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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 2024
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 14, 2024, Pharvaris N.V. issued a press release reporting financial results and other business updates for the three and six months ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein. Exhibit 99.1 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act. Exhibits 99.2 and 99.3 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-273757, 333-277705 and 333-278650) and Form S-8 (Registration Number 333-252897) of Pharvaris N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
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 13, 2024 |
By: |
/s/ Berndt Modig |
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Name: |
Berndt Modig |
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Title: |
Chief Executive Officer |
Exhibit 99.1
Pharvaris Reports Second Quarter 2024 Financial Results and Provides Business Update
•Alignment with regulatory agencies following End-of-Phase 2 meetings for the prophylactic development of deucrictibant; global startup activities of CHAPTER-3, pivotal Phase 3 study of deucrictibant for the prevention of hereditary angioedema (HAE) attacks, underway
•Enrollment of RAPIDe-3, a global pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, progressing as planned
•Executing from a strong financial position with cash and cash equivalents of €344 million as of June 30, 2024
ZUG, Switzerland, August 14, 2024 – Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the financial results for the second quarter ended June 30, 2024, and provided a business update.
“Pharvaris supports the view of the HAE community that achievement of complete control of the disease and normalization of lives of people with HAE through long-term prophylaxis are the main goals of treatment in HAE. Obtaining alignment with regulatory agencies on our proposed global clinical development plan for deucrictibant as a prophylactic HAE treatment is an important milestone for the company,” said Berndt Modig, Chief Executive Officer of Pharvaris. “RAPIDe-3 enrollment is progressing as planned, and CHAPTER-3 start-up activities are underway globally. Diligent execution of the RAPIDe-3 and the CHAPTER-3 pivotal clinical studies remains our top priority, with the goal of establishing differentiated data packages for deucrictibant in both on-demand and prophylaxis. Data from the ongoing open-label extensions in both on-demand and prophylaxis, as well as supplemental analyses from the RAPIDe-1 and CHAPTER-1 studies, will be presented at upcoming medical meetings. Pharvaris continues to operate from a strong financial position with a disciplined approach as we aspire to bring best-in-class oral therapies to the HAE community.”
Recent Business Updates
Development Pipeline
•Alignment with regulatory authorities achieved regarding design of CHAPTER-3, a global Phase 3 study of deucrictibant for the prophylactic treatment of HAE. Pharvaris sought feedback and obtained alignment on key elements of a Phase 3 clinical study design during End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA), the European Union Committee for Medicinal Products for Human Use (CHMP), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). CHAPTER-3 is planned as a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablets for the prophylactic treatment of HAE attacks. The study aims to enroll approximately 81 adult and adolescent participants (12 years and older) with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablets (40 mg/day) or placebo once daily for 24 weeks. The primary endpoint of the study is to evaluate the efficacy of deucrictibant compared to placebo for prophylaxis against angioedema attacks as measured by the time-normalized number of investigator-confirmed HAE attacks during the 24-week treatment period. Other objectives of the study include evaluating additional clinically relevant outcomes, deucrictibant’s safety and tolerability, pharmacokinetics, and its impact on health-related quality of life in the prophylactic setting.
•Advancing RAPIDe-3 (NCT06343779), a global Phase 3 clinical study. RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsules for the on-demand treatment of HAE attacks is progressing as planned with a target enrollment of approximately 120 participants. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of Progression (EoP) in attack symptoms, substantial symptom relief, complete attack resolution, and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S) and by Angioedema Symptom Rating Scale (AMRA).
•Best-in-class properties of deucrictibant further substantiated at recent medical congresses. Pharvaris presented data highlighting deucrictibant’s unique pharmacological and clinical properties at the CIIC Spring 2023 Conference, the 20th Annual Congress of International Drug Discovery Science and Technology (IDDST); the 2024 Eastern Allergy Conference (EAC); and the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. As part of the additional analyses presented at these congresses, one data highlight was a post-hoc analysis
of the RAPIDe-1 data set which showed that 78.6% of the HAE attacks treated with deucrictibant in this study resolved within 24 hours. The full posters and presentation slides are available on the Investors section of the Pharvaris website at https://ir.pharvaris.com/news-events/publications.
Corporate
•David Nassif, J.D., permanently named Chief Legal Officer. Mr. Nassif has acted as interim Chief Legal Officer since June 2024 and was permanently appointed to the position, effective August 1, 2024, in addition to his role as the Chief Financial Officer of the Company. He holds a B.S. in finance and management information systems with honors from the University of Virginia and a J.D. from the University of Virginia School of Law.
Upcoming Investor Events and Presentations
•2024 Wedbush PacGrow Healthcare Conference. New York, NY, August 13-14, 2024.
Format: Panel Presentation: “HAE Ya! The Changing Face of the HAE Therapeutic Landscape”
Participants: Berndt Modig, CEO
Date, time: Wednesday, August 14, 2024, 2:30 p.m. EDT
•Morgan Stanley 22nd Annual Global Healthcare Conference. New York, NY, September 4-6, 2024.
Format: Fireside Chat
Presenters: Berndt Modig, CEO, Morgan Conn, Ph.D., CBO, and David Nassif, J.D., CFO & CLO
Date, time: Friday, September 6, 2024, 11:30 a.m. EDT
Live audio webcasts of the Morgan Stanley presentation 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.
Financials
Second Quarter 2024 Financial Results
•Liquidity Position. Cash and cash equivalents were €344 million as of June 30, 2024, compared to €391 million for December 31, 2023.
•Research and Development (R&D) Expenses. R&D expenses were €23.1 million for the quarter ended June 30, 2024, compared to €14.7 million for the quarter ended June 30, 2023.
•General and Administrative (G&A) Expenses. G&A expenses were €11.3 million for the quarter ended June 30, 2024, compared to €7.8 million for the quarter ended June 30, 2023.
•Loss for the year. Loss for the second quarter was €29.7 million, resulting in basic and diluted loss per share of €0.55 for the quarter ended June 30, 2024, compared to €21.9 million, or basic and diluted loss per share of €0.63, for the quarter ended June 30, 2023.
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, oral small-molecule bradykinin B2 receptor antagonist. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to treat the manifestations of an HAE attack and to prevent the occurrence of attacks. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an immediate-release capsule to enable rapid onset of activity for on-demand treatment, and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment.
About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of HAE effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both on-demand and prophylactically. With positive data in both Phase 2 on-demand and prophylaxis studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks in the coming months. 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 (PHVS416) and deucrictibant extended-release tablets (PHVS719), 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 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, such as the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; 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 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, our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war; 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 External and Internal Communications
maggie.beller@pharvaris.com
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, 2024 and 2023 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 2023, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2023 (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
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 bradykinin-mediated angioedema and other bradykinin-mediated diseases. Our first molecule, deucrictibant (PHA121, PHA-022121), is a novel, small-molecule bradykinin B2 receptor antagonist for the treatment of hereditary angioedema (“HAE”) attacks. Bradykinin B2 receptor inhibition is a clinically validated mechanism for the treatment of HAE, as demonstrated by icatibant, which is a bradykinin B2 receptor antagonist approved in Europe in 2008 and in the United States in 2011 (branded as FIRAZYR). Deucrictibant demonstrated over 4000-fold selectivity for the bradykinin B2 receptor when compared to approximately 170 other molecular targets, including the bradykinin B1 receptor.
Currently approved HAE therapies are limited by burdensome routes of administration (injection or infusion), variable efficacy, or side effects. We believe deucrictibant has the potential to provide an efficacious, well-tolerated, and easy-to-administer option for both on-demand and prophylactic treatments of HAE attacks in the form of (i) an immediate-release capsule, to enable rapid achievement of therapeutic exposure, and (ii) an extended-release tablet, to provide protection from attacks in a single daily dose. We believe deucrictibant may address a broader range of bradykinin-mediated angioedema types than plasma kallikrein inhibitors. This expectation is based on our understanding that deucrictibant will block all pathways that involve bradykinin-mediated activation of the bradykinin B2 receptor, and subsequent bradykinin-mediated angioedema. In contrast, plasma kallikrein inhibitors only target plasma kallikrein-mediated bradykinin generation. Therefore, by blocking the action of bradykinin at the B2 receptor, we can prevent its aberrant signaling regardless of the pathway that generates bradykinin.
In our completed Phase 1 trials to date, we have observed that deucrictibant was orally bioavailable and well-tolerated at all doses studied, with approximately dose-proportional exposure. We also have successfully demonstrated proof-of-concept through a clinical pharmacodynamics ("PD") assessment with the bradykinin challenge, which had been utilized as a validated surrogate assessment for dose selection in the icatibant development program.
We have demonstrated clinical efficacy and tolerability in a Phase 2 study (RAPIDe-1) treating attacks of HAE. The data allowed us to compare the projected therapeutic performance of deucrictibant with that of icatibant. However, we have not conducted a head-to-head comparison of icatibant to deucrictibant in a clinical study. We plan to efficiently progress deucrictibant through clinical development for on-demand and prophylactic use with our on-demand immediate-release product candidate and prophylactic extended-release product candidate, respectively. We commenced our RAPIDe-1 Phase 2 clinical trial of deucrictibant in February 2021 and reported topline Phase 2 data for the on-demand treatment of attacks in people with HAE in December 2022. In March, 2024, we initiated a pivotal Phase 3 clinical study of deucrictibant immediate-release capsules (20 mg) and placebo to evaluate the efficacy and safety of deucrictibant in the on-demand treatment of HAE attacks for people (12 years and older) living with HAE.
Currently we are planning to conduct a registration-directed prophylactic trial with HAE patients who will be randomized to receive extended-release deucrictibant tablets (PHVS719) or placebo once daily to assess safety and efficacy of deucrictibant with extended-release formulation. In addition, we also plan to run an open-label extension study in the prophylactic setting with both rollover and non-rollover subjects to collect long-term safety data.
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.
In addition, unforeseen global events, such as the armed conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war, could adversely impact our business and operations. The invasion of Ukraine and the Hamas attack against Israel and the retaliatory measures that have been taken, or could be taken in the future, by the United States, the NATO alliance, and other countries 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 studies include a significant number of patients in Germany, Poland and Bulgaria, and one patient in Israel. A further escalation of the conflict in Ukraine and the Middle-East may potentially impact our ability to complete our ongoing and planned clinical trials in these countries on a timely basis, or at all. Clinical trials in these countries could be suspended or terminated, and we may be prevented from obtaining data on patients already enrolled at affected sites. Our ability to conduct clinical trials in these regions may also become restricted under applicable sanctions laws, which may require us to identify alternative trial sites. Any of the foregoing could impede the execution of our clinical development plans, which could materially harm our business.
In August 2022, the U.S. Food and Drug Administration (“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 we conduct an additional long-term rodent toxicology study and update the Investigator’s Brochure. We 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.
Additional trials may be required by the FDA, EMA or other regulators even with positive data from RAPIDe-1 and CHAPTER-1.
Recently, we sought feedback and reached alignment on key elements of a proposed Phase 3 pivotal prophylactic study (the "Phase 3 Clinical Program”) of deucrictibant during End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA), the European Union Committee for Medicinal Products for Human Use (CHMP), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablets for the prophylactic treatment of HAE. The study aims to enroll 81 adult and adolescent participants (over 12 years old) with HAE and randomize them in a 2:1 ratio to receive deucrictibant (40 mg/day) or placebo daily for 24 weeks. The primary endpoint of the study is to evaluate the efficacy of deucrictibant compared to placebo for prophylaxis against angioedema attacks as measured by the time-normalized number of investigator-confirmed HAE attacks during the 24-week treatment period. Other objectives of the study include evaluating the safety and tolerability, the pharmacokinetics, and the impact on health-related quality of life of deucrictibant in a prophylactic setting. In the CHAPTER-1 Phase 2 study, deucrictibant significantly reduced the monthly attack rate, the occurrence of moderate and severe attacks, the attacks treated with on-demand medications, and was well-tolerated.
Recent Developments
David Nassif was appointed as Chief Legal Officer, effective August 1, 2024. Mr. Nassif has acted as interim Chief Legal Officer since June 2024 and will now permanently hold this position going forward, in addition to his role as the
Chief Financial Officer of the Company. He holds a B.S. in finance and management information systems with honors from the University of Virginia and a J.D. from the University of Virginia School of Law.
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 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 immediate-release deucrictibant capsules (PHVS416) and PHVS719. 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 PHVS416 and PHVS719, 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 conducting and managing 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 Contract Research Organizations ("CROs") assisting with our clinical development programs;
•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;
•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 continue to increase in 2024 as we continue to focus on the development of our product candidates PHVS416 and PHVS719, as well as explore potential expansion programs. We anticipate that research and development expenses will continue to increase as we continue to progress PHVS416 and PHVS719 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 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” 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.
Selling and distribution expenses
Historically, we have not incurred any selling and distribution expenses. If our product candidates are approved for registration and marketing, we anticipate incurring substantial selling and distribution expenses in future periods in order to establish an infrastructure for marketing and distribution, obtain supplies of active pharmaceutical ingredients, and manufacture commercial quantities of our product candidate.
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 officer’s 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 continue to incur additional costs associated with being a public company in the United States.
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, 2024 and 2023 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.
Comparison of the three months ended June 30, 2024 and June 30, 2023.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Research and development expenses |
|
|
(23,067,934 |
) |
|
|
(14,681,935 |
) |
|
|
(8,385,999 |
) |
|
|
57 |
% |
General and administrative expenses |
|
|
(11,314,067 |
) |
|
|
(7,773,430 |
) |
|
|
(3,540,637 |
) |
|
|
46 |
% |
Total operating expenses |
|
|
(34,382,001 |
) |
|
|
(22,455,365 |
) |
|
|
(11,926,636 |
) |
|
|
53 |
% |
Operating loss |
|
|
(34,382,001 |
) |
|
|
(22,455,365 |
) |
|
|
(11,926,636 |
) |
|
|
53 |
% |
Finance income/(expense) |
|
|
4,721,551 |
|
|
|
651,670 |
|
|
|
4,069,881 |
|
|
|
625 |
% |
Loss before tax |
|
|
(29,660,450 |
) |
|
|
(21,803,695 |
) |
|
|
(7,856,755 |
) |
|
|
36 |
% |
Income taxes |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
23,555 |
|
|
|
(25 |
)% |
Loss for the period |
|
|
(29,731,073 |
) |
|
|
(21,897,873 |
) |
|
|
(7,833,200 |
) |
|
|
36 |
% |
Revenues
We did not generate any revenues for the three months ended June 30, 2024 and June 30, 2023.
