December 11, 2025 Announcement no. 29 Changes to the Executive Management COPENHAGEN, DENMARK and BOSTON, MA, USA, December 11, 2025 (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto”) (CPH:BIOPOR) announced today that Niels Høy Nielsen has resigned as CFO of BioPorto to become CFO at another company. “I have valued the close collaboration with Niels during the last couple of months since I joined BioPorto. He has made important contributions across the company and wish him all the best in his future endeavors” ...

Core Points - BioPorto A/S has completed a private placement of 40,438,426 new shares, raising approximately DKK 43 million in new capital [1][2] - The new shares represent 8.89% of BioPorto's registered share capital prior to the increase [2] - The nominal share capital of BioPorto now amounts to DKK 495,108,887, consisting of 495,108,887 shares [4] Company Overview - BioPorto is an in vitro diagnostics company focused on improving patient outcomes through actionable kidney biomarkers, particularly for Acute Kidney Injury (AKI) [5] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and management of AKI, enabling earlier intervention [5] - BioPorto's tests are marketed under various registrations, including CE mark in several countries and FDA clearance for ProNephro AKI™ in the US [5] Trading and Listing - The new shares will be admitted to trading and officially listed on Nasdaq Copenhagen A/S under the company's permanent ISIN code [3] - The new shares carry the same rights as existing shares, including the right to receive dividends from the time the capital increase is registered [3] Capital Structure - Following the capital increase, BioPorto's Articles of Association have been updated to reflect the new share capital structure [4] - The company emphasizes its commitment to transparency and provides access to its announcements and relevant information through its investor relations platform [4]

Core Insights - BioPorto A/S has successfully completed a private placement, raising approximately DKK 43 million through the issuance of 40,438,426 new shares, which represents 8.89% of the company's registered share capital prior to the increase [1][2]. Group 1: Share Capital Increase - The capital increase has been registered with the Danish Business Authority, and the gross proceeds from the issue amount to approximately DKK 43 million [2]. - The new shares will carry the same rights as existing shares, including the right to receive dividends from the time the capital increase is registered [3]. Group 2: Company Overview - BioPorto is focused on in vitro diagnostics, particularly in developing kidney biomarkers to aid in the management of Acute Kidney Injury (AKI) [5]. - The company's flagship products utilize the NGAL biomarker, which allows for quicker identification of patients at risk of AKI, facilitating earlier intervention [5]. - BioPorto's shares are listed on the Nasdaq Copenhagen stock exchange, and the company has facilities in both Copenhagen, Denmark, and Boston, MA, USA [6].

Core Viewpoint - BioPorto A/S reported continued growth in NGAL sales and outlined strategic milestones in its "Forward" strategy aimed at transforming kidney care globally [1][5]. Financial Performance - Revenue for Q3 2025 reached DKK 10.4 million, a 7% increase year-over-year, and a 10% increase at constant exchange rates [9]. - Total revenue for the first nine months of 2025 was DKK 28.7 million, reflecting a 1% increase compared to the same period last year, with a 2% increase at constant exchange rates [9][10]. - NGAL sales in Q3 2025 totaled DKK 7.2 million, growing by 5% globally and 10% at constant exchange rates [9]. - For the first nine months of 2025, NGAL sales rose by 5% compared to the same period in 2024, and by 7% at constant exchange rates [10]. Strategic Developments - The company successfully delivered its first ProNephro AKI (NGAL) order to the US market in August 2025, marking a significant step in its commercial launch [8]. - Patient enrollment for the clinical cut-off study was completed by the end of October 2025, with a focus on thorough data analysis to ensure high-quality validation study design [4][8]. - The FDA submission has been postponed to the first half of 2027 to align with the updated study design based on FDA feedback [4][8]. Capital and Funding - On November 13, 2025, BioPorto completed a share issuance, raising approximately DKK 43 million, which is expected to support operations through 2026 [6][8]. - The company aims to achieve positive cash flow in the second half of 2027 [6]. Future Guidance - The full-year guidance for 2025 remains unchanged, with total revenue expected to be in the range of DKK 40-45 million and an Adjusted EBITDA loss projected between DKK 75-80 million [11][16].

