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 May 2023

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.

 

 

 

 

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PHARVARIS N.V.

On May 8, 2023, Pharvaris N.V. issued a press release reporting financial results and other business updates for the first quarter of 2023. 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 333-263198) 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.

 

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release, dated May 8, 2023 (Financial results).
99.2		Management’s Discussion and Analysis of Financial Condition and Results of Operations as of and for the Three Months Ended March 31, 2023.
99.3		Unaudited Condensed Consolidated Interim Financial Statements as of and for the Three Months Ended March 31, 2023.

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	PHARVARIS N.V.
Date: May 8, 2023	By:	/s/ Berndt Modig
	Name:	Berndt Modig
	Title:	Chief Executive Officer

 

 

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Exhibit 99.1

 

 

 

Pharvaris Reports First Quarter 2023 Financial Results and Provides Business Update

Zug, Switzerland, May 8, 2023 – Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the first quarter ended March 31, 2023 and provided a business update.

“The Pharvaris team has made strong progress advancing our key studies and initiatives toward meaningful year-end milestones, including the anticipated reporting of topline CHAPTER-1 data and the submission of newly generated non-clinical toxicology data to the FDA to address the clinical holds in the U.S.,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The data presented at the C1-inhibitor Deficiency and Angioedema Workshop provide additional insights into the therapeutic profile of deucrictibant as potential treatment for HAE and other bradykinin-mediated diseases.”

Recent Business Updates

First Quarter 2023 Financial Results

 

 

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Upcoming Events

BofA Securities 2023 Healthcare Conference. Las Vegas, May 9-11, 2023. Morgan Conn, Ph.D., Chief Business Officer, and Wim Souverijns, Ph.D., Chief Community Engagement and Commercial Officer, will present a corporate overview on Wednesday, May 10, at 4:35 p.m. PDT (Thursday, May 11, at 1:35 a.m. CEST). A live audio webcast will be available on the Investors section of the Pharvaris website at https://ir.pharvaris.com/news-events/events-presentations. A replay will be available on Pharvaris’ website for 90 days following the fireside chat.

European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023. Hamburg, Germany, June 9-11, 2023. Two abstracts have been accepted for presentation during the “flash talks on angioedema” Flash Talks:

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 PHVS416 (immediate-release deucrictibant capsules)

PHVS416 (immediate-release deucrictibant capsules) is an investigational medicine intended to treat acute attacks of hereditary angioedema (HAE) containing deucrictibant, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris aims to develop this formulation to provide rapid and reliable symptom relief, through rapid exposure of attack-mitigating therapy in a convenient, small oral dosage form. PHVS416 is currently in Phase 2 clinical development outside the U.S. for the on-demand and proof-of-concept prophylactic treatment of HAE.

 

 

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About PHVS719 (extended-release deucrictibant tablets)

PHVS719 (extended-release deucrictibant tablets) is an investigational medicine intended to prevent attacks of hereditary angioedema (HAE) containing deucrictibant, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide sustained exposure of attack-preventing medicine in a convenient, small oral dosage form. PHVS719 is currently in Phase 1 clinical development for the prophylactic treatment of HAE. In healthy volunteers, a single dose of PHVS719 was well tolerated with an extended-release profile supporting once-daily dosing.

About Pharvaris

Building on its deep-seated roots in HAE, Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks. By directly targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE safe, effective, and convenient alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. 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 with respect to the clinical holds on deucrictibant clinical trials in the U.S.; the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the clinical holds; risks arising from epidemic diseases, such as the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the expected timing and results of the rodent toxicology study; the 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 PHVS416 and PHVS719, 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 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 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 Securities and Exchange Commission.

 

 

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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

Head of Public Relations and Communications

maggie.beller@pharvaris.com

 

 

 

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Exhibit 99.2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this discussion together with our unaudited condensed consolidated interim financial statements, including the notes thereto, for the three months ended March 31, 2023 and 2022 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 2022, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2022 (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 International Financial Reporting 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.

Unless otherwise indicated or the context otherwise requires, all references to “Pharvaris” or the “Company,” “we,” “our,” “ours,” “us”, or similar terms refer to Pharvaris N.V. and its subsidiaries.

