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]

Dedicated to Saving Lives by Transforming At-home Cancer Detection Investor Presentation April 2025 Safe Harbor This presentation may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. We intend all forward-looking statements to be covered by the safe harbor provisions of the Private Secur ...

Core Insights - Mainz Biomed has entered into a technology partnership with EDX Medical Group to enhance cancer diagnostics in the UK [1][3] - The partnership will allow EDX Medical to utilize Mainz Biomed's molecular diagnostic technology, expanding its product offerings [2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection [1] - The company's flagship product, ColoAlert, is a non-invasive test for colorectal cancer, currently marketed in Europe and undergoing FDA clinical studies for US approval [4] - Mainz Biomed's product pipeline includes PancAlert, an early-stage pancreatic cancer screening test [4] EDX Medical Group Overview - EDX Medical Group, based in the UK, develops digital diagnostic products for various diseases, including cancer [1][5] - The company aims to improve disease detection and treatment personalization through advanced biological and digital technologies [6]

Core Insights - Mainz Biomed N.V. is focused on molecular genetics diagnostics for early cancer detection and is progressing towards FDA premarket approval for its products [1][4] Company Developments - The company reported significant progress in Q1 2025, driven by strong clinical results from three studies published in 2024 [1] - The eAArly DETECT 2 study has commenced, evaluating a next-generation colorectal cancer test with results expected by the end of 2025 [4] - Mainz Biomed has signed a license agreement with Liquid Biosciences to access novel mRNA biomarkers for early pancreatic cancer detection, achieving 95% sensitivity and 98% specificity in independent validation [4] - A strategic partnership with labor team w ag has been established to introduce the ColoAlert CRC screening test to the Swiss market, addressing the urgent need for early detection in Switzerland [4] - The enhanced ColoAlert CRC screening test has been launched in Germany, coinciding with Colorectal Cancer Awareness Month in March 2025 [4] Regulatory Compliance - Mainz Biomed has regained compliance with Nasdaq's minimum stockholders' equity requirement and the minimum bid price requirement, ensuring full compliance with all Nasdaq continued listing requirements [4]

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]

