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BioMark: 2025 Achievements & 2026 Vision

By: Newsfile

Celebrating A Year of Extraordinary Achievement

Vancouver, British Columbia--(Newsfile Corp. - December 31, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark" or the "Company"), a leading developer of liquid biopsy technologies for early cancer detection, today issued a Year-End Letter to Shareholders and Team from its Chief Executive Officer and Founder, Rashid Ahmed Bux.

Dear BioMark Shareholders and Team,

As we reflect on 2025, we celebrate a transformative year that positions BioMark as the leader in early cancer detection and precision diagnostics. What we've accomplished together represents not just scientific breakthroughs—it represents the resilience, dedication, and unwavering commitment of our team to a mission that saves lives.

Key Achievements 2025

Team & Capacity

  • Expanded Technical Team: Strengthened scientific and operational capabilities with strategic talent additions
  • Doubled Throughput Capacity: Scaled laboratory infrastructure to meet clinical and commercial demands
  • AI/ML Investment: Enhanced data analytics capabilities to improve diagnostic accuracy

Regulatory & Clinical Validation

  • ISO 15189 Certification Documents Submitted in Dec 2025: for international laboratory standards compliance, and once secured, it will help position us for CLIA and CAP accreditation as we enter the U.S. market
  • HANSE (10,000) Trial Selection: Chosen as exclusive partner for the largest prospective lung cancer study since the Nelson trial-unprecedented data access and platform validation
  • 7,000+ Patient Study Completed: Canada's largest lung cancer diagnostic study, generating robust real-world evidence and biomarker validation

Scientific Leadership & Recognition

  • 6+ Peer-Reviewed Publications: Featured in high-impact journals as thought leaders in metabolomics and AI-based oncology diagnostics
  • CQDM Innovation Prize: Industry recognition for our innovative approach to cancer detection (Partnership with IUCPQ)
  • Featured in CSE Technology Issue June 2025: Recognized as a leading Canadian biotech company advancing precision medicine

Strategic Funding & Partnerships

  • $4.5M Capital Raised: Secured substantial funding in a challenging small-cap market-powerful testament to investor confidence
  • NRC Horizon Europe Funding: European expansion and collaborative research support secured
  • Secured City of Quebec funding
  • Manitoba Lung Association Grant: Pilot First Nations lung cancer detection program-advancing health equity and community access
  • Québec RNA Hub LOI Submitted: Positioned for AReNA program funding supporting miRNA-LNP platform development for RNA therapeutics

What This Means for Our Stakeholders

For Our Team

You are part of an internationally recognized leader in early cancer detection. Your work directly impacts patient outcomes. Our team expansion reflects confidence in our mission-we hire the best because our science demands excellence. You are changing cancer detection.

For Our Shareholders

  • Validated Platform: HANSE trial selection and 7,000+ patient data provide strong clinical evidence for commercialization

  • De-Risked Regulatory Path: ISO 15189 certification unlocks CLIA accreditation and U.S. market entry (16M+ at-risk population requiring annual lung cancer screening)

  • Diversified Revenue Model: Government, Foundations, and industry partnerships validate multiple market pathways

  • International Expansion: Horizon Europe funding opens European opportunities

  • ESG Differentiation: First Nations health equity program positions us attractively for impact-focused investors

2026 Catalysts

Regulatory & Market Access

  • ISO 15189 Accreditation Approval will support CLIA/CAP application for the US market commencement
  • U.S. Reimbursement Strategy Development: Collaborate with screening centers and payors as clinical data expands

IP & Competitive Positioning

  • Broaden IP Estate: Strengthen patent protection for biomarker discovery and diagnostic innovations

Clinical Data & Publications

  • HANSE Lung Cancer Trial Data Generation: First longitudinal validation from 10,000-patient study. This is the second largest longitudinal trial since the Nelson trial was held in 2013

  • 7,000-Patient Study Publication: High-impact manuscripts accelerating commercial partnerships

Commercial Expansion

  • Industry Licensing Negotiations: Major pharma, lab, and diagnostics partnerships leveraging publication and trial data

  • Laboratory Services Launch: ISO 15189-certified clinical diagnostic services; CRO service offerings

  • Expand Distribution Channels: Medical and clinic chains

Business Scaling

  • Leadership Roles: Patient Engagement and Revenue Generating Officers (to optimize consumer experience and financial performance), and a Medical Director (to ensure clinical integrity).

  • Technical and Operational Experts: Data Specialists, Scientists, and Lab Technicians (to enhance R&D and laboratory efficiency).

  • Business Development: Business Development Managers (to secure partnerships and expand market reach).

  • Appointment of a new member of the Board of Directors - support US market entry

Outreach

  • International Collaboration: Secure licensing agreements in strategic geographic markets

Revenue & Coverage

  • Revenue Generation: LDT (lab-developed test) sales, CRO services, and diagnostic tests

  • Strategic Funding: Secure follow-on funding at an elevated valuation based on clinical validation and revenue traction

  • Analyst Coverage: Position for institutional investor engagement and market visibility

Our Culture: A Message of Resilience

To every member of the BioMark family—from lab scientists to business development, clinical operations, regulatory affairs, and leadership - thank you.

This year tested us. We navigated regulatory complexity. We managed ambitious timelines. We scaled operations while maintaining scientific rigor. We faced skepticism and answered with data. And we never backed down.

That spirit - that refusal to accept "no" as final, that commitment to excellence even when the path is uncertain—that is BioMark's culture. That is what makes us different.

We Are Defined By

  • Resilience: Challenges become opportunities; setbacks become insights

  • Dedication: Our team believes in the mission, not titles or accolades

  • Excellence: We accept nothing less than the highest standards in science, operations, and patient care

  • Never Backing Down: When the path is unclear, we forge forward. When obstacles appear, we find solutions.

The investors who backed us, the patients who entrusted us with their samples, the healthcare collaborators who partnered with us - they did so because they saw a team that delivers.

In 2026, we will expand that impact. We build upon the achievements of 2025. Together, we will establish BioMark as the global standard in early cancer detection, transform patient outcomes, and do it with the same unwavering commitment that got us here.

Our Vision: 2026 and Beyond

  • By the end of 2026: Regulatory accreditation complete, clinical partnerships announced, revenue-generating services launched

  • By 2027: Market leadership established; expansion into metabolic disease diagnostics

  • By 2028: International presence across North America and Europe; transformed cancer detection landscape

We have the science. We have the team. We have the partnerships. We have the resolve.

The best of BioMark is not behind us. It's ahead of us.

Thank you for your trust, your hard work, and your belief in what we're building. Let's finish 2025 strong and make 2026 unforgettable.

With deep gratitude and unwavering commitment,

BioMark Leadership Team

"Science. Resilience. Impact."

About BioMark Diagnostics Inc.

BioMark Diagnostics Inc. 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.

Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.

For further information on BioMark, please contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com

Forward-Looking Information:

This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.

The CSE has not reviewed, approved, or disapproved of the content of this press release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/279263

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