Exhibit 99.4

Pharvaris N.V.

Unaudited Condensed Consolidated Interim Financial Statements

As of and for the three and nine months ended September 30, 2022

 

Contents                                                                                                                                                                               Page

 

Unaudited condensed consolidated statements of profit or loss and other comprehensive income or loss

2

 

 

Unaudited condensed consolidated statements of financial position

3

 

 

Unaudited condensed consolidated statements of changes in equity

4

 

 

Unaudited condensed consolidated statements of cash flows

5

 

 

Notes to the unaudited condensed consolidated interim financial statements

6

 

 

1


 

Unaudited condensed consolidated statements of profit or loss and other comprehensive income or loss

 

 

 

 

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

Notes

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

3

 

 

 

(14,088,845

)

 

 

(8,956,174

)

 

 

(41,324,971

)

 

 

(25,088,223

)

General and administrative expenses

 

 

4

 

 

 

(8,297,822

)

 

 

(4,374,081

)

 

 

(21,822,960

)

 

 

(12,810,500

)

Total operating expenses

 

 

 

 

 

 

(22,386,667

)

 

 

(13,330,255

)

 

 

(63,147,931

)

 

 

(37,898,723

)

Finance income - net

 

 

6

 

 

 

11,494,934

 

 

 

4,254,526

 

 

 

26,387,917

 

 

 

7,598,899

 

Loss before income tax

 

 

 

 

 

 

(10,891,733

)

 

 

(9,075,729

)

 

 

(36,760,014

)

 

 

(30,299,824

)

Income taxes

 

 

7

 

 

 

2,403,929

 

 

 

(68,190

)

 

 

(375,888

)

 

 

(89,744

)

Loss for the period

 

 

 

 

 

 

(8,487,804

)

 

 

(9,143,919

)

 

 

(37,135,902

)

 

 

(30,389,568

)

Other comprehensive income/(loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exchange gains arising on translation of foreign operations

 

 

 

 

 

 

208,615

 

 

 

1,245

 

 

 

128,204

 

 

 

2,920

 

Total comprehensive loss attributable to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity holders of the Company

 

 

 

 

 

 

(8,279,189

)

 

 

(9,142,674

)

 

 

(37,007,698

)

 

 

(30,386,648

)

Loss per share attributable to the equity holders of the Company during the periods

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share:

 

 

19

 

 

 

(0.25

)

 

 

(0.28

)

 

 

(1.11

)

 

 

(1.03

)

 

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

 

 

2


 

Unaudited condensed consolidated statements of financial position

 

 

 

 

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

Notes

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

 

 

 

Property, plant and equipment

 

 

8

 

 

 

182,026

 

 

 

108,099

 

Right of use assets

 

 

9

 

 

 

195,922

 

 

 

243,250

 

Current assets

 

 

 

 

 

 

 

 

 

 

 

 

Deferred tax assets

 

 

7

 

 

 

239,432

 

 

 

172,052

 

Receivables

 

 

10

 

 

 

404,155

 

 

 

700,079

 

Other current assets

 

 

11

 

 

 

4,231,283

 

 

 

1,513,452

 

Cash and cash equivalents

 

 

12

 

 

 

197,729,447

 

 

 

209,353,132

 

Total assets

 

 

 

 

 

 

202,982,265

 

 

 

212,090,064

 

Equity and liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

Share capital

 

 

13

 

 

 

4,054,529

 

 

 

3,978,226

 

Share premium

 

 

 

 

 

 

288,461,572

 

 

 

278,742,900

 

Other reserves

 

 

 

 

 

 

17,415,183

 

 

 

9,774,416

 

Currency translation reserve

 

 

 

 

 

 

154,132

 

 

 

25,928

 

Accumulated loss

 

 

 

 

 

 

(124,913,939

)

 

 

(87,568,401

)

Total equity

 

 

 

 

 

 

185,171,477

 

 

 

204,953,069

 

Long term liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Non-current lease liability

 

 

9

 

 

 

86,534

 

 

 

150,752

 

Current liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Trade and other payables

 

 

14

 

 

 

7,095,858

 

 

 

2,490,572

 

Accrued liabilities

 

 

15

 

 

 

10,131,060

 

 

 

4,270,082

 

Current lease liability

 

 

9

 

 

 

112,287

 

 

 

99,432

 

Current tax liability

 

 

 

 

 

 

385,049

 

 

 

126,157

 

Total liabilities

 

 

 

 

 

 

17,810,788

 

 

 

7,136,995

 

Total equity and liabilities

 

 

 

 

 

 

202,982,265

 

 

 

