Unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024 | F-3 |
Unaudited condensed consolidated statements of financial position as of March 31, 2025 and December 31, 2024 | F-4 |
Unaudited condensed consolidated statements of changes in shareholders’ equity for the three months ended March 31, 2025 and 2024 | F-5 |
Unaudited condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 | F-6 |
Notes to the unaudited condensed consolidated financial statements | F-7 |
1. Summary of significant accounting policies and other disclosures | F-7 |
a) Reporting entity and the Group’s structure | F-7 |
b) Basis of preparation | F-7 |
2. Revenues | F-8 |
3. Cost of sales | F-8 |
4. Sales and marketing expenses | F-8 |
5. Research and development expenses | F-8 |
6. General and administrative expenses | F-9 |
7. Other income | F-9 |
8. Net financial result | F-9 |
9. Inventory | F-9 |
10. Other assets | F-10 |
11. Tax receivables | F-10 |
12. Financial assets and financial liabilities | F-10 |
13. Trade and other payables | F-11 |
14. Cash and cash equivalents | F-12 |
15. Equity | F-12 |
16. Share-based payments | F-12 |
c) Equity settled share-based payment arrangements | F-12 |
d) Share-based payment expense recognized | F-13 |
e) Share options exercised | F-14 |
17. Protective foundation | F-14 |
For the three months ended March 31, | ||||||||||||
Note | 2025 (unaudited) | 2024 (unaudited) | ||||||||||
(in €, except for share data) | ||||||||||||
Revenues | 2 | — | 36,037 | |||||||||
Cost of sales | 3 | (9,291 | ) | (220,521 | ) | |||||||
Gross profit (loss) | (9,291 | ) | (184,484 | ) | ||||||||
Sales and marketing expenses | 4 | (1,457,978 | ) | (1,459,539 | ) | |||||||
Research and development expenses | 5 | (7,016,336 | ) | (7,301,810 | ) | |||||||
General and administrative expenses | 6 | (5,062,605 | ) | (3,579,150 | ) | |||||||
Other income | 7 | 541,098 | 36,323 | |||||||||
Other expenses | (26 | ) | (30 | ) | ||||||||
Operating result | (13,005,139 | ) | (12,488,690 | ) | ||||||||
Finance income | 8 | 493,764 | 908,426 | |||||||||
Finance expenses | 8 | (4,086 | ) | (4,632 | ) | |||||||
Foreign exchange result | 8 | (1,908,829 | ) | 1,824,375 | ||||||||
Other financial result | 8 | 6,110,264 | 103,285 | |||||||||
Income taxes | — | — | ||||||||||
Income (loss) for the period | (8,314,027 | ) | (9,657,236 | ) | ||||||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | ||||||||||||
Exchange differences on translation of foreign currency | (150,667 | ) | (25,538 | ) | ||||||||
Total comprehensive income (loss) | (8,464,694 | ) | (9,682,774 | ) | ||||||||
Share information | ||||||||||||
Weighted average number of shares outstanding | 63,312,911 | 58,883,272 | ||||||||||
Income (loss) per share (basic/diluted) | (0.13 | ) | (0.17 | ) |
Note | March 31, 2025 (unaudited) | December 31, 2024 | ||||||||||
(in €) | ||||||||||||
ASSETS | ||||||||||||
Non-current assets | ||||||||||||
Property and equipment | 246,577 | 256,280 | ||||||||||
Right-of-use assets | 659,107 | 758,368 | ||||||||||
Intangible assets | 54,136 | 50,781 | ||||||||||
Other assets | 10 | 190,974 | 204,233 | |||||||||
Financial assets | 12 | 237,711 | 3,092,290 | |||||||||
Total non-current assets | 1,388,505 | 4,361,952 | ||||||||||
Current assets | ||||||||||||
Inventories | 9 | 6,895,371 | 6,897,666 | |||||||||
Current other assets | 10 | 5,548,032 | 5,103,402 | |||||||||
Other assets from government grants and research allowance | 10 | 5,614,632 | 5,081,772 | |||||||||
Tax receivable | 11 | 1,693,150 | 1,735,335 | |||||||||
Other financial assets | 12 | 18,573,783 | 34,462,352 | |||||||||
Cash and cash equivalents | 14 | 47,286,630 | 18,375,979 | |||||||||
Total current assets | 85,611,597 | 71,656,505 | ||||||||||
TOTAL ASSETS | 87,000,103 | 76,018,457 | ||||||||||
EQUITY AND LIABILITIES | ||||||||||||
