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Friday Morning Nasdaq Profile Follow-Up: Breaking News Out On (MYNZ)

February 4th

SCF Readers,

Let's dive in because time's of the essence.

Today, past champ Nasdaq idea (MYNZ) dropped big news. Check it out now:

Mainz Biomed Initiates Clinical Study to Evaluate Integrating Novel mRNA Biomarkers Into ColoAlert

Results to impact ColoAlert profile for FDA submission

Provides opportunity for ColoAlert to achieve gold standard status as the premier at-home screening test for colorectal cancer

BERKELEY, Calif. and MAINZ, Germany, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has commenced ColoFuture, an international clinical study to evaluate the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer which is being commercialized across Europe. The novel gene expression (mRNA) biomarkers, which we acquired an exclusive option to in-license from the Université de Sherbrooke in early January 2022, have demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage colorectal cancer (CRC). The ColoFuture study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

Initiating the ColoFuture study is an exciting opportunity for the company, the patient and medical communities as the outcome could be a game-changer for the role ColoAlert will play in the prevention and treatment of CRC. We look forward to reporting the study’s clinical results by early 2023,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “In its current configuration, the test already represents a top-tier discretionary diagnostic option, and we are thrilled with the commercial traction ColoAlert has achieved to date via our unique business model of partnering with third-party laboratories for test kit processing. However, if the study’s results prove positive, it will be a transformative milestone for the Company as it will solidify ColoAlert’s position as the premier at-home diagnostic tool for this deadly form of cancer.

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Read the full article here.

That's potentially game-changing news.

Remember, it was only back towards the beginning of December that I brought this profile to your attention on the evening of the 7th.

The following day MYNZ opened up at $8.55 before surging all the way to a high of $30.00 by January 18th.

In just over a month, that turned MYNZ into a breakout star of approximately 250%.

One of the main potential catalysts to pop up between then and now was the company news from January 5th: Mainz Biomed Acquires Exclusive Rights to Novel mRNA Biomarkers

Could today's news act as another catapult catalyst like that January 5th announcement did previously?

I've updated some of my initial report below with more current figures, so take a second now to read it and then get MYNZ on your radar quickly.

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Mainz BioMed (NASDAQ: MYNZ) requires your immediate attention now. Here's why...

Cancer screening. None of us want to go through it, but make no doubt about it... It can be a life saver.

That said, with it comes the potential for a giant market.

Colorectal cancer is the 2nd most lethal cancer in the US, but also highly preventable; with early detection providing 5-year survival rates above 90%. (1)

Recent FDA decisions suggest that screening should be conducted once every three years starting at age 45.

Currently, there are 112 Million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. (1)

To dive in a little deeper, check out these stats: (1)

  • 19 million Colonoscopies each year in USA
  • ~38.8% Age 50 to 75 have never been screened (in USA)
  • $3.7Bn Market Opportunity
  • 52,980 Expected deaths in US, 2021

Like I said, potential for a giant market.

Patients with cancers and other conditions are living longer and enjoying better health because of medical revolutions in diagnostic technology.

At its center are genetic and genomic tests that identify the unique genetic profile of individual patients or their disease and allow physicians to tailor treatment to those unique characteristics.

*Mainz BioMed (NASDAQ: MYNZ)* develops market-ready molecular genetic diagnostic solutions for life-threatening conditions.

Mainz Biomed is located just west of Frankfurt in a world-renowned community for advanced DNA & Pharmaceutical research, including the home of vaccine maker BioNTech SE.

The company has historical research & development collaborations with major universities, laboratories and governments across Europe.

MYNZ's Flagship Product - ColoAlert (2)

ColoAlert detects tumors better than the standard test (FIT)

  • Higher patient acceptance than FIT test.
  • Accurate, non-invasive, simple, safe diagnostic solution to increase patient compliance.
  • Proposed partnerships with clinical labs aims to speed test collection & results
  • Designed to offer significant advantages compared to our major competitors

- Colorectal Cancer is the #2 leading killer (men & women combined)

- 52,980 deaths due to CRC in USA (2021)

- 5-year survival rate >90% (If detected at stage A).