Overview

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for rare diseases with significant unmet need, initially focused on angioedema and other bradykinin-mediated diseases. Our first molecule, deucrictibant, is a novel, small-molecule bradykinin B2-receptor antagonist for the treatment of hereditary angioedema, or HAE. 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 (as FIRAZYR). We designed deucrictibant to improve upon the therapeutic profile of existing therapies and, through oral delivery, to provide patients with quality of life and convenience that is superior to current standard-of-care HAE treatments, which are injectables. We believe deucrictibant has the potential to provide a safe, effective and convenient option for both acute and prophylactic treatments of HAE, in the form of our PHVS416 on-demand rapid exposure product candidate, and for prophylaxis of HAE, in the form of our PHVS719 small daily dose extended-release product candidate. We believe that our product candidates may address a broader range of angioedema attacks than other available treatments since deucrictibant blocks the actual signal that leads to angioedema (the interaction of bradykinin, or BK, with the bradykinin B2 receptor), rather than an upstream signal. By blocking the action of bradykinin, we can prevent its aberrant signaling regardless of the pathway that generates it.

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-mechanism through a clinical pharmacodynamics, or 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 concluded 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 product candidate, PHVS416, and extended-release product candidate, PHVS719, respectively. We commenced our RAPIDe-1 Phase 2 clinical trial of PHVS416 in February 2021 and reported topline Phase 2 data for the acute treatment of patients with HAE attacks in December 2022. We also commenced the CHAPTER-1 Phase 2 clinical trial for prophylaxis in 2021 using twice-daily dosing of the PHVS416 softgel capsules. Our primary objective with this trial is to assess the efficacy and safety profile of PHVS416 dose regimens for prophylactic treatments in HAE patients. We expect to have Phase 2 data from CHAPTER-1 by the end of 2023. In February 2022, we reported Phase 1 clinical data with PHVS719 demonstrating pharmacokinetics of the extended-release formulation and the potential for once-daily dosing. In healthy volunteers, a single dose of PHVS719 was well tolerated with an extended-release profile supporting once-daily dosing.

 

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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. While the impact of COVID-19 on the Company’s operations and financial performance has so far been limited, the extent to which COVID-19 may impact our financial condition or results of operations in the future is uncertain. For instance, the ongoing spread of variants of the COVID-19 virus may continue to interrupt, or delay, our clinical trial activities, regulatory reviews, manufacturing activities and supply chain.

The extent to which the COVID-19 pandemic impacts our business will depend on future developments, which are uncertain and cannot be predicted, including new information which may emerge concerning the severity of the COVID-19 pandemic and the actions to contain COVID-19 or treat its impact, including among other things, the effectiveness and outreach of COVID-19 vaccines.

In addition, the invasion of Ukraine and the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries have created global security concerns that could result in a regional conflict and also adversely affect our ability to conduct ongoing and future clinical trials of our product candidates. For example, our RAPIDe-1 and CHAPTER-1 studies include a significant number of patients in Germany, Poland, and Bulgaria. A further escalation of the conflict in Ukraine may potentially impact our ability to complete our ongoing and planned clinical trials in these countries on a timely basis, or at all. Clinical trials in these countries could be suspended or terminated, and we may be prevented from obtaining data on patients already enrolled at affected sites. Any of the foregoing could impede the execution of our clinical development plans.

Furthermore, in August 2022, the FDA placed a hold on the clinical trials of deucrictibant in the U.S. based on its review of nonclinical data. The FDA requested that Pharvaris conduct an additional long-term rodent toxicology study and update the Investigator’s Brochure. Pharvaris participated in a Type A meeting with the FDA to discuss paths to address the on-demand and prophylactic holds. A protocol for a 26-week rodent toxicology study has been aligned with the FDA and the study has initiated. We expect to submit results for this study to the FDA by the end of 2023. However, we cannot provide any assurance that we will be able to resolve the clinical holds.

