공시 • Jul 01
Urteste S.A. Receives U.S. Patent For The Panuri Test Urteste S.A. received a patent from the United States Patent and Trademark Office (USPTO) for an invention developed as part of the Panuri project - “Diagnostic marker for pancreatic cancer.” Panuri, developed as a non-invasive test for detecting pancreatic cancer, is Urteste’s most advanced and high-priority project. The Panuri test is also protected by patents in Poland, Japan, Indonesia, Singapore, Russia, and South Korea. The company is also pursuing patent applications in other key international markets. On June 10, Urteste announced that the Panuri test had been administered to the first participant in a clinical trial conducted in Europe. The primary objective of the trial is to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer, and the primary endpoints include the test’s sensitivity and specificity. Pancreatic cancer is among the most late-stage cancers and has one of the worst prognoses of all cancers. The trial is being conducted in Poland, Hungary, and Italy. Ultimately, it will involve 30 centers in these countries. Samples from 550 participants will be subjected to statistical analysis. The company expects to receive the results of the interim analysis in the Fourth Quarter of this year. The study results will form part of the documentation used in the certification process for the IVD (in vitro diagnostic) medical device developed by Urteste in Europe. Furthermore, they may potentially supplement the clinical data obtained in a planned study in the U.S. Urteste currently has 13 prototype diagnostic tests for cancers of the breast, brain, stomach, bile ducts, ovaries, bladder, endometrium, kidneys, colon, lungs, liver, pancreas, and prostate—which together account for nearly 70% of all cancer-related deaths worldwide. The innovative technology developed by Urteste involves detecting cancers by measuring the activity of enzymes present in urine using specific tests that cause a change in urine color intensity, which may indicate the presence of cancer. 공시 • Jun 12
Urteste S.A. Enrolls First Patient in Panuri Test Clinical Study Urteste S.A. has enrolled the first patient in the clinical study of the Panuri test for the detection of pancreatic cancer. The company expects to receive the results of the interim analysis in the Fourth Quarter of this year. The study is proceeding according to schedule and within budget. Panuri is Urteste’s priority project and involves the development of a non-invasive diagnostic test for in vitro use, based on urine sample analysis. The primary objective of the study is to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer, with the primary endpoints including the test’s sensitivity and specificity. The use of the Panuri test on the first study participant represents a significant step in the project’s implementation and confirms the transition to the active clinical study phase. The start of participant recruitment significantly reduces the risks characteristic of the preparatory and organizational phase of a clinical study, including those related to test production, the launch of study sites, and the initiation of the recruitment process. The study is multicenter and is being conducted in Poland, Hungary, and Italy. Ultimately, it will involve 30 centers in these countries. Urteste collaborates with experienced international partners. The study is being conducted as a CRO by the Finnish group Aurevia, while the German company Biotype is responsible for the production of the test as a CDMO. In the study, samples from 550 participants will undergo statistical analysis, including 400 in the target arm (patients with symptoms suggestive of pancreatic cancer) and 150 in the enriched arm (patients with a planned histopathological evaluation of the pancreas). The study results will form part of the documentation used in the certification process for the IVD (in vitro diagnostic) medical device developed by Urteste in Europe. Furthermore, they may potentially supplement the clinical data obtained in a planned study in the U.S. Development work on the Panuri test, completed in June 2025, provided preliminary data indicating the solution’s diagnostic potential, including a sensitivity of 89%, specificity of 75%, and diagnostic accuracy of 81% in the analyzed study population. The data obtained has attracted the interest of potential strategic partners. Urteste currently has 13 prototypes of diagnostic tests for cancers of the breast, brain, stomach, bile ducts, ovaries, bladder, endometrium, kidneys, colon, lungs, liver, pancreas, and prostate, which together account for nearly 70% of all cancer-related deaths worldwide. The innovative technology developed by Urteste involves detecting cancers by measuring the activity of enzymes present in urine using specific tests that cause a change in urine color intensity, which may indicate the presence of cancer. 공시 • Jun 02
Urteste S.A., Annual General Meeting, Jun 26, 2026 Urteste S.A., Annual General Meeting, Jun 26, 2026. New Risk • Dec 05
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -zł5.5m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-zł5.5m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 8.0% per year over the past 5 years. Revenue is less than US$1m (zł1.8m revenue, or US$496k). Minor Risk Market cap is less than US$100m (zł49.3m market cap, or US$13.6m). 공시 • Aug 25
Urteste S.A. to Report First Half, 2025 Results on Sep 29, 2025 Urteste S.A. announced that they will report first half, 2025 results on Sep 29, 2025 공시 • Jul 21
Urteste S.A. Completes the Development Phase of Panuri Test and Reached Technological Readiness for Clinical Performance Study Urteste S.A. has completed the development phase of its Panuri test and reached technological readiness for clinical performance study. The test is designed to detect pancreatic cancer - one of the most difficult cancers to diagnose. Clinical study in Europe are scheduled to begin in the third quarter of 2025. Urteste has developed all components of the Panuri test, including buffers, reagents, and a positive control. In-process control was conducted, and the pre-analytical phase was optimized, resulting in high-quality reagents with confirmed structure and purity, as well as reproducible test performance. The result-reading process has also been automated. As a result, the Panuri test complies with the IVDR - Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices. 
