27 MARCH 2025 PRESS RELEASE
Urteste plans to start clinical trials for its pancreatic cancer test in Europe in Q3 2025
Gdansk, Poland - 27 March 2025 - Urteste S.A. (Warsaw Stock Exchange: URT), a company specializing in innovative technology for cancer detection through unique urine sample analysis, plans to initiate clinical trials in the European Union in Q3 2025 for the Panuri project-a diagnostic test for pancreatic cancer. In the coming weeks, Urteste will announce a tender to select a Contract Research Organization (CRO) to conduct the clinical trials. Additionally, the company is scheduled to hold its fourth Q-submission meeting with the FDA in mid-2025 to finalize details ahead of clinical trials in the United States.
The European certification study will be conducted in Poland and selected EU countries, involving a group of 550 patients. In collaboration with Avania, Urteste is currently preparing the trial protocol. As part of its grant funding commitments, the company intends to announce a tender in Q2 2025 for selecting the CRO to oversee the trials.
"We plan to begin clinical trials for the Panuri test in Europe in Q3 of this year. The study will be simpler, faster, and more cost-effective than the U.S. trial, but its significance will be substantial. Conducting this trial will enable us to seek certification in Europe. We will also obtain preliminary results sooner, marking a major milestone that brings us closer to commercializing our technology," said Grzegorz Stefanski, CEO and Co-founder of Urteste S.A. "In parallel with the European trials, we are preparing for the U.S. trials. We have decided to hold our fourth Q-submission meeting with the FDA in mid-year, which will be our final discussion regarding the study design. The remaining issue to be determined is the number of patients required. Our three previous meetings with the FDA have been very positive, helping us better understand regulatory expectations, which is crucial for demonstrating the diagnostic value of our test and achieving a smooth registration process in the U.S.," added CEO Stefanski.
By mid-2025, Urteste will also have completed the internal validation of the Panuri test, which will be used in both the European and U.S. clinical trials.
Urteste currently has 12 prototype diagnostic tests for cancers including breast, brain, stomach, bile ducts, ovary, endometrium, kidney, colorectal, lung, liver, pancreas, and prostate, which together account for nearly 70% of global cancer-related deaths.
The company's innovative technology enables cancer detection through enzyme activity measurement in urine samples. These tests trigger a change in urine color intensity, potentially indicating the presence of cancer.
Urteste (Warsaw Stock Exchange: URT) specializes in developing breakthrough technology to detect cancer at early stages. Urteste's motto is "Early cancer detection saves lives." The company's technology detects cancer by measuring the activity of enzymes present in urine. Urteste is developing tests for a dozen of the most common cancers. The Company's team consists of managers with extensive experience in managing medical companies and scientists specialized in the areas of proteolytic enzymes and peptide chemistry.
For more information please visit www.urteste.eu/en/home/
Forfurtherinformationpleasecontact:
Urteste S.A.
Grzegorz Stefanski, CEO urteste@urteste.eu
InvestorandMediaRelations
Kamil Majcher k.majcher@newtechcomm.pl
Importantinformation
This press release (the "Press Release") has been prepared by Urteste S.A. with its registered office in Gdansk (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.
