Mainz Biomed (NASDAQ: MYNZ) stock is showing bullish momentum following several announcements, including strengthening its Board and medical advisory team and expanding its best-in-class cancer diagnostics products deeper into international markets. While the recent bullish action is impressive, it's likely the precursor of more significant moves to come, an assumption supported by a well-fortified balance sheet, evaluation of new product opportunities, and results-driven management that understands the industry and how to capitalize on brand and product opportunities.
The latter of the three just got stronger. On Wednesday, MYNZ announced nominating Dr. Heiner Dreismann as Chairman of the Board and Gregory Tibbitts to its Board of Directors. Both are notable leaders in key areas of the diagnostics field, and they are expected to be added to the team in December. That announcement followed appointing Dr. Douglas K. Rex to its Medical Advisory Board, who is expected to be a valuable contributor to Mainz's forthcoming U.S. pivotal trial for ColoAlert, its highly efficacious and easy-to-use detection test for colorectal cancer (CRC).
In addition to attracting industry-best talent, MYNZ is taking care of its finances. It raised $25.8 million (gross) in new capital, reduced long-term debt to less than $1 million, and increased revenues by expanding its presence in international markets with early cancer detection diagnostics products targeting multi-billion dollar market opportunities.
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Best-in-Class Cancer Screening Products
Those diagnostics products are impressive. Moreover, they position MYNZ to seize on multiple shots on revenue-generating goals. And the better news is that its product portfolio is expected to get larger. In addition to its flagship ColoAlert colorectal cancer diagnostic test, they have another value driver expected to be added to its arsenal, PancAlert, an easy-to-use pancreatic cancer detection test that provides fast results. That product recently reached multiple preclinical milestones supporting its development as a first-in-class diagnostic for this deadly cancer indication. Development updates are expected by year's end.
In the meantime, investors are paying attention to the value inherent to the flagship product, ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. It's more than a best-in-class contribution to the segment; it's also generating revenues, marketed across Europe and the United Arab Emirates. Marketing in the U.S. is in the crosshairs.
Mainz Biomed announced advancing its pivotal FDA clinical study in 2022 for U.S. regulatory approval, receiving supportive feedback from the FDA on ColoAlert's pre-submission package setting up its pivotal U.S. clinical trial to commence in Q4 2022. That's only a few weeks away. And the better news is that ColoAlert is an excellent product that could be made even better, with MYNZ saying it enrolled the first patient in an international clinical study (ColoFuture) evaluating the integration of novel mRNA biomarkers into ColoAlert. If clinical data post as expected, ColoAlert, already a best-in-class diagnostic screen, could reach "gold standard" status for CRC at-home testing.
The Here And Now
Still, investors don't need to be only forward-looking in their evaluation of MYNZ. Many intrinsic and inherent values already in play support the investment proposition, including benefits from key milestones reached during the first half of 2022. These included 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 intended to expedite market penetration in Germany, Italy, and the United Arab Emirates. And results could come sooner than later.
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 a 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 to other core partnerships, including a significant one with GANZIMMUN Diagnostics AG, one of Europe's leading preventive and complementary medicine laboratories, which processes approximately 5,500 laboratory orders daily.
Better still, they have the executive talent to drive the international expansion, led by former Abbott and Luminex executive Darin Leigh as its Chief Commercial Officer. Still, MYNZ isn't a pure international play. The near-term potential from ColoAlert exploiting massive U.S. market opportunities should also be modeled into revenue forecasts, which supports a case for a more appropriate share price to be higher.
There's more to support that bullish assumption.
Multi-Center Study Assessing mRNA Biomarkers
In June, Mainz announced enrolling 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, 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.
The next step is in progress, evaluating the effectiveness of these biomarkers. Positive data accelerates MYNZ's intention 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. Endpoints also include increasing ColoAlert's diagnostic sensitivity and specificity rates. Results from this over 600-patient study are expected to be published in early 2023. Here's potentially better news.
If results are positive, ColoAlert could become the market's most robust and accurate at-home diagnostic screening test. Not only by detecting cancerous polyps with a high degree of accuracy but also by potentially preventing colorectal cancer through early detection of pre-cancerous adenomas. Moreover, that mission could be fueled by data results from the ColoFuture study, likely being included as a part of ColoAlert's pivotal U.S. clinical study, which could help influence a positive outcome there.
Better products are needed. Colorectal cancer is the second most lethal cancer in the U.S. and Europe but also the most preventable, with early detection providing survival rates above 90%. Through diagnostics like ColoAlert, early detection can help save many of the approximately 149,500 new colon and rectal cancer cases in the U.S. each year. In 2021, a reported 52,980 people died from colorectal cancer.
The FDA appears on board, suggesting screening with stool DNA tests such as ColoAlert be conducted once every three years starting at age 45, putting a market of more than 112 million people in the U.S. above the age of 50, a number expected to increase to 157 million within 10 years, in the business crosshairs. If these demographics follow FDA guidance, US-based testing of this population equates to a market opportunity of approximately $3.7 Billion per year, which in the biotech world qualifies as a blockbuster product if MYNZ scores only a third of that potential.
PancAlert Adds Depth To Products Portfolio
That's not all driving the value proposition. In addition to ColoAlert, 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. In layman's terms, because of its accurate real-time results, it, too, can be a first and best-in-class screening for pancreatic cancer. Milestones reached in its development have also been published.
In May, MYNZ announced that PancAlert met 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. Research evaluation is being done to determine if a clinical trial is warranted. Considering that the 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, moving forward, especially with supportive data, is likely.
Like ColoAlert, it's a needed test. Roughly 466,000 lives are lost each year globally from pancreatic cancers, making it the seventh leading cause of cancer-related death worldwide. Worse, it has one of the lowest cancer survival rates due to typically late detection and poor outcomes with standard-of-care treatment(s). In fact, the 5-year overall survival rate is approximately 11% in the U.S. and 9% globally. But results don't have to be the worst case; early diagnosis raises the survival rate significantly, substantiating the rationale behind launching its PancAlert initiative.
A Bullish Consideration
Thus, two products, perhaps a third in the wings, expose an attractive value proposition. Remember, MYNZ products target multi-billion dollar cancer screening markets with first-in-class diagnostics tests that could fuel exponential revenue growth in the coming quarters. That's not all. Investors taking advantage of an apparent valuation disconnect also buy into a company with a mid-year cash balance of over $26 million, minimal debt, and a top-tier management team and Board fluent in how to develop, navigate, and market products. There's more to like.
Investors are also buying into a company that is getting stronger, advancing studies, and penetrating global markets to maximize revenue-generating opportunities related to two of the most lethal cancers. And with supportive FDA guidance for its U.S. trials and commercialization expanding overseas, taking advantage and maximizing opportunities is more than an expectation; it's likely.
Thus, Mainz Biomed presents a compelling value proposition at current levels, especially by being better positioned now compared to when scoring 52-week highs. That case is strengthened knowing they have no current need to go to the capital markets and minimal debt, two metrics supporting higher, not lower, share prices. Simply put, combining the sum of all its parts makes MYNZ a cancer diagnostics play too good to ignore. In fact, with plenty to support that consideration, investors may be wise not to.
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