Mainz Biomed Advances FDA Pathway, Expands into Pancreatic Cancer Screening and Secures $4 Million in Funding

Mainz Biomed reported promising results from its pancreatic cancer test, showing 95% sensitivity and 98% specificity. The company expanded into the Swiss and UK markets through strategic partnerships and secured $4 million in funding, regaining full Nasdaq compliance. Mainz Biomed's focus is on advancing its colorectal and pancreatic cancer screening technologies and expanding its global market presence.

Mainz Biomed N.V. (NASDAQ: MYNZ) has reported significant advancements in its cancer screening technologies during the first half of 2025. The molecular genetics diagnostic company, specializing in early detection, has made notable strides in both colorectal and pancreatic cancer screening, while also expanding its market reach and securing substantial funding.

Key Highlights:

1. Pancreatic Cancer Screening: Mainz Biomed has made substantial progress with its pancreatic cancer screening test. The company's test, developed in partnership with Liquid Biosciences, demonstrated 95% sensitivity and 98% specificity in detecting pancreatic cancer in blood samples. This high accuracy positions Mainz Biomed's test as a potential leader in the market for non-invasive pancreatic cancer screening.

2. Market Expansion: The company has expanded its presence into the Swiss and UK markets through strategic partnerships. In Switzerland, Mainz Biomed introduced ColoAlert®, a DNA-based colorectal cancer screening test, marking its initial footprint in the Swiss market. In the UK, it entered into a technology partnership with EDX Medical Group plc, which will integrate Mainz Biomed's molecular diagnostic technology into its portfolio of products.

3. Funding and Compliance: Mainz Biomed secured $4 million in funding through a follow-on offering, regaining full compliance with Nasdaq's listing requirements. The company priced 2,000,000 units, each consisting of one ordinary share, one Series A warrant, and one Series B warrant, for gross proceeds of approximately $4.0 million.

4. Regulatory Approval: Mainz Biomed announced the commencement of the next phase in its PancAlert project, which aims to develop a non-invasive blood-based screening test for pancreatic cancer. The company also received public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB) to support the development of this test.

Looking Ahead:

Mainz Biomed is poised to continue its momentum in the second half of 2025. The company expects to complete its eAArly DETECT 2 feasibility study, which will serve as the launching point for its ReconAAsense US FDA pivotal colorectal cancer study in 2026. Additionally, the company's focus on expanding its global market presence and advancing its cancer screening technologies positions it well for future growth.

References:
[1] https://www.marketscreener.com/quote/stock/MAINZ-BIOMED-N-V-128954714/news/Mainz-Biomed-Half-Year-2025-Update-Accelerating-FDA-Pathway-for-NextGen-Colorectal-Cancer-Screening-50511730/
[2] https://mainzbiomed.com/mainz-biomed-half-year-2025-update-accelerating-fda-pathway-for-nextgen-colorectal-cancer-screening-and-expansion-with-pancreatic-cancer-screening-acquisition/