212,090,064

 

 

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

 

3


 

 

Unaudited condensed consolidated statements of changes in equity

For the nine months ended September 30, 2022 and 2021

 

 

 

 

 

 

 

Share

capital

 

 

Share

premium

 

 

Other

reserves

 

 

Currency

translation

reserve

 

 

Accumulated

losses

 

 

Total

Equity

 

 

 

Notes

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at January 1, 2021

 

 

 

 

 

 

235,693

 

 

 

138,034,580

 

 

 

1,979,875

 

 

 

(4,365

)

 

 

(44,459,954

)

 

 

95,785,829

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,386,648

)

 

 

(30,386,648

)

Increase in par value

 

 

13

 

 

 

2,592,621

 

 

 

(2,592,621

)

 

 

 

 

 

 

 

 

 

 

 

 

Issue of share capital

 

 

13

 

 

 

1,141,329

 

 

 

156,014,570

 

 

 

 

 

 

 

 

 

 

 

 

157,155,899

 

Transaction costs on issue of shares

 

 

 

 

 

 

 

 

 

(13,154,360

)

 

 

 

 

 

 

 

 

 

 

 

(13,154,360

)

Currency translation reserve

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,920

 

 

 

 

 

 

2,920

 

Shares issued upon exercise of options or RSUs

 

 

18

 

 

 

5,789

 

 

 

133,360

 

 

 

(91,681

)

 

 

 

 

 

(231,803

)

 

 

(184,335

)

Share-based payments

 

 

18

 

 

 

 

 

 

 

 

 

6,207,308

 

 

 

 

 

 

 

 

 

6,207,308

 

Balance at September 30, 2021

 

 

 

 

 

 

3,975,432

 

 

 

278,435,529

 

 

 

8,095,502

 

 

 

(1,445

)

 

 

(75,078,405

)

 

 

215,426,613

 

Balance at January 1, 2022

 

 

 

 

 

 

3,978,226

 

 

 

278,742,900

 

 

 

9,774,416

 

 

 

25,928

 

 

 

(87,568,401

)

 

 

204,953,069

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,135,902

)

 

 

(37,135,902

)

Issue of share capital

 

 

13

 

 

 

70,572

 

 

 

9,464,901

 

 

 

 

 

 

 

 

 

 

 

 

9,535,473

 

Transaction costs on issue of shares

 

 

 

 

 

 

 

 

 

(307,710

)

 

 

 

 

 

 

 

 

 

 

 

(307,710

)

Currency translation reserve

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

128,204

 

 

 

 

 

 

128,204

 

Share-based payments

 

 

18

 

 

 

 

 

 

 

 

 

8,133,588

 

 

 

 

 

 

 

 

 

8,133,588

 

Settlement of share-based payments

 

 

 

 

 

 

5,731

 

 

 

561,481

 

 

 

(492,821

)

 

 

 

 

 

(209,636

)

 

 

(135,245

)

Balance at September 30, 2022

 

 

 

 

 

 

4,054,529

 

 

 

288,461,572

 

 

 

17,415,183

 

 

 

154,132

 

 

 

(124,913,939

)

 

 

185,171,477

 

 

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

 

4


 

 

Unaudited condensed consolidated statements of cash flows

For the nine months ended September 30,

 

 

 

 

 

 

 

2022

 

 

2021

 

 

 

Notes

 

 

 

 

 

Operating activities

 

 

 

 

 

 

 

 

 

 

 

 

Loss before tax

 

 

 

 

 

 

(36,760,014

)

 

 

(30,299,824

)

Non-cash adjustments to reconcile loss before tax to net cash flows from operations:

 

 

 

 

 

 

 

 

 

 

 

 

Share-based payment expense

 

 

18

 

 

 

8,133,588

 

 

 

6,207,308

 

Depreciation expense

 

 

4

 

 

 

106,767

 

 

 

44,003

 

Net foreign exchange gain

 

 

6

 

 

 

(26,492,975

)

 

 

(7,837,250

)

Finance costs

 

 

6

 

 

 

105,058

 

 

 

238,351

 

Changes in working capital:

 

 

 

 

 

 

 

 

 

 

 

 

Decrease/(Increase) in receivables

 

 

 

 

 

 

295,924

 

 

 

(62,789

)

(Increase) in other current assets

 

 

 

 

 

 

(2,192,198

)

 

 

(3,067,974

)

Increase in trade and other payables

 

 

 

 

 

 

4,605,286

 

 

 

2,723,748

 

Increase in accrued liabilities

 

 

 

 

 

 

5,787,859

 

 

 

163,657

 

