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Mainz Biomed Best-In-Class Colorectal Cancer Screening Diagnostics Expand International Presence, Targets Billion Dollar Market Opportunities ($MYNZ)

Mainz Biomed Best-In-Class Colorectal Cancer Screening Diagnostics Expand International Presence, Targets Billion Dollar Market Opportunities ($MYNZ)

Mainz Biomed (NASDAQ: MYNZ) stock gets pushed to degrees with low volume. But make no mistake, the trend in place is decidedly bullish. In fact, MYNZ stock has shown impressive performance in the worst of markets, decoupling from extraordinary small-cap biotech market weakness. On other days, MYNZ stock trades lower against a higher tape. So trying to time the purchase of MYNZ stock can be difficult. But for those playing long-term, daily gyrations shouldn't matter. The most important thing to trade on is confidence. And as this thinly traded molecular genetics diagnostics company makes it to more investor radar screens, moves are likely to be decidedly higher. A potential result of MYNZ advancing a cancer diagnostics products portfolio that could transform this microcap player into a revenue-generating juggernaut. 

That's not an overzealous presumption, either. After raising $25.8 million (gross) in new capital, strengthening its balance by eliminating nearly all long-term debt, and generating revenues from its early cancer detection diagnostics portfolio, MYNZ is in its best-ever position to maximize domestic and international marketing opportunities. Most important to that consideration is having the product arsenal to capitalize on. MYNZ does.

In fact, they have at least two up for the job, both capable of earning a sizable share of the billions of dollars in play for a diagnostics tool able to screen for two of the most deadly cancers- colon and pancreatic. Singularly, the revenue-generating shot on goal is enormous. But combined, MYNZ can be ideally positioned to capitalize on a domestic and international sales opportunity that could add exponential increases to its revenue streams. Best of all, investors won't wait long to see results. 

Mainz Biomed's flagship ColoAlert colorectal cancer diagnostic test is already commercialized overseas. Its PancAlert, a pancreatic cancer detection test, isn't far behind after reaching multiple preclinical milestones supporting its development as a first-in-class diagnostic for that deadly cancer indication. Updates on PancAlert, which could turn milestones into catalysts, are expected throughout next year. Announcements made sooner, if positive, could add fuel to an already impressive Q3 move.

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ColoAlert Is A Significant Value Driver 

Until then, focus on ColoAlert, MYNZ's accurate, non-invasive, and easy-to-use early-detection diagnostic test for colorectal cancer. It's a current value driver already being sold across Europe and the United Arab Emirates. The better news is that international market development is headed by former Abbott and Luminex executive Darin Leigh, MYNZ's Chief Commercial Officer leading international market development, where more than expansion is expected; it's likely. But while the focus now is on overseas sales, things on that front could change quickly, with ColoAlert positioning to exploit potentially massive U.S. market opportunities. When that happens, investors can expect the results to do more than expand market presence; it could add an appreciable multiple to current prices. Investors' recent interest in MYNZ stock indicates they may be aware of that near-term possibility.

High volume sent shares sharply higher in September after Mainz Biomed announced advancing its pivotal FDA clinical study for U.S. regulatory approval. A big focus on that news was MYNZ adding that it received supportive feedback from the FDA on ColoAlert's pre-submission package, an encouraging sign ahead of its pivotal U.S. clinical trial expected to start this quarter. More than a promising start for MYNZ, it also puts another milestone announcement on the imminent list. And there could be another one soon after.

That's an intended result of an already impressive ColoAlert product getting better. Mainz Biomed announced enrolling the first patient in an international clinical study (ColoFuture) evaluating the integration of novel mRNA biomarkers into ColoAlert. If trial data accrue as expected, MYNZ believes its already best-in-class diagnostic screen could reach the "gold standard" status for CRC at-home testing. While it's fair to say that those trials and opportunities present inherent opportunities from a U.S. market perspective, there's plenty of intrinsic value today to support significantly higher share prices. 

Milestones Reached In 2022, With A Tailwind

In fact, Mainz announced reaching several key milestones during the first half of 2022, including high-profile partnerships with leading laboratories like Labor MVZ Dr. Stein + Kollegen, more commonly known as "Laboratory Mönchengladbach," and with Dante Labs. Those agreements are intended to expedite market penetration in Germany, Italy, and the United Arab Emirates. And based on the size of those partner companies, penetrating those markets could happen faster than many expect.

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 colorectal cancer. Dante Labs is no small player, either. They are an established global leader in genome sequencing with product development and commercial franchises in multiple international regions focused on providing preventive healthcare solutions to consumers and healthcare professionals. Those two go beyond adding intrinsic value; the inherent value is equally compelling. Still, there's more to appreciate on the international front. 

Mainz Biomed is also working with GANZIMMUN Diagnostics AG, one of Europe's leading preventive and complementary medicine laboratories, which processes approximately 5,500 laboratory orders daily. Combining the revenue-generating potential from those deals alone presents a lucrative proposition. But, based on how quickly MYNZ adds to its partnership and distribution list, expect more value to get added. The chances for additional accretive deals are high and a likely priority for MYNZ management. 