The FDA agreed to partially lift the clinical hold on on-demand to allow two remaining U.S. participants in RAPIDe-1 to complete treatment of a final HAE attack per protocol. All other clinical studies of deucrictibant are currently on hold in the U.S. Outside the U.S., the regulatory status remains unchanged for the CHAPTER-1 study and other studies, including an open-label, long-term extension study (RAPIDe-2). Pharvaris notified country-specific regulatory authorities in Canada, Europe, Israel, and the UK of the U.S. clinical holds. All active sites outside of the U.S. continue to recruit participants in the CHAPTER-1 clinical study.

 

Recent Developments

There are no recent developments that need to be disclosed.

 

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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 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:

We anticipate that our total 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 for a discussion of these risks and uncertainties.

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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:

We anticipate that the continuing development of our business and the expense of maintaining directors’ and officers’ liability insurance, will contribute to future increase in general and administrative expenses. We also expect that general and administrative expenses will increase in the future as we incur additional costs associated with being a public company in the United States.

Share-based compensation expenses

In 2016, we implemented an Equity Incentive Plan, or 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.

 

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Result of operations

The financial information shown below was derived from our unaudited condensed consolidated interim financial statements for the three months ended March 31, 2023 and 2022 included as Exhibit 99.3 to this Report on Form 6-K. The discussion below should be read along with these condensed consolidated interim financial statements, and it is qualified in its entirety by reference to them.

Comparison of the three months ended March 31, 2023 and March 31, 2022

 

 

		For the three months ended March 31,
		2023				2022				Change				%
		(in €)
Research and development expenses			(13,744,431	)			(13,514,488	)			(229,943	)			2	%
General and administrative expenses			(7,331,596	)			(5,865,006	)			(1,466,590	)			25	%
Total operating expenses			(21,076,027	)			(19,379,494	)			(1,696,533	)			9	%
Operating loss			(21,076,027	)			(19,379,494	)			(1,696,533	)			9	%
Finance (expense) income			(1,494,265	)			3,391,179				(4,885,444	)			(144	)%
Loss before tax			(22,570,292	)			(15,988,315	)			(6,581,977	)			41	%
Income taxes			(60,657	)			(38,715	)			(21,942	)			57	%
Loss for the period			(22,630,949	)			(16,027,030	)			(6,603,919	)			41	%

 

 

Revenues

We did not generate any revenues for the three months ended March 31, 2023 and March 31, 2022.

Research and development expenses

 

		For the three months ended March 31,
		2023				2022				Change				%
		(in €)
Personnel expenses			(4,217,700	)			(2,529,171	)			(1,688,529	)			67	%
Clinical expenses			(4,868,447	)			(6,566,065	)			1,697,618				(26	)%
Nonclinical expenses			(2,751,198	)			(816,125	)			(1,935,073	)			237	%
Manufacturing costs			(1,907,086	)			(3,464,524	)			1,557,438				(45	)%
Intellectual Property costs			—				(138,603	)			138,603				(100	)%
Total research and development expenses			(13,744,431	)			(13,514,488	)			(229,943	)			2	%

 

 

Research and development expenses increased from €13,514,488 for the three months ended March 31, 2022 to €13,744,431 for the three months ended March 31, 2023. The increase in the research and development expenses is mainly driven by the progress made in the PHVS416 and PHVS719 development programs in the three months ended March 31, 2023.

 

Clinical expenses decreased by €1,697,618 for the three months ended March 31, 2023 compared to the three months ended March 31, 2022, due to the progression and read-out of the RAPIDe-1 on demand and progression of the CHAPTER-1 prophylactic Phase 2 studies and their open-label extension studies.

 

Nonclinical expenses increased by €1,935,073 for the three months ended March 31, 2023 compared to the three months ended March 31, 2022, primarily due to studies related to the 26-week rodent toxicology study intended to address the clinical hold in the U.S.

 

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Manufacturing costs relating to the Active Pharmaceutical Ingredient ("API") and pharmaceutical development of PHVS416 and PHVS719 decreased by €1,557,438 for the three months ended March 31, 2023 compared to the three months ended March 31, 2022, due to the procurement of raw materials in Q1-2022. Activities are ongoing to support the clinical programs and preparations for the pre-commercialization phase.

