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A.Operating results
You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes included elsewhere in this Annual Report. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly under the “ITEM 3. KEY INFORMATION—D. Risk factors” and “Cautionary Statement Regarding Forward-Looking Statements” sections.
Our audited consolidated financial statements are included elsewhere in this Annual Report. These financial statements are prepared in accordance with the IFRS Accounting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As permitted by the rules of the SEC for foreign private issuers, we do not reconcile our financial statements to U.S. GAAP.
Overview
We are a late-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for rare diseases with significant unmet need, initially focused on angioedema and other bradykinin-mediated diseases. Our first molecule, deucrictibant (previously referred to as PHA-022121 or PHA121), is a novel, oral, small-molecule bradykinin B2 receptor antagonist under development for the prevention or treatment of attacks due to bradykinin-mediated angioedema (AE-BK ), including hereditary angioedema (HAE) and acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH). Deucrictibant has the potential to address unmet medical needs by bringing improvements beyond the therapeutic profile of existing medicines and providing patients with quality of life and convenience that is superior to current standard-of-care. We believe deucrictibant has the potential to provide injectable-like efficacy™ 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 AE-BK by both preventing attacks from occurring, using an extended-release (XR) tablet formulation of deucrictibant (previously referred to as PHVS719), as well as treat the manifestations of attacks, using an immediate-release (IR) capsule formulation of deucrictibant (previously referred to as PHVS416). The XR tablet formulation is designed to maintain therapeutic levels for over 24 hours and to achieve a steady-state plasma concentration within 72 hours, supporting a once-daily dosing regimen. The IR capsule formulation is designed to rapidly reach therapeutic exposure in order to mitigate HAE attacks symptoms quickly and completely with a single oral dose.
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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 back). This may be particularly valued by children or adolescents who typically begin therapy with on-demand only and gradually move to prophylaxis as attack frequency increases (commonly after puberty).
We initiated RAPIDe-3, a global, pivotal Phase 3, placebo-controlled study to evaluate deucrictibant IR capsule (20 mg) for the on-demand treatment of attacks in people 12 years and older with HAE, in March 2024 and reported topline data in December 2025. Deucrictibant demonstrated a clinically differentiated profile by meeting the primary and all key secondary efficacy endpoints with statistical significance and was well tolerated. Pharvaris plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026 for the on-demand treatment of acute attacks of HAE.
In December 2024, we initiated CHAPTER-3, a global, pivotal, 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.
In addition, we are also running open-label extension studies in both on-demand (RAPIDe-2) and prophylactic (CHAPTER-4) settings to collect long-term safety and efficacy data in HAE patients. In October 2025, we initiated CREAATE, a global, pivotal Phase 3 study of to assess the efficacy and safety of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks.
A wide variety of events beyond our control, including natural or man-made disasters, power shortages, fires, extreme weather conditions, pandemics, epidemics or outbreaks of infectious diseases, political instability or other events could disrupt our business or operations or those of our development partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future. These events may cause businesses and government agencies to be shut down, supply chains to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental restrictions. Additionally, we are exposed to a variety of risks in the ordinary course of our business, including, but not limited to, foreign currency risk and interest rate risk. We regularly assess each of these risks to minimize any adverse effects on our business as a result of those factors. For a detailed discussion, see Note 17 to our consolidated financial statements included elsewhere in this Annual Report.
In addition, the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries with respect to the invasion of Ukraine and the conflict in the Middle East have created global security concerns that could result in regional conflicts and also adversely affect our ability to conduct ongoing and future clinical trials of our product candidates. For example, our RAPIDe-1 and CHAPTER-1 studies include a significant number of patients in Germany, Poland, and Bulgaria, and we have a patient in Israel. 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.
A discussion of our financial condition and results of operations for the year ended December 31, 2024 can be found in our annual report on Form 20-F, filed with the SEC on April 7, 2025.
