Core Insights - BioPorto A/S has provided an update on its ongoing adult clinical study in the US, focusing on the investigational in vitro diagnostic (IVD) urine NGAL assay aimed at identifying patients at risk of acute kidney injury [1][4]. Clinical Study Progress - As of the end of October 2025, BioPorto has successfully completed patient enrollment for its clinical cut-off study, although data collection is taking longer than expected [2]. - The company plans to submit a pre-submission meeting request to the US FDA after analyzing the dataset, which is now anticipated to be completed in Q1 2026 [2]. Regulatory Timeline - The clinical validation study will commence following FDA feedback, leading to a postponement of the FDA regulatory submission from late 2026 to the first half of 2027 [3]. - Despite the delay, the company aims for regulatory clearance in 2027, with plans to initiate commercialization targeting the adult population in the US thereafter [3]. Company Commitment - Carsten Buhl, CEO of BioPorto, emphasized the company's commitment to ensuring high-quality and effective study design, which is intended to mitigate risks associated with the validation study [4]. Product Focus - BioPorto's clinical program is centered on the NGAL biomarker, which is designed to assist in the risk assessment and management of acute kidney injury (AKI), a condition that can lead to severe health consequences if not identified early [7]. - The company markets NGAL tests under various registrations, including CE mark in several countries and FDA clearance for ProNephro AKI in the US [7].

Core Viewpoint - BioPorto A/S reported continued progress in executing its strategic objectives, highlighted by strong sales growth in NGAL products and the initiation of its commercial journey in the US market with the first order of ProNephro AKI [1][3][4]. Financial Performance - Total revenue for the second quarter of 2025 reached DKK 10.6 million, a 15% increase compared to DKK 9.2 million in the same period last year [7]. - For the first half of 2025, total revenue was DKK 18.3 million, reflecting a 2% decrease from DKK 18.7 million in the first half of 2024, primarily due to lower antibody sales [5][9]. - NGAL sales increased by 39% in Q2 2025 compared to Q2 2024, with a 23% rise in the US and a 71% increase in the rest of the world [6][7]. - Adjusted EBITDA loss for Q2 2025 was DKK 18.4 million, compared to DKK 16.2 million in Q2 2024, driven by higher costs associated with clinical studies [7][9]. - The adjusted EBITDA loss for the first half of 2025 was DKK 46.5 million, up from DKK 31.5 million in the same period last year [5][9]. Strategic Developments - A significant milestone was achieved with the receipt of the first purchase order for ProNephro AKI (NGAL) for the US market, marking the start of its commercial launch [6]. - The company is progressing towards FDA submission for ProNephro AKI by the end of 2026, with patient enrollment in clinical studies on track [4][6]. - The board was restructured, with Jens Due Olsen appointed as Chairman and Carsten Buhl as the new CEO effective September 1, 2025, to lead the next growth phase [6]. Guidance - The company has narrowed its full-year revenue guidance for 2025 to DKK 45-50 million, down from the previous range of DKK 45-60 million [8][14]. - Adjusted EBITDA loss guidance for 2025 is now expected to be between DKK 75-80 million, previously estimated at DKK 75-85 million [14].