Core Insights - Mainz Biomed N.V. has initiated the eAArly DETECT 2 clinical study to evaluate its next-generation colorectal cancer test, which integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients [1][4] - The company reported a 100% sensitivity and 95% specificity in a feasibility study for a non-invasive blood-based screening test for pancreatic cancer, utilizing a panel of biomarkers licensed from Liquid Biosciences [3][8] - Mainz Biomed's ColoAlert® test has received regulatory approvals in the UK and Switzerland, marking significant milestones in its market expansion efforts [4][6] Colorectal Cancer Business Highlights - The eAArly DETECT 2 study aims to validate previous results and is a precursor to the upcoming ReconAAsense US FDA pivotal study [5] - ColoAlert®, a DNA-based colorectal cancer screening test, has been officially registered with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and Swissmedic in Switzerland [4] - A strategic partnership with labor team w ag will introduce ColoAlert® to the Swiss market, while a Memorandum of Understanding with OncoVanguard8 aims to expand its reach into South America, starting with Peru [4] Pancreatic Cancer Business Highlights - In March 2025, Mainz Biomed entered a License and Option Agreement with Liquid Biosciences to develop a blood test for pancreatic cancer, achieving a sensitivity of 95% and specificity of 98% in initial studies [3] - The pancreatic cancer project has received public funding from the Investitions- und Strukturbank Rheinland-Pfalz, covering up to 50% of the project's total costs, which underscores the project's scientific and societal value [8] - The company is focused on advancing its blood-based screening test for pancreatic cancer, with expectations to announce further developments in 2026 [5]

Core Insights - Mainz Biomed has partnered with DoctorBox to integrate its ColoAlert® test into DoctorBox's digital health platform, enhancing access to colorectal cancer screening at home [1][2][3] - Colorectal cancer is a significant health issue in Germany, with approximately 60,000 new cases diagnosed annually, underscoring the need for effective early detection solutions [2] - The collaboration aims to lower barriers to screening and promote innovative, personalized preventive healthcare solutions [3][4] Company Overview - Mainz Biomed specializes in molecular genetic diagnostics for early cancer detection, with ColoAlert® being its flagship product for colorectal cancer [7] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for US regulatory approval [7] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test [7] Industry Context - DoctorBox is a leading digital health solution in Europe, with over one million registered users and more than ten million test results transmitted [4][6] - The platform offers a range of preventive healthcare services, including personalized care reminders and at-home tests for various cancers [4][6] - The integration of advanced DNA diagnostics into digital health platforms represents a growing trend in preventive medicine, aiming to make healthcare more accessible [2][3]

Core Insights - Mainz Biomed has signed a Memorandum of Understanding (MOU) with OncoVanguard8 to introduce its DNA-based colorectal cancer screening test, ColoAlert®, to South America, starting with Peru [1][2][3] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product being ColoAlert®, a non-invasive colorectal cancer diagnostic test [4] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for regulatory approval in the US [4] Market Opportunity - Colorectal cancer is one of the most prevalent yet preventable cancers globally, with approximately 17,000 new cases diagnosed annually in the initial launch markets of Peru, Colombia, and Ecuador [2] - The introduction of a DNA-based screening solution is expected to significantly increase screening participation and improve early diagnosis, aligning with public health initiatives to reduce colorectal cancer mortality [2] Strategic Partnership - The MOU outlines the commercial, legal, and regulatory terms, as well as the go-to-market strategy for the initial territory, with a final distribution agreement expected to be signed in the coming weeks [3] - OncoVanguard8 aims to bridge the technological gap in cancer prevention and early detection in Latin America, developing partnerships with insurers, hospitals, and healthcare networks [5]

Core Insights - Mainz Biomed N.V. is participating in MEDICA 2025, a leading healthcare trade show in Düsseldorf, Germany, from November 17-20, 2025 [1] - The event will feature over 5,000 exhibitors from 70 countries and is expected to attract 80,000 visitors, serving as a platform for innovation and business development in medical technology [2] - MEDICA will host healthcare experts, industry leaders, and policymakers, providing opportunities for collaboration and relationship building in cancer prevention and molecular diagnostics [3] Company Highlights - Mainz Biomed will showcase its flagship product, ColoAlert®, a molecular stool-based screening test for early detection of colorectal cancer, along with other upcoming diagnostic solutions [4] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for US regulatory approval [5] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of biomarkers in blood and stool samples [5]

Core Insights - Mainz Biomed N.V. is participating in the 38th Annual Meeting of the Gastroenterological Working Group of Rhineland-Palatinate (GARPS) from November 14-15, 2025, in Bad Kreuznach, Germany, focusing on early cancer detection [1][2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, particularly for early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer [5] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study aimed at obtaining regulatory approval in the US [5] Industry Engagement - The GARPS conference serves as a platform for knowledge exchange among clinical and scientific experts in gastroenterology and hepatology, fostering dialogue between universities, hospitals, and the diagnostics industry [2] - Mainz Biomed aims to strengthen relationships with key opinion leaders in gastroenterology and discuss future cancer prevention strategies during the conference [3] Product Promotion - Attendees at the GARPS conference are invited to learn about the importance of early colorectal cancer detection and explore potential collaborations to offer ColoAlert® to patients [4]