Financial operations overview
Revenues
We did not record any revenues during the period covered by the historical financial information included in this Annual Report. We do not expect to recognize any 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 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 our product candidate XR, 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 ("SBC") expenses, bonus plans, travel and other related costs for research and development staff;
•nonclinical expenses, which include costs of our outsourced discovery and nonclinical development studies;
•clinical expenses, which includes costs of conducting and managing our sponsored clinical trials, including clinical investigator cost, costs of clinical sites, and costs for CROs assisting with our clinical development programs;
•manufacturing expenses, which include costs related to the manufacturing of active pharmaceutical ingredients and manufacturing of the products used in our clinical trials and research and development activities;
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•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
•license costs.
We expect our total research and development expenses to increase in 2026, driven by activities supporting the preparation and submission of the New Drug Application for IR to the U.S. FDA, as well as the continued development of our XR product candidate and our clinical study in AAE.
There is a risk that any clinical development or product discovery program may not result in commercial approval. To the extent that we fail to obtain approval to commercialize our product candidate in a timely manner, we would need to continue to conduct nonclinical studies or clinical trials over a longer period of time, and we anticipate that our research and development expenses may further increase.
Clinical development timelines and associated costs may vary significantly and the successful development of our product candidate 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.”
Certain 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 €4.6 million from General and Administrative expenses to Research and Development expenses for the year ended December 31, 2025. This reclassification had no impact on the total operating expenses, net loss, or loss per share.
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;
•travel related expenses; 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 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, €2.4 million of pre-commercial costs previously reported under “Other expenses” were determined to be more appropriately classified in other line items within the table. Variances that are not discussed below, are due to reclassifications and/or had no impact on the total General and Administrative expenses for the year ended December 31, 2025.
Selling and distribution expenses
Historically, we have not incurred any selling and distribution expenses. We anticipate incurring substantial selling and distribution expenses in future periods in order to establish a U.S. infrastructure for marketing and distribution, obtain supplies of active pharmaceutical ingredients, and manufacture commercial quantities of our product candidate.
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Share-based compensation expenses
In 2016, we implemented an Equity Incentive Plan, or the Plan 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, or the 2021 Plan, for employees, consultants and directors prior to the completion of our initial public offering. The 2021 Plan became effective upon our conversion from Pharvaris B.V. into Pharvaris N.V., which occurred prior to the consummation of our initial public offering. 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.
The SBC expense recorded for the years ended December 31, 2025, 2024 and 2023 were €19.1 million, €16.2 million and €10.7 million, respectively.
Comparison of the years ended December 31, 2024 and 2023
A discussion of the financial results for the year ended December 31, 2024 as compared to the year ended December 31, 2023 can be found in the section entitled “Item 5. Operating and Financial Review and Prospects—A. Operating Results— Financial operations overview—Comparison of the years ended December 31, 2024 and 2023” in our annual report on Form 20-F, filed with the SEC on April 7, 2025.
Comparison of the years ended December 31, 2025 and 2024
The following table summarizes our loss for the periods indicated:
For the year ended
December 31,
2025 2024 Change %
(in €)
Research and development expenses (124,478,334 ) (98,563,529 ) (25,914,805 ) 26 %
General and administrative expenses (45,344,598 ) (47,124,638 ) 1,780,040 (4 )%
Total operating expenses (169,822,932 ) (145,688,167 ) (24,134,765 ) 17 %
Finance income (expense) (3,888,564 ) 13,291,664 (17,180,228 ) (129 )%
Loss before income tax (173,711,496 ) (132,396,503 ) (41,314,993 ) 31 %
Income taxes (1,987,901 ) (1,825,024 ) (162,877 ) 9 %
Loss for the period (175,699,397 ) (134,221,527 ) (41,477,870 ) 31 %
Research and development expenses
For the year ended
December 31,
2025 2024 Change %
(in €)
Clinical expenses (67,744,537 ) (55,867,694 ) (11,876,843 ) 21 %
Personnel expenses (35,755,155 ) (27,767,184 ) (7,987,971 ) 29 %
Manufacturing costs (12,024,982 ) (9,434,537 ) (2,590,445 ) 27 %
Nonclinical expenses (7,485,648 ) (3,324,513 ) (4,161,135 ) 125 %
License costs (1,065,471 ) (1,592,687 ) 527,216 (33 )%
Intellectual property costs (402,541 ) (576,914 ) 174,373 (30 )%
Total research and development expenses (124,478,334 ) (98,563,529 ) (25,914,805 ) 26 %
Research and development expenses increased by €25.9 million in 2025, or 26%, from €98.6 million for the year ended December 31, 2024 to €124.5 million for the year ended December 31, 2025. The increase in research and development expenses was primarily driven by increased clinical and personnel expenditure.
