Welcome to our dedicated page for Mainz Biomed N.V. Ordinary Shares news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed N.V. Ordinary Shares stock.
Mainz Biomed N.V. (symbol: MYNZ) is a pioneering company in the field of molecular genetic diagnostics, dedicated to providing patient-friendly testing solutions for life-threatening conditions. With a mission to improve early detection rates and thereby save lives through science, Mainz Biomed develops market-ready products that are both accurate and easy to use.
One of their key innovations is ColoAlert®, a non-invasive, at-home screening test for colorectal cancer (CRC). Utilizing real-time Polymerase Chain Reaction (PCR) to detect molecular-genetic biomarkers in stool samples, ColoAlert® offers high sensitivity and specificity. This test is available in select European countries and is poised for FDA approval in the United States through the ongoing 'ReconAAsense' clinical trial.
Mainz Biomed aims to expand its market reach by fostering partnerships with laboratories and healthcare providers. The company is also committed to advancing the early detection of other cancers, including pancreatic cancer, through products like PancAlert, which is currently in early stages of development.
Recently, Mainz Biomed showcased ColoAlert® at the UDH Congress, emphasizing its role in enhancing comprehensive health strategies. The company reported a 69% year-over-year revenue increase for ColoAlert® and maintained a stable financial condition with a $7.1 million cash balance at year-end.
In collaboration with healthcare professionals, Mainz Biomed continues to contribute to scientific research and knowledge exchange. This commitment was highlighted by their latest clinical studies, ColoFuture and eAArly DETECT, which demonstrated extraordinary statistical significance in CRC and advanced adenoma detection.
For more details, visit Mainz Biomed's official website at www.mainzbiomed.com.
Mainz Biomed (NASDAQ:MYNZ) has partnered with Quest Diagnostics to advance its colorectal cancer screening test. Quest will provide laboratory services for Mainz's ReconAAsense FDA study, which will involve approximately 15,000 subjects across 150 US sites. The agreement includes an option for Quest to obtain semi-exclusive rights for testing services pending FDA approval.
The company's ColoAlert test, utilizing PCR technology to analyze stool samples for cancer DNA, has demonstrated promising sensitivity in detecting colorectal cancer and advanced adenomas. This development targets a significant market opportunity, as about one-third of US residents aged 50-75 have never undergone colorectal cancer screening, representing a potential $4.0B+ market in the US.
Mainz Biomed (NASDAQ:MYNZ) has completed its previously announced follow-on offering, raising $8.0 million in gross proceeds. The offering consisted of 1,367,521 units priced at $5.85 per unit. Each unit includes one ordinary share (or prefunded warrant), one Class A warrant, and one Class B warrant to purchase ordinary shares.
The Class A warrants are exercisable at $5.85 per share with a five-year expiration, while Class 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 served as the sole placement agent for this at-the-market offering under Nasdaq rules.
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.
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