Berkeley / Mainz: Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetic diagnostics company pioneering early cancer detection, today provided a corporate update for the first half of 2025, highlighting strategic milestones across its colorectal and pancreatic cancer programs.
The Company will report its half-year financial results in September.
Advancing Next-Gen Colorectal Cancer Screening Toward FDA Approval
The company launched eAArly DETECT 2, a U.S.-based feasibility study evaluating its next-generation colorectal cancer (CRC) screening product.
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The study, involving 2,000 average-risk patients, integrates proprietary mRNA biomarkers, an AI-driven algorithm, and the FIT test, aiming to validate results from prior studies and lay the groundwork for the pivotal ReconAAsense FDA premarket approval study in 2026.
Mainz Biomed: Expanding International Footprint
- Switzerland Entry: Mainz partnered with labor team w ag, launching ColoAlert®, its flagship CRC screening test, in the Swiss market.
- UK Partnership: Entered a technology collaboration with EDX Medical Group plc, enabling the integration of Mainz’s molecular diagnostic solutions into EDX’s portfolio for the UK market.
Breakthrough in Pancreatic Cancer Detection
Mainz Biomed signed a License and Option Agreement with Liquid Biosciences to access a cutting-edge mRNA biomarker platform for non-invasive, blood-based pancreatic cancer screening.
Liquid’s EMERGE platform identified markers with 95% sensitivity and 98% specificity, creating the potential for a best-in-class diagnostic solution.
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Additionally, the company:
- Launched the PancAlert project, a research initiative focused on developing this blood-based pancreatic cancer test.
- Secured public funding from ISB Rheinland-Pfalz, which will cover up to 50% of development costs, underscoring the government’s endorsement of Mainz’s innovations in early cancer detection.
Strengthening Capital and Compliance Position
- Nasdaq Compliance Restored: Mainz regained full compliance with all Nasdaq Capital Market listing requirements, including minimum equity and bid price standards.
- Capital Raise: Completed a $4 million follow-on offering of 2 million units, each comprising one ordinary share (or pre-funded warrant), a five-year Series A warrant, and a one-year Series B warrant.
“The first half of 2025 was transformative,” said Guido Baechler, CEO of Mainz Biomed. “We made meaningful progress with our eAArly DETECT 2 study and significantly expanded our pancreatic cancer pipeline through our partnership with Liquid Biosciences. These strategic advances position us to enter H2 2025 with strong momentum, as we prepare for the next phase of our FDA journey.”
