Mainz Biomed NV Stock Price, News & Analysis

Mainz Biomed N.V. (MYNZ) announced a follow-on offering of 1,500,000 ordinary shares at $15.00 per share, aiming for gross proceeds of $22.5 million. The offering is expected to close on January 28, 2022, subject to customary conditions. The underwriter, Boustead Securities, LLC, has an option to purchase an additional 225,000 shares for over-allotments. Mainz Biomed focuses on molecular genetic diagnostic solutions, with its flagship product, ColoAlert, targeting colorectal cancer detection, and plans to seek FDA approval later in 2022.

Mainz Biomed, a molecular genetics diagnostic company, has engaged DCN Dx to conduct a European clinical study for its ColoAlert test, aimed at detecting colorectal cancer. This partnership focuses on integrating recently acquired mRNA biomarkers to enhance ColoAlert's accuracy in detecting pre-cancerous lesions. The study is set to begin in H1 2022, with potential implications for U.S. FDA approval. With the colorectal cancer market projected at $3.7 billion in the U.S., successful results could establish ColoAlert as a leading at-home screening test.

Mainz Biomed N.V. (NASDAQ:MYNZ) announced the appointment of Dr. Michele Pedrocchi to its Strategic Advisory Board. Dr. Pedrocchi, a seasoned healthcare executive with over 25 years at Roche, brings extensive experience in in vitro diagnostics and international market launches. His expertise is expected to enhance the company’s flagship product, ColoAlert, which is designed for early colorectal cancer detection. The company aims to expand its commercial presence across Europe and beyond. Dr. Pedrocchi will also support strategic partnerships related to product development and distribution.

Mainz Biomed N.V. (NASDAQ:MYNZ) announced its participation in the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. CEO Guido Baechler will present at the event, which can be accessed online. Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, particularly with its ColoAlert test for colorectal cancer, which has a high accuracy and is CE-IVD marked. The U.S. market opportunity for colorectal cancer testing is estimated at $3.7 billion annually, with significant growth expected in the 50+ population.

Mainz Biomed (NASDAQ:MYNZ) has secured a Technology Rights Agreement with TTS, gaining access to a portfolio of mRNA biomarkers aimed at enhancing its ColoAlert colorectal cancer screening test. This agreement positions ColoAlert to possibly become the leading at-home screening solution, with previous studies indicating high sensitivity (75% for advanced adenomas and 95% for colorectal cancer). The company plans to initiate a clinical study in Europe to assess these biomarkers, targeting a launch in the first half of 2022. ColoAlert is already CE-IVD marked and aims for U.S. regulatory approval soon.

Mainz Biomed (NASDAQ:MYNZ) announced the appointment of Karen Richards as Vice President of Regulatory Affairs. This strategic hire is expected to aid in navigating U.S. regulatory processes for their colorectal cancer detection product, ColoAlert. With over 30 years in the in vitro diagnostics sector, Richards' extensive experience includes spearheading regulatory approvals globally. ColoAlert, already marketed in Europe, detects early-stage colorectal cancer and has a significant market potential in the U.S., estimated at $3.7 billion annually, given the rising population of those eligible for testing.

Mainz Biomed N.V. (NASDAQ:MYNZ) has partnered with GANZIMMUN Diagnostics to co-brand its colorectal cancer detection test, ColoAlert, in Germany. GD is one of Europe's leading labs, processing around 5,500 orders daily with an expert team of over 370 professionals. GD will purchase customized PCR assay kits from Mainz to enhance colorectal cancer prevention efforts in major cities like Mainz, Wiesbaden, and Frankfurt. This collaboration aims to establish efficient commercial partnerships to improve test accessibility and reliability, positioning ColoAlert as a critical diagnostic tool in early cancer detection.

Mainz Biomed has launched ColoAlert.de, an e-commerce platform allowing German residents to access its colorectal cancer screening test directly. The test offers highly accurate results within nine working days, catering to those facing challenges in obtaining in-person screenings due to the COVID-19 pandemic. The company aims to enhance early detection of colorectal cancer, which affects 370,000 diagnosed patients annually in the EU, reducing mortality rates and healthcare costs in the process.

Mainz Biomed (NASDAQ:MYNZ) announced on Nov 30, 2021, its collaboration with Precision for Medicine to support U.S. regulatory and reimbursement strategies for ColoAlert, a colorectal cancer diagnostic test. This partnership aims to enhance the test's market access and FDA approval process, crucial for its commercial success.

ColoAlert, which boasts high sensitivity and specificity, is already available in Europe. It offers significant potential in the U.S. market, with an estimated opportunity of $3.7 billion annually as the population over 50 increases.