Mainz Biomed Establishes Strategic Partnership with TomaLab to Expand Availability of ColoAlert® in Italy

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 strategic partnership with TomaLab to launch the Company’s flagship product, ColoAlert® in Italy. TomaLab is one of Italy’s premier biotechnology laboratories and is based in Milan. The partnership signifies a major step forward in enhancing colorectal cancer screening and diagnostics within the Italian healthcare system as it enables the implementation of ColoAlert® into Italy's robust healthcare framework, providing patients with access to a cutting-edge diagnostic solution that combines convenience with clinical excellence.

"TomaLab is the ideal partner to bring our pioneering product to Italy given its state-of-the-art facilities and commitment to innovative healthcare solutions," said Guido Baechler, CEO of Mainz Biomed. "This collaboration aligns with our mission to make advanced diagnostic tools widely accessible, improving early detection rates and ultimately saving lives."

ColoAlert®, a highly effective and user-friendly at-home detection test, offers a non-invasive, highly sensitive test for early detection of colorectal cancer (CRC) and precancerous lesions. By utilizing advanced DNA technology, ColoAlert® detects cancerous and precancerous conditions with greater precision than traditional non-invasive screening methods, making it a pivotal tool in the fight against one of the most common and deadly cancers worldwide.

The launch of ColoAlert® in Italy comes at a critical time, given the current landscape where colorectal cancer ranks as the second most common cancer in the country. Furthermore, there's a concerning trend of rising incidence rates among young adults. Early detection remains a key factor in improving survival rates, and with ColoAlert®'s advanced diagnostic capabilities, more individuals will have timely access to life-saving screenings.

"We are thrilled to collaborate with Mainz Biomed to incorporate ColoAlert® into our laboratory procedures," stated Dr. Riccardo Manca, CEO of TomaLab. "This partnership underlines our dedication to embracing cutting-edge technologies that enhance patient care and outcomes."

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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.   

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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.