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]

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]

Core Insights - Mainz Biomed reported a 33% year-over-year increase in lab network revenue, driven by strong demand for its ColoAlert® product in Europe [1][3] - The company achieved a 30% reduction in operating loss and an 18% decrease in net loss, attributed to targeted cost reductions and a sharper strategic focus [1][3] - Strategic partnerships with industry leaders, including collaborations with Thermo Fisher Scientific and Quest Diagnostics, mark significant progress for the company [3][5] Financial Performance - For the year ended December 31, 2024, Mainz Biomed's revenue was $893,991, slightly down from $895,479 in 2023 [9] - The gross profit increased to $574,883, resulting in a gross margin of 64%, up from 57% in the previous year [9] - Operating expenses decreased significantly to $19,270,291 from $27,154,341 in 2023, leading to a loss from operations of $18,695,408, down from $26,644,682 [10] Strategic Initiatives - The company is focusing on three key initiatives for 2025: expanding the ColoAlert® business in Europe, developing a next-generation colorectal cancer screening product, and conducting a 2,000 patient study (eAArly DETECT 2) [3][5] - Mainz Biomed's eAArly DETECT study demonstrated a 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions, with 100% detection of high-grade dysplasia in advanced precancerous patients [3][7] Corporate Developments - Mainz Biomed regained compliance with Nasdaq listing requirements, confirming its continued presence on the Nasdaq Capital Market [7] - The company has initiated the eAArly DETECT 2 study, which aims to validate its next-generation colorectal cancer test and is on track to report results by the end of 2025 [7][9] - A license agreement with Liquid Biosciences was signed to access novel mRNA biomarkers for early pancreatic cancer detection, showing promising preliminary results [7][9]

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]