Equity | ||||||||||||
Issued capital | 15 | 8,129,656 | 7,122,205 | |||||||||
Share premium | 348,956,590 | 334,929,685 | ||||||||||
Other capital reserves | 46,595,867 | 44,115,861 | ||||||||||
Accumulated deficit | (340,506,248 | ) | (332,192,221 | ) | ||||||||
Other components of equity | 7,289,843 | 7,440,510 | ||||||||||
Total equity | 70,465,707 | 61,416,039 | ||||||||||
Non-current liabilities | ||||||||||||
Lease liabilities | 295,444 | 399,066 | ||||||||||
Other liabilities | 13 | 36,877 | 36,877 | |||||||||
Total non-current liabilities | 332,321 | 435,943 | ||||||||||
Current liabilities | ||||||||||||
Trade and other payables | 12 | 8,366,404 | 11,394,232 | |||||||||
Lease liabilities | 407,184 | 406,020 | ||||||||||
Employee benefits | 714,489 | 2,064,678 | ||||||||||
Liabilities to warrant holders | 6,366,158 | — | ||||||||||
Other liabilities | 13 | 347,839 | 301,544 | |||||||||
Total current liabilities | 16,202,075 | 14,166,475 | ||||||||||
Total liabilities | 16,534,396 | 14,602,417 | ||||||||||
TOTAL EQUITY AND LIABILITIES | 87,000,103 | 76,018,457 |
(in €, except for share data) | Note | Shares outstanding | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other compo- nents of equity | Total equity | ||||||||||||||||||||||||
Balance as of January 1, 2025 | 59,351,710 | 7,122,205 | 334,929,685 | 44,115,861 | (332,192,221 | ) | 7,440,510 | 61,416,039 | ||||||||||||||||||||||||
Loss for the period | — | — | — | — | (8,314,027 | ) | — | (8,314,027 | ) | |||||||||||||||||||||||
Exchange differences on translation of foreign currency | — | — | — | — | — | (150,667 | ) | (150,667 | ) | |||||||||||||||||||||||
Total comprehensive loss | — | — | — | — | (8,314,027 | ) | (150,667 | ) | (8,464,694 | ) | ||||||||||||||||||||||
Issuance of ordinary shares | 8,395,420 | 1,007,450 | 15,136,235 | — | — | — | 16,143,687 | |||||||||||||||||||||||||
Transaction costs for ordinary shares | — | — | (1,109,330 | ) | — | — | — | (1,109,330 | ) | |||||||||||||||||||||||
Equity-settled share-based payments | 16 | — | — | — | 2,480,006 | — | — | 2,480,006 | ||||||||||||||||||||||||
Balance as of March 31, 2025* | 67,747,130 | 8,129,656 | 348,956,590 | 46,595,867 | (340,506,248 | ) | 7,289,843 | 70,465,708 | ||||||||||||||||||||||||
Balance as of January 1, 2024 | 58,883,272 | 7,065,993 | 334,211,338 | 40,050,053 | (286,127,819 | ) | 7,382,166 | 102,581,730 | ||||||||||||||||||||||||
Loss for the period | — | — | — | — | (9,657,236 | ) | — | (9,657,236 | ) | |||||||||||||||||||||||
Exchange differences on translation of foreign currency | — | — | — | — | — | (25,538 | ) | (25,538 | ) | |||||||||||||||||||||||
Total comprehensive loss | — | — | — | — | (9,657,236 | ) | (25,538 | ) | (9,682,774 | ) | ||||||||||||||||||||||
Equity-settled share-based payments | 16 | — | — | — | 1,860,701 | — | — | 1,860,701 | ||||||||||||||||||||||||
Balance as of March 31, 2024 | 58,883,272 | 7,065,993 | 334,211,338 | 41,910,754 | (295,785,055 | ) | 7,356,629 | 94,759,658 |
For the three months ended March 31, | ||||||||||||
Note | 2025 (unaudited) | 2024 (unaudited) | ||||||||||
(in €) | ||||||||||||
Operating activities | ||||||||||||
Loss for the period | (8,314,027 | ) | (9,657,236 | ) | ||||||||
Adjustments for: | ||||||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 113,801 | 123,949 | ||||||||||
Net finance income | 8 | (4,691,112 | ) | (2,831,454 | ) | |||||||
Share-based payment expense | 16 | 2,480,006 | 1,860,701 | |||||||||
Net foreign exchange differences and other adjustments | 972,608 | (119,126 | ) | |||||||||
Changes in: | ||||||||||||
Other assets from government grants and research allowances | (532,860 | ) | — | |||||||||
Other assets and trade receivables | 10 | (389,188 | ) | (161,789 | ) | |||||||
Employee benefits | (1,350,189 | ) | (972,159 | ) | ||||||||
Other liabilities | 13 | 46,295 | 62,417 | |||||||||
