Tillkännagivande • May 22
Bioporto A/S Un-changes Earnings Guidance for the Full Year 2026 BioPorto A/S unchanged earnings guidance for the full year 2026. For the full year 2026, Guidance for 2026 remains unchanged as announced April 8, 2026. The Company therefore expects total revenue of DKK 38 million to DKK 48 million, total NGAL revenue of DKK 33 million to DKK 42 million. Tillkännagivande • Apr 02
Bioporto A/S Advances U.S. Adult Urine Ngal Program with Fda Pre-Submission Request BioPorto A/S had formally submitted its FDA pre-submission package to the U.S. Food and Drug Administration (FDA). This marks an important regulatory milestone for the Company and follows the positive preliminary analysis recently completed for the U.S. adult urine NGAL Cut-off Study. On 18 March 2026, BioPorto reported that the preliminary analysis demonstrated results supporting the study’s primary endpoint, providing the foundation for the next phase of the Company’s regulatory strategy. Building on these findings, BioPorto has now submitted its FDA pre-submission package, seeking Agency feedback on the proposed clinical study design for the upcoming Validation Study, which is an essential step toward U.S. regulatory 510(k) clearance. With the pre-submission meeting package now filed, BioPorto seeks FDA feedback to align with the Agency on the Validation Study protocol. This announcement does not alter BioPorto’s financial guidance as recently published on 5 February 2026. Tillkännagivande • Mar 27
BioPorto A/S, Annual General Meeting, Apr 24, 2026 BioPorto A/S, Annual General Meeting, Apr 24, 2026, at 15:00 Romance Standard Time. Location: tuborg havnevej 15, st., dk-2900 hellerup, Denmark Tillkännagivande • Mar 20
BioPorto A S Successfully Completes Preliminary Analysis of U S Adult NGAL Cutoff Study BioPorto A/S announced positive clinical readout update of the preliminary analysis of its U.S. adult NGAL Cutoff Study, designed to evaluate the clinical performance of NGAL in assessing risk of acute kidney injury (AKI). The Company intends to submit its FDA Pre-submission package by the end of March 2026, to ensure robustness in its subsequent Validation Study. Patient enrollment was completed in October 2025, and database lock was finalized in March 2026. The preliminary analysis of the adult study has shown positive results supporting the study’s primary endpoint, consistent with the findings from the Company’s cutoff and validation study conducted in the pediatric segment, which subsequently led to FDA clearance at the end of 2023 for the pediatric indication. This is providing a strong foundation for BioPorto’s regulatory strategy going forward. The planned Pre-submission will seek FDA’s feedback on the regulatory pathway as well as the design of analytical and clinical study protocols for the Validation Study. Subsequently, the Validation Study will be initiated. This announcement does not alter BioPorto’s financial guidance as recently published on 5 February 2026. Tillkännagivande • Feb 06
BioPorto A/S Provides Its Earnings Guidance for Full Year 2026 BioPorto A/S provided its earnings guidance for full year 2026. For the year, the company For 2026, the total NGAL revenue is expected in range of DKK 48 Million to DKK 58 million. Tillkännagivande • Dec 13
BioPorto A/S Announces Resignation of CFO Niels Høy Nielsen BioPorto A/S announced that Niels Høy Nielsen has resigned as Chief Financial Officer of BioPorto to become CFO at another company. Niels Høy Nielsen will continue to serve in his current role at the Company through March 2026. Tillkännagivande • Nov 20
BioPorto A/S Confirms Earnings Guidance for Full Year 2025 BioPorto A/S confirmed its earnings guidance for full year 2025. For the year, the company total revenue expectation is to be in the range of DKK 40 million - DKK 45 million. Tillkännagivande • Jun 30
Bioporto A/S Announces Initiation of Commercialization of Pronephro Aki (Ngal) for Diagnostic Use in the Us BioPorto A/S announced the initiation of commercialization in the US of ProNephro AKITM (NGAL) for clinical use in risk stratification for moderate-to-severe AKI for patients aged 3 months to 21 years, by receiving the first purchase order of ProNephro AK ITM (NGAL) for the US market. This purchase order is to service US hospitals through BioPorto's distribution relationship with Roche Diagnostics. Currently, ProNephro AKI TM (NGAL) has FDA 510(k) marketing clearance for Roche's cobas®? c501 analyzers, that are broadly available in standard medical laboratories and hospitals. Tillkännagivande • Apr 15
