Mainz Biomed(MYNZ)

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Mainz Biomed N.V. Regains Compliance with Nasdaq Capital Market Listing Requirements
GlobeNewswire· 2025-01-27 13:01
Core Points - Mainz Biomed NV has regained compliance with Nasdaq's minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market as of January 23, 2025 [1] - The company had previously confirmed compliance with the minimum bid price requirement, and is now fully compliant with all Nasdaq continued listing requirements [1] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being ColoAlert, a non-invasive test for colorectal cancer [2] - ColoAlert is marketed in Europe and the UAE, and the company is conducting a pivotal FDA clinical study for US regulatory approval [2] - The product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [2]
Mainz Biomed Initiates U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population
Newsfilter· 2025-01-21 13:01
Study Overview - Mainz Biomed NV launches eAArly DETECT 2, a U S feasibility study to evaluate its next-generation colorectal cancer (CRC) test, integrating mRNA biomarkers, AI algorithms, and FIT test, targeting a population of approximately 2,000 average-risk patients [1] - The study aims to validate previous feasibility study results, which included both average-risk and identified-risk patients, and is expected to complete enrollment in the second half of 2025 with topline results reported by Q4 2025 [1][2] Study Objectives and Impact - The eAArly DETECT 2 study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown unique ability to identify advanced adenomas and early-stage CRC [3] - The study aims to enhance product specifications by combining these biomarkers with Mainz Biomed's proprietary AI algorithm, potentially increasing diagnostic sensitivity and specificity for early-stage CRC [3] - Successful outcomes from the study will enable Mainz Biomed to finalize protocols for ReconAAsense, its U S pivotal study, scheduled to initiate in 2026 [2] Company Strategy and Vision - The launch of eAArly DETECT 2 is a significant milestone for Mainz Biomed, accelerating the timeline to evaluate biomarkers for inclusion in the U S pivotal study [3] - The company's next-generation CRC test aims to transform colorectal cancer screening by detecting cancerous polyps with high accuracy and potentially preventing the disease through early detection of precancerous adenomas [2][3] - Mainz Biomed's mission is to transform CRC screening practices and reduce global cancer mortality rates by enabling precise detection of advanced adenomas and early-stage CRC [3] Company Background - Mainz Biomed specializes in molecular genetics diagnostics for life-threatening conditions, with ColoAlert® as its flagship product, marketed in Europe and the UAE [4] - The company is conducting a pivotal FDA clinical study for U S regulatory approval of ColoAlert® and is developing PancAlert, an early-stage pancreatic cancer screening test [4]
Mainz Biomed Forms Agreement with Quest Diagnostics to Provide Clinical Trials Laboratory Services for Colorectal Cancer Screening Test
GlobeNewswire· 2024-12-19 13:01
Quest to Support Mainz Biomed’s ReconAAsense FDA Study and Has Option to Commercialize Test Kit Assuming FDA ApprovalBERKELEY, Calif. and MAINZ, Germany, Dec. 19, 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 an agreement with Quest Diagnostics (NYSE:DGX), a leading provider of diagnostic information services, to support commercialization of Mainz Biomed’s Next ...
Mainz Biomed Announces Closing of $8.0 Million Follow-On Offering
Newsfilter· 2024-12-16 22:00
Core Points - Mainz Biomed N.V. has successfully closed a follow-on offering of 1,367,521 units, generating approximately $8.0 million in gross proceeds [1] - Each unit was sold at an effective price of $5.85, which includes one ordinary share and two types of warrants [1] - The Class A and Class B warrants are both immediately exercisable at the same price and have different expiration conditions [1] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection [3] - The flagship product, ColoAlert®, is a non-invasive test for colorectal cancer, currently marketed in Europe [3] - The company is conducting a pivotal FDA clinical study for regulatory approval in the U.S. and is developing PancAlert, a pancreatic cancer screening test [3]
Mainz Biomed Announces Reverse Stock Split Soon After Collaborating With MedTech Giant Thermo Fisher Scientific
Benzinga· 2024-12-03 19:40
Mainz Biomed N.V. MYNZ announced a 1-for-40 reverse stock split, effective Dec. 3. The company specializes in the early detection of cancer.Last month, Mainz Biomed reported a collaborative agreement with Thermo Fisher Scientific Inc. TMO through its subsidiary Life Technologies Corporation.The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed’s Next Generation colorectal cancer screening product.The collaboration will harness Th ...
Mainz Biomed Announces Stock Split
GlobeNewswire News Room· 2024-11-29 13:45
BERKELEY, Calif. and MAINZ, Germany, Nov. 29, 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, today announced a 1-for-40 reverse stock split of its issued and outstanding shares. The reverse stock split was authorized by the Board of Directors of the Company pursuant to shareholder approval granted at its Extraordinary Shareholders Meeting on November 20, 2024. The reverse stock ...
Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-10-21 12:01
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 diag ...
Mainz Biomed(MYNZ) - 2024 Q2 - Quarterly Report
2024-10-18 20:00
Exhibit 99.2 Mainz Biomed N.V. Consolidated Statements of Financial Position (Unaudited) (Expressed in US Dollars) | | | | | December | | --- | --- | --- | --- | --- | | | | June 30, | | 31, | | | Note | 2024 | | 2023 | | ASSETS | | | | | | Current Assets | | | | | | Cash | | $ 977,764 | | $ 7,070,925 | | Trade and other receivables, net | 4 | 139,414 | | 93,555 | | Inventories | 5 | 520,531 | | 613,638 | | Prepaid expenses and other current assets | 6 | 751,994 | | 1,201,778 | | Total Current Assets | | 2, ...
Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025
GlobeNewswire News Room· 2024-10-01 12:01
BERKELEY, Calif. and MAINZ, Germany, Oct. 01, 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, today released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Management believes 2025 will be a transformat ...
Mainz Biomed Announces Petra Smeltzer Starke to Join Company as Brand Ambassador
GlobeNewswire News Room· 2024-09-18 12:01
BERKELEY, Calif. and MAINZ, Germany, Sept. 18, 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 the addition of Petra Smeltzer Starke as a Brand Ambassador for the Company. As Brand Ambassador she will help the Company in the development and dissemination of messaging focused on the importance of early detection of colorectal cancer. "We are excited about Petra jo ...