Group information
Subsidiaries
The unaudited condensed consolidated interim financial statements of the Group include:
|
|
|
|
Country of |
|
% of equity interest as |
||
Name |
|
Legal seat |
|
incorporation |
|
2026 |
|
2025 |
Pharvaris Holdings B.V. |
|
Leiden |
|
The Netherlands |
|
100% |
|
100% |
Pharvaris Netherlands B.V. |
|
Leiden |
|
The Netherlands |
|
100% |
|
100% |
Pharvaris GmbH |
|
Zug |
|
Switzerland |
|
100% |
|
100% |
Pharvaris, Inc. |
|
Delaware |
|
United States of America |
|
100% |
|
100% |
Pharvaris Pharmaceuticals, Inc.* |
|
Delaware |
|
United States of America |
|
100% |
|
100% |
*Pharvaris Pharmaceuticals, Inc was incorporated in June 2025
The ultimate parent company of the Group is Pharvaris N.V., which is based in the Netherlands.
2. Summary of significant accounting policies
2.1 Basis of preparation
The unaudited condensed consolidated interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting as issued by the International Accounting Standards Board (IASB) and should be read in conjunction with the Group’s annual consolidated financial statements for the year ended December 31, 2025 (“last annual financial statements”). These unaudited condensed consolidated interim financial statements do not include all the information required for a complete set of financial statements prepared in accordance with IFRS as issued by the IASB.
However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group’s financial position and performance since the last annual financial statements.
The unaudited condensed consolidated interim financial statements have been prepared on a historical cost basis. Unless otherwise stated, the unaudited condensed consolidated interim financial statements are presented in euros and all values are rounded to the nearest EUR (€), except per share amounts.
2.2 Going concern
Management assessed the Company’s ability to fund its operations for a period of at least 12 months after the date of signing these financial statements. Management has not identified significant going concern risks. The financial statements of the Company have been prepared on the basis of the going concern assumption based on its existing funding, taking into account the Company’s current cash position and the projected cash flows based on the activities under execution on the basis of Pharvaris’ business plan and budget.
7
2.3 Use of judgements and estimates
In preparing these unaudited condensed consolidated interim financial statements, management has made judgements and estimates that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expense. Actual results may differ from these estimates.
The significant judgements made by management in applying the Group’s accounting policies and the key sources of estimation uncertainty were the same as those described in the last annual financial statements.
2.4 Change in material accounting policies
The accounting policies applied in these unaudited condensed consolidated interim financial statements are the same as those applied in the consolidated financial statements for the year ended December 31, 2025.
Amendment to IFRS 9 and IFRS 7 - Classification and Measurement of Financial Instruments
These amendments clarify the requirements for the timing of recognition and derecognition of some financial assets and liabilities, with a new exception for some financial liabilities settled through an electronic cash transfer system; clarify and add further guidance for assessing whether a financial asset meets the solely payments of principal and interest (SPPI) criterion; add new disclosures for certain instruments with contractual terms that can change cash flows (such as some instruments with features linked to the achievement of environment, social and governance (ESG) targets); and make updates to the disclosures for equity instruments designated at Fair Value through Other Comprehensive Income (FVOCI).
The amendment is effective for reporting periods beginning on or after January 1, 2026. The amendments did not have a material impact on the Group.
New standards and interpretations issued not yet effective
IFRS 18, Presentation and Disclosure in Financial Statements
This is the new standard on presentation and disclosure in financial statements, with a focus on updates to the statement of profit or loss. The key new concepts introduced in IFRS 18 relate to the structure of the statement of profit or loss; required disclosures in the financial statements for certain profit or loss performance measures that are reported outside an entity’s financial statements (that is, management-defined performance measures); and enhanced principles on aggregation and disaggregation which apply to the primary financial statements and notes in general.
The amendment is effective for reporting periods beginning on or after January 1, 2027. The amendments are being assessed by the Group.
There are no other IFRS or IFRIC interpretations that are not yet effective and that are expected to have a material impact to the interim consolidated financial statements.
