Company Advances its Progress toward FDA Premarket Approval Study for its Next Generation Colorectal Cancer Screening Product and Makes a Strategic Acquisition in the Field of Pancreatic Cancer ScreeningBERKELEY, Calif. and MAINZ, Germany, July 15, 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, today reviewed its major accomplishments of the first six months ending June 30, 202 ...

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]

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].