1. A competitor to Exact Sciences (makers of Cologuard) in the non-invasive, at-home colorectal cancer screening market.

2. Like a specialized version of Exact Sciences, singularly focused on developing innovative at-home tests for early cancer detection, starting with colorectal cancer.

• ColoAlert (PrazisionDx): This is a highly accurate, non-invasive molecular diagnostic test for the early detection of colorectal cancer, analyzing DNA biomarkers and occult blood in stool samples.

Guido Baechler, Chief Executive Officer and Executive Director

Guido Baechler has over 30 years of global experience in the life science and diagnostics industries. He was appointed CEO of Mainz Biomed in July 2021. Mr. Baechler founded Berkeley Life Science Advisors in 2019, a consulting firm providing strategic counsel to life science companies. He served as CEO of SummerBio from 2020 to 2021, a high-throughput COVID testing laboratory. Previously, he was President and CEO of Singulex, Inc. from 2013 to 2019, an immunodiagnostics company, where he successfully raised over $180 million through multiple financings. Earlier in his career, he held various executive and leadership roles at Roche Molecular Systems from 1996 to 2008.

William Caragol, Chief Financial Officer and Senior Vice President

William Caragol brings 30 years of experience working with growth-stage technology companies. He currently serves as a Director and Compensation Committee Chair at Worksport (NASDAQ: WKSP) and a Director and Audit Committee Chair at Janover (NASDAQ: JNVR). Mr. Caragol is also the Board Chair of Thermomedics, Inc., a privately held medical diagnostic equipment company. He is a member of the American Institute of Certified Public Accountants.

Dr. Christopher Von Toerne P.M.P., Ph.D., Chief Operating Officer

Dr. Christopher Von Toerne serves as the Chief Operating Officer of Mainz Biomed.

The emergence of highly accurate, blood-based colorectal cancer screening tests from well-capitalized competitors poses a clear emerging threat to Mainz Biomed. Specifically, Guardant Health's Shield blood test for colorectal cancer screening has shown promising clinical trial results (e.g., the ECLIPSE study results announced in May 2024) demonstrating competitive accuracy. This test offers a significant convenience advantage through a simple blood draw compared to Mainz Biomed's stool-based ColoAlert, which could lead to greater patient and physician adoption upon market approval and widespread availability.

Mainz Biomed's flagship product, ColoAlert, a stool-based colorectal cancer screening test, has an estimated addressable market size of $4 billion in the U.S. and $6 billion in Europe.

Mainz Biomed (NASDAQ: MYNZ) is anticipated to drive future revenue growth over the next 2-3 years through several key initiatives:

1. Continued Commercial Expansion and Adoption of Enhanced ColoAlert in Europe and International Markets: Mainz Biomed is actively commercializing its enhanced ColoAlert product, a colorectal cancer (CRC) screening test, across Europe and in select international markets. The company has reported increased demand from existing and prospective laboratory partners for this improved version, which was launched in July 2024. Notable expansions include GANZIMMUN Diagnostics, a leading German laboratory, fully implementing the enhanced ColoAlert by early next year. Furthermore, ColoAlert commercially launched in Switzerland in September 2025 following a strategic partnership and regulatory approval, and received MHRA approval for marketing in the United Kingdom in September 2025. In 2024, Mainz Biomed saw a 33% year-over-year increase in lab network revenue for ColoAlert in Europe.
2. U.S. Market Entry and FDA Approval for Colorectal Cancer Screening Test: A significant driver is the company's progress towards U.S. market entry and securing FDA approval for its colorectal cancer screening solution. Mainz Biomed is currently conducting the eAArly DETECT 2 study in the U.S., enrolling 2,000 average-risk patients, with results expected by the end of 2025. This study is a preparatory step for its pivotal FDA study. Additionally, the company has partnered with Quest Diagnostics for clinical trial services for its ReconAAsense study, a larger prospective clinical study with approximately 15,000 subjects aimed at generating data to support FDA validation for a next-generation test. Mainz Biomed plans to submit comprehensive data to the FDA in 2025 to address feedback and expand its clinical research program with a larger average-risk patient population.
3. Development and Future Commercialization of a Next-Generation Colorectal Cancer Screening Product: Mainz Biomed is focused on developing a next-generation colorectal cancer screening product. This includes a collaboration agreement with Thermo Fisher Scientific for global market development, leveraging Thermo Fisher's technologies to develop proprietary assays for its mRNA-based next-generation CRC screening tests. This advanced product aims to redefine standards in early cancer detection. An FDA trial for this next-generation test is anticipated to commence in 2025.
4. Introduction of PancAlert for Early-Stage Pancreatic Cancer Screening: Diversification into new diagnostic areas presents another growth opportunity. Mainz Biomed's product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test. This test is based on real-time Polymerase Chain Reaction (PCR)-based multiplex detection of molecular-genetic biomarkers in blood and stool samples. Preliminary results for a blood-based pancreatic cancer detection test, utilizing a suite of mRNA biomarkers, have shown outstanding potential. The successful development and commercialization of PancAlert could open a new revenue stream for the company.

Share Issuance

• Mainz Biomed completed an initial public offering (IPO) in November 2021, offering 2,000,000 ordinary shares at an initial public offering price of $5.00 per share.
• In May 2025, the company announced the pricing of a follow-on offering of 2,000,000 units for approximately $4.0 million in gross proceeds, with each unit sold at $2.00.
• In August 2025, Mainz Biomed priced a $3.0 million follow-on offering consisting of 2,222,222 units at $1.35 per unit, with each unit including one ordinary share (or pre-funded warrant) and one Series A warrant.
• A 1-for-40 reverse stock split was effected on December 3, 2024, reducing outstanding shares from approximately 80.1 million to 2.0 million, primarily to meet Nasdaq's minimum bid price requirement.

Inbound Investments

• At the end of 2023, Mainz Biomed reported a cash balance of $7.1 million and subsequently secured an additional $3.3 million in financing through its $50 million borrowing facility.

Outbound Investments

• In September 2021, Mainz Biomed acquired all of the equity interests of PharmGenomics GmbH.
• In 2024, Mainz Biomed entered into a license and option agreement with Liquid Biosciences to gain access to novel mRNA biomarkers for the early detection of pancreatic cancer through blood testing.

Capital Expenditures

• Mainz Biomed's liquidity requirements include capital expenditures.
• Forecasted capital expenditures (CAPEX) include amounts such as $0.009685 million, $0.0167 million, $0.6585 million, and $1.199 million for future periods.
• The primary focus of capital expenditures includes research and development (specifically for ColoAlert, PancAlert, and Genostrip), clinical studies for FDA approval of ColoAlert, and marketing and sales activities.