Urteste S.A.

Urteste S.A. launches European multicenter clinical study of the Panuri test

Urteste S.A. launches European multicenter clinical study of the Panuri test

Gdańsk, Poland – 6 November 2025 – Urteste S.A. (Warsaw Stock Exchange: URT), a company specializing in the development of innovative technology for the early detection of cancer from urine samples, has entered into a tripartite agreement with Aurevia Poland and Aurevia Oy, based in Finland, for CRO services, including the organization and management of a European clinical study of the Panuri test — an IVD medical device for the detection of pancreatic cancer. The study will be conducted in multiple centers in Poland, Hungary, and Italy. The CRO's remuneration, amounting to EUR 3,025,040 net, will be largely financed by a grant awarded by the Polish Agency for Enterprise Development (PARP). 

The main objective of the study is to characterize the effectiveness of the Panuri test in detecting pancreatic cancer. The primary endpoints are sensitivity and specificity in the detection of pancreatic cancer.

- The launch of the Panuri clinical study is a key milestone in the commercialization strategy for our solution. We continue to see strong interest in our technology from leading companies in the Medtech sector. In our opinion, Panuri has real potential to become a non-invasive, effective, and affordable tool supporting the early diagnosis of pancreatic cancer—one of the most late-detected and deadliest cancers, says Grzegorz Stefański, co-founder and CEO of Urteste S.A. — Our cooperation with an experienced partner, Aurevia, and our several years of experience in collecting urine samples allow us to be optimistic that patient recruitment will proceed smoothly. We plan to obtain the first interim analysis results in 2026, added CEO Stefański.

The results of the study will be part of the documentation used in the certification process for the IVD (in vitro diagnostic) medical device developed by Urteste in Europe. In addition, they may potentially supplement the clinical data obtained in the planned study in the US.

Two interim analyses will be conducted during the study. The first will take place once 50% of the expected participants with a positive diagnosis of pancreatic cancer have been enrolled, and the second once 50% of those with a negative diagnosis have been included.

During the study, samples from 550 participants will be statistically analyzed:

- 400 in the target arm – adults with symptoms suggestive of pancreatic cancer;

- 150 in the enriched arm - adults with a planned procedure involving histopathological evaluation of the pancreas due to suspected pancreatic cancer.

The development of the Panuri test, completed in June, demonstrated its high diagnostic parameters: sensitivity – 89%, specificity – 75%, diagnostic accuracy – 81%. These results confirm the strong diagnostic performance of the Panuri test and support its further clinical validation.
Urteste currently has 12 prototypes of diagnostic tests for cancers of the breast, brain, stomach, bile ducts, ovary, endometrial, kidney, colon, lung, liver, pancreas, and prostate, which together account for nearly 70% of all cancer deaths worldwide.

The innovative technology developed by Urteste involves detecting cancer by measuring the activity of enzymes present in urine using appropriate tests, which cause a change in the color intensity of the urine, which may indicate the presence of cancer.

About Urteste:

Urteste (Warsaw Stock Exchange: URT) specializes in developing innovative technology for the early detection of cancer. Urteste's motto is: Early cancer detection saves lives. The company's breakthrough technology involves detecting cancer by measuring the activity of enzymes present in urine. Urteste is developing diagnostic tests for several of the most common types of cancer. The company's team consists of managers with extensive experience in managing companies in the medical industry and scientists specializing in proteolytic enzymes and peptide chemistry.

For more information please visit www.urteste.eu/en/home/

Media and Investor Contact:

Kamil Majcher

NewTech Comm

k.majcher@newtechcomm.pl

Important information 

This press release (the "Press Release") has been prepared by Urteste S.A. with its registered office in Gdańsk (the "Company") and is intended for informational purposes only. Its purpose is to present selected data on the Company and its development prospects. The Press Release does not constitute or form part of, and shall not be construed as, an offer, solicitation or invitation to sell or issue, or an offer, solicitation or invitation to subscribe for, underwrite, purchase or otherwise acquire, any securities of the Company in any jurisdiction, or as an inducement/a recommendation to undertake investment activities in any jurisdiction. This Press Release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the Company's business strategy, plans and objectives for future operations. Although the Company believes that these estimates and assumptions are reasonable, they may prove to be incorrect. The information contained herein is current only as of the date hereof and is subject to material change. The Press Release will not be amended, updated or modified to reflect any changes occurring after that date, unless required by applicable law. The Company shall not be liable for the effects of decisions made after reading the Press Release. This Press Release is not intended for distribution to, or in, any state where the public dissemination of the information contained in this Press Release may be restrictions or be prohibited by law.