Dedicated to Saving Lives by Transforming At-home Cancer Detection Investor Presentation April 2025 Safe Harbor This presentation may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. We intend all forward-looking statements to be covered by the safe harbor provisions of the Private Secur ...

BERKELEY, Calif. and MAINZ, Germany, April 29, 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, has entered into a technology partnership with UK-based EDX Medical Group plc (AQSE: EDX), which develops innovative digital diagnostic products and services supporting personalized treatments for cancer, cardiovascular and infectious diseases. Under the agreement, EDX Medical will acc ...

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 ...

Strategic partnerships with industry leaders mark key progress Mainz Biomed and Thermo Fisher Scientific signed a collaboration agreement for the development of the Company's next generation colorectal cancer (CRC) screening product for global markets. The agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed's next generation colorectal cancer screening product. The collaboration will harness Thermo Fisher's powerful technologies, instrumentation ...

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Core Insights - Mainz Biomed has initiated the eAArly DETECT 2 study to evaluate its next-generation colorectal cancer test, aiming to confirm previous results in detecting advanced precancerous lesions [1][2][3] - The study will enroll approximately 2,000 average-risk patients and is expected to report top-line results in the fourth quarter of 2025 [1][2] - The company plans to finalize protocols for its U.S. pivotal study, ReconAAsense, based on the outcomes of the eAArly DETECT 2 study, with initiation targeted for 2026 [2] Group 1 - The eAArly DETECT 2 study aims to validate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which can identify advanced adenomas and early-stage colorectal cancer [3] - The study integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test to enhance diagnostic sensitivity and specificity for early-stage colorectal cancer [1][3] - The first patient has been enrolled, marking the formal commencement of the study after months of preparatory work [3] Group 2 - Mainz Biomed's flagship product, ColoAlert®, is a non-invasive early-detection diagnostic test for colorectal cancer, currently marketed across Europe [4] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test based on real-time PCR multiplex detection of molecular-genetic biomarkers [4]

Core Insights - Mainz Biomed has entered into an exclusive licensing agreement with Liquid Biosciences to develop a blood test for the non-invasive detection of pancreatic cancer, utilizing a portfolio of novel mRNA biomarkers [1][2][4] - The blood test has demonstrated a sensitivity of 95% and specificity of 98% in detecting pancreatic cancer, based on a study involving 285 subjects, including 35 pancreatic cancer patients [3] - The collaboration aims to enhance commercial assays, refine algorithms, and prepare for potential FDA application and approval for the pancreatic cancer screening test [5] Group 1 - Mainz Biomed's licensing agreement with Liquid Biosciences allows the company to develop a test using effective gene expression biomarkers for pancreatic cancer detection [2] - The discovery process involved multiple independent cohorts, confirming the clinical relevance of the identified biomarkers [3] - The CEO of Mainz Biomed highlighted the agreement as a significant milestone in the early detection and diagnosis of pancreatic cancer, marking a potential paradigm shift in detection methods [4] Group 2 - The agreement includes financial terms such as a license fee and royalties on future revenues if the option for exclusive global rights is exercised [2] - The proprietary EMERGE platform was utilized to identify the mRNA biomarkers, which were validated through additional independent cohorts [3] - Mainz Biomed's existing product portfolio includes ColoAlert®, a diagnostic test for colorectal cancer, and PancAlert, an early-stage pancreatic cancer screening test [6]

Core Insights - Mainz Biomed is focused on early detection of colorectal cancer (CRC) to improve survival rates and reduce mortality associated with the disease [1][5] - The company is advancing diagnostic solutions that emphasize early intervention, utilizing innovative technologies and research to enhance CRC screening [2][5] Group 1: Company Initiatives - Mainz Biomed is committed to combating CRC through the development of next-generation diagnostic products, including a focus on early detection of pre-cancerous adenomas [2] - The company's flagship product, ColoAlert®, is a non-invasive early-detection test for CRC, which is currently marketed in Europe and the UAE, with ongoing efforts for FDA approval in the U.S. [6] - Recent partnerships, such as with European Oncology Lab, aim to increase accessibility to DNA-based screening solutions [3][4] Group 2: Research and Development - Mainz Biomed's research has shown a sensitivity of 82% and specificity of 97% for advanced adenoma detection, indicating significant potential for early intervention [2] - The company is leveraging mRNA biomarkers and a proprietary AI algorithm to enhance the effectiveness of its diagnostic solutions [2] Group 3: Market Context - Colorectal cancer is the second leading cause of cancer-related deaths globally, with over 930,000 fatalities annually, highlighting the urgent need for improved screening participation [1][5] - In the U.S., over 150,000 individuals are diagnosed with CRC each year, while Germany reports approximately 22,836 annual deaths from the disease [1]

Partnership to Launch DNA-Based Colorectal Cancer Screening TestBERKELEY, Calif. and MAINZ, Germany, Feb. 20, 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, announced today a strategic partnership with labor team w ag (“labor team”), a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer (CRC) scre ...

Core Insights - Mainz Biomed's partner GANZIMMUN Diagnostics has launched the enhanced ColoAlert colorectal cancer screening test in Germany, coinciding with Colorectal Cancer Awareness Month in March [1][4] - The enhanced ColoAlert features advanced technology, including a proprietary DNA stabilizing buffer, allowing for accurate results across varying sample volumes [2] - The launch reflects a commitment to improving colorectal cancer prevention and detection through innovative and accessible diagnostics [3][6] Company Developments - The enhanced ColoAlert was first introduced in mid-2024 and is now available to patients, enhancing early detection capabilities for colorectal cancer [2][8] - Mainz Biomed is currently conducting a pivotal FDA clinical study for regulatory approval in the United States, indicating potential market expansion [8] - The company also has other product candidates, such as PancAlert, aimed at early-stage pancreatic cancer detection [8] Industry Context - The launch aligns with updated national screening guidelines in Germany, which now ensure equal access to screening for both men and women starting at age 50, addressing previous gender-based discrepancies [5] - The increased awareness of colorectal cancer screening is expected to drive broader participation in preventive measures within healthcare settings [5] - The collaborative effort between Mainz Biomed and GANZIMMUN highlights the importance of innovative diagnostics in the fight against colorectal cancer [6]