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Clinical expenses |
|
|
(15,065,644 |
) |
|
|
(7,629,432 |
) |
|
|
(7,436,212 |
) |
|
|
97 |
% |
Personnel expenses |
|
|
(6,450,500 |
) |
|
|
(4,544,244 |
) |
|
|
(1,906,256 |
) |
|
|
42 |
% |
Manufacturing costs |
|
|
(1,572,017 |
) |
|
|
(736,427 |
) |
|
|
(835,590 |
) |
|
|
113 |
% |
Nonclinical expenses |
|
|
130,020 |
|
|
|
(1,667,811 |
) |
|
|
1,797,831 |
|
|
|
(108 |
)% |
Intellectual Property costs |
|
|
(109,793 |
) |
|
|
(104,021 |
) |
|
|
(5,772 |
) |
|
|
6 |
% |
Total research and development expenses |
|
|
(23,067,934 |
) |
|
|
(14,681,935 |
) |
|
|
(8,385,999 |
) |
|
|
57 |
% |
Research and development expenses increased from €14.7 million for the three months ended June 30, 2023 to €23.1 million for the three months ended June 30, 2024. The increase in the research and development expenses is primarily due to increased clinical expenses and increased personnel related costs.
For the three months ended June 30, 2024 and 2023, clinical expenses were €15.1 million and €7.6 million, respectively. The increase in clinical expenses is primarily due to higher expenses on the on demand Phase 3 Clinical Program.
For the three months ended June 30, 2024 and 2023, personnel expenses were €6.5 million and €4.5 million, respectively. The increase is primarily due to the increased headcount to support the increased clinical and regulatory activities and yearly merit pay adjustments. Personnel expenses in this period in 2024 included an amount of €1.8 million of share-based compensation versus €1.3 million in the prior-year period.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Personnel expenses |
|
|
(4,407,998 |
) |
|
|
(3,434,343 |
) |
|
|
(973,655 |
) |
|
|
28 |
% |
Professional fees |
|
|
(2,155,727 |
) |
|
|
(1,294,705 |
) |
|
|
(861,022 |
) |
|
|
67 |
% |
Facilities, communication and office expenses |
|
|
(1,466,955 |
) |
|
|
(1,419,334 |
) |
|
|
(47,621 |
) |
|
|
3 |
% |
Accounting, tax and auditing fees |
|
|
(850,599 |
) |
|
|
(537,961 |
) |
|
|
(312,638 |
) |
|
|
58 |
% |
Consulting fees |
|
|
(732,951 |
) |
|
|
(126,447 |
) |
|
|
(606,504 |
) |
|
|
480 |
% |
Travel expenses |
|
|
(399,111 |
) |
|
|
(455,717 |
) |
|
|
56,606 |
|
|
|
(12 |
)% |
Other expenses |
|
|
(1,300,726 |
) |
|
|
(504,923 |
) |
|
|
(795,803 |
) |
|
|
158 |
% |
Total general and administrative expenses |
|
|
(11,314,067 |
) |
|
|
(7,773,430 |
) |
|
|
(3,540,637 |
) |
|
|
46 |
% |
General and administrative expenses increased from €7.8 million for the three months ended June 30, 2023 to €11.3 million for the three months ended June 30, 2024. The increase in general and administrative expenses was primarily due to increased personnel expenses, professional fees, consulting fees and other expenses.
For the three months ended June 30, 2024 and 2023, personnel expenses were €4.4 million and €3.4 million, respectively. The increase is primarily due to an increase in share-based compensation expense from €1.5 million in the prior-year quarter to €2.1 million in the current-year quarter. The share-based compensation expense increase is the result of additional hiring during the current quarter, including a Chief Financial Officer, a Vice President, Controller and a Vice President of Financial Planning and Analysis. These additional hires also resulted in increased salary and benefit costs.
For the three months ended June 30, 2024 and 2023, professional fees were €2.1 million and €1.3 million respectively. The increase is primarily due to increased legal fees associated with corporate and SEC regulatory disclosures and governance, and commercial and market access consulting activities related to launch preparation.
For the three months ended June 30, 2024 and 2023, consulting fees were €0.7 million and €0.1 million respectively. The increase is primarily due to one-time payments to two financial advisory and investor relations firms.
For the three months ended June 30, 2024 and 2023, other expenses were €1.3 million and €0.5 million respectively. The increase is primarily due to increased commercial and market access outside activities related to product launch preparation.
Finance income - net / (expense)
Finance income for the three months ended June 30, 2024 and 2023 were €4.7 million and €0.7 million, respectively. The amount primarily relates to unrealized foreign exchange (losses)/income, which is mostly the result of translating the Company’s bank balances held in USD to EUR, which is the functional 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, 2024 relates to the Company's U.S. and Dutch fiscal unity.
Comparison of the six months ended June 30, 2024 and June 30, 2023.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Research and development expenses |
|
|
(41,580,950 |
) |
|
|
(28,426,366 |
) |
|
|
(13,154,584 |
) |
|
|
46 |
% |
General and administrative expenses |
|
|
(21,112,910 |
) |
|
|
(15,105,026 |
) |
|
|
(6,007,884 |
) |
|
|
40 |
% |
Total operating expenses |
|
|
(62,693,860 |
) |
|
|
(43,531,392 |
) |
|
|
(19,162,468 |
) |
|
|
44 |
% |
Operating loss |
|
|
(62,693,860 |
) |
|
|
(43,531,392 |
) |
|
|
(19,162,468 |
) |
|
|
44 |
% |
Finance income/(expense) |
|
|
5,299,771 |
|
|
|
(842,595 |
) |
|
|
6,142,366 |
|
|
|
(729 |
)% |
Loss before tax |
|
|
(57,394,089 |
) |
|
|
(44,373,987 |
) |
|
|
(13,020,102 |
) |
|
|
29 |
% |
Income taxes |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
|
|
(200,905 |
) |
|
|
130 |
% |
Loss for the period |
|
|
(57,749,829 |
) |
|
|
(44,528,822 |
) |
|
|
(13,221,007 |
) |
|
|
30 |
% |
Revenues
We did not generate any revenues for the six months ended June 30, 2024 and June 30, 2023.
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Clinical expenses |
|
|
(22,387,056 |
) |
|
|
(12,497,879 |
) |
|
|
(9,889,177 |
) |
|
|
79 |
% |
Personnel expenses |
|
|
(11,630,976 |
) |
|
|
(8,761,944 |
) |
|
|
(2,869,032 |
) |
|
|
33 |
% |
Manufacturing costs |
|
|
(4,135,971 |
) |
|
|
(2,643,513 |
) |
|
|
(1,492,458 |
) |
|
|
56 |
% |
Nonclinical expenses |
|
|
(1,705,446 |
) |
|
|
(4,419,009 |
) |
|
|
2,713,563 |
|
|
|
(61 |
)% |
License costs |
|
|
(1,500,000 |
) |
|
|
— |
|
|
|
(1,500,000 |
) |
|
|
100 |
% |
Intellectual Property costs |
|
|
(221,501 |
) |
|
|
(104,021 |
) |
|
|
(117,480 |
) |
|
|
— |
|
Total research and development expenses |
|
|
(41,580,950 |
) |
|
|
(28,426,366 |
) |
|
|
(13,154,584 |
) |
|
|
46 |
% |
Research and development expenses increased from €28.4 million for the six months ended June 30, 2023 to €41.6 million for the six months ended June 30, 2024. The increase in the research and development expenses is primarily due to increased clinical expenses and increased personnel expenses as well as the payment of a license fee to Analyticon Discovery GmbH.
For the six months ended June 30, 2024 and 2023, clinical expenses were €22.4 million and €12.5 million, respectively. The increase in clinical expenses is primarily due to higher expenses on the on demand Phase 3 Clinical Program.
For the six months ended June 30, 2024 and 2023, personnel expenses were €11.6 million and €8.8 million respectively. The increase is primarily due to the increased headcount and yearly merit pay adjustments. Personnel expenses in this period in 2024 included an amount of €2.9 million of share-based compensation expense versus €2.5 million in the prior-year period.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
% |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
|
|
Personnel expenses |
|
|
(7,678,193 |
) |
|
|
(6,735,927 |
) |
|
|
(942,266 |
) |
|
|
14 |
% |
Professional fees |
|
|
(3,332,956 |
) |
|
|
(2,177,175 |
) |
|
|
(1,155,781 |
) |
|
|
53 |
% |
Facilities, communication and office expenses |
|
|
(3,147,222 |
) |
|
|
(2,910,607 |
) |
|
|
(236,615 |
) |
|
|
8 |
% |
Accounting, tax and auditing fees |
|
|
(2,104,685 |
) |
|
|
(897,314 |
) |
|
|
(1,207,371 |
) |
|
|
135 |
% |
Consulting fees |
|
|
(859,476 |
) |
|
|
(304,316 |
) |
|
|
(555,160 |
) |
|
|
182 |
% |
Travel expenses |
|
|
(1,023,140 |
) |
|
|
(778,450 |
) |
|
|
(244,690 |
) |
|
|
31 |
% |
Other expenses |
|
|
(2,967,238 |
) |
|
|
(1,301,237 |
) |
|
|
(1,666,001 |
) |
|
|
128 |
% |
Total general and administrative expenses |
|
|
(21,112,910 |
) |
|
|
(15,105,026 |
) |
|
|
(6,007,884 |
) |
|
|
40 |
% |
General and administrative expenses increased from €15.1 million for the six months ended June 30, 2023, to €21.1 million for the six months ended June 30, 2024. The increase in general and administrative expenses was primarily due to increased personnel expenses, professional fees, consulting fees and other expenses.
For the six months ended June 30, 2024 and 2023, personnel expenses were €7.7 million and €6.7 million, respectively. The increase is primarily due to an increase in share-based compensation expense from €2.8 million in the prior-year quarter to €3.4 million in the current-year quarter. The share-based compensation expense increase is the result of additional hiring during the current quarter, including a Chief Financial Officer, a Vice President, Controller and a Vice President of Financial Planning and Analysis. These additional hires also resulted in increased salary and benefit costs.
For the six months ended June 30, 2024 and 2023, professional expenses were €3.3 million and €2.2 million, respectively. The increase is primarily due to increased legal fees associated with corporate and SEC regulatory disclosures and governance, and commercial and market access consulting activities related to launch preparation.
For the six months ended June 30, 2024 and 2023, accounting, tax and auditing fees were €2.1 million and €0.9 million, respectively. The increase is primarily due to increased contractor fees, SOX implementation and financing-related expenses.
For the six months ended June 30, 2024 and 2023, other expenses were €3.0 million and €1.3 million, respectively. he increase is primarily due to increased commercial and market access outside activities related to product launch preparation.
Finance income - net / (expense)
Finance income - net / (expense) for the six months ended June 30, 2024 and 2023 was €4.7 million and (€0.8) million, respectively, a change of €6.1 million. The change primarily relates to unrealized foreign exchange income, which is the result of translating the group’s bank balances held in USD to EUR.
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, 2024 and 2023, we incurred losses of €57.7 million and €44.5 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.
On June 30, 2024, 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, 2024 and December 31, 2023, the total number of issued and fully paid shares was 54,007,711 and 52,290,212, respectively. On June 30, 2024, the issued share capital totaled €6.5 million (2023: €4.9 million). On December 31, 2023, the issued share capital totaled €6.3 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.
To date, we have relied solely on the issuance of equity securities to finance our operations and internal growth. On March 1, 2022, we entered into a sales agreement (the "2022 Sales Agreement") with Leerink Partners (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, allowing us 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.
As of June 30, 2024, we have sold a total of 593,927 ordinary shares under the 2022 Sales Agreement and the April 2024 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.
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 approximately $70 million (€64.2 million).
During December 2023, we entered into an underwriting agreement with Morgan Stanley & Co. LLC and Leerink Partners 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). The pre-funded warrants were exercised in January 2024 for gross exercise proceeds of $0.01 million and resulted 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.
As of June 30, 2024 we held cash and cash equivalents of €343.6 million. Of the cash on hand, €0.07 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, 2024 amounted to €95.4 million, primarily related to research and development contracts.
Cash Flows
Comparison for the six months ended June 30, 2024 and 2023.
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, |
|
|
2024 |
|
|
2023 |
|
Change |
|
|
% |
|
|
€ |
|
|
€ |
|
€ |
|
|
|
|
Net cash flows used in operating activities |
|
(51,914,977 |
) |
|
|
(45,687,465 |
) |
|
(6,227,512 |
) |
|
|
14 |
% |
Net cash flows used in investing activities |
|
(70,844 |
) |
|
|
(54,114 |
) |
|
(16,730 |
) |
|
|
31 |
% |
Net cash flows provided by (used in) financing activities |
|
1,118,466 |
|
|
|
63,784,231 |
|
|
(62,665,765 |
) |
|
|
(98 |
)% |
Net change in cash and cash equivalents |
|
(50,867,355 |
) |
|
|
18,042,652 |
|
|
(68,910,007 |
) |
|
|
(382 |
)% |
Cash and cash equivalents at the beginning of the period |
|
391,231,637 |
|
|
|
161,837,429 |
|
|
229,394,208 |
|
|
|
142 |
% |
Effect of exchange rate changes |
|
3,210,104 |
|
|
|
(691,322 |
) |
|
3,901,426 |
|
|
|
(564 |
)% |
Cash and cash equivalents at the end of the period |
|
343,574,386 |
|
|
|
179,188,759 |
|
|
164,385,627 |
|
|
|
92 |
% |
Operating activities
Net cash flows used in operating activities reflects 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 €51.9 million for the six months ended June 30, 2024, an increase of €6.2 million compared to €45.7 million for the six months ended June 30, 2023. Operating cash is adjusted for non-cash items such as the increase in share-based compensation of €1.0 million and a change in net foreign exchange (gains) losses of €3.9 million. Working capital decreased by €51.2 million, in part due to the change of current assets by €46.7 million and increased accrued liabilities of €4.8 million.
Financing activities
Net cash flows provided by financing activities decreased by €62.7 million from €63.8 million for the six months ended June 30, 2023, to €1.1 million for the six months ended June 30, 2024. The decrease is primarily due to €0.6 million financing proceeds in 2024 as compared to €64.1 million from financing proceeds in 2023.
Off-Balance Sheet Arrangements
As of June 30, 2024, 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, 2024, 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 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 PHVS416 (immediate-release deucrictibant capsules) and PHVS719 (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, such as the COVID-19 pandemic, 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 PHVS416 and PHVS719 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 PHVS416 and PHVS719 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 successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting;
•our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act or a foreign private issuer; and
•changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war.
