6-K
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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 August 2025
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 August 12, 2025, Pharvaris N.V. issued a press release reporting financial results and other business updates for the three and six months ended June 30, 2025. 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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PHARVARIS N.V. |
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Date: August 12, 2025 |
By: |
/s/ Berndt Modig |
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Name: |
Berndt Modig |
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Title: |
Chief Executive Officer |
EX-99.1

Exhibit 99.1
Pharvaris Reports Second Quarter 2025 Financial Results and Provides Business Update
•Topline results for RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, expected in 4Q2025
•Enrollment continues in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline results expected in 2H2026
•Startup activities for CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, on track; study is expected to initiate by YE2025
•Strong financial position with cash and cash equivalents of €200 million as of June 30, 2025; subsequent closing of $201 million public offering extends cash runway into 1H2027
ZUG, Switzerland, August 12, 2025 – Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today reported financial results for the second quarter ended June 30, 2025, and provided a business update.
“Halfway through 2025, an important executional year for the company, Pharvaris is making meaningful progress in our ambition to address unmet needs of people living with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The readout of RAPIDe-3 topline results, which is estimated to be in the fourth quarter of this year, is anticipated to be an important inflection point for our stakeholders. CHAPTER-3 continues to progress with topline results expected in the second half of 2026, and we are on track to initiate CREAATE in 2025. Our ability to conduct multiple global Phase 3 studies, deliver and present data supporting deucrictibant’s potentially differentiated profile in bradykinin-mediated angioedema diligently and on-time, and maintain financial discipline, supported the oversubscribed raise of approximately $200 million, which we expect will extend our cash runway beyond the estimated topline data readout date for the prophylactic program.”
Recent Business Updates and Highlights
Development Pipeline
•Topline results from RAPIDe-3 (NCT06343779) anticipated in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg, which is the intended commercial dosage) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment in March 2025; the study continues to assess HAE attacks in enrolled participants. Given the current dataset of evaluable attacks, Pharvaris anticipates announcing topline results in the fourth quarter of 2025.
•Enrollment continues in CHAPTER-3 (NCT06669754). CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg, which is the intended commercial dosage), or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline results of CHAPTER-3 in the second half of 2026.
•CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, is expected to initiate by year end 2025. CREAATE will assess the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants will receive either deucrictibant extended-release tablet (40 mg), or placebo, once daily to assess deucrictibant as a prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants will treat two attacks in a double-blinded cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo, to assess deucrictibant as an on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study that will assess the long-term safety and efficacy of deucrictibant immediate-release capsule (20 mg) as an on-demand treatment.
•R&D Call explored the potential expansion of treatment applications for bradykinin B2 receptor antagonism. Pharvaris management hosted a call in which they explored the pathophysiology and prevalence of bradykinin-mediated angioedema, the current treatment paradigm and unmet needs of those living with bradykinin-mediated angioedema, such as HAE with normal C1 inhibitor and AAE-C1INH, the potential of deucrictibant to address those unmet needs, and Pharvaris’ biomarker approach to aid in the identification of those living with bradykinin-mediated angioedema and other diseases.
•Presentations at recent medical congresses highlight clinical and non-clinical deucrictibant data. Data providing further evidence for deucrictibant’s potential to address unmet needs of people living with bradykinin-mediated angioedema were presented at recent medical congresses, such as the 14th C1-Inhibitor Deficiency and Angioedema Workshop, European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, U.S. Hereditary Angioedema Association (HAEA) 2025 National Summit, CIIC 2025 Spring Conference, ISPOR 2025, and 2025 Eastern Allergy Conference (EAC).
Corporate
•Closing of approximately $201 million public offering in July 2025 extends cash runway. The proceeds from the public offering with cash proceeds of approximately $201 million shares will be used to fund research and development expenses for late-stage clinical programs, the hiring of a sales and marketing team in the U.S. and related commercialization expenses and for working capital and general corporate purposes. Pharvaris remains diligent in its operational management and expects to have a cash runway into the first half of 2027.
Upcoming Investor Conference Presentations
Pharvaris management will participate in the following upcoming investor conferences in September:
•Cantor Global Healthcare Conference 2025. New York, NY, September 3-5, 2025.
oFormat: Fireside Chat
Date, time: Wednesday, September 3, 2025, 11:30 a.m. ET (17:30 CEST)
•2025 Wells Fargo Healthcare Conference. Boston, MA, September 3-5, 2025.
oFormat: Fireside Chat
Date, time: Thursday, September 4, 2025, 3:45 p.m. ET (21:45 CEST)
•H.C. Wainwright 27th Annual Global Investment Conference. New York, NY, September 8-10, 2025.
oFormat: Fireside Chat
Date, time: Tuesday, September 9, 2025, 8:00 a.m. ET (14:00 CEST)
•Morgan Stanley 23rd Annual Global Healthcare Conference. New York, NY, September 8-10, 2025.
oFormat: Fireside Chat
Date, time: Wednesday, September 10, 2025, 8:30 a.m. ET (14:30 CEST)
A live audio webcast of the fireside chat will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replay will be available on Pharvaris’ website for 30 days following the presentation.
Upcoming Medical Congress Presentations
•European Academy of Allergy & Clinical Immunology (EAACI) 2025 Hong Kong Allergy School 2025.
Hong Kong, August 27-29, 2025. Details for the accepted oral presentations at EAACI Hong Kong Allergy School 2025 are as follows:
•Title: Efficacy and Safety of Oral Deucrictibant for Prophylactic (CHAPTER-3) and for On-Demand Treatment (RAPIDe-3) of Hereditary Angioedema Attacks in Adolescents and Adults: Two Phase 3 Trial Designs
Presenter: Phillip H. Li, MD, FRCP
Date, time: Thursday, August 28, 2025, 15:45-15:55 HKT (3:45-3:55 a.m. ET, 9:45-9:55 CEST)
•Title: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylactic and On-Demand Treatment of Hereditary Angioedema Attacks: Results of the CHAPTER-1 and RAPIDe-2 Extension Trials
Presenter: Ramon Lleonart, M.D.
Date, time: Friday, August 29, 2025, 16:05-16:15 HKT (4:05-4:15 a.m. ET, 10:05-10:15 CEST)
Financials
Second Quarter 2025 Financial Results
•Liquidity Position. Cash and cash equivalents were €200 million as of June 30, 2025, compared to €281 million for December 31, 2024.
•Research and Development (R&D) Expenses. R&D expenses were €29.6 million for the quarter ended June 30, 2025, compared to €23.1 million for the quarter ended June 30, 2024.
•General and Administrative (G&A) Expenses. G&A expenses were €10.8 million for the quarter ended June 30, 2025, compared to €11.3 million for the quarter ended June 30, 2024.
•Loss for the year. Loss for the second quarter was €45.5 million, resulting in basic and diluted loss per share of €0.83 for the quarter ended June 30, 2025, compared to €29.7 million, or basic and diluted loss per share of €0.55, for the quarter ended June 30, 2024.
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 and orphan designation by the European Commission.
About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). 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,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development
programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; 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 outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, 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
Executive Director, Head of Corporate and Investor Communications
maggie.beller@pharvaris.com
EX-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 six months ended June 30, 2025 and 2024 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 2024, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2024 (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, is a novel, oral, small-molecule bradykinin B2 receptor antagonist under development for the prevention or treatment of attacks due to bradykinin-mediated angioedema, including hereditary angioedema (HAE) and acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH). Deucrictibant has the potential to address unmet medical need by improving upon the therapeutic profile of existing medicines and providing patients with quality of life and ease-of-administration that is superior to current standard-of-care. We believe deucrictibant has the potential to provide injectable-like efficacy and placebo-like tolerability with the convenience of an oral therapy for both the prophylactic and on-demand treatment of HAE attacks.
Deucrictibant may address unmet medical needs of people living with HAE by both preventing attacks from occurring, using an extended-release (XR) tablet formulation of deucrictibant, as well as treat the manifestations of HAE attacks, using an immediate-release (IR) capsule formulation of deucrictibant. The XR tablet formulation is designed to maintain therapeutic levels for at least 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 quickly 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 when they change their dosing regimen and delivery mechanism moving from on-demand to prophylactic treatment (or the other way around). This may be particularly valued by children or adolescents who typically begin therapy with on-demand only and gradually move to prophylaxis as attack frequency increases (commonly after puberty).
