Mainz Biomed Provides Review of 2025 Highlights
Rhea-AI Summary
Mainz Biomed (NASDAQ:MYNZ) reviewed 2025 highlights including clinical, regulatory, partnership, and funding progress for its cancer-detection programs.
Key items: launch of eAArly DETECT 2 (U.S. feasibility study, ~2,000 average-risk patients) to validate a next-generation CRC test; ColoAlert received MHRA and Swissmedic registrations and entered Swiss and South American distribution partnerships; pancreatic program licensed mRNA biomarkers from Liquid Biosciences with a discovery cohort (285 subjects; 35 pancreatic cancers) showing 95% sensitivity / 98% specificity, and a feasibility panel achieving 100% sensitivity / 95% specificity in a 30-subject cohort. State funding may cover up to 50% of pancreatic project costs.
Positive
- eAArly DETECT 2 launched with ~2,000 average-risk U.S. patients
- ColoAlert registered by MHRA and Swissmedic for UK and Swiss markets
- Pancreatic biomarkers discovery: 95% sensitivity and 98% specificity (285-subject cohort)
- Feasibility panel achieved 100% sensitivity and 95% specificity in a 30-subject study
- ISB funding may cover up to 50% of pancreatic project costs
Negative
- Pancreatic leading panel validated on only a 30-subject feasibility cohort
- Discovery accuracy derived from a cohort with 35 pancreatic cancer patients
News Market Reaction – MYNZ
On the day this news was published, MYNZ gained 9.48%, reflecting a notable positive market reaction. Argus tracked a peak move of +20.0% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $12M at that time. Trading volume was elevated at 2.6x the daily average, suggesting notable buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
MYNZ gained 3.57% with mixed peer action: ISPC up 5.93%, CHEK up 2.55%, BIAF and ADVB modestly positive, while XWEL fell 6.25%. Momentum scanner shows NOTV up and ISPC down, reinforcing a stock‑specific move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 02 | Commercial partnership | Positive | +2.6% | ColoAlert added to DoctorBox’s digital health portfolio in Germany. |
| Nov 18 | Geographic expansion | Positive | -4.8% | MOU to introduce ColoAlert in South America starting with Peru. |
| Nov 12 | Conference showcase | Positive | +4.6% | Showcased ColoAlert and early cancer diagnostics at MEDICA 2025. |
| Nov 10 | Medical meeting | Positive | +0.8% | Participation in GARPS meeting to present ColoAlert and pipeline. |
| Oct 15 | Investor conference | Positive | -3.9% | Attendance at 2025 Maxim Growth Summit for investor meetings. |
Recent company news has often produced modest positive reactions, with occasional negative divergence on commercial expansion updates.
Over the last few months, Mainz Biomed focused on expanding ColoAlert’s reach and investor visibility. In October–November 2025, the company attended the Maxim Growth Summit and GI-focused conferences, and showcased solutions at MEDICA 2025. Commercially, it advanced ColoAlert distribution in South America and Germany via OncoVanguard8 and DoctorBox. Price reactions to these updates ranged from about -4.76% to +4.62%, showing mixed but generally moderate sensitivity to non-financial milestones, which frames today’s 2025 program review.
Regulatory & Risk Context
An effective Form F-3 shelf filed on Dec 5, 2025 allows Mainz Biomed to offer up to $150,000,000 of securities, subject to Form F-3 limits that cap primary sales at one-third of public float in any 12‑month period until the non‑affiliate market value exceeds $75,000,000. Proceeds are expected to be used primarily for working capital, providing flexibility for funding clinical programs and operations.
Market Pulse Summary
The stock moved +9.5% in the session following this news. A strong positive reaction aligns with upbeat 2025 clinical and commercial milestones, including eAArly DETECT 2 initiation and pancreatic cancer feasibility data showing up to 100% sensitivity and 95% specificity. However, investors have also faced ongoing capital-raising capacity under a $150,000,000 shelf and prior ATM usage, which can weigh on longer-term performance. Past news produced mixed moves, suggesting that enthusiasm for clinical progress could be tempered if financing activity resumes.
Key Terms
mrna biomarkers medical
fit test medical
biomarkers medical
specificity medical
pcr medical
non-invasive medical
AI-generated analysis. Not financial advice.
Initiation of eAArly DETECT 2 - U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial
Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project
Study Demonstrated a Sensitivity of
BERKELEY, Calif. and MAINZ, Germany, Jan. 05, 2026 (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 for the year ended December 31, 2025. The Company expects to release its year-end financial results in March 2026.
Key Highlights During 2025
Colorectal Cancer Business Highlights
- 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.
- ColoAlert®, the Company’s DNA-based colorectal cancer (CRC) screening test, received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
- ColoAlert® has also been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
- 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 signed a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert® to South America, starting with Peru.
- Mainz Biomed collaborated with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance companies as part of special online-based screening concepts based on the widely used fecal immunochemical test (FIT). Thanks to the cooperation with Mainz Biomed, the range of services for risk groups could potentially be expanded to include the ColoAlert® test, which uses molecular genetic analysis of biomarkers in stool using PCR to increase the detection rate, particularly in the early stages of the disease.
- Mainz Biomed also announced that ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.
Pancreatic Cancer Business Highlights
- In March 2025 the Company 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. - In October 2025 the Company announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier in 2025. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved
100% sensitivity and95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors. - 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.
“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Looking ahead to the first half of 2026, we expect to complete our eAArly DETECT 2 feasibility study, which will be the launching point for our ReconAAsense US FDA pivotal colorectal cancer study in 2026, and to announce our next steps in advancing our blood-based screening test for the early detection of pancreatic cancer.”
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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 its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook..
For media inquiries as to Mainz Biomed:
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
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 and its mid-year report on Form 6-K filed on September 26, 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
What is Mainz Biomed’s eAArly DETECT 2 study (MYNZ) and how many patients are enrolled?
When does Mainz Biomed plan its ReconAAsense U.S. FDA pivotal colorectal cancer trial (MYNZ)?
What performance did Mainz Biomed report for its pancreatic cancer biomarker panels (MYNZ)?
Where is ColoAlert marketed following recent registrations by Mainz Biomed (MYNZ)?
What partnerships did Mainz Biomed announce for ColoAlert distribution (MYNZ)?
How much public funding did Mainz Biomed secure for its pancreatic project (MYNZ)?
