Mainz Biomed (NASDAQ: MYNZ) stock is earning bullish sentiment. Rightly so. This thinly traded molecular genetics diagnostics company is doing the right things at the right time. So right, in fact, that's its been able to decouple from weakness in the smallcap biotech sector as investors pay closer attention to its cancer diagnostics products portfolio that could appreciably strengthen its revenue-generating ability.
The better news- after completing a $25.8 million (gross) capital raise, strengthening its balance sheet to show less than $1 million in long-term debt, and generating revenues from an early cancer detection diagnostics portfolio with best-in-class potential, MYNZ is on that path. In fact, the above puts MYNZ in its best-ever position to maximize domestic and international marketing opportunities and, more importantly, has the product arsenal to capitalize.
At least two cancer screening diagnostics are targeting the challenge. And each is capable of earning a sizable share of the billions of dollars in play from a diagnostics tool market needing better screens against two of the most deadly cancers- colon and pancreatic. Individually, the revenue-generating potential is substantial. But combined, these diagnostics position MYNZ to maximize near-term opportunities and quickly expand its marketing presence.
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Flagship ColoAlert Is Driving Revenues
The flagship product, ColoAlert, is the current value driver. It's an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer currently sold across Europe and the United Arab Emirates. The excellent news here is that international market development is headed by former Abbott and Luminex executive Darin Leigh, MYNZ's Chief Commercial Officer, whose product development experience is expected to accelerate product adoption, driving revenues higher in the process. Still, while the focus now is on international sales, the U.S. markets could soon be in play, with MYNZ taking steps to position ColoAlert to exploit enormous U.S. market opportunities. Recent investor interest suggests that MYNZ is starting to get the attention it deserves.
The bullish sentiment started in September after Mainz Biomed announced advancing its pivotal FDA clinical study for U.S. regulatory approval. Supporting the bullish position, MYNZ noted receiving supportive feedback from the FDA on ColoAlert's pre-submission package, which is excellent news going into its pivotal U.S. clinical trial expected to start in Q4 2022. Of course, that quarter is upon us, meaning a catalyst could be near. And there may be more than one.
That's an intended result of MYNZ working to improve an already impressive ColoAlert product. The company 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 that trial puts inherent opportunities in the crosshairs, there's plenty of intrinsic value today to support a higher share price.
Milestones Often Become Catalysts
Several key milestones were reached 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 Dante Labs support that assumption. Those agreements are already creating value by accelerating market penetration in Germany, Italy, and the United Arab Emirates. And based on the size of those partner companies, earning marketing traction in 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 add tremendous value, but there's more to like.
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. All tolled, the revenue-generating potential from those deals presents a lucrative proposition. But, based on how quickly MYNZ is adding to its partnership and distribution list, investors would be foolish to ignore the likelihood of additional accretive deals that would further strengthen the company's near and long-term revenue-generating potential.
Enhance ColoAlert By Assessing mRNA Biomarkers
That potential is getting stronger. As noted, Mainz Biomed enrolled the first patient in an international multi-center clinical study (ColoFuture) in Q2, 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 the field. That work led to researchers testing multiple novel transcriptional biomarkers using colorectal cancer and pre-cancerous lesion samples.
MYNZ is currently evaluating 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. Looking toward those results adds more than a potential 2nd or 3rd catalyst; if results are positive, ColoAlert could become the market's most robust and accurate at-home diagnostic screening test.
And not only because it may be the best at detecting cancerous polyps with a high degree of accuracy. But also by potentially preventing colorectal cancer through early detection of pre-cancerous adenomas. And keep in mind that data from the ColoFuture trial could be included as a part of ColoAlert's pivotal U.S. clinical study, which, if positive, could help influence a positive outcome.
For Mainz, product users, and investors, that would be a welcomed event, noting that MYNZ targets colorectal cancer screening, the second most lethal cancer in the U.S. and Europe. While often fatal, it doesn't need to be. With early detection, the survival rates surge to over 90%, meaning that by simply using early-screening diagnostics like ColoAlert, many of the 52,980 people that died from colorectal cancer in 2021 might have been saved. And of the 149,500 new colon and rectal cancer cases in the U.S. each year, it's also a fair assumption that many of those cases detected early could be treated early and cancer put into remission. The FDA wants people to take notice of that difference.
They suggest screening with stool DNA tests such as ColoAlert be conducted once every three years starting at age 45, putting an addressable U.S. market of people over 50 at roughly 112 million. However, changing demographics are contributing to that number, 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, likely recommended by their physician as part of preventive care, U.S.-based testing of that population will generate roughly $3.7 billion per year in potential revenues.
And with a best-in-class product targeting that market opportunity already in the crosshairs, a case is justified supporting an MYNZ valuation higher than its current roughly $97 million market cap. But as noted, there's a second value driver that investors should include in their appraisals.
PancAlert Reaches Development Milestones
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. More simply, it's an accurate test providing near-instant results that could help position it commercially as a first and best-in-class diagnostic screen for pancreatic cancer. MYNZ has scored important milestones to help get this needed product to market sooner than later.
In Q2, MYNZ announced that PancAlert reached pre-clinical 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 underway 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 to continue. In other words, interest based on current data should invite additional investment in the project. It would align with the original mission and, most important, meet a critical need.
Statistics indicate 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. And worse, because of its propensity for late detection and poor outcomes with 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. Again, results don't have to be dire.
Research shows that survival rates increase significantly after early detection, supporting MYNZ and its partnered investors in continuing its PancAlert initiative. Remember, too. Don't assume that MYNZ needs to undertake these development initiatives alone. Positive data from its evaluations would likely attract significant outside interest, including partnerships and grants to expedite and fund the development of that critically needed diagnostic.
MYNZ Positioned For A Breakout in Q4 And 2023
Thus, many moving parts are working together to make this commercial-stage cancer diagnostics products company an investment to consider. And it's a value proposition made even better by MYNZ having a mid-year cash balance of over $26 million, minimal debt, and a Who's Who management team executing a plan to develop, market, and maximize revenue-generating opportunities in markets that will likely never see diminished demand. And that's not all they get.
Investors should benefit further in the coming weeks and quarters from an excellent company getting even better, an intentional result of MYNZ advancing studies, penetrating global markets to maximize income-producing opportunities, and nearing its milestone of earning U.S. commercialization privileges, which could happen by early 2023.
All tolled, MYNZ has the products, expertise, market demand, partnerships, and technology to exploit several enormous revenue-generating opportunities. And best of all, their success could mean lives saved. So while MYNZ presents a worthy value candidate on the investment side, the contribution on the humanitarian side is also appreciable. Thus, MYNZ can offer what most companies and investments can't...the rare but coveted win-win-win proposition.
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