Core Insights - Mainz Biomed has launched its flagship product, ColoAlert®, in Switzerland, marking a significant milestone for the company [1] - The launch follows a strategic partnership with labor team w ag, a leading diagnostic laboratory in Switzerland, which will facilitate the distribution of ColoAlert® [2] - Swissmedic has granted official registration and marketing approval for ColoAlert®, allowing its distribution in Switzerland and enhancing patient access to colorectal cancer screening [3] Company Developments - Mainz Biomed completed a technology transfer with labor team, enabling local processing and analysis of ColoAlert® samples in Switzerland, ensuring operational efficiency and high-quality diagnostics [4] - The company is progressing with its eAArly DETECT clinical study, aiming to enroll 2,000 patients from the average risk population by the end of 2025, without pausing for interim readouts [5] - Mainz Biomed is also preparing for a pivotal FDA study for US regulatory approval, indicating its commitment to expanding its market presence [6]

Company Overview - Mainz Biomed N.V. is a molecular genetics diagnostic company focused on early cancer detection [1][4] - The company's flagship product, ColoAlert®, is a non-invasive diagnostic test for colorectal cancer, marketed across Europe [4] - Mainz Biomed is conducting a clinical study to prepare for FDA clinical study and US regulatory approval [4] Offering Details - Mainz Biomed announced a follow-on offering of 2,222,222 units, with gross proceeds expected to be approximately $3.0 million [1] - Each unit consists of one ordinary share (or pre-funded warrant) and one Series A warrant to purchase one and one half ordinary shares, priced at $1.35 per unit [1] - The Series A warrants are immediately exercisable at an exercise price of $1.35 per share and will expire five years from issuance [1] Placement Agent and Closing - Maxim Group LLC is acting as the sole placement agent for the offering [2] - The offering is expected to close on or about August 5, 2025, subject to customary closing conditions [2] Regulatory Information - The offering is made pursuant to a registration statement on Form F-1, declared effective by the SEC on August 4, 2025 [3] - A final prospectus relating to the offering will be filed with the SEC [3]

Core Insights - Mainz Biomed is advancing its FDA premarket approval study for its next-generation colorectal cancer screening product and has made a strategic acquisition in pancreatic cancer screening [1] - The company launched the eAArly DETECT 2 study, a US feasibility study involving approximately 2,000 average-risk patients to validate previous colorectal cancer test results [3] - A strategic partnership with labor team w ag introduces the ColoAlert® test to the Swiss market, marking Mainz Biomed's entry into Switzerland [3] - Mainz Biomed has partnered with EDX Medical Group to expand its molecular diagnostic technology in the UK [3] - A License and Option Agreement with Liquid Biosciences aims to develop a blood test for pancreatic cancer detection, showing a sensitivity of 95% and specificity of 98% based on a cohort of 285 subjects [3] - The PancAlert project is progressing with public funding from the Investitions- und Strukturbank Rheinland-Pfalz, covering up to 50% of the project's costs [3] - Mainz Biomed has regained compliance with Nasdaq listing requirements, ensuring continued trading on the Nasdaq Capital Market [3] - The company priced a follow-on offering of 2,000,000 units for gross proceeds of approximately $4.0 million, with each unit sold at an effective price of $2.00 [3] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being the ColoAlert® test for colorectal cancer [5] - The company is conducting a pivotal FDA clinical study for US regulatory approval and is developing the PancAlert test for pancreatic cancer screening [5]

Core Insights - Mainz Biomed N.V. has secured public funding for its pancreatic cancer project from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), which will cover up to 50% of the project's total costs, highlighting the project's scientific and societal value [1][2] - The funding is a significant endorsement of Mainz Biomed's non-invasive, blood-based screening test aimed at early detection of pancreatic cancer, which is crucial for improving treatment outcomes [2][3] - The project is currently in the feasibility phase, focusing on evaluating mRNA biomarkers and a machine learning-driven algorithm using real clinical blood samples, as part of a broader strategy to enhance non-invasive diagnostics for various cancers [4] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product, ColoAlert®, being a non-invasive early-detection test for colorectal cancer, marketed in Europe and the UAE [5] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [5]

Core Viewpoint - Mainz Biomed N.V. has announced a follow-on offering of 2,000,000 units at an effective price of $2.00 per unit, aiming for gross proceeds of approximately $4.0 million [1] Group 1: Offering Details - Each unit in the offering consists of one ordinary share (or pre-funded warrant), one Series A warrant, and one Series B warrant [1] - The Series A and Series B warrants are immediately exercisable at an exercise price of $2.00 per share, with Series A expiring in five years and Series B expiring either 30 days after results from the eAArly Detect 2 study or one year from issuance [1] - The offering is expected to close on or about May 21, 2025, subject to customary closing conditions [2] Group 2: Warrant Amendment Agreement - The company has entered into a Warrant Amendment Agreement to reduce the effective strike price of previously issued Series A and Series B Warrants from December 12, 2024, to an amended exercise price of $2.00 [3] Group 3: Regulatory Information - The newly issued securities are being offered under a registration statement on Form F-1, which was declared effective by the SEC on May 16, 2025 [4] - A final prospectus related to the offering will be filed with the SEC, and copies can be obtained from Maxim Group LLC [4] Group 4: Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer marketed in Europe [5] - The company is conducting a clinical study to prepare for its pivotal FDA clinical study and US regulatory approval [5] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test [5]