Issuer: Mainz BioMed N.V. / Key word(s): Miscellaneous
Mainz Biomed Provides Year-End 2022 Corporate Review
BERKELEY, US – MAINZ, Germany – January 3, 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 a corporate summary for the fiscal year ended December 31, 2022.
Key Commercial, Operational and Product Development Highlights
“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:
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.
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 Mainz Biomed NV
In the US:
For investor inquiries, please contact email@example.com
Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
Mainz BioMed N.V.
EQS News ID:
End of News
EQS News Service