Industry Leading Clinical Data Position the Company for FDA Premarket Approval Study
BERKELEY, Calif. and MAINZ, Germany, July 02, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024.
Key Highlights During First Half 2024
- Mainz Biomed presented industry leading results of its pooled study at ASCO 2024; which confirmed the previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia; the results from the pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed’s mRNA biomarkers to detect CRC and precancerous lesions
- Mainz Biomed was awarded a Poster of Distinction at Digestive Disease Week presenting data from its eAArly DETECT study, positioning the Company for its planned FDA trial; the poster presented industry leading results: 97% sensitivity for colorectal cancer, 82% for advanced precancerous lesions; the study demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected
- The Company participated in the 39th UDH Congress 2024, in Fellbach, Germany. One of the main focus topics for this year’s event, organized by the German Complementary Medicine Association (Union Deutscher Heilpraktiker, Landesverband Baden-Württemberg), was the gut and its significance in the manifestation of diseases
- Mainz Biomed participated and exhibited at the esteemed Gynecology Congress (‘Gynäkologie und Geburtshilfe aktuell’) in Stuttgart, Germany. This engagement signifies the Company’s commitment to advancing colorectal cancer screening through their innovative diagnostic solution ColoAlert® and highlights the pivotal role of gynecologists in the early detection of this prevalent disease
- The Company continues to make strong progress in the development of strategic partners to assist in the Mainz Biomed’s efforts to achieve pre-market approval from the FDA and in its go-to-market strategy in the U.S.
- Mainz Biomed partnered with Trusted Health Advisors to support its U.S. go-to-market strategy for the next generation early colorectal cancer diagnostic test; Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, are leading the collaboration
- The Company formed a strategic partnership with TomaLab, a premier biotechnology laboratory based in Milan, to launch the Company’s flagship product, ColoAlert® in Italy. 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
“I’m extremely pleased with the progress achieved during the first half of 2024 as we execute our ambitious corporate growth strategy driven by our incredible clinical results in three studies published so far this year,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of 2024 with a great deal of momentum as we plan for the beginning of enrollment planning for the ReconAAsense U.S. FDA pivotal CRC study.”
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About Colorectal Cancer
Colorectal 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 planning to run 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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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.
