
Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition
Issuer: Mainz BioMed N.V.
/ Key word(s): Miscellaneous
Mainz Biomed Half Year 2025 Update: Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition Company Advances its Progress toward FDA Premarket Approval Study for its Next Generation Colorectal Cancer Screening Product and Makes a Strategic Acquisition in the Field of Pancreatic Cancer Screening BERKELEY, US – MAINZ, Germany – July 15, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), 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, 2025, and provided a corporate update. The Company expects to release its half year financial results in September 2025. Key Highlights During First Half 2025
“I’m extremely pleased with the progress achieved during the first half of 2025 as we execute our ambitious growth strategy driven by our eAArly DETECT 2 study and advancements of our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of this year with a great momentum as we plan for the completion of our eAArly DETECT 2 feasibility study which will be the launching point for the ReconAAsense US FDA pivotal colorectal cancer study in 2026.”
Please follow us to stay up to date: About Mainz Biomed NV 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. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook. For media inquiries MC Services AG For investor inquiries, please contact ir@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 March 31, 2025. 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. |
Language: | English |
Company: | Mainz BioMed N.V. |
Robert-Koch-Strasse 50 | |
55129 Mainz | |
Germany | |
Internet: | mainzbiomed.com |
EQS News ID: | 2169898 |
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