How does ColoAlert work?

Early detection of colorectal cancer through tumor DNA analysis

Colorectal cancer originates from the genetic mutation of intestinal cells. These are continuously excreted through the stool and can be examined for tumor DNA using modern genetic diagnostic methods. ColoAlert analyzes samples for the following tumor markers:

  • KRAS-mutation
  • BRAF-mutation
  • total amount of human DNA
  • occult blood

These tumor markers can be associated with the occurrence of cancer.

How precise is ColoAlert?

Clinical studies confirm the advantages of tumor DNA analysis

In a multicentric study, a total of 566 patients were examined simultaneously using the occult blood test, M2-PK test and ColoAlert. All methods were also compared with the colonoscopy.

With a sensitivity of 85% and a specificity of 92%, ColoAlert showed the most accurate test results among the non-invasive screening methods.

Read the publication here.

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Major Market Opportunity #2 - Commercial Pipeline Development – Future Product PancAlert (2)

  • As GenX individuals age into their 40's and 50's they become part of the age group recommended to begin testing for CRC and more.
  • Mainz BioMed is currently developing proprietary genetic testing methods for pancreatic cancer.
  • Fighting what could soon become the world’s second most deadly cancer.
  • Convenient stool test for at-home use.
  • Potential for over 50 million tests per year in Europe alone.
  • Supported by federal grant from Germany’s Federal Ministry for Education and Research.
  • Cost of goods sold (COGS) & reimbursement analogous to ColoAlert program.

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And right now, due to several potential catalysts, MYNZ should hold the top spot on your watch-list. Here's what you need to know...

No. 1 MYNZ Potential Catalyst - Low Float Profile

According to the Yahoo Finance website, MYNZ has a low float.

The website reports this profile to have approximately 12.01Mn outstanding shares total.

Why is that important? It's important on one crucial level. Volatility.

With so few shares available for trading, other potential catalysts (like big news) could spark a vertical move in the short-term.

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No. 2 MYNZ Potential Catalyst - Multiple Oversold Leaning Technicals

As of close on Thursday, Barchart was reporting this profile to have several oversold leaning technicals.

These technicals could be signaling that MYNZ is undervalued at the moment.

Here is a quick list of key technicals (as of close Thursday) that could signal MYNZ to be leaning oversold and packing a ton of upside potential towards recent highs.

  • 9-Day Relative Strength Index:
  • 14-Day Relative Strength Index:

When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.

Keep an eye on these technicals closely.

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No. 3 MYNZ Potential Catalyst - Engaging A Leading Global Clinical Research Organization

Mainz Biomed Establishes Partnership with Precision for Medicine to Support ColoAlert’s U.S. Regulatory and Commercial Strategy

BERKELEY, Calif. and MAINZ, Germany, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics company specializing in the early detection of cancer, announced today the Company has engaged Precision for Medicine, a leading global Clinical Research Organization, to provide U.S. regulatory and reimbursement advisory support for ColoAlert, Mainz’s highly efficacious and easy-to-use diagnostic test for colorectal cancer.

As an emerging commercial stage company with a portfolio of non-invasive, highly efficacious diagnostics for detection of early-stage cancer indications in development, we are mindful of the need to operate a streamlined corporate and clinical organization,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “I’m extremely pleased to partner with Precision for Medicine as they provide premier and comprehensive solutions that can help ensure ColoAlert is well positioned to achieve FDA regulatory approval, and acceptance by the Centers for Medicare and Medicaid (CMS) for reimbursement, which is of course, essential for gaining commercial traction.

