Mainz Biomed NV Stock Price, News & Analysis

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.

Mainz Biomed (NASDAQ:MYNZ) has announced the pricing of a $4.0 million follow-on offering, consisting of 2,000,000 units priced at $2.00 per unit. Each unit includes one ordinary share (or pre-funded warrant), one Series A warrant, and one Series B warrant to purchase ordinary shares. The Series A warrants have a 5-year term, while Series B warrants expire either 30 days after eAArly Detect 2 study results or one year from issuance. Both warrant series are immediately exercisable at $2.00 per share. Additionally, the company has amended previous December 2024 warrants, reducing their exercise price to $2.00 for both Series A (1,367,521 shares) and Series B (1,367,521 shares). Maxim Group LLC is serving as the sole placement agent, with the offering expected to close around May 21, 2025.

Mainz Biomed (NASDAQ:MYNZ) announced plans to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025. The study evaluates the company's next-generation colorectal cancer (CRC) screening test across approximately 2,000 average-risk patients.

The test combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test to detect both cancerous polyps and precancerous adenomas. Based on the study's outcome, Mainz Biomed plans to finalize protocols for ReconAAsense, its U.S. pivotal study, scheduled to begin in 2026.

The company's five novel gene expression biomarkers, acquired from Sherbrooke University in 2022, have shown capability in identifying advanced adenomas and early-stage CRC, potentially advancing CRC screening to prevention.

Mainz Biomed (NASDAQ:MYNZ), a molecular genetics diagnostic company focused on early cancer detection, has formed a strategic technology partnership with EDX Medical Group (AQSE: EDX). This collaboration will enable EDX Medical to leverage Mainz Biomed's molecular diagnostic technology for expanding its product portfolio in the UK market.

The partnership combines Mainz Biomed's expertise in molecular diagnostics with EDX Medical's capabilities in developing digital diagnostic products for cancer, cardiovascular, and infectious diseases. EDX Medical, based in the UK, specializes in creating diagnostic solutions that support personalized treatments.

Key highlights of the partnership:

• Focus on improving access to high-quality cancer diagnostics in the UK
• Integration of molecular biomarkers for enhanced early cancer detection
• Expansion of EDX Medical's diagnostic product portfolio