In our Phase 1 clinical trials to-date, we have observed rapid exposure and predictable linear pharmacokinetics (PK) with and without food. In addition, we observed deucrictibant to be a potent antagonist of the bradykinin B2 receptor, in vitro and in vivo with healthy volunteers.
A Phase 2 placebo-controlled trial evaluating the efficacy and tolerability of deucrictibant IR capsules for the on-demand treatment of attacks in patients with HAE type 1 and 2 (RAPIDe-1) commenced in February 2021 and reported positive topline Phase 2 data in December 2022, demonstrating the clinical efficacy and tolerability of deucrictibant. We believe these positive Phase 2 data support further development of deucrictibant as a potential oral on-demand therapy for HAE attacks. In March 2024, we initiated a global, pivotal, randomized, double-blind-placebo-controlled Phase 3 study, RAPIDe-3, of orally administered deucrictibant IR capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), and have enrolled approximately 120
participants. Topline data from RAPIDe-3 is anticipated in the fourth quarter of 2025 and, pending positive data, we expect to submit a New Drug Application with the FDA in the first half of 2026.
A Phase 2 placebo-controlled trial evaluating the efficacy and the safety and tolerability of deucrictibant for long-term prophylaxis against angioedema attacks in HAE type 1 and 2 (CHAPTER-1) commenced in 2021 using twice-daily dosing of deucrictibant IR capsules as a proof-of-concept for once-daily deucrictibant XR tablets, and announced positive topline data in December 2023, demonstrating the clinical efficacy and tolerability of deucrictibant. We believe these positive Phase 2 data support further development of deucrictibant as a potential oral prophylactic therapy for HAE attacks. In December 2024, we initiated a global, pivotal, randomized, double-blind, placebo-controlled Phase 3 study, CHAPTER-3, of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants with HAE and randomize them in a 2:1 ratio to receive deucrictibant XR tablet (40 mg/day), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Topline data from CHAPTER-3 is anticipated in the second half of 2026.
In addition, we are also running open-label extension studies in both on-demand and prophylactic settings to collect long-term safety and efficacy data in HAE patients.
In August 2022, the FDA placed a hold on the clinical trials of deucrictibant in the U.S. based on its review of nonclinical data. The FDA requested that Pharvaris conduct an additional long-term rodent toxicology study and update the Investigator’s Brochure. Pharvaris participated in a Type A meeting with the FDA to discuss paths to address the on-demand and prophylactic holds and aligned on a protocol for a 26-week rodent toxicology study. Following review of data from a preplanned interim analysis of the ongoing 26-week nonclinical rodent study, the FDA lifted the clinical hold on the IND application for deucrictibant for the on-demand treatment of HAE in June 2023. In January 2024, the FDA lifted the clinical hold on the IND application for deucrictibant for the prophylactic treatment of HAE attacks following review of the full data set from the completed 26-week rodent toxicology study.
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 and changes in regulations and customs, tariffs and trade barriers. We regularly assess each of these risks to minimize any adverse effects on our business as a result of those factors. For a detailed discussion, see Note 17 to our consolidated financial statements included elsewhere in 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 in response to escalating regional conflicts, such as the Russia/Ukraine War, that have created global security concerns and also could adversely affect our ability to conduct ongoing and future clinical trials of our product candidates. For example, our current studies have participants enrolled at sites in approximately 30 countries. A further escalation of the conflict in Ukraine 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 do not expect to recognize any product sales related revenues before we are able to commercialize our first product.
Research and development expenses
We are 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:
•employee benefits expenses, which includes salaries, pensions, share-based compensation expenses, bonus plans and other related costs for research and development staff;
•nonclinical expenses, which include costs of our outsourced discovery and nonclinical development studies and associated travel;
•clinical expenses, which includes costs of conducting and managing our sponsored clinical trials, including clinical investigator cost, costs of clinical sites, costs for CROs assisting with our clinical development programs and associated travel;
•manufacturing expenses, which include costs related to manufacturing of active pharmaceutical ingredients and manufacturing of the products used in our clinical trials and research and development activities and associated travel;
•costs related to regulatory activities, including collecting data, preparing and submitting filings, communicating with regulatory authorities and reviewing the design and conduct of clinical trials for compliance with applicable requirements;
•costs in connection with investigator-sponsored clinical trials and evaluations;
•advisers’ fees, including discovery, nonclinical, clinical, chemistry, manufacturing, and controls-related and other consulting services;
•intellectual property costs, which includes costs associated with obtaining and maintaining patents and other intellectual property; and
We expect that our total research and development expenses will increase in 2025 as we continue to focus on the development of our product candidates IR and XR, as well as explore potential expansion programs. We anticipate that research and development expenses will continue to increase as we continue to progress IR and XR through clinical development.
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 the successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing, and estimated costs of the efforts, including patient recruitment and selection that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from, our product candidates. Moreover, we cannot assure that we will be able to successfully develop or commercialize our product candidates, 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.
Sales, Marketing, and Distribution expenses
If our product candidates are approved for registration and marketing, we anticipate incurring substantial sales, marketing, and distribution expenses in future periods in order to complete the commercial infrastructure we have begun and manufacture commercial quantities of our product candidates.
General and administrative expenses
We anticipate that we will continue to incur significant general and administrative expenses as we advance our research and development portfolio. General and administrative expenses consist of the following:
•employee benefits, including salaries, pensions, share-based compensation expenses, bonus plans and other related costs for staff and independent contractors in executive and operational functions;
•independent auditors’ and advisers’ fees, including accounting, tax, legal and other consulting services;
•rental expenses, insurance, facilities and IT expenses and other general expenses relating to our operations; and
•expenses related to the build-out of our commercial organization, including assessments of the HAE market landscape, pricing research and congress attendance.
We anticipate that the continuing development of our business and the expense of maintaining directors’ and officers’ liability insurance, will contribute to future increase in general and administrative expenses. We also expect that general and administrative expenses will increase in the future as we incur additional costs associated with being a public company in the United States.
We undertook a review of our expense classification methodology within the General and Administrative section to better align with the nature of the underlying activities and industry practices. As a result of this review, certain pre-commercial costs previously reported under “Other expenses” were determined to be more appropriately classified as “Professional Fees.” We recorded approximately €0.5 and €1.6 million in Professional fees for the three and six months ending June 30, 2025, respectively. This reclassification had no impact on the total General and Administrative expenses.
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 six months ended June 30, 2025 and 2024 included as Exhibit 99.3 to this 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.
During the six-month period ended June 30, 2025, we undertook a review of our expense classification methodology to better align with the nature of the underlying activities and industry practices. As a result of this review, certain personnel, consulting, and facility related costs previously reported under General and Administrative expenses were determined to be more appropriately classified as Research and Development expenses. The Company reclassified approximately €0.5 million and €0.7 million from General and Administrative expenses to Research and Development expenses for the three and six months ending, June 30, 2025, respectively. This reclassification had no impact on the total operating expenses, net loss, or loss per share.
Comparison of the three months ended June 30, 2025 and June 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Research and development expenses |
|
|
(29,607,908 |
) |
|
|
(23,067,934 |
) |
|
|
(6,539,974 |
) |
|
|
28 |
% |
General and administrative expenses |
|
|
(10,765,189 |
) |
|
|
(11,314,067 |
) |
|
|
548,878 |
|
|
|
(5 |
)% |
Total operating expenses |
|
|
(40,373,097 |
) |
|
|
(34,382,001 |
) |
|
|
(5,991,096 |
) |
|
|
17 |
% |
Operating loss |
|
|
(40,373,097 |
) |
|
|
(34,382,001 |
) |
|
|
(5,991,096 |
) |
|
|
17 |
% |
Finance (expense)/income |
|
|
(4,904,807 |
) |
|
|
4,721,551 |
|
|
|
(9,626,358 |
) |
|
|
(204 |
)% |
Loss before tax |
|
|
(45,277,904 |
) |
|
|
(29,660,450 |
) |
|
|
(15,617,454 |
) |
|
|
53 |
% |
Income taxes |
|
|
(202,782 |
) |
|
|
(70,623 |
) |
|
|
(132,159 |
) |
|
|
187 |
% |
Loss for the period |
|
|
(45,480,686 |
) |
|
|
(29,731,073 |
) |
|
|
(15,749,613 |
) |
|
|
53 |
% |
Revenues
We did not generate any revenues for the three months ended June 30, 2025 and June 30, 2024.
