Mainz Biomed N.V. Ordinary Shares - MYNZ STOCK NEWS

Mainz Biomed has submitted an application to the FDA for Breakthrough Device Designation for its Next Generation CRC Screening Test, which incorporates novel mRNA biomarkers. The submission follows promising results from the ColoFuture and eAArly Detect studies, showing 97% sensitivity for colorectal cancer and 88% for advanced adenomas, with 93% specificity. The test uses a combination of Fecal Immunochemical Test (FIT) and proprietary mRNA biomarkers, supported by AI and machine learning algorithms. If approved, the FDA designation could accelerate the product's market release, providing more effective cancer detection and potentially improving global CRC screening practices.

Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company focusing on early cancer detection, has provided a mid-year corporate update for 2024. The company highlighted its significant accomplishments in the first half of 2024, emphasizing the strong clinical data from various studies.

Mainz Biomed presented pooled study results at ASCO 2024, confirming previous findings with a 92% sensitivity for colorectal cancer (CRC) and 82% for advanced adenomas, including 95.8% for high-grade dysplasia. Additionally, the company received a Poster of Distinction at Digestive Disease Week for its eAArly DETECT study, demonstrating 97% sensitivity for CRC and 82% for advanced precancerous lesions.

Mainz Biomed engaged in strategic partnerships, notably with Trusted Health Advisors for its U.S. go-to-market strategy and TomaLab for launching ColoAlert® in Italy. These collaborations are pivotal for the company's FDA premarket approval plans and market expansion efforts.

The company remains on track for its U.S. FDA pivotal CRC study, set to begin enrollment in the second half of 2024.

Mainz Biomed presented findings from their largest cohort study at the ASCO 2024 Annual Meeting. The study, involving 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the US, confirmed the high sensitivity and specificity of their multimodal screening test for colorectal cancer (CRC) and advanced adenomas (AA). The test integrates Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, supported by AI and machine learning algorithms. The results showed a 92.3% sensitivity for CRC, 90.1% specificity, and 82.2% sensitivity for AA, with a 95.8% detection rate for high-grade dysplasia, demonstrating superior performance over existing non-invasive methods.

Mainz Biomed held its 2024 Annual General Meeting on May 31, 2024, in Amsterdam. Shareholders representing 10.9% of the company's ordinary shares attended, meeting the quorum requirement. All proposals, including the adoption of the statutory annual accounts, discharge of directors, amendments to the articles of association, and reappointment of directors, were approved with significant majorities. The company also disclosed a non-compliance notice from Nasdaq for failing to meet the minimum bid price requirement, giving Mainz Biomed 180 days to regain compliance. Failure to comply by November 25, 2024, could result in delisting, although an extension may be granted.

Mainz Biomed will present its largest colorectal cancer screening study to date at the ASCO 2024 Annual Meeting. The study, combining data from ColoFuture and eAArly DETECT studies, includes 690 subjects across 30 clinical sites. The novel screening test, which uses mRNA biomarkers, FIT tests, and an AI algorithm, showed a 92.3% sensitivity for colorectal cancer and 82.3% for advanced precancerous lesions. This innovative, non-invasive approach aims to enhance early detection of colorectal cancer and advanced adenomas, potentially reducing cancer mortality rates globally. The presentation session will be held on June 1, 2024, from 13:30 to 16:30 CDT.

Mainz Biomed unveiled groundbreaking eAArly DETECT study results at Digestive Disease Week (DDW) 2024, achieving a Poster of Distinction award. The study demonstrated 97% sensitivity for colorectal cancer (CRC) and 82% for advanced precancerous lesions, with 100% detection in high-grade dysplasia patients. Conducted across multiple US sites with 254 clinical subjects, the study utilized a multimodal screening test combining Fecal Immunochemical Test (FIT), proprietary mRNA biomarkers, AI, and machine learning. These findings highlight a significant improvement in CRC and advanced adenoma (AA) detection, aligning with previous European ColoFuture study results. Mainz Biomed aims to shift from cancer detection to prevention, potentially reducing CRC mortality rates worldwide.

Mainz Biomed N.V. will present the results of its eAArly DETECT study at Digestive Disease Week in Washington D.C. The study reported a sensitivity for colorectal cancer of 97% and a specificity of 97%, along with a sensitivity for advanced adenoma of 82%. The results indicate promising performance of a multimodal screening test combining various biomarkers with an AI algorithm to improve early detection rates for colorectal cancer and precancerous conditions.

Mainz Biomed reports positive topline results from a pooled study evaluating novel mRNA biomarkers and a proprietary AI algorithm for integration into a pivotal FDA PMA clinical trial for next-generation colorectal cancer diagnostic. The groundbreaking results show a sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%. The study included 690 subjects from Mainz Biomed's clinical trials, aiming to optimize sensitivity and specificity in CRC screening. The results represent a critical milestone towards launching the FDA PMA pivotal study ReconAAsense, planned to recruit up to 15,000 patients. Mainz Biomed's innovative next-generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing a robust and accurate test.

Mainz Biomed N.V. reported a 69% increase in revenue year over year, with a net loss in line with the previous year. The company's cash balance at year-end was $7.1 million. Key highlights include positive clinical study results for colorectal cancer detection, progress towards FDA PMA study for a self-administered CRC screening tool, and expansion of international commercialization of ColoAlert®. Financially, the company saw revenue growth, but also significant operating expenses leading to a net loss.