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.
Pharvaris N.V.
Unaudited Condensed Consolidated Interim Financial Statements
For the six months ended June 30, 2024
Contents
|
|
Unaudited condensed consolidated statement of Loss and Other Comprehensive 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 income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
Notes |
|
€ |
|
€ |
|
€ |
|
€ |
|
Research and development expenses |
|
3 |
|
|
(23,067,934 |
) |
|
(14,681,935 |
) |
|
(41,580,950 |
) |
|
(28,426,366 |
) |
General and administrative expenses |
|
4 |
|
|
(11,314,067 |
) |
|
(7,773,430 |
) |
|
(21,112,910 |
) |
|
(15,105,026 |
) |
Total operating expenses |
|
|
|
(34,382,001 |
) |
|
(22,455,365 |
) |
|
(62,693,860 |
) |
|
(43,531,392 |
) |
Finance income/(expense) |
|
6 |
|
|
4,721,551 |
|
|
651,670 |
|
|
5,299,771 |
|
|
(842,595 |
) |
Loss before income tax |
|
|
|
(29,660,450 |
) |
|
(21,803,695 |
) |
|
(57,394,089 |
) |
|
(44,373,987 |
) |
Income taxes |
|
7 |
|
|
(70,623 |
) |
|
(94,178 |
) |
|
(355,740 |
) |
|
(154,835 |
) |
Net Loss |
|
|
|
(29,731,073 |
) |
|
(21,897,873 |
) |
|
(57,749,829 |
) |
|
(44,528,822 |
) |
Other comprehensive income (Loss) |
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified to profit or loss: |
|
|
|
|
|
|
|
|
|
|
Exchange gains/(losses) arising on translation of foreign operations |
|
|
|
21,106 |
|
|
1,624 |
|
|
56,739 |
|
|
(28,885 |
) |
Total comprehensive loss attributable to: |
|
|
|
|
|
|
|
|
|
|
Equity holders of the Company |
|
|
|
(29,709,967 |
) |
|
(21,896,249 |
) |
|
(57,693,090 |
) |
|
(44,557,707 |
) |
Loss per share attributable to the equity holders of the Company during the periods |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
19 |
|
|
(0.55 |
) |
|
(0.63 |
) |
|
(1.07 |
) |
|
(1.30 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated statement of financial position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
Notes |
|
|
€ |
|
|
€ |
|
Assets |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
8 |
|
|
|
258,551 |
|
|
|
223,678 |
|
Right of use assets |
|
|
9 |
|
|
|
133,981 |
|
|
|
231,893 |
|
Deferred tax assets |
|
|
7 |
|
|
|
346,621 |
|
|
|
387,529 |
|
Current assets |
|
|
|
|
|
|
|
|
|
Receivables |
|
|
10 |
|
|
|
515,304 |
|
|
|
423,486 |
|
Other current assets |
|
|
11 |
|
|
|
5,921,334 |
|
|
|
5,580,704 |
|
Cash and cash equivalents |
|
|
12 |
|
|
|
343,574,386 |
|
|
|
391,231,637 |
|
Current tax receivable |
|
|
|
|
|
1,095,589 |
|
|
|
615,538 |
|
Total assets |
|
|
|
|
|
351,845,766 |
|
|
|
398,694,465 |
|
|
|
|
|
|
|
|
|
|
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
Share capital |
|
|
13 |
|
|
|
6,480,925 |
|
|
|
6,274,833 |
|
Share premium |
|
|
|
|
|
619,047,642 |
|
|
|
615,811,986 |
|
Other reserves |
|
|
|
|
|
31,965,648 |
|
|
|
27,894,796 |
|
Currency translation reserve |
|
|
|
|
|
42,155 |
|
|
|
(14,584 |
) |
Accumulated loss |
|
|
|
|
|
(324,767,645 |
) |
|
|
(265,918,628 |
) |
Total equity |
|
|
|
|
|
332,768,725 |
|
|
|
384,048,403 |
|
|
|
|
|
|
|
|
|
|
|
Long term liabilities |
|
|
|
|
|
|
|
|
|
Non-current lease liability |
|
|
9 |
|
|
|
43,750 |
|
|
|
43,564 |
|
Current liabilities |
|
|
|
|
|
|
|
|
|
Trade and other payables |
|
|
14 |
|
|
|
2,968,446 |
|
|
|
2,909,725 |
|
Accrued liabilities |
|
|
15 |
|
|
|
15,857,612 |
|
|
|
11,067,510 |
|
Current lease liability |
|
|
9 |
|
|
|
96,628 |
|
|
|
195,341 |
|
Current tax payable |
|
|
|
|
|
110,605 |
|
|
|
429,922 |
|
Total liabilities |
|
|
|
|
|
19,077,041 |
|
|
|
14,646,062 |
|
Total equity and liabilities |
|
|
|
|
|
351,845,766 |
|
|
|
398,694,465 |
|
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, 2024 and June 30, 2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital |
|
|
Share premium |
|
|
Other reserves |
|
|
Currency translation reserve |
|
|
Accumulated losses |
|
|
Total Equity |
|
|
|
Notes |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Balance at January 1, 2023 |
|
|
|
|
|
4,057,976 |
|
|
|
289,177,197 |
|
|
|
20,169,459 |
|
|
|
43,290 |
|
|
|
(164,188,892 |
) |
|
|
149,259,030 |
|
Net Loss |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
(44,528,822 |
) |
|
|
(44,528,822 |
) |
Issue of share capital |
|
|
|
|
|
834,161 |
|
|
|
63,250,792 |
|
|
— |
|
|
— |
|
|
— |
|
|
|
64,084,953 |
|
Transaction costs on issue of shares |
|
|
|
|
— |
|
|
|
(209,870 |
) |
|
— |
|
|
— |
|
|
— |
|
|
|
(209,870 |
) |
Currency translation reserve |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
|
(28,885 |
) |
|
— |
|
|
|
(28,885 |
) |
Settlement of share-based payments |
|
|
|
|
|
6,614 |
|
|
|
1,213,329 |
|
|
|
(1,219,943 |
) |
|
|
— |
|
|
|
(145,653 |
) |
|
|
(145,653 |
) |
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
— |
|
|
|
5,299,814 |
|
|
— |
|
|
|
— |
|
|
|
5,299,814 |
|
Balance at June 30, 2023 |
|
|
|
|
|
4,898,751 |
|
|
|
353,431,448 |
|
|
|
24,249,330 |
|
|
|
14,405 |
|
|
|
(208,863,367 |
) |
|
|
173,730,567 |
|
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 |
|
|
13 |
|
|
|
165,000 |
|
|
|
(165,000 |
) |
|
|
12,609 |
|
|
|
— |
|
|
|
— |
|
|
|
12,609 |
|
Transaction costs on issue of shares, net |
|
|
|
|
|
— |
|
|
|
592,000 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
592,000 |
|
Currency translation reserve |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
56,739 |
|
|
|
— |
|
|
|
56,739 |
|
Settlement of share-based payments |
|
|
|
|
|
41,092 |
|
|
|
2,808,656 |
|
|
|
(2,230,060 |
) |
|
|
— |
|
|
|
(1,099,188 |
) |
|
|
(479,500 |
) |
Share-based payments |
|
|
18 |
|
|
|
— |
|
|
|
— |
|
|
|
6,288,303 |
|
|
|
— |
|
|
|
— |
|
|
|
6,288,303 |
|
Balance at June 30, 2024 |
|
|
|
|
|
6,480,925 |
|
|
|
619,047,642 |
|
|
|
31,965,648 |
|
|
|
42,155 |
|
|
|
(324,767,645 |
) |
|
|
332,768,725 |
|
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,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
|
Notes |
|
€ |
|
|
€ |
|
Operating activities |
|
|
|
|
|
|
|
|
Loss before tax |
|
|
|
|
(57,394,089 |
) |
|
|
(44,373,987 |
) |
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
|
|
|
|
|
|
|
|
Share-based payment expense |
|
18 |
|
|
6,288,303 |
|
|
|
5,299,814 |
|
Depreciation expense |
|
4 |
|
|
135,032 |
|
|
|
123,593 |
|
Net foreign exchange (gain) loss |
|
6 |
|
|
(3,146,528 |
) |
|
|
928,172 |
|
Finance income |
|
6 |
|
|
(2,160,801 |
) |
|
|
(85,173 |
) |
|
|
|
|
|
|
|
|
|
Changes in working capital: |
|
|
|
|
|
|
|
|
Decrease (increase) in receivables |
|
|
|
|
(91,786 |
) |
|
|
48,169 |
|
Increase in other current assets |
|
|
|
|
(300,336 |
) |
|
|
(4,855,629 |
) |
Increase (decrease) trade and other payables |
|
|
|
|
58,721 |
|
|
|
(1,522,938 |
) |
Increase (decrease) in accrued liabilities |
|
|
|
|
3,690,913 |
|
|
|
(948,917 |
) |
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
|
|
|
(1,114,758 |
) |
|
|
(383,953 |
) |
Received interest |
|
|
|
|
2,120,352 |
|
|
|
83,384 |
|
Net cash flows used in operating activities |
|
|
|
|
(51,914,977 |
) |
|
|
(45,687,465 |
) |
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
8 |
|
|
(70,844 |
) |
|
|
(54,114 |
) |
Net cash flows used in investing activities |
|
|
|
|
(70,844 |
) |
|
|
(54,114 |
) |
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from issue of shares |
|
13 |
|
|
632,737 |
|
|
|
64,084,953 |
|
Transaction costs on issue of shares, net |
|
|
|
|
592,968 |
|
|
|
(210,473 |
) |
Payment of principal portion of lease liabilities |
|
9 |
|
|
(107,239 |
) |
|
|
(90,249 |
) |
Net cash flows provided by financing activities |
|
|
|
|
1,118,466 |
|
|
|
63,784,231 |
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
|
|
(50,867,355 |
) |
|
|
18,042,652 |
|
Cash and cash equivalents at the beginning of the period |
|
|
|
|
391,231,637 |
|
|
|
161,837,429 |
|
Effect of exchange rate changes |
|
|
|
|
3,210,104 |
|
|
|
(691,322 |
) |
Cash and cash equivalents at the end of the period |
|
12 |
|
|
343,574,386 |
|
|
|
179,188,759 |
|
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, 2024, and December 31, 2023, and for the three and six months ended June 30, 2024 and 2023 were authorized for issue in accordance with a resolution of the directors on August 13, 2024.
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 |
|
2024 |
|
2023 |
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% |
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, 2023 (“last annual financial statements”). These unaudited condensed consolidated interim financial statements do not include all the information required for a complete set of financial statements prepared in accordance with IFRS as issued by the IASB.
However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group’s financial position and performance since the last annual financial statements.
The unaudited condensed consolidated interim financial statements have been prepared on a historical cost basis. Unless otherwise stated, the unaudited condensed consolidated interim financial statements are presented in euros and all values are rounded to the nearest EUR (€), except per share amounts.
2.2 Going concern
Management assessed the Company’s ability to fund its operations for a period of at least one year after the date the financial statements are issued. Management has not identified a material uncertainty relating to the Company’s ability to continue as a going concern for a period of at least a year from the issuance of these financial statements. 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, 2023.
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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Clinical expenses |
|
|
(15,065,644 |
) |
|
(7,629,432 |
) |
|
(22,387,056 |
) |
|
(12,497,879 |
) |
Personnel expenses (Note 5) |
|
|
(6,450,500 |
) |
|
(4,544,244 |
) |
|
(11,630,976 |
) |
|
(8,761,944 |
) |
Manufacturing costs |
|
|
(1,572,017 |
) |
|
(736,427 |
) |
|
(4,135,971 |
) |
|
(2,643,513 |
) |
Nonclinical expenses |
|
|
130,020 |
|
|
(1,667,811 |
) |
|
(1,705,446 |
) |
|
(4,419,009 |
) |
License costs |
|
|
— |
|
|
— |
|
|
(1,500,000 |
) |
|
— |
|
Intellectual Property costs |
|
|
(109,793 |
) |
|
(104,021 |
) |
|
(221,501 |
) |
|
(104,021 |
) |
|
|
|
(23,067,934 |
) |
|
(14,681,935 |
) |
|
(41,580,950 |
) |
|
(28,426,366 |
) |
Research and development expenses are currently not capitalized but are recorded in the unaudited 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.
Nonclinical expenses include costs of our outsourced discovery, preclinical and nonclinical development studies.
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.
4. General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Personnel expenses (Note 5) |
|
|
(4,407,998 |
) |
|
(3,434,343 |
) |
|
(7,678,193 |
) |
|
(6,735,927 |
) |
Professional fees |
|
|
(2,155,727 |
) |
|
(1,294,705 |
) |
|
(3,332,956 |
) |
|
(2,177,175 |
) |
Facilities, communication & office expenses |
|
|
(1,466,955 |
) |
|
(1,419,334 |
) |
|
(3,147,222 |
) |
|
(2,910,607 |
) |
Accounting, tax and auditing fees |
|
|
(850,599 |
) |
|
(537,961 |
) |
|
(2,104,685 |
) |
|
(897,314 |
) |
Consulting fees |
|
|
(732,951 |
) |
|
(126,447 |
) |
|
(859,476 |
) |
|
(304,316 |
) |
Travel expenses |
|
|
(399,111 |
) |
|
(455,717 |
) |
|
(1,023,140 |
) |
|
(778,450 |
) |
Other expenses |
|
|
(1,300,726 |
) |
|
(504,923 |
) |
|
(2,967,238 |
) |
|
(1,301,237 |
) |
|
|
|
(11,314,067 |
) |
|
(7,773,430 |
) |
|
(21,112,910 |
) |
|
(15,105,026 |
) |
Since 2022, the Group entered into a number of short-term rental arrangements, the expenses are included in "Other expenses".
Depreciation expense in the six months ended June 30, 2024 and 2023 was €0.1 million and €0.1 million, respectively, which related to property, plant and equipment and leases and is included in the 'Other expenses' line.