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Clinical expenses |
|
|
(14,712,960 |
) |
|
|
(15,065,644 |
) |
|
|
352,684 |
|
|
|
(2 |
)% |
Personnel expenses |
|
|
(9,351,648 |
) |
|
|
(6,450,500 |
) |
|
|
(2,901,148 |
) |
|
|
45 |
% |
Nonclinical expenses |
|
|
(2,858,075 |
) |
|
|
130,020 |
|
|
|
(2,988,095 |
) |
|
|
(2298 |
)% |
Manufacturing costs |
|
|
(2,571,095 |
) |
|
|
(1,572,017 |
) |
|
|
(999,078 |
) |
|
|
64 |
% |
Intellectual Property costs |
|
|
(114,130 |
) |
|
|
(109,793 |
) |
|
|
(4,337 |
) |
|
|
4 |
% |
Total research and development expenses |
|
|
(29,607,908 |
) |
|
|
(23,067,934 |
) |
|
|
(6,539,974 |
) |
|
|
28 |
% |
Research and development expenses increased from €23.1 million for the three months ended June 30, 2024 to €29.6 million for the three months ended June 30, 2025. The increase in research and development expenses is primarily due to the increase in personnel expenses, which includes increased headcount to support the three Phase 3 studies (IR, XR and AAE), as well as an increase in nonclinical expenses.
For the three months ended June 30, 2025 and 2024, personnel expenses were €9.4 million and €6.5 million, respectively. This represents an increase of €2.9 million, or 45%. The increase in personnel expenses is driven by the hiring of additional employees. Personnel expenses include €2.8 million of share-based compensation versus €1.8
million in the prior year period. The three month increase in share based compensation is due to the net effect of the annual and new hire grants awarded through June 30, 2025.
For the three months ended June 30, 2025 and 2024, nonclinical expenses were €2.9 million and (€0.1 million), respectively. This represents an increase of €3.0 million. The increase is primarily due to non-deucrictibant preclinical activities.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Personnel expenses |
|
|
(5,775,619 |
) |
|
|
(4,407,998 |
) |
|
|
(1,367,621 |
) |
|
|
31 |
% |
Professional fees |
|
|
(1,686,774 |
) |
|
|
(2,155,727 |
) |
|
|
468,953 |
|
|
|
(22 |
)% |
Facilities, communication and office expenses |
|
|
(1,389,322 |
) |
|
|
(1,466,955 |
) |
|
|
77,633 |
|
|
|
(5 |
)% |
Accounting, tax and auditing fees |
|
|
(743,906 |
) |
|
|
(850,599 |
) |
|
|
106,693 |
|
|
|
(13 |
)% |
Travel expenses |
|
|
(274,070 |
) |
|
|
(399,111 |
) |
|
|
125,041 |
|
|
|
(31 |
)% |
Consulting fees |
|
|
(28,497 |
) |
|
|
(732,951 |
) |
|
|
704,454 |
|
|
|
(96 |
)% |
Other expenses |
|
|
(867,001 |
) |
|
|
(1,300,726 |
) |
|
|
433,725 |
|
|
|
(33 |
)% |
Total general and administrative expenses |
|
|
(10,765,189 |
) |
|
|
(11,314,067 |
) |
|
|
548,878 |
|
|
|
(5 |
)% |
General and administrative expenses decreased from €11.3 million for the three months ended June 30, 2024 to €10.8 million for the three months ended June 30, 2025. During the current period, the increase in personnel expenses was offset by decreases in other categories primarily consulting fees and other expenses.
For the three months ended June 30, 2025 and 2024, personnel expenses were €5.8 million and €4.4 million, respectively, an increase of €1.4 million, or 31%. The increase in personnel expenses is driven by the hiring of additional employees, and the increase in share-based compensation due to the net effect of the annual and new hire grants awarded through June 30, 2025. Personnel expenses include an amount of €2.7 million of share-based compensation versus €2.1 million in the prior-year period.
For the three months ended June 30, 2025 and 2024, consulting fees were €0.03 million and €0.7 million, respectively, a decrease of €0.7 million, or (96)%. The decrease is primarily due to a decrease in investor relations expenses due to one-time payments to two financial advisory firms in the prior-year period.
For the three months ended June 30, 2025 and 2024, other expenses were €0.9 million and €1.3 million, respectively, a decrease of €0.4 million, or (33)%. The decrease is primarily due to the general and administrative reclassification discussed above which was approximately €0.5 million of pre-commercial expenses now recorded in professional fees.
Finance (expense) / income - net
Finance (expense) income for the three months ended June 30, 2025 and 2024 were (€4.9) million and €4.7 million, respectively. Of the change of €9.6 million, €9.1 million relates to translating the group’s bank balances and other balance sheet items held in USD to EUR, which is the reporting currency of the Company.
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 June 30, 2025 relates to the Company's U.S. and Dutch fiscal unity.
Comparison of the six months ended June 30, 2025 and June 30, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Research and development expenses |
|
|
(60,522,301 |
) |
|
|
(41,580,950 |
) |
|
|
(18,941,351 |
) |
|
|
46 |
% |
General and administrative expenses |
|
|
(22,037,107 |
) |
|
|
(21,112,910 |
) |
|
|
(924,197 |
) |
|
|
4 |
% |
Total operating expenses |
|
|
(82,559,408 |
) |
|
|
(62,693,860 |
) |
|
|
(19,865,548 |
) |
|
|
32 |
% |
Operating loss |
|
|
(82,559,408 |
) |
|
|
(62,693,860 |
) |
|
|
(19,865,548 |
) |
|
|
32 |
% |
Finance (expense)/income |
|
|
(8,756,652 |
) |
|
|
5,299,771 |
|
|
|
(14,056,423 |
) |
|
|
(265 |
)% |
Loss before tax |
|
|
(91,316,060 |
) |
|
|
(57,394,089 |
) |
|
|
(33,921,971 |
) |
|
|
59 |
% |
Income taxes |
|
|
(505,449 |
) |
|
|
(355,740 |
) |
|
|
(149,709 |
) |
|
|
42 |
% |
Loss for the period |
|
|
(91,821,509 |
) |
|
|
(57,749,829 |
) |
|
|
(34,071,680 |
) |
|
|
59 |
% |
Revenues
We did not generate any revenues for the six months ended June 30, 2025 and June 30, 2024.
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Clinical expenses |
|
|
(32,049,342 |
) |
|
|
(22,387,056 |
) |
|
|
(9,662,286 |
) |
|
|
43 |
% |
Personnel expenses |
|
|
(17,777,098 |
) |
|
|
(11,630,976 |
) |
|
|
(6,146,122 |
) |
|
|
53 |
% |
Manufacturing costs |
|
|
(5,799,627 |
) |
|
|
(4,135,971 |
) |
|
|
(1,663,656 |
) |
|
|
40 |
% |
Nonclinical expenses |
|
|
(4,708,265 |
) |
|
|
(1,705,446 |
) |
|
|
(3,002,819 |
) |
|
|
176 |
% |
License costs |
|
|
— |
|
|
|
(1,500,000 |
) |
|
|
1,500,000 |
|
|
|
(100 |
)% |
Intellectual Property costs |
|
|
(187,969 |
) |
|
|
(221,501 |
) |
|
|
33,532 |
|
|
|
(15 |
)% |
Total research and development expenses |
|
|
(60,522,301 |
) |
|
|
(41,580,950 |
) |
|
|
(18,941,351 |
) |
|
|
46 |
% |
Research and development expenses increased from €41.6 million for the six months ended June 30, 2024 to €60.5 million for the six months ended June 30, 2025. The increase in research and development expenses is primarily due to the increase in clinical expenses in the ongoing deucrictibant Phase 3 studies (IR, XR and AAE), as well as increased personnel expenses due to increased headcount to support the three Phase 3 studies.
