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By Meg Flippin, Benzinga
From clinical developments to an upcoming FDA trial anticipated in 2025, Mainz Biomed NV (NASDAQ: MYNZ), the molecular genetics diagnostic company, is making headway in growing its business on its path to profitability.
ColoAlert®, its flagship product, is a key driver of its growth. Aimed at revolutionizing the colorectal cancer testing industry, ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases, often in the very early stages of the disease, compared to the closest US competitor, Exas Science, delivering only 43% of Sensitivity for Advanced Adenomas. That is a key edge for the company, given the company says 71% of diagnoses made are in the later stages of the disease.
U.S. Clinical Trials On The Horizon
The product appears to be making inroads, with the company demonstrating at two conferences what it says are significant clinical successes in U.S. and European trials. Presentations at Digestive Disease Week – the meeting for professionals working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields – and the American Society of Clinical Oncology meeting highlighted ColoAlert’s success.
Mainz Biomed said in presentations that based on trials, ColoAlert’s sensitivities exceeded 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development, reports Mainz. The company was also awarded as a Poster of Distinction by the Digestive Disease Week judges for the presentation of industry-leading results.
Mainz said the positive data presented at those conferences puts it in a good position as it gears up for U.S. FDA clinical trials next year. It will mark a key milestone in its efforts to break into the U.S. market. If it gets the nod from the FDA, Mainz Biomed will be able to market ColoAlert to millions of Americans at risk of colorectal cancer. That, says the company, represents a major revenue growth opportunity.
“As we enter a critical phase in our company’s journey, Mainz Biomed’s vision remains focused on leading the way in cancer diagnostics,” said Guido Baechler, CEO of Mainz Biomed. “Our groundbreaking clinical results with our mRNA based next generation CRC screening test and our strategic pathway to FDA trials, which we plan to start in 2025, demonstrate our commitment to expanding into the world’s largest healthcare market. These efforts, combined with our growing international footprint, underscore why we believe Mainz Biomed is currently undervalued relative to its potential.”
Growing Support
Since those conferences, Mainz reports it has seen increased demand from existing and prospective laboratory partners for its enhanced ColoAlert product launched in July and currently being commercialized across Europe and in select international markets. The enhancement implemented in the ColoAlert product significantly simplified the workflow and reduced the retest rates, and the company reported reducing its net loss for the first six months of 2024 by 26% compared to the previous year’s first half.
Mainz said feedback from the lab communities has been very positive, and the company expects this new product to further accelerate growth and lab expansion. The company is betting the advanced version of ColoAlert will become the standard offering for all existing partners. GANZIMMUN Diagnostics, one of Germany’s premier laboratories, is one of the earliest partners to make the transition to the new version of ColoAlert.
Brand Ambassadors Get It
The support of existing and new lab partners isn’t the only backing the biopharmaceutical company is getting for ColoAlert. It recently announced Petra Smeltzer Starke, a former General Counsel to the White House Council of Economic Advisors, Senior Advisor to President Obama, and founder and CEO of a global growing hot yoga healthy lifestyle brand SweatNGlow, is now a brand ambassador. Mainz said Starke will help the company develop and disseminate messages focused on the importance of early detection of colorectal cancer.
Meanwhile, Frankie Muniz, an Emmy Award- and Golden Globe-nominated actor from Malcolm in the Middle and a professional NASCAR Craftsman Truck Series driver, is also backing the company as he speaks out about colorectal cancer cases in young people, which has surged 500% in the past twenty-two years. Among kids between 10 and 14 cases have risen 333%, according to the University of Missouri-Kansas City. “Colorectal cancer is no longer considered just a disease of the elderly population,” said lead researcher Islam Mohamed, MD, an internal medicine resident physician at the University of Missouri-Kansas City. “It’s important that the public is aware of signs and symptoms of colorectal cancer,” Muniz told his nearly 350,000 followers on X that ColoAlert is a game-changer.
PancAlert Up Next
Beyond ColoAlert, Mainz Biomed says it has a robust pipeline of diagnostic technologies aimed at detecting multiple cancers, with PancAlert leading the way. Mainz Biomed is collaborating with Liquid Biosciences on the next-generation detection test for pancreatic cancer. The companies are leveraging Liquid Biosciences' proprietary AI analysis technology platform EMERGE to extend and optimize the selection of novel biomarkers for PancAlert. The first phase of the collaboration included the evaluation of biomarkers from Mainz’s research program co-funded by the German Federal Ministry for Education and Research. The companies applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, which leads Maniz and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with ColoAlert.
“Our focus on molecular diagnostics, powered by proprietary biomarkers, positions us to address a wide range of cancers early, improving patient outcomes and reducing healthcare costs globally. The success of our upcoming products will help diversify our revenue streams and strengthen our leadership in cancer diagnostics,” said Baechler.
Photo by National Cancer Institute on Unsplash
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