Core Insights - Mainz Biomed is participating in the Colorectal Cancer Screening Committee Plenary Meeting and Expert Working Group Sessions hosted by the World Endoscopy Organization on October 3, 2025, in Berlin, Germany [1][2] - The meeting aims to evaluate emerging technologies and shape future strategies for early detection and prevention of colorectal cancer (CRC) [2][4] - Dr. Lena Krammes will present findings from the eAArly DETECT study, focusing on RNA-based diagnostics for identifying colorectal cancer and precancerous lesions [3][5] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product being ColoAlert, a non-invasive early-detection test for colorectal cancer marketed in Europe [6] - The company is conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for US regulatory approval [6] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR for detecting molecular-genetic biomarkers [6] Clinical Findings - The eAArly DETECT study highlights the potential of stool RNA testing to identify colorectal cancer and precancerous lesions, emphasizing its role in early detection and prevention [3] - Key clinical data includes 97% sensitivity and 97% specificity for detecting colorectal cancer, 82% sensitivity for advanced adenomas, and 100% detection of advanced adenomas with high-grade dysplasia [7]

Accounting Standards and Financial Reporting - The new accounting standard will be effective for annual reporting periods beginning on or after January 1, 2027, with earlier adoption permitted, but the company does not expect material impacts on financial disclosures[20]. - The company recognizes revenue from genetic diagnostic tests upon delivery to laboratory partners, aligning with IFRS 15 standards[30][32]. - Current income tax assets and liabilities are measured at the expected amounts to be recovered or paid, with management evaluating tax positions periodically[54][55]. - Financial assets and liabilities are classified at fair value through profit and loss, fair value through other comprehensive income, or at amortized cost, depending on the business model[37]. Revenue and Expenses - For the six months ended June 30, 2025, the cost of revenue was $97,128, a decrease from $201,735 in the same period of 2024, indicating a reduction of approximately 52%[34]. - Research and development expenditures are recognized in profit or loss as incurred, with development costs capitalized only if certain criteria are met[35][36]. - For the six months ended June 30, 2025, total operating expenses were $2,349,005, a slight decrease from $2,361,105 in 2024, representing a reduction of approximately 0.5%[154]. - Research and development expenses for the same period were $3,055,088, down from $3,242,622 in 2024, indicating a decrease of about 5.8%[154]. - General and administrative expenses totaled $2,876,845 for the six months ended June 30, 2025, compared to $4,522,639 in 2024, reflecting a significant decrease of approximately 36.4%[155]. Assets and Liabilities - As of June 30, 2025, the company recorded trade receivables of $55,692, with an allowance for doubtful accounts of $15,570, resulting in a net trade receivable of $40,122[73]. - The company reported inventory of $548,715 as of June 30, 2025, with a reserve of $45,662, and an inventory write-down of $35,041 for the six months ended June 30, 2025[76]. - The company’s property and equipment balance increased to $2,034,233 as of June 30, 2025, with accumulated depreciation of $645,689, resulting in a net book value of $1,388,544[79]. - The net book amount of intangible assets increased from $3,017,462 on December 31, 2024, to $4,008,871 on June 30, 2025, reflecting an addition of $1,200,000[85]. - The Company has a liability of $850,606 and $1,000,000 recorded as intellectual property acquisition liability as of June 30, 2025[87]. - Lease liabilities increased from $1,146,127 on December 31, 2024, to $1,472,825 on June 30, 2025, with current and long-term portions of $372,619 and $1,100,206, respectively[95]. - Accounts payable decreased from $1,254,187 on December 31, 2024, to $596,886 on June 30, 2025, while accrued expenses decreased from $822,917 to $399,669[96]. - Convertible debt decreased from $1,093,975 on December 31, 2024, to $482,149 on June 30, 2025, primarily due to the repayment of convertible promissory notes[97]. Shareholder Equity and Financing - The weighted average number of ordinary shares outstanding increased significantly to 3,144,409 as of June 30, 2025, compared to 558,751 in the previous year[64]. - The Company issued multiple promissory notes totaling $5,500,000 each in 2023, receiving $5,060,000 net of discount for each note[102]. - The Company granted 416,750 stock options valued at $1,743,636 during the six months ended June 30, 2025, with a vesting schedule of 50% at grant date and 25% at each of the first and second anniversaries[131]. - Share-based compensation recorded for the six months ended June 30, 2025, was $823,863, with unamortized expense of $951,883 as of the same date[132]. - The Company has authorized share capital of EUR 3,500,000, consisting of 7,875,000 ordinary shares and 875,000 preferred shares, with no preferred shares currently outstanding[117]. Strategic Initiatives and Developments - The company operates in one segment, genetic diagnostic testing, indicating a focused business strategy[65]. - The Company licensed a novel set of mRNA biomarkers in January 2022 and acquired the rights on February 15, 2023, planning to use them in its next generation product[83]. - A License and Option Agreement with Liquid Bioscience, Inc. was closed on March 12, 2025, for $1.2 million, allowing the Company to develop a non-invasive pancreatic cancer detection test[84]. - The company plans to manage its capital structure by potentially issuing new shares or taking on additional debt as needed to support growth[150]. Cash Flow and Financial Health - As of June 30, 2025, the company had an unrestricted cash balance of $1,911,069, a significant decrease from $6,235,670 as of December 31, 2024, reflecting a decline of approximately 69.4%[146]. - The company had accounts payable related to parties amounting to $620,290 as of June 30, 2025, a substantial increase from $10,399 as of December 31, 2024[138]. - For the six months ended June 30, 2025, the company incurred no bad debt expense related to trade receivables, a significant improvement compared to $16,090 in the same period of 2024[145]. - The company had revenue from three major customers that accounted for approximately 91% of total revenue for the six months ended June 30, 2025, compared to two customers accounting for 38% in 2024[153].

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]

Core Insights - Mainz Biomed N.V. has received official registration for its ColoAlert® test from the Medicines and Healthcare products Regulatory Agency (MHRA), allowing it to be marketed in the UK [1][4] - The approval follows a technology partnership with EDX Medical Group plc, aimed at increasing accessibility of the DNA-based colorectal cancer screening test [2] - Colorectal cancer is the fourth most common cancer in the UK, with around 44,000 new cases diagnosed each year, and ColoAlert offers a non-invasive screening option [3] Company Developments - The approval of ColoAlert enables the UK laboratory partner to provide a reliable and user-friendly test, supporting the goal of increasing participation in preventive screening [4] - Mainz Biomed is committed to expanding access to innovative diagnostic solutions for early cancer detection, addressing a leading cause of cancer-related mortality [4] - The company is also running a pivotal FDA clinical study for US regulatory approval and has other product candidates like PancAlert for pancreatic cancer screening [5]

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]

As filed with the United States Securities and Exchange Commission on July 30, 2025 Registration No. 333-_______ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MAINZ BIOMED N.V. (Exact name of registrant as specified in its charter) | | | (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Mainz Biomed N.V. Rober ...

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]