Mainz Biomed NV Stock Price, News & Analysis

Mainz Biomed (NASDAQ:MYNZ) will present groundbreaking clinical data from their eAArly DETECT study at the World Endoscopy Organization's CRC Screening Committee Meeting on October 3rd, 2025 in Berlin.

Dr. Lena Krammes will showcase the company's RNA-based diagnostic test results, which demonstrated remarkable efficacy with 97% sensitivity and specificity for colorectal cancer detection, 82% sensitivity for advanced adenomas, and 100% detection rate for advanced adenomas with high-grade dysplasia.

The presentation, titled "From Detection to Prevention," will highlight the potential of stool RNA testing in both early cancer detection and prevention through identification of high-risk lesions.

Mainz Biomed (NASDAQ:MYNZ) has announced the commercial launch of its flagship product ColoAlert® in Switzerland, marking a significant expansion of its colorectal cancer screening solution. The launch follows three key achievements: a strategic partnership with labor team w ag, one of Switzerland's leading diagnostic laboratories; regulatory approval from Swissmedic; and successful completion of technology transfer to labor team's facility in Goldach.

Additionally, the company provided an update on its eAArly DETECT 2 Study, which aims to enroll 2,000 average-risk patients. Management has decided to proceed with complete enrollment through the end of 2025 without pausing for an interim readout.

Mainz Biomed (NASDAQ:MYNZ) has achieved a significant milestone with the registration of ColoAlert®, its DNA-based colorectal cancer screening test, by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This regulatory approval enables marketing authorization across the United Kingdom.

The registration follows Mainz's technology partnership with EDX Medical Group plc and aims to address the UK's colorectal cancer burden, where approximately 44,000 new cases are diagnosed annually. ColoAlert will complement the existing Bowel Cancer Screening Program, which currently serves people aged 50-74, by providing a non-invasive screening option that detects DNA biomarkers in stool samples.

Mainz Biomed (NASDAQ:MYNZ) has received regulatory approval from Swissmedic to market ColoAlert®, its non-invasive colorectal cancer screening test, in Switzerland. The approval follows the company's partnership with labor team w ag, a local Swiss laboratory.

The Swiss market represents a significant opportunity, with 2.8 million people (31.4% of the population) in the target age group of 50-74 years. Current colorectal cancer screening participation rates in Switzerland are below 50% despite having over 13 screening programs nationwide. ColoAlert®, designed to detect CRC tumor DNA and other biomarkers in stool samples, aims to improve these participation rates.

Mainz Biomed (NASDAQ:MYNZ), a molecular genetics diagnostic company focused on early cancer detection, has announced the pricing of a $3.0 million follow-on offering. The offering consists of 2,222,222 units priced at $1.35 per unit, with each unit including one ordinary share (or pre-funded warrant) and one Series A warrant.

The Series A warrants will be immediately exercisable at $1.35 per share with a five-year expiration term. Maxim Group LLC serves as the sole placement agent, with the offering expected to close around August 5, 2025, subject to customary conditions.

Mainz Biomed (NASDAQ:MYNZ) has announced a strategic collaboration with CARE diagnostica Laborreagenzien GmbH to expand colorectal cancer screening services in Germany. The partnership will integrate Mainz Biomed's ColoAlert® test into CARE's existing screening programs, which currently serve more than 15 statutory health insurance companies.

The collaboration enables CARE to enhance its screening offerings by incorporating ColoAlert®'s molecular genetic analysis capabilities, which use PCR to analyze biomarkers in stool samples. This advanced technology aims to improve early-stage detection rates compared to traditional fecal immunochemical tests (FIT).

Mainz Biomed (NASDAQ:MYNZ) reported significant progress in H1 2025, focusing on advancing its colorectal and pancreatic cancer screening technologies. The company launched eAArly DETECT 2, a US feasibility study evaluating its next-gen colorectal cancer test across 2,000 average-risk patients.

A key development was the License and Option Agreement with Liquid Biosciences for pancreatic cancer screening biomarkers, which demonstrated 95% sensitivity and 98% specificity in initial studies. The company secured public funding from ISB for up to 50% of the pancreatic cancer project costs.

Additionally, Mainz Biomed expanded its market presence through partnerships with labor team w ag in Switzerland and EDX Medical Group in the UK. The company also completed a $4.0 million follow-on offering and regained full Nasdaq compliance.

Mainz Biomed (NASDAQ:MYNZ) has secured significant public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB) for its pancreatic cancer screening test development. The ISB will fund up to 50% of the total project costs through its Innovation and Technology Support Program.

The company is currently in the feasibility phase, collaborating with Crown Bioscience to evaluate a panel of mRNA biomarkers and a machine learning-driven algorithm using clinical blood samples. This non-invasive, blood-based screening test aims to enable earlier detection of pancreatic cancer, potentially improving treatment outcomes.

Mainz Biomed (NASDAQ:MYNZ) has launched the feasibility phase of its PancAlert project, aimed at developing a non-invasive blood-based screening test for early pancreatic cancer detection. This phase follows successful discovery analysis conducted with Liquid Biosciences in early 2025, which showed 95% sensitivity and 98% specificity. The company is partnering with Crown Bioscience to verify a panel of mRNA biomarkers and ML-based algorithm using real clinical blood samples. The study will evaluate the assay's robustness, reproducibility, and diagnostic performance. If successful, Mainz Biomed plans to proceed with a larger validation study, potentially leading to FDA submission. The project is part of the company's strategy to develop early cancer detection diagnostics where current screening options are limited.