Mr. John Price reports

TELO GENOMICS REPORTS ADDITIONAL CLINICAL RESEARCH RESULTS COMPARING BLOOD-BASED TELO-MRD WITH BONE-MARROW NEXT-GENERATION FLOW AND NEXT-GENERATION SEQUENCING

Telo Genomics Corp. has released additional clinical research results from its Telo-MRD program for multiple myeloma, including a comparison of blood-based Telo enumeration with matched-bone-marrow Adaptive clonoSEQ next-generation sequencing (NGS) MRD testing.

Telo-MRD is a type of liquid biopsy applied to finding minimal residual disease (MRD) in samples of peripheral blood. It combines enumeration of circulating tumour cells (CTCs), specifically malignant plasma cells, with three-dimensional telomere profiling of those cells using the company's proprietary TeloView platform. The assay is designed to detect minimal residual disease in peripheral blood but also within malignant cells can assess the hallmarks of genomic instability. That combination is intended to help distinguish patients whose residual cells appear biologically at lesser risk from patients whose residual disease demonstrates features associated with a higher risk of relapse or lack of response to therapy.

The analytic sensitivity of other MRD tests for multiple myeloma is reliant on the collection of bone marrow, a significantly invasive procedure, using next-generation flow cytometry (including EuroFlow next-generation flow, or NGF) or next-generation sequencing such as Adaptive Biotechnologies' clonoSEQ assay. Those methods quantify residual tumour burden. Because of the requirement for bone marrow aspirates for a disease that is typically patchy in its distribution, there is a risk of false negative results. In the case of clonotype-dependent NGS, there is the added requirement that a dominant clone can first be identified. Importantly, both of these tests provide limited information about the biological aggressiveness of any cells that remain.

The company previously reported a head-to-head analysis of blood-based Telo-MRD against matched-bone-marrow EuroFlow NGF. Among 42 evaluable samples with exact patient- and date-matched EuroFlow NGF results, Telo-MRD detected circulating myeloma cells in 39 out of 42 samples (92.9 per cent), compared with MRD detection in 23 out of 42 samples (54.8 per cent) by EuroFlow NGF. That comparison was based on a limited, matched cohort and requires confirmation in larger, independent studies.

The company is now reporting a separate comparison of blood-based manual Telo enumeration with matched-bone-marrow Adaptive clonoSEQ MRD results from two independent research cohorts at Cleveland Clinic and Jewish General Hospital. A total of 17 matched comparisons were available, including baseline clonality assessments and longitudinal MRD follow-up samples. Manual Telo blood enumeration identified circulating plasma cells in every evaluable specimen, including all cases that were Adaptive positive or positive below limit of detection.

Among 10 matched longitudinal MRD assessments, all Adaptive-positive samples and all positive-below-LOD samples (five of 10) were also positive by Telo. In addition, all four samples classified as MRD negative by Adaptive retained detectable circulating plasma cells by Telo enumeration, and the one sample that was not evaluable by Adaptive was Telo positive. No case was identified in which Adaptive detected residual disease while Telo blood enumeration was negative. These blood and bone marrow results are complementary comparisons of different sample types and methods, not a claim that the assays are interchangeable.

Two patients were not trackable by Adaptive because a dominant clonotype could not be established. Telo identified circulating plasma cells in these patients, indicating that cell-based analysis remained informative when clonotype-dependent molecular MRD could not be performed. The Adaptive comparison is based on a limited research data set, includes manual enumeration and requires confirmation in larger, independent studies with standardized assay procedures.

"These additional research results are consistent with what we have seen versus bone marrow flow cytometry," said John Farlinger, chief executive officer and chairman of Telo Genomics. "In this Adaptive clonoSEQ comparison, blood-based Telo enumeration was positive in every Adaptive-positive sample reviewed and also detected circulating plasma cells in Adaptive-negative and non-evaluable samples. We believe a blood-based, cell-based method can complement marrow NGS and NGF, particularly when a clone cannot be tracked or residual cells may be missed in a single marrow site."

"Direct identification of circulating myeloma cells does not depend on first locking a dominant clonotype," said Dr. Sabine Mai, co-founder and director of Telo Genomics. "That is a practical difference versus clonotype-dependent NGS. These data are preliminary, the sample size is small, and blood is not the same compartment as bone marrow. The next step is to confirm both detection and the biological profiling of those cells in larger studies."

"Accurate, reliable and efficient peripheral blood MRD testing is a priority for our patients with myeloma who are currently undergoing recurrent bone marrow biopsies for this important disease response assessment. Telo not only achieves this need, but with the single-cell telomere technology can go well beyond MRD assessment to help us better understand the behaviour of plasma cells. I am quite excited about future research results as we continue to work with Telo," said Dr. Sandra Mazzoni of the Cleveland Clinic.

The study was a limited, matched research comparison. Telo counts in this data set were generated by manual enumeration. Differences between a blood assay and a bone marrow NGS assay may reflect residual cells in circulation, spatial heterogeneity of myeloma, differences in analytical targets, or false-positive or false-negative calls by either method. These results should not be interpreted as a head-to-head clinical performance claim or as a basis for treatment decisions.

While Telo-MRD is not yet commercially available, the company intends to continue development of Telo-MRD, including analytical validation of automated workflows, with the objective of a commercial application by the end of calendar 2027.

Multiple myeloma remains incurable. Therapy has extended survival, but residual cancer cells persist and most patients eventually relapse. The company believes that combining sensitive blood-based detection of residual myeloma cells with single-cell 3-D telomere profiling could, if further validated, add information beyond tumour-burden measurements from bone marrow NGF or NGS alone.

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 Telo Genomics 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 Telo Genomics' 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. Telo Genomics' 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.

We seek Safe Harbor.