Denver, Colorado — March 14, 2022 — Theralink Technologies (OTC: THER) (“Theralink” or the “Company”), a precision oncology molecular profiling company with a patented, novel phosphoprotein-based assay for breast cancer today announced early results showing actionability and clinical utility for its commercial CLIA assay. Actionability is defined as providing physicians with test results that are actionable for patient treatment selection and Clinical Utility is defined as the percentage of times that the physician acts upon those test results to select next course of treatment for the patient.
Theralink assay results were analyzed from an initial cohort of 118 patients with advanced breast cancer whose oncologists ordered the Theralink assay for treatment planning. Biomarker treatment implications were summarized for potential therapy options that are commonly listed on the Theralink Report which also factors into each patient’s prior treatment history and ER/PR/HER2 status. Actionable insights from this novel phosphoprotein panel assay span a wide range of therapy options. Overall actionability rate was greater than 90% in each breast cancer subtype.
A subset analysis of post report physician surveys found that Theralink’s novel CLIA phosphoprotein/protein panel assay has both actionability and clinical utility in treatment planning across a multitude of therapy options. Oncologists considered changing therapy 78% of the time when provided the phosphoprotein data. A prospective study on post-report outcomes is underway.
Emanuel Petricoin, Ph.D., Chairman of Theralink’s Scientific Advisory Board said, “These results to date, across all different types of advanced breast cancer, are very exciting–especially given that aside from the PIK3CA biomarker, the frequency of actionable findings by Next Generation Sequencing (NGS) panel profiling is in the 1-10% range and often fails to identify new actionable drug targets beyond what is already known from traditional HER2/ER testing”. Dr. Petricoin went on to say, “The Theralink assay provides new insights and choices for physician treatment planning and the results strongly suggest that the phosphoprotein-based assay, which is the only assay to directly measure the in-use and activated state of the drug target itself, should be a routine part of patient molecular profiling in synergy with current NGS panel assays.”
Mick Ruxin, M.D., President & CEO of Theralink said “We are extremely encouraged about the early results of our analysis as they demonstrate what we have known for some time – – that the Theralink assay, based on the early results, provides actionable information and clinical utility for clinical oncologists in treatment selection for their patients.” Dr. Ruxin went on to say, “We plan to publish results from our prospective registry trial, additional physician surveys, and retrospective real-world evidence data later this year to prove our early findings on greater than 90% actionability and greater than 75% clinical utility of the Theralink assay for advanced breast cancer patients.” Dr Ruxin continued, “These results will help us substantially with our reimbursement initiatives with various 3rd party payers.”
Theralink plans to present and publish the results data above, along with other data, at various scientific conferences throughout 2022 and 2023.
About Theralink Technologies, Inc.
Theralink Technologies is a proteomics-based, molecular profiling and precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink’s technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit www.theralink.com.
Mick Ruxin, M.D.
President & CEO
Theralink Technologies, Inc.
Certain statements contained in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof.