MYNZ Mainz BioMed NV

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 a corporate summary for the fiscal year ended December 31, 2022.

Key Commercial, Operational and Product Development Highlights

• Launched U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomarkers in identifying Advance Adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC); on track to report results in 1H 2023.
• Initiated ReconAAsense, U.S. Pivotal Clinical Study with Company’s CRC screening test; anticipate commencing patient enrollment in mid-2023.
• Continued executing differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
• Ramped up international commercial activities for ColoAlert, the Company’s highly efficacious and easy-to-use detection test for CRC, including five new lab partners in Germany and Italy.
• Enhanced leadership team with appointments to Board of Directors and Company executives to lead commercial and product development groups, with former executives and senior management from Roche, Abbott, Luminex, and Qiagen; expanded Medical Advisory Board of global leaders in molecular diagnostic development.
• Initiated and commenced patient enrollment in ColoFuture, a European study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert; potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC; with results expected in 2023.
• Achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer.
• Acquired a portfolio of novel mRNA biomarkers to upgrade ColoAlert’s technical profile to achieve “gold standard” status for AA and CRC at-home testing.
• Executed a USD 25.8 million (gross) public follow-on offering.

“The past year has proven to be an extraordinary period of growth as we strengthened every aspect of the Company while expanding our international commercial footprint and executing our product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We head into 2023 with a great deal of momentum, and on behalf of the management team and Board of Directors, I wish to extend gratitude to our shareholders for their support as we continue our journey to become a leading provider of cancer-focused early detection and disease prevention molecular diagnostics.”

Commercial Update: Establishing an international market presence for ColoAlert

Throughout 2022, Mainz Biomed executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.

Key partnership highlights included establishing high-profile commercial arrangements with leading laboratories such as Labor MVZ Dr. Stein + Kollegen, covering the North Rhine-Westphalia region of Germany, and Dante Labs in Italy and the United Arab Emirates. Labor MVZ Dr. Stein + Kollegen, commonly referred to as “Laboratory Mönchengladbach,” is one of the largest diagnostics laboratories in Germany, servicing over 2,500 physicians, processing over five million samples annually and screening approximately 1,000 patients per week specifically for CRC. Dante Labs is a global leader in genome sequencing with product development and a commercial franchise focused on providing preventive healthcare solutions to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions and operating a robust e-commerce platform. With the addition of Laboratory Mönchengladbach and Dante Labs, Mainz Biomed now has five core partnerships, including GANZIMMUN Diagnostics AG, one of Europe’s leading laboratories for preventive and complementary medicine, which processes approximately 5,500 laboratory orders daily. Additional partnership agreements are currently being negotiated with other leading laboratories.

During the year, and specifically in the European region, Mainz Biomed enhanced its commercial strategy to include corporate health programs and direct-to-consumer sales capabilities.

ColoAlert Research and Development Summary: Achieved major clinical development milestones with the goal of upgrading ColoAlert to identify Advanced Adenomas

Over 2022, Mainz Biomed accomplished significant clinical development achievements for ColoAlert based on evaluating acquired mRNA biomarkers to potentially upgrade its technical profile to achieve “gold standard” status for CRC at-home testing. The Company received approval from an independent Institutional Review Board (IRB) and initiated ReconAAsense, a U.S. Pivotal Clinical Study, and commenced enrollment in ColoFuture and eAArly DETECT, an international multi-center clinical study (U.S. and Europe), assessing the potential to integrate mRNA biomarkers into ColoAlert. The mRNA biomarkers being evaluated were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and precancerous lesion samples. The results from these studies demonstrated that the mRNA targets chosen by Mainz Biomed provided a market-leading combination of sensitivity and specificity of detection (Herring et al. 2021). The ColoFuture study (extended into the U.S. as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

The ColoFuture study is enrolling over 600 patients in the age range of 40-85, and the Company is targeting to report study results in 2023. ColoFuture’s eAArly DETECT study is on track to complete enrollment in Q1 2023, with results reported in the first half of 2023. Based on the study’s outcome, Mainz Biomed will decide on integrating the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023, with results reported in 2025.

The ReconAAsense study (ClinicalTrials.gov Identifier: NCT05636085) will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the U.S. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. If successful, the Company’s mRNA and DNA-based CRC screening test will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.

