BERKELEY, US – MAINZ, Germany – April 12, 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 operational results for the first quarter ended March 31, 2022.
Key Highlights
- Continued to ramp up EU commercial activities for ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer
- Acquired portfolio of novel mRNA biomarkers to potentially upgrade ColoAlert’s technical profile to achieve “gold standard” status for CRC at-home testing
- Commenced international clinical study (ColoFuture) to evaluate integration of these biomarkers into ColoAlert
- Received supportive feedback from the U.S. Food and Drug Administration (FDA) on ColoAlert’s pre-submission package for its U.S. pivotal clinical trial
- Formally initiated ColoAlert’s U.S. medical reimbursement process with the Centers for Medicare Services (CMS)
- Executed a $25.8 million public follow-on offering
- Expanded Strategic Advisory Board of global leaders in molecular diagnostic development and commercialization
“This past quarter has proven to be an excellent period of progress across commercial, corporate and product development fronts,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The entire Mainz team is excited by the rapid growth achieved to date and remains steadfast in our conviction to advance an ambitious yet balanced strategy to maximize ColoAlert’s potential in the marketplace, and to build our oncology-focused diagnostic franchise via a unique commercial model and robust technical approach to product development.”
Commercial Update: ColoAlert marketed across Europe via unique business model
During the quarter, Mainz continued 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. During the first quarter (February 2022), Mainz announced a partnership with Labor MVZ Dr. Stein + Kollegen (“Laboratory Mönchengladbach”), one of the largest diagnostics laboratories in the North Rhine-Westphalia region of Germany. The Lab services over 2,500 physicians, processing over five million samples in total annually and screening approximately 1,000 patients per week specifically for CRC. With the addition of Laboratory Mönchengladbach, Mainz now has four core partnerships including GANZIMMUN Diagnostics AG, one of Europe’s leading laboratories for preventive and complementary medicine which processes approximately 5,500 laboratory orders daily.
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.
To ensure optimal study execution, the Company announced during the first quarter strategic partnerships with Sentinel Diagnostics and Alcedis GmbH. Sentinel Diagnostics is a global leader in the development and production of in vitro diagnostics (IVD), and Alcedis GmbH is a full-service state-of-the-art contract research organization (CRO) providing clinical trial management for biotechnology and medical device companies across the globe. With Sentinel, Mainz has been granted access to the SENTiFIT® 270 Analyzer, Sentinel’s leading automated Fecal Immunochemical Test (FIT) processing system. An essential component of ColoAlert is the utilization of a FIT which provides a complete review of blood in the stool, a condition often associated with cancerous polyps and colorectal carcinoma. It is the combination of ColoAlert and FIT results that provide the diagnostic outcome. This partnership enables Mainz to transition from deploying a manual FIT processing methodology to a state-of-the-art automated system for potential future use in the EU commercial setting, and in the Company’s forthcoming U.S. clinical trial. Alcedis is providing Mainz with the full range of services and responsibilities associated with executing ColoFuture, including patient recruitment, overseeing study protocol compliance, and the documentation and reporting of patient results.
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 enrollment 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 receives feedback from the FDA and medical reimbursement process launched with CMS
In March 2022, Mainz announced that it received supportive feedback from the U.S. Food & Drug Administration on its pre-submission package for ColoAlert. The Company will continue working with its clinical team to finalize the study’s protocols and prepare for the multi-center study which is on track to commence in late 2022. As part of the Company’s activities to prepare for the initiation of the pivotal trial, Mainz also announced the formal commencement of its medical reimbursement process for ColoAlert by scheduling an initial meeting with the Centers for Medicare and Medicaid Services (CMS) which is set to take place in April 2022. CMS is a federal agency in the U.S. Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (CHIP), and health insurance portability standards.
Corporate Update: Successful follow-on offering, key appointments to management team & Strategic Advisory Board.
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 the transaction. 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 April 2022.
Throughout the first quarter, the Company continued to bolster its leadership team highlighted by the appointments of former Abbott Diagnostics executive Steve Quinn as Vice President of Business Development (January) along with the two high profile additions to Mainz’s Strategic Advisory Board. In January, Dr. Michele Pedrocchi joined the SAB followed by the February appointment of Dr. Rainer Metzger. Dr. Pedrocchi is the former Head of Roche Diagnostics Business Development and brings to the SAB over 25 years of international experience at Roche spanning in vitro diagnostics, digital health, and personalized medicine. Dr. Metzger is a Former Danaher, Roche and Qiagen Executive with over 25 years of experience within the pharmaceutical and diagnostic industries.
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-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.
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 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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Forward-Looking Statements
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 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.