Paid interest

 

 

 

 

 

 

(138,915

)

 

 

(177,640

)

Income taxes paid

 

 

 

 

 

 

(200,041

)

 

 

(28,157

)

Net cash flows used in operating activities

 

 

 

 

 

 

(46,749,661

)

 

 

(32,096,567

)

Investing activities

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property, plant and equipment

 

 

8

 

 

 

(100,657

)

 

 

(61,494

)

Net cash flows used in investing activities

 

 

 

 

 

 

(100,657

)

 

 

(61,494

)

Financing activities

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from issue of shares

 

 

13

 

 

 

9,609,865

 

 

 

157,236,819

 

Transaction costs

 

 

 

 

 

 

(726,367

)

 

 

(12,925,547

)

Decrease in financial liability

 

 

 

 

 

 

(73,320

)

 

 

(20,575

)

Net cash flows provided by financing activities

 

 

 

 

 

 

8,810,178

 

 

 

144,290,697

 

Net increase (decrease) in cash and cash equivalents

 

 

 

 

 

 

(38,040,140

)

 

 

112,132,636

 

Cash and cash equivalents at the beginning of the period

 

 

 

 

 

 

209,353,132

 

 

 

98,628,871

 

Effect of exchange rate changes

 

 

 

 

 

 

26,416,455

 

 

 

7,834,271

 

Cash and cash equivalents at the end of the period

 

 

12

 

 

 

197,729,447

 

 

 

218,595,778

 

 

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

 

5


 

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 address of its registered office is J.H. Oortweg 21, Leiden. The Company’s registered office is located at J.H. Oortweg 21, 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 September 30, 2022 and December 31, 2021, and for the three and nine months ended September 30, 2022 and 2021 were authorized for issue in accordance with a resolution of the directors on December 8, 2022.

1.2 Group information

Subsidiaries

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

 

 

 

 

 

Country of

 

% of

equity interest as

September 30,

 

Name

 

Legal seat

 

incorporation

 

2022

 

 

2021

 

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.

Major developments during the three months ended September 30, 2022

In August 2022, the Company announced that the U.S. Food and Drug Administration (the “FDA”) had placed a clinical hold on the clinical trials of PHA121 in the United States (the “clinical hold”).

The clinical hold letters stated that the nonclinical observations are unlikely due to B2 receptor antagonism, the primary mechanism of action of the compound. The FDA has requested that the Company conduct an additional long-term rodent toxicology study and update the Investigator’s Brochure.

The Company notified country-specific regulatory authorities in Canada, Europe, Israel, and the UK of the U.S. clinical hold. The regulatory status of the CHAPTER-1 study outside the U.S. remains unchanged. All active sites outside of the U.S. continue to enroll participants in the CHAPTER-1 clinical study.

 

6


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 and should be read in conjunction with the Group’s annual consolidated financial statements for the year ended December 31, 2021 (“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.

Revision of prior period loss per share

In the period ended June 30, 2022, the Company determined that it had incorrectly computed the weighted average number of ordinary shares outstanding used as denominator in calculating its basic and diluted loss per share in previously issued interim financial statements. This error had no impact on the Company’s operating expenses, or loss for the period, and had no impact on the Company’s consolidated statements of financial position, consolidated statements of changes in equity or consolidated statements of cash flows.

The Company assessed the materiality of these errors on the previously issued condensed consolidated interim financial statements and concluded that the errors were not material to any period presented. The impact of the revision of the previously issued interim financial statements is as follows:

As reported vs revised ‘weighted average number of shares’:

 

 

As reported

weighted

average

number of

shares

(Quarterly)

 

 

As reported

weighted

average

number of

shares

(YTD)

 

 

Revision of

weighted

average

number of

shares

(Quarterly)

 

 

Revision of

weighted

average

number of

shares

(YTD)

 

Q3 2021

 

 

23,282,105

 

 

 

23,282,105

 

 

 

33,128,593

 

 

 

29,493,657

 

 

As reported vs revised ‘basic and diluted loss per share’:

 

 

As reported

basic and

diluted

loss per share

(Quarterly)

 

 

As reported

basic and

diluted

loss per share

(YTD)

 

 

Revision of

basic and

diluted

loss per share

(Quarterly)

 

 

Revision of

basic and

diluted

loss per share

(YTD)

 

Q3 2021

 

 

(0.39

)

 

 

(1.31

)

 

 

(0.28

)

 

 

(1.03

)

 

2.2 Going concern

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. These therapies will need to go through clinical development trials to achieve regulatory approval for commercialization. Therefore, Pharvaris is incurring annual research and development and other operating costs and has no revenues to date (as is typical in the biotech industry for development stage and early commercial stage companies). As such, Pharvaris anticipates on-going negative operating cash flows for the foreseeable future before the company has a product candidate ready for commercialization, if at all. This makes the Group dependent on external capital sources, debt capital and equity capital. The Group is currently fully financed by equity capital.

