New Risk • Jul 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Polish stocks, typically moving 6.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 5.4% per year over the past 5 years. Revenue is less than US$1m (zł2.5m revenue, or US$658k). Minor Risks Share price has been volatile over the past 3 months (6.9% average weekly change). Market cap is less than US$100m (zł69.3m market cap, or US$18.3m). Announcement • 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. Announcement • 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. 
