MYNZ Mainz BioMed NV

Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is proud to announce its participation as an exhibitor at the esteemed Gynecology Congress (‘Gynäkologie und Geburtshilfe aktuell’) in Stuttgart, Germany, on March 1st. This engagement signifies the company's commitment to advancing colorectal cancer (CRC) screening through their innovative diagnostic solution ColoAlert® and highlights the pivotal role of gynecologists in the early detection of this prevalent disease.

In the landscape of CRC prevention, a broad spectrum of healthcare professionals, including gastroenterologists, general practitioners, gynecologists (GYNs), and urologists, play crucial roles, primarily through the administration of Fecal Immunochemical Tests (FIT), the current standard of non-invasive CRC screening, that identifies blood in stool samples. With over 3 million FIT tests conducted in Germany annually, gynecologists stand out as a key group, responsible for 27% of these screenings, second only to general practitioners who conduct 34%. This data underscores the significant impact gynecologists have in the early detection and prevention efforts against CRC.

The Gynecology Congress is a premier event dedicated to gynecological health, offering Mainz Biomed an invaluable opportunity to connect with these vital healthcare providers. The company's showcase of ColoAlert®, an advanced diagnostic tool that surpasses traditional FIT by detecting not only blood in stool but also tumor DNA, aims to set a new standard in CRC screening. By addressing the limitations of FIT tests, which cannot detect non-bleeding tumors, ColoAlert® offers a more comprehensive screening approach, potentially identifying CRC at earlier stages.

Mainz Biomed's presence at the congress is part of a broader initiative to build stronger relationships with healthcare professionals who are integral to the company's laboratory partnerships. This effort is aimed at increasing brand awareness and establishing ColoAlert® as a key component in medical practices for CRC screening.

In the coming months, Mainz Biomed will continue to actively participate in medical conferences that cater to its key demographic. A highlight will be the company's involvement in the 130th Congress of the German Society for Internal Medicine in April, where Mainz Biomed is expected to contribute significantly through a symposium presentation, further emphasizing its leadership in molecular diagnostics for cancer screening.

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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 20mainzbiomed@mc-services.eu

In the U.S.:Blueprint Life Science GroupHershel Berry+1 415 505 3749hberry@bplifescience.com

For investor inquiries, please contact info@mainzbiomed.com

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.