Trade and other payables | 13 | (3,027,828 | ) | (4,366,605 | ) | |||||||
Inventories | 9 | 2,295 | 319,162 | |||||||||
Interest received | 10 | 678,717 | 875,990 | |||||||||
Interest paid | 10 | (4,191 | ) | (2,214 | ) | |||||||
Net cash used in operating activities | (14,015,672 | ) | (14,868,364 | ) | ||||||||
Investing activities | ||||||||||||
Purchase of intangible assets, property and equipment | (10,446 | ) | (16,069 | ) | ||||||||
Purchase of current financial assets | — | (3,566,235 | ) | |||||||||
Proceeds from the maturity of financial assets | 17,666,078 | 30,527,108 | ||||||||||
Net cash from / (used in) investing activities | 17,655,632 | 26,944,804 | ||||||||||
Financing activities | ||||||||||||
Proceeds from issuance of ordinary shares | 16,143,686 | — | ||||||||||
Transaction costs from issuance of ordinary shares and pre-funded warrants | (1,949,998 | ) | — | |||||||||
Proceeds from pre-funded warrants | 12,915,909 | — | ||||||||||
Repayment of lease liabilities | (100,097 | ) | (85,706 | ) | ||||||||
Net cash from / (used in) financing activities | 27,009,268 | (85,706 | ) | |||||||||
Net in-/ decrease in cash and cash equivalents | 30,649,459 | 11,990,733 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (1,738,808 | ) | 344,381 | |||||||||
Cash and cash equivalents at beginning of period | 18,375,979 | 12,767,943 | ||||||||||
Cash and cash equivalents at end of period | 14 | 47,286,630 | 25,103,058 |
1. | Summary of significant accounting policies and other disclosures |
a) | Reporting entity and the Group’s structure |
b) | Basis of preparation |
• | Amendments to IAS 21 Effects of Changes in Foreign Exchange Rates: Lack of exchangeability |
• | Amendments to IFRS 9 Financial Instruments and IFRS 7 Financial Instruments: Disclosures, Classification and Measurement of Financial Instruments |
• | Amendments to IFRS 9 Financial Instruments and IFRS 7 Financial Instruments: Disclosures, Contracts Referencing Nature-dependent Electricity |
• | IFRS 18 Presentation and Disclosure in Financial Statements |
c) | Pre-funded warrants issued in February 2025 |
2. | Revenues |
For the three months ended March 31, | ||||||||
2025 (unaudited) | 2024 (unaudited) | |||||||
(in €) | ||||||||
Revenues | — | 36,037 | ||||||
Total | — | 36,037 |
3. | Cost of sales |
For the three months ended March 31, | ||||||||
2025 (unaudited) | 2024 (unaudited) | |||||||
(in €) | ||||||||
Cost of sales | 9,291 | 220,521 | ||||||
Total | 9,291 | 220,521 |
4. | Sales and marketing expenses |
5. | Research and development expenses |
6. | General and administrative expenses |
7. | Other income |
8. | Net financial result |
For the three months ended March 31, | ||||||||
2025 (unaudited) | 2024 (unaudited) | |||||||
(in €) | ||||||||
Interest income | 493,764 | 908,426 | ||||||
Interest expenses | (443 | ) | (439 | ) | ||||
Interest on lease liabilities | (3,643 | ) | (4,193 | ) | ||||
Financial result | 489,678 | 903,794 | ||||||
Foreign exchange income | 1,229,009 | 2,049,582 | ||||||
Foreign exchange expense | (3,137,838 | ) | (225,207 | ) | ||||
Foreign exchange result | (1,908,829 | ) | 1,824,375 | |||||
Result of expected credit loss adjustment on marketable securities | — | 103,285 | ||||||
Result from the revaluation of pre-funded warrants at fair value | 6,110,264 | — | ||||||
Other financial result | 6,110,264 | 103,285 | ||||||
Net financial result | 4,691,112 | 2,831,454 |
9. | Inventory |
As of March 31, 2025 (unaudited) | As of December 31, 2024 | |||||||
(in €) | ||||||||
Raw material and supplies | 82,087 | 82,087 | ||||||
Unfinished goods | 6,758,952 | 6,758,952 | ||||||
Finished goods | 54,332 | 56,627 | ||||||
Total | 6,895,371 | 6,897,666 |
10. | Other assets |
As of March 31, 2025 (unaudited) | As of December 31, 2024 | |||||||
(in €) | ||||||||