Enhance ColoAlert By Assessing mRNA Biomarkers 

And one could accrue from a new initiative. In Q2, Mainz Biomed enrolled the first patient in an international multi-center clinical study (ColoFuture) assessing the potential integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. The mRNA biomarkers were acquired from the Université de Sherbrooke in January 2022, resulting from the institution's pioneering work in researching and testing multiple novel transcriptional biomarkers using colorectal cancer and pre-cancerous lesion samples.

MYNZ is now working to evaluate the effectiveness of these biomarkers in a study intending to enhance ColoAlert's technical profile and extend its capability to identify advanced adenomas (A.A.), a pre-cancerous polyp often attributed to colorectal cancer. Additional endpoints in this over 600-patient study include increasing ColoAlert's diagnostic sensitivity and specificity rates, with results from this over 600-patient trial expected to be published in early 2023. In addition to positive results scoring a second or third near-term catalyst, the more excellent news is that if results post as expected, ColoAlert could become the market's most robust and accurate at-home diagnostic screening test. 

And not only from its ability to detect cancerous polyps with a high degree of accuracy but also by potentially preventing colorectal cancer through early detection of pre-cancerous adenomas. Also, data from the ColoFuture trial could be included as a part of ColoAlert's pivotal U.S. clinical study, which could help influence a positive outcome there. For Mainz and product users, that would be a welcomed event, noting that colorectal cancer is the second most lethal cancer in the U.S. and Europe. However, with early detection, the survival rates above surge to over 90%. Put another way, using early-screening diagnostics like ColoAlert, many of the 52,980 people that died from colorectal cancer in 2021 might have been saved. Moreover, of the 149,500 new colon and rectal cancer cases in the U.S. each year, it's fair to assume that many of those cases detected early could be treated early and the cancer put into remission. The FDA thinks so.

They agree that early detection can save lives, suggesting screening with stool DNA tests such as ColoAlert be conducted once every three years starting at age 45. The addressable U.S. market of people over 50 sits at roughly 112 million. However, with changing demographics, that number is expected to eclipse the 157 million mark within ten years, substantially increasing the revenue-generating opportunities for MYNZ in the process. In dollar terms and if the over-50 population follows FDA guidance, which will likely be recommended by their physician, U.S.-based testing of that population will generate roughly $3.7 billion per year in potential revenues. 

With that massive market opportunity already in the crosshairs, a case is easily made supporting valuations higher than MYNZ's current $95 million market cap. But as noted, a second value driver could push that appreciation higher.

PancAlert Milestones Reached 

PancAlert, a second asset being advanced by MYNZ, is 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. Simply said, it's an accurate test providing real-time results, which could help position it commercially as a first and best-in-class diagnostic screen for pancreatic cancer. Mainz has reached several milestones in its mission to get it commercialized. 

In Q2, MYNZ announced that PancAlert reached preclinical milestones supporting continued development, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of a prototype biomarker test. Evaluation is being done to determine if a clinical trial is warranted. Considering that the project commenced with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, the supportive data accrued thus far supports the case for ongoing development as more than probable; it's likely. Similar to the need for ColoAlert, there should be no shortage of demand for PancAlert.

Statistics show that upwards of 466,000 lives are lost each year globally from pancreatic cancers, making it the seventh leading cause of cancer-related death worldwide. Worse, because of its propensity for late detection and poor outcomes using the standard of care treatment, the 5-year overall survival rate is approximately 11% in the U.S. and 9% globally. That makes it among the lowest survival rates of all cancers. But results don't have to be dire.

Research shows that survival rates increase significantly after early detection, supporting MYNZ's ongoing PancAlert interests. Remember, too. MYNZ doesn't need to go it alone. Positive data from its evaluations could attract additional outside interest, including partnerships and grants to expedite and fund the development of that critically needed diagnostic, a scenario likely to create additional shareholder value in the process.

MYNZ Ready To Run With The Bulls

Thus, as a commercial-stage cancer diagnostics products company targeting enormous market opportunities, MYNZ may be presenting a value proposition too big to ignore. And remember, it's not all about what they might do to create value. A mid-year cash balance of over $26 million, minimal debt, and a Who's Who management team that knows how to develop, market, and maximizes opportunities are worthy reasons to support higher current prices. 

Investors get more. In addition to being timely to a current value proposition, investors may benefit further in the coming quarters from an excellent company getting even better. That can result from MYNZ advancing studies, penetrating global markets to maximize revenue-generating opportunities, and being on the cusp of an expected U.S. marketing approval that could generate exponential revenue growth by early 2023. 

Thus, Mainz Biomed stock's recent bullish move is more than appropriate. But it still may not be enough to fully value MYNZ having no need for the capital markets and their position to grow appreciably from best-in-class products targeting billion-dollar marketing opportunities. Indeed, volatile markets should cause investors to choose investment propositions more critically. And a big part of that consideration should be to recognize valuation disconnects in companies having excellent products that meet a compelling need. Mainz Biomed checks those boxes. But better still, capitalized to turn market ambition into real-time sales matters, MYNZ checks off that box as well. 

All tolled, MYNZ has the products, expertise, market demand, partnerships, and technology to exploit an enormous revenue-generating opportunity. Best of all, that combination may do more than help save thousands of lives, it may save portfolios as well. For investors, that also matters.


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