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Theralink® and IMAC Holdings announce receipt and response to the Securities and Exchange Commission comments on the previously filed Form S4
Golden, Colorado & Nashville, Tennessee, Nov. 13, 2023 (GLOBE NEWSWIRE) -- 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 with its merger partner, IMAC Holdings, INC (Nasdaq: BACK), announce that the companies have responded to the SEC’s first round of comments on the jointly filed form S-4. A Form S-4 is a registration statement that the Securities and Exchange Commission requires all reporting companies to file in order to publicly offer new securities pursuant to a merger or acquisition. The Companies previously filed the S-4 on September 29th and received comments from the SEC in late October.
Theralink’s Chief Executive Officer, Faith Zaslavsky previously stated “The filing of the Form S-4 is a major milestone, as it signifies Theralink and IMAC have reached a definitive agreement and that the transaction is moving forward. The result of the Merger will be a well-positioned proteomics pure play squarely focused on the next generation of cancer care and protein analysis, an opportunity that all stakeholders in our companies are highly excited about. I am unaware of any other proteomics company with a robust patent estate, certified and accredited laboratory, and reimbursement agreements in place with major payors like Medicare that parallels what our new combined company possesses along with the leadership to execute and build value.”
The companies expect to hear back from the Securities and Exchange Commission within the next 10 business days.
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.
Contact Information
Theralink Technologies, Inc.
Trevor McCartney
VP, Strategic Partnerships
Cell: (720) 800-2160
trevor.mccartney@theralink.com
https://www.globenewswire.com/newsroom/ti?nf=ODk3ODQ2MiM1OTI2MzI5IzUwMDExNzA4OA==
https://ml.globenewswire.com/media/NTkyMjViOTUtYjIwZi00NGIxLWI5ZjUtZGQwMzUyYzllZGFlLTUwMDExNzA4OA==/tiny/Theralink-Technologies-Inc-.png
Source: Theralink Technologies, Inc.
© 2023 GlobeNewswire, Inc.
https://www.otcmarkets.com/stock/THER/news/story?e&id=2689544
Theralink® Announces Promising Interim Results on the Implementation of Proteomic Analysis into Inova Schar Cancer Institute’s Molecular Tumor Board
Golden, Colorado, Nov. 03, 2023 (GLOBE NEWSWIRE) -- 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 Information
Theralink Technologies, Inc.
Trevor McCartney
VP, Strategic Partnerships
Cell: (720) 800-2160
trevor.mccartney@theralink.com
https://www.globenewswire.com/newsroom/ti?nf=ODk3MjA1MyM1OTA4NDM2IzUwMDExNzA4OA==
https://ml.globenewswire.com/media/NGUwYjI5N2YtZmNkMi00NjZlLTg5ZjQtZWY5NzA3YmQ1NzBiLTUwMDExNzA4OA==/tiny/Theralink-Technologies-Inc-.png
Source: Theralink Technologies, Inc.
© 2023 GlobeNewswire, Inc.
https://www.otcmarkets.com/stock/THER/news/story?e&id=2678926
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