For the six months ended June 30, 2025 and 2024, personnel expenses were €17.8 million and €11.6 million, respectively, an increase of €6.1 million, or 53%. The increase in personnel expenses is primarily driven by the hiring of additional employees. Personnel expenses include €5.0 million of share-based compensation versus €2.9 million in the prior-year period. The six month increase in share-based compensation is due to the net effect of the annual and new hire grants awarded through June 30, 2025.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Personnel expenses |
|
|
(10,804,858 |
) |
|
|
(7,678,193 |
) |
|
|
(3,126,665 |
) |
|
|
41 |
% |
Professional fees |
|
|
(4,290,920 |
) |
|
|
(3,332,956 |
) |
|
|
(957,964 |
) |
|
|
29 |
% |
Facilities, communication and office expenses |
|
|
(2,740,083 |
) |
|
|
(3,147,222 |
) |
|
|
407,139 |
|
|
|
(13 |
)% |
Accounting, tax and auditing fees |
|
|
(1,361,229 |
) |
|
|
(2,104,685 |
) |
|
|
743,456 |
|
|
|
(35 |
)% |
Travel expenses |
|
|
(599,201 |
) |
|
|
(1,023,140 |
) |
|
|
423,939 |
|
|
|
(41 |
)% |
Consulting fees |
|
|
(76,065 |
) |
|
|
(859,476 |
) |
|
|
783,411 |
|
|
|
(91 |
)% |
Other expenses |
|
|
(2,164,751 |
) |
|
|
(2,967,238 |
) |
|
|
802,487 |
|
|
|
(27 |
)% |
Total general and administrative expenses |
|
|
(22,037,107 |
) |
|
|
(21,112,910 |
) |
|
|
(924,197 |
) |
|
|
4 |
% |
General and administrative expenses increased from €21.1 million for the six months ended June 30, 2024, to €22.0 million for the six months ended June 30, 2025. During the current period, increases in personnel expenses and professional fees were substantially offset by decreases in other categories, primarily consulting fees; accounting, tax and auditing fees; and other expenses.
For the six months ended June 30, 2025 and 2024, personnel expenses were €10.8 million and €7.7 million, respectively, an increase of €3.1 million, or 41%. Personnel expenses includes €4.7 million of share-based compensation versus €3.4 million in the prior-year period and is due to the net effect of the annual and new hire grants awarded through June 30, 2025.
For the six months ended June 30, 2025 and 2024, professional fees were €4.3 million and €3.3 million, respectively, an increase of €1.0 million, or 29%. The increase was primarily due to the general and administrative reclassification discussed above which was approximately €1.6 million of pre-commercial expenses now recorded in professional fees partially offset by a reduction in legal fees driven by not reactivating the at-the-market financing facility put in place in 2024.
For the six months ended June 30, 2025 and 2024, accounting, tax and auditing fees were €1.4 million and €2.1 million, respectively, a decrease of €0.7 million, or (35)%. The decrease reflects Pharvaris’ ongoing efforts of moving from external consultants to employees.
For the six months ended June 30, 2025 and 2024, consulting fees were €0.1 million and €0.9 million, respectively, a decrease of €0.8 million, or (91)%. The decrease is primarily due to lower investor relations expenses as the prior-year period included one-time payments to two financial advisory firms.
For the six months ended June 30, 2025 and 2024, other expenses were €2.2 million and €3.0 million, respectively, a decrease of €0.8 million, or (27)%. The decrease was primarily due to the general and administrative reclassification discussed above which was approximately €1.6 million of pre-commercial expenses now recorded in professional fees and partially offset by increased software licensing expenses.
Finance (expense) / income - net
Finance (expense) / income - net, for the six months ended June 30, 2025 and 2024 was €(8.8) million and €5.3 million, respectively. Of the change of €14.1 million, €14.9 million relates to translating the group’s bank balances and other balance sheet items held in USD to EUR, which is the reporting currency of the Company. While interest and other income remained flat over the comparative periods.
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 six months ended June 30, 2025 and 2024, we incurred losses of €91.8 million and €57.7 million, respectively. Since inception, we have not generated any revenues or net cash flows from sales. We will not receive any revenues or net cash flows from sales until we successfully develop a product candidate, obtain regulatory approval and successfully commercialize it. There is no assurance that we will be able to do so.
To date, we have relied on the issuance of equity securities to finance our operations and internal growth. We have previously offered and sold ordinary shares and pre-funded warrants 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 $189 million.
As of June 30, 2025 we held cash and cash equivalents of €199.6 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 execute our operating plan and strategies and to meet the anticipated working capital requirements and settle all expected liabilities for at least twelve months from the issuance date of the consolidated statements of loss and comprehensive loss. Accordingly, the consolidated statements of loss and comprehensive loss 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 June 30, 2025 amounted to €133 million primarily related to research and development contracts.
Cash Flows
Comparison for the three months ended June 30, 2025 and 2024.
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 six months ended June 30, |
|
|
2025 |
|
|
2024 |
|
Change |
|
|
% |
|
|
€ |
|
|
€ |
|
€ |
|
|
|
|
Net cash flows used in operating activities |
|
(68,451,963 |
) |
|
|
(51,914,977 |
) |
|
(16,536,986 |
) |
|
|
32 |
% |
Net cash flows used in investing activities |
|
(144,367 |
) |
|
|
(70,844 |
) |
|
(73,523 |
) |
|
|
104 |
% |
Net cash flows provided by (used in) financing activities |
|
(98,347 |
) |
|
|
1,118,466 |
|
|
(1,216,813 |
) |
|
|
(109 |
)% |
Net decrease in cash and cash equivalents |
|
(68,694,677 |
) |
|
|
(50,867,355 |
) |
|
(17,827,322 |
) |
|
|
35 |
% |
Cash and cash equivalents at the beginning of the period |
|
280,728,037 |
|
|
|
391,231,637 |
|
|
(110,503,600 |
) |
|
|
(28 |
)% |
Effect of exchange rate changes |
|
(12,461,675 |
) |
|
|
3,210,104 |
|
|
(15,671,779 |
) |
|
|
(488 |
)% |
Cash and cash equivalents at the end of the period |
|
199,571,685 |
|
|
|
343,574,386 |
|
|
(144,002,701 |
) |
|
|
(42 |
)% |
Operating activities
Net cash used in operating activities was €68.5 million for the six months ended June 30, 2025 and primarily consisted of a net loss before taxes of €91.32 million adjusted for share-based compensation of €9.6 million, net
foreign exchange losses of €12.0 million and finance income of €0.4 million, an increase in other current assets of €0.4 million and increase in accrued liabilities of €0.9 million and other changes in net working capital.
Net cash used in operating activities was €51.9 million for the six months June 30, 2024, and primarily consisted of a net loss of €57.4 million adjusted for share-based compensation of €6.3 million, an increase in current assets of €0.3 million, an increase in trade and other payables of €0.1 million and an increase of €3.7 million in accrued liabilities and other changes in net working capital.
Off-Balance Sheet Arrangements
As of June 30, 2025, we did not have any off-balance sheet arrangements other than the disclosed commitments.
