DENVER, Colorado — November 16, 2020 —Theralink Technologies (OTC: OBMP) (“Theralink” or the “Company”), a precision oncology molecular profiling company with a novel phosphoprotein-based laboratory developed test (LDT), today announced its partnership with Perthera, a market leader in Precision Oncology technology and services. The alliance will facilitate and accelerate access to Theralink’s 32 phosphoprotein panel, the Theralink assay, across the U.S. for breast cancer patients.
Theralink will be launching its Reverse Phase Protein Array (RPPA) based LDT this year. This unique assay is the world’s only phosphoprotein panel LDT that directly measures the activation state of targets of over 100 precision therapeutics at once. Together, Theralink and Perthera will collaborate to provide the Theralink assay results to oncologists in an easy to interpret, “powered by Perthera” report for potentially improved insights into therapeutic options for the patient’s care plan.
Through this partnership, Perthera will develop and manage Theralink’s observational registry trial, TRACE (Theralink Registry to Assess Comprehensive Effectiveness). Perthera will utilize its Precision Oncology Platform, and serve as a Clinical Research Organization (CRO), to establish and launch the participation of Oncology practices and hospitals in the observational study throughout the US, implement the TRACE protocol, and assist in the enrollment of patients. Theralink will also utilize Perthera’s Therapeutic Intelligence Engine™ to deliver a highly differentiated clinical report for physicians to gain clinical decision support more effectively from the innovative Theralink assay.
Theralink has established TRACE to determine clinical utility using three indicators: Frequency of Actionable Data, Therapy Selection based upon the Theralink Assay, and Outcomes. Demonstrating clinical utility will allow Theralink to apply for a reimbursement code to potentially obtain full reimbursement from 3rd party payors for patients. In TRACE, the Theralink assay will be assessed alongside commercially available NGS-based genomic assay results. In addition, all patients enrolled in TRACE will have access to Perthera’s Precision Medicine Platform and proprietary report.
“Partnering with Perthera, whose Platform has been utilized by over 250 cancer care sites, provides us with an opportunity to have our Theralink Assay reach thousands of breast cancer patients in the U.S. and the oncologists who treat them. Further, the expert team at Perthera has the proven ability to deploy their established Precision Oncology Platform to develop and manage the TRACE program to comprehensively assess the clinical utility of the Theralink assay and to advance our efforts for reimbursement from the payor community,” said Mick Ruxin, M.D., President and CEO of Theralink Technologies, Inc. “Together, we may reveal therapeutic options for oncologists, and in turn, potentially provide better outcomes for breast cancer patients.”
“We are excited to partner with Theralink and use our Platform to drive the TRACE program as we galvanize the clinical utility of their unique RPPA assay for patients, physicians and payers. The Program will also capitalize upon Perthera’s outcomes capture capabilities by integrating the world’s first phosphoprotein assay within Perthera’s proprietary computational engine with AI to deliver precisely ranked therapeutic options, proven to advance patient outcomes. Initially targeting those who suffer from breast cancer, and expanding the Program to additional cancer types, this unique combination of RPPA technology, medicine, science and big data may help dramatically improve outcomes for patients. We look forward to advancing our integrated partnership and driving Theralink’s innovative testing across the nation,” said Gary Gregory, CEO of Perthera.
About the RPPA phosphoprotein and protein panel LDT
The RPPA phosphoprotein and protein panel LDT is a custom-built RPPA-based test that measures the functional activation state of more than thirty proteins that are targets of oncology therapeutics. The LDT is intended to provide insights as to which therapeutics may be likely to generate the greatest clinical benefit for a patient’s specific cancer profile and to potentially reveal therapeutics that may be unlikely to yield clinical benefit. The RPPA phosphoprotein and protein panel LDT has been developed and its performance characteristics determined by Theralink, the CLIA-certified laboratory performing the assay. The Theralink assay has not been cleared or approved by the US Food and Drug Administration.
Perthera is one of the leading Precision Oncology Companies advancing cancer care through our Precision Medicine Platform. Our innovative technology matches cancer patients with precisely ranked therapeutic
recommendations and has been utilized across 250+ US healthcare sites and over 10% of US Oncologists. We have developed a turnkey, Precision Oncology Platform with an AI-driven Intelligence Engine, which has been clinically proven to significantly extend cancer patients’ Overall and Progression-Free Survival rates. Perthera empowers hospitals and physicians to deliver Best-In-Class Cancer Care that may improve patient outcomes and save lives without altering their current clinical practices, patient flow or lab preferences. The Perthera Platform allows for the capture, structure and curation of comprehensive Real-World-Data which delivers significant value to physicians, hospitals, Labs, CROs and Biopharma organizations.
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 (RPPA) 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, potentially revealing 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.
Theralink Technologies, Inc.
KCSA Strategic Communications
Valter Pinto, Managing Director
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 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.