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]

Core Insights - Mainz Biomed's partner GANZIMMUN Diagnostics has launched the enhanced ColoAlert colorectal cancer screening test in Germany, coinciding with Colorectal Cancer Awareness Month in March [1][4] - The enhanced ColoAlert features advanced technology, including a proprietary DNA stabilizing buffer, allowing for accurate results across varying sample volumes [2] - The launch reflects a commitment to improving colorectal cancer prevention and detection through innovative and accessible diagnostics [3][6] Company Developments - The enhanced ColoAlert was first introduced in mid-2024 and is now available to patients, enhancing early detection capabilities for colorectal cancer [2][8] - Mainz Biomed is currently conducting a pivotal FDA clinical study for regulatory approval in the United States, indicating potential market expansion [8] - The company also has other product candidates, such as PancAlert, aimed at early-stage pancreatic cancer detection [8] Industry Context - The launch aligns with updated national screening guidelines in Germany, which now ensure equal access to screening for both men and women starting at age 50, addressing previous gender-based discrepancies [5] - The increased awareness of colorectal cancer screening is expected to drive broader participation in preventive measures within healthcare settings [5] - The collaborative effort between Mainz Biomed and GANZIMMUN highlights the importance of innovative diagnostics in the fight against colorectal cancer [6]

Core Points - Mainz Biomed NV has regained compliance with Nasdaq's minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market as of January 23, 2025 [1] - The company had previously confirmed compliance with the minimum bid price requirement, and is now fully compliant with all Nasdaq continued listing requirements [1] 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 [2] - ColoAlert is marketed in Europe and the UAE, and the company is conducting a pivotal FDA clinical study for US regulatory approval [2] - The product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [2]