BioPorto A/S has completed a Follow-on Equity Offering in the amount of DKK 33.505 million. BioPorto A/S has completed a Follow-on Equity Offering in the amount of DKK 33.505 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 25,000,000
Price\Range: DKK 1.3402
Transaction Features: Subsequent Direct Listing Tillkännagivande • Apr 14
BioPorto A/S has filed a Follow-on Equity Offering in the amount of DKK 33.505 million. BioPorto A/S has filed a Follow-on Equity Offering in the amount of DKK 33.505 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 25,000,000
Price\Range: DKK 1.3402
Transaction Features: Subsequent Direct Listing Tillkännagivande • Apr 12
BioPorto A/S Approves Board Appointments BioPorto A/S held its Annual General on April 11, 2025, elected Jens Due Olsen and Donna Haire as new members of the Board of Directors. After the Annual General Meeting, the Board of Directors constituted itself by electing Jens Due Olsen as Chair and Henrik Juuel as Vice Chair of the Board of Directors. Tillkännagivande • Mar 20
BioPorto Provides Earnings Guidance for the Fiscal Year 2025 and Aspirations for 2026 Towards 2029 BioPorto A/S provided earnings guidance for the fiscal year 2025. For the year, the company is targeting total revenue of DKK 45 million to DKK 60 million, corresponding to a growth in the range of 24 % to 66% compared to 2024. Growth will be driven by increased ProNehro AKI (NGAL) sales, especially in the US. Revenue in 2025 is expected to be back-end loaded.
For the 2026, the company aspired to reach total revenue of DKK 80 million to DKK 125 million (app. USD 12 million to USD 18 million). BioPorto’s aspiration to reach and exceed DKK 700 million (app. USD 100 million) in total revenue by 2029. Tillkännagivande • Mar 06
BioPorto A/S, Annual General Meeting, Apr 11, 2025 BioPorto A/S, Annual General Meeting, Apr 11, 2025. Tillkännagivande • Mar 05
Bioporto A/S Announces Ninfa Saunders, Michael S. Singer and Don M. Hardison Will Not Seek Re-Election BioPorto A/S announced that Ninfa Saunders, Michael S. Singer and Don M. Hardison will not seek re-election at the General Meeting. Tillkännagivande • Feb 28
BioPorto A/S Appoints Hanne Søgaard as Head of Investor Relations, Effective 1 March 2025 BioPorto A/S announced that, effective 1 March 2025, Hanne Søgaard will join BioPorto as the Company's new Head of Investor Relations. Hanne brings extensive experience within Investor Relations and financial communication, having previously led Nykredit's Investor Relations and ESG initiatives. With a strong background in financial analysis and communication from her roles at Nykredit, Juristernes og Økonomernes Pensionskasse, Danske Markets, Skandia Pension, and Alm. Brand Forsikring, Hanne is well-suited to enhance Investor Relations efforts communicating and engaging with investors on strategy and helping drive strategic goals forward. Tillkännagivande • Jan 30
BioPorto A/S Announces Board Changes BioPorto A/S announced that Board Member Henrik Juuel will be appointed interim Chairman of the Board of Directors in BioPorto A/S as John McDonough steps down and resigns as Chair and member of the Board of Directors at the end of this month. Henrik Juuel joined the Board of Directors of BioPorto A/S in 2024 and has more than 30 years of experience from the Life Science industry. Henrik is EVP & CFO of Bavarian Nordic A/S since 2018. Until the Annual General Meeting on April 11, 2025, focus will be on assessing the necessary composition of the Board to address the needs of the Company during its initiation of commercialization and indication expansion phase. As announced on December 16, 2024, the Board is seeking a new Chair to be elected at the Company’s Annual General Meeting in April 2025, which can support the Company’s engagement with investors and stakeholders in the local market and contribute to the Company’s growth. Tillkännagivande • Jan 23
