Mr. Rashid Bux reports

BIOMARK'S LIQUID BIOPSY PLATFORM SELECTED FOR HOLISTIC GERMAN LUNG CANCER SCREENING TRIAL

Biomark Diagnostics Inc. has been invited to participate in the landmark HANSE lung cancer screening trial in Germany. This strategic clinical collaboration with Prof. Jens Vogel-Claussen at Medizinische Hochschule Hannover, Prof. Martin Reck at LungenClinic Grosshansdorf and Dr. Sabine Bohnet at Universitatsklinikum Schleswig-Holstein positions Biomark as the core diagnostic partner for Germany's largest and most comprehensive screening study. The trial is designed to encompass 10,000 participants from both high-risk and general population cohorts, providing critical international market validation for Biomark's platform.

The consortium focuses on developing and implementing metabolomic profiling, radiomic and clinical data into a risk-based model to improve the accuracy of early lung cancer detection and distinguish benign from malignant nodules. Biomark has been collaborating intensively with the German clinical team to finalize work packages and critical logistics for sample handling and processing as the trial started this October. This major initiative, which is supported through the international Eureka network program, leverages Biomark's advanced Quebec City laboratory facilities, which are progressing toward full certification and accreditation to meet the stringent requirements of this large-scale European clinical trial.

"This collaboration represents a transformative milestone for Biomark," said Rashid Ahmed Bux, chief executive officer and president of Biomark Diagnostics. "Our recent successful capital raise has allowed us to scale our laboratory operations to effectively manage this prestigious trial. We are honoured to partner with Dr. Vogel-Claussen and his exceptional team. Their scientific rigour validates our liquid biopsy technology on the international stage and establishes a strong pathway to European market commercialization."

Prof. Vogel-Claussen commented: "With the integration of blood-based biomarkers in the HANSE study, we aim to detect early lung cancer in the asymptomatic population aged 55 to 79 years, which is currently not eligible for lung cancer screening with low-dose CT according to current risk-assessment criteria. Furthermore, we aim to reduce the number of benign biopsies and surgical resections of positive low-dose CT cases. If successful, the blood test from Biomark Diagnostics could significantly enhance the performance of future lung cancer screening programs."

Successful execution of the HANSE trial is expected to generate critical clinical evidence supporting Biomark's regulatory submissions and commercial expansion strategies throughout North America and Europe. This partnership not only provides substantial validation of the technology platform but also establishes the company as a key player in the global early cancer detection market.

About the HANSE trial

The HANSE study represents Germany's most ambitious lung cancer screening program, designed to evaluate innovative early detection methodologies across diverse population demographics. Led by key investigators at Medizinische Hochschule Hannover, LungenClinic Grosshansdorf and Universitatsklinikum Schleswig-Holstein, this landmark trial aims to establish new gold standards for lung cancer screening protocols while addressing Europe's critical need for improved early detection capabilities. The trial's comprehensive design includes both high-risk populations and general screening cohorts, providing unprecedented clinical insights into early lung cancer detection across multiple demographic groups, and the data will be instrumental in advancing screening protocols throughout Europe and globally.

The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated into the current infrastructure of certified lung cancer centres. This study has been registered.

About Biomark Diagnostics Inc.

Biomark is a leading developer of liquid biopsy tests for the early detection of cancer that leverages the power of metabolomics and machine learning algorithms. The company's proprietary technology utilizes a simple blood draw to detect the presence of cancer-associated biomarkers, enabling earlier diagnosis and improved patient outcomes. The technology can also be used for measuring response to treatment and potentially for serial monitoring of cancer survivors. Biomark is committed to developing innovative and accessible diagnostic solutions to address unmet medical needs in oncology.

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