Mainz Biomed NV Stock Price, News & Analysis

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

Mainz Biomed (NASDAQ: MYNZ) has provided its Q1 2025 corporate update, highlighting significant progress in its colorectal cancer (CRC) screening initiatives. The company enrolled its first patient in the eAArly DETECT 2 feasibility study, which will evaluate their next-generation CRC test incorporating mRNA biomarkers, AI algorithms, and FIT testing across 2,000 average-risk patients.

Key developments include a license agreement with Liquid Biosciences for pancreatic cancer biomarkers showing 95% sensitivity and 98% specificity, and a strategic partnership with labor team w ag to introduce ColoAlert® in Switzerland. Additionally, GANZIMMUN Diagnostics launched an enhanced version of ColoAlert across Germany in January 2025.

The company has regained full compliance with Nasdaq listing requirements, including minimum stockholders' equity and bid price requirements.

Mainz Biomed (NASDAQ:MYNZ) reported its 2024 financial results, highlighting a 33% year-over-year increase in lab network revenue for ColoAlert® in Europe. The company achieved significant cost reductions, resulting in a 30% decrease in operating loss and an 18% reduction in net loss.

Key developments include strategic partnerships with Thermo Fisher Scientific for next-generation colorectal cancer screening product development and Quest Diagnostics for clinical trial services. The company completed an $8.0 Million follow-on offering and focused on three core initiatives: European ColoAlert® business growth, next-generation product development, and the 2,000-patient eAArly DETECT 2 study.

Financial highlights for 2024 include:

• Revenue: $893,991
• Gross profit: $574,883 (64% margin)
• Net loss: $21.65 million
• Cash position: $6.24 million as of December 31, 2024

Mainz Biomed (NASDAQ:MYNZ) has enrolled its first patient in the eAArly DETECT 2 clinical study, a significant milestone in evaluating their next-generation colorectal cancer (CRC) test. The study will assess approximately 2,000 average-risk patients and combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test.

The study aims to validate previous feasibility results and support the transition from CRC screening to prevention. Enrollment is expected to complete in H2 2025, with top-line results targeted for Q4 2025. The outcome will help finalize protocols for ReconAAsense, the company's U.S. pivotal study planned for 2026.

The test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, which have shown ability to identify both advanced adenomas (precancerous colonic polyps) and early-stage CRC. The study seeks to enhance diagnostic sensitivity and specificity for early-stage CRC detection.

Mainz Biomed (NASDAQ:MYNZ) has entered into a License and Option Agreement with Liquid Biosciences for novel mRNA biomarkers enabling non-invasive pancreatic cancer detection via blood tests. The groundbreaking discovery analysis demonstrated 95% sensitivity and 98% specificity in detecting pancreatic cancer.

The study involved multiple independent cohorts, with initial discovery using a blood-based cohort of 285 subjects, including 35 pancreatic cancer patients. The agreement grants Mainz exclusive license rights and an option to acquire global rights to the gene expression biomarkers, involving both a license fee and future revenue royalties.

The companies will jointly develop the pancreatic cancer screening test, focusing on commercial assay enhancement, algorithm refinement, and FDA application preparation. If statistical results prove replicable in a new product, this could position Mainz's test as the market's most robust pancreatic cancer screening solution.

Mainz Biomed (NASDAQ:MYNZ) is marking Colorectal Cancer Awareness Month with a focus on transforming screening into prevention. The company highlights that colorectal cancer (CRC) remains the second leading cause of cancer deaths globally, causing over 930,000 deaths annually, with 150,000 diagnoses in the U.S. and 22,836 deaths in Germany.

The company's research has yielded promising results through their ColoFuture and eAArly DETECT studies, achieving 82% sensitivity in advanced adenoma detection with 97% specificity using mRNA biomarkers, FIT test, and AI algorithms. Their flagship product, ColoAlert®, is expanding through laboratory partnerships, including a recent collaboration in Switzerland.

To increase accessibility, Mainz Biomed has implemented at-home testing solutions through European Oncology Lab's web platform. The company emphasizes that while CRC is highly preventable, low screening participation continues to make it a leading cause of cancer deaths, driving their mission to enhance early detection and prevention strategies.