Telo Genomics Provides Positive Interim Data from Ongoing Clinical Trial Advancing Genomic Instability-Based Relapse Risk Assessment

Clinical Study on Track to Meet Primary Endpoints with Interim Data Demonstrating Blood-Based Assay Capable of Predicting Relapse Risk Through Analysis of Genomic Instability and Telomere Architecture

Telo Genomics Corp. (TSXV: TELO,OTC:TDSGF) (OTCQB: TDSGF) (the "Company" or "Telo Genomics"), a leader in the development of diagnostic and prognostic tests for human disease through the 3D analysis of telomeres (which are the ends of chromosomes), announced positive interim results from an ongoing retrospective clinical study conducted in collaboration with National and Kapodistrian University of Athens. The clinical trial, which is expected to conclude in summer 2026, analyzes baseline blood samples from multiple myeloma patients treated with standard-of-care regimens. The study cohort includes patients with known two-year clinical outcomes, enabling direct comparisons between patients who relapsed and those who remained in remission.

The interim analysis evaluated diagnostic blood samples from 50 multiple myeloma patients with sufficient follow-up data. The study identified "Average Distance to Nuclear Center," a telomere-associated nuclear architecture parameter linked to genomic instability, as the strongest predictor of relapse status. Receiver Operating Characteristic (ROC) analysis demonstrated strong discriminatory performance, with the assay achieving an Area Under the Curve (AUC) of 0.849, a level considered highly predictive in clinical diagnostics

"These interim results support our belief that telomere-driven genomic instability analysis may provide clinicians with a fundamentally new way to assess relapse risk in multiple myeloma," said John Farlinger, CEO and Chairman of Telo Genomics. "Current monitoring approaches are valuable for measuring disease burden, but do not fully address the challenge of identifying which patients are most likely to experience relapse. We believe our platform can help fill that gap, representing a significant opportunity in multiple myeloma and, potentially, multiple other cancers as well as Alzheimer's disease."

"These results provide preliminary evidence that the Telo Genomics platform can deliver liquid-biopsy-based prognostic information," said Dr. Sabine Mai, Co-Founder and Director of Telo Genomics. "Current MRD approaches, including EuroFlow-based next-generation flow cytometry and Adaptive Biotechnologies' ClonoSEQ® assay, provide valuable information regarding residual disease burden, but are not designed to assess the biological characteristics that may drive future relapses. By evaluating genomic instability through three-dimensional telomere organization at the single-cell level, our platform may provide prognostic insight into relapse risk that complements existing MRD methodologies."

The interim data suggest that Telo Genomics' platform may offer a differentiated precision-medicine approach to multiple myeloma by combining disease detection, relapse-risk prediction, and monitoring of disease progression in a single genomic instability-based assay. Specifically, the interim results demonstrate several important clinical and technological capabilities:

  • Telomere-driven nuclear architecture patterns may serve as predictive biomarkers of relapse risk.
  • The platform may identify biologically aggressive disease not apparent through conventional residual disease measurements.
  • The assay may combine residual disease detection and relapse-risk stratification within a single test.
  • Serial 3D telomere profiling may enable monitoring of disease evolution over time.
  • Blood-based testing may reduce dependence on repeated bone marrow sampling.

To the Company's knowledge, no clinically implemented MRD scoring model currently integrates residual disease detection with single-cell genomic-instability profiling to predict relapse risk in this manner. The Telo Genomics platform addresses a key limitation of current MRD technologies. While Next-Generation Flow (NGF) and Next-Generation Sequencing (NGS) primarily measure residual disease burden, Telo Genomics combines highly sensitive CTC detection with single-cell 3D telomere profiling to assess the genomic instability and biologic behavior of residual tumor cells. This approach has the potential to provide relapse-risk stratification that complements tumor-burden measurements and supports clinically important treatment decisions.

The Company believes the platform's ability to combine MRD assessment, malignant cell identification, and relapse-risk prognostication within a single assay could support more personalized treatment decisions and improve clinical management of multiple myeloma patients.

Additional Clinical Studies

Telo Genomics has also partnered with the Cleveland Clinic and Montreal Jewish General Hospital to analyze MRD in a cumulative cohort of approximately 20 multiple myeloma patients, with blood and bone marrow samples from different stages of treatment progression. Telo Genomics previously demonstrated an analytical limit of detection of one tumor cell per 10 million white blood cells, which was published in BioTechniques (PMID: 41873241). Building on these findings, the current study is designed to directly compare Telo Genomics' ability to isolate and characterize circulating tumor cells from peripheral blood in a clinical multiple myeloma cohort against NGS-based MRD results by Adaptive Biotechnologies' ClonoSEQ®, a leading NGS-based MRD platform.

In addition to MRD status assessment, the study evaluates Telo Genomics platform by incorporating serial three-dimensional telomere profiling of circulating tumor cells. The studies are designed to longitudinally monitor both MRD status and genomic instability over time, enabling evaluation of how changes in telomere architecture correlate with disease evolution, treatment response and eventual clinical outcomes.

Telo Genomics intends to continue validating its technology against current standards of care, including directly with EuroFlow, Adaptive and other established MRD methodologies, with broader validation efforts expected through the end of 2026.

Minimal Residual Disease (MRD)

MRD refers to the small number of cancer cells that remain in the body after treatment and may ultimately lead to relapse. MRD testing is increasingly being adopted as an important clinical endpoint in oncology and hematologic malignancies, including multiple myeloma. Existing MRD technologies primarily focus on detecting residual tumor cells and often require invasive bone marrow biopsies. Telo Genomics' blood-based platform is designed to add prognostic insight by analyzing 3D telomere architecture and genomic instability associated with disease evolution and relapse risk.

About Telo Genomics

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 our team's considerable expertise in quantitative analysis of 3D 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 our proprietary technology have been substantiated in 190+ peer reviewed publications and in 30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our 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. For more information, please visit www.telodx.com.

For further information, please contact:

Telo Genomics Investor Relations
IR@telodx.com

555 Richmond Street West
Toronto, ON, Canada, M5V 3B1
www.telodx.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "intends", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Certain forward-looking statements, including statements regarding the results from this clinical study being received by the summer of 2026, upcoming additional clinical trials, commercializing and monetizing our platform, our position within the MRD market and the potential to complement existing bone-marrow-based methods and, over time, reduce or eliminate the need for repeated invasive biopsies are subject to known and unknown risks, uncertainties and other factors that may cause the actual outcome to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/305392

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