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BERKELEY, Calif. and MAINZ, Germany - Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company with a market capitalization of $6.9 million, announced plans to provide an interim update on its eAArly DETECT 2 feasibility study by the end of summer 2025. According to InvestingPro data, the company maintains a strong cash position relative to debt, though it faces challenges with rapid cash burn. The study focuses on evaluating the company’s next-generation colorectal cancer (CRC) screening test, which aims to improve early detection and prevention of the disease.
The eAArly DETECT 2 feasibility study is currently assessing the integration of proprietary mRNA biomarkers, an AI-developed algorithm, and a fecal immunochemical test (FIT) across a population of around 2,000 average-risk patients. The goal is to validate the promising results of previous studies and support the transition from CRC screening to prevention. While the company’s stock has experienced significant pressure, trading near its 52-week low of $2.18, InvestingPro analysis suggests the stock may be undervalued at current levels.
Mainz Biomed expects to complete enrollment for the study in the second half of 2025, with top-line results anticipated in the fourth quarter of the same year. These results will be crucial in finalizing the protocols for ReconAAsense, the company’s upcoming U.S. pivotal study slated to begin in 2026.
The company’s CEO, Guido Baechler, expressed enthusiasm about the progress of eAArly DETECT 2 and the potential impact on patients and medical professionals. By identifying advanced precancerous lesions and early-stage CRC, Mainz Biomed aims to contribute to the global reduction of cancer mortality rates.
The study will further evaluate the five novel gene expression (mRNA) biomarkers acquired from Sherbrooke University in 2022. These biomarkers have shown a unique ability to detect advanced adenomas, which are curable precancerous colonic polyps, as well as early-stage treatable CRC. The eAArly DETECT 2 study aims to confirm the effectiveness of these biomarkers combined with the company’s proprietary algorithm to improve diagnostic sensitivity and specificity for early-stage CRC.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions, including its flagship product, ColoAlert®, which is already marketed across Europe. Despite reporting revenue of $0.89 million in the last twelve months and maintaining a gross profit margin of 64%, the company’s overall financial health score is rated as WEAK by InvestingPro, which offers 12 additional investment insights for subscribers. The company is also conducting a pivotal FDA clinical study for U.S. regulatory approval. Mainz Biomed’s product portfolio also features PancAlert, a screening test for early-stage pancreatic cancer.
The information in this article is based on a press release statement from Mainz Biomed N.V.
In other recent news, Mainz Biomed N.V. has made notable advancements in its colorectal cancer (CRC) test development, with the enrollment of the first patient in the eAArly DETECT 2 study. This study aims to validate the effectiveness of its next-generation CRC test, which utilizes proprietary mRNA biomarkers and an AI-developed algorithm. The company expects to enroll approximately 2,000 participants by the second half of 2025, with top-line results anticipated by the fourth quarter of the same year. Additionally, Mainz Biomed has secured a licensing agreement with Liquid Biosciences to develop a blood test for pancreatic cancer, using mRNA biomarkers with a 95% sensitivity and 98% specificity. This collaboration aims to enhance the PancAlert program, focusing on early detection and diagnosis of pancreatic cancer. Furthermore, Mainz Biomed has regained compliance with Nasdaq listing requirements, confirming its adherence to minimum stockholders’ equity and bid price rules. In another development, the company has partnered with labor team w ag to introduce ColoAlert®, a DNA-based CRC screening test, to the Swiss market. These recent developments reflect Mainz Biomed’s ongoing efforts in cancer detection and regulatory compliance.
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