 

In the personnel expenses for the three months ended March 31, 2023 and 2022 an amount of €1,212,616 and €928,911, respectively, was included which related to share-based compensation arrangements. The increase in the share-based payments for the three months ended March 31, 2023, relates to the new grants awarded in the period after March 31, 2022 up to and including March 31, 2023. The remaining increase in personnel expenses is driven by the growth of our organization resulting in additional employees hired, and yearly merit adjustments.

 

General and administrative expenses

 

		For the three months ended March 31
		2023				2022				Change				%
		(in €)
Personnel expenses			(3,301,584	)			(2,444,883	)			(856,701	)			35	%
Consulting fees			(177,869	)			(177,912	)			43				(0	)%
Professional fees			(882,470	)			(884,000	)			1,530				(0	)%
Accounting, tax and auditing fees			(359,353	)			(304,498	)			(54,855	)			18	%
Facilities, communication and office expenses			(1,491,273	)			(1,628,098	)			136,825				(8	)%
Travel expenses			(322,733	)			(143,754	)			(178,979	)			125	%
Other expenses			(796,314	)			(281,861	)			(514,453	)			183	%
Total general and administrative expenses			(7,331,596	)			(5,865,006	)			(1,466,590	)			25	%

 

 

General and administrative expenses increased from €5,865,006 for the three months ended March 31, 2022 to €7,331,596 for the three months ended March 31, 2023. The increase in general and administrative expenses was mainly driven by the growth of the Company and increasing costs related to our commercial buildout. In the personnel expenses for the three months ended March 31,2023 and 2022 an amount of €1,370,271 and €1,018,027 respectively, was included which related to share-based compensation arrangements. The increase in the share-based payments for the three months ended March 31, 2023, relates to the new grants awarded in the period after March 31, 2022 up to and including March 31, 2023. The remaining increase in personnel expenses is driven by the growth of our organization resulting in additional employees hired, and yearly merit adjustments.

 

Finance (expense) income

Finance (expense) income for the three months ended March 31, 2023 and 2022 were (€1,494,265) and €3,391,179, respectively. The amount mainly relates to unrealized foreign exchange (losses)/income, which is mostly the result of translating the Company’s bank balances held in USD to EUR.

 

Income taxes

 

The tax expense over the three months ended March 31, 2023 and 2022 relates to the Company's U.S. subsidiary as the result of a cost-plus agreement between the U.S. and the Company’s principal entity, resulting in an estimated taxable profit in the U.S.

 

Liquidity and Capital Resources

 

Since inception, we have incurred significant operating losses. For the three months ended March 31, 2023 and 2022 we incurred losses of €22,630,949 and €16,027,030, 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.

 

 

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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 with SVB Securities LLC, or SVB Securities, pursuant to which we may sell ordinary shares having an aggregate offering price of up to $75 million from time to time through SVB Securities. During 2022, we sold a total of 588,100 ordinary shares in two different transactions under the sales agreement generating total net proceeds of $9,698,504, after deducting $299,954 which was payable to SVB Securities as commission in respect of such sales. Our understanding is that SVB Securities is not impacted by the Silicon Valley Bank ("SVB") receivership proceedings.

 

As of March 31, 2023 we had cash and cash equivalents of €135,181,223. Of the cash on hand, €65,567 relates to guarantees. Our cash and cash equivalents consist solely of cash at bank.

 

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 our unaudited condensed consolidated interim financial statements for the three months ended March 31, 2023 and 2022. Accordingly, the unaudited condensed consolidated interim financial statements have been prepared on a going concern basis.

Our future viability is dependent on our ability to raise additional capital to finance operations. We will need to finance our operations through public or private securities offerings, debt financings or other sources, which may include licensing, collaborations or other strategic transactions or arrangements. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining such additional financing on terms acceptable to us, if at all. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.

 

Our contractual obligations and commitments as of March 31, 2023 amounted to €26,736,388 primarily related to research and development commitments.

 

Cash Flows

Comparison for the three months ended March 31, 2023 and 2022.

