BERKELEY, Calif. and MAINZ, Germany, Sept. 02, 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, announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom. This milestone follows the technology partnership announced earlier this year with EDX Medic ...

Core Insights - Mainz Biomed has received regulatory approval from Swissmedic for its non-invasive colorectal cancer screening test, ColoAlert, allowing it to be distributed in Switzerland [1][3][4] - The target demographic for colorectal cancer screening in Switzerland includes individuals aged 50 to 74, with an estimated population of 2.8 million in this age group, representing approximately 31.4% of the total population [2] - Current participation rates in existing screening programs are below 50%, indicating a significant opportunity for ColoAlert to enhance participation and support national health objectives [2][4] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with ColoAlert being its flagship product [5] - The company is expanding its market presence through partnerships with local laboratories and healthcare providers to ensure broad access to its diagnostic solutions [4][5] - In addition to ColoAlert, Mainz Biomed is developing PancAlert, an early-stage pancreatic cancer screening test [5]

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 has announced a collaboration with CARE diagnostica Laborreagenzien GmbH to enhance colorectal cancer screening services in Germany [1][2][3] - The partnership will expand the service offerings to include the ColoAlert test, which utilizes molecular genetic analysis of stool samples to improve early detection rates [2][3] - This collaboration aligns with the increasing demand for personalized screening solutions focused on early intervention in cancer detection [3] Company Overview - Mainz Biomed specializes in developing molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product being the ColoAlert test for colorectal cancer [4] - The company is also conducting a pivotal FDA clinical study for regulatory approval in the United States and has additional product candidates like PancAlert for pancreatic cancer screening [4] - CARE has over 40 years of experience in colorectal cancer screening in Germany and collaborates with more than 15 statutory health insurance companies [5]

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 Insights - Mainz Biomed is advancing its PancAlert project, focusing on a non-invasive blood test for early pancreatic cancer detection, aiming to confirm previous findings of 95% sensitivity and 98% specificity [1][5] Group 1: Project Development - The feasibility phase will verify candidate mRNA biomarkers and an accompanying machine learning algorithm in clinical blood samples to assess diagnostic performance [2][3] - The company plans to collaborate with Crown Bioscience, a CRO specializing in oncology, to support the verification process [2] Group 2: Objectives and Future Plans - The primary goal of the feasibility stage is to evaluate the robustness, reproducibility, and diagnostic performance of the assay, including sensitivity and specificity [3] - Following the feasibility phase, Mainz Biomed intends to conduct a validation study with a larger cohort, which is crucial for optimizing the test for clinical use and potential FDA submission [5] Group 3: Market Context - Early detection of pancreatic cancer is a significant unmet need in oncology, and the company is committed to improving patient outcomes through its diagnostic solutions [4] - The PancAlert project is part of Mainz Biomed's broader strategy to develop accessible molecular diagnostics for early cancer detection in areas with limited screening tools [5][7]

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]

Core Insights - Mainz Biomed N.V. plans to provide an interim readout of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025 [1][2] - The study aims to validate a next-generation colorectal cancer screening test that combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test on approximately 2,000 average-risk patients [1][3] - The company is on track to initiate its U.S. pivotal trial, ReconAAsense, in 2026 based on the outcomes of the eAArly DETECT 2 study [2][3] Study Details - The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, targeting the reporting of top-line results by Q4 2025 [2] - The study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown the ability to identify advanced adenomas and early-stage colorectal cancer [3] Company Mission - The company aims to advance its mission of eliminating colorectal cancer and reducing global cancer mortality rates through precise detection of advanced precancerous lesions and early-stage colorectal cancer [3]

Company Overview - Mainz BioMed is developing a novel standard for non-invasive detection of advanced adenomas (AA)[8] - The company has a disruptive, decentralized business model[9] - Mainz BioMed launched its first-generation CRC screening test, ColoAlert®, in Europe[10] - The company possesses a strong intellectual property position[12] Market Opportunity and Product - The US annual market for colorectal cancer (CRC) screening is estimated to be > $30 billion by 2032[14] - ColoAlert® is a highly efficacious, at-home, stool-based screening test for early CRC detection, combining a FIT test with PCR results of specific tumor DNA markers[15] - ColoAlert® has high accuracy with 92% specificity and 85% sensitivity[25] - In a screening population >= 45, 21% sensitivity for adenomas would reduce mortality from CRC by 47%, and 76% sensitivity would reduce mortality from CRC by 67%[21] Partnerships and Financials - Mainz BioMed entered into a Collaboration Agreement with Thermo Fisher Scientific in November 2024, with Thermo Fisher providing resources and discounts on instrumentation[17] - Mainz BioMed also entered into Agreements with Quest Diagnostics in November 2024, with Quest becoming a lab partner for the pivotal study and having a semi-exclusive distributor option right in the U S[17] - For the year ended December 31, 2024, ColoAlert® revenue was $893,991, with a gross profit of $574,883[50]