3. Research and development expenses
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Clinical |
|
|
(17,058,384 |
) |
|
(16,501,843 |
) |
|
(52,460,272 |
) |
|
(48,551,185 |
) |
Personnel (Note 5) |
|
|
(11,324,489 |
) |
|
(9,019,095 |
) |
|
(32,075,450 |
) |
|
(26,796,193 |
) |
Manufacturing |
|
|
(2,952,041 |
) |
|
(2,747,027 |
) |
|
(8,397,899 |
) |
|
(8,546,654 |
) |
Nonclinical |
|
|
(945,383 |
) |
|
(1,433,314 |
) |
|
(3,167,244 |
) |
|
(6,141,579 |
) |
License fees |
|
|
— |
|
|
— |
|
|
(1,000,000 |
) |
|
— |
|
Intellectual Property |
|
|
(139,450 |
) |
|
(113,629 |
) |
|
(480,212 |
) |
|
(301,598 |
) |
|
|
|
(32,419,747 |
) |
|
(29,814,908 |
) |
|
(97,581,077 |
) |
|
(90,337,209 |
) |
Development expenses are currently not capitalized but are recorded in the condensed consolidated statements of profit or loss and other comprehensive loss because the recognition criteria for capitalization are not met.
Clinical expenses include costs of conducting and managing our sponsored clinical trials, including clinical investigator cost, costs of clinical sites, and costs for CRO’s assisting with our clinical development programs and travel expenses.
Manufacturing expenses include costs related to manufacturing of active pharmaceutical ingredients and manufacturing of the products used in our clinical trials and research and development activities as well as travel expenses.
8
Nonclinical expenses include costs of our outsourced discovery and nonclinical development studies and associated travel expenses.
Licensing costs consist of milestone payments reflecting the submission of the New Drug Application with the FDA in the first half of 2026.
4. General and administrative expenses
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Personnel (Note 5) |
|
|
(8,484,610 |
) |
|
(5,345,074 |
) |
|
(22,235,450 |
) |
|
(16,149,932 |
) |
Professional fees |
|
|
(4,487,309 |
) |
|
(1,627,647 |
) |
|
(11,342,672 |
) |
|
(5,994,632 |
) |
Insurance, facilities and office |
|
|
(1,673,971 |
) |
|
(1,276,944 |
) |
|
(4,699,440 |
) |
|
(4,017,027 |
) |
Accounting, tax and auditing fees |
|
|
(669,978 |
) |
|
(566,839 |
) |
|
(1,791,951 |
) |
|
(1,928,068 |
) |
Travel |
|
|
(574,524 |
) |
|
(252,162 |
) |
|
(1,301,082 |
) |
|
(851,363 |
) |
Other |
|
|
(1,772,112 |
) |
|
(780,925 |
) |
|
(6,190,867 |
) |
|
(2,945,676 |
) |
|
|
|
(17,662,504 |
) |
|
(9,849,591 |
) |
|
(47,561,462 |
) |
|
(31,886,698 |
) |
Since 2022, the Group entered into a number of short-term rental arrangements, the expenses are included in "Other expenses".
Depreciation expense for the nine months ended September 30, 2026 and 2025 was €0.4 million and €0.3 million, respectively, which related to property, plant and equipment and leases, and is included in the 'Other expenses' line.
5. Personnel expenses
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Wages and salaries |
|
|
(10,691,767 |
) |
|
(8,061,028 |
) |
|
(29,495,974 |
) |
|
(24,016,378 |
) |
Share-based payments |
|
|
(6,805,207 |
) |
|
(4,887,538 |
) |
|
(18,334,566 |
) |
|
(14,512,568 |
) |
Other social security charges |
|
|
(1,199,372 |
) |
|
(801,356 |
) |
|
(3,492,696 |
) |
|
(2,428,092 |
) |
Pension charges |
|
|
(530,630 |
) |
|
(438,180 |
) |
|
(1,755,682 |
) |
|
(1,572,337 |
) |
Other employee related costs |
|
|
(582,123 |
) |
|
(176,067 |
) |
|
(1,231,982 |
) |
|
(416,750 |
) |
|
|
|
(19,809,099 |
) |
|
(14,364,169 |
) |
|
(54,310,900 |
) |
|
(42,946,125 |
) |
The average number of staff (in FTEs) employed by the Group in the nine months ended September 30, 2026 was 168 (2025: 118).