5. Personnel expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Wages and salaries |
|
|
(5,953,069 |
) |
|
(4,618,862 |
) |
|
(11,023,525 |
) |
|
(8,823,246 |
) |
Pension charges |
|
|
(357,282 |
) |
|
(271,140 |
) |
|
(751,915 |
) |
|
(560,023 |
) |
Other social security charges |
|
|
(660,711 |
) |
|
(371,658 |
) |
|
(1,245,426 |
) |
|
(814,788 |
) |
Share-based payments |
|
|
(3,887,436 |
) |
|
(2,716,927 |
) |
|
(6,288,303 |
) |
|
(5,299,814 |
) |
|
|
|
(10,858,498 |
) |
|
(7,978,587 |
) |
|
(19,309,169 |
) |
|
(15,497,871 |
) |
The average number of staff (in FTEs) employed by the Group in the six months ended June 30, 2024 was 83 (2023: 68).
6. Finance income/(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Foreign exchange differences |
|
|
2,616,719 |
|
|
667,710 |
|
|
3,138,970 |
|
|
(927,768 |
) |
Interest income over bank balances |
|
|
2,114,635 |
|
|
(11,161 |
) |
|
2,178,556 |
|
|
95,366 |
|
Other finance expenses |
|
|
(9,803 |
) |
|
(4,879 |
) |
|
(17,755 |
) |
|
(10,193 |
) |
|
|
|
4,721,551 |
|
|
651,670 |
|
|
5,299,771 |
|
|
(842,595 |
) |
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, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
The tax expense over the three and six months ended June 30, 2024 and 2023 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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Loss before income tax |
|
|
(29,660,450 |
) |
|
(21,803,695 |
) |
|
(57,394,089 |
) |
|
(44,373,987 |
) |
Income tax against statutory rate in The Netherlands (25.8%) |
|
|
7,652,396 |
|
|
5,625,353 |
|
|
14,807,675 |
|
|
11,448,489 |
|
Effect of tax rates in other countries |
|
|
(4,260,352 |
) |
|
(3,135,934 |
) |
|
(8,412,880 |
) |
|
(6,380,538 |
) |
Deferred tax assets recognition effects |
|
|
(3,224,214 |
) |
|
(2,473,007 |
) |
|
(6,007,203 |
) |
|
(4,989,138 |
) |
Non-deductible expenses |
|
|
(238,743 |
) |
|
(110,591 |
) |
|
(573,609 |
) |
|
(233,648 |
) |
Prior period adjustments |
|
|
290 |
|
|
— |
|
|
(169,723 |
) |
|
— |
|
Total tax charge |
|
|
(70,623 |
) |
|
(94,178 |
) |
|
(355,740 |
) |
|
(154,835 |
) |
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, 2024 was (0.6%), compared to (0.3%) for the six months ended June 30, 2023.
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, 2024 |
|
|
December 31, 2023 |
|
Net book value |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
223,678 |
|
|
|
193,474 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Depreciation expenses |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
258,551 |
|
|
|
223,678 |
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative depreciation |
|
€ |
|
|
€ |
|
As of January 1, |
|
|
(125,373 |
) |
|
|
(65,526 |
) |
Depreciation |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
(161,344 |
) |
|
|
(125,373 |
) |
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative Costs |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
349,051 |
|
|
|
259,000 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Balance at end of period |
|
|
419,895 |
|
|
|
349,051 |
|
During the six months ended June 30, 2024, the Group acquired assets with a cost of €0.1 million (December 31, 2023: €0.1 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, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
231,893 |
|
|
|
432,965 |
|
Addition |
|
|
— |
|
|
|
(3,302 |
) |
Depreciation charges |
|
|
(99,062 |
) |
|
|
(197,770 |
) |
Impact of transaction of foreign currency |
|
|
1,150 |
|
|
|
— |
|
Balance at end of period |
|
|
133,981 |
|
|
|
231,893 |
|
The following table provides information about the Group’s lease liabilities at June 30, 2024:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Office leases |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Total lease liability |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Current portion |
|
|
(96,628 |
) |
|
|
(195,341 |
) |
Non-current portion |
|
|
(43,750 |
) |
|
|
(43,564 |
) |
Office leases consist of a lease agreement entered into on June 1, 2021 for office space in Lexington, United States of America (the " U.S."), which has ended as of June 30, 2024 and a lease entered into on December 1, 2022, for
offices in Leiden, The Netherlands. Both leases have lease terms of three years and were assessed as being long-term.
Cash outflows related to leases during the six months ended June 30, 2024 and 2023, were €0.1 million and €0.09 million, respectively.
10. Receivables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Current tax receivable |
|
|
1,095,589 |
|
|
|
615,538 |
|
VAT receivables |
|
|
515,304 |
|
|
|
423,486 |
|
|
|
|
1,610,893 |
|
|
|
1,039,024 |
|
11. Other current assets
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Prepayments |
|
|
5,921,334 |
|
|
|
4,959,889 |
|
Other assets |
|
|
— |
|
|
|
620,815 |
|
|
|
|
5,921,334 |
|
|
|
5,580,704 |
|
Prepayments mainly relate to prepaid insurance, sign-on bonus to personnel, prepaid research and development expenses and rent.
Other assets for the year ended December 31, 2023, primarily consisted of deferred transaction costs related to the Group’s in-process equity financing (refer to note 13). The Company deferred the transaction costs related to any in-process financing. Upon recognition of the equity instruments, the related transaction costs are deducted from share premium.
12. Cash and cash equivalents
Cash and cash equivalents comprise of cash in bank and are not subject to any restriction.
13. Equity
On June 30, 2024, 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, 2024 and December 31, 2023, the total number of issued and fully paid shares was 54,007,711 and 52,290,212, respectively. On June 30, 2024, the issued share capital totaled €6.5 million (2023: €4.9 million). On December 31, 2023, the issued share capital totaled €6.3 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, 2024, 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, 2024 |
|
|
December 31, 2023 |
|
|
|
Number of shares |
|
|
Number of shares |
|
Ordinary shares |
|
|
54,007,711 |
|
|
|
52,290,212 |
|
|
|
|
54,007,711 |
|
|
|
52,290,212 |
|
14. Trade and other payables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Trade payables |
|
|
2,968,446 |
|
|
|
2,909,725 |
|
|
|
|
2,968,446 |
|
|
|
2,909,725 |
|
15. Accrued liabilities
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Consulting, professional and audit liability |
|
|
1,933,366 |
|
|
|
351,064 |
|
Clinical accrued liabilities |
|
|
8,154,946 |
|
|
|
1,832,590 |
|
Manufacturing accrued liabilities |
|
|
1,108,601 |
|
|
|
2,079,900 |
|
Nonclinical accrued liabilities |
|
|
618,128 |
|
|
|
493,907 |
|
Personnel related accruals |
|
|
3,594,600 |
|
|
|
5,892,087 |
|
Other accrued liabilities |
|
|
447,971 |
|
|
|
417,962 |
|
|
|
|
15,857,612 |
|
|
|
11,067,510 |
|
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, 2023.
17. Fair values
Fair values of cash and cash equivalents, trade receivables, trade payables, and other current liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.
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 long term incentive plan (“LTIP”).
Set out below is an overview of changes in the Stock Options and Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
RSUs |
|
|
|
Outstanding options |
|
|
Weighted average exercise price |
|
|
Outstanding RSUs |
|
|
|
|
|
|
$ |
|
|
|
|
Outstanding January 1, 2024 |
|
|
3,830,652 |
|
|
|
9.46 |
|
|
|
1,033,814 |
|
Granted |
|
|
785,000 |
|
|
|
21.68 |
|
|
|
531,129 |
|
Exercised (Vested and Settled) |
|
|
(234,694 |
) |
|
|
2.29 |
|
|
|
(157,989 |
) |
Forfeited |
|
|
(159,687 |
) |
|
|
15.80 |
|
|
|
(127,543 |
) |
Outstanding June 30, 2024 |
|
|
4,221,271 |
|
|
|
13.29 |
|
|
|
1,279,411 |
|
On April 11, 2024, a total of 70,000 stock options were granted to members of the Board of Directors with an exercise price of $22.31 per share with a final exercise date of April 11, 2034, 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 April 11, 2024, a total of 485,000 stock options were granted to members of key management with an exercise price of $22.31 per share with a final exercise date of April 11, 2034, 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.
On April 15, 2024 a total of 230,000 stock options were granted to a member of key management with an exercise price of $20.15 per share with a final exercise date of April 15, 2034, 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, 2024, a total number of 4,221,271 stock options are exercisable (June 30, 2023: 2,065,270).
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
April 15, 2024 |
|
April 11, 2024 |
|
April 11, 2024 |
|
Number of options |
|
|
230,000 |
|
|
485,000 |
|
|
70,000 |
|
Fair value of the options |
|
$ |
16.37 |
|
$ |
18.12 |
|
$ |
18.05 |
|
Fair value of the ordinary shares |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Exercise price |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Expected volatility (%) |
|
|
100 |
% |
|
100 |
% |
|
105 |
% |
Expected life (years) |
|
|
6.1 |
|
|
6.1 |
|
|
5.5 |
|
Risk-free interest rate (%) |
|
|
4.7 |
% |
|
4.7 |
% |
|
4.7 |
% |
Expected dividend yield |
|
|
— |
|
|
— |
|
|
— |
|
During the six months ended June 30, 2024 a total of 281,644 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.
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 six months of 2024 were: January 2 ($25.87), February 1 ($29.95), March 1 ($24.16), April 11 ($22.31), April 15 ($20.15), May 1 ($24.57) and June 1 ($17.71), respectively.
During the six months ended June 30, 2024, 226,150 RSUs were issued to existing and newly joining 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, 2024, 23,335 RSUs were issued to members of the Board of Directors. The RSUs shall vest on the 12-month anniversary of the vesting start date.
For the six months ended June 30, 2024, the Group recognized €6.3 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, 2023: €5.3 million).
19. Basic and diluted loss per share
Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of issued and outstanding ordinary shares during the three and six months ended June 30, 2024 and 2023.
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, |
|
|
|
2024 |
|
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
|
€ |
|
€ |
|
€ |
|
Net Loss |
|
|
(29,731,073 |
) |
|
|
(21,897,873 |
) |
|
(57,749,829 |
) |
|
(44,528,822 |
) |
Weighted average number of ordinary shares outstanding |
|
|
53,939,597 |
|
|
|
34,556,017 |
|
|
53,843,789 |
|
|
34,191,993 |
|
Basic and diluted loss per share |
|
|
(0.55 |
) |
|
|
(0.63 |
) |
|
(1.07 |
) |
|
(1.30 |
) |
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, 2024 amounted to €95.4 million, (December 31, 2023: €49 million) primarily related to research and development commitments.
The Group had no contingent liabilities and no contingent assets as of June 30, 2024 and December 31, 2023.
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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Short term employee benefits |
|
|
1,300,557 |
|
|
1,092,741 |
|
|
2,661,986 |
|
|
2,176,182 |
|
Post employee benefits |
|
|
62,130 |
|
|
43,090 |
|
|
126,189 |
|
|
93,521 |
|
Share-based payments |
|
|
2,088,045 |
|
|
1,699,794 |
|
|
3,400,920 |
|
|
3,224,788 |
|
Total |
|
|
3,450,732 |
|
|
2,835,625 |
|
|
6,189,095 |
|
|
5,494,491 |
|
Refer to note 18 for disclosures on the share-based payments related to RSUs and Options granted to key management during the six months ended June 30, 2024.
The Group engages two management entities for the purpose of providing key management services to the Group. These management entities are considered related parties, as they provide key management services and key management personnel which have key management functions within these entities. Certain key management personnel are also shareholders of the Company.
The aggregate amount of expense recognized in the unaudited condensed consolidated interim financial statements related to these related parties were €0.3 million and €0.6 million in the three and six months ended June 30, 2024 (2023: €0.3 million; €0.5 million), respectively.
The outstanding balances payable to key management personnel, or entities which they control, as per six months ended June 30, 2024 and December 31, 2023, were €0.6 million and €1.4 million, respectively.
22. Events after the reporting period
The Company has evaluated subsequent events through August 13, 2024, which is the date the condensed consolidated interim financial statements were authorized for issuance, and did not identify any significant event after reporting period that needs to be disclosed.
Signatories to the unaudited condensed consolidated interim financial statements
Leiden, August 13, 2024
Pharvaris N.V.
