Mainz BioMed NV (MYNZ) Quote

Is there a projected target price on this?

MYNZ......................https://stockcharts.com/h-sc/ui?s=MYNZ&p=W&b=5&g=0&id=p86431144783

submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.
The regulatory submission follows consistently excellent read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO 2024. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the Company plans to use in its Next Generation product, and the FDA premarket approval study.

The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.

Key Findings

Sensitivity for Colorectal Cancer: 97% (95% confidence interval: 83.3-99.9)
Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence interval: 77.2-94.5)
Specificity: 93% (95% confidence interval: 88.4-98.3)
Guido Baechler, Chief Executive Officer at Mainz Biomed, commented, “On the back of our extremely positive clinical results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our Company. Our Next Generation Test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and specificity for CRC. Moreover, we believe that our unique decentralized model of working with third party laboratory partners provides better access to underserved communities and our simple collection process will increase the adherence to testing. These benefits support our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”

The FDA’s Breakthrough Devices Designation is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to allow patients and health care providers timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ or subscribe to our news alert to keep up to date on our pivotal FDA PMA clinical trial ReconAAsense and further corporate news.

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About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market oppo

MYNZ .68 + 40%

MYNZ new 52 week low

MYNZ new 52+ low

MYNZ new 52 week low

MYNZ under $2

MYNZ under $2

MYNZ new 52 week low

Looking for strong upside for this stock in the March-June 2024 timeliness. Should be aver 3.00 imo

here comes the eod run up after the little dip there.

weeeeeee!

grabbed some this morning at 3.89.

Still stable

That cat bounced. Poped back over $4.

Watching for the dead cat bounce.

$MYNZ Mainz Biomed Provides Full Year 2022 Financial Results

ColoAlert Revenue Increases 130% Year over Year

Year End Cash Balance of $17.1 Million

BERKELEY, Calif. and MAINZ, Germany, April 10, 2023 (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 financial results for the fiscal year ended December 31, 2022.

This Could Send Mainz Biomed (MYNZ) Soaring Past Wainwright’s $25 Target https://smallcapexclusive.com/this-could-send-mainz-biomed-mynz-soaring-past-wainwrights-25-target/

$MYNZ Analysts Model Over 74% Upside For Mainz Biomed Stock Ahead Of Key 1/H 2023 Updates https://www.benzinga.com/pressreleases/23/03/ab31469781/analysts-model-over-74-upside-for-mainz-biomed-stock-ahead-of-key-1h-2023-updates-mynz

But some... heering fda approval rumbles here.

$MYNZ Mainz Biomed Announces Partnership with Labor Staber to Expand ColoAlert Commercialization in Germany

BERKELEY, Calif. and MAINZ, Germany, March 15, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a partnership with Dr Staber & Kollegen GmbH (Labor Staber) as part of its growing network of laboratories offering ColoAlert, its flagship product that is a highly efficacious and easy-to-use at-home screening test for colorectal cancer (CRC). For more than 35 years, Labor Staber has been providing physicians and hospitals with medical laboratory services at nine locations across Germany.

Read for release: https://finance.yahoo.com/news/mainz-biomed-announces-partnership-labor-070100006.html

$MYNZ Mainz Biomed Nears Multiple Data Set Releases Expected To Fuel 2023 Growth

Mainz Biomed's share price weakness presents an opportunity to trade ahead of potential near-term catalysts. Shares dropped on Monday, possibly in sympathy with the Silicon Valley Bankfiasco. However, while MYNZ does list a Berkeley, California connection on its byline, this company is primarily based in Germany. Thus, financial exposure, if any, is more of a distraction than an MYNZ-specific event. Moreover, its significance is outweighed by the planned data releases expected over the next 90 days.

Read full release:

$MYNZ Mainz Biomed Launches Number of Educational Events in Germany to Raise Awareness for CRC Screening and Early Detection

https://finance.yahoo.com/news/mainz-biomed-launches-number-educational-080100640.html

Mainz Biomed 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. https://www.benzinga.com/pressreleases/23/02/ab31084658/mainz-biomeds-milestones-reached-in-2022-can-be-catalysts-in-1h-2023-heres-why-mynz

Very,very low float !!!!

If it ever comes !!!!!

MYNZ excellent NEWS OUT >>>>>>>>>> Looks like big time coming. Loaded some shares for 10 X potential for 2023/24 imho...

https://www.globenewswire.com/news-release/2022/12/06/2567955/0/en/Mainz-Biomed-Announces-IRB-Approval-and-Initiation-of-US-Pivotal-FDA-Clinical-Study.html


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FDA approval in USA will blow this up to 30-40. Market cap 140M

Outstanding 14 M
25% insider owned.

Long term winner

“The Company is financially well positioned to maintain momentum as ColoAlert continues to gain impressive commercial traction across Europe and select international territories, and as we ramp up to launch its U.S. pivotal clinical trial by the end of the year.”
- Guido Baechler, Chief Executive Officer of Mainz Biomed, $MYNZ

$MYNZ trading at the high of the day.

ColoAlert - The Company’s Flagship Product (ColoAlert) Could Become An Inexpensive Alternative In A $3.7 Billion Market? $MYNZ
https://investorbrandmedia.com/mynz-stock-alert/

Yes, $MYNZ had an amazing day yesterday... a continuation would be awesome.

Yesterday was a great day, let’s see if we can hold that trend today!!

$MYNZ - Mainz Biomed Strengthens Board of Directors...
*Dr. Dreismann, Former Roche Molecular Diagnostics CEO
*Over 35 years of experience in the life sciences and health care industries
*Mr. Tibbitts, a Highly-accomplished Life-Sciences Executive
*Certified Public Accountant with over 30 years of professional experience as a senior financial executive
*Together provide Extensive Experience in Diagnostics and Financial Strategy
https://finance.yahoo.com/news/mainz-biomed-strengthens-board-directors-110000523.html

Don't forget about this...$MYNZ - Another Value-Creating Asset, PancAlert...
*Advancing a second portfolio asset
*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.
*Accurate real-time results
*Can be a first and best-in-class screening for pancreatic cancer
https://www.marketwatch.com/press-release/mainz-biomed-targets-multi-billion-dollar-sales-opportunities-with-best-in-class-cancer-screening-diagnostics-mynz-2022-09-26

$MYNZ coming up on 2x its 10-day average volume as we head into Power Hour... let's rock!

Bids increasing, heating up here!

$MYNZ

$MYNZ $25.8 million (gross) in new capital, having less than $1 million in long-term debt, and generating revenues from an early cancer detection diagnostics portfolio.

Should see $8 in power Hour again... $MYNZ

$MYNZ breakout! $8.01 hit and it's consolidating around $7.50... Power Hour should be interesting.

7.65 not much on the ask now, $8's coming!

$MYNZ

$MYNZ 7.65 up now, something brewing here!

WOWZA, really nice volume as $MYNZ now trading nearly 60% over its 10-day average volume with about 3 hours still left in the day... UP almost 2%.

Definitely picking up now

$MYNZ now trading nearly 10% over its 10-day average volume in lunchtime... Still holding steady.

$MYNZ hot sector here:

Nice premarket volume and it's continuing into the open...might break its 10-day average volume within the first hour.

Wow, great News this morning! $MYNZ trading nearly 70% of its 10-day average volume within the first 30 minutes...and holding steady near yesterday's close.

Looks ready for new highs on the week, ask is super thin now!

$MYNZ

Nice pre market volume