6. Finance income/ (expense)
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Foreign exchange differences |
|
|
974,898 |
|
|
244,644 |
|
|
6,371,973 |
|
|
(10,645,113 |
) |
Interest and other income over bank balances |
|
|
2,002,382 |
|
|
2,151,385 |
|
|
5,656,502 |
|
|
4,348,577 |
|
Other finance expenses |
|
|
(93,498 |
) |
|
(50,034 |
) |
|
(252,500 |
) |
|
(114,121 |
) |
|
|
|
2,883,782 |
|
|
2,345,995 |
|
|
11,775,975 |
|
|
(6,410,657 |
) |
7. Income taxes
Income taxes are accounted for in line with IAS 34. The interim period is considered part of a larger financial year, where the income tax is recognized in each interim period based on the best estimate of the weighted average annual income tax rate expected for the full financial year. The estimated tax expenses are determined based on a full-year
9
basis (P&L) and subsequently allocated using the expected full year effective tax rate. The discrete items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/ income.
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
For the three months ended September 30, |
|
|
For the nine months ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
||||
Income tax expense |
|
|
(369,494 |
) |
|
|
11,006 |
|
|
|
(916,515 |
) |
|
|
(363,915 |
) |
Deferred tax charge |
|
|
154,970 |
|
|
|
170,463 |
|
|
|
(173,316 |
) |
|
|
39,935 |
|
Income tax expense |
|
|
(214,524 |
) |
|
|
181,469 |
|
|
|
(1,089,831 |
) |
|
|
(323,980 |
) |
The tax expense over the three and nine months ended September 30, 2026 and 2025 relates to the Company's U.S. and Dutch subsidiaries as the result of a cost-plus agreement between the Company's principal entity and the U.S. and the Dutch subsidiaries, resulting in an estimated taxable profit in the U.S. and the Netherlands.
Reconciliation of income tax benefit at statutory tax rate and the income tax expense as reported in the unaudited condensed consolidated statement of profit or loss and other comprehensive income is as follows:
|
|
For the three months ended September 30, |
|
For the nine months ended |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Loss before income tax |
|
|
(47,198,469 |
) |
|
(37,318,504 |
) |
|
(133,366,564 |
) |
|
(128,634,564 |
) |
Income tax at statutory income tax rate in the Netherlands (25.8%) |
|
|
12,177,205 |
|
|
9,628,175 |
|
|
34,408,574 |
|
|
33,187,718 |
|
Effect of tax rates in other countries |
|
|
(7,259,182 |
) |
|
(5,527,205 |
) |
|
(19,837,699 |
) |
|
(18,449,216 |
) |
Deferred tax assets recognition effects |
|
|
(5,284,073 |
) |
|
(4,016,655 |
) |
|
(15,697,527 |
) |
|
(14,553,604 |
) |
Temporary differences for which no deferred tax assets/liabilities have been recognized |
|
|
489,515 |
|
|
— |
|
|
1,311,234 |
|
|
— |
|
Non-deductible expenses |
|
|
(185,183 |
) |
|
(180,840 |
) |
|
(572,138 |
) |
|
(696,700 |
) |
Transfer Pricing adjustment |
|
|
— |
|
|
(3,795 |
) |
|
— |
|
|
(47,782 |
) |
Prior period adjustments |
|
|
(152,806 |
) |
|
281,789 |
|
|
(702,275 |
) |
|
235,604 |
|
Income tax expense |
|
|
(214,524 |
) |
|
181,469 |
|
|
(1,089,831 |
) |
|
(323,980 |
) |
Income tax expense is recognized based on management’s estimate of the weighted average effective annual income tax rate expected for the full financial year, bearing in mind the impact of non-discrete and discrete items. Non discrete items in the income tax expense are recognized based on management’s estimate of the weighted average effective annual income tax rate expected for the full financial year. Discrete items in the income tax expense are recognized at the applicable statutory tax rate.
