Mainz Biomed NV Stock Price, News & Analysis

Mainz Biomed NV (NASDAQ:MYNZ) has announced key activities for May 2023, including the commencement of voluntary quarterly financial reporting, starting with Q1 results due on May 16, 2023. CEO Guido Baechler will present at the Equity Forum Spring Conference in Frankfurt on May 17, where he will discuss the company’s progress in expanding sales in Europe and advancing regulatory approvals in the U.S. The company is focused on its flagship product, ColoAlert®, a non-invasive colorectal cancer screening test, and is conducting pivotal studies to establish its efficacy and market potential. Results from the eAArly Detect study are anticipated in mid-2023, with further enrollment in U.S. studies expected in the second half of the year. The U.S. market for colorectal cancer screening presents a significant opportunity, with over $4 billion in potential revenue.

Mainz Biomed (NASDAQ:MYNZ) has partnered with Instituto de Microecologia in Madrid to market its at-home colorectal cancer detection test, ColoAlert, to physicians and patients in Spain and Portugal. This collaboration enhances Mainz Biomed's testing network in Europe, where colorectal cancer (CRC) is a leading cause of morbidity and mortality. With over 10,500 new CRC cases reported in Portugal in 2020 and significant early-stage survival rates exceeding 90%, accessibility to reliable screening is crucial. The ColoAlert test offers high sensitivity in detecting tumors via stool DNA analysis, surpassing traditional methods. Mainz Biomed aims to increase consumer access to affordable screening to improve early detection and prevention. The potential market for CRC screening in the US is estimated at over $4 billion, highlighting a significant commercial opportunity.

On April 10, 2023, Mainz Biomed (NASDAQ:MYNZ) reported a significant 130% increase in revenue from its ColoAlert product year-over-year, reaching $519,728. The company ended 2022 with a strong cash balance of $17.1 million, supporting its growth strategies. Key developments included expanding its commercial activities in Germany and Italy, acquiring exclusive rights to novel mRNA biomarkers, and progressing clinical studies aimed at enhancing colorectal cancer detection. Mainz Biomed raised $25.8 million through a follow-on share offering and appointed industry veterans to its leadership team, indicating a robust commitment to product development. Despite a growing revenue stream, the company faced substantial operating losses, amounting to $26.4 million in net losses for the fiscal year.

Mainz Biomed NV (NASDAQ:MYNZ) announced that three German companies have adopted its ColoAlert^® colorectal cancer screening test in their health programs. This initiative aims to increase accessibility to screening, given that Germany sees nearly 73,000 new CRC cases each year. CEO Guido Baechler emphasized the importance of early detection for better treatment options and outcomes. The ColoAlert^® test promises high sensitivity and specificity, making it a superior option compared to traditional tests. The company is also pursuing FDA approval for the test, while tackling a significant market opportunity in the U.S., estimated over $4 billion.

Mainz Biomed (NASDAQ:MYNZ) announced successful results from a feasibility study evaluating its novel gene expression biomarkers for colorectal cancer (CRC) detection. The study showed that the company's proprietary nucleic acid extraction and PCR processes effectively obtained DNA and mRNA from patient samples stored for over 15 years. Two mRNA biomarkers demonstrated significant efficacy in detecting disease signals in advanced adenoma and CRC specimens. The ongoing eAArly DETECT clinical trial is set to report its findings in mid-2023, which may influence the inclusion of these biomarkers in the ReconAAsense pivotal trial aimed at FDA approval.

Mainz Biomed NV (NASDAQ:MYNZ) announced that CFO Bill Caragol will present at the Sidoti March Virtual Investor Conference on March 22, 2023, at 12:15 ET. The event will also include one-on-one investor meetings on March 22-23, 2023. Registration for the presentation is free and available at Sidoti's website. Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product, ColoAlert, designed for at-home colorectal cancer screening. The company is currently seeking FDA approval for ColoAlert, which is already available in select EU markets.