For the years ended December 31, 2025 and 2024, clinical expenses were €67.7 million and €55.9 million, respectively. This represents an increase of €11.9 million, or 21%. The increase in clinical expenses is primarily due to higher expenses in the deucrictibant Phase 3 studies (IR, XR and AAE), although expenses for the IR program slowed down towards the data readout in December 2025, while XR and AAE continued enrolling patients through the end of 2025 (see project-specific table below).
For the years ended December 31, 2025 and 2024, personnel expenses were €35.8 million and €27.8 million, respectively. This represents an increase of €8.0 million, or 29%. The increase in personnel expenses is primarily driven by increases in salary, bonus and benefits expenses for existing employees and hiring new employees to support the three Phase 3 studies. The remaining increase in
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personnel expenses is driven by SBC expenses due to the new grants made during the period. SBC expense in the current period was €8.6 million versus €7.9 million in the prior period.
The following table summarizes our research and development expenses by project for the years ended December 31, 2025 and 2024:
For the year ended
December 31,
2025 2024 Change %
(in €)
Project-Specific Expenses
On-Demand (IR) (HAE - Phase 3) (28,227,615 ) (30,528,841 ) 2,301,226 (8 )%
Prophylaxis (XR) (HAE - Phase 3) (32,103,855 ) (27,033,364 ) (5,070,491 ) 19 %
AAE (AAE - Phase 3) (6,947,530 ) (212,533 ) (6,734,997 ) 3169 %
Unallocated Expenses
Personnel (35,755,155 ) (27,767,184 ) (7,987,971 ) 29 %
Other (21,444,179 ) (13,021,606 ) (8,422,573 ) 65 %
Total research and development expenses (124,478,334 ) (98,563,529 ) (25,914,805 ) 26 %
On-Demand (IR) project-specific expense decreased in the second half of 2025, due to completion of the RAPIDe-3 pivotal Phase 3 study.
Prophylaxis (XR) project-specific expense increased due to continued enrollment in the CHAPTER-3 pivotal Phase 3 study.
AAE project-specific expense increased during the current period due to the ramp-up of CREAATE, a global, pivotal Phase 3 study.
General and Administrative Expenses
For the year ended
December 31,
2025 2024 Change %
(in €)
Personnel expenses (23,139,822 ) (18,883,708 ) (4,256,114 ) 23 %
Professional fees (8,616,327 ) (7,757,750 ) (858,577 ) 11 %
Insurance, facilities and office expenses (5,957,027 ) (6,509,691 ) 552,664 (8 )%
Accounting, tax and auditing fees (2,626,525 ) (4,017,669 ) 1,391,144 (35 )%
Travel expenses (1,212,356 ) (2,129,631 ) 917,275 (43 )%
Consulting fees (103,848 ) (858,843 ) 754,995 (88 )%
Other expenses (3,688,693 ) (6,967,346 ) 3,278,653 (47 )%
General and administrative expenses (45,344,598 ) (47,124,638 ) 1,780,040 (4 )%
General and administrative expenses decreased by €1.8 million, or (4)% from €47.1 million for the year ended December 31, 2024 to €45.3 million for the year ended December 31, 2025. The decrease was primarily driven by an increase of €3.9 million in personnel and professional Fees, offset by €6.9 million across the remaining general and administrative expenses categories.