 

7


As of September 30, 2022 and December 31, 2021 the Group had cash of €197.7 million and €209.4 million, respectively. The Group incurred net losses of €37.1 million in the nine months ended September 30, 2022 and €30.4 million in the same period in 2021 and negative operating cash flows of €46.7 million and €32.1 million in the nine months ended September 30, 2022 and the nine months ended September 30, 2021 respectively.

The Group does not expect positive operating cash flows in the foreseeable future and remains dependent on additional financing to fund its research and development expenses, general and administrative expenses and financing costs. The Group believes that the available cash balances are sufficient to execute the Group’s 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 these unaudited condensed consolidated interim financial statements. Accordingly, the unaudited condensed consolidated interim financial statements have been prepared on a going concern basis.

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

Impact of COVID-19

The Group has taken steps to identify and mitigate the adverse effects and risks to it as a result of the pandemic. The Group has modified its business practices, including implementing work from home arrangements for employees able to perform their duties remotely and practicing safe social distancing in our operations. The Group expects to continue to take actions as may be required or recommended by government authorities or in the best interests of its employees and business partners. While the impact of COVID-19 on the Group’s operations and financial performance has so far been limited, the extent to which COVID-19 may impact its 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, the Group’s clinical trial activities, regulatory reviews, manufacturing activities and supply chain.

The extent to which the COVID-19 pandemic impacts the Group’s business will depend on future developments, which are uncertain and cannot be predicted, including amongst other things, 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. If the Group is unable to meet its milestones it might jeopardize our funding opportunities.

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 significant 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, 2021.

 

8


3. Research and development expenses

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Personnel expenses (Note 5)

 

 

(3,692,003

)

 

 

(2,382,973

)

 

 

(9,282,210

)

 

 

(6,151,138

)

Clinical expenses

 

 

(8,037,012

)

 

 

(4,568,346

)

 

 

(21,778,622

)

 

 

(11,330,269

)

Nonclinical expenses

 

 

(862,643

)

 

 

(924,636

)

 

 

(2,695,561

)

 

 

(3,068,349

)

Manufacturing costs

 

 

(1,437,370

)

 

 

(1,052,191

)

 

 

(7,321,038

)

 

 

(3,972,363

)

License costs

 

 

 

 

 

 

 

 

 

 

 

(500,000

)

Intellectual Property costs

 

 

(59,817

)

 

 

(28,028

)

 

 

(247,540

)

 

 

(66,104

)

 

 

 

(14,088,845

)

 

 

(8,956,174

)

 

 

(41,324,971

)

 

 

(25,088,223

)

 

Development expenses are currently not capitalized but are recorded in the unaudited condensed consolidated statements of profit or loss and other comprehensive income 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

License costs during the period ended September 30, 2021 consist of a milestone payment of €500,000 which was paid to AnalytiCon upon commencement of Phase 2 development.

 4. General and administrative expenses

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Personnel expenses (Note 5)

 

 

(3,537,264

)

 

 

(1,982,190

)

 

 

(9,807,298

)

 

 

(5,018,977

)

Consulting fees

 

 

(246,269

)

 

 

(207,461

)

 

 

(679,080

)

 

 

(598,337

)

Professional fees

 

 

(1,379,416

)

 

 

(349,575

)

 

 

(3,174,586

)

 

 

(1,482,281

)

Accounting, tax and auditing fees

 

 

(444,057

)

 

 

(230,113

)

 

 

(1,038,714

)

 

 

(1,316,869

)

Facilities, communication & office expenses

 

 

(1,807,806

)

 

 

(1,550,713

)

 

 

(5,054,636

)

 

 

(4,012,860

)

Travel expenses

 

 

(379,369

)

 

 

(6,760

)

 

 

(783,569

)

 

 

(10,117

)

Other expenses

 

 

(503,641

)

 

 

(47,269

)

 

 

(1,285,077

)

 

 

(371,059

)

 

 

 

(8,297,822

)

 

 

(4,374,081

)

 

 

(21,822,960

)

 

 

(12,810,500

)

 

In 2021 the Group entered into a number of lease arrangements, which were assessed to be short-term leases (with a lease term of 12 months equaling its non-cancellable period).