The (estimated) average annual tax rate used for the nine months ended September 30, 2026 was 0.82%, compared to 0.25% for the nine months ended September 30, 2025.
The current period losses for which no deferred tax asset has been recognized mainly consists of the unrecognized tax effect of losses incurred in Switzerland. The differences in the overseas tax rates are due to the lower tax rate in Switzerland compared to the statutory income tax rate in the Netherlands.
Pharvaris N.V. is the head of the fiscal unity including Pharvaris Netherlands B.V. and Pharvaris Holdings B.V.
Deferred tax
Deferred taxes have been recognized to the extent that management concludes that there is sufficient probability as per IAS 12 that there will be future taxable profits available in the foreseeable future against which the unused tax losses and deductible temporary differences can be utilized.
Deferred tax assets relating to losses carried forward have not been recognized, and deferred tax assets on deductible temporary differences in excess of deferred tax liabilities on taxable temporary differences have not been recognized in the consolidated statement of profit and loss and other comprehensive income for the Dutch fiscal unity.
10
8. Property, plant and equipment
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Net book value |
|
€ |
|
|
€ |
|
||
Balance at beginning of period |
|
|
642,470 |
|
|
|
667,000 |
|
Additions |
|
|
79,004 |
|
|
|
164,620 |
|
Depreciation expenses |
|
|
(215,110 |
) |
|
|
(189,150 |
) |
Currency translation adjustments |
|
|
(10,101 |
) |
|
|
— |
|
Balance at end of period |
|
|
496,263 |
|
|
|
642,470 |
|
|
|
|
|
|
|
|
||
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Cumulative depreciation |
|
€ |
|
|
€ |
|
||
As of January 1, |
|
|
(409,286 |
) |
|
|
(220,136 |
) |
Depreciation |
|
|
(215,110 |
) |
|
|
(189,150 |
) |
Currency translation adjustments |
|
|
12,068 |
|
|
|
— |
|
Balance at end of period |
|
|
(612,328 |
) |
|
|
(409,286 |
) |
|
|
|
|
|
|
|
||
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Cumulative Costs |
|
€ |
|
|
€ |
|
||
Balance at beginning of period |
|
|
1,051,756 |
|
|
|
887,136 |
|
Additions |
|
|
79,004 |
|
|
|
164,620 |
|
Currency translation adjustments |
|
|
(22,169 |
) |
|
|
- |
|
Balance at end of period |
|
|
1,108,591 |
|
|
|
1,051,756 |
|
During the nine months ended September 30, 2026, the Group acquired assets with a cost of €0.1 million (December 31, 2025: €0.2 million). The acquisitions were mainly related to equipment, tools and installations.
9. Leases
The following table provides information about the Group’s right-of-use assets:
|
|
September 30, |
|
|
December 31, 2025 |
|
||
|
|
€ |
|
|
€ |
|
||
Balance at beginning of period |
|
|
756,951 |
|
|
|
813,842 |
|
Remeasurement |
|
|
— |
|
|
|
251,427 |
|
Depreciation charges |
|
|
(161,304 |
) |
|
|
(229,203 |
) |
Currency translation adjustments |
|
|
18,542 |
|
|
|
(79,115 |
) |
Balance at end of period |
|
|
614,189 |
|
|
|
756,951 |
|
The following table provides information about the Group’s lease liabilities at September 30, 2026:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
€ |
|
|
€ |
|
||
Office leases |
|
|
(603,935 |
) |
|
|
(776,798 |
) |
Total lease liability |
|
|
(603,935 |
) |
|
|
(776,798 |
) |
Current portion |
|
|
(173,658 |
) |
|
|
(200,213 |
) |
Non-current portion |
|
|
(430,277 |
) |
|
|
(576,585 |
) |
11
Office leases consist of (i) a lease that was renewed on December 1, 2025 with an expiration date of November 30, 2028 for offices in Leiden, the Netherlands. The lease has a lease term of three years, and (ii) a new lease agreement entered into on October 16, 2024 with an expiration date of December 31, 2029, for office space in Lexington, Massachusetts, United States of America (the "U.S.").