For the years ended December 31, 2025 and 2024, personnel expenses were €23.1 million and €18.9 million, respectively. This represents an increase of €4.3 million, or 23%. The increase was primarily driven by the transition from contractors to employees, higher salaries, bonuses, and benefits for existing staff, and the hiring of additional employees to support growth. Share-based compensation expense also increased as a result of equity awards granted to new and existing employees. Share-based compensation expense in the current-year period was €10.4 million compared to €8.3 million in the prior-year period.
Excluding the previously described reclassification of €4.6 million from General and Administrative expenses to Research and Development expenses, the €6.9 million decline was driven primarily by the absence of €0.7 million in one-time Investor Relations expenses associated with financing that was recorded in consulting fees, as well as a €0.8 million reduction in legal fees that was recorded in professional fees. The decrease also reflects a €1.2 million reduction in consulting costs that was recorded in accounting, tax and audit fees, resulting from the replacement of external contractors with internal employees, a €1.0 million decrease in implementation related expenditures, and a €0.9 million reduction in conference, event, and other administrative expenses.
Finance (expense) / income - net
Finance (expense) / income – net, was (€3.9) million for the year ended December 31, 2025, compared to €13.3 million in 2024, representing a change of €17.2 million. This variance was primarily driven by a €19.1 million reduction in the value of U.S. dollar–denominated bank balances due to foreign exchange exposure, as the U.S. dollar depreciated by approximately 12% against the euro in 2025, compared to a 6% appreciation in 2024, partially offset by a €1.1 million increase in interest income.
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Income taxes
The current period losses for which no deferred tax asset has been recognized, consists of the unrecognized tax effect of losses incurred in the principal Company in Switzerland. Following discussions with the Dutch tax authorities in November 2022, the Company concluded that foreign exchange results should be allocated to the principal Company in Switzerland. As a result, the current losses for the principal Company are partly exacerbated by the allocated foreign exchange results. The principal Company did not recognize the tax benefit of the losses incurred in previous years.
The Company and its subsidiaries have tax loss carry-forwards as of December 31, 2025 of approximately €643.0 million (2024: €449.8 million; 2023: €325.0 million), that are available for offsetting against future taxable profits of the Companies in which the losses arose. In the Netherlands, profits in a given year can be offset against tax loss carry forwards for an unlimited period of time. The amount of the offset is, however, limited to 50% of taxable income (in excess of €1.0 million). Under Swiss law, losses can be offset against future income or capital gains for seven years.
Critical accounting estimates and judgments
We believe that the following accounting policies involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our consolidated financial condition and results of our operations. See Note 2 to our consolidated financial statements included elsewhere in this Annual Report for a description of our other material accounting policies. The preparation of our consolidated financial statements in conformity with IFRS requires us to make estimates and judgments that affect the amounts reported in those financial statements and accompanying notes. Although we believe that the estimates we use are reasonable, due to the inherent uncertainty involved in making those estimates, actual results reported in future periods could differ from those estimates.
Share-based Compensation Arrangements
We adopted an equity-settled share-based compensation plan in 2016, pursuant to which certain participants are granted the right to acquire ordinary shares or RSUs of the Company. This plan has been superseded by the 2021 long term incentive plan. The grants made under these plans are accounted for in accordance with the policy as stated in Note 2.15 to our consolidated financial statements included elsewhere in this Annual Report. The total amount to be expensed is determined by reference to the fair value of the options or restricted stock units granted. The fair value of the options is measured at the date of grant using the Black-Scholes formula.
The use of the Black-Scholes formula requires use of certain assumptions relating to the expected option life, the volatility of stock price, the determination of an appropriate risk-free interest rate and expected dividends.
