Gold prices steady with focus on Ukraine-Russia, Jackson Hole
CINCINNATI - Onconetix, Inc. (NASDAQ:ONCO), a cancer diagnostics company currently trading at $0.13 per share with a market cap of just over $1 million, presented new clinical data for its prostate cancer diagnostic tool, Proclarix, during the European Association of Urology (EAU) congress yesterday. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, though investors should note its significant cash burn rate and weak financial health score. The study demonstrated Proclarix’s clinical effectiveness, particularly in reducing unnecessary biopsies for prostate cancer detection.
Proclarix is designed to address the limitations of prostate-specific antigen (PSA) testing by improving the accuracy of prostate cancer diagnosis. The test combines in-vitro assays for biomarkers and a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer.
The clinical data presented came from a study involving 808 patients with suspected prostate cancer. Notably, in a subpopulation of 371 patients with enlarged prostates who often have elevated PSA levels leading to false positives, a negative Proclarix test indicated a 5% or less probability of clinically significant cancer. While the clinical results are promising, InvestingPro data shows the company faces financial challenges, with negative EBITDA of -$13.1 million in the last twelve months and a concerning current ratio of 0.06. This performance was superior to other diagnostic tools such as %fPSA and the ERSPC risk calculator.
In a broader group of 654 patients with PSA levels ranging from 2-20 ng/ml, Proclarix confirmed its clinical utility with a 96% sensitivity rate and significantly higher specificity compared to the other methods.
Dr. Ahmed H. Zedan, the primary investigator from the University Hospital of Southern Denmark, stated that Proclarix could safely reduce the number of performed biopsies by ruling out patients with clinically insignificant or no prostate cancer, minimizing the risk of missing clinically significant cases.
Proclarix is CE-certified under the In Vitro Diagnostic Regulation (IVDR) and recommended by European (EAU) and American (AUA) guidelines for prostate cancer diagnosis in patients with specific criteria.
Onconetix, formerly known as Blue Water Biotech, Inc., acquired Proclarix through its purchase of Proteomedix. The company anticipates marketing Proclarix in the U.S. as a lab developed test (LDT) through a licensing agreement with Labcorp. InvestingPro subscribers have access to 17 additional ProTips and comprehensive financial analysis for ONCO, including detailed insights into its revenue forecasts and growth potential. Get the full picture with InvestingPro’s exclusive Research Report, available for over 1,400 US stocks.
The information in this article is based on a press release statement from Onconetix, Inc.
In other recent news, Oncopeptides reported robust financial results for the fourth quarter of 2024, with a 35% increase in European sales compared to the previous quarter. The company’s total revenue for Q4 was SEK 9.9 million, contributing to full-year sales of SEK 31.6 million, up from SEK 10.9 million in 2023. Oncopeptides is making strategic market expansions in Europe and is exploring new markets in Japan and South Korea, with aims to achieve cash flow positivity by the end of 2026. Meanwhile, Onconetix announced leadership changes, appointing James Sapirstein as Executive Chairman and Andrew Oakley as a new board member, alongside increasing its board size. These changes coincide with Onconetix’s upcoming 2025 annual meeting of stockholders. In terms of analyst activity, Oncopeptides did not report any upgrades or downgrades, but they continue to focus on expanding their market presence and securing regulatory progress in new markets. Both companies are navigating significant developments, with Oncopeptides focusing on expanding sales and regulatory pathways, while Onconetix is strengthening its leadership team.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.