Mainz Biomed Reviews H1 2025 Accomplishments; Plans To Complete eAArly DETECT 2 Feasibility Study In H2 2025.

Benzinga·07/15/2025 12:09:30

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Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company's next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed's initial footprint in Switzerland.
Mainz Biomed entered into a technology partnership with UK-based EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalized treatments for cancer, cardiovascular and infectious diseases. Under the agreement, EDX Medical will access the Company's molecular diagnostic technology as part of the expansion of its portfolio of products for sale in the UK.
Mainz Biomed entered into a License and Option Agreement with Liquid Biosciences ("Liquid") to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed's test to be the most robust and accurate screening test for pancreatic cancer on the market.
The Company announced the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of 95% with specificity of 98% for the detection of pancreatic cancer in blood samples.
Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB's Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to 50% of the project's total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company's non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development.
The Company received formal notice from The Nasdaq Stock Market LLC ("Nasdaq") confirming that it has regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on The Nasdaq Capital Market.
Mainz Biomed priced a follow-on offering of 2,000,000 units, with each unit consisting of one ordinary share (or pre-funded warrant in lieu thereof), one Series A warrant (five-year life) to purchase one ordinary share, and one Series B warrant (one-year life) to purchase one ordinary share for gross proceeds of approximately $4.0 million. Each unit was sold at an effective offering price of $2.00 per unit.

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