The average incremental borrowing rate applied to the lease liability related to the Leiden lease was 7.77% during the nine months ended September 30, 2026 and the twelve months ended December 31, 2025.
The average incremental borrowing rate applied to the lease liability related to the U.S. lease was 6.39% during the nine months ended September 30, 2026 and the twelve months ended December 31, 2025.
Depreciation expense related to right-of-use assets was €0.2 million during each of the nine months ended September 30, 2026 and 2025, respectively, and is reflected in general and administrative expenses as determined by the underlying activities.
The total expense related to short-term and low-value leases for the nine months ended September 30, 2026 and 2025, was €0.2 million and €0.1 million, respectively, and is included in facility, communication, and office expenses.
Cash outflows related to leases during each of the nine months ended September 30, 2026 and 2025 were €0.2 million.
10. Receivables
|
|
September 30, |
|
|
December 31, |
|
||
|
|
€ |
|
|
€ |
|
||
Current tax receivable |
|
|
4,615,830 |
|
|
|
3,994,384 |
|
VAT receivables |
|
|
1,367,904 |
|
|
|
556,739 |
|
|
|
|
5,983,734 |
|
|
|
4,551,123 |
|
11. Other current assets
|
|
September 30, |
|
|
December 31, |
|
||
|
|
€ |
|
|
€ |
|
||
Prepayments |
|
|
4,490,654 |
|
|
|
2,938,215 |
|
|
|
|
4,490,654 |
|
|
|
2,938,215 |
|
Prepayments mainly relate to prepaid insurance, prepaid research and development expenses and rent.
12. Cash and cash equivalents
As of September 30, 2026 and December 31, 2025, there were no restricted cash and cash equivalent balances. Cash and cash equivalent balances as of September 30, 2026 include investments in money market funds of €229.2 million at fair market value. (Cost: €223.4 million). December 31, 2025 include investments in money market funds of €232.5 million at fair market value. (Cost: €241.2 million).
13. Equity
On September 30, 2026, the Company’s authorized share capital amounted to € 14.1 million divided into 117.5 million ordinary shares each with a nominal value of twelve eurocents (€0.12).
As of September 30, 2026, the total number of issued and fully paid shares was 70.8 million (December 31, 2025: 65.2 million). On September 30, 2026, the issued share capital totaled €8.5 million (December 31, 2025: €7.8 million).
In April 2024, the Company entered into an at-the-market sales agreement with Leerink Partners, pursuant to which it may sell ordinary shares having an aggregate offering price of up to $175 million from time to time through Leerink Partners. As of September 30, 2026, no ordinary shares have been sold under this agreement.
12
In July 2025, the Company entered into an underwriting agreement with Morgan Stanley & Co. and Leerink Partners, as representatives of the underwriters, pursuant to which the Company agreed to issue and sell (i) 9,562,500 ordinary shares, par value €0.12 per share and (ii) pre-funded warrants to purchase up to 500,000 ordinary shares in an underwritten offering. The offering closed on July 24, 2025, and the Company generated net proceeds of €160.3 million ($188.5 million), after deducting fees and expenses of €10.9 million ($12.8 million).The pre-funded warrants were exercised in September 2025 for gross exercise proceeds of €0.04 million ($0.05 million) and resulted in issuance of 500,000 ordinary shares.
On May 8, 2026, the Company entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners LLC as representatives of the underwriters named therein, pursuant to which the Company agreed to issue and sell in an underwritten offering 4,455,863 ordinary shares, par value €0.12 per share (which includes the exercise in full by the underwriters of their option to purchase up to an additional 581,199 ordinary shares). The offering closed on May 11, 2026, and the Company generated net proceeds of approximately €105.7 million ($124.3 million), after deducting bank fees of approximately €6.7 million ($7.9 million).
