Mainz Biomed Announces Collaboration with Fugene Genetics in Israel

Mainz Biomed Announces Collaboration with Fugene Genetics in Israel

Israel has one of the highest screening compliance rates in the world with over one million people being screened each year

BERKELEY, US – MAINZ, Germany – JULY 18, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces today its commercial partnership for ColoAlert with Fugene Genetics, a renowned genetic testing service provider based in Israel. Fugene Genetics, established in 2008, offers a wide range of advanced genetic testing services to private clients, health organizations, hospitals, and genetic institutes throughout the country.

ColoAlert is Mainz Biomed’s flagship product, an effective and user-friendly at-home detection test for colorectal cancer (CRC). The test is currently being rolled out in Europe and selected international markets through a unique business model of partnering with third-party laboratories and experienced distribution partners for test kit processing, as opposed to operating a single facility, which is the traditional approach.

“We continue to make great strides in growing the market access to ColoAlert around the globe, aligning with experienced partners that have significant expertise in their national markets and are able to meet the strong clinical need for differentiated products,” said Darin Leigh, Chief Commercial Officer for Mainz Biomed. “Fugene Genetics has a highly successful track record of introducing novel molecular diagnostic products into Israel using its extensive commercial network and relationships with leading laboratories.”

Israel has one of the highest screening compliance rates in the world with over one million people being screened each year. It is expected that over 3.5 million adults could benefit from the availability of ColoAlert in Israel. Mainz Biomed will provide ColoAlert to Fugene Genetics under their standard partnership agreements. In the coming weeks, the two companies will collaborate on co-marketing activities to ensure a successful commercial launch in Israel.

"We are thrilled to collaborate with Mainz Biomed on the commercial partnership for ColoAlert, an innovative early screening test for colon cancer," said Noa Rinzler Diwan, PhD, CEO of Fugene Genetics. "ColoAlert's effectiveness and user-friendly nature make it a valuable addition to our genetic testing services in Israel. With our extensive commercial network and strong relationships with healthcare providers, we are well positioned to introduce ColoAlert and promote early detection of colon cancer among our clients. This partnership aligns with our commitment to delivering cutting-edge genetic testing solutions and improving healthcare outcomes. We are excited about the opportunity to work closely with Mainz Biomed to ensure a successful commercial launch and make a significant impact on colon cancer screening in Israel."

About ColoAlert®
ColoAlert, Mainz Biomed's flagship product, offers high sensitivity and specificity as an easy-to-use at-home screening kit for colorectal cancer (CRC). This non-invasive test analyzes tumor DNA and provides better early detection than fecal occult blood tests (FOBT). Utilizing PCR-technology, ColoAlert has demonstrated superior performance in detecting colorectal cancer compared to other stool tests, enabling earlier diagnosis (Gies et al., 2018). The product is currently available in select EU countries through independent laboratories, corporate health programs, and direct sales. In the US, ColoAlert is undergoing evaluation in the FDA-registration trial 'ReconAAsense' for marketing approval. Mainz Biomed's commercial strategy for the US market involves establishing scalable distribution through collaborations with regional and national laboratory service providers across the country.

About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with over 1.9 million new cases reported in 2020 according to the World Cancer Research Fund International. The US Preventive Services Task Force recommends stool DNA tests, such as ColoAlert, to be conducted every three years starting at age 45. Despite this recommendation, approximately one-third of US residents aged 50-75 have never been screened for colon cancer, representing a significant untapped market opportunity estimated at over $4.0 billion in the US alone.

About Mainz Biomed NV
Mainz Biomed NV specializes in developing market-ready molecular genetic diagnostic solutions for life-threatening conditions. ColoAlert is the company's flagship product, offering 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. Currently available in Europe, Mainz Biomed is conducting a pivotal FDA clinical study for regulatory approval in the US. In addition to ColoAlert, Mainz Biomed's product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test. For more information, please visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries, please contact press@mainzbiomed.com
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

In the US:
Josh Stanbury
+1 416 628 7441
josh@sjspr.co

For investor inquiries, please contact info@mainzbiomed.com

About Fugene Genetics
Fugene Genetics is a leading genetic testing services provider based in Israel, since 2008. With a strong commitment to improving healthcare outcomes, through innovative molecular diagnostic solutions, Fugene Genetics offers a wide range of genetic testing services to patients and healthcare providers throughout the country. Fugene Genetics is dedicated to maintaining the highest standards of quality and precision in their testing services, ensuring accurate and reliable results for their clients. Fugene Genetics plays a major role in bringing a wide range cutting-edge genetic testing options to the healthcare market in Israel.

Please visit Fugene.co.il or follow us on Facebook or LinkedIn

Contact:
info@fugene.co.il
+972 3 762 0606

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 May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at 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.