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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 For the transition period from _______________ to _______________ OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell ...

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 ...

BERKELEY, Calif. and MAINZ, Germany, Feb. 11, 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, is pleased to share that its partner, GANZIMMUN Diagnostics, has officially launched the enhanced ColoAlert colorectal cancer (CRC) screening test. Starting this January, patients across Germany can access this new version of the Company's screening test, in time for Colorectal Cancer A ...

BERKELEY, Calif. and MAINZ, Germany, Jan. 27, 2025 (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 that on January 23, 2025, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) confirming that it has regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rul ...

Study Overview - Mainz Biomed NV launches eAArly DETECT 2, a U S feasibility study to evaluate its next-generation colorectal cancer (CRC) test, integrating mRNA biomarkers, AI algorithms, and FIT test, targeting a population of approximately 2,000 average-risk patients [1] - The study aims to validate previous feasibility study results, which included both average-risk and identified-risk patients, and is expected to complete enrollment in the second half of 2025 with topline results reported by Q4 2025 [1][2] Study Objectives and Impact - The eAArly DETECT 2 study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown unique ability to identify advanced adenomas and early-stage CRC [3] - The study aims to enhance product specifications by combining these biomarkers with Mainz Biomed's proprietary AI algorithm, potentially increasing diagnostic sensitivity and specificity for early-stage CRC [3] - Successful outcomes from the study will enable Mainz Biomed to finalize protocols for ReconAAsense, its U S pivotal study, scheduled to initiate in 2026 [2] Company Strategy and Vision - The launch of eAArly DETECT 2 is a significant milestone for Mainz Biomed, accelerating the timeline to evaluate biomarkers for inclusion in the U S pivotal study [3] - The company's next-generation CRC test aims to transform colorectal cancer screening by detecting cancerous polyps with high accuracy and potentially preventing the disease through early detection of precancerous adenomas [2][3] - Mainz Biomed's mission is to transform CRC screening practices and reduce global cancer mortality rates by enabling precise detection of advanced adenomas and early-stage CRC [3] Company Background - Mainz Biomed specializes in molecular genetics diagnostics for life-threatening conditions, with ColoAlert® as its flagship product, marketed in Europe and the UAE [4] - The company is conducting a pivotal FDA clinical study for U S regulatory approval of ColoAlert® and is developing PancAlert, an early-stage pancreatic cancer screening test [4]

Quest to Support Mainz Biomed’s ReconAAsense FDA Study and Has Option to Commercialize Test Kit Assuming FDA ApprovalBERKELEY, Calif. and MAINZ, Germany, Dec. 19, 2024 (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 an agreement with Quest Diagnostics (NYSE:DGX), a leading provider of diagnostic information services, to support commercialization of Mainz Biomed’s Next ...