MYNZ Mainz BioMed NV

Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Dr. Douglas K. Rex to its Medical Advisory Board (MAB). Dr. Rex is the latest industry expert to join the MAB which was established to support Mainz’s forthcoming U.S. pivotal trial for ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC).

“As one of the world’s leading experts in the field of colorectal cancer screening, we’re proud to welcome Dr. Rex to our MAB and will certainly benefit greatly from his participation,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “We are fortunate to have a remarkable group of experts join our MAB. Their unparalleled expertise is already paying dividends and will continue to be invaluable as we take the necessary steps to prepare for our pivotal US clinical trial which is on track to commence in 2022.”

Dr. Rex is Distinguished Professor Emeritus of Medicine at Indiana University School of Medicine, Chancellor’s Professor at Indiana University Purdue University Indianapolis, and Director of Endoscopy at Indiana University Hospital in Indianapolis. He graduated from Harvard College, Summa Cum Laude in 1976 and with highest distinction from Indiana University School of Medicine in 1980. He served as Chief Medical Resident at Indiana University Hospital and joined the faculty at Indiana University in 1985. He is a full-time clinical gastroenterologist at Indiana University Hospital.

His major research interests have been in colorectal disease and, in particular, colorectal cancer screening and the technical performance of colonoscopy. He co-authored the colorectal cancer screening recommendations of the American College of Gastroenterology and the U.S. Multi-Society Task Force on Colorectal Cancer. He also authored the recommendations on quality in colonoscopy of the U.S. Multi-Society Task Force on Colorectal Cancer and the American College of Gastroenterology/American Society of Gastrointestinal Endoscopy. He has authored more than 300 original research papers, 70 book chapters, 230 invited papers, 75 editorials, and 40 guideline papers. He has twice chaired the U.S. Multi-Society (ACG, ASGE, AGA) Task Force on Colorectal Cancer. He is a past president of the American College of Gastroenterology and The American Society for Gastrointestinal Endoscopy.

“As someone who has devoted much of their career to the fight against colorectal cancer, I believe that advanced, accurate and simple-to-administer screening solutions like ColoAlert have the potential to significantly impact the scale and devastating nature of this terrible disease,” said Dr. Rex. “I’m very pleased to be working with the highly-talented Mainz Biomed team and distinguished fellow Medical Advisory Board members and trust that we can provide meaningful benefit from our combined expertise to ably support the Company’s forthcoming U.S. pivotal trial for ColoAlert.”

Mainz is currently marketing ColoAlert through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The Company is also running ColoFuture, an international clinical study evaluating the potential to integrate a portfolio of in-licensed novel mRNA biomarkers into the product which have previously demonstrated the unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC (Herring et al 2021). ColoFuture is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. The results of the study will ultimately impact the configuration of ColoAlert prior to commencing the U.S. pivotal study which is on track to begin in 2022.

About ColoAlert

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements). The product is commercially available in a selection of countries in the European Union and in the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

*Dollinger MM et al. (2018)

About Colorectal CancerColorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

About Mainz Biomed N.V.Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe and in the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.

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Forward-Looking StatementsCertain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its registration statement on Form F-1 filed on January 21, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.