Core Viewpoint - BioPorto A/S has pre-announced its key financial results for Q3 2025, showing continued growth in NGAL sales, while also revising its full-year guidance for 2025 downward due to performance in the first nine months of the year [1][6]. Financial Performance - Total revenue for the first nine months of 2025 reached DKK 28.7 million, a 1% increase year-over-year, with a 2% increase at constant exchange rates [3]. - NGAL sales increased by 5% compared to the same period in 2024, and by 7% at constant exchange rates, primarily driven by US NGAL RUO sales and ProNephro AKI sales [3]. - US NGAL RUO sales surged by 21% year-over-year, and by 23% at constant exchange rates [3]. - Revenue for Q3 2025 totaled DKK 10.4 million, reflecting a 7% increase compared to Q3 2024, and a 10% increase at constant exchange rates [9]. - Adjusted EBITDA loss for the first nine months of 2025 was DKK 63.3 million, compared to DKK 51.1 million in the same period last year [4]. Sales Breakdown - Q3 2025 NGAL sales in the US amounted to DKK 4.7 million, a 20% increase from Q3 2024, while ROW NGAL sales plummeted by 87% to DKK 0.4 million [5]. - ProNephro AKI sales through distributors in Q3 2025 were DKK 2.1 million [9]. - Total NGAL sales for the first nine months of 2025 were DKK 19.3 million, a 5% increase from the previous year [5]. Guidance Adjustment - The full-year revenue guidance for 2025 has been revised to a range of DKK 40-45 million, down from the previous estimate of DKK 45-50 million [10]. - The adjusted EBITDA loss expectation remains unchanged, projected to be in the range of DKK 75-80 million [10].

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 Insights - BioPorto A/S is sponsoring conferences focused on pediatric solid organ transplants and critical care nephrology, presenting new NGAL scientific data that enhances the identification and management of Acute Kidney Injury (AKI) in patients [1][2]. Group 1: Conference Participation - The International Pediatric Transplant Association (IPTA) held a biennial event in Berlin with over 500 participants, addressing AKI concerns in pediatric patients through various sessions [2]. - Dr. Kyle Merrill and Dr. June Oh presented a special session on NGAL usage, attended by over 100 participants, highlighting its application in patient cases [2]. - The 5th International Symposium on AKI in Children commenced on September 26 in Cincinnati, aiming for scientific collaboration across pediatric communities [2]. Group 2: Research and Publications - Multiple abstracts and posters will feature NGAL research from academic clinicians globally, with a notable publication discussing NGAL's role in predicting kidney support therapy duration in critically ill children [3]. - The research on NGAL is significant as there is currently no standard of care in this area, indicating potential future diagnostic applications [3]. Group 3: Company Information - BioPorto has facilities in Copenhagen and Boston, and its shares are listed on the Nasdaq Copenhagen stock exchange [6].

Core Insights - BioPorto A/S is sponsoring conferences focused on pediatric solid organ transplants and critical care nephrology, presenting new NGAL scientific data that enhances the identification and management of Acute Kidney Injury (AKI) in patients [1][2]. Group 1: Conference Participation - The International Pediatric Transplant Association (IPTA) held a biennial event in Berlin with over 500 participants, addressing AKI concerns in pediatric patients through various sessions [2]. - Dr. Kyle Merrill and Dr. June Oh presented a special session on NGAL usage, attended by over 100 participants, highlighting its application in patient cases [2]. - The 5th International Symposium on AKI in Children commenced on September 26 in Cincinnati, aiming for scientific collaboration across pediatric communities [2]. Group 2: Research and Publications - Multiple abstracts and posters will feature NGAL research from academic clinicians globally, with a notable publication discussing NGAL's role in predicting kidney support therapy duration in critically ill children [3]. - The research on NGAL is significant as it addresses the lack of current standards in AKI management and may lead to future diagnostic testing applications [3]. Group 3: Company Information - BioPorto has facilities in Copenhagen and Boston, and its shares are listed on the Nasdaq Copenhagen stock exchange [6].