Board of Directors
|
|
B.A.E. Modig |
R.H. Glassman |
|
|
E. Björk |
J.G.C.P. Schikan |
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v3.24.2.u1
Condensed consolidated statement of loss and other comprehensive income - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Profit or loss [abstract] |
|
|
|
|
Research and development expenses |
€ (23,067,934)
|
€ (14,681,935)
|
€ (41,580,950)
|
€ (28,426,366)
|
General and administrative expenses |
(11,314,067)
|
(7,773,430)
|
(21,112,910)
|
(15,105,026)
|
Total operating expenses |
(34,382,001)
|
(22,455,365)
|
(62,693,860)
|
(43,531,392)
|
Finance income/(expense) |
4,721,551
|
651,670
|
5,299,771
|
(842,595)
|
Loss before income tax |
(29,660,450)
|
(21,803,695)
|
(57,394,089)
|
(44,373,987)
|
Income taxes |
(70,623)
|
(94,178)
|
(355,740)
|
(154,835)
|
Net Loss |
(29,731,073)
|
(21,897,873)
|
(57,749,829)
|
(44,528,822)
|
Items that may be reclassified to profit or loss: |
|
|
|
|
Exchange gains/(losses) arising on translation of foreign operations |
21,106
|
1,624
|
56,739
|
(28,885)
|
Total comprehensive loss attributable to: |
|
|
|
|
Equity holders of the Company |
€ (29,709,967)
|
€ (21,896,249)
|
€ (57,693,090)
|
€ (44,557,707)
|
Loss per share attributable to the equity holders of the Company during the periods |
|
|
|
|
Basic loss per share |
€ (0.55)
|
€ (0.63)
|
€ (1.07)
|
€ (1.3)
|
Diluted loss per share |
€ (0.55)
|
€ (0.63)
|
€ (1.07)
|
€ (1.3)
|
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v3.24.2.u1
Condensed consolidated statement of financial position - EUR (€)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Non-current assets |
|
|
Property, plant and equipment |
€ 258,551
|
€ 223,678
|
Right of use assets |
133,981
|
231,893
|
Deferred tax assets |
346,621
|
387,529
|
Current assets |
|
|
Receivables |
515,304
|
423,486
|
Other current assets |
5,921,334
|
5,580,704
|
Cash and cash equivalents |
343,574,386
|
391,231,637
|
Current tax receivable |
1,095,589
|
615,538
|
Total assets |
351,845,766
|
398,694,465
|
Equity |
|
|
Share capital |
6,480,925
|
6,274,833
|
Share premium |
619,047,642
|
615,811,986
|
Other reserves |
31,965,648
|
27,894,796
|
Currency translation reserve |
42,155
|
(14,584)
|
Accumulated loss |
(324,767,645)
|
(265,918,628)
|
Total equity |
332,768,725
|
384,048,403
|
Long term liabilities |
|
|
Non-current lease liability |
43,750
|
43,564
|
Current liabilities |
|
|
Trade and other payables |
2,968,446
|
2,909,725
|
Accrued liabilities |
15,857,612
|
11,067,510
|
Current lease liability |
96,628
|
195,341
|
Current tax payable |
110,605
|
429,922
|
Total liabilities |
19,077,041
|
14,646,062
|
Total equity and liabilities |
€ 351,845,766
|
€ 398,694,465
|
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v3.24.2.u1
Condensed consolidated statement of changes in equity - EUR (€)
|
Total |
Share capital [member] |
Share premium [member] |
Other reserves [member] |
Currency translation reserve [member] |
Accumulated losses [member] |
Beginning balance at Dec. 31, 2022 |
€ 149,259,030
|
€ 4,057,976
|
€ 289,177,197
|
€ 20,169,459
|
€ 43,290
|
€ (164,188,892)
|
Net Loss |
(44,528,822)
|
|
|
|
|
(44,528,822)
|
Issue of share capital |
64,084,953
|
834,161
|
63,250,792
|
|
|
|
Transaction costs on issue of shares |
(209,870)
|
|
(209,870)
|
|
|
|
Currency translation reserve |
(28,885)
|
|
|
|
(28,885)
|
|
Settlement of share-based payments |
(145,653)
|
6,614
|
1,213,329
|
(1,219,943)
|
|
(145,653)
|
Share-based payments |
5,299,814
|
|
|
5,299,814
|
|
|
Ending balance at Jun. 30, 2023 |
173,730,567
|
4,898,751
|
353,431,448
|
24,249,330
|
14,405
|
(208,863,367)
|
Beginning balance at Dec. 31, 2023 |
384,048,403
|
6,274,833
|
615,811,986
|
27,894,796
|
(14,584)
|
(265,918,628)
|
Net Loss |
(57,749,829)
|
|
|
|
|
(57,749,829)
|
Issue of share capital |
12,609
|
165,000
|
(165,000)
|
12,609
|
|
|
Transaction costs on issue of shares |
592,000
|
|
592,000
|
|
|
|
Currency translation reserve |
56,739
|
|
|
|
56,739
|
|
Settlement of share-based payments |
(479,500)
|
41,092
|
2,808,656
|
(2,230,060)
|
|
(1,099,188)
|
Share-based payments |
6,288,303
|
|
|
6,288,303
|
|
|
Ending balance at Jun. 30, 2024 |
€ 332,768,725
|
€ 6,480,925
|
€ 619,047,642
|
€ 31,965,648
|
€ 42,155
|
€ (324,767,645)
|
X |
- DefinitionThe amount of change in equity resulting from transactions and other events, other than those changes resulting from transactions with owners in their capacity as owners.
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v3.24.2.u1
Condensed consolidated statement of cash flows $ in Millions |
6 Months Ended |
Jun. 30, 2024
EUR (€)
|
Jun. 30, 2023
EUR (€)
|
Operating activities |
|
|
Loss before tax |
€ (57,394,089)
|
€ (44,373,987)
|
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
|
|
Share-based payment expense |
6,288,303
|
5,299,814
|
Depreciation expense |
135,032
|
123,593
|
Net foreign exchange (gain) loss |
(3,146,528)
|
928,172
|
Finance income |
(2,160,801)
|
(85,173)
|
Changes in working capital: |
|
|
Decrease (increase) in receivables |
(91,786)
|
48,169
|
Increase in other current assets |
(300,336)
|
(4,855,629)
|
Increase (decrease) trade and other payables |
58,721
|
(1,522,938)
|
Increase (decrease) in accrued liabilities |
3,690,913
|
(948,917)
|
Income taxes paid |
(1,114,758)
|
(383,953)
|
Received interest |
2,120,352
|
83,384
|
Net cash flows used in operating activities |
(51,914,977)
|
(45,687,465)
|
Investing activities |
|
|
Purchase of property, plant and equipment |
(70,844)
|
(54,114)
|
Net cash flows used in investing activities |
(70,844)
|
(54,114)
|
Financing activities |
|
|
Proceeds from issue of shares |
632,737
|
64,084,953
|
Transaction costs on issue of shares ,net |
592,968
|
(210,473)
|
Payment of principal portion of lease liabilities |
(107,239)
|
(90,249)
|
Net cash flows provided by financing activities |
1,118,466
|
63,784,231
|
Net (decrease) increase in cash and cash equivalents |
(50,867,355)
|
18,042,652
|
Cash and cash equivalents at the beginning of the period |
391,231,637
|
161,837,429
|
Effect of exchange rate changes |
3,210,104
|
(691,322)
|
Cash and cash equivalents at the end of the period |
€ 343,574,386
|
€ 179,188,759
|
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v3.24.2.u1
Corporate and Group information
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Corporate And Group Information [Abstract] |
|
Corporate and Group information |
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, 2024, and December 31, 2023, and for the three and six months ended June 30, 2024 and 2023 were authorized for issue in accordance with a resolution of the directors on August 13, 2024. 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 |
|
2024 |
|
2023 |
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% |
The ultimate parent company of the Group is Pharvaris N.V., which is based in the Netherlands.
|
v3.24.2.u1
Summary of significant accounting policies
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of voluntary change in accounting policy [abstract] |
|
Summary of significant accounting policies |
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, 2023 (“last annual financial statements”). These unaudited condensed consolidated interim financial statements do not include all the information required for a complete set of financial statements prepared in accordance with IFRS as issued by the IASB. However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group’s financial position and performance since the last annual financial statements. The unaudited condensed consolidated interim financial statements have been prepared on a historical cost basis. Unless otherwise stated, the unaudited condensed consolidated interim financial statements are presented in euros and all values are rounded to the nearest EUR (€), except per share amounts. 2.2 Going concern Management assessed the Company’s ability to fund its operations for a period of at least one year after the date the financial statements are issued. Management has not identified a material uncertainty relating to the Company’s ability to continue as a going concern for a period of at least a year from the issuance of these financial statements. 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, 2023. 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.
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v3.24.2.u1
Research and development expenses
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Detailed Information Research And Development Expenses [Abstract] |
|
Research and development expenses |
3. Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Clinical expenses |
|
|
(15,065,644 |
) |
|
(7,629,432 |
) |
|
(22,387,056 |
) |
|
(12,497,879 |
) |
Personnel expenses (Note 5) |
|
|
(6,450,500 |
) |
|
(4,544,244 |
) |
|
(11,630,976 |
) |
|
(8,761,944 |
) |
Manufacturing costs |
|
|
(1,572,017 |
) |
|
(736,427 |
) |
|
(4,135,971 |
) |
|
(2,643,513 |
) |
Nonclinical expenses |
|
|
130,020 |
|
|
(1,667,811 |
) |
|
(1,705,446 |
) |
|
(4,419,009 |
) |
License costs |
|
|
— |
|
|
— |
|
|
(1,500,000 |
) |
|
— |
|
Intellectual Property costs |
|
|
(109,793 |
) |
|
(104,021 |
) |
|
(221,501 |
) |
|
(104,021 |
) |
|
|
|
(23,067,934 |
) |
|
(14,681,935 |
) |
|
(41,580,950 |
) |
|
(28,426,366 |
) |
Research and development expenses are currently not capitalized but are recorded in the unaudited 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. Nonclinical expenses include costs of our outsourced discovery, preclinical and nonclinical development studies. 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.
|
X |
- DefinitionThe disclosure of research and development expense. [Refer: Research and development expense]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
General and administrative expenses
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Detailed Information General And Administrative Expenses [Abstract] |
|
General and administrative expenses |
4. General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Personnel expenses (Note 5) |
|
|
(4,407,998 |
) |
|
(3,434,343 |
) |
|
(7,678,193 |
) |
|
(6,735,927 |
) |
Professional fees |
|
|
(2,155,727 |
) |
|
(1,294,705 |
) |
|
(3,332,956 |
) |
|
(2,177,175 |
) |
Facilities, communication & office expenses |
|
|
(1,466,955 |
) |
|
(1,419,334 |
) |
|
(3,147,222 |
) |
|
(2,910,607 |
) |
Accounting, tax and auditing fees |
|
|
(850,599 |
) |
|
(537,961 |
) |
|
(2,104,685 |
) |
|
(897,314 |
) |
Consulting fees |
|
|
(732,951 |
) |
|
(126,447 |
) |
|
(859,476 |
) |
|
(304,316 |
) |
Travel expenses |
|
|
(399,111 |
) |
|
(455,717 |
) |
|
(1,023,140 |
) |
|
(778,450 |
) |
Other expenses |
|
|
(1,300,726 |
) |
|
(504,923 |
) |
|
(2,967,238 |
) |
|
(1,301,237 |
) |
|
|
|
(11,314,067 |
) |
|
(7,773,430 |
) |
|
(21,112,910 |
) |
|
(15,105,026 |
) |
Since 2022, the Group entered into a number of short-term rental arrangements, the expenses are included in "Other expenses". Depreciation expense in the six months ended June 30, 2024 and 2023 was €0.1 million and €0.1 million, respectively, which related to property, plant and equipment and leases and is included in the 'Other expenses' line.
|
X |
- DefinitionThe disclosure of general and administrative expenses. [Refer: Administrative expenses]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Personnel expenses
|
6 Months Ended |
Jun. 30, 2024 |
Personnel Expenses [Abstract] |
|
Personnel expenses |
5. Personnel expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Wages and salaries |
|
|
(5,953,069 |
) |
|
(4,618,862 |
) |
|
(11,023,525 |
) |
|
(8,823,246 |
) |
Pension charges |
|
|
(357,282 |
) |
|
(271,140 |
) |
|
(751,915 |
) |
|
(560,023 |
) |
Other social security charges |
|
|
(660,711 |
) |
|
(371,658 |
) |
|
(1,245,426 |
) |
|
(814,788 |
) |
Share-based payments |
|
|
(3,887,436 |
) |
|
(2,716,927 |
) |
|
(6,288,303 |
) |
|
(5,299,814 |
) |
|
|
|
(10,858,498 |
) |
|
(7,978,587 |
) |
|
(19,309,169 |
) |
|
(15,497,871 |
) |
The average number of staff (in FTEs) employed by the Group in the six months ended June 30, 2024 was 83 (2023: 68).
|
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v3.24.2.u1
Finance income/(expense)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Financial Income [Abstract] |
|
Finance income/(expense) |
6. Finance income/(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Foreign exchange differences |
|
|
2,616,719 |
|
|
667,710 |
|
|
3,138,970 |
|
|
(927,768 |
) |
Interest income over bank balances |
|
|
2,114,635 |
|
|
(11,161 |
) |
|
2,178,556 |
|
|
95,366 |
|
Other finance expenses |
|
|
(9,803 |
) |
|
(4,879 |
) |
|
(17,755 |
) |
|
(10,193 |
) |
|
|
|
4,721,551 |
|
|
651,670 |
|
|
5,299,771 |
|
|
(842,595 |
) |
|
X |
- DefinitionThe disclosure of finance income. [Refer: Finance income]
+ ReferencesReference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Name IAS -Number 1 -IssueDate 2023-01-01 -Paragraph 10 -Subparagraph e -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_10_e&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Income taxes
|
6 Months Ended |
Jun. 30, 2024 |
Income Taxes [Abstract] |
|
Income taxes |
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, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
The tax expense over the three and six months ended June 30, 2024 and 2023 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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Loss before income tax |
|
|
(29,660,450 |
) |
|
(21,803,695 |
) |
|
(57,394,089 |
) |
|
(44,373,987 |
) |
Income tax against statutory rate in The Netherlands (25.8%) |
|
|
7,652,396 |
|
|
5,625,353 |
|
|
14,807,675 |
|
|
11,448,489 |
|
Effect of tax rates in other countries |
|
|
(4,260,352 |
) |
|
(3,135,934 |
) |
|
(8,412,880 |
) |
|
(6,380,538 |
) |
Deferred tax assets recognition effects |
|
|
(3,224,214 |
) |
|
(2,473,007 |
) |
|
(6,007,203 |
) |
|
(4,989,138 |
) |
Non-deductible expenses |
|
|
(238,743 |
) |
|
(110,591 |
) |
|
(573,609 |
) |
|
(233,648 |
) |
Prior period adjustments |
|
|
290 |
|
|
— |
|
|
(169,723 |
) |
|
— |
|
Total tax charge |
|
|
(70,623 |
) |
|
(94,178 |
) |
|
(355,740 |
) |
|
(154,835 |
) |
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, 2024 was (0.6%), compared to (0.3%) for the six months ended June 30, 2023. 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.
|
v3.24.2.u1
Property, plant and equipment
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of detailed information about property, plant and equipment [abstract] |
|
Property, plant and equipment |
8. Property, plant and equipment
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Net book value |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
223,678 |
|
|
|
193,474 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Depreciation expenses |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
258,551 |
|
|
|
223,678 |
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative depreciation |
|
€ |
|
|
€ |
|
As of January 1, |
|
|
(125,373 |
) |
|
|
(65,526 |
) |
Depreciation |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
(161,344 |
) |
|
|
(125,373 |
) |
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative Costs |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
349,051 |
|
|
|
259,000 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Balance at end of period |
|
|
419,895 |
|
|
|
349,051 |
|
During the six months ended June 30, 2024, the Group acquired assets with a cost of €0.1 million (December 31, 2023: €0.1 million). The acquisitions were mainly related to equipment, tools and installations.
|
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v3.24.2.u1
Leases
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Leases [Abstract] |
|
Leases |
9. Leases The following table provides information about the Group’s right-of-use assets:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
231,893 |
|
|
|
432,965 |
|
Addition |
|
|
— |
|
|
|
(3,302 |
) |
Depreciation charges |
|
|
(99,062 |
) |
|
|
(197,770 |
) |
Impact of transaction of foreign currency |
|
|
1,150 |
|
|
|
— |
|
Balance at end of period |
|
|
133,981 |
|
|
|
231,893 |
|
The following table provides information about the Group’s lease liabilities at June 30, 2024:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Office leases |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Total lease liability |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Current portion |
|
|
(96,628 |
) |
|
|
(195,341 |
) |
Non-current portion |
|
|
(43,750 |
) |
|
|
(43,564 |
) |
Office leases consist of a lease agreement entered into on June 1, 2021 for office space in Lexington, United States of America (the " U.S."), which has ended as of June 30, 2024 and a lease entered into on December 1, 2022, for offices in Leiden, The Netherlands. Both leases have lease terms of three years and were assessed as being long-term. Cash outflows related to leases during the six months ended June 30, 2024 and 2023, were €0.1 million and €0.09 million, respectively.
