Executive Summary / Key Takeaways

• Mainz Biomed is a molecular genetics diagnostic company at the forefront of non-invasive cancer screening, with its flagship ColoAlert test for colorectal cancer and the promising PancAlert for pancreatic cancer. The company's investment thesis centers on the successful commercialization and regulatory approval of these advanced diagnostic solutions.
• ColoAlert, already marketed in Europe and the UAE, is progressing towards a pivotal U.S. FDA study, ReconAAsense, in 2026, following the expected completion of the eAArly DETECT 2 feasibility study by the end of 2025. Recent regulatory approvals in the UK and Switzerland, alongside strategic partnerships in Germany, underscore its expanding market footprint.
• The PancAlert project, a blood-based screening test for pancreatic cancer, has demonstrated compelling early-stage results with 95% sensitivity and 98% specificity in discovery analysis. Public funding from the German state of Rheinland-Pfalz supports its accelerated development, targeting a critical unmet need in oncology.
• Financially, Mainz Biomed is an early-stage growth company characterized by significant R&D investments and operational losses, with a TTM net income of -$21.65 million on revenues of $893,991. The company relies on capital raises, such as the recent $3.0 million offering in August 2025, to fund its ambitious development and market expansion strategies.
• Mainz Biomed's competitive edge lies in its proprietary PCR-based molecular genetic technology and strategic collaborations, positioning it as an innovator against larger, more established players in the rapidly evolving cancer diagnostics market.

A New Era in Cancer Diagnostics: Mainz Biomed's Vision

Mainz Biomed N.V. (NASDAQ:MYNZ), founded in 2008 in Mainz, Germany, is carving out a significant niche in the global healthcare sector by specializing in in-vitro diagnostic (IVD) tests for the early detection of life-threatening cancers. The company's core mission addresses a critical global health challenge: improving patient outcomes through earlier and more accessible cancer screening. This focus is particularly pertinent in the colorectal cancer (CRC) and pancreatic cancer markets, which are undergoing a transformative shift towards non-invasive, molecular diagnostics. The global colorectal cancer screening market, valued at approximately $15.5 billion in 2024, is projected to reach $31.1 billion by 2034, growing at a compound annual growth rate (CAGR) of 7.2% from 2025 to 2034. Similarly, the pancreatic cancer diagnostic market, estimated at $2.5 billion in 2024, is expected to grow to $5 billion by 2034, also at a CAGR of 7.2%.

Mainz Biomed's overarching strategy is to develop and commercialize highly accurate, user-friendly, and non-invasive diagnostic solutions. This strategy is built upon a foundation of proprietary molecular genetic technology and is executed through a combination of direct operations, strategic partnerships, and a focused regulatory pathway, particularly for the lucrative U.S. market. The company's journey has been marked by a commitment to innovation, aiming to fill critical gaps where current screening tools are limited or participation rates are low.

Technological Edge: Precision Through Molecular Genetics

At the heart of Mainz Biomed's investment thesis lies its differentiated technology, primarily embodied in its flagship product, ColoAlert, and its promising pipeline candidate, PancAlert. These tests leverage advanced molecular genetics to offer non-invasive and highly accurate early cancer detection.

ColoAlert, an early-detection diagnostic test for colorectal cancer, utilizes real-time Polymerase Chain Reaction (PCR)-based multiplex detection of molecular-genetic biomarkers in stool samples. This technology is designed to detect DNA biomarkers, providing an accurate, non-invasive, and easy-to-use screening solution. A key benefit of ColoAlert is its ability to "increase the detection rate, particularly in the early stages of the disease" when compared to traditional fecal immunochemical tests (FIT). This enhanced detection capability is crucial, as early diagnosis significantly improves treatment outcomes for colorectal cancer. The test also aims to complement existing screening programs by offering an "additional, accessible option that could help increase participation" in preventive screening. Recent enhancements to ColoAlert include a novel DNA stabilizing buffer that reduces the need for additional sample submissions, leading to industry-low retesting rates and results delivered within 2-3 days of laboratory arrival.

Beyond colorectal cancer, Mainz Biomed is making strides with PancAlert, an early-stage pancreatic cancer screening test. While initially described as stool-based, recent developments indicate a strategic shift towards a non-invasive, blood-based screening test. The PancAlert project employs a panel of mRNA biomarkers and a machine learning (ML)-driven algorithm. Discovery-phase results, conducted in partnership with Liquid Biosciences, demonstrated exceptional accuracy, achieving 95% sensitivity and 98% specificity for the detection of pancreatic cancer in blood samples. These metrics represent a significant leap over current diagnostic methods, which often lack the precision for early-stage detection of pancreatic cancer, a disease known for its grim prognosis due to late diagnosis. The company is currently in a feasibility phase with Crown Bioscience to verify the performance of this biomarker panel and algorithm using real clinical blood samples.

