Advertorial

With its flagship diagnostics test ColoAlert, this little-known NASDAQ company makes early detection of colon cancer easier than ever….

As cases of colorectal cancer continue to affect people, with now younger groups being diagnosed, Mainz Biomed N.V. (NASDAQ: MYNZ) may represent one of the biggest health stock opportunities hiding in the market!

Despite significant progress, cancer continues to be the second-largest cause of death in the U.S. Unfortunately, more than 1.9 million new cases of cancer are likely to be diagnosed in the U.S. alone this year and more than 600,000 deaths are expected from the disease.

This is a good time to take a look at the cancer-fighting space on Wall Street, especially as healthcare is often considered an inflation hedge.

Download Research Report

Learn More about Mainz Biomed N.V. by gaining access to the latest research report

Thanks for subscribing!

CLICK HERE TO VIEW REPORT

Check your email for a confirmation message.

Mainz Biomed N.V. is a client of Tradigital IR, an investor relations and communications firm. Please see our disclosures in the research report as well as on our website www.Tradigitalir.com.

10 Immediate reasons to be paying attention to MYNZ

A flagship product that could position company as a leader in early detection for colorectal cancer.
Former executives from major pharma giants on board… the company’s CEO Guido Baechler was a former Roche Molecular diagnostics executive… Chief Commercial Officer Darin Leigh held executive commercial positions at several leading life science and healthcare firms including Abbott, Luminex, Metabolon, and CDR Health!;
Exciting FDA feedback has been received for their lead product ColoAlert...
A whopping $25 price target….
ColoAlert rivals Cologuard from Exact Sciences Corporation (NASDAQ: EXAS) which trades over $60 a share…
Ramped up international commercial activities for ColoAlert, with at least five new lab partners in Germany and Italy…
Ample cash to fund operations…
Executed its option from Uni Targeting Research AS to acquire all of the previously licensed scientific intellectual property ("I.P.") for its flagship product ColoAlert. That deal makes ColoAlert a wholly-owned asset…
Exercised its exclusive option with SOCPRA Sciences Sante et Humaines S.E.C. to outright purchase I.P., including a pending patent, associated with a portfolio of novel gene expression (mRNA) biomarkers that have demonstrated the ability to detect C.R.C. lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease…
A commercial strategy and product development plans intended to bring what the company describes as the gold-standard C.R.C. self-administered diagnostic test to market…

Colorectal cancer is the third most common cancer globally, with more than 1.9 million new cases in 2020 alone. There is a dire need for early detection!

“Our goal is to reduce these statistics and save lives by raising awareness about the simplicity and efficacy of using at-home CRC detection kits, like ColoAlert. Our non-invasive DNA stool test allows people to screen themselves in the comfort of their own home and then receive a follow-up notification from their physician to discuss results and next steps.”

Guido Baechler, Chief Executive Officer of Mainz Biomed

ColoAlert Holds Potential as a Blockbuster Early Detection Test for Colorectal Cancer and Could Turn Mainz Biomed (NASDAQ: MYNZ) into a 2023 Breakout Story!

Greetings Investors,

Overall, the lifetime risk of developing colorectal cancer is about 1 in 23 for men and 1 in 26 for women says the American Cancer Society.

The American Cancer Society’s estimates for the number of colorectal cancers in the United States for 2023 are:

106,970 new cases of colon cancer
46,050 new cases of rectal cancer

And colorectal cancer cases are rising in young adults.

Why is there an uptick? Nobody knows for sure but a sedentary lifestyle, overweight and obesity, smoking, heavy alcohol use, low-fiber, high-fat diets or diets high in processed meats, and other environmental factors have all been associated with the disease.

Screening is important because when found early, colorectal cancer is highly treatable. Early stages of colorectal cancer usually present no symptoms so screening is crucial.

According to the Centers for Disease Control and Prevention (“CDC”), Colorectal cancer (CRC) is the second most lethal cancer in the United States and Europe, but also the most preventable, with early detection providing survival rates above 90%!

A colonoscopy is one of several screening tests for colorectal cancer, but they can be awfully invasive.

THE ANSWER? COLOALERT!

MYNZ’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. It is simple, fast, accurate, and non-invasive.

ColoAlert 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.

Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.

While the product is not approved yet for the U.S., it may be in the future, and this could be a game changer considering that it needs smaller samples than rival Cologuard!

ColoAlert Highlights

A PCR-based molecular genetic CRC early detection stool test
Up to 60% fewer missed cases compared to fecal immunochemical test (FIT) 10
Non-invasive, no preparation or sedation, no time off work
98% patient satisfaction – Easy product to use 11
Designed to offer affordable CRC screening solutions

10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)

11 98% overall satisfaction with ColoAlert in our internal customer survey.

PROPRIETARY STATE OF THE ART TECHNOLOGY

Colorectal cancer begins when cells in the intestine undergo genetic mutations. Tumor cells shed into the intestines. Stool samples can be examined for tumor DNA using PCR technology.
Polymerase chain reaction (PCR) is used to rapidly make millions to billions of copies of a specific DNA sample and only requires a very small sample of DNA to amplify it large enough for detailed study.
ColoAlert utilizes proprietary methods to analyse the cell DNA for specific tumor markers.
ColoAlert is designed to detect tumor DNA and detect 85% of colorectal cancer cases - often in the earliest stages of the disease.*
Ease-of-use drives ongoing patient adherence as the ColoAlert method requires very small samples compared to ColoGuard.

*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453. * 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.

COMPANY OVERVIEW

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions and is transforming at-home cancer detection.

Clinical laboratory tests save costs and lives by enabling early detection and prevention of disease. Patients with cancers and other conditions are living longer and enjoying better health because of medical revolutions in diagnostic technology.

At its center are genetic and genomic tests that identify the unique genetic profile of individual patients or their disease and allow physicians to tailor treatment to those unique characteristics.

Key Corporate & Product Development Highlights in 2022 include:

Accelerated international commercial activities for ColoAlert, the Company’s highly efficacious and easy-to-use detection test for colorectal cancer (CRC).
Appointed Darin Leigh, former Abbott and Luminex executive, as Chief Commercial Officer.
Established partnership with Dante Labs to market ColoAlert in Italy and the United Arab Emirates.
A high-profile partnerships with leading laboratory Labor MVZ Dr. Stein + Kollegen, commonly referred to as “Laboratory Mönchengladbach” (February), 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.
Initiated and enrolled the first patient in an international clinical study (ColoFuture) evaluating the integration of novel mRNA biomarkers into ColoAlert – potentially upgrading its technical profile to achieve “gold standard” status for CRC at-home testing.
Received supportive feedback from the U.S. Food and Drug Administration (FDA) on ColoAlert’s pre-submission package for its U.S. pivotal clinical trial set to commence in Q4 2022.
Achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer.
Executed a $25.8 million (gross) public follow-on offering.
Expanded Strategic Advisory Board of global leaders in molecular diagnostic development and commercialization.

Mainz Biomed has historical research & development collaborations with major universities, laboratories and governments across Europe.

COMMERCIALIZATION ACROSS EUROPE AND INTERNATIONAL MARKETS

Mainz Biomed is commercializing ColoAlert across Europe and in select international markets through a differentiated business model 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.

A STRONG PARTNERSHIP FOR GROWTH

DNA extraction for the company’s flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.

This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.

Automated DNA extraction with magnetic particles
Tailored protocol for ColoAlert
Up to 96 samples per run in ~ 2 hours*
Brings convenience, performance and reproducibility to the ColoAlert workflow

* Extraction time, does not include sample pre-treatment. For Laboratory Use.

ENHANCING ALREADY EXCELLENT ASSETS

MYNZ is evaluating the mRNA biomarkers acquired from SOCPRA in ColoFuture and eAArly DETECT, an international multi-center clinical study (U.S. and Europe) assessing the potential for integrating the mRNA biomarkers into ColoAlert.

This particular portfolio of mRNA biomarkers selected by the company was based on work in the field by the University of Sherbrooke, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and pre-cancerous lesion samples.

Results from these studies demonstrated that the mRNA targets chosen by the company provided a dynamic combination of sensitivity and specificity of detection.

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 A.A. while increasing ColoAlert's rates of diagnostic sensitivity and specificity. As noted, ColoFuture's eAArly DETECT study is on track to complete enrollment in the first quarter of 2023, with results also expected in the first half of 2023. That milestone, once reached, could become a catalyst for growth!

Even studying mRNA biomarkers is a hot sector. Both Pfizer (NYSE: P.F.E.) and Moderna (NASDAQ: MRNA) are investing considerable resources in appraising their value in a new generation of medicine!

MYNZ has highlighted that the outcome of its eAArly DETECT study will inform its decision of whether to integrate the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023!

The results from that study are planned to be reported in 2025, forming the basis of the data package to be reviewed by the F.D.A. to achieve marketing authorization.

MYNZ has also announced additional commercial partnerships for ColoAlert with Marylebone Laboratory and Instituto de Microecologia, two leading independent laboratories covering England and Spain.

That deal will expand MYNZ's revenue-generating reach and target an addressable market in Spain estimated at 26 million patients and a London-region patient treatment opportunity of roughly 9 million individuals.

Revenues from that deal could accrue quickly. MYNZ says they are working on completing the necessary technical and co-marketing activities to ensure a successful commercial launch in these markets.

COMMERCIAL PIPELINE DEVELOPMENT: FUTURE PRODUCTS

In addition to MYNZ's flagship ColoAlert product, the company is also developing a novel early-detection pancreatic cancer screening test.

Mainz BioMed is currently developing proprietary genetic testing methods for pancreatic cancer.

Fighting what could soon become the world’s second most deadly cancer.
Convenient stool test for at-home use.
Potential for over 50 million tests per year in Europe alone
Supported by federal grant from Germany’s Federal Ministry for Education and Research.
Cost of goods sold (COGS) & reimbursement analogous to ColoAlert program.

PRIORITY ROLLOUT MARKETS

- ColoAlert launches from Germany… to Europe and America
- Expansion into EU markets is aligned with early-stage plans for American market entry.
- Upon FDA approval, Mainz BioMed plans to offer ColoAlert CRC screening test kits to national reference labs and major health institutions in the USA.
- Mainz BioMed is carefully evaluating FDA requirements to ensure an expedited strategy is aligned with future clinical, regulatory and related guideline requirements.

Key clinical studies will be co-located in the US and abroad to meet the requirements set by FDA for a screening application

IN SUMMARY

With every problem comes an opportunity -- in this case, a massive opportunity because cancer is a big problem. Both large and small companies are developing new ways of diagnosing and treating cancer and MYNZ may have one of the best ways to fight off colon cancer early on.

The company's closest peer, Exact Sciences (NASDAQ: EXAS) - ColoGuard product is only sold in the US - and has a market cap of about $11 billion. TO REITERATE.... COLOALERT IS EASIER TO ADMINISTER AND MORE ACCURATE!

AND… MYNZ currently carries an $18 price target! With leading analysts CANTOR FITZGERALD and H C WAINWRIGHT recommending the stock!

With a blockbuster early detection test for colorectal cancer that could give Exact Science's Cologuard a run for its money... now is the time to be paying attention to emerging player Mainz Biomed N.V. (NASDAQ: MYNZ)!

Learn More about Mainz Biomed N.V. by gaining access to the latest
research report

Download