Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic

Mainz Biomed N.V.

 (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.

Mainz Biomed is in late-stage clinical development of a highly accurate and easy-to-use nucleic acid-based detection test for colorectal cancer (CRC) screening diagnostics that it intends to distribute, if approved, via the Company’s unique business model of marketing products via partnerships with third-party laboratories. In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test. The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories.

“As we make the final preparations to commence patient enrollment in the ReconAAsense trial and given the potentially transformative role the test will have on the market if approved, we are excited by the opportunity to be in a position to advance our U.S. go-to-market strategy for our innovative approach in CRC screening,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Through our partnership with THA, we plan to expedite and enhance the deployment of our differentiated commercial strategy to enable an efficient and impactful transition to the marketplace for the product which if approved, we anticipate will occur in 2026. We look forward to working with Drs. Wohlgemuth, Tabibiazar and the entire THA team.”

“Mainz Biomed’s early data in accurate detection of Advanced Adenoma has the potential to transform colon cancer screening” said Dr. Jay Wohlgemuth, Managing Partner at THA. “Detecting AA lesions allows for early intervention and significantly increases the chance of successful treatment and survival. Furthermore, early detection and treatment of AA is more cost-effective than treating cancer.”

“Mainz Biomed’s easy-to-use kit as well as their differentiated business model to commercialize their diagnostic test via partnerships with third-party laboratories versus the traditional methodology of operating a single facility, could dramatically increase patient access to the test and help improve patient outcomes,” said Dr. Ray Tabibiazar, Managing Partner at THA, “the THA team is excited to support Mainz Biomed in its efforts to advance this promising pre-cancer test for patients in need.”

The partnership with THA will be led by Drs. Jay Wohlgemuth and Ray Tabibiazar, Managing Partners of the firm. Dr. Wohlgemuth brings to the project a prolific development and commercial background in healthcare innovation having most recently served in multiple senior executive roles at Quest Diagnostics including, Chief Medical Officer, Chief Scientific Officer and Senior Vice President. In addition, Dr. Wohlgemuth was a co-founder, Chief Medical Officer and Vice President of R&D for CareDx, a leader in testing for transplant patients for which he was awarded Technology Pioneer 2005 at the World Economic Forum in Davos. Dr. Tabibiazar is a veteran CEO, entrepreneur and investor in the biotechnology and diagnostics space. The THA team brings extensive experience and capabilities, from R&D through commercialization, across the diagnostics industry, including lab diagnostics, in vitro diagnostics, medical devices, and population health management. To learn more about THA, please visit https://www.trustedhealthadvisors.us

ReconAAsense (ClinicalTrials.gov Identifier: NCT05636085) is Mainz Biomed’s pivotal FDA PMA clinical trial evaluating a next generation CRC screening test which will integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. Recently (Q4 2023), Mainz Biomed announced groundbreaking results from ColoFuture (international) and eAArly DETECT (U.S.) clinical studies evaluating these biomarkers whereby ColoFuture reported sensitivity for CRC of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80% and eAArly DETECT reported sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. Mainz Biomed is in the process of selecting the biomarkers for inclusion into ReconAAsense of which the results will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It will include approximately 15,000 subjects from 150 sites across the U.S. The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. Given the integration of Mainz Biomed’s portfolio of novel gene expression (mRNA) biomarkers into ReconAAsense, if the trial produces positive results, this next iteration of Mainz Biomed’s CRC test will be positioned as one of the most robust and accurate at-home diagnostic screening solutions 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.

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About ColoAlert®ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ 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 CancerColorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is 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. To learn more, visit mainzbiomed.com.   

For media inquiries

In Europe:MC Services AGAnne Hennecke/Caroline Bergmann+49 211 529252 [e-mail]

In the U.S.:Blueprint Life Science GroupHershel Berry+1 415 505 [e-mail]

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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 annual report on Form 20-F filed on April 7, 2023. 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.