Mainz Biomed Half Year 2025 Update: Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition
Mainz Biomed (NASDAQ:MYNZ) reported significant progress in H1 2025, focusing on advancing its colorectal and pancreatic cancer screening technologies. The company launched eAArly DETECT 2, a US feasibility study evaluating its next-gen colorectal cancer test across 2,000 average-risk patients.
A key development was the License and Option Agreement with Liquid Biosciences for pancreatic cancer screening biomarkers, which demonstrated 95% sensitivity and 98% specificity in initial studies. The company secured public funding from ISB for up to 50% of the pancreatic cancer project costs.
Additionally, Mainz Biomed expanded its market presence through partnerships with labor team w ag in Switzerland and EDX Medical Group in the UK. The company also completed a $4.0 million follow-on offering and regained full Nasdaq compliance.
Mainz Biomed (NASDAQ:MYNZ) ha riportato notevoli progressi nel primo semestre del 2025, concentrandosi sullo sviluppo delle sue tecnologie per lo screening del cancro colorettale e pancreatico. L'azienda ha lanciato eAArly DETECT 2, uno studio di fattibilità negli Stati Uniti che valuta il suo test di nuova generazione per il cancro colorettale su 2.000 pazienti a rischio medio.
Un importante traguardo è stato il Contratto di Licenza e Opzione con Liquid Biosciences per i biomarcatori dello screening del cancro pancreatico, che hanno mostrato una sensitivity del 95% e una specificity del 98% negli studi iniziali. L'azienda ha ottenuto finanziamenti pubblici dall'ISB per coprire fino al 50% dei costi del progetto sul cancro pancreatico.
Inoltre, Mainz Biomed ha ampliato la sua presenza sul mercato attraverso partnership con laboratori come w ag in Svizzera e EDX Medical Group nel Regno Unito. L'azienda ha anche completato un offerta di follow-on da 4,0 milioni di dollari e ha riconquistato la piena conformità con il Nasdaq.
Mainz Biomed (NASDAQ:MYNZ) reportó avances significativos en el primer semestre de 2025, centrando sus esfuerzos en el desarrollo de tecnologías para la detección del cáncer colorrectal y pancreático. La compañía lanzó eAArly DETECT 2, un estudio de viabilidad en Estados Unidos que evalúa su prueba de próxima generación para cáncer colorrectal en 2,000 pacientes de riesgo promedio.
Un avance clave fue el Acuerdo de Licencia y Opción con Liquid Biosciences para biomarcadores de detección del cáncer pancreático, que demostraron una sensibilidad del 95% y especificidad del 98% en estudios iniciales. La empresa aseguró financiamiento público de ISB para cubrir hasta el 50% de los costos del proyecto de cáncer pancreático.
Además, Mainz Biomed amplió su presencia en el mercado mediante alianzas con el equipo de laboratorios w ag en Suiza y EDX Medical Group en el Reino Unido. La compañía también completó una oferta pública secundaria de 4.0 millones de dólares y recuperó el cumplimiento total con Nasdaq.
Mainz Biomed (NASDAQ:MYNZ)는 2025년 상반기에 대장암 및 췌장암 선별 기술 개발에 집중하며 상당한 진전을 보고했습니다. 회사는 2,000명의 평균 위험군 환자를 대상으로 차세대 대장암 검사 평가를 위한 미국 내 타당성 연구 eAArly DETECT 2를 시작했습니다.
주요 성과로는 췌장암 선별 바이오마커에 대한 Liquid Biosciences와의 라이선스 및 옵션 계약이 있으며, 초기 연구에서 95% 민감도와 98% 특이도를 입증했습니다. 또한 회사는 췌장암 프로젝트 비용의 최대 50%를 지원하는 ISB의 공공 자금을 확보했습니다.
추가로 Mainz Biomed는 스위스의 w ag 연구팀 및 영국의 EDX Medical Group과의 파트너십을 통해 시장 입지를 확장했습니다. 회사는 400만 달러 규모의 후속 공모를 완료하고 나스닥 완전 준수를 회복했습니다.
Mainz Biomed (NASDAQ:MYNZ) a annoncé des progrès significatifs au premier semestre 2025, en se concentrant sur l'avancement de ses technologies de dépistage du cancer colorectal et du pancréas. La société a lancé eAArly DETECT 2, une étude de faisabilité aux États-Unis évaluant son test de nouvelle génération pour le cancer colorectal auprès de 2 000 patients à risque moyen.
Un développement clé a été le contrat de licence et d'option avec Liquid Biosciences pour les biomarqueurs du dépistage du cancer du pancréas, qui ont démontré une sensibilité de 95 % et une spécificité de 98 % lors des études initiales. La société a obtenu un financement public de l'ISB couvrant jusqu'à 50 % des coûts du projet sur le cancer du pancréas.
De plus, Mainz Biomed a étendu sa présence sur le marché grâce à des partenariats avec l'équipe de laboratoire w ag en Suisse et le groupe EDX Medical au Royaume-Uni. La société a également réalisé une augmentation de capital de 4,0 millions de dollars et a retrouvé sa pleine conformité avec le Nasdaq.
