1 July 2026
Newsletter
Dear Shareholders,
As we progress through 2026, we are pleased to share an update on BioPorto’s continued development and strategic progress. The first half of the year has been marked by disciplined execution, important clinical and regulatory advancement, and a sharper organizational focus on our core mission: improving kidney health and patient outcomes.
Since the beginning of the year, our work has been guided by our “Forward” strategy and our ambition to establish NGAL as a standard-of-care biomarker in relation to acute kidney injury (AKI). The “Forward” strategy was announced in November 2025 and focused on creating market access & commercialize the biomarker developed by the BioPorto.
Progress in the U.S. market
The United States remains a key priority for BioPorto and an important growth opportunity both from a market access as a commercial point of view. During the first half of 2026, we reported preliminary results from our adult NGAL cutoff study, supporting the clinical value of NGAL in identifying patients at risk of AKI. Following interactions with the U.S. Food and Drug Administration (FDA), we are initiating the validation study in the adult population. All with the focus of gaining access to the much larger adult part of the market.
At the same time, we continue to build our commercial understanding through increasing adoption of NGAL in the research-use-only (RUO) segment. We are on track to have more than 60 US university hospitals at the end of 2026.
Clinical and Scientific Developments
The broader clinical environment around AKI continues to evolve positively. The recently published draft of the updated KDIGO guidelines highlights a continued shift toward biomarker-driven diagnostics and improved clinical decision-making. The final KDIGO guidelines are expected to be published toward the end of the year.
We view these developments as supportive of BioPorto’s NGAL platform and believe they can help increase awareness and support the long-term adoption of biomarker-based diagnostics – like the Company’s biomarker – and thereby support long-term value creation for our shareholders.
Building a scalable organization
Preparing the Company for capturing growth remains a key priority. During 2026, we completed the transfer of R&D activities from the U.S. to Denmark and strengthened capabilities in project leadership, design control, and research through targeted hires. These investments are helping create a stronger and more scalable organization for the future.
We continued to strengthen the operational foundation of the Company through enhanced processes, quality systems, and compliance practices. The voluntary recall announced in June 2026 should be viewed in this context. It was a proactive and responsible action, reflecting our commitment to high standards of product quality and patient safety and thereby supporting long-term value creation for our shareholders.
The “Forward” Strategy and Focused Execution
In April 2026, we completed the divestment of our antibody business. This refined our strategic focus and strengthened our financial flexibility. By divesting a non-core activity, we focused our capital and organizational resources toward the “Forward” strategy. We remain committed to disciplined execution against our strategic long-term ambitions:
- Achieving strong revenue growth as NGAL adoption increases; deliver revenue in 2028 of DKK 135-185 million
- Capturing the benefit of scalability; deliver an EBITDA margin of at least 15% in 2028
- Creating sustainability; deliver cash flow break-even during second half 2028
We welcome and highly appreciate the continued trust and support from our shareholders and value the ongoing dialogue we have with you. We look forward to updating you further as we progress through what we expect to be an important and milestone-driven period for BioPorto.
Wishing you all a lovely summer.
Carsten Buhl, CEO
