Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update
Revenue increases 4% year over year while loss from operations decreases by 32%
Pooled Results of ColoFuture and eAArly DETECT studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia
Company highlights its path to success for 2025
BERKELEY, Calif. and MAINZ, Germany, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the first half of 2024, an update on 2024 accomplishments, and its outlook for the end of the year and strategic direction for 2025.
Key 2024 Accomplishments
During the first six months of 2024, the Company's revenue increased by 4% year over year while the loss from operations and net loss decreased by 32% and 26%, respectively. These decreases are the result of the Company's efforts to reduce costs during the first half of the year.
Mainz Biomed published key findings from its groundbreaking eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The Company was awarded as a Poster of Distinction by the Digestive Disease Week judges for the presentation of industry leading results: 97% sensitivity for colorectal cancer (CRC) and 82% for advanced precancerous lesions. The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected.
The Company presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois. This data combined results from the ColoFuture and eAArly DETECT studies including additional patient samples collected since the first reported study results, demonstrating the significance of its innovative screening approach. The new study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 96% detection of high-grade dysplasia.
The Company announced significant improvements to its ColoAlert® product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. To increase screening/lab efficiency, Mainz Biomed introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes, addressing a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. The new proprietary buffer used in ColoAlert® significantly reduces the necessity for additional sample submissions, thereby decreasing the time for the patients to obtain their results. This enhancement has enabled ColoAlert® to achieve the industry's lowest retesting rates, ensuring that screening outcomes are delivered within just 2, 3 days upon arrival at the laboratory.
The Company expanded its collaboration with Liquid Biosciences to Mainz Biomed's 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 the Company's research program co-funded by the German Federal Ministry for Education and Research, and applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, leading the Company and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with Mainz Biomed's colorectal cancer screening product.
Post-period Update
In September 2024, Mainz Biomed announced encouraging feedback received from the FDA for the breakthrough device designation with the request to expand the current clinical data set with additional average risk population.
In October 2024, the Company made the strategic decision to focus its efforts on three key initiatives for the remainder of 2024 and into 2025 in order to maximize shareholder value. Those initiatives are:
The continued growth of its ColoAlert® business in Europe;
Development of its next generation colorectal cancer screening product; and
Running a 2,000 patient study, with average risk patients in the U.S., to read out in the second half of 2025 (eAArly DETECT 2). With eAArly DETECT 2, the Company addresses the recent FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population.
In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.
"2024 has been a transitional year for Mainz Biomed. While navigating through a period of difficult markets, especially for small cap technology stocks, we are proud to have achieved many significant accomplishments to date," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "As the Board and management team evaluated our path forward, we believe that a narrower focus on key strategic initiatives gives us the best opportunity to unlock shareholder value in the remainder of 2024 and 2025."
Condensed Consolidated Financial Statements (unaudited):
Mainz Biomed N.V.
Condensed Consolidated Statements of Profit or Loss and Comprehensive Loss (unaudited)
(in U.S. Dollars)
Six months ended
June 30,
2024
2023
Revenue
$
520,773
$
499,049
Cost of sales
201,735
211,310
Product margin
319,038
287,739
61%
58%
Operating expenses:
Sales and marketing
2,361,105
3,992,975
Research and development
3,242,622
5,481,229
General and administrative
4,522,639
5,227,181
Total operating expenses
10,126,366
14,701,385
Loss from operations
(9,807,328)
(14,413,646)
Other income (expense)
Other income
105,851
125,968
Change in fair value of ...