Quantitative and Qualitative Disclosures About Market Risk
During the six months ended June 30, 2025, 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:
•uncertainty in the outcome of our interactions with regulatory authorities, including the U.S. Food and Drug Administration or FDA, with respect to clinical trials in the U.S. and our ability to resolve any issues to the satisfaction of the FDA or any regulatory agency in a timely manner;
•the expected timing, progress, or success of our clinical development programs, especially for IR (immediate-release deucrictibant capsules) and XR (extended-release deucrictibant tablets), which are in late-stage global clinical trials;
•our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1 and CHAPTER-1 Phase 2 study in ongoing and future nonclinical studies and clinical trials;
•risks arising from epidemic diseases which may adversely impact our business, nonclinical studies and clinical trials, the outcome and timing of regulatory approvals and the value of our ordinary shares;
•the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates IR and XR or any other product candidate that we may develop in the future;
•our ability to market, commercialize and achieve market acceptance for our product candidates IR and XR or any of our other product candidates that we may develop in the future, if approved;
•our ability to establish commercial capabilities or enter into agreements with third parties to market, sell and distribute our product candidates;
•our dependence on third parties to perform critical activities related to the research, nonclinical safety and toxicology studies, development and manufacturing of our product candidates;
•disruptions at the FDA and other government agencies;
•the expense, time and uncertainty involved in the development and consistent manufacturing and supply of our product candidates, some or all of which may never reach the regulatory approval stage;
•our ability to raise capital when needed and on acceptable terms;
•our ability to enter into any new licensing agreements or to maintain any licensing agreements with respect to our product candidates;
•our reliance on collaboration partners and licensees, whose actions we cannot control;
•the willingness of private insurers and other payors to provide reimbursement for our products;
•regulatory developments in the United States, the European Union and other jurisdictions;
•the outcome and timing of price negotiations with governmental authorities;
•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 protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others;
•side effects or adverse events associated with the use of our product candidates;
•our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales;
•the loss of any of our key personnel;
•our estimates of market sizes and anticipated uses of our product candidates;
•our estimates of future performance;
•our estimates regarding anticipated operating losses, future revenues, expenses, capital requirements and our needs for additional financing;
•our ability to comply with existing or future laws and regulations in a cost-efficient manner;
•our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws;
•our ability to maintain an effective system of internal control over financial reporting;
•our expectations regarding the time during which we will be a foreign private issuer; and
•changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; and
•changes in regulations and customs, tariffs and trade barriers.
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 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.
EX-99.3
Pharvaris N.V.
Unaudited Condensed Consolidated Interim Financial Statements
For the six months ended June 30, 2025
Contents
|
|
Unaudited condensed consolidated statement of loss and other comprehensive (loss) /income |
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 |
|
|
Unaudited condensed consolidated statement of loss and other comprehensive (loss) /income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
Notes |
|
€ |
|
€ |
|
€ |
|
€ |
|
Research and development expenses |
|
3 |
|
|
(29,607,908 |
) |
|
(23,067,934 |
) |
|
(60,522,301 |
) |
|
(41,580,950 |
) |
General and administrative expenses |
|
4 |
|
|
(10,765,189 |
) |
|
(11,314,067 |
) |
|
(22,037,107 |
) |
|
(21,112,910 |
) |
Total operating expenses |
|
|
|
(40,373,097 |
) |
|
(34,382,001 |
) |
|
(82,559,408 |
) |
|
(62,693,860 |
) |
Finance (expense)/income |
|
6 |
|
|
(4,904,807 |
) |
|
4,721,551 |
|
|
(8,756,652 |
) |
|
5,299,771 |
|
Loss before income tax |
|
|
|
(45,277,904 |
) |
|
(29,660,450 |
) |
|
(91,316,060 |
) |
|
(57,394,089 |
) |
Income taxes |
|
7 |
|
|
(202,782 |
) |
|
(70,623 |
) |
|
(505,449 |
) |
|
(355,740 |
) |
Net Loss |
|
|
|
(45,480,686 |
) |
|
(29,731,073 |
) |
|
(91,821,509 |
) |
|
(57,749,829 |
) |
Other comprehensive (loss) income |
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified to profit or loss: |
|
|
|
|
|
|
|
|
|
|
Exchange (losses) gains arising on translation of foreign operations |
|
|
|
(261,162 |
) |
|
21,106 |
|
|
(389,917 |
) |
|
56,739 |
|
Total comprehensive loss attributable to: |
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company |
|
|
|
(45,741,848 |
) |
|
(29,709,967 |
) |
|
(92,211,426 |
) |
|
(57,693,090 |
) |
Loss per share attributable to the equity holders of the Company during the periods |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share: |
19 |
|
|
(0.83 |
) |
|
(0.55 |
) |
|
(1.68 |
) |
|
(1.07 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated statement of financial position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
Notes |
|
|
€ |
|
|
€ |
|
Assets |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
8 |
|
|
|
719,994 |
|
|
|
667,000 |
|
Right of use assets |
|
|
9 |
|
|
|
618,613 |
|
|
|
813,842 |
|
Deferred tax assets |
|
|
7 |
|
|
|
297,873 |
|
|
|
474,347 |
|
Current assets |
|
|
|
|
|
|
|
|
|
Receivables |
|
|
10 |
|
|
|
531,640 |
|
|
|
457,834 |
|
Other current assets |
|
|
11 |
|
|
|
6,004,953 |
|
|
|
5,747,025 |
|
Cash and cash equivalents |
|
|
12 |
|
|
|
199,571,685 |
|
|
|
280,728,037 |
|
Current tax receivable |
|
|
10 |
|
|
|
2,065,568 |
|
|
|
2,486,680 |
|
Total assets |
|
|
|
|
|
209,810,326 |
|
|
|
291,374,765 |
|
|
|
|
|
|
|
|
|
|
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
Share capital |
|
|
13 |
|
|
|
6,568,445 |
|
|
|
6,525,539 |
|
Share premium |
|
|
|
|
|
628,674,864 |
|
|
|
623,641,380 |
|
Other reserves |
|
|
|
|
|
44,289,200 |
|
|
|
39,711,103 |
|
Currency translation reserve |
|
|
|
|
|
(252,191 |
) |
|
|
137,726 |
|
Accumulated loss |
|
|
|
|
|
(494,944,426 |
) |
|
|
(402,255,007 |
) |
Total equity |
|
|
|
|
|
184,335,892 |
|
|
|
267,760,741 |
|
|
|
|
|
|
|
|
|
|
|
Long term liabilities |
|
|
|
|
|
|
|
|
|
Non-current lease liability |
|
|
9 |
|
|
|
472,606 |
|
|
|
639,043 |
|
Current liabilities |
|
|
|
|
|
|
|
|
|
Trade and other payables |
|
|
14 |
|
|
|
4,859,249 |
|
|
|
4,562,900 |
|
Accrued liabilities |
|
|
15 |
|
|
|
19,400,357 |
|
|
|
17,588,407 |
|
Current lease liability |
|
|
9 |
|
|
|
161,544 |
|
|
|
222,427 |
|
Current tax payable |
|
|
|
|
|
580,678 |
|
|
|
601,247 |
|
Total liabilities |
|
|
|
|
|
25,474,434 |
|
|
|
23,614,024 |
|
Total equity and liabilities |
|
|
|
|
|
209,810,326 |
|
|
|
291,374,765 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated statement of changes in equity
For the six months ended June 30, 2025 and June 30, 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Share premium |
|
|
Other reserves |
|
|
Currency translation reserve |
|
|
Accumulated losses |
|
|
Total Equity |
|
|
|
Notes |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Balance at January 1, 2024 |
|
|
|
|
|
6,274,833 |
|
|
|
615,811,986 |
|
|
|
27,894,796 |
|
|
|
(14,584 |
) |
|
|
(265,918,628 |
) |
|
|
384,048,403 |
|
Net Loss |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
(57,749,829 |
) |
|
|
(57,749,829 |
) |
Issue of share capital |
|
|
|
|
|
165,000 |
|
|
|
(165,000 |
) |
|
|
12,609 |
|
|
— |
|
|
— |
|
|
|
12,609 |
|
Transaction costs on issue of shares |
|
|
|
|
— |
|
|
|
592,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
592,000 |
|
Currency translation reserve |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
|
56,739 |
|
|
— |
|
|
|
56,739 |
|
