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BERKELEY, Calif. - Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company trading near its 52-week low of $3.65, has announced the enrollment of the first patient in eAArly DETECT 2, a study designed to assess the effectiveness of its next-generation colorectal cancer (CRC) test. According to InvestingPro data, the company’s stock has declined nearly 90% over the past year, reflecting investor concerns about its rapid cash burn rate. The test, which includes proprietary mRNA biomarkers and an AI-developed algorithm, aims to improve the detection of advanced precancerous lesions (APL) and early-stage CRC in average-risk patients.
The company expects to complete the enrollment of approximately 2,000 participants for the study in the second half of 2025, with top-line results anticipated by the fourth quarter of 2025. These findings will inform the final protocols for ReconAAsense, Mainz Biomed’s upcoming U.S. pivotal study slated to begin in 2026. With a current market capitalization of just $14.4 million and an overall financial health score rated as ’Weak’ by InvestingPro, the company faces significant challenges in funding its research pipeline.
Guido Baechler, CEO of Mainz Biomed, expressed the significance of the eAArly DETECT 2 study for the patient community and medical professionals, highlighting the potential impact on reducing global cancer mortality rates through early detection.
The five novel gene expression biomarkers involved in the study were acquired from Sherbrooke University in 2022 and have shown promise in identifying curable precancerous colonic polyps and treatable early-stage CRC. The current study will further validate these biomarkers in conjunction with the company’s proprietary algorithm, aiming to enhance diagnostic sensitivity and specificity for early-stage CRC.
Mainz Biomed, known for its flagship product ColoAlert®, a non-invasive diagnostic test for colorectal cancer marketed in Europe, is working towards U.S. regulatory approval. The company also has a product candidate, PancAlert, for early-stage pancreatic cancer screening in its portfolio.
This news is based on a press release statement and further information can be found on Mainz Biomed’s official investor website. The company’s filings are also available on the SEC’s website, and investors are advised to consider the forward-looking statements with caution due to various risks and uncertainties that may cause actual results to differ materially from expectations. With the next earnings report due on April 15, 2025, investors seeking deeper insights into Mainz Biomed’s financial health and growth prospects can access additional analysis and 10+ exclusive ProTips through InvestingPro.
In other recent news, Mainz Biomed has achieved a significant milestone by regaining compliance with Nasdaq’s stockholders’ equity requirement, ensuring its continued listing on the Nasdaq Capital Market. The company had previously met Nasdaq’s minimum bid price requirement, and now with full compliance, it maintains its standing on the stock exchange. Additionally, Mainz Biomed has entered into an exclusive licensing agreement with Liquid Biosciences to develop a blood test for pancreatic cancer detection. This agreement allows Mainz Biomed to potentially acquire global rights to biomarkers with high sensitivity and specificity. The companies plan to develop the screening test further, aiming for FDA approval.
In another development, Brera Holdings PLC has announced the date for its 2024 annual general meeting, scheduled for March 28, 2025. The meeting will be accessible online, allowing shareholders to participate remotely. The company has filed the necessary documents with the United States Securities and Exchange Commission, ensuring compliance with regulatory requirements. While the agenda for the meeting was not detailed, it typically includes discussions on financial statements and board elections. These recent developments reflect ongoing activities and strategic moves by both Mainz Biomed and Brera Holdings PLC.
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