For investors, these technological differentiators are critical. They form the basis of Mainz Biomed's competitive moat, enabling the company to offer superior diagnostic performance in areas of high unmet medical need. The potential for earlier and more accurate detection translates into improved patient outcomes, which can drive market adoption, higher average selling prices (ASPs), and ultimately, robust revenue growth and profitability in niche markets. The ongoing R&D initiatives, particularly the progression of PancAlert and the next-generation ColoAlert, underscore a strategic roadmap aimed at sustained innovation and market leadership.

Strategic Expansion and Regulatory Milestones

Mainz Biomed has aggressively pursued a multi-pronged strategy to expand the market reach of ColoAlert and advance its pipeline. The test is currently marketed across Europe and the United Arab Emirates. Recent regulatory successes include the official registration of ColoAlert with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in September 2025, authorizing its marketing across the country. This follows a technology partnership with EDX Medical Group plc, a UK laboratory, aimed at broad accessibility. In August 2025, ColoAlert also received official registration and approval for distribution by Swissmedic, the Swiss regulatory authority, facilitated by a partnership with labor team w ag. These European market entries are crucial, especially given that the European in-vitro colorectal cancer screening tests market generated $306.0 million in revenue in 2023 and is expected to grow at a CAGR of 3.2% from 2024 to 2030.

In Germany, Mainz Biomed entered a cooperation agreement with CARE diagnostica Laborreagenzien GmbH in July 2025 to expand ColoAlert's distribution, leveraging CARE's existing relationships with over 15 statutory health insurance companies. This collaboration aims to integrate ColoAlert's molecular genetic analysis into personalized screening concepts, enhancing detection rates, particularly in early disease stages.

The most significant strategic initiative for long-term growth is the pathway to U.S. FDA approval for ColoAlert. The company is currently running the eAArly DETECT 2 feasibility study, with results expected by the end of 2025. This study is a critical precursor to the ReconAAsense US FDA pivotal colorectal cancer study, which is slated to begin enrollment in 2026 and will involve approximately 15,000 subjects across 150 sites in the United States. A collaboration agreement with Thermo Fisher Scientific Inc. (TMO) for the development and commercialization of a next-generation colorectal cancer screening product further strengthens this pathway, providing access to advanced technologies and infrastructure. Additionally, Mainz Biomed has partnered with Quest Diagnostics (DGX) to support the commercialization and FDA validation of ColoAlert, with Quest providing clinical trial laboratory services for the ReconAAsense study.

The PancAlert project has also seen strategic advancements, securing public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB) in June 2025, with the state funding up to 50% of the total project costs. This governmental support underscores the scientific and societal value of the non-invasive pancreatic cancer screening test and is expected to accelerate its development. Subject to the successful outcome of the feasibility phase, Mainz Biomed intends to proceed with a larger validation study, a crucial step towards optimizing the test for clinical utility and preparing for a potential FDA submission.

Navigating the Competitive Landscape

Mainz Biomed operates in a highly competitive and rapidly evolving cancer diagnostics market. Its primary direct competitors include established players like Exact Sciences (EXAS), Guardant Health , and Illumina , each with distinct strengths and market positioning.

Mainz Biomed's ColoAlert directly competes with Exact Sciences' Cologuard in the colorectal cancer screening segment. While Cologuard has a well-established brand and broad distribution in the U.S., Mainz Biomed's molecular genetic approach with ColoAlert emphasizes potentially greater accuracy, particularly in detecting early-stage disease. This technological differentiation could provide a competitive edge in capturing market share, especially as demand for more precise non-invasive tests grows.

In the broader cancer screening and precision oncology space, Guardant Health (GH) is a leader in liquid biopsy tests. While Guardant Health's Guardant360 and Guardant Reveal offer comprehensive genomic profiling and multi-cancer screening, Mainz Biomed's PancAlert is specifically focused on addressing the acute unmet need for early pancreatic cancer detection. PancAlert's reported 95% sensitivity and 98% specificity in discovery trials for blood samples position it as a potentially superior tool for this specific indication, where current imaging and biomarker-based methods often lack precision. Guardant Health's recent upgrade to Guardant360, covering over 10 times more genes and quantifying tumor burden with 10 times higher sensitivity, highlights the intense innovation in this space. However, PancAlert's targeted approach and promising early data could allow Mainz Biomed to establish leadership in a market with minimal direct competition for early-stage pancreatic cancer screening.

Illumina (ILMN) dominates the genomic sequencing market, providing tools and services that underpin much of the advanced genetic testing. While Illumina's platforms offer broad applications, Mainz Biomed's strategy is to develop streamlined, user-friendly IVD products for specific clinical diagnostic needs. This specialization allows Mainz Biomed to potentially offer greater accessibility for smaller healthcare providers and focus its R&D on targeted, high-impact solutions.

