Mainz Biomed (NASDAQ: MYNZ) may be doing a bit of a zig zag in recent trading but at the end of the day its stock has done something that few micro-cap biotech stocks have been able to match- trade higher. And with its decoupling putting a technical uptrend into motion, the best part of recent trading could be that it’s the precursor of more to come. In fact, the more this thinly traded molecular genetics diagnostics company makes it to investor radar screens, the more likely it solidifies the presumption that MYNZ stock’s path of least resistance is higher.
It’s a more likely scenario than not after MYNZ successfully raised $25.8 million (gross) in new capital, strengthened its balance sheet to show less than $1 million in long-term debt, and is generating revenues from an early cancer detection diagnostics portfolio that has best-in-class potential and market opportunities. By far, its cancer screening diagnostics are the feature attraction.
They target more than near and long-term revenue-generating opportunities; they tap into a market where billions are in play for a diagnostics tool that can screen for two of the most deadly cancers- colon and pancreatic. And MYNZ investors won’t wait long for the company to take advantage of its potentially massive shots on goal. Their flagship ColoAlert colorectal cancer diagnostic test is already commercialized, and its PancAlert, a pancreatic cancer detection test, isn’t far behind after scoring multiple preclinical milestones supporting its development as a first-in-class diagnostic for that deadly cancer indication.
Moreover, after raising significant capital to maximize focus initiatives, MYNZ is well-positioned to accelerate growth, with an experienced management team capable of driving substantially higher domestic and international development initiatives during the current and coming quarters.
ColoAlert Fuels International Growth
Its flagship product ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer, is the current value driver. It’s already marketed across Europe and the United Arab Emirates. And with former Abbott and Luminex executive Darin Leigh as MYNZ’s Chief Commercial Officer leading international market development, expansion from those markets is more an expectation; it’s likely. Keep in mind that MYNZ isn’t a pure international play. ColoAlert is also setting up to exploit massive U.S. market opportunities, which would do more than expand market presence; it could add a multiple to current prices. Investors may be aware of that possibility.
Shares started to move higher after Mainz Biomed announced advancing its pivotal FDA clinical study for U.S. regulatory approval. That happened along with receiving supportive feedback from the FDA on ColoAlert’s pre-submission package, which sets up its pivotal U.S. clinical trial to commence in Q4 2022. That’s only weeks away.
While that’s a targeted catalyst, investors could also be valuing that ColoAlert is an excellent product that’s getting even better. Mainz Biomed announced enrolling the first patient in an international clinical study (ColoFuture) evaluating the integration of novel mRNA biomarkers into ColoAlert. If data from that trial accrue as expected, an already best-in-class diagnostic screen could reach the “gold standard” status for CRC at-home testing.
While those trials and opportunities are forward-looking from a U.S. market perspective, there’s plenty of intrinsic value today to support significantly higher share prices. In fact, Mainz reached key milestones during the first half of 2022, including announcing 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 expected to accelerate market penetration in Germany, Italy, and the United Arab Emirates. And it could happen faster than many expect.
That would result from Laboratory Mönchengladbach leveraging its position as 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. That’s not all on the international front.
Mainz Biomed also works with GANZIMMUN Diagnostics AG, one of Europe’s leading preventive and complementary medicine laboratories, which processes approximately 5,500 laboratory orders daily. Combined opportunities through those deals present MYNZ as a lucrative proposition. Still, as noted, ColoAlert is an excellent product on a mission to get even better.
Assessing mRNA Biomarkers To Enhance ColoAlert
In June, Mainz 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 the field, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and pre-cancerous lesion samples.
Today, MYNZ is taking the next steps by 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. More than a second or third near-term catalyst, the better news is that if results are positive, 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.
Colorectal cancer is the second most lethal cancer in the U.S. and Europe, but with early detection, the survival rates above surge to over 90%. That means that through diagnostics like ColoAlert, many of the 52,980 people that died from colorectal cancer in 2021 might have been saved. What’s likely is that of the 149,500 new colon and rectal cancer cases in the U.S. each year, many patients would have been treated early and cancer put into remission. The FDA is paying attention.
They currently suggest screening with stool DNA tests such as ColoAlert be conducted once every three years starting at age 45, putting an over age 50 target market at roughly 112 million in play in the U.S. However, within ten years, that addressable market is expected to eclipse the 157 million mark, substantially increasing the revenue-generating opportunities for MYNZ in the process. Specifically, if this market demographic follows FDA guidance, US-based testing of this population will serve a market opportunity of approximately $3.7 billion per year.
That opportunity, already in the crosshairs, supports a valuation higher than MYNZ’s current $101.9 million market cap. But as noted, a second portfolio asset could boost that consideration.
PancAlert Milestones Reached
Mainz Biomed is advancing a second portfolio asset, 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. More simply, 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 milestones in its mission to get it commercialized.
In Q2, MYNZ announced that PancAlert reached multiple 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. However, 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, supportive data helps suggest that ongoing development is more than probable; it’s likely. There should be no shortage of demand.
Statistics indicate that about 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, making it among the lowest survival rates of all cancers.
But results don’t have to be dire; survival rates increase significantly after early detection, which supports continuing its PancAlert initiative. Moreover, positive data could attract additional outside interest, including partnerships and grants to expedite that critically needed diagnostic and create additional shareholder value.
A Bullish Proposition Exposed
As a commercial-stage cancer diagnostics products company targeting enormous market opportunities, the sum of MYNZ’s parts exposes a valuation disconnect that is hard to ignore. And part of that disconnect is inherent to the value of MYNZ’s 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. That’s not all they get.
Investors at current levels are timely to a value proposition from an excellent company getting stronger. MYNZ is advancing studies, penetrating global markets to maximize revenue-generating opportunities, and is 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; it’s relevant to a company having no need for the capital markets and positioned to grow appreciably from best-in-class products targeting billion-dollar marketing opportunities. In uncertain markets, the wise choice may be to stick with companies whose products meet a compelling need, and Mainz Biomed checks that box. Better yet, being well funded to execute its business mission, exploiting its enormous revenue-generating opportunities could happen sooner rather than later.
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