Theralink Technologies, Inc.
(OTC: THER) (“Theralink”), a precision oncology
company with its exclusive commercial RPPA (reverse phase protein
array) technology that can help predict which FDA-approved drug is
effective in each cancer, today announced that their long-standing,
strategic partnership with the Inova Schar Cancer Institute (Inova)
is beginning to deliver promising results by way of assessing the
feasibility and impact of the actionable information provided by
the Theralink assay into Inova’s Molecular Tumor Board (MTB)-based
treatment decisioning making for cancer patients.
The partnership involves the integration of the
Theralink assay, protected by ten patents, into Inova’s molecular
tumor board’s operational workflow. Over the past year, Inova has
undertaken a feasibility study to develop and implement the
procedures and infrastructure necessary for proteomic analysis
within the context of the Inova Schar Molecular Tumor Board. The
Theralink assay provides a direct means of determining the
actionability of genomic derangements identified, as well as
directly measuring the activation/elevation of protein drug targets
otherwise missed by genomic analysis alone. Thus, the incorporation
of key phosphoprotein and protein data generated by Theralink’s
RPPA technology into the Inova MTB could synergize with current
genomics analysis to produce more accurate treatment selection and
patient-tailored therapy regimes.
Interim results of this pan-tumor study were
presented at the 2023 ASCO Conference in Chicago. Specifically, the
analysis examined the feasibility of incorporating laser capture
microdissection (LCM) enrichment of tumor specimens and reverse
phase protein array (RPPA) analysis with next generation sequencing
(NGS) into a molecular tumor board for improving selection of
targeted cancer therapy. Integrated review of the RPPA and
NGS data by the MTB supported a clinical recommendation change for
over half of the patients overall. Further, the proteomics data
from the Theralink assay provided additional treatment
considerations for 59% of the patients, the outcomes for whom
continue to be monitored. Moreover, the collaboration with Inova
and their MTB resulted in a recent
finding1 wherein the Theralink
proteomics data revealed a specific mechanism of resistance and
likely lack of benefit to a targeted therapy being considered by
the MTB for a patient with a rare form of inflammatory
myofibroblastic cancer.
Lastly, Inova and Theralink presented the
results of another important study at ASCO 2023 that focused on
Theralink’s unique ability to quantitatively measure HER2 abundance
and activation and found that nearly 50% of pancreatic tumor
actually express moderate amounts of HER2 protein, which could be
missed by existing commercial HER2 assays. While HER2 expression is
not routinely evaluated in clinical practice for pancreatic cancer
these results may have clinical implications, especially as new
classes of HER2 antibody drug conjugates are considered for
patients with HER2 non amplified tumors across organ sites.
“Theralink is extremely encouraged by the work
done to date at Inova Schar Cancer Institute- the interim results
and clinical intelligence speak for themselves. We look forward to
completing this study with Inova for our mutual goal of improving
outcomes for all cancer patients”, said Faith Zaslavsky, President
and Chief Executive Officer of Theralink.
Dr. Timothy Cannon, who is the Sheridan Director
of the Inova Molecular Tumor Board and Co-Director of the
Gastrointestinal Cancer Program at Inova said, “We have tested over
100 patients with Theralink’s RPPA technology as part of this
study. We are hopeful final study analysis and results will
continue to underscore the importance of real-time clinical
integration of functional protein drug target activation data
provided by the Theralink assay with NGS in the Inova MTB for
cancer patients.”
Theralink and Inova will update findings and
results post study completion. Published results are anticipated in
early 2024.
About Theralink Technologies,
Inc.
Theralink Technologies is a proteomics-based,
precision medicine company with a nationally CLIA-certified and
CAP-accredited 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. In addition to the Company's first assay for
advanced breast cancer, Theralink is actively working on a second
assay that is planned to be pan-tumor for solid tumors across
multiple tumor types such as ovarian, endometrial, pancreatic,
liver, head and neck, colorectal, lung, prostate, among others.
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.
