Mr. John Price reports

TELO GENOMICS ANNOUNCES CLINICAL RESEARCH RESULTS EVIDENCING UTILITY OF ITS TELOMERE ANALYSIS PLATFORM IN PREDICTING MULTIPLE MYELOMA RELAPSE

Telo Genomics Corp. has released clinical research results from its TELO-MRD program in multiple myeloma.

TELO-MRD is a new liquid-biopsy approach to minimal residual disease (MRD) testing. It combines enumeration of circulating tumour cells (CTCs), specifically circulating myeloma plasma cells, with three-dimensional telomere profiling of those cells using the company's proprietary TeloView platform. The assay is designed to measure both residual disease in peripheral blood and single-cell genomic instability. That combination is intended to help distinguish patients whose residual cells appear biologically quieter from patients whose residual cells show features associated with a higher risk of relapse. In the company's current relapse-risk modelling based on quantitative 3-D telomere parameters, discriminatory performance has been in the range of an area under the curve of approximately 0.8.

Standard MRD assessment in multiple myeloma relies mainly on highly sensitive testing of bone marrow using next-generation flow cytometry (including EuroFlow next-generation flow, or NGF) or next-generation sequencing (NGS). Those methods quantify residual tumour burden. They primarily rely on a bone marrow aspirate or biopsy, sample a single site in a disease that is often patchy, and provide limited information about the biological aggressiveness of any cells that remain.

TELO-MRD has been evaluated in retrospective and prospective multiple myeloma work comparing the company's blood-based assay with established bone-marrow MRD methods. In a retrospective collaboration with the University of Athens, approximately 100 samples were analyzed at diagnosis and 64 samples during MRD monitoring. A head-to-head analysis was performed on matched patient samples against bone-marrow EuroFlow NGF. EuroFlow is a European consortium that develops and standardizes high-sensitivity flow cytometry protocols for diagnosing, classifying, and monitoring hematologic malignancies.

Among 42 evaluable samples with exact patient- and date-matched bone-marrow EuroFlow NGF results, TELO-MRD detected circulating myeloma cells in 39/42 samples (92.9 per cent; 95 per cent CI, 80.5 per cent to 98.5 per cent), compared with MRD detection in 23/42 (54.8 per cent; 95-per-cent CI, 38.7 per cent to 70.2 per cent) by EuroFlow NGF. TELO-MRD was positive in 17/19 NGF-negative samples (89.5 per cent; 95-per-cent CI, 66.9 per cent to 98.7 per cent) and in 22/23 NGF-positive samples (95.7 per cent; 95 per cent CI, 78.1 per cent to 99.9 per cent), with a statistically significant difference in paired detection (two-sided exact McNemar P equals 0.000145). The paired blood and bone-marrow samples were obtained at the same clinical time point, and both assays assessed residual myeloma disease. The study was based on a limited, matched cohort and requires confirmation in larger, independent studies, with reproducibility evaluated as part of cotinuing assay validation.

Separately, TELO-MRD demonstrated an analytical limit of detection of one myeloma cell per 10 to the power of seven white blood cells in controlled cell-spiking experiments reported in BioTechniques (PMID: 41873241).

The company is also introducing its TELO-MRD scoring model, which is intended to estimate relapse risk in multiple myeloma patients who have residual disease. To the company's knowledge, no clinically implemented MRD scoring model currently combines residual-disease detection with single-cell genomic-instability profiling for that purpose. NGF and NGS primarily measure residual disease burden. TELO-MRD is designed to add 3-D telomere profiling of individual CTCs so that residual cells can be assessed for genomic instability and biologic behaviour, not only counted. The company believes that this approach may complement tumour-burden measurements and, if validated, support treatment decisions.

"Clinical study data showed that our TeloView solution detected residual disease in a higher proportion of matched samples than bone-marrow EuroFlow NGF in this dataset," said John Farlinger, chief executive officer and chairman of Telo Genomics. "We are also introducing the TELO-MRD scoring model, which is designed to help assess relapse risk in patients with residual multiple myeloma. We anticipate further development of our TeloView solution to potentially address other medical conditions."

"These results provide preliminary evidence that the Telo Genomics platform can combine sensitive, blood-based detection of residual myeloma cells with biological profiling of those cells, with the goal of adding relapse-risk information beyond tumour burden alone," said Dr. Sabine Mai, co-founder and director of Telo Genomics. "TELO-MRD is designed to detect rare circulating myeloma cells in peripheral blood and to profile their genomic instability through three-dimensional telomere organization at the single-cell level."

"These results are promising but need confirmation in larger studies. The concept of not only detecting tumour cells but also defining their biology may inform prognosis and therapy in the future," said Dr. Kenneth C Anderson, MD, Kraft Family professor of medicine at Harvard Medical School, Dana-Farber Cancer Institute.

"These are encouraging results that strongly support further investigation of TELO-MRD as a sensitive, non-invasive method to profile the tumour and follow the course of the disease," said Dr. Efstathios Kastritis, MD, department of clinical therapeutics, national and kapodistrian, University of Athens School of Medicine.

Multiple myeloma remains incurable. Therapy has extended survival, but residual cancer cells persist and most patients eventually relapse. The company believes that combining MRD detection, identification of malignant circulating cells and relapse-risk information in one blood-based workflow could, if further validated and commercialized, support more individualized management. While TELO-MRD is not yet commercially available, the company intends to continue development of TELO-MRD with the objective of a commercial application by the end of calendar 2027. The company estimates the global addressable market for MRD testing in multiple myeloma at approximately $300-million (U.S.) to $400-million (U.S.). Market-size figures are estimates only and are not a forecast of company revenue.

About Telo Genomics Corp.

Telo Genomics is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining the company's team's considerable expertise in quantitative analysis of 3-D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, Telo Genomics is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of the company's proprietary technology have been substantiated in 190-plus peer-reviewed publications and in 30-plus clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. The company's lead application, Telo-MM, is being developed to provide important, actionable information to medical professionals in the treatment of multiple myeloma, a deadly form of blood cancer.

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