The input 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, March 12, August 1, April 15, April 11, April 11, November 15, April 6,
2025 2025 2024 2024 2024 2024 2023 2023
Number of options 75,000 555,000 75,000 230,000 70,000 485,000 90,000 846,000
Fair value of the options € 11.86 € 12.19 € 11.65 € 15.41 € 16.83 € 16.90 € 12.27 € 5.92
Fair value of the ordinary shares € 14.71 € 14.71 € 14.43 € 18.97 € 20.80 € 20.80 € 15.12 € 7.36
Exercise price € 14.74 € 14.74 € 14.43 € 18.97 € 20.80 € 20.80 € 15.12 € 7.36
Expected volatility (%) 105 % 105 % 100 % 100 % 105 % 100 % 100 % 100 %
Expected life (years) 5.5 6.1 6.1 6.1 5.5 6.1 6.1 6.1
Risk-free interest rate (%) 4.3 % 4.3 % 4.0 % 4.7 % 4.7 % 4.7 % 4.6 % 3.6 %
Expected volatility in 2025, 2024 and 2023, was based on the volatility of the Company and comparable peer group companies, while in prior periods expected volatility was based on an evaluation of the historical volatilities of comparable listed biotech-companies only. The expected life is based on Management’s best estimate of when the options will be exercised. The risk-free interest rate is based on the yield on US Government bonds depending on whether the exercise price is in euros or in US dollars. The expected dividend yield is zero considering the stage of the Company.
Research and development expenditures
Research and development expenses are currently not capitalized but are expensed because the criteria for capitalization are not met, see Note 2.16 and Note 3 to our consolidated financial statements included elsewhere in this Annual Report. At each balance sheet date, we estimate the level of services performed by the vendors and the associated costs incurred for the services performed. Although we do not expect the estimates to be materially different from amounts actually incurred, the understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in reporting amounts that are too high or too low in any particular period.
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B.Liquidity and capital resources
Since inception, we have incurred significant operating losses. We incurred losses of €175.7 million during the year ended December 31, 2025 and €134.2 million during the year ended December 31, 2024. 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 and pre-funded warrants to finance our operations and internal growth.
From inception through December 31, 2025, we have raised the following capital:
•issuance of 4,850,000 Common shares raising €0.2 million;
•issuance of 5,242,850 Series A preferred shares raising €14.9 million (net of transaction costs);
•issuance of 3,003,391 Series B-1 preferred shares raising €21.6 million (net of transaction costs);
•issuance of 4,646,756 Series B-2 preferred shares raising €34.2 million (net of transaction costs);
•issuance of 5,826,279 Series C preferred shares raising €67.2 million (net of transaction costs);
•issuance of 9,511,075 ordinary shares raising €146.2 million (net of transaction costs);
•issuance of 593,927 ordinary shares raising €9.3 million (net of transaction costs);
•issuance of 6,951,340 ordinary shares raising €64.1 million (net of transaction costs);
•issuance of 11,125,000 ordinary shares and 1,375,000 pre-funded warrants raising €261.6 million (net of transaction costs); and
•issuance of 9,562,500 ordinary shares and 500,000 pre-funded warrants raising €160.3 million (net of transaction costs).
On February 5, 2021, the Company became public by listing its ordinary shares on the Nasdaq Stock Exchange. On the same date all Series A preferred shares, Series B and Series C preferred shares were automatically converted to ordinary shares and 9,511,075 ordinary shares were issued. Together with the issuance of new ordinary shares, the par value of each ordinary share was increased from €0.01 to €0.12.
On March 1, 2022, we entered into a sales agreement (the "2022 Sales Agreement") with Leerink Partners LLC (formerly known as SVB Securities LLC), pursuant to which we may sell ordinary shares having an aggregate offering price of up to $75 million from time to time through Leerink Partners. On April 12, 2024, we terminated the 2022 Sales Agreement and entered into a new sales agreement with Leerink Partners, pursuant to which we may sell ordinary shares having an aggregate offering price of up to $175 million from time to time through Leerink Partners (the “2024 Sales Agreement”). In April 2024, we filed a Form F-3 ASR Registration Statement (the “F-3 ASR”) and prospectus with the Securities and Exchange Commission, allowing us to sell an unspecified amount of its securities. 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.