 

Depreciation expense for the three and nine months ended September 30, 2022 was €38,572 and €106,767 (2021: €28,955, €44,003), which related to property, plant and equipment and leases and is included in the ‘Other expenses’ line.

 

9


5. Personnel expenses

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Wages and salaries

 

 

(3,647,977

)

 

 

(1,671,507

)

 

 

(9,493,153

)

 

 

(4,290,152

)

Pension charges

 

 

(205,053

)

 

 

(94,587

)

 

 

(560,782

)

 

 

(175,876

)

Other social security charges

 

 

(332,426

)

 

 

(261,109

)

 

 

(901,985

)

 

 

(496,779

)

Share-based payments

 

 

(3,043,811

)

 

 

(2,337,960

)

 

 

(8,133,588

)

 

 

(6,207,308

)

 

 

 

(7,229,267

)

 

 

(4,365,163

)

 

 

(19,089,508

)

 

 

(11,170,115

)

 

The average number of staff (in FTEs) employed by the Group in the nine months ended September 30, 2022 was 56 (2021: 21).

6. Finance income - net

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Foreign exchange differences

 

 

11,520,977

 

 

 

4,333,264

 

 

 

26,492,975

 

 

 

7,837,250

 

Interest expenses over bank balances

 

 

(25,863

)

 

 

(69,812

)

 

 

(104,380

)

 

 

(221,576

)

Other finance expenses

 

 

(180

)

 

 

(8,926

)

 

 

(678

)

 

 

(16,775

)

 

 

 

11,494,934

 

 

 

4,254,526

 

 

 

26,387,917

 

 

 

7,598,899

 

 

The foreign exchange differences mainly relate to unrealized foreign exchange income which is the result of translating the Company’s bank balances held in USD to EUR. 

 

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 and subsequently allocated using the expected full year effective tax rate. The discrete items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/income.

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Income tax benefit/(expense)

 

 

2,403,929

 

 

 

(68,190

)

 

 

(375,888

)

 

 

(89,744

)

 

 

 

2,403,929

 

 

 

(68,190

)

 

 

(375,888

)

 

 

(89,744

)

 

Following discussions with the Dutch tax authorities in November 2022, the Company concluded that foreign exchange results should be allocated to the principal Company in Switzerland. As a result, the estimated tax expense for the Dutch fiscal unity is lower than estimated in the previous quarter resulting in a tax benefit of €2.6 million for the three months ended September 30, 2022. The Swiss entity has net operating losses and no deferred tax assets are recognized in this respect. The tax expenses over the nine months ended September 30, 2022 relates to the Company's U.S. and Dutch

 

10


subsidiaries as the result of a cost-plus agreement between the U.S. and Dutch entities and the Group's principal entity 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 benefit (expense) as reported in the unaudited condensed consolidated statement of profit or loss and other comprehensive income or loss is as follows:

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Income/(loss) before tax

 

 

(10,891,733

)

 

 

(9,075,729

)

 

 

(36,760,014

)

 

 

(30,299,824

)

Income tax at statutory income tax rate in The Netherlands (25.8%)

 

 

2,810,068

 

 

 

2,268,932

 

 

 

9,484,084

 

 

 

7,574,956

 

Effect of tax rates in other countries

 

 

613,514

 

 

 

(2,084,950

)

 

 

(5,403,944

)

 

 

(5,256,906

)

Temporary differences for which no deferred tax assets/liabilities have been recognized

 

 

 

 

 

(106,338

)

 

 

 

 

 

(268,918

)

Nondeductible expenses

 

 

(112,887

)

 

 

(294

)

 

 

(302,947

)

 

 

(881

)

Current period losses for which no deferred tax asset has been recognized

 

 

(906,766

)

 

 

(197,353

)

 

 

(4,153,081

)

 

 

(2,189,808

)

Other

 

 

 

 

 

51,813

 

 

 

 

 

 

51,813

 

Income tax benefit (expense)

 

 

2,403,929

 

 

 

(68,190

)

 

 

(375,888

)

 

 

(89,744

)

 

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 for the applicable statutory tax rate.

The (estimated) average annual tax rate used for the nine months ended September 30, 2022 is (1.02%) compared to (0.30%) for the nine months ended September 30, 2021. For the nine months ended September 30, 2022 no discrete items are applicable. Hence, tax expense is in line with estimated effective tax rate.

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. Following discussions with the Dutch tax authorities in November 2022, the Company concluded that foreign exchange results should be allocated to the principal Company in Switzerland. As a result, the current losses for Switzerland are partly offset by the allocated foreign exchange results and the utilization of the previously unrecognized losses carry forward losses of the Dutch fiscal unity are lower than estimated in the previous quarter. The Company did not recognize the tax benefit of the losses incurred in previous years.

