Continued Progress On Key Strategic Milestones In Q1 2025. Total Revenue In Line With Expectations And Guidance For 2025 Maintained.

Continued progress on key strategic milestones in Q1 2025. Total revenue in line with expectations and guidance for 2025 maintained.

Interim results and a business update for the first quarter of fiscal 2025

Copenhagen, Denmark, May 8, 2025, (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto” or the“Company”) (CPH:BIOPOR) today announced interim financial results for the first three months of 2025 and a business update.

Continued progress on key strategic milestones in Q1 2025

• Preparations for the commercial launch of ProNephro AKI NGAL in the U.S. for pediatric use are progressing as expected.
• The enrollment of patients in the ProNephro AKI (NGAL) study for adult use has been progressing at a faster pace than anticipated. We maintain our goal to submit to the FDA by the end of 2026.

• Continued NGAL Research Use Only (RUO) sales growth of 20% in BioPorto's key strategic market in the U.S.
  

Peter Mørch Eriksen, BioPorto's Group Chief Executive Officer (CEO), comments:

“I am satisfied with the progress made in the first quarter of 2025. I am pleased with the continued growth in NGAL RUO sales in the U.S. despite the pending launch of ProNephro AKI (NGAL) for pediatric use. The enrollment of patients in the adult clinical study has been progressing faster than anticipated and we are well on track with 2025 milestones.

Finally, on April 16, we successfully completed an issuance of 25,000,000 new shares, providing gross proceeds of DKK 33.5 million. I am delighted by the strong commitments from both our largest existing shareholders and new investors drawn to our Company and the investment case.”

Financial highlights for Q1 2025

• Revenue in the first three months of 2025 totaled DKK 7.7 million as expected. This corresponds to a 19% decrease compared to the same period last year, primarily due to a shift in timing of bulk orders for NGAL sales in the rest of the world (ROW) from Q1 2025 to later in 2025.
• NGAL sales in the U.S. for RUO continued to increase and were up 20% compared to Q1 2024. However, sales in ROW declined, leading to a 25% decline in total NGAL sales compared to the same period last year.
• EBITDA loss in Q1 2025 amounted to DKK 28.1 million compared to DKK 15.3 million in the same period last year. The increase is primarily driven by higher costs associated with the clinical study for adults.
• Full-year guidance is maintained. In 2025, BioPorto expects revenue of DKK 45-60 million, with back end loaded sales. Adjusted EBITDA loss is expected in the range DKK 75-85 million.

Events after the reporting period

• On April 16, 2025, the Company successfully completed a funding round of 25,000,000 new shares in a direct issue at market price providing gross proceeds of DKK 33.5 million.
  

To receive BioPorto's Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on

Investor Relations Contacts

Hanne S. Foss, Head of Investor Relations, BioPorto A/S, ... , C: +45 26368918

About BioPorto

BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company's tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.

The Company's flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide.

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit .

Forward looking statement disclaimer

Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company's expectations, intentions and projections regarding its future performance including the Company's Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company's ability to successfully market both new and existing products. These forward-looking statements, which may use words such as“aim”,“anticipate”,“believe”,“intend”,“estimate”,“expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company's business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto's success are more fully disclosed in BioPorto's periodic financial filings, including its Annual Report for 2024 particularly under the heading“Risk Factors”.

Attachments

• 2025 05 08 - Announcement no. 15 - UK
• 2025 05 08 - Q1 2025 Interim Report - BioPorto

MENAFN08052025004107003653ID1109521934