Results of operation (Tables)

6 Months Ended

Jun. 30, 2026

Results of operation

Schedule of sales based on country of customer


		For the three months ended June 30				For the six months ended June 30
(in EUR 000)		2026		2025		2026		2025
Sales US		5,197		—		9,451		—
Sales Germany		1,391		1,175		2,615		2,104
Sales UAE		469		—		814		32
Sales England		481		—		658		—
Sales Switzerland		24		—		357		—
Sales Netherlands		—		—		39		—
Sales Austria		37		165		37		268
Sales Spain		3		—		3		—
Sales Italy		73		—		73		—
Total sales		7,675		1,340		14,047		2,404

Schedule of information about cost of goods sold


		For the three months ended				For the six months ended
		June 30,				June 30,
(in EUR 000)		2026		2025		2026		2025
Purchases of goods and services (*)		2,452		843		4,872		1,512
Inventory movement		639		(353)		954		(616)
Total cost of goods sold		3,091		490		5,826		896

(*)	Including purchases of raw material, direct labour allocation, indirect labour allocation, fees of subcontractors, warranty and shipping cost (direct)

Schedule of information about operating expenses


						Operating
						expense for the
(in EUR 000)		Total cost		Capitalized		period
Research and development		18,506		(159)		18,347
Selling, general and administrative expenses		30,992		—		30,992
Other income/(expense)		(40)		11		(29)
For the six months ended June 30, 2026		49,458		(148)		49,310


						Operating
						expense for the
(in EUR 000)		Total cost		Capitalized		period
Research and development		20,602		(1,554)		19,048
Selling, general and administrative expenses		23,063		—		23,063
Other income/(expense)		(171)		56		(115)
For the six months ended June 30, 2025		43,494		(1,498)		41,996


						Operating
						expense for the
(in EUR 000)		Total cost		Capitalized		period
Research and development		9,543		—		9,543
Selling, general and administrative expenses		15,618		—		15,618
Other income/(expense)		6		5		11
For the three months ended June 30, 2026		25,167		5		25,172


						Operating
						expense for the
(in EUR 000)		Total cost		Capitalized		period
Research and development		10,750		(691)		10,059
Selling, general and administrative expenses		10,672		—		10,672
Other income/(expense)		(56)		25		(31)
For the three months ended June 30, 2025		21,366		(666)		20,700

Schedule of information about research and development expenses


		For the three months ended				For the six months ended
		June 30,				June 30,
(in EUR 000)		2026		2025		2026		2025
Staff costs		3,050		3,700		5,775		8,280
Consulting and contractors’ fees		2,234		3,004		4,246		3,877
Q&A regulatory		91		43		99		119
Depreciation and amortization expense		1,470		418		2,746		829
Travel		352		434		737		713
Manufacturing and outsourced development		803		1,292		1,912		2,600
Clinical studies		1,049		1,396		2,073		3,250
IT		150		39		218		68
Rent		252		104		461		227
Other expenses		92		320		234		639
Capitalized costs		—		(691)		(154)		(1,554)
Total research and development expenses		9,543		10,059		18,347		19,048

Schedule of detailed information about selling, general and administrative expenses


		For the three months ended				For the six months ended
		June 30,				June 30,
(in EUR 000)		2026		2025		2026		2025
Staff costs		8,942		6,326		17,718		13,270
Consulting and contractors’ fees		3,816		2,527		7,053		5,734
Legal fees		995		217		2,540		479
Rent		101		124		138		230
Depreciation and amortization expense		342		356		782		719
IT		413		587		812		1,045
Travel		814		410		1,577		1,168
Insurance fees		103		108		213		221
Impairment loss on trade receivables		39		—		37		—
Other		53		17		122		197
Total selling, general and administrative expenses		15,618		10,672		30,992		23,063

Schedule of detailed information about other operating income


		For the three months ended				For the six months ended
		June 30,				June 30,
(in EUR 000)		2026		2025		2026		2025
Recoverable cash advances
Initial measurement and re-measurement		12		7		30		25
R&D incentives		(18)		49		10		110
Capitalization of R&D incentive		(5)		(25)		(11)		(56)
Other income/(expenses)		—		—		—		36
Total Other Operating Income/(Expenses)		(11)		31		29		115