The differences in the overseas tax rates are due to the lower tax rate in Switzerland and the higher tax rate in the USA 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 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 neither been recognized in the unaudited condensed consolidated statement of profit or loss and other comprehensive income nor in the unaudited condensed consolidated statement of financial position.

 

11


8. Property, plant and equipment

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Balance at January 1, 2022 and 2021

 

 

108,099

 

 

 

48,503

 

Additions

 

 

100,657

 

 

 

78,251

 

Depreciation expense

4

 

(26,730

)

 

 

(18,655

)

Net book amount

 

 

182,026

 

 

 

108,099

 

 

 

 

 

 

 

 

 

 

Cost

 

 

235,361

 

 

 

134,704

 

Accumulated depreciation

 

 

(53,335

)

 

 

(26,605

)

Net book amount

 

 

182,026

 

 

 

108,099

 

 

During the nine months ended September 30, 2022, the Group acquired assets with a cost of €100,657 (December 31, 2021: €78,251). The acquisitions during the nine months ended September 30, 2022 and the year ended December 31, 2021 were related to equipment, tools and installations.

9. Leases

The following table provides information about the Group’s right-of-use assets:

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Balance at January 1

 

 

243,250

 

 

 

-

 

Addition

 

 

-

 

 

 

301,965

 

Depreciation charges

 

 

(80,037

)

 

 

(58,715

)

Impact of transaction of foreign currency

 

 

32,709

 

 

 

-

 

Balance

 

 

195,922

 

 

 

243,250

 

 

The following table provides information about the Group’s lease liabilities:

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Office lease

 

 

(198,821

)

 

 

(250,184

)

Total lease liability

 

 

(198,821

)

 

 

(250,184

)

Current portion

 

 

112,287

 

 

 

99,432

 

Non-current portion

 

 

86,534

 

 

 

150,752

 

 

The lease agreement started on June 1, 2021 and has a lease term of three years. The average incremental borrowing rate applied to the lease liabilities was 3.12% during the nine months ended September 30, 2022 (2021: 2.91%). The incremental borrowing rate was reassessed during the period and increased to 8.47% on September 1, 2022. Cash outflows related to leases during the nine months ended September 30, 2022 and 2021 were €73,320 and €20,575, respectively.

10. Receivables

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Trade Receivables

 

 

518

 

 

 

8,451

 

VAT receivables

 

 

403,637

 

 

 

691,628

 

 

 

 

404,155

 

 

 

700,079

 

 

 

12


 

11. Other current assets

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Prepayments

 

 

3,597,987

 

 

 

1,507,753

 

Other assets

 

 

633,296

 

 

 

5,699

 

 

 

 

4,231,283

 

 

 

1,513,452

 

 

Prepayments mainly relate to prepaid insurance, sign-on bonus to personnel, prepaid R&D expenses and rent.

Other assets mainly consist of deferred transaction costs related to Group’s in-process equity financing (refer to note 13). The company defers 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 September 30, 2022, the Company’s authorized share capital amounted to €14,100,000 divided into 58,750,000 ordinary shares and 58,750,000 preferred shares, each with a nominal value of €0.12. As at September 30, 2022, a total number of ordinary shares issued was 33,787,740 (2021: 33,128,593). On September 30, 2022, the issued share capital totaled to €4,054,529 (2021: €3,975,432).

In March 2022, the Company filed a Form F-3 Registration Statement and prospectus with the Securities and Exchange Commission relating to an at-the-market program providing for the sales from time to time of up to $75,000,000 of its ordinary shares pursuant to a Sales Agreement with SVB Securities LLC. During the nine months ended September 30, 2022, the Company sold a total of 588,100 ordinary shares in two different transactions under the sales agreement generating total net proceeds of $9,698,504 (€9.2 million), after deducting $299,954 (€308,000), which was payable to SVB Securities as commission in respect of such sales.

On February 5, 2021, the Company became public by listing its ordinary shares on the Nasdaq Stock Exchange. On the same date all Preferred shares A, Preferred shares B and Preferred shares C were automatically converted to ordinary shares and 9,511,075 ordinary shares were issued. Together with the issuance of the ordinary shares, the par value of each ordinary share was increased from €0.01 to €0.12.

Ordinary shares hold the right to one vote per share.

