Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025
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), un'azienda di diagnostica genetica molecolare, ha rilasciato una dichiarazione che evidenzia i suoi piani strategici per il 2025. L'amministratore delegato Guido Baechler prevede un anno trasformativo con una significativa crescita e prove FDA negli Stati Uniti per le loro innovative soluzioni diagnostiche per il cancro. Il test di screening per il CRC di nuova generazione basato su mRNA dell'azienda ha dimostrato un notevole successo clinico, con sensibilità superiori al 90% per il cancro colorettale e 80% per gli adenomi avanzati.
Mainz Biomed prevede di presentare dati completi alla FDA nel 2025, mirano a penetrare nel mercato statunitense. L'azienda sta anche avanzando una pipeline di tecnologie diagnostiche, tra cui PancAlert. Nonostante le attuali preoccupazioni sui prezzi delle azioni, la direzione rimane concentrata sul raggiungimento di obiettivi chiave e sull'esecuzione della propria strategia per sbloccare il valore per gli azionisti.
Mainz Biomed N.V. (NASDAQ:MYNZ), una empresa de diagnóstico genético molecular, ha emitido un comunicado destacando sus planes estratégicos para 2025. El director ejecutivo Guido Baechler anticipa un año transformador con un crecimiento importante y ensayos de la FDA en EE. UU. para sus innovadoras soluciones de diagnóstico del cáncer. La prueba de detección de CRC de nueva generación basada en ARNm de la empresa ha mostrado un éxito clínico significativo, con sensibilidades que superan el 90% para el cáncer colorrectal y 80% para adenomas avanzados.
Mainz Biomed planea presentar datos completos a la FDA en 2025, con la intención de penetrar en el mercado estadounidense. La empresa también está avanzando en un portafolio de tecnologías de diagnóstico, incluido PancAlert. A pesar de las preocupaciones actuales sobre el precio de las acciones, la dirección se mantiene enfocada en cumplir hitos clave y ejecutar su estrategia para desbloquear el valor para los accionistas.
Mainz Biomed N.V. (NASDAQ:MYNZ), 분자 유전학 진단 회사가 2025년 전략 계획을 강조하는 성명을 발표했습니다. CEO 귀도 베흘러는 그들의 혁신적인 암 진단 솔루션을 위한 미국 FDA 시험과 주요 성장이 함께할 변혁의 해가 될 것으로 예상하고 있습니다. 이 회사의 mRNA 기반 차세대 CRC 스크리닝 테스트는 대장암에 대해 90% 이상의 민감성을 보이며, 고급 선종에 대해서는 80%에 달하는 중요한 임상적 성공을 보여주었습니다.
Mainz Biomed는 2025년 FDA에 종합 데이터를 제출할 계획이며, 미국 시장에 진입하는 것을 목표로 하고 있습니다. 회사는 PancAlert를 포함하여 진단 기술의 파이프라인을 발전시키고 있습니다. 현재 주가에 대한 우려가 있음에도 불구하고, 경영진은 주요 이정표 달성과 주주 가치를 열기 위한 전략 실행에 집중하고 있습니다.
Mainz Biomed N.V. (NASDAQ:MYNZ), une entreprise de diagnostic génétique moléculaire, a publié un communiqué soulignant ses plans stratégiques pour 2025. Le PDG Guido Baechler prévoit une année transformative avec une croissance majeure et des essais de la FDA aux États-Unis pour leurs solutions diagnostiques innovantes contre le cancer. Le test de dépistage du CRC de nouvelle génération à base d'ARNm de l'entreprise a montré un succès clinique significatif, avec des sensibilités dépassant 90% pour le cancer colorectal et 80% pour les adénomes avancés.
Mainz Biomed prévoit de soumettre des données complètes à la FDA en 2025, visant à pénétrer le marché américain. L'entreprise avance également un portefeuille de technologies diagnostiques, y compris PancAlert. Malgré les préoccupations actuelles concernant le prix des actions, la direction reste concentrée sur la réalisation des jalons clés et l'exécution de sa stratégie pour débloquer la valeur pour les actionnaires.
Mainz Biomed N.V. (NASDAQ:MYNZ), ein Unternehmen für molekulare genetische Diagnostik, hat eine Erklärung veröffentlicht, die die strategischen Pläne für 2025 hervorhebt. CEO Guido Baechler erwartet ein transformierendes Jahr mit signifikantem Wachstum und FDA-Studien in den USA für ihre innovativen Krebsdiagnoselösungen. Der mRNA-basierte Next-Generation CRC-Screening-Test des Unternehmens hat erhebliche klinische Erfolge mit einer Empfindlichkeit von über 90% für Kolorektalkrebs und 80% für fortgeschrittene Adenome gezeigt.
Mainz Biomed plant, 2025 umfassende Daten bei der FDA einzureichen, um in den US-Markt einzudringen. Das Unternehmen arbeitet auch an einer Pipeline von Diagnosetechnologien, einschließlich PancAlert. Trotz der aktuellen Bedenken bezüglich des Aktienkurses bleibt das Management fokussiert auf die Erreichung wesentlicher Meilensteine und die Umsetzung seiner Strategie zur Freisetzung des Aktionärswertes.
- mRNA-based CRC screening test shows over 90% sensitivity for colorectal cancer detection
- Plans to submit comprehensive data to FDA in 2025 for U.S. market entry
- Expanding diagnostic pipeline, including PancAlert for multiple cancer detection
- Relaunched expanded version of first-generation CRC screening test in Europe
- Anticipating major growth and U.S. FDA trials in 2025
- Current stock price performance is disappointing
- Withdrew FDA Breakthrough Device Designation application to focus on extending clinical research
- Delayed filing of June 30, 2024 financials to fourth quarter of 2024
Insights
The CEO's statement outlines significant progress in Mainz Biomed's colorectal cancer (CRC) screening technology. Their mRNA-based test has shown impressive sensitivity rates of over 90% for CRC detection and over 80% for advanced adenomas. These results, presented at major medical conferences, position the company's technology as potentially superior to existing screening methods.