As of December 31, 2024, we have 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, LLC as commission in respect of such sales. The Company has not sold any securities under the April 2024 Sales Agreement.
In June, 2023, we 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 $70.0 million (€64.1 million).
During December 2023, we entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners LLC as underwriters, pursuant to which we 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 we generated net proceeds of $282.0 million (€261.6 million), after deducting bank fees of $18.0 million (€16.7 million). 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 share premium.
In July 2025, the Company entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners, LLC as representatives of the underwriters, pursuant to which the Company agreed to issue and sell (i) 9,562,500 ordinary shares, par value €0.12 per share and (ii) pre-funded warrants to purchase up to 500,000 ordinary shares in an underwritten offering. The offering closed on July 24, 2025, and the Company generated net proceeds of €160.3 million ($188.5 million), after deducting fees and expenses of €10.9 million ($12.8 million).
The pre-funded warrants were exercised in September 2025 for gross exercise proceeds of €0.004 million ($0.005 million) and resulted in issuance of 500,000 ordinary shares.
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As of December 31, 2025 we held cash and cash equivalents of €291.7 million. Of the cash on hand, €0.1 million relates to guarantees. We do not expect positive operating cash flows in the foreseeable future and remain dependent on additional financing to fund our research and development expenses, general and administrative expenses and financing costs. We believe that the available cash balances are sufficient to 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.
We have based our estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. For example, we may require additional capital resources due to underestimation of the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We may also need to raise additional funds more quickly if we choose to expand our development activities, our portfolio or if we consider acquisitions. Factors that could influence our future capital requirements and the timing thereof include:
•the progress and cost of our discovery and nonclinical development;
•the progress and cost of our clinical trials, including payments of patient cost, clinical investigator cost and payments to CROs that are assisting with our sponsored clinical trials, and other research and development activities;
•the cost and timing of obtaining regulatory approval to commence further clinical trials;
•the costs associated with any future investigator-sponsored clinical trials;
•the cost of filing, prosecuting, defending and enforcing any patent applications, claims, patents and other intellectual property rights;
•the cost and timing of obtaining sufficient quantities of our product candidates for clinical trials by establishing our contracted and/or own production capacities;
•the costs and expenditures associated with process optimizations and nonclinical and clinical manufacturing;
•the cost and timing to develop suitable formulations and manufacture final product;
•the terms and timing of any collaborative, licensing and other arrangements that we may establish;
•the cost of acquiring or licensing additional products or technologies, if any;
•the cost of preparing for launch and commercialization of our product candidates; and
•the cost of operating as a public company in the United States.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, convertible loans, warrants, collaborations or other means. We may consider raising additional capital to take advantage of favorable market conditions or other strategic considerations even if we have sufficient funds for planned operations.
To the extent that we raise additional funds by issuing and selling equity or equity-linked securities, shareholders will experience dilution. Debt financing, if available, may subject us to financial and other restrictive covenants that limit our ability to engage in activities that we may believe to be in our long-term best interests. Additional financing may not be available on acceptable terms, if at all. Capital may become difficult or impossible to obtain due to poor market or other conditions outside of our control (including wars, regional unrest, pandemics and epidemics). If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license other technologies or our clinical product candidate that we would prefer to develop and commercialize ourselves.
In addition, while we seek to minimize our exposure to third-party losses of our cash and cash equivalents, we hold our balances in a number of large financial institutions. However, these institutions are subject to risk of failure. For example, in March 2023, the Federal Deposit Insurance Corporation was appointed as receiver for Silicon Valley Bank ("SVB"). As of April 2, 2026, none of our cash and cash equivalents are held with SVB. All of our cash and cash equivalents are held with other large financial institutions, and we do not expect further developments with SVB to have a material impact on our cash and cash equivalents balance, expected results of operations, or financial performance for the foreseeable future. However, if there are issues in the wider financial system and if other financial institutions fail, our business and financial condition could be materially affected.