|
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v3.24.2.u1
Receivables
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of acquired receivables [abstract] |
|
Receivables |
10. Receivables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Current tax receivable |
|
|
1,095,589 |
|
|
|
615,538 |
|
VAT receivables |
|
|
515,304 |
|
|
|
423,486 |
|
|
|
|
1,610,893 |
|
|
|
1,039,024 |
|
|
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v3.24.2.u1
Other current assets
|
6 Months Ended |
Jun. 30, 2024 |
Other Current Assets [Abstract] |
|
Other current assets |
11. Other current assets
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Prepayments |
|
|
5,921,334 |
|
|
|
4,959,889 |
|
Other assets |
|
|
— |
|
|
|
620,815 |
|
|
|
|
5,921,334 |
|
|
|
5,580,704 |
|
Prepayments mainly relate to prepaid insurance, sign-on bonus to personnel, prepaid research and development expenses and rent. Other assets for the year ended December 31, 2023, primarily consisted of deferred transaction costs related to the Group’s in-process equity financing (refer to note 13). The Company deferred the transaction costs related to any in-process financing. Upon recognition of the equity instruments, the related transaction costs are deducted from share premium.
|
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- DefinitionThe disclosure of other current assets. [Refer: Other current assets]
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v3.24.2.u1
Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [abstract] |
|
Equity |
13. Equity On June 30, 2024, 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, 2024 and December 31, 2023, the total number of issued and fully paid shares was 54,007,711 and 52,290,212, respectively. On June 30, 2024, the issued share capital totaled €6.5 million (2023: €4.9 million). On December 31, 2023, the issued share capital totaled €6.3 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, 2024, 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, 2024 |
|
|
December 31, 2023 |
|
|
|
Number of shares |
|
|
Number of shares |
|
Ordinary shares |
|
|
54,007,711 |
|
|
|
52,290,212 |
|
|
|
|
54,007,711 |
|
|
|
52,290,212 |
|
|
X |
- DefinitionThe entire disclosure for share capital, reserves and other equity interest.
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v3.24.2.u1
Trade and other payables
|
6 Months Ended |
Jun. 30, 2024 |
Trade and other payables [abstract] |
|
Trade and other payables |
14. Trade and other payables
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Trade payables |
|
|
2,968,446 |
|
|
|
2,909,725 |
|
|
|
|
2,968,446 |
|
|
|
2,909,725 |
|
|
X |
- DefinitionThe disclosure of trade and other payables. [Refer: Trade and other payables]
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v3.24.2.u1
Accrued liabilities
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of Accrued liabilities [Abstract] |
|
Accrued liabilities |
15. Accrued liabilities
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Consulting, professional and audit liability |
|
|
1,933,366 |
|
|
|
351,064 |
|
Clinical accrued liabilities |
|
|
8,154,946 |
|
|
|
1,832,590 |
|
Manufacturing accrued liabilities |
|
|
1,108,601 |
|
|
|
2,079,900 |
|
Nonclinical accrued liabilities |
|
|
618,128 |
|
|
|
493,907 |
|
Personnel related accruals |
|
|
3,594,600 |
|
|
|
5,892,087 |
|
Other accrued liabilities |
|
|
447,971 |
|
|
|
417,962 |
|
|
|
|
15,857,612 |
|
|
|
11,067,510 |
|
|
X |
- DefinitionThe disclosure of accrued expenses and other liabilities. [Refer: Accruals; Other liabilities]
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- DefinitionThe disclosure of the entity's financial risk management practices and policies.
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v3.24.2.u1
Share-based payments
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of terms and conditions of share-based payment arrangement [abstract] |
|
Share-based payments |
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 long term incentive plan (“LTIP”). Set out below is an overview of changes in the Stock Options and Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
RSUs |
|
|
|
Outstanding options |
|
|
Weighted average exercise price |
|
|
Outstanding RSUs |
|
|
|
|
|
|
$ |
|
|
|
|
Outstanding January 1, 2024 |
|
|
3,830,652 |
|
|
|
9.46 |
|
|
|
1,033,814 |
|
Granted |
|
|
785,000 |
|
|
|
21.68 |
|
|
|
531,129 |
|
Exercised (Vested and Settled) |
|
|
(234,694 |
) |
|
|
2.29 |
|
|
|
(157,989 |
) |
Forfeited |
|
|
(159,687 |
) |
|
|
15.80 |
|
|
|
(127,543 |
) |
Outstanding June 30, 2024 |
|
|
4,221,271 |
|
|
|
13.29 |
|
|
|
1,279,411 |
|
On April 11, 2024, a total of 70,000 stock options were granted to members of the Board of Directors with an exercise price of $22.31 per share with a final exercise date of April 11, 2034, 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 April 11, 2024, a total of 485,000 stock options were granted to members of key management with an exercise price of $22.31 per share with a final exercise date of April 11, 2034, 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. On April 15, 2024 a total of 230,000 stock options were granted to a member of key management with an exercise price of $20.15 per share with a final exercise date of April 15, 2034, 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, 2024, a total number of 4,221,271 stock options are exercisable (June 30, 2023: 2,065,270). 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
April 15, 2024 |
|
April 11, 2024 |
|
April 11, 2024 |
|
Number of options |
|
|
230,000 |
|
|
485,000 |
|
|
70,000 |
|
Fair value of the options |
|
$ |
16.37 |
|
$ |
18.12 |
|
$ |
18.05 |
|
Fair value of the ordinary shares |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Exercise price |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Expected volatility (%) |
|
|
100 |
% |
|
100 |
% |
|
105 |
% |
Expected life (years) |
|
|
6.1 |
|
|
6.1 |
|
|
5.5 |
|
Risk-free interest rate (%) |
|
|
4.7 |
% |
|
4.7 |
% |
|
4.7 |
% |
Expected dividend yield |
|
|
— |
|
|
— |
|
|
— |
|
During the six months ended June 30, 2024 a total of 281,644 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. 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 six months of 2024 were: January 2 ($25.87), February 1 ($29.95), March 1 ($24.16), April 11 ($22.31), April 15 ($20.15), May 1 ($24.57) and June 1 ($17.71), respectively. During the six months ended June 30, 2024, 226,150 RSUs were issued to existing and newly joining 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, 2024, 23,335 RSUs were issued to members of the Board of Directors. The RSUs shall vest on the 12-month anniversary of the vesting start date. For the six months ended June 30, 2024, the Group recognized €6.3 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, 2023: €5.3 million).
|
X |
- DefinitionThe entire disclosure for share-based payment arrangements.
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v3.24.2.u1
Basic and diluted loss per share
|
6 Months Ended |
Jun. 30, 2024 |
Basic And Diluted Earnings Per Share1 [Abstract] |
|
Basic and diluted loss per share |
19. Basic and diluted loss per share Basic and diluted loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of issued and outstanding ordinary shares during the three and six months ended June 30, 2024 and 2023. 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, |
|
|
|
2024 |
|
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
|
€ |
|
€ |
|
€ |
|
Net Loss |
|
|
(29,731,073 |
) |
|
|
(21,897,873 |
) |
|
(57,749,829 |
) |
|
(44,528,822 |
) |
Weighted average number of ordinary shares outstanding |
|
|
53,939,597 |
|
|
|
34,556,017 |
|
|
53,843,789 |
|
|
34,191,993 |
|
Basic and diluted loss per share |
|
|
(0.55 |
) |
|
|
(0.63 |
) |
|
(1.07 |
) |
|
(1.30 |
) |
|
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Commitments And Contingencies [Abstract] |
|
Commitments and Contingencies |
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, 2024 amounted to €95.4 million, (December 31, 2023: €49 million) primarily related to research and development commitments. The Group had no contingent liabilities and no contingent assets as of June 30, 2024 and December 31, 2023.
|
X |
- DefinitionThe disclosure of commitments and contingent liabilities. [Refer: Contingent liabilities [member]]
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v3.24.2.u1
Related parties
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of transactions between related parties [abstract] |
|
Related parties |
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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Short term employee benefits |
|
|
1,300,557 |
|
|
1,092,741 |
|
|
2,661,986 |
|
|
2,176,182 |
|
Post employee benefits |
|
|
62,130 |
|
|
43,090 |
|
|
126,189 |
|
|
93,521 |
|
Share-based payments |
|
|
2,088,045 |
|
|
1,699,794 |
|
|
3,400,920 |
|
|
3,224,788 |
|
Total |
|
|
3,450,732 |
|
|
2,835,625 |
|
|
6,189,095 |
|
|
5,494,491 |
|
Refer to note 18 for disclosures on the share-based payments related to RSUs and Options granted to key management during the six months ended June 30, 2024. The Group engages two management entities for the purpose of providing key management services to the Group. These management entities are considered related parties, as they provide key management services and key management personnel which have key management functions within these entities. Certain key management personnel are also shareholders of the Company. The aggregate amount of expense recognized in the unaudited condensed consolidated interim financial statements related to these related parties were €0.3 million and €0.6 million in the three and six months ended June 30, 2024 (2023: €0.3 million; €0.5 million), respectively. The outstanding balances payable to key management personnel, or entities which they control, as per six months ended June 30, 2024 and December 31, 2023, were €0.6 million and €1.4 million, respectively.
|
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X |
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v3.24.2.u1
Summary of significant accounting policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of voluntary change in accounting policy [abstract] |
|
Basis of preparation |
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, 2023 (“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.
|
Going concern |
2.2 Going concern Management assessed the Company’s ability to fund its operations for a period of at least one year after the date the financial statements are issued. Management has not identified a material uncertainty relating to the Company’s ability to continue as a going concern for a period of at least a year from the issuance of these financial statements. 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.
|
Use of judgements and estimates |
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.
|
Change in material accounting policies |
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, 2023. 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.
|
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v3.24.2.u1
Corporate and Group information (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Corporate And Group Information [Abstract] |
|
Summary of Subsidiaries |
The unaudited condensed consolidated interim financial statements of the Group include:
|
|
|
|
|
|
|
|
|
|
|
|
|
Country of |
|
% of equity interest as June 30, |
Name |
|
Legal seat |
|
incorporation |
|
2024 |
|
2023 |
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% |
|
X |
- DefinitionThe disclosure of subsidiaries. [Refer: Subsidiaries [member]]
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Name IAS -Number 27 -IssueDate 2023-01-01 -Paragraph 17 -Subparagraph b -URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=27&code=ifrs-tx-2023-en-r&anchor=para_17_b&doctype=Standard -URIDate 2023-03-23
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v3.24.2.u1
Research and development expenses (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Detailed Information Research And Development Expenses [Abstract] |
|
Schedule of Breakdown of Research and Development Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Clinical expenses |
|
|
(15,065,644 |
) |
|
(7,629,432 |
) |
|
(22,387,056 |
) |
|
(12,497,879 |
) |
Personnel expenses (Note 5) |
|
|
(6,450,500 |
) |
|
(4,544,244 |
) |
|
(11,630,976 |
) |
|
(8,761,944 |
) |
Manufacturing costs |
|
|
(1,572,017 |
) |
|
(736,427 |
) |
|
(4,135,971 |
) |
|
(2,643,513 |
) |
Nonclinical expenses |
|
|
130,020 |
|
|
(1,667,811 |
) |
|
(1,705,446 |
) |
|
(4,419,009 |
) |
License costs |
|
|
— |
|
|
— |
|
|
(1,500,000 |
) |
|
— |
|
Intellectual Property costs |
|
|
(109,793 |
) |
|
(104,021 |
) |
|
(221,501 |
) |
|
(104,021 |
) |
|
|
|
(23,067,934 |
) |
|
(14,681,935 |
) |
|
(41,580,950 |
) |
|
(28,426,366 |
) |
|
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v3.24.2.u1
General and administrative expenses (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Detailed Information General And Administrative Expenses [Abstract] |
|