Precision for Medicine will work with Mainz’s management team to develop and implement a U.S. focused regulatory and market access strategy for ColoAlert, the Company’s unique, life-saving early detection test for colorectal cancer (CRC). This will include assistance in drafting ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. Inherent to this exercise will be the integration of CMS guidelines, utilizing currently marketed CRC screening tests as benchmarks to provide ColoAlert with an optimal product profile for regulatory approval and success in the marketplace. Along the way, Precision for Medicine will advise Mainz throughout its interaction with the FDA’s pre-submission protocol.

Read the full article here.

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No. 4 MYNZ Potential Catalyst - Recent Hire Could Add Significant Value To Company

Mainz Biomed Appoints Dr. Soren Thestrup-Nielsen M.D. to Strategic Advisory Board

  • Former Danaher executive provides significant clinical, global market, and product development expertise in cancer diagnostics

BERKELEY, Calif. and MAINZ, Germany, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Dr. Soren Thestrup-Nielsen M.D. to its Strategic Advisory Board.

It’s a pleasure to welcome Soren to our newly formed Strategic Advisory Board as he brings us tremendous leadership in all aspects of a product’s life cycle,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “All of us at the company are excited to work with Soren as we embark on ColoAlert’s commercial roll-out across Europe and develop the regulatory and clinical strategy for the U.S. market.

Dr. Thestrup-Nielsen has spent over 25 years in the medical device industry, first at Boston Scientific and later at Danaher Corporation where he led the inorganic growth of Danaher’s acute care and laboratory diagnostics portfolio. He has previously held a series of notable executive roles including Chairman of Althea Group, as well as board member at numerous companies including lung cancer screening company Oncimmune. During his career Dr. Thestrup-Nielsen has overseen IPO’s, trade-sales, acquisitions, and a variety of investment transactions with medical companies in both North America and Europe. He received a M.D. from the University of Copenhagen, School of Medicine, practiced 5 years as a general & vascular surgeon, and received an MBA from the IMD in Lausanne, Switzerland.

In his advisory role with Mainz Biomed, Dr. Thestrup-Nielsen will take an active role in the development of the Company product strategy for Europe, the United States, and the rest of the world, to include clinical development, market segmentation, go-to-market strategy, and regulatory strategy. He will also provide expert counsel on the development of the global commercial strategy, the development of the clinical strategy for future iterations of Mainz Biomed’s ColoAlert test and lead the clinical advisors board once established.

Read the full article here.

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No. 5 MYNZ Potential Catalyst - Joining The Nasdaq Capital Market

Mainz Biomed Commences Trading on Nasdaq Under Ticker Symbol ‘MYNZ’

  • Flagship product ‘ColoAlert’ provides a unique, life-saving early detection test for colorectal cancer
  • European registration completed and commercial rollout underway across multiple territories
  • FDA clinical study process to be launched for U.S. regulatory approval

BERKELEY, Calif. and MAINZ, Germany, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce the Company’s ordinary shares have commenced trading on The Nasdaq Capital Market (the “Nasdaq”) under the ticker symbol “MYNZ”.

Transitioning to the public markets via a Nasdaq listing is an important milestone for the Company, as it provides a platform to facilitate growth, and to ultimately execute on our mission to become a leader in developing next generation early detection diagnostics for multiple cancer indications,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We are excited to ramp-up commercial activities across Europe for ColoAlert and look forward to commencing U.S. clinical and regulatory activities for this cost-effective, highly efficacious, and easy-to-use detection test for colorectal cancer.

Read the full article here.

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Nasdaq Profile Recap: Key MYNZ Potential Catalysts To Know Now

No. 1 - Low Float Profile

No. 2 - Multiple Oversold Leaning Technicals

No. 3 - Engaging A Leading Global Clinical Research Organization

No. 4 - Recent Hire Could Add Significant Value To Company

No. 5 - Joining The Nasdaq Capital Market

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Coverage is officially reinitiated on MYNZ. When you have time later, do this:

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Get MYNZ on your radar now.

Sincerely,

Axel Adams

Editor, SCF


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(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)​

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