Theralink Technologies, Inc. (OTC: THER)
(“Theralink”) and IMAC Holdings, Inc. (Nasdaq: BACK) have entered
into a definitive Agreement and Plan of Merger (the “Merger
Agreement”) under which Theralink will merge with a newly formed,
wholly-owned subsidiary of IMAC in a stock-for-stock reverse merger
transaction (the “Merger”) in which Theralink will survive as a
wholly-owned subsidiary of IMAC, a Nasdaq-listed company. If
completed, the Merger will result in a combined company that will
focus on end-to-end proteomics testing, one of the most robust and
growing areas of medicine.
Cautionary Note Regarding Forward-Looking
Statements
This communication contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. All statements, other than statements of
historical fact, included in this communication that address
activities, events or developments that IMAC or Theralink expects,
believes or anticipates will or may occur in the future are
forward-looking statements. Words such as “estimate,” “project,”
“predict,” “believe,” “expect,” “anticipate,” “potential,”
“create,” “intend,” “could,” “would,” “may,” “plan,” “will,”
“guidance,” “look,” “goal,” “future,” “build,” “focus,” “continue,”
“strive,” “allow” or the negative of such terms or other variations
thereof and words and terms of similar substance used in connection
with any discussion of future plans, actions, or events identify
forward-looking statements. However, the absence of these words
does not mean that the statements are not forward-looking. These
forward-looking statements include, but are not limited to,
statements regarding the proposed Merger, the expected closing of
the proposed Merger and the timing thereof and as adjusted
descriptions of the post-transaction company and its operations,
strategies and plans, integration, debt levels and leverage ratio,
capital expenditures, cash flows and anticipated uses thereof,
synergies, opportunities and anticipated future performance,
including maintaining current Theralink management. Information
adjusted for the proposed Merger should not be considered a
forecast of future results. There are a number of risks and
uncertainties that could cause actual results to differ materially
from the forward-looking statements included in this communication.
These include the risk that cost savings, synergies and growth from
the proposed Merger may not be fully realized or may take longer to
realize than expected; the possibility that shareholders of IMAC
may not approve the issuance of new shares of IMAC common stock in
the proposed Merger or that shareholders of IMAC may not approve
the proposed Merger; the risk that a condition to closing of the
proposed Merger may not be satisfied, that either party may
terminate the Merger Agreement or that the closing of the proposed
Merger might be delayed or not occur at all; potential adverse
reactions or changes to business or employee relationships,
including those resulting from the announcement or completion of
the proposed Merger; the occurrence of any other event, change or
other circumstances that could give rise to the termination of the
Merger Agreement relating to the proposed Merger; the risk that
changes in IMAC’s capital structure and governance could have
adverse effects on the market value of its securities and its
ability to access the capital markets; the ability of IMAC to
retain its Nasdaq listing; the ability of Theralink to retain
customers and retain and hire key personnel and maintain
relationships with their suppliers and customers and on Theralink’s
operating results and business generally; the risk the proposed
Merger could distract management from ongoing business operations
or cause IMAC and/or Theralink to incur substantial costs; the risk
that Theralink may be unable to reduce expenses; the impact of the
COVID-19 pandemic, any related economic downturn; the risk of
changes in regulations effecting the healthcare industry; and other
important factors that could cause actual results to differ
materially from those projected. All such factors are difficult to
predict and are beyond IMAC’s or Theralink’s control, including
those detailed in IMAC’s Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K that are
available on IMAC’s website at www.ir.imacregeneration.com and on
the website of the Securities and Exchange Commission (the “SEC”)
at www.sec.gov, and those detailed in Theralink’s Annual Reports on
Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K that are available on Theralink’s website at
www.theralink.com and on the website of the SEC. All
forward-looking statements are based on assumptions that IMAC and
Theralink believe to be reasonable but that may not prove to be
accurate. Any forward-looking statement speaks only as of the date
on which such statement is made, and neither IMAC nor Theralink
undertakes any obligation to correct or update any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by applicable law. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof.
1 Hunt AL, et al. Integration of Multi-omic Data
in a Molecular Tumor Board Reveals EGFR-Associated ALK-Inhibitor
Resistance in a Patient With Inflammatory Myofibroblastic Cancer.
Oncologist. 2023 Aug 3;28(8):730-736.
Contact InformationTheralink
Technologies, Inc.Trevor McCartneyVP, Strategic PartnershipsCell:
(720) 800-2160trevor.mccartney@theralink.com
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