Accounting Standards and Financial Reporting - The new accounting standard effective from January 1, 2027, is expected to shift certain performance measures and cash flow categorizations but will not materially affect overall financial disclosure [550]. - The company assesses the impacts of new accounting standards but does not expect material effects from the amendments to IFRS 9 and IFRS 7 effective January 1, 2026 [550][552]. - The company has not recognized deferred tax assets due to uncertainty around utilizing all of the losses carry-forwards, which totaled $2,475,532 in deferred tax assets as of December 31, 2024 [19]. Revenue and Cost of Revenue - For the years ended December 31, 2024, 2023, and 2022, the cost of revenue was $319,108, $385,820, and $347,726 respectively, indicating a decrease of 17.3% from 2023 to 2024 [565]. - The company recognizes revenue from genetic diagnostic tests upon the satisfaction of performance obligations, with revenue recorded upon delivery to laboratory partners and end users [561][563]. - The company’s revenue from genetic diagnostic tests is primarily derived from sales to laboratory partners and direct sales to patients [561][563]. Assets and Liabilities - The company’s functional currency is the Euro (EUR), while the presentation currency is the US dollar [576][580]. - Trade receivables decreased from $121,735 in 2023 to $33,577 in 2024, with a net allowance for doubtful accounts of $28,180 [601]. - Inventory decreased from $670,471 in 2023 to $372,870 in 2024, with a significant inventory write-down of $186,339 recorded in 2024 due to expiration of raw materials [602]. - Property and equipment net book value decreased from $1,702,317 in 2023 to $1,365,144 in 2024, with depreciation expense increasing to $319,446 in 2024 from $202,983 in 2023 [605]. - As of December 31, 2024, the company recorded lease liabilities of $1,146,127, down from $1,454,186 in 2023, with current liabilities of $280,145 and long-term liabilities of $865,982 [619]. - The company’s financial liabilities as of December 31, 2024 totaled $5,949,546 due within one year [685]. Impairment and Allowance - The company has not recognized any impairment in its consolidated financial statements for the years ended December 31, 2024, 2023, and 2022 [556]. - The company recorded an impairment loss of $47,449 on construction in progress due to the project being on hold with no future use planned [606]. - The company recorded a reduction in allowance for doubtful accounts of $28,180 in 2024, compared to $38,672 in 2023 [601]. - The company recognized bad debt reserve of $16,261 for VAT receivables in 2024, down from $53,295 in 2023 [603]. - The Company incurred bad debt expenses of ($11,919) in 2024, compared to $14,357 in 2023 [682]. Research and Development - Research and development expenditures are recognized in profit or loss as incurred, while development costs are capitalized only if certain criteria are met [566][567]. - Research and development expenses decreased by 39.1% from $9,590,393 in 2023 to $5,839,033 in 2024 [20]. Financing and Capital Structure - The Company issued a total of four Promissory Notes with principal amounts of $5,500,000, $5,500,000, $3,300,000, and $1,500,000, receiving net amounts of $5,060,000, $5,060,000, $2,970,000, and $1,350,000 respectively [627][628][629]. - The Initial Promissory Note had an original issue discount of $440,000, recorded at a fair value of $5,060,000, while the Second Promissory Note was recorded at a fair value of $5,008,000 [634]. - The Company incurred default interest of 15% per annum starting November 2023, and made principal payments totaling $1,100,000 during November and December 2023 [635]. - The Company recorded a change in fair value of $2,039,622 for the year ended December 31, 2024, resulting in a balance of $1,021,000 as of December 31, 2024 [637]. - The Company raised approximately $8,000,000 in gross proceeds from the sale of 1,367,521 units at an offering price of $5.85 per unit, with net proceeds of $7.2 million after expenses [649]. Stock and Shareholder Information - The Company issued 7,691 ordinary shares under a Controlled Equity Offering in 2023, generating net proceeds of $1,894,742 at an average price of $246.4 per share [645]. - As of December 31, 2024, the Company had 3,905,208 outstanding warrants with an average exercise price of $5.38 and an intrinsic value of $4,945,104 [654]. - The Company granted 3,000 stock options valued at $914,861 during the year ended December 31, 2024, with an exercise price ranging from $12.0 to $24.8 [662][665]. - The estimated fair value of stock options granted in 2024 was based on an expected average volatility of 106% to 113% and a risk-free interest rate of 3.8% to 4.22% [665]. Management and Personnel - Key management personnel remuneration for the year ended December 31, 2024, was $1,113,370, compared to $1,647,186 in 2023 [666]. - The company experienced a significant reduction in employee stock option expense from $3,266,702 in 2023 to $149,510 in 2024, a decrease of approximately 95.4% [21]. - The company restructured operations in 2024, focusing on the ColoAlert business and reducing personnel by 65%, resulting in severance expenses of $277,160 [674]. Government Grants and Related Party Transactions - The Company received government grants totaling $46,087 and $27,741 for research and development projects in 2024 and 2023, respectively [676]. - Revenue from related party sales reached $61,569 in 2024 following the sale of the European Oncology Lab business [675]. Overall Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $21,650,663, compared to a net loss of $26,344,492 in 2023, indicating a 17.5% improvement year-over-year [19]. - Total operating expenses for the year ended December 31, 2024, were $6,581,333 for sales and marketing, $5,839,033 for research and development, and $6,572,765 for general and administrative, reflecting a total operating expense of $19,993,131 [20][21][22].

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]

Core Insights - Mainz Biomed has announced a strategic partnership with labor team w ag to launch ColoAlert, a DNA-based colorectal cancer screening test in Switzerland, marking its first entry into the Swiss market [1][5] - The partnership aims to enhance early detection and prevention of colorectal cancer, which remains a significant health issue in Switzerland with thousands of new cases diagnosed annually [2][5] - This collaboration combines Mainz Biomed's expertise in DNA diagnostics with labor team's established laboratory services, providing a state-of-the-art screening solution [3][4] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions, with ColoAlert being its flagship product for early detection of colorectal cancer [6] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test, and is pursuing FDA approval for its products in the US market [6] - Labor team w ag is one of Switzerland's leading private medical laboratories, established in 2001, and is known for its comprehensive laboratory services across the country [7][8] Market Implications - The introduction of ColoAlert aligns with the increasing demand for personalized healthcare solutions focused on early intervention and prevention [5] - The screening test will be available through labor team's extensive network of healthcare providers starting in spring 2025, potentially increasing participation rates in colorectal cancer screening [5] - This partnership positions both companies to contribute significantly to public health by improving access to reliable diagnostic tools for colorectal cancer [4][5]