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

Mainz Biomed (NASDAQ:MYNZ) reported a 127% year-over-year increase in ColoAlert revenue, totaling $238,255 for the six months ended June 30, 2022.

The company achieved a mid-year cash balance of $26 million and initiated key international partnerships. The U.S. pivotal clinical trial for ColoAlert is set to start in Q4 2022, following supportive FDA feedback. However, Mainz recorded a net loss of $12.6 million and a gross profit decline, emphasizing increased operating expenses.

Mainz Biomed, a molecular genetics diagnostic company, announced participation in the H.C. Wainwright Annual Global Investment Conference from September 12-14, 2022, in New York City. CFO Bill Caragol will represent the company at this prestigious event. Mainz Biomed specializes in early cancer detection, particularly colorectal cancer, through its product ColoAlert. This non-invasive test boasts high sensitivity and specificity, providing a crucial tool for early diagnosis and intervention in colorectal cancer, a leading cause of cancer mortality.

Mainz Biomed N.V. (NASDAQ:MYNZ) announced the appointment of Dr. D. Kim Turgeon to its Medical Advisory Board to support its upcoming pivotal trial for ColoAlert, a colorectal cancer detection test. Dr. Turgeon, an expert in gastroenterology and clinical research at University of Michigan Health, brings extensive experience in clinical trials. Mainz aims to enhance ColoAlert's capabilities and prepare for FDA submission, which follows positive feedback on its pre-submission package. The U.S. market for colorectal cancer screening is projected to be approximately $3.7 billion annually.

Mainz Biomed (NASDAQ:MYNZ) has launched its ColoAlert consumer program in Italy and the UAE through a partnership with Dante Genomics. ColoAlert is an at-home colorectal cancer detection test that is CE-IVD certified, ensuring compliance with EU standards. This expansion represents a significant step in increasing accessibility to early detection services, leveraging Dante’s extensive database and regional e-commerce platforms. The test, noted for its high sensitivity and specificity, emphasizes Mainz's commitment to advancing personalized medicine in oncology.

Mainz Biomed has appointed Dr. Frank Krieg-Schneider as Vice President of Development to enhance its cancer detection portfolio, including the flagship product ColoAlert. Dr. Krieg-Schneider brings over 25 years of experience in diagnostics, having previously held executive roles at QIAGEN and GNA Biosolutions. His role will focus on advancing ColoAlert through the integration of novel mRNA biomarkers and ensuring compliance with US regulatory standards to support FDA submission. The company aims to significantly expand its market presence, particularly in the US, addressing a potential $3.7 billion opportunity.

Mainz Biomed N.V. (NASDAQ:MYNZ) has established a Medical Advisory Board (MAB) with Dr. Timothy Wang as its inaugural member. The MAB aims to support the forthcoming U.S. pivotal trial for ColoAlert, a colorectal cancer detection test, and evaluate its potential for additional oncology applications. Dr. Wang's expertise in gastroenterology and cancer research enhances the team's capabilities. The pivotal trial is set to start in 2023 following positive feedback from the FDA. Mainz is also advancing ColoFuture, a clinical study aimed at integrating novel biomarkers to improve detection sensitivity.

Mainz Biomed N.V. (NASDAQ:MYNZ) will host a webcast today, July 12, 2022, at 4:00 PM ET to discuss its first half 2022 progress and future plans. The forum will cover its flagship product, ColoAlert, a non-invasive colorectal cancer detection test, including updates on its U.S. regulatory approval and ongoing R&D initiatives. The company aims to enhance ColoAlert's profile while developing additional diagnostic solutions. CEO Guido Baechler emphasized the operational advancements since the company's public transition in November 2021.

Mainz Biomed is set to host a webcast on July 12, 2022, at 4:00 PM ET to discuss its first-half 2022 progress and future plans. The session will feature updates on its flagship product, ColoAlert, a non-invasive colorectal cancer detection test. The webcast aims to inform investors about ColoAlert's regulatory pathway and ongoing R&D efforts to enhance its effectiveness. CEO Guido Baechler emphasized the importance of this update following the company’s transition to the public sector in November 2021.

Mainz Biomed (NASDAQ:MYNZ) has initiated the ColoFuture clinical trial to enhance the ColoAlert test for colorectal cancer detection. The trial, involving over 600 patients across Norway and Germany, aims to incorporate novel mRNA biomarkers acquired from Université de Sherbrooke, and results are expected by early 2023. If successful, these developments could position ColoAlert as a leading home screening test. Additionally, Mainz is preparing for a pivotal U.S. trial, which will adapt based on ColoFuture outcomes.