Cash Flows
Comparison for the years ended December 31, 2024 and December 31, 2023
A discussion of our cash flows for the year ended December 31, 2024 as compared to the year ended December 31, 2023 can be found in the section entitled “Item 5. Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Cash Flows—Comparison of the years ended December 31, 2024 and 2023” in our annual report on form 20-F, filed with the SEC on April 7, 2025.
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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 year ended
December 31,
2025 2024 Change %
(in €)
Net cash flows used in operating activities (137,073,634 ) (120,130,191 ) (16,943,443 ) 14 %
Net cash flows used in investing activities (164,619 ) (538,086 ) 373,467 (69 )%
Net cash flows provided by financing activities 160,607,219 2,676,555 157,930,664 5901 %
Net increase (decrease) in cash and cash equivalents 23,368,966 (117,991,722 ) 141,360,688 (120 )%
Cash and cash equivalents at beginning of period 280,728,037 391,231,637 (110,503,600 ) (28 )%
Effect of exchange rate changes (12,418,115 ) 7,488,122 (19,906,237 ) (266 )%
Cash and cash equivalents at end of period 291,678,888 280,728,037 10,950,851 4 %
Operating activities
Net cash flows used in operating activities reflect our results for the period adjusted for, among other things, depreciation, unrealized foreign exchange results, share-based compensation arrangements, changes in working capital and accruals.
Net cash used in operating activities was €137.1 million for the year ended December 31, 2025 and primarily consisted of a net loss before taxes of €173.7 million adjusted for share-based compensation of €19.1 million, net foreign exchange losses €11.7 million and finance income of (€0.4) million, an increase in other current assets of €9.9 million and increase in accrued liabilities of €7.1 million and other changes in net working capital.
Financing activities
Net cash flows provided by financing activities increased by €157.9 million from €2.7 million for the year ended December 31, 2024 to €160.6 million for the year ended December 31, 2025.
The net cash provided by financing activities for the year ended December 31, 2025 consisted primarily of the receipt of €160.6 million received from the sale of ordinary shares and pre-funded warrants, offset by transaction costs of €10.9 million.
Net cash provided by financing activities in the year ended December 31, 2024 consisted primarily of the gross proceeds related to the pre-funded warrants that were exercised in January 2024 that resulted in the issuance of 1,375,000 ordinary shares.
Disclosure of contractual obligations
The Group has entered into research and development commitments amounting to a total of €119.2 million as of December 31, 2025 (2024: €109.9 million). The amount for research and development commitments does not include potential milestone fees, sublicense fees, royalty fees, licensing maintenance fees, and reimbursement of patent maintenance costs that we may be required to pay under the BRAIN License.
Under the BRAIN License, up to €8.0 million in aggregate potential milestone payments remain outstanding. In addition, we will be required to pay low to medium single-digit tiered royalties on direct or indirect net sales of licensed products. The royalties that we are required to pay under this agreement may be reduced on a country-by-country and product-by-product basis if sales of a generic version of a product account for 1% or more of the relevant market. We have not included such potential obligations because they are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding this agreement and amounts that could become payable in the future under this agreement, please see “ITEM 4. INFORMATION ON THE COMPANY -- B. Business Overview-License Agreement.”
Service contracts
The commitments from service contracts mainly result from contracts with nonclinical and clinical CROs and CDMOs.
C.Research and development, patents and licenses, etc.
See “ITEM 4. INFORMATION ON THE COMPANY——B. Business Overview—Intellectual Property.”
D.Trend information
For a discussion of trend information, see “ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS.”
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E.Critical accounting estimates
Our consolidated financial statements are prepared in conformity with IFRS, as issued by the IASB. In preparing our consolidated financial statements, we make judgements, estimates and assumptions about the application of our accounting policies which affect the reported amounts of assets, liabilities, revenue and expenses. Our critical accounting judgements and sources of estimation uncertainty are described in Note 2.19 to our consolidated financial statements, which are included elsewhere in this Annual Report.
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