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
1
Unaudited condensed consolidated statements of profit or loss and other comprehensive income or loss
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Three months ended September 30, |
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Nine months ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Notes |
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€ |
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€ |
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€ |
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€ |
|
|||||
Research and development expenses |
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3 |
|
|
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(14,088,845 |
) |
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(8,956,174 |
) |
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(41,324,971 |
) |
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(25,088,223 |
) |
General and administrative expenses |
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4 |
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(8,297,822 |
) |
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(4,374,081 |
) |
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(21,822,960 |
) |
|
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(12,810,500 |
) |
Total operating expenses |
|
|
|
|
|
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(22,386,667 |
) |
|
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(13,330,255 |
) |
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(63,147,931 |
) |
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(37,898,723 |
) |
Finance income - net |
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6 |
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11,494,934 |
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4,254,526 |
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26,387,917 |
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7,598,899 |
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Loss before income tax |
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|
|
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(10,891,733 |
) |
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(9,075,729 |
) |
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(36,760,014 |
) |
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(30,299,824 |
) |
Income taxes |
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|
7 |
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2,403,929 |
|
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(68,190 |
) |
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(375,888 |
) |
|
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(89,744 |
) |
Loss for the period |
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|
|
|
|
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(8,487,804 |
) |
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(9,143,919 |
) |
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(37,135,902 |
) |
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(30,389,568 |
) |
Other comprehensive income/(loss) |
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Exchange gains arising on translation of foreign operations |
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208,615 |
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1,245 |
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128,204 |
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2,920 |
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Total comprehensive loss attributable to: |
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Equity holders of the Company |
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(8,279,189 |
) |
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(9,142,674 |
) |
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(37,007,698 |
) |
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(30,386,648 |
) |
Loss per share attributable to the equity holders of the Company during the periods |
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Basic and diluted loss per share: |
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19 |
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(0.25 |
) |
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(0.28 |
) |
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(1.11 |
) |
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(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
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September 30, 2022 |
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December 31, 2021 |
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Notes |
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€ |
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€ |
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Assets |
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Non-current assets |
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Property, plant and equipment |
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8 |
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182,026 |
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108,099 |
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Right of use assets |
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9 |
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195,922 |
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243,250 |
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Current assets |
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Deferred tax assets |
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7 |
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239,432 |
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172,052 |
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Receivables |
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10 |
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404,155 |
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700,079 |
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Other current assets |
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11 |
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4,231,283 |
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1,513,452 |
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Cash and cash equivalents |
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12 |
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197,729,447 |
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209,353,132 |
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Total assets |
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202,982,265 |
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212,090,064 |
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Equity and liabilities |
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Equity |
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Share capital |
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13 |
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4,054,529 |
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3,978,226 |
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Share premium |
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288,461,572 |
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278,742,900 |
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Other reserves |
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17,415,183 |
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9,774,416 |
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Currency translation reserve |
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154,132 |
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25,928 |
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Accumulated loss |
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(124,913,939 |
) |
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(87,568,401 |
) |
Total equity |
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185,171,477 |
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204,953,069 |
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Long term liabilities |
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Non-current lease liability |
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9 |
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86,534 |
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150,752 |
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Current liabilities |
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Trade and other payables |
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14 |
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7,095,858 |
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2,490,572 |
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Accrued liabilities |
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15 |
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10,131,060 |
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4,270,082 |
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Current lease liability |
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9 |
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112,287 |
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99,432 |
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Current tax liability |
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385,049 |
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126,157 |
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Total liabilities |
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17,810,788 |
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7,136,995 |
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Total equity and liabilities |
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202,982,265 |
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212,090,064 |
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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
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Share capital |
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Share premium |
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Other reserves |
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Currency translation reserve |
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Accumulated losses |
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Total Equity |
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Notes |
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€ |
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€ |
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€ |
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€ |
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€ |
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€ |
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Balance at January 1, 2021 |
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235,693 |
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138,034,580 |
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1,979,875 |
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(4,365 |
) |
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(44,459,954 |
) |
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95,785,829 |
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Net loss |
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— |
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— |
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— |
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|
|
— |
|
|
|
(30,386,648 |
) |
|
|
(30,386,648 |
) |
Increase in par value |
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|
13 |
|
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|
2,592,621 |
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(2,592,621 |
) |
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— |
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|
|
— |
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|
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— |
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|
— |
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Issue of share capital |
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13 |
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|
1,141,329 |
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|
156,014,570 |
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|
— |
|
|
|
— |
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|
|
— |
|
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|
157,155,899 |
|
Transaction costs on issue of shares |
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|
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|
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— |
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(13,154,360 |
) |
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— |
|
|
|
— |
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|
|
— |
|
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|
(13,154,360 |
) |
Currency translation reserve |
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— |
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— |
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— |
|
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|
2,920 |
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— |
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|
2,920 |
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Shares issued upon exercise of options or RSUs |
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18 |
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5,789 |
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133,360 |
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(91,681 |
) |
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— |
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(231,803 |
) |
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(184,335 |
) |
Share-based payments |
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18 |
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— |
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— |
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6,207,308 |
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— |
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|
|
— |
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|
6,207,308 |
|
Balance at September 30, 2021 |
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|
|
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|
3,975,432 |
|
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|
278,435,529 |
|
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|
8,095,502 |
|
|
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(1,445 |
) |
|
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(75,078,405 |
) |
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|
215,426,613 |
|
Balance at January 1, 2022 |
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|
|
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|
3,978,226 |
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|
278,742,900 |
|
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9,774,416 |
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|
25,928 |
|
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(87,568,401 |
) |
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|
204,953,069 |
|
Net loss |
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|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(37,135,902 |
) |
|
|
(37,135,902 |
) |
Issue of share capital |
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|
13 |
|
|
|
70,572 |
|
|
|
9,464,901 |
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|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,535,473 |
|
Transaction costs on issue of shares |
|
|
|
|
|
|
— |
|
|
|
(307,710 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(307,710 |
) |
Currency translation reserve |
|
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|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
128,204 |
|
|
|
— |
|
|
|
128,204 |
|
Share-based payments |
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|
18 |
|
|
|
— |
|
|
|
— |
|
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|
8,133,588 |
|
|
|
— |
|
|
|
— |
|
|
|
8,133,588 |
|
Settlement of share-based payments |
|
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|
|
|
|
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,
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2022 |
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|
2021 |
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|
Notes |
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|
€ |
|
|
€ |
|
||||
Operating activities |
|
|
|
|
|
|
|
|
|
|
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Loss before tax |
|
|
|
|
|
|
(36,760,014 |
) |
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|
(30,299,824 |
) |
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
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|
|
|
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|
|
|
|
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Share-based payment expense |
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|
18 |
|
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|
8,133,588 |
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|
6,207,308 |
|
Depreciation expense |
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|
4 |
|
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|
106,767 |
|
|
|
44,003 |
|
Net foreign exchange gain |
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|
6 |
|
|
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(26,492,975 |
) |
|
|
(7,837,250 |
) |
Finance costs |
|
|
6 |
|
|
|
105,058 |
|
|
|
238,351 |
|
Changes in working capital: |
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|
|
|
|
|
|
|
|
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|
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:
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Country of |
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% of equity interest as September 30, |
|
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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.
16
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
17