CelLBxHealth (CLBX) Investor Update summary

Strategic Direction and Business Model

• New leadership is implementing a focused commercialization strategy, shifting from academic collaborations to strategic partnerships and lab service providers, especially in the U.S. oncology diagnostics market.

• The Parsortix platform is positioned as a best-in-class solution for circulating tumor cell (CTC) isolation, with strong clinical validation, FDA clearance, ISO 13485 certification, and integration into existing lab workflows.

• Key partnerships include Myriad Genetics, Roche, Illumina, QIAGEN, BioView, and others, targeting unmet needs where tissue and ctDNA tests fail, and aiming to expand into high-throughput clinical environments.

• The company is narrowing its focus to work with select CROs and clinical labs, avoiding broad risk-sharing in drug development, and emphasizing revenue-generating activities through product sales, lab services, and lab-developed tests.

• A razor-blade model is being adopted, with consumables and technology transfers to U.S. labs, and a clear sales pipeline of £12.6 million gross, weighted to £4.5 million in expected revenues over two years.

Market Opportunity and Clinical Need

• The global CTC market is valued at $12.6 billion, projected to reach $25 billion by 2030 with a 12.2% CAGR.

• Cancer incidence is expected to grow 65% by 2050, with 31 million new cases annually.

• CTCs provide unique, actionable insights beyond ctDNA, addressing gaps in current diagnostics, and independent expert consensus predicts CTC integration into routine care within 5 years.

• The liquid biopsy market is growing at 12% annually, with increasing recognition of the limitations of ctDNA and the need for CTC-based diagnostics.

• Current standard tissue biopsies are invasive, costly, and unsuitable for repeat testing; 2 in 3 patients lack access to precision medicine.

Technology and Platform Validation

• The Parsortix platform enables minimally invasive, repeatable CTC capture from blood, validated across 24 cancer types.

• Over 50 platforms sold post-FDA clearance, with 80% sales growth from 2022 to 2024.

• Platform is protected by 27 patents to 2034 and is compatible with standard protein, RNA, and DNA analysis, integrating with existing lab instruments.

• Demonstrated commercial traction with 15 service contracts and over 1,800 patient samples analyzed.

• Multiple revenue streams leverage the same IP, improving ROI and scalability.