Mainz Biomed N.V. Ordinary Shares - MYNZ STOCK NEWS

Mainz Biomed (NASDAQ:MYNZ) reported significant strategic achievements for the year ended December 31, 2021. Highlights include a successful IPO on Nasdaq, progress in European commercialization of ColoAlert, and the recruitment of key management personnel. The company acquired novel mRNA biomarkers aimed at enhancing its ColoAlert test for colorectal cancer detection. Additionally, it raised $25.8 million in a public follow-on offering. Mainz initiated a clinical study, ColoFuture, and received FDA acceptance for its pivotal trial design pre-submission, positioning the company for U.S. regulatory advancements in 2022.

Mainz Biomed (NASDAQ:MYNZ) is participating in an international campaign for Colorectal Cancer Awareness Month. Partnering with healthcare professionals and laboratories in Germany, the initiative aims to promote early detection through screening, vital for successful treatment. CEO Guido Baechler highlighted the importance of awareness, indicating over 500,000 expected diagnoses in Europe this year. The campaign includes advertising to encourage screening and offers resources at gemeinsam-gegen-darmkrebs.de. Mainz's ColoAlert test is pivotal in this effort.

Mainz Biomed N.V. (NASDAQ:MYNZ) announced that the U.S. FDA has accepted their pre-submission for ColoAlert, a test for early colorectal cancer detection, for review. The feedback expected in Q2 2022 will inform the clinical trial design, which is set to start in 2023. The acceptance is part of Mainz's strategy following their ColoFuture study, which aims to enhance ColoAlert's diagnostic capabilities. Currently marketed in Europe, ColoAlert's anticipated U.S. approval could tap into a market worth $3.7 billion annually.

Mainz Biomed N.V. (NASDAQ:MYNZ) has partnered with Laboratory MVZ Dr. Stein + Kollegen for the commercialization of ColoAlert, a colorectal cancer detection test. This collaboration enables Mainz Biomed to leverage Laboratory Mönchengladbach's extensive network, processing over five million samples annually. The partnership will include co-branding and a comprehensive marketing campaign to enhance awareness and adoption of ColoAlert. With colorectal cancer being a major health issue, this partnership aims to improve early detection, which is crucial for successful treatment.

Mainz Biomed (NASDAQ:MYNZ) has appointed Dr. Rainer Metzger to its Strategic Advisory Board, bringing over 25 years of experience in the pharmaceuticals and diagnostics industry. Dr. Metzger's expertise in oncology diagnostics is expected to enhance Mainz's commercial expansion and partnerships. The company emphasizes the early detection capabilities of its ColoAlert test for colorectal cancer, which holds significant market potential, especially with an increasing 50+ population in the U.S. The test is CE-IVD marked and aims for U.S. regulatory approval in 2022.

Mainz Biomed has launched the ColoFuture international clinical study aimed at enhancing ColoAlert, its at-home colorectal cancer screening test. The study will assess the integration of novel mRNA biomarkers to improve diagnostic sensitivity and specificity, particularly for identifying advanced adenomas. Conducted with over 600 patients across Norway and Germany, results are expected in early 2023. The company is also preparing for a regulatory pathway in the U.S., targeting a market opportunity of approximately $3.7 billion annually.

Mainz Biomed N.V. (NASDAQ:MYNZ) has successfully closed its underwritten public follow-on offering, raising $25.875 million through the sale of 1,725,000 ordinary shares at a price of $15.00 each. This offering included an option exercised by underwriters for an additional 225,000 shares. The funds are earmarked for the development of recently acquired mRNA biomarkers and clinical studies to support the ColoAlert FDA submission. Mainz Biomed, focused on cancer diagnostics, aims to enhance its product portfolio and expedite U.S. market access.

Mainz Biomed N.V. (NASDAQ:MYNZ) has appointed Steve Quinn as Vice President of Business Development to spearhead international growth, particularly for its ColoAlert colorectal cancer screening test. With extensive experience in molecular genetics and diagnostics, Quinn aims to enhance market penetration across Europe, the Middle East, Asia, and the U.S. pending FDA approval. The ColoAlert test, with its high sensitivity and specificity, represents a significant opportunity in the colorectal cancer screening market, projected to be worth approximately $3.7 billion annually in the U.S.

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.