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


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