Mainz Biomed Narrows Its Losses, Grows Revenue For Full Year 2024

From expanding partnerships to advancing trials, Mainz Biomed NV MYNZ, the molecular genetics diagnostic company, had a busy 2024 – which appears to have shown in its revenue growth. The company recently reported full year 2024 earnings, and it was able to grow revenue by double digits and narrow its losses over the year. That is expected to position the company for more milestones during 2025. 

"We are proud of the accomplishments our team achieved in 2024, which was a transitional year for Mainz Biomed," said Guido Baechler, Chief Executive Officer of Mainz Biomed in a press release announcing the results. "While navigating through a period of difficult market conditions, especially for small cap healthcare and technology stocks, we reached many significant milestones."

The molecular genetics diagnostic company's flagship product ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer (CRC) cases, often in the very early stages of the disease.

Trial Starting Up 

In addition to continuing to grow its ColoAlert business in Europe, the company is developing next-generation colorectal cancer screening products and also running a 2,000-patient study in the U.S. dubbed eAArly DETECT 2. The feasibility study is aimed at evaluating Mainz Biomed's next-generation CRC test. The test integrates the company's proprietary mRNA biomarkers, an AI-developed algorithm and a FIT test to validate the results of previous feasibility studies and support the transition of CRC screening to CRC prevention. The first person was enrolled in the study in early 2025. Mainz Biomed expects to report top-line results by the end of 2025.

The company's work with CRC screening and CRC prevention is addressing an unmet need. Colorectal cancer is a leading cause of death in America, killing 50,000 people each year. But if it’s caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in ten colorectal cancers are spotted at the early stage. It’s a sizable market opportunity for Mainz Biomed, given the colorectal cancer screening and diagnostics market is forecast to hit $46.1 billion by 2029.

Mainz Biomed is also going after the early detection of pancreatic cancer, a market that's forecast to reach $3.2 billion by 2035. In 2025 Mainz Biomed signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity, reports Mainz Biomed. 

For the full year 2024, Mainz Biomed reported its year-over-year loss from operations and net loss decreased by 30% and 18%, respectively. Meanwhile, revenue from sales through its lab partner network increased 33% year-over-year. During 2024 Mainz Biomed executed an $8 million follow-on offering for 1,367,521 units sold at an offering price of $5.85 per unit and, in late January, regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market.

Deals For Growth 

During 2024, Mainz Biomed struck key alliances aimed at developing its CRC screening tests and bringing them to global markets, including a collaboration agreement signed with Thermo Fisher Scientific Inc. TMO. That deal will enable Mainz Biomed and Thermo Fisher Scientific to jointly develop and potentially commercialize Mainz Biomed's next-generation colorectal cancer screening product. Mainz Biomed says the collaboration leverages Thermo Fisher's technologies, instrumentation and information translation systems to enable Mainz Biomed to develop proprietary assays for its mRNA-based next-generation CRC screening tests. The company further says it has a robust pipeline of diagnostic technologies aimed at detecting multiple cancers. 

During 2024, Mainz Biomed also inked a deal with Quest Diagnostics Inc. DGX to provide clinical trial laboratory services for Mainz Biomeds's ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of its CRC screening tests. In addition, Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an eighteen-month period, assuming it’s approved by the FDA.

"As we look at our early results for 2025, we are encouraged by the progress of our eAArly DETECT 2 study and by our recently announced discovery and license of a suite of mRNA biomarkers, showing outstanding preliminary results for a blood-based pancreatic cancer detection test," said Baechler. 

Featured photo by National Cancer Institute on Unsplash.

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