Mainz Biomed Provides First Quarter 2025 Corporate Update and Path to FDA Premarket Approval

Rhea-AI Summary

Mainz Biomed (NASDAQ: MYNZ) has provided its Q1 2025 corporate update, highlighting significant progress in its colorectal cancer (CRC) screening initiatives. The company enrolled its first patient in the eAArly DETECT 2 feasibility study, which will evaluate their next-generation CRC test incorporating mRNA biomarkers, AI algorithms, and FIT testing across 2,000 average-risk patients.

Key developments include a license agreement with Liquid Biosciences for pancreatic cancer biomarkers showing 95% sensitivity and 98% specificity, and a strategic partnership with labor team w ag to introduce ColoAlert® in Switzerland. Additionally, GANZIMMUN Diagnostics launched an enhanced version of ColoAlert across Germany in January 2025.

The company has regained full compliance with Nasdaq listing requirements, including minimum stockholders' equity and bid price requirements.

Positive

• First patient enrolled in eAArly DETECT 2 study, keeping timeline for end-2025 results
• Licensed pancreatic cancer biomarkers with 95% sensitivity and 98% specificity
• Expanded market presence with first entry into Swiss market via labor team w ag partnership
• Regained full Nasdaq listing compliance
• Successfully launched enhanced ColoAlert test in Germany

Negative

• None.

Insights

Medical Diagnostics Expert

Mainz Biomed advances colorectal cancer screening with feasibility study progress, impressive pancreatic biomarkers, and commercial expansion in European markets.

Mainz Biomed has reached a significant clinical milestone with the enrollment of its first patient in the eAArly DETECT 2 feasibility study, which remains on schedule to report top-line results by the end of 2025. This study will evaluate the company's next-generation colorectal cancer (CRC) test in approximately 2,000 average-risk patients, integrating proprietary mRNA biomarkers with an AI-developed algorithm and FIT testing. The successful completion of this study is designed to support the transition to the company's pivotal FDA study called ReconAAsense.

The company has also expanded its cancer detection portfolio through a license and option agreement with Liquid Biosciences for novel mRNA biomarkers targeting pancreatic cancer detection via blood test. The independent validation results for this technology are particularly notable, showing 95% sensitivity and 98% specificity. These metrics represent exceptional performance parameters for pancreatic cancer, which has historically been challenging to detect in early stages.

On the commercial front, Mainz has established two important European market expansions. The partnership with labor team w ag introduces ColoAlert to Switzerland, where thousands of new CRC cases are diagnosed annually. Additionally, GANZIMMUN Diagnostics has launched the enhanced ColoAlert CRC screening test in Germany as of January 2025. These commercial deployments demonstrate the practical application of the company's DNA-based approach to colorectal cancer screening, which offers potential advantages over traditional screening methods by potentially increasing participation rates and improving early detection capabilities.

Healthcare Financial Analyst

Strategic execution through clinical advancement, market expansion, and renewed Nasdaq compliance strengthens Mainz Biomed's position in the cancer diagnostics sector.

Mainz Biomed's Q1 2025 update showcases methodical execution of its regulatory pathway for colorectal cancer screening. The initiation of patient enrollment in the eAArly DETECT 2 feasibility study represents a critical step toward the company's FDA approval strategy. By maintaining their timeline to deliver top-line results by end-2025, management demonstrates operational discipline in executing their clinical development plan, with the pivotal ReconAAsense study scheduled to begin enrollment shortly after these results.

The company has strategically expanded its product portfolio through the Liquid Biosciences agreement, securing access to pancreatic cancer biomarkers with impressive preliminary validation metrics. This move diversifies their cancer detection capabilities beyond colorectal cancer, addressing another high-mortality cancer with significant unmet medical needs.

Mainz has also strengthened its commercial foundation through two European market initiatives. The Swiss market entry via labor team w ag partnership marks the company's first presence in Switzerland, while the enhanced ColoAlert test launch through GANZIMMUN Diagnostics expands their footprint in Germany. These commercial activities establish concrete market presence while the company pursues its longer-term FDA strategy.

Perhaps most significant for near-term investor confidence is Mainz's successful resolution of Nasdaq compliance issues. The company has regained full compliance with both the minimum stockholders' equity requirement and the minimum bid price requirement. This regulatory milestone removes a significant overhang and stabilizes the company's market position, potentially broadening its appeal to institutional investors who may have been restricted from positions in non-compliant companies.

BERKELEY, Calif., April 28, 2025 (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, today reviewed its major accomplishments of the first quarter of 2025, and provided an outlook on its path to FDA premarket approval.  

During the first quarter of 2025:

• Path to FDA premarket approval: The Company enrolled the first patient into its feasibility study eAArly DETECT 2, which evaluates the Mainz Biomed’s next-generation colorectal cancer (CRC) test, integrating a portfolio of proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test. The study is expected to include a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to prevention. The inclusion of the first patient keeps the Company on schedule to report top-line results by the end of 2025.
• Mainz Biomed signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity.
• The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert^®, a DNA-based CRC screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland. In Switzerland, thousands of new cases are diagnosed annually, underscoring the urgent need for early detection and prevention. The introduction of a DNA-based CRC screening test offers a transformative opportunity to increase participation rates and ensure early detection, aligning with national efforts to reduce CRC-related mortality and improve population health outcomes.
• Mainz Biomed announced that GANZIMMUN Diagnostics has officially launched the enhanced ColoAlert CRC screening test. Since January 2025, patients across Germany can access this new version of the Company’s screening test. The announcement was made in conjunction with Colorectal Cancer Awareness Month in March.
• On January 23, 2025, the Company received formal notice from Nasdaq confirming that it had regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now in full compliance with all Nasdaq continued listing requirements.
  

“I’m extremely pleased with the progress achieved during the first quarter of 2025 as we execute our strategy driven by our excellent clinical results in three studies published during 2024,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Our eAArly DETECT 2 study, scheduled to report results by the end of 2025, is essential to move rapidly to the beginning of enrollment for our pivotal U.S. FDA study ReconAAsense shortly thereafter.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert^®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert^® is marketed across Europe. The Company is currently running a development study to finalize with the next gen CRC screening test as preparation for the pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke / Maximilian Schur
+49 211 529252 17
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; and (iii) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

FAQ

What are the key features of Mainz Biomed's eAArly DETECT 2 study for MYNZ's CRC screening test?

The study will evaluate a next-generation CRC test combining mRNA biomarkers, AI algorithms, and FIT testing across 2,000 average-risk patients, with top-line results expected by end of 2025.

What accuracy rates did MYNZ's pancreatic cancer biomarkers achieve in validation testing?

The algorithm-biomarker combination showed 95% sensitivity and 98% specificity in independent validation testing.

When did Mainz Biomed (MYNZ) launch its enhanced ColoAlert test in Germany?

The enhanced ColoAlert CRC screening test was launched by GANZIMMUN Diagnostics across Germany in January 2025.

How has Mainz Biomed (MYNZ) addressed its Nasdaq listing compliance issues?

As of January 23, 2025, MYNZ regained full compliance with all Nasdaq listing requirements, including minimum stockholders' equity and bid price requirements.