Mainz Biomed Provides Corporate Update for First Half of 2022

Rhea-AI Summary

Mainz Biomed is set to host a webcast on July 12, 2022, at 4:00 PM ET to discuss its first-half 2022 progress and future plans. The session will feature updates on its flagship product, ColoAlert, a non-invasive colorectal cancer detection test. The webcast aims to inform investors about ColoAlert's regulatory pathway and ongoing R&D efforts to enhance its effectiveness. CEO Guido Baechler emphasized the importance of this update following the company’s transition to the public sector in November 2021.

Positive

• Webcast scheduled to provide comprehensive updates on ColoAlert and future plans.
• ColoAlert shows potential to be a leading product in colorectal cancer detection.
• R&D efforts aimed at achieving 'gold standard' status for at-home testing.
• Expansion strategy includes partnering with third-party laboratories for test kit processing.

Negative

• None.

Company to Host Webcast on July 12 at 4.00pm ET

BERKELEY, Calif. and MAINZ, Germany, July 05, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to host a webcast on July 12, 2022 at 4:00pm ET to provide an update on the Company’s progress for the first half of 2022, and to outline the plan for the balance of the fiscal year.

The webcast will offer the investment community a comprehensive briefing by Mainz’s executive management team on the Company’s flagship product ColoAlert, a highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) which is being commercialized internationally through a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The presentation will also include an update on the status of ColoAlert’s U.S. regulatory approval pathway, the ongoing R&D efforts to potentially upgrade ColoAlert’s technical profile to achieve “gold standard” status for CRC at-home testing, an overview of additional products in development, and the Company’s go-forward strategy to facilitate growth.

“Given the progress achieved over the past six months across all aspects of the company, the management and Board thought it was appropriate to host this interactive forum to provide an overall update on progress, especially in light of our recent transition to the public sector this past November,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to providing a detailed presentation covering ColoAlert’s commercial execution and clinical development status along with commentary on the balance of the product development pipeline, and our overall strategy to become a leading oncology focused diagnostic company.”

Mainz Biomed - Mid-Year Update
Conference ID: 13730909
Date and Time: Tuesday July 12, 2022, 4:00 PM ET

To access the webcast, please register HERE

For dial in access, please use the following:
Toll Free: 1-877-269-7751
Toll/International: 1-201-389-0908

The Mainz mid-year update will be made available for replay for 14 days after the event.

The webcast replay can be accessed HERE
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13730909
Replay Start: Tuesday July 12, 2022, 7:00 PM ET
Replay Expiry: Tuesday July 26, 2022, 11:59 PM ET

About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., 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.
*Dollinger MM et al. (2018)

About Colorectal Cancer
Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently, there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

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. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio 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, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information, please visit www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, 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 registration statement on Form F-1 filed on January 21, 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.

FAQ

What is the purpose of Mainz Biomed's webcast on July 12, 2022?

The webcast aims to provide updates on the company's first-half 2022 progress and outline future plans.

What is ColoAlert and how does it relate to Mainz Biomed?

ColoAlert is Mainz Biomed's flagship product, an easy-to-use test for the early detection of colorectal cancer.

What updates will be discussed regarding ColoAlert in the upcoming webcast?

The updates will include ColoAlert's regulatory approval pathway, R&D advancements, and commercialization strategies.

How does ColoAlert compare to traditional colorectal cancer detection methods?

ColoAlert is a non-invasive test with high sensitivity and specificity, nearly matching that of invasive colonoscopies.

What market opportunity exists for ColoAlert in the U.S.?

The U.S. market opportunity for ColoAlert is approximately $3.7 billion annually, targeting Americans aged 50 and older.