BERKELEY, US – MAINZ, Germany – November 2, 2022 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer today provided an update on accomplishments during the third quarter which ended September 30, 2022.
Key Highlights and Recent Developments
- Expanded European and international commercial franchise for ColoAlert, the Company’s highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (CRC) via the launch of direct-to-consumer programs in Italy and the United Arab Emirates (UAE)
- Maintained execution timeline for ColoFuture, an international multi-center clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert – on track to report results in 1H 2023
- Continued final preparations for U.S. pivotal clinical study evaluating next-generation CRC test – on track to commence in Q4 2022
- Formed a Medical Advisory Board of renowned scientific oncology experts to support the advancement of product portfolio candidates and assist with pipeline enhancement opportunities
- Bolstered leadership team by appointing two highly accomplished healthcare executives to the Board of Directors
“The major emphasis for the past quarter was to continue executing our commercial strategy for ColoAlert across Europe and in select international territories while making final preparations to launch our U.S. pivotal clinical study designed to evaluate a next-generation self-administered diagnostic test for CRC,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We head into the final months of 2022 with great momentum across corporate and product development fronts, and I look forward to keeping our shareholders and interested parties posted on progress.”
Commercial Update: Full commercial availability of ColoAlert in Italy and the United Arab Emirates
During the quarter (August), Mainz Biomed launched ColoAlert’s consumer commercial program in Italy and the United Arab Emirates (UAE) through its partnership with Dante Labs, a global leader in genomics and precision medicine. This milestone serves as an important example of Mainz Biomed’s unique business model of commercializing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility. Dante is now marketing ColoAlert through its extensive database and selling via Dante’s region-specific eCommerce websites. Under the terms of the partnership, samples are initially being processed at Mainz Biomed’s in-house facility. In the longer term, Dante will purchase Mainz Biomed’s CE-I VD polymerase chain reaction (PCR) assay kits and transition all test processing to Dante’s wholly owned automated genomic sequencing laboratories in Italy and Dubai to offer localized service and support.
Product Development Update: Advancing ColoFuture & preparing for U.S pivotal clinical trial
Throughout the third quarter, Mainz Biomed continued enrolling patients in ColoFuture, its international multi-center study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. The study is recruiting over 600 patients in the age range of 40-85. It is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile and to extend its capability to identify advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. If successful, ColoAlert will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas. The study remains on target to report results in the first half of 2023. In the U.S., the Company continued preparing to initiate its pivotal clinical study of a next-generation CRC diagnostic test. A leading global Contract Research Organization (CRO), with vast experience in the oncology space and specific domain expertise in conducting clinical studies for colorectal screening applications, has been appointed to support the launch and management of the pivotal trial. Mainz Biomed is on track to initiate the trial in Q4 2022 and anticipates reporting results in 2025.
Corporate Update: Formation of Medical Advisory Board & corporate leadership appointments
In July, Mainz Biomed announced the formation of a Medical Advisory Board (MAB) to support the forthcoming U.S. pivotal trial, provide counsel and direction on the balance of the Company’s products in development (e.g., PancAlert), and potential additions to the R&D pipeline. The inaugural members of the MAB are Dr. Doug Rex, 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; Dr. Timothy Wang, Gastrointestinal Division Chief at Columbia University Vagelos College of Physicians and Surgeons in New York, and Co-leader of the Tumor Biology and Microenvironment Program of the Herbert Irving Comprehensive Cancer Center; and Dr. D. Kim Turgeon, an esteemed clinical professor and board-certified gastroenterologist at the University of Michigan Health System and clinical translational researcher with a specific interest in colon cancer and chemoprevention. Mainz Biomed also enhanced its leadership team with the addition of former Qiagen executive Frank Krieg-Schneider, PhD, as Vice President of Development and nominated former Roche Molecular Diagnostics CEO, Heiner Dreismann, PhD to become the Chairman of Mainz Biomed, and Gregory Tibbitts, CPA to serve on the Board of Directors.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It 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) and is commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the US, 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.
About Colorectal Cancer
According to the Centers for Disease Control and Prevention (CDC), colorectal 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 US, with 52,980 resulting in death. Recent decisions by the US Food and Drug Administration (FDA) 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 and a US market opportunity of approximately $3.7 billion per year.
About Mainz Biomed NV
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 the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for US 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. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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Certain 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 annual report on Form 20-F filed on May 5, 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.