Welcome to our dedicated page for Mainz Biomed NV news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed NV stock.
Mainz Biomed NV (MYNZ) pioneers non-invasive cancer detection through advanced molecular diagnostics like its flagship ColoAlert test. This page aggregates official news releases and clinical updates critical for understanding the company’s progress in colorectal and pancreatic cancer screening.
Investors and researchers will find timely updates on regulatory milestones, product developments, and strategic partnerships. Content spans clinical trial results, technology enhancements leveraging AI, and market expansion efforts across Europe and North America.
Key focus areas include advancements in PCR-based testing, collaborations with medical institutions, and data from ongoing studies. Bookmark this page to efficiently track Mainz Biomed’s contributions to early cancer detection and molecular diagnostics innovation.
Mainz Biomed (NASDAQ:MYNZ) has announced the pricing of a follow-on offering expected to raise $8.0 million in gross proceeds. The offering consists of 1,367,521 units, each priced at $5.85 and including one ordinary share (or prefunded warrant), one Series A warrant, and one Series B warrant.
The Series A warrants will be exercisable at $5.85 per share with a five-year expiration, while Series B warrants, also exercisable at $5.85, will expire either 30 days after the eAArly Detect 2 study results or one year from issuance. Maxim Group is serving as the sole placement agent, with the offering expected to close around December 16, 2024.
Mainz Biomed (NASDAQ:MYNZ) announced a 1-for-40 reverse stock split effective December 3, 2024. The split will reduce outstanding shares from approximately 80.1 million to 2.0 million. This action aims to increase market price per share to comply with Nasdaq's continued listing requirements. The company received notice of non-compliance with Nasdaq's minimum bid price requirement of $1.00 and the $2,500,000 minimum stockholders' equity requirement. Following a staff determination letter, Mainz Biomed plans to request a hearing to stay any suspension or delisting action.
Mainz Biomed (NASDAQ:MYNZ) has announced a collaborative agreement with Thermo Fisher Scientific to jointly develop and potentially commercialize Mainz's Next Generation colorectal cancer screening product. The collaboration will utilize Thermo Fisher's technologies, instrumentation, and information translation systems to develop proprietary mRNA-based screening tests.
The partnership aims to enhance Mainz Biomed's non-invasive test that targets both early detection of colorectal cancer and precancerous lesions, particularly advanced adenomas. The development will take place at Mainz Biomed's laboratories in Mainz, Germany, focusing on creating a home collection colorectal screening tool with enhanced adenoma detection capabilities.
Mainz Biomed N.V. (NASDAQ:MYNZ) reported mid-year 2024 financial results and provided a corporate update. Key highlights include:
- Revenue increased 4% year-over-year
- Loss from operations decreased by 32%
- Presented groundbreaking results at DDW 2024 and ASCO 2024, showing high sensitivity for colorectal cancer (CRC) and advanced adenomas
- Improved ColoAlert® product with new DNA stabilizing buffer
- Expanded collaboration with Liquid Biosciences for pancreatic cancer detection
- Received FDA feedback on breakthrough device designation
- Announced strategic focus on three key initiatives for 2024-2025
The company aims to grow its ColoAlert® business in Europe, develop its next-generation CRC screening product, and conduct a 2,000-patient study (eAArly DETECT 2) in the U.S. Mainz Biomed also implemented cost reductions to streamline operations.
Mainz Biomed N.V. (NASDAQ:MYNZ) has reported increased demand for its enhanced ColoAlert product, launched in July 2024. The improved version of this colorectal cancer (CRC) screening test is being adopted by existing partners and attracting new ones across Europe and select international markets. GANZIMMUN Diagnostics, a leading German laboratory, will fully implement the enhanced ColoAlert by early next year.
The enhanced ColoAlert features a proprietary DNA stabilizing buffer and streamlined collection devices, reducing retesting needs and offering faster results in 2-3 days. GANZIMMUN will showcase ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress focusing on complementary medicine, from October 30 to November 3, 2024. This event will promote Mainz Biomed's DNA-based CRC screening test to medical professionals and researchers interested in advanced diagnostic solutions.
Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company, has released a statement highlighting its strategic plans for 2025. CEO Guido Baechler anticipates a transformative year with major growth and U.S. FDA trials for their innovative cancer diagnostic solutions. The company's mRNA-based next-generation CRC screening test has shown significant clinical success, with sensitivities exceeding 90% for colorectal cancer and 80% for advanced adenomas.
Mainz Biomed plans to submit comprehensive data to the FDA in 2025, aiming to penetrate the U.S. market. The company is also advancing a pipeline of diagnostic technologies, including PancAlert. Despite current stock price concerns, management remains focused on delivering key milestones and executing their strategy to unlock shareholder value.
Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company focusing on early cancer detection, has announced the addition of Petra Smeltzer Starke as a Brand Ambassador. In this role, Starke will assist in developing and disseminating messaging about the importance of early colorectal cancer detection. The company aims to launch a pivotal PMA trial for its next-generation colorectal cancer screening product by the end of 2025.
CEO Guido Baechler expressed excitement about Starke joining the team, highlighting her extensive experience as invaluable to their mission. Starke, in turn, expressed pride in working with Mainz Biomed as they advance early detection of colorectal cancer and pre-cancerous polyps.
Mainz Biomed (NASDAQ:MYNZ) has expanded its collaboration with Liquid Biosciences to leverage AI for optimizing biomarker selection in PancAlert, its next-generation pancreatic cancer detection test. The partnership aims to enhance early-stage disease detection, potentially combining PancAlert with Mainz Biomed's colorectal cancer screening product.
The first phase of collaboration showed promising results, leading to a second phase that will include microbiome biomarkers analyzed with Microba Life Sciences in 2023. The companies plan to complete this analysis in Q4 2024. Pancreatic cancer, with a global mortality rate of 466,000 annually, has one of the lowest survival rates among major cancers, emphasizing the critical need for early detection methods.
Mainz Biomed N.V. (NASDAQ: MYNZ) has announced significant improvements to its ColoAlert product, a highly efficacious at-home detection test for colorectal cancer (CRC). The enhancements include:
1. A novel DNA stabilizing buffer that accommodates varying sample volumes, reducing the need for retesting and enabling results delivery within 2-3 days.
2. Refined kit features for improved usability, including an enhanced collection device and new tube design.
These upgrades aim to enhance customer satisfaction, streamline lab operations, and maintain ColoAlert's position as a leading CRC screening solution. The improved product is now available to existing and prospective laboratory partners.
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.
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