BERKELEY, US – MAINZ, Germany – April 27, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the following activities in May:
Commencement of Voluntary Quarterly Reporting:
Under the disclosure requirements of the U.S. NASDAQ listing, foreign issuers are required to disclose full year financial results (20-F). In addition, Mainz Biomed will commence voluntary quarterly reporting with the release of its Q1 2023 financial results. The Q1 results will be announced on May 16, 2023.
Presentation at Equity Forum Spring Conference 2023:
CEO Guido Baechler will present at the Equity Forum Spring Conference 2023 in Frankfurt, Germany, on Wednesday, May 17, 2023, and will be available for meetings with investors at the Forum on Tuesday and Wednesday, May 16 & 17:
Equity Forum Spring Conference 2023
May 15-17, 2023
Frankfurt am Main, Germany, Le Meridien
Company presentation: May 17, Session I, 7:45 a.m. ET
“After a successful start to the year with the expansion of sales activities in Germany, the commencement of new laboratory partnerships and the development of further European markets, we are focused on implementing our strategy to expand our commercial business in Europe and to advance the approval process in the US, as announced. The Board and Management are committed to continue to execute the business plan to grow shareholder value. I look forward to the upcoming results of our eAArly Detect study to demonstrate the potential of our new biomarkers and also to face-to-face interactions with existing and potential new investors,” said Guido Baechler, Chief Executive Officer of Mainz Biomed.
Mainz Biomed is currently commercializing its flagship product ColoAlert®, a highly efficacious and easy-to-use detection test for colorectal cancer (CRC) in select international territories and in December of 2022, initiated a U.S. Pivotal Clinical Study (ReconAAsense) for a CRC screening test that may integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. These biomarkers have demonstrated potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC that are being evaluated in European and U.S. studies (ColoFuture/eAArly DETECT). Results from eAArly DETECT are expected in mid-2023 and Mainz Biomed anticipates enrollment in ReconAAsense to commence in the second half of 2023. The Company’s early-stage pipeline is highlighted by PancAlert, a potential first-in-class screening test for pancreatic cancer.
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 (Gies 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 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 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 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 or follow us on LinkedIn, Twitter and Facebook.
For media inquiries, please contact email@example.com
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
In the US:
Melissa Laverty/Valerie Enes
+1 540 272 6465
For investor inquiries, please contact firstname.lastname@example.org
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 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.