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
— |
|
|
|
6,288,303 |
|
|
— |
|
|
|
— |
|
|
|
6,288,303 |
|
Settlement of share-based payments |
|
|
|
|
|
41,092 |
|
|
|
2,808,656 |
|
|
|
(2,230,060 |
) |
|
|
— |
|
|
|
(1,099,188 |
) |
|
|
(479,500 |
) |
Balance at June 30, 2024 |
|
|
|
|
|
6,480,925 |
|
|
|
619,047,642 |
|
|
|
31,965,648 |
|
|
|
42,155 |
|
|
|
(324,767,645 |
) |
|
|
332,768,725 |
|
Balance at January 1, 2025 |
|
|
|
|
|
6,525,539 |
|
|
|
623,641,380 |
|
|
|
39,711,103 |
|
|
|
137,726 |
|
|
|
(402,255,007 |
) |
|
|
267,760,741 |
|
Net Loss |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(91,821,509 |
) |
|
|
(91,821,509 |
) |
Currency translation reserve |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(389,917 |
) |
|
|
— |
|
|
|
(389,917 |
) |
Settlement of share-based payments |
|
|
|
|
|
42,906 |
|
|
|
5,033,484 |
|
|
|
(5,046,933 |
) |
|
|
— |
|
|
|
(867,910 |
) |
|
|
(838,453 |
) |
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
|
— |
|
|
|
9,625,030 |
|
|
|
— |
|
|
|
— |
|
|
|
9,625,030 |
|
Balance at June 30, 2025 |
|
|
|
|
|
6,568,445 |
|
|
|
628,674,864 |
|
|
|
44,289,200 |
|
|
|
(252,191 |
) |
|
|
(494,944,426 |
) |
|
|
184,335,892 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated statement of cash flows
For the six months ended June 30, 2025 and 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2025 |
|
|
2024 |
|
|
|
Notes |
|
€ |
|
|
€ |
|
Operating activities |
|
|
|
|
|
|
|
|
Loss before tax |
|
|
|
|
(91,316,060 |
) |
|
|
(57,394,089 |
) |
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
|
|
|
|
|
|
|
|
Share-based payment expense |
|
18 |
|
|
9,625,030 |
|
|
|
6,288,303 |
|
Depreciation expense |
|
4 |
|
|
208,333 |
|
|
|
135,032 |
|
Net foreign exchange loss (gain) |
|
6 |
|
|
12,001,515 |
|
|
|
(3,146,528 |
) |
Finance income |
|
6 |
|
|
(438,896 |
) |
|
|
(2,160,801 |
) |
|
|
|
|
|
|
|
|
|
Changes in working capital: |
|
|
|
|
|
|
|
|
(Increase) in receivables |
|
|
|
|
(73,806 |
) |
|
|
(91,786 |
) |
Increase in other current assets |
|
|
|
|
(383,606 |
) |
|
|
(300,336 |
) |
Increase trade and other payables |
|
|
|
|
422,029 |
|
|
|
58,721 |
|
Increase in accrued liabilities |
|
|
|
|
942,596 |
|
|
|
3,690,913 |
|
|
|
|
|
|
|
|
|
|
Income taxes received (paid) |
|
|
|
|
98,343 |
|
|
|
(1,114,758 |
) |
Received interest |
|
|
|
|
462,559 |
|
|
|
2,120,352 |
|
Net cash flows used in operating activities |
|
|
|
|
(68,451,963 |
) |
|
|
(51,914,977 |
) |
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
8 |
|
|
(144,367 |
) |
|
|
(70,844 |
) |
Net cash flows used in investing activities |
|
|
|
|
(144,367 |
) |
|
|
(70,844 |
) |
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from issue of shares |
|
13 |
|
|
29,458 |
|
|
|
632,737 |
|
Transaction costs on issue of shares, net |
|
|
|
|
— |
|
|
|
592,968 |
|
Payment of principal portion of lease liabilities |
|
9 |
|
|
(127,805 |
) |
|
|
(107,239 |
) |
Net cash flows (used in) provided by financing activities |
|
|
|
|
(98,347 |
) |
|
|
1,118,466 |
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
|
|
(68,694,677 |
) |
|
|
(50,867,355 |
) |
Cash and cash equivalents at the beginning of the period |
|
|
|
|
280,728,037 |
|
|
|
391,231,637 |
|
Effect of exchange rate changes |
|
|
|
|
(12,461,675 |
) |
|
|
3,210,104 |
|
Cash and cash equivalents at the end of the period |
|
12 |
|
|
199,571,685 |
|
|
|
343,574,386 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
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 June 30, 2025, and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024 were authorized for issue in accordance with a resolution of the directors on August 12, 2025.
1.2 Group information
Subsidiaries
The unaudited condensed consolidated interim financial statements of the Group include:
|
|
|
|
|
|
|
|
|
|
|
|
|
Country of |
|
% of equity interest as June 30, |
Name |
|
Legal seat |
|
incorporation |
|
2025 |
|
2024 |
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% |
|
NA |
*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, 2024 (“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.
During the six-month period ended June 30, 2025, the Company undertook a review of its expense classification methodology to better align with the nature of the underlying activities and industry practices. As a result of this review, certain personnel, consulting, and facility related costs previously reported under General and Administrative expenses were determined to be more appropriately classified as Research and Development expenses. The Company reclassified approximately €0.5 million and €0.7 million from General and Administrative expenses to Research and Development expenses for the three and six months ending, June 30, 2025, respectively. This reclassification had no impact on the total operating expenses, net loss, or loss per share.
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.
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, 2024.
Effective Standards
IASB’s Amendments to IAS 21 — Lack of Exchangeability (issued May 2024, effective for annual reporting periods beginning on or after 1 January 2025) provide guidance on how to determine the spot exchange rate when a currency is not exchangeable into another currency. An entity applies the amendments for annual reporting periods beginning on or after 1 January 2025. The Group has evaluated that there is no impact on the company due to this amendment.
New standards and interpretations issued not yet effective
In April 2024, the IASB issued IFRS 18 Presentation and Disclosure in Financial Statements (“IFRS 18”) which replaces IAS 1 Presentation of Financial Statements. IFRS 18 requires an entity to classify all income and expenses within its statement of profit or loss into one of five categories: operating; investing; financing; income taxes; and discontinued operations. The first three categories are new. These categories are complemented by the requirement to present subtotals and totals for “operating profit or loss”, “profit or loss before financing income and taxes” and “profit or loss”. IFRS 18, and the amendments to the other standards, is effective for reporting periods beginning on or after January 1, 2027, but earlier application is permitted. The Group is currently evaluating the impact of this amendment.
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 June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Clinical expenses |
|
|
(14,712,960 |
) |
|
(15,065,644 |
) |
|
(32,049,342 |
) |
|
(22,387,056 |
) |
Personnel expenses (Note 5) |
|
|
(9,351,648 |
) |
|
(6,450,500 |
) |
|
(17,777,098 |
) |
|
(11,630,976 |
) |
Nonclinical expenses |
|
|
(2,858,075 |
) |
|
130,020 |
|
|
(4,708,265 |
) |
|
(1,705,446 |
) |
Manufacturing costs |
|
|
(2,571,095 |
) |
|
(1,572,017 |
) |
|
(5,799,627 |
) |
|
(4,135,971 |
) |
License costs |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,500,000 |
) |
Intellectual Property costs |
|
|
(114,130 |
) |
|
(109,793 |
) |
|
(187,969 |
) |
|
(221,501 |
) |
|
|
|
(29,607,908 |
) |
|
(23,067,934 |
) |
|
(60,522,301 |
) |
|
(41,580,950 |
) |
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.
Nonclinical expenses include costs of our outsourced discovery and nonclinical development studies and associated travel expenses.
Licensing costs consist of milestone payments reflecting the start of the Phase III study.
4. General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Personnel expenses (Note 5) |
|
|
(5,775,619 |
) |
|
(4,407,998 |
) |
|
(10,804,858 |
) |
|
(7,678,193 |
) |
Professional fees |
|
|
(1,686,774 |
) |
|
(2,155,727 |
) |
|
(4,290,920 |
) |
|
(3,332,956 |
) |
Facilities, communication & office expenses |
|
|
(1,389,322 |
) |
|
(1,466,955 |
) |
|
(2,740,083 |
) |
|
(3,147,222 |
) |
Accounting, tax and auditing fees |
|
|
(743,906 |
) |
|
(850,599 |
) |
|
(1,361,229 |
) |
|
(2,104,685 |
) |
Travel expenses |
|
|
(274,070 |
) |
|
(399,111 |
) |
|
(599,201 |
) |
|
(1,023,140 |
) |
Consulting fees |
|
|
(28,497 |
) |
|
(732,951 |
) |
|
(76,065 |
) |
|
(859,476 |
) |
Other expenses |
|
|
(867,001 |
) |
|
(1,300,726 |
) |
|
(2,164,751 |
) |
|
(2,967,238 |
) |
|
|
|
(10,765,189 |
) |
|
(11,314,067 |
) |
|
(22,037,107 |
) |
|
(21,112,910 |
) |
Since 2022, the Group entered into a number of short-term rental arrangements, the expenses are included in "Other expenses".
