Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025

Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025

BERKELEY, US and MAINZ, Germany – October 1, 2024 -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Management believes 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through its innovative diagnostic solutions.

“As we enter a critical phase in our company’s journey, Mainz Biomed’s vision remains focused on leading the way in cancer diagnostics,” said Guido Baechler, CEO of Mainz Biomed. “Our groundbreaking clinical results with our mRNA based next generation CRC screening test and our strategic pathway to FDA trials, which we plan to start in 2025, demonstrate our commitment to expanding into the world’s largest healthcare market. These efforts, combined with our growing international footprint, underscore why we believe Mainz Biomed is currently undervalued relative to its potential.”  In the notes below, you will find more information about our current status and upcoming plans that we are executing, reaffirming our commitment to early cancer detection and the exciting developments that are currently underway.”  Baechler commented further, “like all our shareholders, management and the Board of Directors are concerned and disappointed with the performance of our stock price.  We commit to our shareholders that we will continue to strive to deliver what we have promised under difficult market conditions.”  Baechler commented further, “We are strongly convinced that 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through our innovative diagnostic solutions.”

Corporate Flagship Product: Breakthrough Data and U.S. Expansion

mRNA-based next-generation CRC screening tests are redefining standards in early cancer detection. Mainz Biomed's flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials. Presentations at DDW and ASCO this year have highlighted sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development.

Mainz Biomed, alongside other companies, emphasizes the use of stool-based samples for CRC and advanced adenoma detection due to their direct connection to cancer cells and adenomas. Recent reports suggesting the ease of blood tests over stool tests must be carefully evaluated, as extensive studies in the US and Europe have shown significantly lower sensitivity of blood tests in identifying advanced adenomas. This limitation arises because early-stage advanced adenomas are not typically connected to the body's blood supply, making them undetectable through blood samples.

In early July the Company has announced that based on its robust clinical data package it submitted for FDA Breakthrough Device Designation (BDD) for its next generation CRC screening test. Following encouraging feedback from the FDA, the Company has made the strategic decision to withdraw its BDD application to focus on extending its clinical research program. Mainz Biomed will expand its dataset to include a larger average-risk patient population with its pivotal ReconAAsense trial. The Company plans to submit this comprehensive data in 2025 to FDA.

The consistently positive data from the Company’s clinical feasibility studies presented at ASCO 2024 and Digestive Disease Week (DDW), provide a strong foundation as Mainz Biomed prepares for U.S. FDA clinical trials in 2025, a key milestone in its strategy to penetrate the U.S. market. Successful completion of the FDA trial will allow Mainz Biomed’s next generation CRC screening test to be marketed to millions of Americans at risk of colorectal cancer, representing a major revenue growth opportunity for the company.

Innovative Diagnostic Pipeline

In addition to its mRNA next generation CRC screening test, Mainz Biomed is advancing a robust pipeline of cutting-edge diagnostic technologies aimed at detecting multiple cancers, with PancAlert leading the way. Our focus on molecular diagnostics, powered by proprietary biomarkers, positions us to address a wide range of cancers early, improving patient outcomes and reducing healthcare costs globally. The success of our upcoming products will help diversify our revenue streams and strengthen our leadership in cancer diagnostics.

Current development and expansion of the current ColoAlert screening test

Mainz Biomed has redeveloped and relaunched an expanded version of its first-generation CRC screening test currently commercialized in Germany and selected other countries in Europe. The change implemented in the ColoAlert product significantly simplified the workflow and reduced the retest rates. The feedback from the lab communities has been very positive and the Company expects this new product to further accelerate the growth and lab expansion.

Committed on delivering on key milestones for fair Company valuation

Mainz Biomed’s strong clinical results, expanding pipeline, and upcoming FDA trial, it is the management’s position that the Company’s current stock price does not adequately reflect its true value. While the Mainz Biomed cannot directly influence the stock market, the management team is fully focused on delivering on key milestones and executing its strategy to unlock value for shareholders.

Pursuant to Nasdaq and SEC rules the June 30, 2024, financials are required by December 31, 2024.  The Company plans to file during the fourth quarter of 2024. 

Looking Ahead: FDA Trials and Major Growth in 2025

2024 is a year of continued clinical progress and market expansion, but the FDA trials anticipated for 2025 represent a pivotal moment for Mainz Biomed. Successfully navigating the regulatory landscape in the U.S. will unlock significant opportunities to serve millions of patients in the world’s largest healthcare market.

In the meantime, the Company will continue to scale operations across Europe and other international markets, building on its scientific leadership in cancer diagnostics. With exciting innovations in the pipeline, Management is confident that Mainz Biomed is on track to revolutionize early cancer detection globally.

Further, we are pleased to have added a leader like Petra Starke to our team as a Brand Ambassador.  Petra is a thought leader in the field of colorectal cancer.  Her insights will continue to be invaluable as we focus our efforts in both Europe and the U.S. 

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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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 marketed across Europe. The Company is currently running a pivotal FDA clinical study 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.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
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For investor inquiries, please contact info@mainzbiomed.com

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 annual report on Form 20-F filed on April 9, 2024. 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.