PancAlert Research and Development Update: A novel screening test for pancreatic cancer achieved multiple preclinical milestones

During the year, Mainz Biomed announced that PancAlert met multiple preclinical milestones that support the continued development of this potential first-in-class diagnostic for this deadly cancer indication. These predefined milestones included achieving a specificity target, collecting a set of characterized clinical samples, selecting potential biomarker candidates, and developing a prototype biomarker test. The Company plans to continue PancAlert’s research and development to determine if a clinical trial is warranted.

PancAlert’s technical profile may include functioning as a stool-based test, mirroring the Company’s flagship product ColoAlert. Given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate real-time PCR-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples and evaluate other collection methodologies, including saliva, urine, and blood.

The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.1 It has one of the lowest cancer survival rates, with typically late detection and poor outcomes with standard-of-care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.2 and 9% globally.3 If diagnosis occurs in the early stages of the disease, the survival rate is significantly higher. However, there are currently no routine screening options available.

Corporate Update: Bolstered balance sheet, made key appointments to the management team and enhanced its Board of Directors and Medical Advisory Board

Throughout 2022, Mainz Biomed operated in a position of financial strength, having successfully executed a USD 25.8 million public follow-on offering in January, which consisted of 1,725,000 ordinary shares priced at USD 15.00 per share.

During the year, to keep pace with product development and commercial growth, the Company made it a priority to bolster its leadership team. Key additions to the executive team include:

• Darin Leigh, Chief Commercial Officer – Mr. Leigh is a former Abbott and Luminex executive with over 30 years of In Vitro Diagnostic (IVD) and life science experience.
• Amy Levin, Vice President of Regulatory Affairs – Ms. Levin brings to Mainz Biomed over 20 years of regulatory affairs experience. Previously, she worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs.
• Jane Edwards, Vice President of Clinical Affairs – Ms. Edwards, has over 20 years of experience developing clinical trial strategies in diagnostics and medical devices. She was previously at L3 Healthcare, a full-service contract research organization, where she led clinical research and operations.
• Frank Krieg-Schneider, Vice President of Development – Mr. Krieg has over 25 years of experience in the diagnostics and life science industry, including leading various divisions within Qiagen’s diagnostic and life science practice, heading up research and development for Diagnostic Sample Preparation and later serving as Head of Global Strategic Alliances.

Having achieved the transformational corporate growth milestone of going public onto Nasdaq in Q4 2021, Mainz Biomed made it a priority during 2022 to enhance the Company’s Board of Directors and advisory team in order to rely on their vast industry experience for the decisive inflections points in 2023 and beyond. Over the course of the year, Mainz Biomed appointed Dr. Heiner Dreismann as Chairman of the Board, Gregory Tibbitts to its Board of Directors, and added Dr. Michelle Pedrocchi, Dr. Rainer Metzger to its Strategic Advisory Board and Dr. Douglas Rex, Dr. Timothy Wang, and Dr. D. Kim Turgeon to the Medical Advisory Board.

Dr. Dreismann is the former Chief Executive Officer of Roche Molecular Diagnostics and is widely considered a pioneer in PCR, one of the most revolutionary techniques in molecular biology and genetics research. Mr. Tibbitts is an accomplished life science executive and certified public accountant with over 30 years of experience as a senior financial executive and board member of publicly traded and privately held companies.

References

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338. The online GLOBOCAN 2020 database is accessible at http://gco.iarc.fr/, as part of IARC’s Global Cancer Observatory.
2. National Cancer Institute, Surveillance, Epidemiology and End Results Program (SEER). Cancer Stat Facts: Pancreatic Cancer. July 2021. https://seer.cancer.gov/statfacts/html/pancreas.html
3. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019;10(1):10-27. doi:10.14740/wjon1166

About ColoAlertColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements) and commercially available in a selection of countries in the European Union and the United Arab Emirates. 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.

About Mainz Biomed NVMainz 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, please contact press@mainzbiomed.com In Europe:MC Services AGAnne Hennecke/Caroline Bergmann+49 211 529252 20mainzbiomed@mc-services.eu

In the US:Spectrum ScienceMelissa Laverty/Valerie Enes+1 540 272 6465mainz@spectrumscience.com

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 registration statement 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.