Mainz Biomed (NASDAQ: MYNZ) has laid the groundwork in 2022 for what could be a transformative 2023. That means from a market cap perspective, its roughly $98 million level could be undervaluing much of the progress made last year. In fact, current valuations could be considered accurate if just historical evidence provided the model's input. But that's not the case. There's plenty of forward-looking considerations contributing to MYNZ's case of deserving a more appropriate and higher valuation.
In fact, while 2022 was a significant formative period, the real story is how that work has shifted MYNZ into hypergrowth. And for considering investors, the better news is that the work can be leveraged to generate sustainable and significant revenue growth for this molecular genetics and cancer diagnostics company this year. There's better news.
Mainz has not slowed its pace of expansion so far in 2023. That's potentially excellent news for the company, its investors, and most importantly, the patients needing the types of diagnostics and screens that MYNZ provides. Before jumping to the accretive deals made this year, a quick recap of MYNZ's impressive performance in 2022 is warranted. After all, that period established much of the framework required to accelerate expanding its product presence and set up the company for a potential 2023 breakout.
2021 Was A Year Of Milestones Reached
Scoring a breakout performance isn't an overly optimistic assessment, considering the milestones reached last year. In no particular order, MYNZ launched its U.S.-based eAArly DETECT study and enrolled the first patient in a study focused on the performance of Mainz Biomed's mRNA biomarkers in identifying Advance Adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC). An update on that trial is expected before the end of Q2.
They also initiated ReconAAsense, a U.S. Pivotal Clinical Study with its CRC screening test. Enrollment for that study is expected to commence in mid-2023. They did much more. The company also continued executing a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. In addition, MYNZ ramped up international commercial activities for ColoAlert, its highly efficacious and easy-to-use detection test for CRC, with at least five new lab partners in Germany and Italy. That's still not all.
Supported by an enhanced management team, MYNZ initiated and commenced patient enrollment in ColoFuture, a European study evaluating integrating a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, potentially able to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC. Results from this study are also expected in 1H/2023.
If that wasn't enough to show MYNZ is hitting its stride, consider this too. They achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer, acquired a portfolio of novel mRNA biomarkers to upgrade ColoAlert's technical profile to achieve "gold standard" status for AA and CRC at-home testing, and successfully completed a $25.8 million public follow-on offering.
Positioned For Significant Growth In 2023
The sum of those initiatives is easy to calculate. The answer shows that MYNZ is in its best position ever to capitalize on and maximize several near-term revenue-generating opportunities, including shots on goals in overseas markets and those inherent to ongoing product development programs. In other words, MYNZ entered 2023 with a significant operations tailwind in its mission to become a leading provider of cancer-focused early detection and disease prevention molecular diagnostics. Details of the work completed can be found on the company's website. Those considering taking advantage of an apparent valuation disconnect are encouraged to read its publications. They are informative and inspiring and detail how impactful the work completed and planned can be in making this year a transformative one.
Progress toward that goal is underway. Last week, Mainz Biomed announced executing its option from Uni Targeting Research AS to acquire all of the previously licensed scientific intellectual property ("IP") for its flagship product ColoAlert. That deal makes this highly productive and easy-to-use detection test for colorectal cancer being commercialized across Europe a wholly-owned asset. Simultaneously, Mainz exercised its exclusive option with SOCPRA Sciences Sante et Humaines S.E.C. to outright purchase IP, including a pending patent, associated with a portfolio of novel gene expression (mRNA) biomarkers that have demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease.
It's a big deal and one that should not go under-appreciated. In addition to being an immediate value driver from an existing market perspective, it allows the company to more aggressively execute its commercial strategy and product development plans intending to bring to market what MYNZ describes as the gold-standard CRC self-administered diagnostic test. Better still, MYNZ can earn more money since securing complete IP ownership expedites the company's growth strategy, streamlines administration, reduces per-test expenses, and allows MYNZ to ramp up corporate development activities.
Adding To Revenue Streams
Remember, too, that the deal adds to existing revenue streams. Mainz Biomed is already commercializing ColoAlert across Europe and in select international markets through partnerships with third-party laboratories for test kit processing. The terms are accretive to MYNZ's mission. Mainz Biomed provides 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. That reach extends to those facilities' respective networks of physicians and patients, which by using ColoAlert, offers a comprehensive solution for advanced CRC detection.
Mainz is doing more to create value. They are also evaluating the mRNA biomarkers it acquired from SOCPRA in ColoFuture and eAArly DETECT, an international multi-center clinical study (US and Europe) assessing the potential for integrating the mRNA biomarkers into ColoAlert. This particular portfolio of mRNA biomarkers selected by Mainz Biomed 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.
The 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 US as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert's technical profile to expand its capability to identify AA 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 reported in the first half of 2023. That milestone reached could become a catalyst. Keep in mind that studying mRNA biomarkers is a hot sector.
Both Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) are spending enormous sums evaluating their value in a new generation of medicine. MYNZ is also in the game, noting that based on its study's outcome, it will decide on integrating the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023, and the results from that reported in 2025 forming the basis of the data package put for review to the FDA to achieve marketing authorization.
Also, in February, MYNZ 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. Revenues from that deal could start to accrue quickly. MYNZ noted they are working on completing the necessary technical and co-marketing activities to ensure a successful commercial launch in these markets.
A Bullish Proposition
All told, it's clear that MYNZ is advancing a focused mission seamlessly and strategically that should make its company bigger faster. And they are demonstrating that despite having many moving parts and a unique business model in some respects, the team knows how to advance its revenue-generating objectives and make its best-in-class diagnostics better.
Moreover, with a strong balance sheet, minimal debt, and a Who's Who management team executing a plan to develop, market, and maximize revenue-generating opportunities, meeting its objectives doesn't present an "if" proposition. Instead, the groundwork laid and current plans to execute express a "when" proposition, with evidence suggesting the answer to that question is "faster than many think."
Thus, with MYNZ checking all the right boxes and a history of delivering more than expected, taking advantage of a fast-moving company may be an excellent prescription for portfolios needing help. Keep in mind weak markets tend to devalue most company valuations. But when the bulls return, it's typically the best of the breed that recovers fastest. With all going on and more expected in the next 90 days, Mainz Biomed makes that list.
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