Issued shares

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

Number of

shares

 

 

Number of

shares

 

Ordinary shares

 

 

33,787,740

 

 

 

33,151,881

 

 

 

 

33,787,740

 

 

 

33,151,881

 

 

14. Trade and other payables

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Trade payables

 

 

6,366,190

 

 

 

2,125,511

 

Tax and social security liabilities

 

 

729,668

 

 

 

365,061

 

 

 

 

7,095,858

 

 

 

2,490,572

 

 

 

13


 

15. Accrued liabilities

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

 

 

 

Consulting, professional and audit liability

 

 

1,150,860

 

 

 

786,116

 

Clinical accrued liabilities

 

 

2,808,000

 

 

 

386,328

 

Manufacturing accrued liabilities

 

 

2,398,171

 

 

 

1,231,514

 

Pre-clinical accrued liabilities

 

 

2,771,109

 

 

 

398,468

 

Personnel related accruals

 

 

934,000

 

 

 

1,459,162

 

Other accrued liabilities

 

 

68,920

 

 

 

8,494

 

 

 

 

10,131,060

 

 

 

4,270,082

 

 

 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, 2021.

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 nine months ended September 30, 2022

 

 

 

Stock Options

 

 

RSUs

 

 

 

Outstanding

options

 

 

Weighted average

exercise price

 

 

Outstanding

RSUs

 

Outstanding January 1, 2022

 

 

2,470,295

 

 

9.18

 

 

 

259,714

 

Granted

 

 

742,500

 

 

16.12

 

 

 

430,596

 

Exercised

 

 

(31,257

)

 

2.38

 

 

 

(26,061

)

Forfeited

 

 

 

 

 

 

 

 

(58,533

)

Outstanding September 30, 2022

 

 

3,181,538

 

 

10.84

 

 

 

605,716

 

 

On January 1, 2022, a total of 70,000 stock options were granted to members of the Board of Directors with an exercise price of $14.39 per share with a final exercise date of December 31, 2031 unless forfeited or exercised on an earlier date. 25% of the aggregate number of share options shall vest on December 31, 2022 and thereafter 1/48th of the aggregate number of share options shall vest on each subsequent monthly anniversary of the vesting commencement date until either the option is fully vested, or the option holders’ continuous service terminates.

 

On April 1, 2022, a total of 552,500 stock options were granted to members of the Board of Directors and key management with an exercise price of $18.14 per share with a final exercise date of March 31, 2032 unless forfeited or exercised on an earlier date. 25% of the aggregate number of share options shall vest on March 31, 2023 and thereafter 1/48th of the aggregate number of share options shall vest on each subsequent monthly anniversary of the vesting commencement date until either the option is fully vested, or the option holders’ continuous service terminates.

 

On June 1, 2022, a total of 120,000 stock options were granted to members of key management with an exercise price of $17.98 per share with a final exercise date of May 31, 2032 unless forfeited or exercised on an earlier date. 25% of the

 

14


aggregate number of share options shall vest on May 31, 2023 and thereafter 1/48th of the aggregate number of share options shall vest on each subsequent monthly anniversary of the vesting commencement date until either the option is fully vested, or the option holders’ continuous service terminates.

 

During the nine months ended September 30, 2022 a total of 430,596 RSUs were granted to employees that joined the Group in the same period and 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 were January 1, 2022, February 1, 2022, March 1, 2022, April 1, 2022, May 1, 2022, June 1, 2022, July 1, 2022, August 1, 2022 and September 1, 2022. The share closing price was $16.41, $17.00, $18.47, $18.14, $17.10, $17.98, $23.65, $20.00 and $8.99 at January 3, 2022, February 1, 2022, March 1, 2022, April 1, 2022, May 2, 2022, June 1, 2022, July 1, 2022, August 1, 2022 and September 1, 2022 respectively.

 

For the nine months ended September 30, 2022, the Group recognized €8,133,588 of share-based payment expense in the unaudited condensed consolidated statement of income or loss and other comprehensive income (nine months ended September 30, 2021: €6,207,308). For the three months ended September 30, 2022, the Group recognized €3,043,811 of share-based payment expense in the unaudited condensed consolidated statement of income or loss and other comprehensive income (three months ended September 30, 2021: €2,337,961).

 

As of September 30, 2022, a total number of 1,453,439 stock options are exercisable (September 30, 2021: 384,417).