Non-current other assets | ||||||||
Prepaid expenses | 190,974 | 204,233 | ||||||
Total | 190,974 | 204,233 | ||||||
Current other assets | ||||||||
Prepayments on research & development projects | 4,290,839 | 4,628,878 | ||||||
Prepaid expenses | 1,162,012 | 354,948 | ||||||
Others | 95,181 | 119,576 | ||||||
Total | 5,548,032 | 5,103,402 | ||||||
Total other assets | 5,739,006 | 5,307,635 | ||||||
Other assets from research allowances | ||||||||
Current other assets from research allowances | 5,614,632 | 5,081,772 | ||||||
Other assets from research allowances | 5,614,632 | 5,081,772 |
11. | Tax receivables |
12. | Financial assets and financial liabilities |
As of March 31, 2025 (unaudited) | As of December 31, 2024 | |||||||
(in €) | ||||||||
Financial assets at amortized cost | ||||||||
Non-current financial assets | 237,711 | 3,092,290 | ||||||
Thereof marketable securities | — | 2,854,405 | ||||||
Current financial assets | 18,573,783 | 34,462,352 | ||||||
Thereof marketable securities | 18,390,455 | 33,969,390 | ||||||
Financial liabilities at amortized cost | ||||||||
Trade and other payables | 8,538,238 | 11,549,150 | ||||||
Financial liabilities at fair value | ||||||||
Liabilities to warrant holders | 6,366,158 | — |
13. | Trade and other payables |
As of March 31, 2025 (unaudited) | As of December 31, 2024 | |||||||
(in €) | ||||||||
Accrued liabilities from R&D projects | 5,486,874 | 6,609,925 | ||||||
Accrued liabilities from commercial activities | 132,600 | 69,250 | ||||||
Accounts payable | 1,414,098 | 3,413,064 | ||||||
Other accrued liabilities and payables | 1,680,671 | 1,603,538 | ||||||
Total | 8,714,243 | 11,695,777 |
14. | Cash and cash equivalents |
As of March 31, 2025 (unaudited) | As of December 31, 2024 | |||||||
(in €) | ||||||||
Short-term deposits | ||||||||
Deposits held in U.S. dollars | 39,480,125 | 13,408,478 | ||||||
Deposits held in euros | 800,000 | 700,000 | ||||||
Total | 40,280,125 | 14,108,478 | ||||||
Cash at banks | ||||||||
Cash held in U.S. dollars | 6,406,362 | 2,805,655 | ||||||
Cash held in euros | 600,144 | 1,461,847 | ||||||
Total | 7,006,506 | 4,267,501 | ||||||
Total cash and cash equivalents | 47,286,630 | 18,375,979 |
15. | Equity |
16. | Share-based payments |
a) | Equity settled share-based payment arrangements |
Number of share options | 2025 | 2024 | ||||||
Outstanding as of January 1, | 148,433 | 148,433 | ||||||
Exercised during the three months ended March 31 | — | — | ||||||
Outstanding as of March 31, | 148,433 | 148,433 | ||||||
thereof vested / exercisable | 148,433 | 148,433 |
Number of share options | 2025 | 2024 | ||||||
Outstanding as of January 1, | 888,632 | 888,632 | ||||||
Exercised during the three months ended March 31 | — | — | ||||||
Outstanding as of March 31, | 888,632 | 888,632 | ||||||
thereof vested / exercisable | 888,632 | 888,632 |
Number of share options | 2025 | 2024 | ||||||
Outstanding as of January 1, | 8,905,446 | 6,584,946 | ||||||
Granted during the three months ended March 31, | 2,452,000 | 2,275,000 | ||||||
Exercised during the three months ended March 31, | — | — | ||||||
Forfeited during the three months ended March 31, | (110,500 | ) | (7,000 | ) | ||||
Outstanding as of March 31, | 11,246,946 | 8,852,946 | ||||||
thereof vested / exercisable | 8,772,946 | 5,986,946 |
Share options granted 2025 | Number | Fair value per option | FX rate as of grant date | Fair value per option | Share price at grant date / Exercise price | Expected volatility | Expected life (midpoint based) | Risk-free rate (interpola ted, U.S. sovereign strips curve) | ||||||||||||||||||||||||
January 03 | 2,452,000 | $ | 1.86 | 0.971 | € | 1.81 | $ | 2.41 | 0.97 | 5.50 | 4.435 | % | ||||||||||||||||||||
2,452,000 |
b) | Share-based payment expense recognized |
c) | Share options exercised |
17. | Protective foundation |