Mainz Biomed (NASDAQ:MYNZ) meldete bedeutende Fortschritte im ersten Halbjahr 2025 und konzentrierte sich auf die Weiterentwicklung seiner Screening-Technologien für Darm- und Bauchspeicheldrüsenkrebs. Das Unternehmen startete die eAArly DETECT 2, eine Machbarkeitsstudie in den USA, die seinen nächsten Darmkrebstest bei 2.000 Patienten mit durchschnittlichem Risiko evaluiert.
Ein wichtiger Meilenstein war der Lizenz- und Optionsvertrag mit Liquid Biosciences für Biomarker zum Screening von Bauchspeicheldrüsenkrebs, die in ersten Studien eine 95% Sensitivität und 98% Spezifität zeigten. Das Unternehmen sicherte sich öffentliche Fördermittel vom ISB für bis zu 50% der Projektkosten im Bereich Bauchspeicheldrüsenkrebs.
Darüber hinaus erweiterte Mainz Biomed seine Marktpräsenz durch Partnerschaften mit dem Laborteam w ag in der Schweiz und der EDX Medical Group im Vereinigten Königreich. Das Unternehmen schloss außerdem ein Folgeangebot über 4,0 Millionen US-Dollar ab und erreichte die vollständige Nasdaq-Konformität zurück.
- Promising pancreatic cancer biomarker results showing 95% sensitivity and 98% specificity
- Secured public funding covering up to 50% of pancreatic cancer project costs
- Successful expansion into Swiss market through strategic partnership
- Regained full Nasdaq compliance
- Raised $4.0 million through follow-on offering
- Share dilution from 2 million unit offering at $2.00 per unit
- FDA pivotal study for colorectal cancer delayed until 2026
Insights
Mainz Biomed advances FDA pathway for colorectal cancer screening while expanding into pancreatic cancer diagnostics with promising preliminary results.
Mainz Biomed's half-year update reveals significant progress on two critical fronts: advancing their colorectal cancer (CRC) screening technology toward FDA approval and expanding into pancreatic cancer diagnostics through a strategic acquisition.
The company launched eAArly DETECT 2, a 2,000-patient US feasibility study evaluating their next-generation CRC test that integrates proprietary mRNA biomarkers, an AI algorithm, and FIT testing. This study represents a crucial stepping stone toward their planned ReconAAsense pivotal FDA study in 2026, which would be required for Premarket Approval.
Mainz's market expansion continues with new partnerships bringing their ColoAlert® test to Switzerland through labor team w ag and to the UK via EDX Medical Group. These commercial agreements extend their European footprint while generating potential revenue streams before FDA approval.
Perhaps most notable is Mainz's strategic move into pancreatic cancer screening - a significantly underserved area with poor survival rates due to typically late diagnosis. Their License and Option Agreement with Liquid Biosciences provides access to novel mRNA biomarkers that demonstrated
The pancreatic cancer project gained further validation through public funding from Germany's Investitions- und Strukturbank Rheinland-Pfalz, covering up to
Financially, Mainz regained full Nasdaq compliance and raised
Company Advances its Progress toward FDA Premarket Approval Study for its Next Generation Colorectal Cancer Screening Product and Makes a Strategic Acquisition in the Field of Pancreatic Cancer Screening
BERKELEY, Calif. and MAINZ, Germany, July 15, 2025 (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 reviewed its major accomplishments of the first six months ending June 30, 2025, and provided a corporate update. The Company expects to release its half year financial results in September 2025.
Key Highlights During First Half 2025
- Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
- The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland.
- Mainz Biomed entered into a technology partnership with UK-based EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalized treatments for cancer, cardiovascular and infectious diseases. Under the agreement, EDX Medical will access the Company’s molecular diagnostic technology as part of the expansion of its portfolio of products for sale in the UK.
- Mainz Biomed entered into a License and Option Agreement with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of
95% and a98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed’s test to be the most robust and accurate screening test for pancreatic cancer on the market. - The Company announced the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of
95% with specificity of98% for the detection of pancreatic cancer in blood samples. - Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to
50% of the project’s total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company’s non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development. - The Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) confirming that it has regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on The Nasdaq Capital Market.
- Mainz Biomed priced a follow-on offering of 2,000,000 units, with each unit consisting of one ordinary share (or pre-funded warrant in lieu thereof), one Series A warrant (five-year life) to purchase one ordinary share, and one Series B warrant (one-year life) to purchase one ordinary share for gross proceeds of approximately
$4.0 million . Each unit was sold at an effective offering price of$2.00 per unit.
“I’m extremely pleased with the progress achieved during the first half of 2025 as we execute our ambitious growth strategy driven by our eAArly DETECT 2 study and advancements of our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of this year with a great momentum as we plan for the completion of our eAArly DETECT 2 feasibility study which will be the launching point for the ReconAAsense US FDA pivotal colorectal cancer study in 2026.”
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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 and the United Arab Emirates. 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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mainzbiomed@mc-services.eu
For investor inquiries, please contact ir@mainzbiomed.com
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 March 31, 2025. 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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