BioPorto A/S Announces the Publication of Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL)Reference Intervals in Healthy Adult and Pediatric Individuals BioPorto A/S announced their publication of reference intervals using BioPorto's NGAL immunoassay in healthy adult and pediatric individuals. The study was published in Diagnostics, an international, open-access, peer-reviewed journal and provides clinicians with a standardized comparison to evaluate NGAL levels ensuring broad clinical applicability in their patients. The publication of the reference range study results will be used by laboratories implementing NGAL assays from BioPorto as a baseline of healthy patient populations, a required step for laboratories to implement clinical tests. These findings address the critical gaps in kidney injury management and ultimately can help with earlier identification of AKI with the use of biomarkers. This BioPorto study is the largest comprehensive study to date of 629 patients with ages ranging from three months to older than 65 years. Tillkännagivande • Nov 14
Bioporto A/S Maintains Revenue Guidance for the Year 2024 BioPorto A/S maintained revenue guidance for the year 2024. Based on the progress and results obtained in the first nine months of 2024 the company maintains Total Revenue target of DKK 40 million. Tillkännagivande • Oct 29
BioPorto A/S Initiates Patient Enrollment for US Study of ProNephro AKI (NGAL) for Adult Use at Massachusetts General Hospital BioPorto A/S announced the enrollment of the first patient in its US clinical study for ProNephro AKI (NGAL) with the goal of determining a cut-off point for risk stratification of moderate to severe of AKI in adult patients. BioPorto's ProNephro AKI (NGAL), currently cleared by the US Food and Drug Administration (FDA) for those 3 months through 21 years of age, has been widely recognized for its groundbreaking potential in refining AKI diagnosis. NGAL is a direct real-time marker of kidney cell damage and can potentially detect AKI days earlier than previously possible. Early detection of AKI may enable prompt intervention to save lives. BioPorto's proprietary assay is a kidney injury marker versus the traditionally used serum creatinine (SCr) functional test. The cut-off study is the first of two studies which will form a substantial part of the submission for US clearance of ProNephro AKI (NGAL) in adult patients. The cut-off study seeks to enroll patients at up to 12 US sites in 2024 and 2025. After having established the cut-off, BioPorto expects to commence enrollment for the second study, the validation study, enabling the Company to submit its FDA application for adult usage of ProNephro AKI (NGAL) by 2026. Tillkännagivande • Aug 15
Bioporto A/S Affirms Earnings Guidance for 2024 BioPorto A/S affirmed earnings guidance for 2024. For the period, the company expects total revenue target of DKK 40 million. Tillkännagivande • May 09
Bioporto A/S Provides Revenue Guidance for 2024 BioPorto A/S provided revenue guidance for 2024. For the period, the company expects total revenue target of DKK 40 million. Tillkännagivande • Apr 10
Bioporto A/S Appoints Gry Louise Husby Larsen as Chief Legal Officer and Member of the Executive Management Team, Effective as of April 15, 2024 BioPorto A/S announced the appointment of Gry Louise Husby Larsen as its new Executive Vice President and Chief Legal Officer (CLO), and member of the Executive Management team as of April 15, 2024. Gry Louise Husby Larsen has been employed as General Counsel at BioPorto from 2011 leading the Company’s corporate legal activities within compliance, fundraising, IPR, contracts, HR and ESG ect. In the period from 2019 to 2024, Gry Louise Husby Larsen acted as external General Counsel for BioPorto while also serving as part time General Counsel for FluoGuide A/S, Algiecel A/S and Unibio A/S. Gry Louise Husby Larsen holds a Master of Law from University of Copenhagen and was an Attorney-at-law at Knop & Co. Law Firm until 2011. To further strengthen the leadership of BioPorto, the company expects to announce the appointment of a US CEO for BioPorto’s subsidiary BioPorto Inc. and a group CFO later this quarter. Tillkännagivande • Apr 05
Bioporto A/S Announces Tonni Bülow-Nielsennot to Stand for Election BioPorto A/S announced that it has received notice that Tonni Bülow-Nielsen, due to personal reasons, will not be a candidate for the upcoming general meeting on 30 April 2024. Tillkännagivande • Jan 10