Issued shares
|
|
September 30, |
|
|
December 31, |
|
||
|
|
Number of shares |
|
|
Number of shares |
|
||
Ordinary shares |
|
|
70,791,931 |
|
|
|
65,210,590 |
|
|
|
|
70,791,931 |
|
|
|
65,210,590 |
|
14. Trade and other payables
|
|
September 30, |
|
|
December 31, |
|
||
|
|
€ |
|
|
€ |
|
||
Trade payables |
|
|
5,304,404 |
|
|
|
5,114,186 |
|
|
|
|
5,304,404 |
|
|
|
5,114,186 |
|
15. Accrued liabilities
|
|
September 30, |
|
|
December 31, |
|
||
|
|
€ |
|
|
€ |
|
||
Clinical accrued liabilities |
|
|
8,522,639 |
|
|
|
5,806,522 |
|
Personnel related accruals |
|
|
10,190,630 |
|
|
|
11,432,445 |
|
Manufacturing accrued liabilities |
|
|
1,008,709 |
|
|
|
2,879,222 |
|
Nonclinical accrued liabilities |
|
|
517,175 |
|
|
|
527,935 |
|
Consulting, professional and audit liability |
|
|
1,409,097 |
|
|
|
1,226,432 |
|
Other accrued liabilities |
|
|
2,532,899 |
|
|
|
1,475,916 |
|
|
|
|
24,181,149 |
|
|
|
23,348,472 |
|
16. Risk management activities
The Group’s risk management activities are the same as disclosed in Note 17 of the consolidated financial statements for the year ended December 31, 2025.
17. Fair values
Fair values of cash balances, trade receivables, trade payables, and other current liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.
The fair value of the cash equivalents, Group’s financial instruments measured at fair value on recurring basis, is categorized within level 1 of the fair value hierarchy, as the valuation is based on quoted net asset values (NAV) in active markets at the reporting date.
13
18. Share-based payments
In 2016, the Company implemented an Equity Incentive Plan (the “Plan”) in order to advance the interests of the Company’s shareholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make important contributions to the Company and by providing such persons with performance-based incentives that are intended to better align the interests of such persons with those of the Company’s shareholders. This plan has been superseded by the 2021 Equity Incentive Plan (the “2021 Plan”).
Set out below is an overview of changes in the Stock Options and Restricted Stock Units (“RSUs”) during the nine months ended September 30, 2026.
|
|
Stock Options |
|
|
RSUs |
|
||||||
|
|
Outstanding |
|
|
Weighted |
|
|
Outstanding |
|
|||
|
|
|
|
|
€ |
|
|
|
|
|||
Outstanding January 1, 2026 |
|
|
3,951,032 |
|
|
|
13.01 |
|
|
|
1,417,632 |
|
Granted |
|
|
717,500 |
|
|
|
24.26 |
|
|
|
729,180 |
|
Exercised (Vested and Settled) |
|
|
(729,872 |
) |
|
|
8.93 |
|
|
|
(495,324 |
) |
Forfeited |
|
|
— |
|
|
|
— |
|
|
|
(90,482 |
) |
Outstanding September 30, 2026 |
|
|
3,938,660 |
|
|
|
12.56 |
|
|
|
1,561,006 |
|
During the nine months ended September 30, 2026, a total of 459,105 RSUs were granted to employees that joined the Group in the same period and to existing employees. The RSUs shall vest equally over a four-year period on each of the four anniversaries of the vesting start date until either the RSUs are fully vested or the RSUs holders’ continuous service terminates.
During the nine months ended September 30, 2026, a total of 29,575 RSUs were issued to existing employees. The RSUs shall vest subject to certain milestone achievements.
During the nine months ended September 30, 2026, 193,000 RSUs were issued to existing key management. The RSUs shall vest over a four-year period, with 25% of the aggregate number of RSUs vesting on the 12-month anniversary of the vesting commencement date, and thereafter 1/48th of the aggregate number of RSUs vesting on each subsequent monthly anniversary of the vesting commencement date, subject to continuous service through each applicable vesting date.
During the nine months ended September 30, 2026, 27,500 RSUs were issued to members of the Board of Directors. The RSUs shall vest on the 12-month anniversary of the vesting start date.
