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Mainz Biomed In Focus Ahead Of Two Data-Set Releases In 1H/2023 ($MYNZ)

Mainz Biomed In Focus Ahead Of Two Data-Set Releases In 1H/2023  ($MYNZ)

Mainz Biomed's (NASDAQ: MYNZ) share price consolidation at the $7.00 level may be ready to break - higher. Yes, that's a bullish presumption, but it's justified by recognizing how the groundwork completed in 2022 has set MYNZ up for a potentially transformative 2023. Current valuations might be fair if there were no forward-looking considerations, but that isn’t the case. In fact, while the intrinsics in the MYNZ portfolio are impressive, the inherent value in play from a forward-looking perspective exposes a valuation disconnect worth considering. 

And taking advantage of the gap sooner than later may be timely. That's because MYNZ has shifted into a period of hyper-growth, with several investor updates indicating that its mission to grow revenues from molecular genetics and cancer diagnostics assets is accelerating. In fact, while 2022 was a pivotal growth year, Mainz has not slowed its expansion pace so far in 2023 and is moving closer to exploiting the full potential of a diagnostics and screens portfolio that may earn best-in-class designations. 

In turn, and considering they are expected to deliver at least two critical updates during the first half of 2023, the path of least resistance for its shares could be paved higher.

2022 Was A Year Of Milestones Reached

That bullish sentiment is justified considering that MYNZ is nourishing plenty of value drivers, including launching its U.S.-based eAArly DETECT study to evaluate the performance of its mRNA biomarkers in identifying Advance Adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC). The first patient has been enrolled, and 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, including the continued execution of its 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.

Expertly managed, MYNZ initiated and commenced patient enrollment in ColoFuture, a European study evaluating integrating a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, which could potentially enable the screening test to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC. Results from this study are also expected in 1H/2023.

Consider the following if that wasn't enough to show MYNZ is hitting its stride: 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.

MYNZ Has Momentum Entering 2023

The combined value of those initiatives can be tremendous; frankly, success from any of them can be transformative to revenue growth. But with several in play, perhaps the best analysis suggests that MYNZ is in its strongest position ever to create sustainable shareholder value, including that accrued from overseas market opportunities and those inherent to ongoing product development programs. Put simply, MYNZ entered 2023 with a significant operations tailwind to advance its mission of becoming a leading provider of cancer-focused early detection and disease prevention molecular diagnostics. 

Considerable progress toward that goal is being made. Last month, 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.

The value inherent to that deal should not be undervalued or under-appreciated. In addition to being an immediate value driver from an existing market perspective, it allows MYNZ to more aggressively execute its commercial strategy and product development plans intending to bring to market what the company 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.

Strengthening Revenue Streams With ColoAlert 

Notably, MYNZ's recent 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 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.

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, once 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 appraising their value in a new generation of medicine. MYNZ is also in the game, noting that the outcome of its eAArly DETECT study will inform its decision of whether to integrate the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023. The results from that study are planned to be reported in 2025 and will form the basis of the data package to be reviewed by the FDA to achieve marketing authorization. There's more to like.

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 individuals. Revenues from that deal could start to accrue quickly, as MYNZ says they are working on completing the necessary technical and co-marketing activities to ensure a successful commercial launch in these markets.

A Bullish Proposition That Is Portfolio Supported

While parts of the MYNZ proposition justify investment consideration, the sum total can demand it. Even in the face of significant downside pressure on biotech stocks, MYNZ is showing strength, and that's not easy in the small-cap world of risk-off sentiment. Bouncing off lows could indicate buyers are waiting for shares, sitting on the bid, and content not to chase. But patience may run out, and MYNZ has shown that when the biotech bulls return, its stock can surge ahead of the averages. That could result from a management team proving to its investors that they know how to leverage a unique business model to advance its revenue-generating objectives and improve its best-in-class diagnostics. 

Furthermore, fundamentally, MYNZ is solid. They have a strong balance sheet, minimal debt, and a Who's Who executive and scientific team executing a plan to develop, market, and maximize value-generating opportunities. Thus, in many respects, meeting its objectives doesn't present an "if" proposition. Instead, the groundwork laid and plans to accelerate expose a "when" proposition. And for investors seeking value from a near-term news queue, the most plausible answer to "when" is sooner rather than later. 

Remember, guidance already puts potential catalysts on target, which, in turbulent markets, is an attractive feature that will be taken advantage of as its target release dates get closer. In other words, the MYNZ window of opportunity may not stay open much longer. 




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