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 three months ended  March 31,
	2023			2022			Change				%
	(in €)
Net cash flows used in operating activities		(25,204,785	)		(17,881,192	)		(7,323,593	)			41	%
Net cash flows used in investing activities		(19,038	)		(26,372	)		7,334				(28	)%
Net cash flows used in financing activities		(56,752	)		(110,126	)		53,374				(48	)%
Net decrease in cash and cash equivalents		(25,280,575	)		(18,017,690	)		(7,262,885	)			40	%
Cash and cash equivalents at the beginning of the period		161,837,429			209,353,132			(47,515,703	)			(23	)%
Effect of exchange rate changes		(1,375,631	)		3,439,302			(4,814,933	)			(140	)%
Cash and cash equivalents at the end of the period		135,181,223			194,774,744			(59,593,521	)			(31	)%

 

 

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.

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Net cash used in operating activities was €25,204,785 for the three months ended March 31, 2023, an increase of €7,323,593 compared to €17,881,192 for the three months ended March 31, 2022, primarily reflecting the increase in research and development expenses and other operating expenses, due to progression made in the PHVS416 and PHVS719 development programs and the growth of our organization in 2022.

Investing activities

Net cash flows used in investing activities decreased by €7,334 from €26,372 for the three months ended March 31, 2022, to €19,038 for the three months ended March 31, 2023, primarily as a result of lower capital expenditure related to office equipment in 2023.

Financing activities

Net cash flows provided by financing activities decreased by €53,374 from €110,126 for the three months ended March 31, 2022, to €56,752 for the three months ended March 31, 2023. The cash outflow in three months ended March 31, 2023 relates to the financial leases only, while for the three months ended March 31, 2022 it relates to the financial lease and transaction costs.

Off-Balance Sheet Arrangements

As of March 31, 2023, we did not have any off-balance sheet arrangements other than the disclosed commitments.

Quantitative and Qualitative Disclosures About Market Risk

During the three months ended March 31, 2023, 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:

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You should refer to “ITEM 3. Key information—D. Risk factors.” section of our Annual Report 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.

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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.

 

 

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Exhibit 99.3

 

Pharvaris N.V.

Unaudited Condensed Consolidated Interim Financial Statements

At March 31, 2023

 

 

 

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Contents

 

Unaudited condensed consolidated statements of Loss and Comprehensive Loss	3
Unaudited condensed consolidated statements of financial position	4
Unaudited condensed consolidated statements of changes in equity	5
Unaudited condensed consolidated statements of cash flows	6
Notes to the unaudited condensed consolidated interim financial statements	7

 

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Unaudited condensed consolidated statements of loss and other comprehensive loss

						Three months ended March 31,
						2023				2022
		Notes				€				€
Research and development expenses			3				(13,744,431	)			(13,514,488	)
General and administrative expenses			4				(7,331,596	)			(5,865,006	)
Total operating expenses							(21,076,027	)			(19,379,494	)
Finance (expense) income			6				(1,494,265	)			3,391,179
Loss before income tax							(22,570,292	)			(15,988,315	)
Income taxes			7				(60,657	)			(38,715	)
Net Loss							(22,630,949	)			(16,027,030	)
Other comprehensive income (Loss)
Exchange (losses) gains arising on translation of foreign operations							(30,509	)			8,680
Total comprehensive loss attributable to:
Equity holders of the Company							(22,661,458	)			(16,018,350	)
Loss per share attributable to the equity holders of the Company during the periods
Basic and diluted loss per share:		19					(0.67	)			(0.48	)

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

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Unaudited condensed consolidated statements of financial position

 

 

 

						March 31, 2023				December 31, 2022
		Notes				€				€
Assets
Non-current assets
Property, plant and equipment			8				199,224				193,474
Right of use assets			9				381,652				432,965
Deferred tax assets			7				90,062				259,803
Current assets
Receivables			10				394,082				382,468
Other current assets			11				11,554,398				4,626,844
Cash and cash equivalents			12				135,181,223				161,837,429
Total assets							147,800,641				167,732,983
Equity and liabilities
Equity
Share capital			13				4,059,724				4,057,976
Share premium							289,452,258				289,177,197
Other reserves							22,475,537				20,169,459
Currency translation reserve							12,781				43,290
Accumulated loss							(186,852,641	)			(164,188,892	)
Total equity							129,147,659				149,259,030
Long term liabilities
Non-current lease liability			9				158,398				249,418
Current liabilities
Trade and other payables			14				8,030,293				6,685,080
Accrued liabilities			15				9,883,925				10,890,749
Current lease liability			9				228,120				187,404
Current tax payable							352,246				461,302
Total liabilities							18,652,982				18,473,953
Total equity and liabilities							147,800,641				167,732,983