During the nine months ended September 30, 2026, 20,000 RSUs were issued to an existing member of key management. The RSUs shall vest subject to a milestone-based vesting condition based on the achievement of the below milestones:
(a) Milestone 1- the approval by the U.S. Food and Drug Administration ("FDA") of the Company's New Drug Application ("NDA") for deucrictibant immediate-release capsules for the on-demand treatment of hereditary angioedema ("HAE") attacks: Forty percent (40%) of the aggregate number of RSUs (i.e. 8,000 RSUs) shall vest upon the achievement of Milestone 1, as determined by the Board in its sole discretion.
(b) Milestone 2 - the approval by the U.S. Food and Drug Administration ("FDA") of the Company's New Drug Application ("NDA") for deucrictibant extended-release tablets for the prophylactic treatment of hereditary angioedema ("HAE") attacks: Sixty percent (60%) of the aggregate number of RSUs (i.e. 12,000 RSUs) shall vest upon the achievement of Milestone 2, as determined by the Board in its sole discretion.
The fair value of the RSUs is determined based on the share value per ordinary share at the grant date (or at the first trading day after the grant date if the Nasdaq Stock Exchange is not open on this date). The grant dates and share closing prices for grants during the first nine months of 2026 were: January 1 (€23.63), February 1 (€22.83), March 1 (€24.03), March 3 (€23.05), April 1 (€25.42), May 1, (€25.12), June 1 (€25.02), July 1 (€29.84), August 1 (€28.30) August 14 (€30.07) and September 1 (€29.79), respectively.
On March 3, 2026, a total of 82,500 stock options were granted to members of the Board of Directors with an exercise price of €24.11 per share with a final exercise date of March 2, 2036, unless forfeited or exercised on an earlier date. 100% of the aggregate number of shares subject to the option shall vest on the 12-month anniversary of the vesting commencement date, subject to the option holder’s continuous service.
On March 3, 2026, a total of 575,000 stock options were granted to members of key management with an exercise price of €24.11 per share with a final exercise date of March 2, 2036, unless forfeited or exercised on an earlier date. 25% of the aggregate number of shares subject to the option shall vest on the 12-month anniversary of the vesting commencement date, and thereafter 1/48th of the aggregate number of shares subject to the option shall vest on
14
each subsequent monthly anniversary of the vesting commencement date, subject to the option holder’s continuous service through each applicable vesting date.
On June 1, 2026, 60,000 Options were issued to an existing member of key management. The Options shall vest subject to a milestone-based vesting condition based on the achievement of the below milestones:
Milestone 1 - the approval by the U.S. Food and Drug Administration ("FDA") of the Company's New Drug Application ("NDA") for deucrictibant immediate-release capsules for the on-demand treatment of hereditary angioedema ("HAE") attacks: Forty percent (40%) of the aggregate number of Shares subject to the Option (i.e. 24,000 options) shall vest upon the achievement of Milestone 1, as determined by the Board in its sole discretion.
Milestone 2 - the approval by the U.S. Food and Drug Administration ("FDA") of the Company's New Drug Application ("NDA") for deucrictibant extended-release tablets for the prophylactic treatment of hereditary angioedema ("HAE") attacks: Sixty percent (60%) of the aggregate number of Shares subject to the Option (i.e. 36,000 options) shall vest upon the achievement of Milestone 2, as determined by the Board in its sole discretion.
As of September 30, 2026, a total number of 2,467,753 stock options are exercisable (September 30, 2025: 2,652,936).
For the nine months ended September 30, 2026, the Group recognized €18.3 million of share-based payment expense in the unaudited condensed consolidated statement of income or loss and other comprehensive income (nine months ended September 30, 2025: €14.5 million).