Depreciation expense for the six months ended June 30, 2025 and 2024 was €0.2 million and €0.1 million, 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 June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Wages and salaries |
|
|
(8,053,043 |
) |
|
(5,953,069 |
) |
|
(15,955,350 |
) |
|
(11,023,525 |
) |
Share-based payments |
|
|
(5,497,118 |
) |
|
(3,887,436 |
) |
|
(9,625,030 |
) |
|
(6,288,303 |
) |
Other social security charges |
|
|
(915,557 |
) |
|
(660,711 |
) |
|
(1,626,736 |
) |
|
(1,245,426 |
) |
Pension charges |
|
|
(589,441 |
) |
|
(357,282 |
) |
|
(1,134,157 |
) |
|
(751,915 |
) |
Other employee related costs |
|
|
(72,108 |
) |
|
— |
|
|
(240,683 |
) |
|
— |
|
|
|
|
(15,127,267 |
) |
|
(10,858,498 |
) |
|
(28,581,956 |
) |
|
(19,309,169 |
) |
The average number of staff (in FTEs) employed by the Group in the six months ended June 30, 2025 was 114 (2024: 83).
6. Finance (expense)/ income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Foreign exchange differences |
|
|
(5,867,219 |
) |
|
2,616,719 |
|
|
(10,889,757 |
) |
|
3,138,970 |
|
Interest and other income over bank balances |
|
|
1,000,543 |
|
|
2,114,635 |
|
|
2,197,192 |
|
|
2,178,556 |
|
Other finance expenses |
|
|
(38,131 |
) |
|
(9,803 |
) |
|
(64,087 |
) |
|
(17,755 |
) |
|
|
|
(4,904,807 |
) |
|
4,721,551 |
|
|
(8,756,652 |
) |
|
5,299,771 |
|
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 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 June 30, |
|
|
For the six months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Income tax expense |
|
|
(157,772 |
) |
|
|
(70,623 |
) |
|
|
(374,921 |
) |
|
|
(355,740 |
) |
Deferred tax charge |
|
|
(45,010 |
) |
|
|
— |
|
|
|
(130,528 |
) |
|
|
— |
|
Income tax expense |
|
|
(202,782 |
) |
|
|
(70,623 |
) |
|
|
(505,449 |
) |
|
|
(355,740 |
) |
The tax expense over the three and six months ended June 30, 2025 and 2024 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 June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Loss before income tax |
|
|
(45,277,904 |
) |
|
(29,660,450 |
) |
|
(91,316,060 |
) |
|
(57,394,089 |
) |
Income tax at statutory income tax rate in the Netherlands (25.8%) |
|
|
11,681,699 |
|
|
7,652,396 |
|
|
23,559,543 |
|
|
14,807,675 |
|
Effect of tax rates in other countries |
|
|
(6,368,484 |
) |
|
(4,260,352 |
) |
|
(12,922,011 |
) |
|
(8,412,880 |
) |
Deferred tax assets recognition effects |
|
|
(5,236,870 |
) |
|
(3,224,214 |
) |
|
(10,536,949 |
) |
|
(6,007,203 |
) |
Non-deductible expenses |
|
|
(186,549 |
) |
|
(238,743 |
) |
|
(515,860 |
) |
|
(573,609 |
) |
Transfer Pricing adjustment |
|
|
(43,987 |
) |
|
— |
|
|
(43,987 |
) |
|
— |
|
Prior period adjustments |
|
|
(48,591 |
) |
|
290 |
|
|
(46,185 |
) |
|
(169,723 |
) |
Income tax expense |
|
|
(202,782 |
) |
|
(70,623 |
) |
|
(505,449 |
) |
|
(355,740 |
) |
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 six months ended June 30, 2025 was 0.55%, compared to 0.62% for the six months ended June 30, 2024.
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.
8. Property, plant and equipment
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
Net book value |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
667,000 |
|
|
|
223,678 |
|
Additions |
|
|
144,367 |
|
|
|
538,085 |
|
Depreciation expenses |
|
|
(91,373 |
) |
|
|
(94,763 |
) |
Balance at end of period |
|
|
719,994 |
|
|
|
667,000 |
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
Cumulative depreciation |
|
€ |
|
|
€ |
|
As of January 1, |
|
|
(220,136 |
) |
|
|
(125,373 |
) |
Depreciation |
|
|
(91,373 |
) |
|
|
(94,763 |
) |
Balance at end of period |
|
|
(311,509 |
) |
|
|
(220,136 |
) |
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
Cumulative Costs |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
887,136 |
|
|
|
349,051 |
|
Additions |
|
|
144,367 |
|
|
|
538,085 |
|
Balance at end of period |
|
|
1,031,503 |
|
|
|
887,136 |
|
During the six months ended June 30, 2025, the Group acquired assets with a cost of €0.1 million (December 31, 2024: €0.5 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:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
813,842 |
|
|
|
231,893 |
|
Addition |
|
|
25,735 |
|
|
|
756,748 |
|
Depreciation charges |
|
|
(116,960 |
) |
|
|
(174,799 |
) |
Impact of transaction of foreign currency |
|
|
(104,004 |
) |
|
|
— |
|
Balance at end of period |
|
|
618,613 |
|
|
|
813,842 |
|
The following table provides information about the Group’s lease liabilities at June 30, 2025:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Office leases |
|
|
(634,150 |
) |
|
|
(861,470 |
) |
Total lease liability |
|
|
(634,150 |
) |
|
|
(861,470 |
) |
Current portion |
|
|
(161,544 |
) |
|
|
(222,427 |
) |
Non-current portion |
|
|
(472,606 |
) |
|
|
(639,043 |
) |
Office leases consist of (i) a lease that was entered into on December 1, 2022 with an expiration date of November 30, 2025 for offices in Leiden, the Netherlands, 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.").
On June 30, 2024 a lease related to office space in Lexington, Cranberry One Suite 300, expired.
The average incremental borrowing rate applied to the lease liability related to the Leiden lease was 7.77% during the six months ended June 30, 2025 and the twelve months ended December 31, 2024.
The average incremental borrowing rate applied to the lease liability related to the U.S. lease was 6.39% for the year ended six months ended June 30, 2025 and the twelve months ended December 31, 2024.
Depreciation expense was €0.1 million for each of the six months ended June 30, 2025 and 2024, 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 six months ended June 30, 2025 and 2024, was €0.1 million and €0.1 million, respectively, and is included in facility, communication, and office expenses.
Cash outflows related to leases during the six months ended June 30, 2025 and 2024 were €0.1 million and €0.1 million, respectively.
10. Receivables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Current tax receivable |
|
|
2,065,568 |
|
|
|
2,486,680 |
|
VAT receivables |
|
|
531,640 |
|
|
|
457,834 |
|
|
|
|
2,597,208 |
|
|
|
2,944,514 |
|
11. Other current assets
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Prepayments |
|
|
6,004,953 |
|
|
|
5,747,025 |
|
|
|
|
6,004,953 |
|
|
|
5,747,025 |
|
Prepayments mainly relate to prepaid insurance, prepaid research and development expenses and rent.
12. Cash and cash equivalents
As of June 30, 2025 and December 31, 2024, there were no restricted cash and cash equivalent balances. Cash and cash equivalent balances as of June 30, 2025 include investments in money market funds of €95.7 million at fair market value. (Cost: €95.7 million) (December 31, 2024: Euro nil).
13. Equity
On June 30, 2025, the Company’s authorized share capital amounted to € 14.1 million divided into 117,500,000 ordinary shares each with a nominal value of twelve eurocents (€0.12).
As of June 30, 2025, the total number of issued and fully paid shares was 54,737,043 (2024: 54,007,711). On June 30, 2025, the issued share capital totaled €6.6 million (2024: €6.5 million).
In March 2022, the Company filed a Form F-3 Registration Statement and prospectus, allowing the Company to sell up to $350 million of its securities with the Securities and Exchange Commission. This Registration Statement was supplemented by a prospectus supplement covering an at-the-market program providing for the sales from time to time of up to $75 million of its ordinary shares pursuant to a Sales Agreement with Leerink Partners.
