Brief: BioPorto Initiates U.S. Adult Validation Study
BRIEF-BioPorto Initiates U.S. Adult Validation Study June 9 (Reuters) - Bioporto A/S BIOPOR.CO:
TO INITIATE PRONEPHRO AKI U.S. ADULT URINE NGAL VALIDATION STUDY
INITIATION FOLLOWS U.S. FOOD AND DRUG ADMINISTRATION (FDA) FEEDBACK ON PRE-SUBMISSION REQUEST FILED MARCH 31, 2026
AS A RESULT OF INCREASED STUDY SIZE FDA CLEARANCE IS NOW EXPECTED MID-2028
LARGER SAMPLE SIZE RESULTS IN ADDITIONAL STUDY COSTS OF ABOUT DKK 20 MILLION, CORRESPONDING TO AN INCREASE OF ABOUT 70%
UPDATES 2028 ASPIRATIONS: REVENUE DKK 135-185 MILLION, CASH FLOW POSITIVE SECOND HALF 2028
ADJUSTED EBITDA MARGIN EXPECTATION FOR 2028 MAINTAINED AT AT LEAST 15%
EXPECTS TO BRIDGE CASH FLOW REQUIREMENTS THROUGH MIX OF OPERATIONAL EFFICIENCIES AND OTHER OPTIONS, FOR EXAMPLE CREDIT FACILITIES
Source text: ID:nGNE6TnrrN
Further company coverage: BIOPOR.CO
(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))