The inputs and outputs used in the measurement of the fair value per option at each grant/ measurement date using the Black-Scholes formula (including the related number of options and the fair value of the options) were as follows:
|
|
June 1, 2026** |
|
March 3, 2026* |
|
March 3, 2026** |
|
March 12, 2025* |
|
March 12, 2025** |
|
|||||
Number of options |
|
|
60,000 |
|
|
82,500 |
|
|
575,000 |
|
|
75,000 |
|
|
555,000 |
|
Fair value of the options |
|
€ |
20.71 |
|
€ |
18.88 |
|
€ |
19.45 |
|
€ |
11.86 |
|
€ |
12.19 |
|
Fair value of the ordinary shares |
|
€ |
25.93 |
|
€ |
24.11 |
|
€ |
24.11 |
|
€ |
14.71 |
|
€ |
14.71 |
|
Exercise price |
|
€ |
25.93 |
|
€ |
24.11 |
|
€ |
24.11 |
|
€ |
14.74 |
|
€ |
14.74 |
|
Expected volatility (%) |
|
|
100 |
% |
|
100 |
% |
|
100 |
% |
|
105 |
% |
|
105 |
% |
Expected life (years) |
|
5.8 |
|
5.5 |
|
|
6.1 |
|
5.5 |
|
|
6.1 |
|
|||
Risk-free interest rate (%) |
|
|
4.3 |
% |
|
3.8 |
% |
|
3.8 |
% |
|
4.3 |
% |
|
4.3 |
% |
Expected dividend yield |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
* Granted to the Board of Directors
** Granted to members of key management
19. Basic and diluted loss per share
Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of issued and outstanding ordinary shares during the three and nine months ended September 30, 2026 and 2025.
All of the Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share attributable to ordinary stockholders as the effect of including them would be antidilutive.
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
|||||||||
|
|
2026 |
|
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
|
€ |
|
€ |
|
€ |
|
||||
Net Loss |
|
|
(47,412,993 |
) |
|
|
(37,137,035 |
) |
|
(134,456,395 |
) |
|
(128,958,544 |
) |
Weighted average number of ordinary shares outstanding |
|
|
70,325,917 |
|
|
|
62,255,988 |
|
|
67,919,745 |
|
|
57,172,297 |
|
Basic and diluted loss per share |
|
|
(0.67 |
) |
|
|
(0.60 |
) |
|
(1.98 |
) |
|
(2.26 |
) |
20. Commitments and Contingencies
Claims
There are no material claims known to management related to the activities of the Group.
15
Commitments
The Group's contractual obligations and commitments as of September 30, 2026 amounted to €123 million, (December 31, 2025: €119.2 million) primarily related to research and development activities.
The Group had no contingent liabilities and no contingent assets as of September 30, 2026 and December 31, 2025.
21. Related parties
Note 1.2 provides information about the Group’s structure, including details of the subsidiaries and the holding company. The following provides the total amount of transactions that have been entered into with related parties for the relevant financial period.
Key management personnel compensation
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
||||||||
|
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
||||
|
|
€ |
|
€ |
|
€ |
|
€ |
|
||||
Short term employee benefits |
|
|
974,003 |
|
|
1,238,937 |
|
|
4,781,357 |
|
|
3,856,915 |
|
Post employee benefits |
|
|
66,308 |
|
|
63,781 |
|
|
207,639 |
|
|
196,793 |
|
Share-based payments |
|
|
4,046,282 |
|
|
2,744,836 |
|
|
10,697,323 |
|
|
8,697,178 |
|
Total |
|
|
5,086,593 |
|
|
4,047,554 |
|
|
15,686,319 |
|
|
12,750,886 |
|
The Company engages GrayMatters Consulting BV, a management entity for the purpose of providing key management services to the Company. This management entity is considered a related party, as it provides key management services and exercises key management functions.
The aggregate amount of expense recognized in the unaudited condensed consolidated interim financial statements related to this related party was €0.5 million in the nine months ended September 30, 2026 and 2025, respectively.
The outstanding balances payable to key management personnel, or entities which they control, as per September 30, 2026 and December 31, 2025 were €1.3 million and €1.6 million, respectively.
16
22. Events after the reporting period
The Company has evaluated subsequent events through November 12, 2026, which is the date the condensed consolidated interim financial statements were authorized for issuance, and did not identify any significant event after reporting period that needs to be disclosed.
17
Signatories to the unaudited condensed consolidated interim financial statements
Leiden, November 12, 2026
Pharvaris N.V.
Board of Directors
B.A.E. Modig |
R.H. Glassman |
E. Björk |
J.G.C.P. Schikan |
D.P. Meeker |
V. Monges |
|
|
18