Core Viewpoint - BioPorto A/S has successfully completed a private placement of 40,438,426 new shares, raising approximately DKK 43 million, which will enhance the company's financial flexibility to pursue strategic priorities and strengthen its commercial platform [1][2]. Group 1: Private Placement Details - The private placement involved 40,438,426 new shares and is expected to generate gross proceeds of around DKK 43 million [1][2]. - The subscription price for the new shares is scheduled to be paid by 24 November 2025, with the share capital increase registration to follow shortly thereafter [2]. - BioPorto anticipates that the new shares will be listed on Nasdaq Copenhagen A/S by no later than 26 November 2025 [2]. Group 2: Strategic Implications - The funds raised will support the completion of data collection, submission of a pre-submission to the FDA, and initiation of a Validation Study in the U.S. clinical trial [2]. - The Board of BioPorto has considered various future financing options, including potential divestments of non-core assets and credit facilities, to ensure a balanced funding structure [2]. - The company aims to position itself for positive cash flow by the second half of 2027 [2]. Group 3: Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable kidney biomarkers to improve patient management and outcomes [4][5]. - The flagship products are based on the NGAL biomarker, which aids in the risk assessment and management of Acute Kidney Injury (AKI) [5]. - BioPorto's tests are marketed under various registrations, including CE mark and FDA clearance for ProNephro AKI™ in the U.S. [5].

Core Viewpoint - BioPorto A/S has initiated a pre-subscribed private placement of up to 40,438,426 new shares to support its financing strategy aimed at achieving positive cash flow by the second half of 2027 [3][4][5]. Financing Strategy - The company identified a funding need of DKK 60–70 million to complete a U.S. clinical study and strengthen its commercial platform [4]. - A variety of financing alternatives were evaluated, including equity issuance and strategic financing solutions, to support long-term growth [4]. Private Placement Details - The private placement is fully pre-subscribed, with indications for the entire amount, expected to raise approximately DKK 43 million [5][9]. - The subscription price is set at DKK 1.072, matching the closing price of BioPorto shares on Nasdaq Copenhagen on the announcement date [9]. Share Offering Terms - The offering includes up to 40,438,426 new shares, representing 8.89% of the company's registered share capital prior to the increase [8]. - The new shares will carry the same rights as existing shares and will be registered through VP Securities A/S [10]. Timeline and Trading - The subscription period has commenced and will close at short notice, with results to be announced shortly thereafter [12]. - New shares are expected to be listed on Nasdaq Copenhagen by November 26, 2025, subject to the offering not being withdrawn [13]. Company Overview - BioPorto specializes in in vitro diagnostics, focusing on actionable kidney biomarkers to improve patient management [15][16]. - The company's flagship products are based on the NGAL biomarker, aiding in the risk assessment and management of Acute Kidney Injury (AKI) [16].

Core Insights - BioPorto A/S has announced a business strategy update, outlining its "Forward" strategic direction and aspirations towards 2028, with a focus on achieving cash flow positivity by the second half of 2027 [1][10] Strategic Direction - The "Forward" plan is a three-year strategy aimed at improving kidney health through actionable biomarkers, with a goal to transform kidney care globally [2] - The plan includes building market adoption, capturing high growth, and expanding the addressable market [2] Aspirations Towards 2028 - The company aims to be cash flow positive in the second half of 2027, requiring DKK 60-70 million in funding [10] - Revenue expectations for FY 2028 are set between DKK 150-200 million, with an adjusted EBITDA margin of at least 15% [9][16] Market Adoption Goals - By the end of 2026, BioPorto aims to have over 60 active hospitals in the US and reach 100 active hospitals globally by the end of 2027 [5][7] - The company plans to expand its market penetration in both pediatric and adult segments, leveraging enhanced clinical guidelines [7] Commercialization Strategy - BioPorto will focus on securing strategic partnerships with instrument manufacturers to drive product adoption and facilitate faster laboratory utilization of its biomarkers [5] - The company is preparing for EU IVDR certification, expected in 2027, to support its European market growth [6] Product Development and Market Expansion - The company intends to broaden its product portfolio to address additional clinical settings relevant to the NGAL biomarker, with a goal of having over 170 active hospitals globally by the end of 2028 [8]

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 - QuidelOrtho Corporation showcases its leadership in transfusion medicine with the FDA approval of the MTS DAT Card and the expansion of its immunohematology portfolio at the AABB 2025 Annual Meeting [1][2][3] Product Highlights - The MTS DAT Card completes the gel-based solution for direct antiglobulin testing, enhancing laboratory efficiency and reliability when paired with the ORTHO VISION Platform [2][3] - The ORTHO VISION Max Swift Analyzer is designed for high-throughput labs, offering speed, reliability, and automation with increased sample and reagent capacity [7] - The ORTHO CONNECT Lab Management Software streamlines operations and addresses staffing challenges in laboratory networks [7] Educational Contributions - QuidelOrtho's participation in the AABB Annual Meeting includes sessions on Rh(D) antigen identification, gel test typing for DARA patients, and advanced immunohematology techniques for complex serological cases [3][7]