Issuer: Mainz BioMed N.V. / Key word(s): Conference/Study results 27.09.2023 / 14:01 CET/CEST The issuer is solely responsible for the content of this announcement. Mainz Biomed to Present Detailed Results of ColoFuture Study at International Conference on Gastroenterology
BERKELEY, US – MAINZ, Germany – September 27, 2023 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it will present the positive detailed results from its ColoFuture study at the 4th International Conference on Gastroenterology which occurs on October 16th – 18th in Paris, France. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert®, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. “The data generated from this study represents a potentially ground-breaking milestone for CRC detection and we are excited to share the details of our findings with the attending audience of international medical experts,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Multiple novel mRNA biomarkers were identified for possible integration into our pivotal FDA PMA clinical trial, and we look forward to comparing ColoFuture’s data outcome with results from our eAArly DETECT clinical study which remains on track to report in Q4 of this year.” Presentation Details:
The ColoFuture study was an international clinical trial assessing the performance of ColoAlert with the Company’s novel mRNA markers to determine sensitivity and specificity for colorectal adenocarcinoma and advanced precancerous lesions in the colon. It included 220 subjects aged 40-85 (45% female, 55% male, average age 62.3 years) from participating centers in Germany, Norway and Denmark. The Company reported topline results from ColoFuture in September 2023, and key highlights included a sensitivity of 94% and specificity of 97% for colorectal cancer, along with a sensitivity of 81% for advanced adenomas. The eAArly DETECT study is the U.S. component of ColoFuture which is enrolling 250 subjects across 25 sites. The 4th International Conference on Gastroenterology brings together world-renowned speakers including scientists, doctors, professors, examiners, instructors, and researchers to share discoveries and ground-breaking ideas in the field of gastrointestinal research. About ColoAlert® About Colorectal Cancer About Mainz Biomed N.V. For media inquiries: In Europe: In the US: For investor inquiries, please contact info@mainzbiomed.com 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 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. Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
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