お知らせ • 2h
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. お知らせ • 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). お知らせ • 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 お知らせ • 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. New Risk • Jun 05
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 7.5% 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 Less than 1 year of cash runway based on free cash flow trend (-zł15m free cash flow). Earnings have declined by 8.0% per year over the past 5 years. Revenue is less than US$1m (zł1.5m revenue, or US$410k). Minor Risks Share price has been volatile over the past 3 months (7.5% average weekly change). Market cap is less than US$100m (zł80.6m market cap, or US$21.5m). お知らせ • May 29
Urteste S.A., Annual General Meeting, Jun 25, 2025 Urteste S.A., Annual General Meeting, Jun 25, 2025. お知らせ • May 29
Urteste S.A. Successfully Develops A Prototype Urine-Based Diagnostic Test for Detecting Brain Tumours Urteste S.A. developed a prototype IVD test for detecting brain tumours. Urteste now has a pipeline of 12 prototype diagnostic tests for the following cancers: pancreatic, brain, breast, stomach, bile ducts, ovary, endometrial, kidney, colorectal, lung, liver and prostate accounting collectively for nearly 70% of all cancer deaths worldwide. In the coming months, Urteste plans to start a multi- centre clinical trial in the US and Europe for its project PANURI, a test for pancreatic cancer. Urteste’s breakthrough technology allows for early detection of cancer by measuring the activity of enzymes present in urine using proprietary synthetic peptides. One urine sample can be used to screen for many types of cancers. Urteste technology is non-invasive, low-cost to produce, has high sensitivity and specificity, and results are available in up to 2 hours. The diagnostic process is automated to minimize the likelihood of human error. PANURI - the pancreatic cancer test is Urteste's most advanced project. Pancreatic cancer is one of the worst prognosis cancers. A proof-of-concept study of 322 participants confirmed the high sensitivity (95.6%) and specificity (95.5%) of the PANURI test. Urteste is currently undergoing an FDA Q-Submission programme. In the MULTI-CANCER project, Urteste is developing a diverse portfolio of tests. The company already has prototypes of 12 diagnostic tests for the most common cancers. In the coming months, Urteste plans to add the final prototypes to its pipeline and complete the prototype development phase of the tests. The company will then focus on preparing for clinical trials. Urteste holds polish patents and international patent applications for its technology. Urteste's patent strategy is to seek patent protection in countries that collectively generate around 90% of global GDP. お知らせ • May 21
Urteste S.A., Annual General Meeting, Jun 14, 2024 Urteste S.A., Annual General Meeting, Jun 14, 2024. New Risk • Jun 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 24% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk No financial data reported. Minor Risks Share price has been volatile over the past 3 months (7.5% average weekly change). Shareholders have been diluted in the past year (24% increase in shares outstanding). Market cap is less than US$100m (zł155.1m market cap, or US$38.0m). お知らせ • May 31
Urteste S.A., Annual General Meeting, Jun 22, 2023 Urteste S.A., Annual General Meeting, Jun 22, 2023, at 14:00 Central European Standard Time.