Breakdown of General and Administrative Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Personnel expenses (Note 5) |
|
|
(4,407,998 |
) |
|
(3,434,343 |
) |
|
(7,678,193 |
) |
|
(6,735,927 |
) |
Professional fees |
|
|
(2,155,727 |
) |
|
(1,294,705 |
) |
|
(3,332,956 |
) |
|
(2,177,175 |
) |
Facilities, communication & office expenses |
|
|
(1,466,955 |
) |
|
(1,419,334 |
) |
|
(3,147,222 |
) |
|
(2,910,607 |
) |
Accounting, tax and auditing fees |
|
|
(850,599 |
) |
|
(537,961 |
) |
|
(2,104,685 |
) |
|
(897,314 |
) |
Consulting fees |
|
|
(732,951 |
) |
|
(126,447 |
) |
|
(859,476 |
) |
|
(304,316 |
) |
Travel expenses |
|
|
(399,111 |
) |
|
(455,717 |
) |
|
(1,023,140 |
) |
|
(778,450 |
) |
Other expenses |
|
|
(1,300,726 |
) |
|
(504,923 |
) |
|
(2,967,238 |
) |
|
(1,301,237 |
) |
|
|
|
(11,314,067 |
) |
|
(7,773,430 |
) |
|
(21,112,910 |
) |
|
(15,105,026 |
) |
|
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v3.24.2.u1
Personnel expenses (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Personnel Expenses [Abstract] |
|
Summary of Personnel Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Wages and salaries |
|
|
(5,953,069 |
) |
|
(4,618,862 |
) |
|
(11,023,525 |
) |
|
(8,823,246 |
) |
Pension charges |
|
|
(357,282 |
) |
|
(271,140 |
) |
|
(751,915 |
) |
|
(560,023 |
) |
Other social security charges |
|
|
(660,711 |
) |
|
(371,658 |
) |
|
(1,245,426 |
) |
|
(814,788 |
) |
Share-based payments |
|
|
(3,887,436 |
) |
|
(2,716,927 |
) |
|
(6,288,303 |
) |
|
(5,299,814 |
) |
|
|
|
(10,858,498 |
) |
|
(7,978,587 |
) |
|
(19,309,169 |
) |
|
(15,497,871 |
) |
|
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v3.24.2.u1
Finance income/(expense) (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Financial Income [Abstract] |
|
Summary of Financial Income /(Expenses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Foreign exchange differences |
|
|
2,616,719 |
|
|
667,710 |
|
|
3,138,970 |
|
|
(927,768 |
) |
Interest income over bank balances |
|
|
2,114,635 |
|
|
(11,161 |
) |
|
2,178,556 |
|
|
95,366 |
|
Other finance expenses |
|
|
(9,803 |
) |
|
(4,879 |
) |
|
(17,755 |
) |
|
(10,193 |
) |
|
|
|
4,721,551 |
|
|
651,670 |
|
|
5,299,771 |
|
|
(842,595 |
) |
|
X |
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v3.24.2.u1
Income taxes (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Income Taxes [Abstract] |
|
Summary of Income Tax Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
€ |
|
|
€ |
|
|
€ |
|
|
€ |
|
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
Income tax expense |
|
|
(70,623 |
) |
|
|
(94,178 |
) |
|
|
(355,740 |
) |
|
|
(154,835 |
) |
|
Summary of Reconciliation of Income Tax Benefit And The Accounting Loss |
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, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Loss before income tax |
|
|
(29,660,450 |
) |
|
(21,803,695 |
) |
|
(57,394,089 |
) |
|
(44,373,987 |
) |
Income tax against statutory rate in The Netherlands (25.8%) |
|
|
7,652,396 |
|
|
5,625,353 |
|
|
14,807,675 |
|
|
11,448,489 |
|
Effect of tax rates in other countries |
|
|
(4,260,352 |
) |
|
(3,135,934 |
) |
|
(8,412,880 |
) |
|
(6,380,538 |
) |
Deferred tax assets recognition effects |
|
|
(3,224,214 |
) |
|
(2,473,007 |
) |
|
(6,007,203 |
) |
|
(4,989,138 |
) |
Non-deductible expenses |
|
|
(238,743 |
) |
|
(110,591 |
) |
|
(573,609 |
) |
|
(233,648 |
) |
Prior period adjustments |
|
|
290 |
|
|
— |
|
|
(169,723 |
) |
|
— |
|
Total tax charge |
|
|
(70,623 |
) |
|
(94,178 |
) |
|
(355,740 |
) |
|
(154,835 |
) |
|
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v3.24.2.u1
Property, plant and equipment (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of detailed information about property, plant and equipment [abstract] |
|
Summary of Property, Plant and Equipment |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Net book value |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
223,678 |
|
|
|
193,474 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Depreciation expenses |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
258,551 |
|
|
|
223,678 |
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative depreciation |
|
€ |
|
|
€ |
|
As of January 1, |
|
|
(125,373 |
) |
|
|
(65,526 |
) |
Depreciation |
|
|
(35,971 |
) |
|
|
(59,847 |
) |
Balance at end of period |
|
|
(161,344 |
) |
|
|
(125,373 |
) |
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Cumulative Costs |
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
349,051 |
|
|
|
259,000 |
|
Additions |
|
|
70,844 |
|
|
|
90,051 |
|
Balance at end of period |
|
|
419,895 |
|
|
|
349,051 |
|
|
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v3.24.2.u1
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure Of Leases [Abstract] |
|
Summary of information about right of use assets |
The following table provides information about the Group’s right-of-use assets:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Balance at beginning of period |
|
|
231,893 |
|
|
|
432,965 |
|
Addition |
|
|
— |
|
|
|
(3,302 |
) |
Depreciation charges |
|
|
(99,062 |
) |
|
|
(197,770 |
) |
Impact of transaction of foreign currency |
|
|
1,150 |
|
|
|
— |
|
Balance at end of period |
|
|
133,981 |
|
|
|
231,893 |
|
|
Summary of information about lease lease liabilities |
The following table provides information about the Group’s lease liabilities at June 30, 2024:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Office leases |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Total lease liability |
|
|
(140,378 |
) |
|
|
(238,905 |
) |
Current portion |
|
|
(96,628 |
) |
|
|
(195,341 |
) |
Non-current portion |
|
|
(43,750 |
) |
|
|
(43,564 |
) |
|
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v3.24.2.u1
Receivables (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of acquired receivables [abstract] |
|
Summary of Receivables |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Current tax receivable |
|
|
1,095,589 |
|
|
|
615,538 |
|
VAT receivables |
|
|
515,304 |
|
|
|
423,486 |
|
|
|
|
1,610,893 |
|
|
|
1,039,024 |
|
|
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v3.24.2.u1
Other current assets (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Other Current Assets [Abstract] |
|
Summary of Other Current Assets |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Prepayments |
|
|
5,921,334 |
|
|
|
4,959,889 |
|
Other assets |
|
|
— |
|
|
|
620,815 |
|
|
|
|
5,921,334 |
|
|
|
5,580,704 |
|
|
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v3.24.2.u1
Equity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [abstract] |
|
Summary of Share Capital |
Issued shares
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
Number of shares |
|
|
Number of shares |
|
Ordinary shares |
|
|
54,007,711 |
|
|
|
52,290,212 |
|
|
|
|
54,007,711 |
|
|
|
52,290,212 |
|
|
X |
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v3.24.2.u1
Trade and other payables (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Trade and other payables [abstract] |
|
Summary of Trade and Other Liabilities |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Trade payables |
|
|
2,968,446 |
|
|
|
2,909,725 |
|
|
|
|
2,968,446 |
|
|
|
2,909,725 |
|
|
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v3.24.2.u1
Accrued liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of Accrued liabilities [Abstract] |
|
Summary of Accrued Liabilities |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
€ |
|
|
€ |
|
Consulting, professional and audit liability |
|
|
1,933,366 |
|
|
|
351,064 |
|
Clinical accrued liabilities |
|
|
8,154,946 |
|
|
|
1,832,590 |
|
Manufacturing accrued liabilities |
|
|
1,108,601 |
|
|
|
2,079,900 |
|
Nonclinical accrued liabilities |
|
|
618,128 |
|
|
|
493,907 |
|
Personnel related accruals |
|
|
3,594,600 |
|
|
|
5,892,087 |
|
Other accrued liabilities |
|
|
447,971 |
|
|
|
417,962 |
|
|
|
|
15,857,612 |
|
|
|
11,067,510 |
|
|
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v3.24.2.u1
Share-based payments (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of terms and conditions of share-based payment arrangement [abstract] |
|
Summary of Changes in Stock Options and Restricted Stock Units |
Set out below is an overview of changes in the Stock Options and Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
RSUs |
|
|
|
Outstanding options |
|
|
Weighted average exercise price |
|
|
Outstanding RSUs |
|
|
|
|
|
|
$ |
|
|
|
|
Outstanding January 1, 2024 |
|
|
3,830,652 |
|
|
|
9.46 |
|
|
|
1,033,814 |
|
Granted |
|
|
785,000 |
|
|
|
21.68 |
|
|
|
531,129 |
|
Exercised (Vested and Settled) |
|
|
(234,694 |
) |
|
|
2.29 |
|
|
|
(157,989 |
) |
Forfeited |
|
|
(159,687 |
) |
|
|
15.80 |
|
|
|
(127,543 |
) |
Outstanding June 30, 2024 |
|
|
4,221,271 |
|
|
|
13.29 |
|
|
|
1,279,411 |
|
|
Summary of Fair Value Per Option at Each Grant/Measurements Date Using the Black-Scholes Formula |
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
April 15, 2024 |
|
April 11, 2024 |
|
April 11, 2024 |
|
Number of options |
|
|
230,000 |
|
|
485,000 |
|
|
70,000 |
|
Fair value of the options |
|
$ |
16.37 |
|
$ |
18.12 |
|
$ |
18.05 |
|
Fair value of the ordinary shares |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Exercise price |
|
$ |
20.15 |
|
$ |
22.31 |
|
$ |
22.31 |
|
Expected volatility (%) |
|
|
100 |
% |
|
100 |
% |
|
105 |
% |
Expected life (years) |
|
|
6.1 |
|
|
6.1 |
|
|
5.5 |
|
Risk-free interest rate (%) |
|
|
4.7 |
% |
|
4.7 |
% |
|
4.7 |
% |
Expected dividend yield |
|
|
— |
|
|
— |
|
|
— |
|
|
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v3.24.2.u1
Basic and diluted loss per share (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Basic And Diluted Earnings Per Share1 [Abstract] |
|
Summary of Earnings Per Share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
|
€ |
|
€ |
|
€ |
|
Net Loss |
|
|
(29,731,073 |
) |
|
|
(21,897,873 |
) |
|
(57,749,829 |
) |
|
(44,528,822 |
) |
Weighted average number of ordinary shares outstanding |
|
|
53,939,597 |
|
|
|
34,556,017 |
|
|
53,843,789 |
|
|
34,191,993 |
|
Basic and diluted loss per share |
|
|
(0.55 |
) |
|
|
(0.63 |
) |
|
(1.07 |
) |
|
(1.30 |
) |
|
X |
- DefinitionThe entire disclosure for earnings per share.
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v3.24.2.u1
Related parties (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Disclosure of transactions between related parties [abstract] |
|
Summary of Compensation to Key Management Personnel |
Key management personnel compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, |
|
For the six months ended June 30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
€ |
|
€ |
|
€ |
|
€ |
|
Short term employee benefits |
|
|
1,300,557 |
|
|
1,092,741 |
|
|
2,661,986 |
|
|
2,176,182 |
|
Post employee benefits |
|
|
62,130 |
|
|
43,090 |
|
|
126,189 |
|
|
93,521 |
|
Share-based payments |
|
|
2,088,045 |
|
|
1,699,794 |
|
|
3,400,920 |
|
|
3,224,788 |
|
Total |
|
|
3,450,732 |
|
|
2,835,625 |
|
|
6,189,095 |
|
|
5,494,491 |
|
|
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v3.24.2.u1
Research and development expenses - Breakdown of Research and Development Expenses (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
€ (23,067,934)
|
€ (14,681,935)
|
€ (41,580,950)
|
€ (28,426,366)
|
Clinical expenses [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
(15,065,644)
|
(7,629,432)
|
(22,387,056)
|
(12,497,879)
|
Personnel expenses [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
(6,450,500)
|
(4,544,244)
|
(11,630,976)
|
(8,761,944)
|
Manufacturing costs [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
(1,572,017)
|
(736,427)
|
(4,135,971)
|
(2,643,513)
|
Nonclinical expenses [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
(130,020)
|
(1,667,811)
|
(1,705,446)
|
(4,419,009)
|
License costs [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
|
|
(1,500,000)
|
|
Intellectual Property costs [Member] |
|
|
|
|
Disclosure of disaggregation of revenue from contracts with customers [line items] |
|
|
|
|
Research and development expenses |
€ (109,793)
|
€ (104,021)
|
€ (221,501)
|
€ (104,021)
|
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v3.24.2.u1
General and administrative expenses - Breakdown of General and Administrative Expenses (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disclosure Of Detailed Information General And Administrative Expenses [Abstract] |
|
|
|
|
Personnel expenses (Note 5) |
€ (4,407,998)
|
€ (3,434,343)
|
€ (7,678,193)
|
€ (6,735,927)
|
Professional fees |
(2,155,727)
|
(1,294,705)
|
(3,332,956)
|
(2,177,175)
|
Facilities, communication & office expenses |
(1,466,955)
|
(1,419,334)
|
(3,147,222)
|
(2,910,607)
|
Accounting, tax and auditing fees |
(850,599)
|
(537,961)
|
(2,104,685)
|
(897,314)
|
Consulting fees |
(732,951)
|
(126,447)
|
(859,476)
|
(304,316)
|
Travel expenses |
(399,111)
|
(455,717)
|
(1,023,140)
|
(778,450)
|
Other expenses |
(1,300,726)
|
(504,923)
|
(2,967,238)
|
(1,301,237)
|
Total |
€ (11,314,067)
|
€ (7,773,430)
|
€ (21,112,910)
|
€ (15,105,026)
|
X |
- DefinitionThe amount of fees paid or payable to the entity's auditors for auditing services.