Core Insights - BioPorto A/S is participating in the US News & World Report webinar titled "New Frontiers in Kidney Care," focusing on acute and chronic kidney disease and the importance of kidney health integration into broader health strategies [1][2] - The webinar will feature a panel discussion moderated by Shanley Chien, with speakers who have extensive experience in kidney biomarker research, particularly the NGAL biomarker [2][5] - BioPorto's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), allowing for earlier intervention and tailored patient management strategies [6][7] Company Overview - BioPorto is an in vitro diagnostics company dedicated to improving patient outcomes through actionable kidney biomarkers, addressing significant unmet medical needs in kidney care [6][7] - The company has facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [8] Product Information - The NGAL tests developed by BioPorto are designed to identify patients at risk of AKI more rapidly than standard care measurements, which can significantly reduce morbidity and mortality associated with delayed diagnosis [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].

Core Viewpoint - BioPorto A/S will present its financial results for the first half of 2025 during an investor webcast scheduled for August 15, 2025 [1] Company Overview - BioPorto A/S is an in vitro diagnostics company focused on improving patient management through actionable biomarkers [2] - The company specializes in antibody and assay development, aiming to address significant unmet medical needs with its product pipeline [2] Key Products - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of Acute Kidney Injury (AKI) [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier intervention [3] Market Presence - BioPorto has facilities located in Copenhagen, Denmark, and Boston, MA, USA, and its shares are listed on the Nasdaq Copenhagen stock exchange [4]

Core Points - BioPorto A/S has initiated the commercialization of ProNephro AKI (NGAL) for diagnostic use in the US, marking a significant milestone in the company's kidney diagnostics platform [1][3] - The first purchase order for ProNephro AKI (NGAL) has been received from Roche Diagnostics, which will facilitate distribution to US hospitals [2][3] - ProNephro AKI (NGAL) has received FDA 510(k) marketing clearance for use with Roche's cobas® c501 analyzers, which are widely available in medical laboratories and hospitals [2] Company Overview - BioPorto is an in vitro diagnostics company focused on developing actionable biomarkers to improve patient management and outcomes [4] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), a condition that can lead to severe health consequences if not identified early [5] - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [6]

Core Viewpoint - BioPorto A/S has announced the appointment of Carsten Buhl as the new CEO, effective September 1, 2025, as part of its succession planning strategy [1][2]. Company Leadership Transition - Current CEO Peter Mørch Eriksen will remain in his position until September 1, 2025, and will assist Carsten Buhl during the transition period [2]. - Carsten Buhl has over 25 years of experience in the MedTech/life science industries, previously serving as President of Americas at WSAudiology and holding senior leadership roles at Natus Medical Inc, Ambu, and GN Store Nord [3]. Strategic Goals and Future Plans - Jens Due Olsen, Chair of BioPorto, emphasized that Carsten Buhl will play a crucial role in launching ProNephro AKI (NGAL)™ in the US market, driving revenue growth, and finalizing clinical studies for an FDA application for adult use in 2026 [4]. - Carsten Buhl expressed enthusiasm about joining BioPorto and aims to unlock the full potential of the company's biomarker tests for kidney health, which can enhance clinical and economic outcomes globally [4]. Company Achievements - Under Peter Mørch Eriksen's leadership, BioPorto achieved significant milestones, including the development of a comprehensive Corporate Strategy Plan, revenue growth, preparation for the commercial launch of ProNephro AKI (NGAL) in the US, and securing critical financing rounds [4]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable biomarkers to improve patient management and outcomes [5]. - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), enabling earlier intervention and tailored patient management strategies [6].

Core Viewpoint - BioPorto A/S has issued 1,700,000 warrants to its Board of Directors as part of their remuneration, with each warrant allowing the purchase of one share at an exercise price of DKK 1.50, reflecting the current closing price on Nasdaq Copenhagen [1][2]. Summary by Sections Warrants Issuance - The issuance of warrants was approved during the annual general meeting on April 11, 2025, and is part of the company's compensation strategy for its Board members [1]. - The warrants will vest in equal tranches quarterly over a two-year period, with the first tranche becoming available at the start of the first calendar quarter following the grant date [3]. Terms and Conditions - The warrants are governed by the company's incentive warrant program and include provisions for claw-back in cases of erroneous financial information and accelerated vesting in the event of a takeover or business combination [4]. - The theoretical market value of the newly issued warrants is calculated to be DKK 1,843,580, based on the Black-Scholes formula, with an interest rate of 2.37% and historical volatility of 63.82% over 120 months [5]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable biomarkers to enhance patient management and improve clinical outcomes [7]. - The company's flagship products utilize the NGAL biomarker to assist in the risk assessment and diagnosis of Acute Kidney Injury (AKI), enabling faster identification and intervention for at-risk patients [8]. - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [9].