As of June 30, 2025, the Company has sold a total of 593,927 ordinary shares under the sales agreement generating total net proceeds of $9.8 million (€9.3 million), after deducting $0.3 million (€0.3 million), which was payable to Leerink Partners as commission in respect of such sales. On April 12, 2024, the Company terminated the March 2022 sales agreement and entered into a new sales agreement with Leerink Partners (the “April 2024 Sales Agreement”), 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. In April 2024, the Company filed a Form F-3 ASR Registration Statement (the “F-3 ASR”) and prospectus, allowing the Company to sell an unspecified amount of its securities with the Securities and Exchange Commission. The F-3 ASR was supplemented by a prospectus supplement covering an at-the-market program providing for the sales from time to time of up to $175 million of its ordinary shares pursuant to the April 2024 Sales Agreement.
In June 2023, the Company sold a total of 6,951,340 ordinary shares, par value €0.12 per share, in a private placement at a purchase price of $10.07 per ordinary share. The sale generated total proceeds of approximately $70 million (€64.2 million).
In December, 2023, the Company entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners, LLC as underwriters, pursuant to which the Company agreed to issue and sell (i) 11,125,000 ordinary shares, par value €0.12 per share and (ii) pre-funded warrants to purchase up to 1,375,000 ordinary shares in an underwritten offering. The offering closed on December 8, 2023, and the Company generated net proceeds of $282.0 million (€261.6 million), after deducting bank fees of $18.0 million (€16.7 million).
The pre-funded warrants were exercised in January 2024 for gross exercise proceeds of $0.01 million and resulted in issuance of 1,375,000 ordinary shares.
In March 2024, the Company received a partial reimbursement for certain of its expenses in connection with the December 2023 offering which have been accounted for in the share premium.
Issued shares
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
Number of shares |
|
|
Number of shares |
|
Ordinary shares |
|
|
54,737,043 |
|
|
|
54,379,491 |
|
|
|
|
54,737,043 |
|
|
|
54,379,491 |
|
14. Trade and other payables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Trade payables |
|
|
4,859,249 |
|
|
|
4,562,900 |
|
|
|
|
4,859,249 |
|
|
|
4,562,900 |
|
15. Accrued liabilities
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
|
|
€ |
|
|
€ |
|
Clinical accrued liabilities |
|
|
7,950,639 |
|
|
|
5,221,572 |
|
Personnel related accruals |
|
|
6,387,541 |
|
|
|
7,827,392 |
|
Manufacturing accrued liabilities |
|
|
3,204,474 |
|
|
|
1,767,291 |
|
Nonclinical accrued liabilities |
|
|
331,605 |
|
|
|
445,238 |
|
Consulting, professional and audit liability |
|
|
238,400 |
|
|
|
729,162 |
|
Other accrued liabilities |
|
|
1,287,698 |
|
|
|
1,597,752 |
|
|
|
|
19,400,357 |
|
|
|
17,588,407 |
|
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, 2024.
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.
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 six months ended June 30, 2025.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
RSUs |
|
|
|
Outstanding options |
|
|
Weighted average exercise price |
|
|
Outstanding RSUs |
|
|
|
|
|
|
€ |
|
|
|
|
Outstanding January 1, 2025 |
|
|
3,869,188 |
|
|
|
12.36 |
|
|
|
1,272,790 |
|
Granted |
|
|
630,000 |
|
|
|
14.74 |
|
|
|
614,655 |
|
Exercised (Vested and Settled) |
|
|
(138,635 |
) |
|
|
1.66 |
|
|
|
(286,389 |
) |
Forfeited |
|
|
— |
|
|
|
— |
|
|
|
(18,219 |
) |
Expired Options |
|
|
(139,167 |
) |
|
|
16.55 |
|
|
|
— |
|
Outstanding June 30, 2025 |
|
|
4,221,386 |
|
|
|
12.29 |
|
|
|
1,582,837 |
|
During the six months ended June 30, 2025, a total of 403,655 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 six months ended June 30, 2025, 186,000 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 six months ended June 30, 2025, 25,000 RSUs were issued to members of the Board of Directors. The RSUs shall vest on the 12-month anniversary of the vesting start date.
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 three months of 2025 were: February 1 (€16.57), March 1 (€14.60), March 12 (€14.71), April 1 (€13.74), and May 1 (€15.80), respectively.
On March 12, 2025, a total of 75,000 stock options were granted to members of the Board of Directors with an exercise price of €14.74 per share with a final exercise date of March 11, 2035, 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 12, 2025, a total of 555,000 stock options were granted to members of key management with an exercise price of €14.74 per share with a final exercise date of March 11, 2035, 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 each subsequent monthly anniversary of the vesting commencement date, subject to the option holder’s continuous service through each applicable vesting date.
As of June 30, 2025, a total number of 2,601,619 stock options are exercisable (June 30, 2024: 4,221,271).
For the six months ended June 30, 2025, the Group recognized €9.6 million of share-based payment expense in the unaudited condensed consolidated statement of income or loss and other comprehensive income (six months ended June 30, 2024: €6.3 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:
|
|
|
|
|
|
|
|
|
|
March 12, 2025 |
|
March 12, 2025 |
|
Number of options |
|
|
75,000 |
|
|
555,000 |
|
Fair value of the options |
|
€ |
11.86 |
|
€ |
12.19 |
|
Fair value of the ordinary shares |
|
€ |
14.71 |
|
€ |
14.71 |
|
Exercise price |
|
€ |
14.74 |
|
€ |
14.74 |
|
Expected volatility (%) |
|
|
105 |
% |
|
105 |
% |
Expected life (years) |
|
5.5 |
|
|
6.1 |
|
Risk-free interest rate (%) |
|
|
4.3 |
% |
|
4.3 |
% |
Expected dividend yield |
|
|
— |
|
|
— |
|
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 months ended June 30, 2025 and 2024.
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 June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
|
€ |
|
€ |
|
€ |
|
Net Loss |
|
|
(45,480,686 |
) |
|
|
(29,731,073 |
) |
|
(91,821,509 |
) |
|
(57,749,829 |
) |
Weighted average number of ordinary shares outstanding |
|
|
54,688,182 |
|
|
|
53,939,597 |
|
|
54,588,321 |
|
|
53,843,789 |
|
Basic and diluted loss per share |
|
|
(0.83 |
) |
|
|
(0.55 |
) |
|
(1.68 |
) |
|
(1.07 |
) |
20. Commitments and Contingencies
Claims
There are no material claims known to management related to the activities of the Group.
Commitments
The Group's contractual obligations and commitments as of June 30, 2025 amounted to €133 million, (December 31, 2024: €109.9 million) primarily related to research and development activities.
The Group had no contingent liabilities and no contingent assets as of June 30, 2025 and December 31, 2024.
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 June 30, |
|
For the six months ended June 30, |
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Short term employee benefits |
|
|
1,208,362 |
|
|
1,300,557 |
|
|
2,617,978 |
|
|
2,661,986 |
|
Post employee benefits |
|
|
62,837 |
|
|
62,130 |
|
|
133,012 |
|
|
126,189 |
|
Share-based payments |
|
|
3,091,132 |
|
|
2,088,045 |
|
|
5,952,342 |
|
|
3,400,920 |
|
Total |
|
|
4,362,331 |
|
|
3,450,732 |
|
|
8,703,332 |
|
|
6,189,095 |
|
The Group engages a management entity for the purpose of providing key management services and/or strategic advisory services to the Company. This management entity is considered a related party, as it provides key management advisory 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 €0.4 million in each of the six months ended June 30, 2025 and 2024, respectively.
The outstanding balances payable to key management personnel, or entities which they control, as per June 30, 2025 and December 31, 2024 were €0.8 million and €1.5 million, respectively.
22. Events after the reporting period
On July 22, 2025, 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 (i) 9,562,500 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 1,312,500 ordinary shares) and (ii) pre-funded warrants to purchase up to 500,000 ordinary shares. The offering closed on July 24, 2025, and the Company generated net proceeds of approximately $189 million, after deducting bank fees of approximately $12 million.
Signatories to the unaudited condensed consolidated interim financial statements
Leiden, August 12, 2025
Pharvaris N.V.
Board of Directors
|
|
B.A.E. Modig |
R.H. Glassman |
|
|
E. Björk |
J.G.C.P. Schikan |