The company's strategic decision to withdraw its FDA Breakthrough Device Designation application in favor of expanding clinical research demonstrates a commitment to robust data collection. This move, while delaying immediate FDA engagement, could strengthen their position for the planned 2025 FDA trials. The focus on stool-based testing over blood tests for advanced adenoma detection aligns with current scientific understanding and could be a key differentiator.
However, investors should note that the June 30, 2024 financials have not yet been filed, with plans to do so in Q4 2024. This delay in financial reporting, while explained, may raise questions about the company's current financial position and burn rate as they approach critical clinical milestones.
Mainz Biomed's market strategy appears focused on global expansion, with a particular emphasis on entering the lucrative U.S. market through FDA trials planned for 2025. The company's current commercialization in Germany and select European countries provides a foundation for growth, but the U.S. market entry represents a significant potential revenue catalyst.
The redevelopment and relaunch of their first-generation CRC screening test in Europe, with reported positive feedback from labs, suggests potential for accelerated growth in their existing markets. This could provide a revenue boost while the company prepares for U.S. expansion.
However, with a current market cap of only
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 transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through its innovative diagnostic solutions.
“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.” In the notes below, you will find more information about our current status and upcoming plans that we are executing, reaffirming our commitment to early cancer detection and the exciting developments that are currently underway.” Baechler commented further, “Like all our shareholders, management and the Board of Directors are concerned and disappointed with the performance of our stock price. We commit to our shareholders that we will continue to strive to deliver what we have promised under difficult market conditions.” Baechler commented further, “We are strongly convinced that 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through our innovative diagnostic solutions.”
Corporate Flagship Product: Breakthrough Data and U.S. Expansion
mRNA-based next-generation CRC screening tests are redefining standards in early cancer detection. Mainz Biomed's flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both U.S. and European trials. Presentations at DDW and ASCO this year have highlighted sensitivities exceeding
Mainz Biomed, alongside other companies, emphasizes the use of stool-based samples for CRC and advanced adenoma detection due to their direct connection to cancer cells and adenomas. Recent reports suggesting the ease of blood tests over stool tests must be carefully evaluated, as extensive studies in the U.S. and Europe have shown significantly lower sensitivity of blood tests in identifying advanced adenomas. This limitation arises because early-stage advanced adenomas are not typically connected to the body's blood supply, making them undetectable through blood samples.
In early July the Company has announced that based on its robust clinical data package it submitted for FDA Breakthrough Device Designation (BDD) for its next generation CRC screening test. Following encouraging feedback from the FDA, the Company has made the strategic decision to withdraw its BDD application to focus on extending its clinical research program. Mainz Biomed will expand its dataset to include a larger average-risk patient population with its pivotal ReconAAsense trial. The Company plans to submit this comprehensive data in 2025 to FDA.
The consistently positive data from the Company’s clinical feasibility studies presented at ASCO 2024 and Digestive Disease Week (DDW), provide a strong foundation as Mainz Biomed prepares for U.S. FDA clinical trials in 2025, a key milestone in its strategy to penetrate the U.S. market. Successful completion of the FDA trial will allow Mainz Biomed’s next generation CRC screening test to be marketed to millions of Americans at risk of colorectal cancer, representing a major revenue growth opportunity for the company.
Innovative Diagnostic Pipeline
In addition to its mRNA next-generation CRC screening test, Mainz Biomed is advancing a robust pipeline of cutting-edge diagnostic technologies aimed at detecting multiple cancers, with PancAlert leading the way. 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.
Current development and expansion of the current ColoAlert screening test
Mainz Biomed has redeveloped and relaunched an expanded version of its first-generation CRC screening test currently commercialized in Germany and selected other countries in Europe. The change implemented in the ColoAlert product significantly simplified the workflow and reduced the retest rates. The feedback from the lab communities has been very positive and the Company expects this new product to further accelerate the growth and lab expansion.
Committed on delivering on key milestones for fair Company valuation
Mainz Biomed’s strong clinical results, expanding pipeline, and upcoming FDA trial, it is the management’s position that the Company’s current stock price does not adequately reflect its true value. While the Mainz Biomed cannot directly influence the stock market, the management team is fully focused on delivering on key milestones and executing its strategy to unlock value for shareholders.
Pursuant to Nasdaq and SEC rules the June 30, 2024, financials are required by December 31, 2024. The Company plans to file during the fourth quarter of 2024.
Looking Ahead: FDA Trials and Major Growth in 2025
2024 is a year of continued clinical progress and market expansion, but the FDA trials anticipated for 2025 represent a pivotal moment for Mainz Biomed. Successfully navigating the regulatory landscape in the U.S. will unlock significant opportunities to serve millions of patients in the world’s largest healthcare market.
In the meantime, the Company will continue to scale operations across Europe and other international markets, building on its scientific leadership in cancer diagnostics. With exciting innovations in the pipeline, Management is confident that Mainz Biomed is on track to revolutionize early cancer detection globally.
Further, we are pleased to have added a leader like Petra Starke to our team as a Brand Ambassador. Petra is a thought leader in the field of colorectal cancer. Her insights will continue to be invaluable as we focus our efforts in both Europe and the U.S.
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
FAQ
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