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Personnel expenses - Summary of Personnel Expenses (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disclosure Of Expenses By Nature [Abstract] |
|
|
|
|
Wages and salaries |
€ (5,953,069)
|
€ (4,618,862)
|
€ (11,023,525)
|
€ (8,823,246)
|
Pension charges |
(357,282)
|
(271,140)
|
(751,915)
|
(560,023)
|
Other social security charges |
(660,711)
|
(371,658)
|
(1,245,426)
|
(814,788)
|
Share-based payments |
(3,887,436)
|
(2,716,927)
|
(6,288,303)
|
(5,299,814)
|
Total |
€ (10,858,498)
|
€ (7,978,587)
|
€ (19,309,169)
|
€ (15,497,871)
|
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v3.24.2.u1
Finance income/(expense) - Summary of Financial Income/ ( Expenses) (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disclosure Of Financial Expenses [Abstract] |
|
|
|
|
Foreign exchange differences |
€ 2,616,719
|
€ 667,710
|
€ 3,138,970
|
€ (927,768)
|
Interest income over bank balances |
2,114,635
|
(11,161)
|
2,178,556
|
95,366
|
Other finance expenses |
(9,803)
|
(4,879)
|
(17,755)
|
(10,193)
|
Total finance (expenses)/income |
€ 4,721,551
|
€ 651,670
|
€ 5,299,771
|
€ (842,595)
|
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Income taxes - Summary of Income Tax Expense (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Major components of tax expense (income) [abstract] |
|
|
|
|
Income tax expense |
€ (70,623)
|
€ (94,178)
|
€ (355,740)
|
€ (154,835)
|
Income tax expense |
€ (70,623)
|
€ (94,178)
|
€ (355,740)
|
€ (154,835)
|
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Income taxes - Summary of Reconciliation of Income Tax Benefit And The Accounting Loss (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Reconciliation of accounting profit multiplied by applicable tax rates [abstract] |
|
|
|
|
Loss before income tax |
€ (29,660,450)
|
€ (21,803,695)
|
€ (57,394,089)
|
€ (44,373,987)
|
Income tax against statutory rate in The Netherlands (25.8%) |
7,652,396
|
5,625,353
|
14,807,675
|
11,448,489
|
Effect of tax rates in other countries |
(4,260,352)
|
(3,135,934)
|
(8,412,880)
|
(6,380,538)
|
Deferred tax assets recognition effects |
(3,224,214)
|
(2,473,007)
|
(6,007,203)
|
(4,989,138)
|
Non-deductible expenses |
(238,743)
|
(110,591)
|
(573,609)
|
(233,648)
|
Prior period adjustments |
290
|
0
|
(169,723)
|
0
|
Total tax charge |
€ (70,623)
|
€ (94,178)
|
€ (355,740)
|
€ (154,835)
|
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v3.24.2.u1
Property, plant and equipment - Summary of Property, Plant and Equipment (Detail) - EUR (€)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure Of Property Plant And Equipment [Line Items] |
|
|
Balance at beginning of period |
€ 223,678
|
€ 193,474
|
Additions |
70,844
|
90,051
|
Depreciation expenses |
(35,971)
|
(59,847)
|
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258,551
|
223,678
|
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|
|
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|
|
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|
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|
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(35,971)
|
(59,847)
|
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(161,344)
|
(125,373)
|
Cumulative Costs [member] |
|
|
Disclosure Of Property Plant And Equipment [Line Items] |
|
|
Balance at beginning of period |
349,051
|
259,000
|
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70,844
|
90,051
|
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€ 419,895
|
€ 349,051
|
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v3.24.2.u1
Leases - Summary of information about right of use assets (Detail) - EUR (€)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure Of Leases [Abstract] |
|
|
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€ 231,893
|
€ 432,965
|
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|
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|
Depreciation charges |
(99,062)
|
(197,770)
|
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1,150
|
|
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€ 133,981
|
€ 231,893
|
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure Of Lease Liabilities [Line Items] |
|
|
Lease liabilities |
€ (140,378)
|
€ (238,905)
|
Current portion |
(96,628)
|
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|
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(43,750)
|
(43,564)
|
Office Lease [Member] |
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|
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v3.24.2.u1
Receivables - Summary of Receivables (Detail) - EUR (€)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure of acquired receivables [abstract] |
|
|
Current tax receivable |
€ 1,095,589
|
€ 615,538
|
VAT receivables |
515,304
|
423,486
|
Total |
€ 1,610,893
|
€ 1,039,024
|
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Other current assets - Summary of Other Current Assets (Detail) - EUR (€)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Other Current Assets [Abstract] |
|
|
Prepayments |
€ 5,921,334
|
€ 4,959,889
|
Other assets |
0
|
620,815
|
Total |
€ 5,921,334
|
€ 5,580,704
|
X |
- DefinitionThe amount of current prepayments. [Refer: Prepayments]
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v3.24.2.u1
Equity - Additional Information (Detail) € / shares in Units, $ in Thousands |
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Apr. 30, 2024
USD ($)
|
Jan. 31, 2024
USD ($)
shares
|
Mar. 31, 2022
USD ($)
|
Jun. 30, 2024
EUR (€)
€ / shares
shares
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
EUR (€)
|
Dec. 31, 2023
EUR (€)
shares
|
Disclosure of classes of share capital [line items] |
|
|
|
|
|
|
|
Number of shares issued and fully paid |
|
|
|
54,007,711
|
|
|
52,290,212
|
Nominal value per share | € / shares |
|
|
|
€ 0.12
|
|
|
|
Proceeds from issue of ordinary shares |
|
|
|
€ 9,300,000
|
$ 9,800
|
|
|
Authorized share capital | € |
|
|
|
14,100,000
|
|
|
|
Share capital | € |
|
|
|
6,480,925
|
|
€ 4,900,000
|
€ 6,274,833
|
Proceeds from sales |
|
|
$ 350,000
|
632,737
|
|
€ 64,084,953
|
|
Proceeds from exercise of pre-funded warrants | $ |
|
$ 10
|
|
|
|
|
|
Issuance of ordinary shares |
|
1,375,000
|
|
|
|
|
|
Leerink Partners [member] |
|
|
|
|
|
|
|
Disclosure of classes of share capital [line items] |
|
|
|
|
|
|
|
At-the-market program providing for sales from time to time | $ |
$ 175,000
|
|
|
|
|
|
|
Payments for share issue costs |
|
|
|
€ 300,000
|
$ 300
|
|
|
Ordinary shares [member] |
|
|
|
|
|
|
|
Disclosure of classes of share capital [line items] |
|
|
|
|
|
|
|
Number of shares issued and fully paid |
|
|
|
54,007,711
|
|
|
52,290,212
|
Sale of shares |
|
|
|
593,927
|
|
|
|
Number of shares authorized |
|
|
|
117,500,000
|
|
|
|
Ordinary shares [member] | S V B Leerink [Member] |
|
|
|
|
|
|
|
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure of classes of share capital [line items] |
|
|
Number of shares issued and fully paid |
54,007,711
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52,290,212
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Ordinary shares [member] |
|
|
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|
|
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Trade and other payables [abstract] |
|
|
Trade payables |
€ 2,968,446
|
€ 2,909,725
|
Total Trade And Other Payables |
€ 2,968,446
|
€ 2,909,725
|
X |
- DefinitionThe amount of current trade payables and current other payables. [Refer: Current trade payables; Other current payables]
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Accrued liabilities - Summary of Accrued Liabilities (Detail) - EUR (€)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
€ 15,857,612
|
€ 11,067,510
|
Consulting Professional And Audit Liability [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
1,933,366
|
351,064
|
Clinical Accrued Liabilities [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
8,154,946
|
1,832,590
|
Manufacturing Accrued Liabilities [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
1,108,601
|
2,079,900
|
Nonclinical Accrued Liabilities [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
618,128
|
493,907
|
Personnel Related Accruals [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
3,594,600
|
5,892,087
|
Other Accrued Liabilities [Member] |
|
|
Disclosure of financial liabilities [line items] |
|
|
Accrued liabilities |
€ 447,971
|
€ 417,962
|
X |
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v3.24.2.u1
Share-based Payments - Summary of Changes in Stock Options and Restricted Stock Units (Detail)
|
6 Months Ended |
Jun. 30, 2024
shares
$ / shares
|
Stock Options [Member] |
|
Disclosure Of Number And Weighted Average Exercise Prices Of Share Options [Line Items] |
|
Beginning balance |
3,830,652
|
Granted |
785,000
|
Exercised (Vested and Settled) |
(234,694)
|
Forfeited |
(159,687)
|
Ending balance |
4,221,271
|
Beginning balance, Weighted average | $ / shares |
$ 9.46
|
Granted , Weighted average | $ / shares |
21.68
|
Exercised (Vested and Settled) , Weighted average | $ / shares |
2.29
|
Forfeited , Weighted average | $ / shares |
15.8
|
Ending balance , Weighted average | $ / shares |
$ 13.29
|
Restricted Stock Units [Member] |
|
Disclosure Of Number And Weighted Average Exercise Prices Of Share Options [Line Items] |
|
Beginning balance |
1,033,814
|
Granted |
531,129
|
Exercised (Vested and Settled) |
(157,989)
|
Forfeited |
(127,543)
|
Ending balance |
1,279,411
|
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v3.24.2.u1
Share-based Payments - Summary of Fair Value Per Option at Each Grant/Measurements Date Using the Black-Scholes Formula (Detail)
|
Jun. 01, 2024
$ / shares
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May 01, 2024
$ / shares
|
Apr. 15, 2024
yr
shares
€ / shares
$ / shares
|
Apr. 15, 2024
yr
shares
€ / shares
|
Apr. 11, 2024
yr
shares
€ / shares
$ / shares
|
Apr. 11, 2024
yr
shares
€ / shares
|
Mar. 01, 2024
$ / shares
|
Feb. 01, 2024
$ / shares
|
Jan. 02, 2024
$ / shares
|
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] |
|
|
|
|
|
|
|
|
|
Exercise price | $ / shares |
$ 17.71
|
$ 24.57
|
$ 20.15
|
|
$ 22.31
|
|
$ 24.16
|
$ 29.95
|
$ 25.87
|
Key management personnel of entity or parent [member] |
|
|
|
|
|
|
|
|
|
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] |
|
|
|
|
|
|
|
|
|
Exercise price | $ / shares |
|
|
$ 20.15
|
|
22.31
|
|
|
|
|
Stock options granted to board of directors [Member] |
|
|
|
|
|
|
|
|
|
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] |
|
|
|
|
|
|
|
|
|
Exercise price | $ / shares |
|
|
|
|
$ 22.31
|
|
|
|
|
Black-Scholes formula [member] | Key management personnel of entity or parent [member] |
|
|
|
|
|
|
|
|
|
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] |
|
|
|
|
|
|
|
|
|
Number of options | shares |
|
|
230,000
|
230,000
|
485,000
|
485,000
|
|
|
|
Fair value of the options |
|
|
$ 16.37
|
€ 16.37
|
$ 18.12
|
€ 18.12
|
|
|
|
Fair value of the ordinary shares |
|
|
$ 20.15
|
20.15
|
$ 22.31
|
22.31
|
|
|
|
Exercise price |
|
|
|
€ 20.15
|
|
€ 22.31
|
|
|
|
Expected volatility |
|
|
100.00%
|
100.00%
|
100.00%
|
100.00%
|
|
|
|
Expected life | yr |
|
|
6.1
|
6.1
|
6.1
|
6.1
|
|
|
|
Risk-free interest rate |
|
|
4.70%
|
4.70%
|
4.70%
|
4.70%
|
|
|
|
Expected dividend yield |
|
|
0.00%
|
0.00%
|
0.00%
|
0.00%
|
|
|
|
Black-Scholes formula [member] | Stock options granted to board of directors [Member] |
|
|
|
|
|
|
|
|
|
Disclosure of significant unobservable inputs used in fair value measurement of assets [line items] |
|
|
|
|
|
|
|
|
|
Number of options | shares |
|
|
|
|
70,000
|
70,000
|
|
|
|
Fair value of the options |
|
|
|
|
$ 18.05
|
€ 18.05
|
|
|
|
Fair value of the ordinary shares |
|
|
|
|
$ 22.31
|
22.31
|
|
|
|
Exercise price |
|
|
|
|
|
€ 22.31
|
|
|
|
Expected volatility |
|
|
|
|
105.00%
|
105.00%
|
|
|
|
Expected life | yr |
|
|
|
|
5.5
|
5.5
|
|
|
|
Risk-free interest rate |
|
|
|
|
4.70%
|
4.70%
|
|
|
|
Expected dividend yield |
|
|
|
|
0.00%
|
0.00%
|
|
|
|
X |
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Share-based Payments - Additional Information (Detail) $ / shares in Units, € in Millions, $ in Millions |
|
|
|
|
|
|
|
6 Months Ended |
Jun. 01, 2024
$ / shares
|
May 01, 2024
$ / shares
|
Apr. 15, 2024
shares
$ / shares
|
Apr. 11, 2024
shares
$ / shares
|
Mar. 01, 2024
$ / shares
|
Feb. 01, 2024
$ / shares
|
Jan. 02, 2024
$ / shares
|
Jun. 30, 2024
EUR (€)
shares
|
Jun. 30, 2023
USD ($)
shares
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Weighted average share price | $ / shares |
$ 17.71
|
$ 24.57
|
$ 20.15
|
$ 22.31
|
$ 24.16
|
$ 29.95
|
$ 25.87
|
|
|
Number of share options exercisable in share-based payment arrangement |
|
|
|
|
|
|
|
4,221,271
|
2,065,270
|
Expense from share-based payment transactions |
|
|
|
|
|
|
|
€ 6.3
|
$ 5.3
|
Key management personnel of entity or parent [member] |
|
|
|
|
|
|
|
|
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of instruments granted in share based payment arrangement |
|
|
230,000
|
485,000
|
|
|
|
|
|
Description of maximum term of options granted for share-based payment arrangement |
|
|
April 15, 2034
|
April 11, 2034
|
|
|
|
|
|
Weighted average share price | $ / shares |
|
|
$ 20.15
|
$ 22.31
|
|
|
|
|
|
Percentage of aggregate number of stock options shall vest on one year at grant date |
|
|
25.00%
|
25.00%
|
|
|
|
|
|
Percentage of aggregate number of stock options shall vest on One Month at grant date |
|
|
48.00%
|
48.00%
|
|
|
|
|
|
Key management personnel of entity or parent [member] | Restricted Stock Units [Member] |
|
|
|
|
|
|
|
|
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of instruments granted in share based payment arrangement |
|
|
|
|
|
|
|
226,150
|
|
Percentage of aggregate number of stock options shall vest on one year at grant date |
|
|
|
|
|
|
|
25.00%
|
|
Percentage of aggregate number of stock options shall vest on One Month at grant date |
|
|
|
|
|
|
|
48.00%
|
|
Employees [Member] | Restricted Stock Units [Member] |
|
|
|
|
|
|
|
|
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of instruments granted in share based payment arrangement |
|
|
|
|
|
|
|
281,644
|
|
Stock options granted to board of directors [Member] |
|
|
|
|
|
|
|
|
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of instruments granted in share based payment arrangement |
|
|
|
70,000
|
|
|
|
|
|
Description of maximum term of options granted for share-based payment arrangement |
|
|
|
April 11, 2034
|
|
|
|
|
|
Weighted average share price | $ / shares |
|
|
|
$ 22.31
|
|
|
|
|
|
Percentage of aggregate number of stock options shall vest on one year at grant date |
|
|
|
100.00%
|
|
|
|
|
|
Stock options granted to board of directors [Member] | Restricted Stock Units [Member] |
|
|
|
|
|
|
|
|
|
statement of Lineitems [Line Items] |
|
|
|
|
|
|
|
|
|
Number of instruments granted in share based payment arrangement |
|
|
|
|
|
|
|
23,335
|
|
X |
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v3.24.2.u1
Basic and diluted loss per share - Summary of Earnings Per Share (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings per share [line items] |
|
|
|
|
Net Loss |
€ (29,731,073)
|
€ (21,897,873)
|
€ (57,749,829)
|
€ (44,528,822)
|
Weighted average number of ordinary shares outstanding |
53,939,597
|
34,556,017
|
53,843,789
|
34,191,993
|
Basic loss per share |
€ (0.55)
|
€ (0.63)
|
€ (1.07)
|
€ (1.3)
|
Diluted loss per share |
€ (0.55)
|
€ (0.63)
|
€ (1.07)
|
€ (1.3)
|
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Related parties - Summary of Compensation to Key Management Personnel (Detail) - EUR (€)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disclosure of transactions between related parties [abstract] |
|
|
|
|
Short term employee benefits |
€ 1,300,557
|
€ 1,092,741
|
€ 2,661,986
|
€ 2,176,182
|
Post employee benefits |
62,130
|
43,090
|
126,189
|
93,521
|
Share-based payments |
2,088,045
|
1,699,794
|
3,400,920
|
3,224,788
|
Total |
€ 3,450,732
|
€ 2,835,625
|
€ 6,189,095
|
€ 5,494,491
|
X |
- DefinitionThe amount of compensation to key management personnel. [Refer: Key management personnel of entity or parent [member]]
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