The inputs and outputs used in the measurement of the fair value per option at each grant/ measurement date using the Black-Scholes formula (including the related number of options and the fair value of the options) were as follows:

 

 

 

June 1, 2022

 

 

April 1, 2022

 

 

January 1, 2022

 

Number of options

 

 

120,000

 

 

 

552,500

 

 

 

70,000

 

Fair value of the options

 

11.83

 

 

11.50

 

 

9.10

 

Fair value of the ordinary shares

 

16.78

 

 

16.41

 

 

12.67

 

Exercise price

 

16.78

 

 

16.41

 

 

12.67

 

Expected volatility (%)

 

 

80

%

 

 

80

%

 

 

85

%

Expected life (years)

 

 

6.1

 

 

 

6.1

 

 

 

6.1

 

Risk-free interest rate (%)

 

 

3.0

%

 

 

2.6

%

 

 

1.4

%

Expected dividend yield

 

 

 

 

 

 

 

 

 

 

Expected volatility is based on an evaluation of the historical volatilities of comparable listed biotech-companies over the most recent historical period that commensurate with the expected option life. The expected life is based on Management’s best estimate of when the options will be exercised. The risk-free interest rate is based on the yield on U.S. Government bonds, with tenure equal to the expected life. The expected dividend yield is zero considering the stage of the Group.

19. Basic and diluted loss per share

Basic and diluted loss per share is calculated by dividing the loss for the period of the Company by the weighted average number of issued and outstanding ordinary shares during the three and nine months ended September 30, 2022 and 2021.

All of the Company’s potential dilutive securities have been excluded from the computation of diluted loss per share, as the effect of including them would be antidilutive.

  

 

15


 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021 (*)

 

 

2022

 

 

2021 (*)

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

(8,487,804

)

 

 

(9,143,919

)

 

 

(37,135,902

)

 

 

(30,389,568

)

Weighted average number of ordinary

   shares outstanding

 

 

33,785,026

 

 

 

33,128,593

 

 

 

33,508,682

 

 

 

29,493,657

 

Basic and diluted loss per share

 

 

(0.25

)

 

 

(0.28

)

 

 

(1.11

)

 

 

(1.03

)

 

(*) This has been revised. Refer to Note 2.1.

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 September 30, 2022 amounted to €27 million, (December 31, 2021: €19.5 million) primarily related to research and development commitments.

The Group had no contingent liabilities and no contingent assets as at September 30, 2022 and at September 30, 2021, respectively.

21. Related parties

Note 1.2 provides information about the Group’s structure, including details of the subsidiaries and the holding company. The following provides the total amount of transactions that have been entered into with related parties for the relevant financial period.

Key management personnel compensation

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

Short term employee benefits

 

 

829,616

 

 

 

838,302

 

 

 

2,350,022

 

 

 

2,274,408

 

Post employee benefits

 

 

30,228

 

 

 

34,079

 

 

 

108,787

 

 

 

56,178

 

Share-based payments

 

 

1,780,394

 

 

 

3,342,072

 

 

 

3,955,492

 

 

 

5,464,808

 

Total

 

 

2,640,238

 

 

 

4,214,453

 

 

 

6,414,301

 

 

 

7,795,394

 

 

A total number of 585,000 stock options and 14,216 RSUs were granted to key management during the nine months ended September 30, 2022. Refer to note 18 for disclosures on the share-based payments.

The Group engages several management entities for the purpose of providing key management services to the Group. The aggregate value of transactions related to key management personnel, or entities which they control were €834,685 and €1,896,264 in the nine months ended September 30, 2022 and 2021, respectively.

The estimated liabilities related to key management personnel, or entities which they control, as per September 30, 2022 and December 31, 2021 were €529,440 and €1,157,029, respectively.

22. Events after the reporting period

In August 2022, the Company announced that the FDA had placed a clinical hold on the clinical trials of PHA121 in the United States.

 

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The Company notified country-specific regulatory authorities in Canada, Europe, Israel, and the UK of the U.S. clinical hold. The regulatory status of the CHAPTER-1 study outside the U.S. remains unchanged. All active sites outside of the U.S. continue to enroll participants in the CHAPTER-1 clinical study. Pharvaris anticipates announcing top-line data from the CHAPTER-1 trial in the second half of 2023.

Subsequent to the period, the Company conducted a Type A meeting with the FDA. During the meeting, the Company proposed potential paths to resolve the clinical holds for each of the on-demand and prophylactic programs. The Company will provide additional information following receipt of the formal meeting minutes.

In the RAPIDe-1 study, the Company announced top-line Phase 2 data on December 8, 2022.

Signatories to the unaudited condensed consolidated interim financial statements

Leiden, December 8, 2022

Pharvaris N.V.

Board of Directors

 

 

 

 

 

B.A.E. Modig

A.M. de Jonge Schuermans

 

 

 

 

 

E. Björk

R.H. Glassman

 

 

 

 

 

D.P. Meeker

J.G.C.P. Schikan

 

V. Monges

 

 

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