BioPorto A/S Announces CEO Changes BioPorto A/S announced changes to the Executive Management. By mutual agreement, BioPorto’s CEO, Anthony Pare, is stepping down and leaving BioPorto with effect from January 9, 2024. Peter Mørch Eriksen has been appointed as interim CEO. The Board of Directors has as of January 9, 2024 appointed Board Member Peter Mørch Eriksen as interim CEO of the Company. Peter Mørch Eriksen will remain in his position as Board Member at least until the expiry of his election period at this year’s Annual General Meeting. Peter Mørch Eriksen has spent more than 25 years in the MedTech/life science industries, including as CEO of Sense A/S and VP of Medtronic. Peter has previously been the CEO of BioPorto in the period from 2013 – 2021 and has served as a Board Member in BioPorto since then. Further, Peter is the Chairman of FluoGuide A/S and MONSENSO A/S. Together with the Board of Directors and the BioPorto team, Peter will finalize work that has already been commenced on the Company’s plans for commercialization, FDA instrument- & indication expansion, financial guidance for 2024 and capital requirements which is to be published by mid-February 2024. Tillkännagivande • Dec 16
BioPorto A/S, Annual General Meeting, Apr 30, 2024 BioPorto A/S, Annual General Meeting, Apr 30, 2024. Tillkännagivande • Dec 08
BioPorto A/S Receives FDA 510(k) Clearance for NGAL Test in the United States BioPorto A/S announced receipt of a US Food and Drug Administration (FDA) 510(k) clearance for BioPorto’s NGAL test, to be marketed as ProNephro AKITM (NGAL). ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (aged 3 months through 21 years) in the US. ProNephro AKI (NGAL) is designed to help doctors identify patients at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours in the intensive care unit (ICU) setting. Unlike serum creatinine, a muscle by-product that is the current standard of care but slow to rise in AKI, NGAL is a direct real time marker of kidney cell damage and can potentially detect AKI days earlier than serum creatinine. Early detection of AKI may enable prompt intervention to save lives. Until now, the risk for developing or having persistent AKI has been difficult to assess early because current standard-of-care methods, such as sCr, rise slowly in AKI. As such, ProNephro AKI (NGAL) was developed to help save kidneys and lives through faster and more timely intervention. Tillkännagivande • Dec 05
BioPorto A/S Announces Resignation of Jan Leth Christensen as Board Member BioPorto A/S announced that Jan Leth Christensen has informed the Company that he has decided to resign from his position as a board member for BioPorto. The search for a successor with relevant expertise, including familiarity with public company practices in the Nordics, will be initiated and a new candidate is expected to be proposed in connection with the Company’s Annual General Meeting in 2024. Tillkännagivande • Nov 01
Bioporto A/S Provides Revenue Guidance for the Fiscal Year 2023 BioPorto A/S provided revenue guidance for the fiscal year 2023, for the year, the company expects revenue of approximately DKK 30 million to DKK 33 million. Tillkännagivande • Sep 20
Bioporto A/S Announces Resignation of Neil Goldman as CFO BioPorto A/S announced that Neil Goldman has informed the Company that he has decided to resign to take up the CFO position at another company. The search for a successor will be initiated and Neil Goldman will assist with the transition until a date to be determined. Tillkännagivande • Aug 02
BioPorto A/S announced that it has received $0.11 million in funding On July 31, 2023, BioPorto A/S closed the transaction. The transaction included participation from 8 investor. Tillkännagivande • Aug 01
BioPorto A/S Maintains Earnings Guidance for the Year 2023 BioPorto A/S maintained earnings guidance for the year 2023. Based on the progress and results obtained in the first six months of 2023, the company maintains its financial guidance for 2023. Revenue of approximately DKK 30 million to DKK 33 million. Tillkännagivande • May 11
BioPorto A/S Maintains Financial Guidance for 2023 BioPorto A/S maintained financial guidance for 2023. Based on the progress and results obtained in the first three months of 2023, BioPorto maintains its financial guidance for 2023, as most recently described in its Annual Report 2022 of: Revenue of approximately DKK 30 million to DKK 33 million.