Mainz Biomed's competitive advantages, or "moats," include its proprietary molecular genetic technology, which offers enhanced specificity in biomarker identification, and its growing portfolio of regulatory licenses in Europe. These factors contribute to stronger customer loyalty through reliable screening and potentially superior margins from efficient R&D processes. However, Mainz Biomed faces vulnerabilities due to its smaller scale, which can lead to higher operational costs and slower product development cycles compared to its larger, more financially robust competitors. The company's ability to scale its operations and maintain a rapid pace of innovation will be critical in sustaining its competitive position.

Financial Performance: Investment in Growth

As an early-stage molecular diagnostics company heavily invested in research and development, Mainz Biomed's financial profile reflects its growth-oriented strategy. For the trailing twelve months (TTM) as of September 23, 2025, the company reported total revenue of $893,991. While revenue from its lab partner network increased by 33% year-over-year in 2024, this was offset by a decrease in direct-to-consumer sales, resulting in an overall revenue decrease of 0.17% in 2024 compared to 2023.

The company's profitability metrics highlight the significant investments required for product development and market expansion. Mainz Biomed reported a TTM gross profit of $574,883, translating to a gross profit margin of 64.31%. However, substantial operating expenses led to a TTM operating profit margin of -2091.23% and a net profit margin of -2421.80%, with a TTM net income of -$21.65 million. The loss from operations and net loss decreased by 30% and 18% respectively in 2024, reflecting cost-cutting efforts.

Cash flow generation remains a challenge, with TTM operating cash flow at -$17.09 million and free cash flow at -$17.34 million. This negative cash flow profile is typical for biotech companies in the R&D and early commercialization phases. To fund its operations and strategic initiatives, Mainz Biomed has actively raised capital. In August 2025, the company completed a follow-on offering, generating approximately $3.00 million in gross proceeds from the sale of 2.22 million pre-funded units, each consisting of one pre-funded warrant and one and one-half ordinary warrants. This followed a $4.0 million follow-on offering in May 2025. These capital raises are essential for sustaining the company's extensive clinical studies and market expansion efforts.

As of the latest available data, Mainz Biomed holds $6.24 million in total cash and has $3.27 million in total debt, resulting in a debt-to-equity ratio of 0.54. The current ratio stands at 1.32, indicating moderate liquidity. However, the company's financial health grades highlight risks such as high leverage and a significantly negative Altman Z-Score of -11.67, which places it in a distress zone, implying a high risk of bankruptcy within the next two years. This underscores the critical need for continued capital raises and successful commercialization to achieve financial sustainability.

Outlook and Risks

Mainz Biomed's outlook is heavily tied to the successful execution of its clinical development programs and market expansion strategies. The completion of the eAArly DETECT 2 feasibility study by the end of 2025 and the subsequent initiation of the ReconAAsense pivotal FDA study in 2026 are crucial milestones for U.S. market entry for ColoAlert. Positive results from these studies could significantly de-risk the investment thesis and unlock substantial revenue opportunities in the large U.S. colorectal cancer screening market, which is projected to reach $17.53 billion by 2032.

For PancAlert, the successful completion of the feasibility phase and progression to a larger validation study are key indicators of its potential to address a significant unmet medical need. Public funding for PancAlert accelerates its development, and a potential FDA submission could establish Mainz Biomed as a leader in early pancreatic cancer detection.

However, the investment carries notable risks. The failure to meet projected development and related targets for both ColoAlert and PancAlert could severely impact the company's future prospects. Changes in applicable laws or regulations, particularly regarding diagnostic test approvals and reimbursement, pose ongoing challenges. The highly competitive nature of the diagnostics market, coupled with the company's smaller scale and ongoing financial losses, means that Mainz Biomed must continually innovate and execute flawlessly to gain and maintain market share. The need for continuous capital raises to fund operations and R&D also presents a risk of further shareholder dilution.

Conclusion

Mainz Biomed stands at a pivotal juncture, poised to capitalize on the growing demand for non-invasive, molecular cancer diagnostics. Its proprietary ColoAlert and PancAlert technologies represent significant advancements in early detection, offering the potential for improved patient outcomes and substantial market opportunities in colorectal and pancreatic cancer screening. The strategic expansion into key European markets and the clear pathway towards U.S. FDA approval for ColoAlert, supported by robust clinical studies and strategic partnerships, underscore the company's ambitious growth trajectory.

While Mainz Biomed's innovative product pipeline and market potential are compelling, investors must weigh these against the inherent risks of an early-stage biotech company. The current financial profile, characterized by significant R&D expenditures and operational losses, necessitates ongoing capital raises. The successful execution of its clinical programs, favorable regulatory outcomes, and effective commercialization will be paramount in transforming its technological leadership into sustainable financial performance and securing its position as a key player in the future of cancer diagnostics.