BERKELEY, Calif. and MAINZ, Germany, March 09, 2022 — 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 key strategic and operational results for the year ended December 31, 2021.
Key Highlights and 2021 Accomplishments
- Executed successful U.S. Initial Public Offering (IPO) onto Nasdaq
- Accelerated EU commercialization of ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer
- Bolstered management team with the addition of Karen Richards as Vice President of Regulatory Affairs and Steve Quinn as Vice President of Business Development
- Established Strategic Advisory Board of global leaders in molecular diagnostic development and commercialization
- Participated in leading healthcare industry and investor conferences
- Acquired portfolio of novel mRNA biomarkers to potentially upgrade ColoAlert’s technical profile to achieve “gold standard” status for CRC at-home testing
- Consummated a $25.8 million public follow-on offering
- Commenced clinical study (ColoFuture) to evaluate potential integration of these biomarkers into ColoAlert
- Initiated communications with the U.S. Food and Drug Administration (FDA) and Centers for Medicare Services (CMS) for ColoAlert clinical trials and reimbursement strategies, including having its pre-submission accepted for review by the FDA
“The past year was an exceptional period of growth for the company highlighted by our transformational milestone of going public onto the Nasdaq stock exchange,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Heading into the second quarter of 2022, I’m extremely pleased with the pace of progress being made on commercial and U.S. regulatory fronts for our flagship product ColoAlert, and we are well positioned to facilitate achieving our goal of becoming the leading developer of cancer-focused molecular diagnostics.”
Commercial Update: ColoAlert being rolled out across Europe via unique business model
In December 2021, Mainz commenced its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides to their respective network of physicians and patients a comprehensive solution for advanced CRC protection. As a start, the Company announced (December 14th), a partnership with GANZIMMUN Diagnostics AG (GD), one of Europe’s leading laboratories for preventive and complementary medicine. GD has an interdisciplinary team of over 370 medical technical assistants, physicians, chemists, biologists, and nutritionists who process approximately 5,500 laboratory orders daily. Mainz is now embarking on an aggressive program to ramp up this commercial plan as evidenced by the recent (February 2022) announcement of a partnership with Labor MVZ Dr. Stein + Kollegen (“Laboratory Mönchengladbach”), one of the largest diagnostics laboratories in the North Rhine-Westphalia region of Germany. With a team of over 500 employees that includes biologists, chemists, doctors and other specialists, Laboratory Mönchengladbach services over 2500 physicians, processing over five million samples in total annually and screening approximately 1000 patients per week specifically for CRC.
ColoAlert R&D Update: ColoFuture study evaluating acquired mRNA biomarkers
In February 2022, Mainz initiated a clinical study (ColoFuture) to evaluate a portfolio of five gene expression biomarkers acquired from Socpra Sciences Santé Et Humaines S.E.C. in January 2022. The results from a published study in the peer review journal MDPI (March 11, 2021) demonstrated that these specific biomarkers have a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease. As such, the ColoFuture study will determine if the biomarkers enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA) while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. If the data results from ColoFuture are 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 ColoFuture study will enroll over 600 patients in the age range of 40-85 at two participating centers in Norway and two in Germany. The Company expects to complete enrolment during the second half of 2022 and is targeting reporting study results in early 2023. Additionally, data results from ColoFuture will impact ColoAlert’s profile for FDA submission.
ColoAlert’s U.S. Regulatory Approval Update: Pre-submission for pivotal trial design accepted for review by the FDA
In February 2022, Mainz announced that ColoAlert’s pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review. The FDA will now provide feedback to the Company on its proposed pivotal U.S. clinical trial design for the test which is expected in Q2 2022. As part of the Company’s activities to prepare for the initiation of the pivotal trial, Mainz established a partnership with Precision for Medicine (November 2021), a leading global Clinical Research Organization (CRO) in which the CRO will work with Mainz’s management team to develop and implement the U.S. focused regulatory and market access strategy for ColoAlert. This will include assistance in drafting ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. Inherent to this exercise will be the integration of CMS guidelines, utilizing currently marketed CRC screening tests as benchmarks to provide ColoAlert with an optimal product profile for regulatory approval and success in the marketplace.
Corporate Update: Positioned for long-term success
In November 2021, Mainz executed a successful IPO onto Nasdaq raising $11.5 million by placing 2,300,000 common shares at a public offering price of $5.00 per share. And in January 2022, the Company announced a $25.8 million public follow-on offering consisting of 1,725,000 of ordinary shares priced at $15.00 per share. Boustead Securities, LLC acted as the sole underwriter for both transactions. The Company plans to file its Report on Form 20-F, including audited financial statements for 2021, with the U.S. Securities and Exchange Commission in late March or early April.
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 immunochemistry test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. 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 Cancer
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 estimates that in 2021 there will be 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 with an FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio 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, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.
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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 Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021 as well as the Prospectus 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.