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

 

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Unaudited condensed consolidated statements of changes in equity

For the three months ended March 31, 2023 and March 31, 2022

 

 

						Share capital				Share premium				Other reserves				Currency translation reserve				Accumulated losses				Total Equity
		Notes				€				€				€				€				€				€
Balance at January 1, 2022							3,978,226				278,742,900				9,774,416				25,928				(87,568,401	)			204,953,069
Net Loss						—				—				—				—					(16,027,030	)			(16,027,030	)
Issue of share capital			13				60				8,279			—				—				—					8,339
Transaction costs on issue of shares						—					(250	)		—				—				—					(250	)
Currency translation reserve						—				—				—					8,680			—					8,680
Share-based payments			18			—				—					1,946,938			—				—					1,946,938
Balance at March 31, 2022							3,978,286				278,750,929				11,721,354				34,608				(103,595,431	)			190,889,746
Balance at January 1, 2023							4,057,976				289,177,197				20,169,459				43,290				(164,188,892	)			149,259,030
Net Loss							—				—				—				—				(22,630,949	)			(22,630,949	)
Currency translation reserve							—				—				—				(30,509	)			—				(30,509	)
Settlement of share-based payments							1,748				275,061				(276,809	)			—				(32,800	)			(32,800	)
Share-based payments			18				—				—				2,582,887				—				—				2,582,887
Balance at March 31, 2023							4,059,724				289,452,258				22,475,537				12,781				(186,852,641	)			129,147,659

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

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Unaudited condensed consolidated statements of cash flows

For the three months ended March 31,

 

 

				2023				2022
		Notes		€				€
Operating activities
Loss before tax					(22,570,292	)			(15,988,315	)
Non-cash adjustments to reconcile loss before tax to net cash flows from operations:
Share-based payment expense		18			2,582,887				1,946,938
Depreciation expense		4			61,869				32,850
Net foreign exchange (gain) loss		6			1,595,478				(3,436,187	)
Finance expense (income)		6			(101,213	)			40,311
Changes in working capital:
Increase (decrease) in receivables					(11,614	)			31,065
Increase in other current assets					(6,927,554	)			(3,275,589	)
Increase in trade and other payables					1,215,762				854,291
(Decrease) increase in accrued liabilities					(1,101,550	)			1,963,578
Income taxes paid					(2,270	)			—
(Paid) received interest					53,712				(50,134	)
Net cash flows used in operating activities					(25,204,785	)			(17,881,192	)
Investing activities
Purchase of property, plant and equipment		8			(19,038	)			(26,372	)
Net cash flows used in investing activities					(19,038	)			(26,372	)
Financing activities
Proceeds from issue of shares		13			—				8,339
Transaction costs on issue of shares					—				(102,443	)
Payment of principal portion of lease liabilities		9			(56,752	)			(16,022	)
Net cash flows used in by financing activities					(56,752	)			(110,126	)
Net decrease in cash and cash equivalents					(25,280,575	)			(18,017,690	)
Cash and cash equivalents at the beginning of the period					161,837,429				209,353,132
Effect of exchange rate changes					(1,375,631	)			3,439,302
Cash and cash equivalents at the end of the period		12			135,181,223				194,774,744

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements

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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. It has been registered at the Chamber of Commerce under file number 64239411.

Pharvaris is a clinical-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 March 31, 2023 and December 31, 2022, and for the three months ended March 31, 2023 and 2022 were authorized for issue in accordance with a resolution of the directors on May 8, 2023.

1.2 Group information

Subsidiaries

The unaudited condensed consolidated interim financial statements of the Group include:

 

				Country of		% of equity interest as March 31,
Name		Legal seat		incorporation		2023		2022
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

The ultimate parent company of the Group is Pharvaris N.V., which is based in the Netherlands.

 

 

 

 

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