Financial Performance - Total revenues for Q3 2025 were $21.2 million, a decrease of 62.3% compared to $56.3 million in Q3 2024[14] - Gross profit for Q3 2025 was negative at $(102.7) million, compared to $(65.8) million in Q3 2024, indicating a significant increase in losses[14] - Operating loss for the nine months ended September 30, 2025, was $(6.8) million, up from $(3.8) million for the same period in 2024, reflecting a 78.5% increase in losses[14] - Net loss available to common stockholders for Q3 2025 was $(4.4) million, compared to $(3.4) million in Q3 2024, representing a 29.4% increase in losses[14] - The net loss for the nine months ended September 30, 2025, was $7,398,666, compared to a net loss of $3,995,271 for the same period in 2024, representing an increase of approximately 85.3%[20] - For the three months ended September 30, 2025, the Company reported net revenue of $0.02 million and a net loss of $3.1 million, which includes a one-time impairment loss of $0.75 million related to property and equipment[59] - For the nine months ended September 30, 2025, the Company had net revenue of $0.02 million and a net loss of $7.4 million, also including a one-time impairment loss of $0.75 million[59] Cash Flow and Liquidity - Cash reserves decreased significantly to $45,054 as of September 30, 2025, down from $504,189 at December 31, 2024[12] - Net cash used in operating activities from continuing operations was $3,752,128 for the nine months ended September 30, 2025, compared to $1,993,235 for the same period in 2024, indicating an increase of about 88.2%[20] - Net cash used in operations increased to $3.8 million for the nine months ended September 30, 2025, compared to $2.0 million for the same period in 2024, largely due to increased accounts payable and impairment losses[74] - Net cash provided by financing activities was $3.3 million for the nine months ended September 30, 2025, compared to $2.4 million for the same period in 2024, primarily from the sale of common stock and issuance of promissory notes[75] Liabilities and Deficits - Total current liabilities increased to $13.3 million as of September 30, 2025, from $7.2 million at December 31, 2024, marking an 84.5% rise[12] - The accumulated deficit increased to $(72.4) million as of September 30, 2025, compared to $(65.0) million at December 31, 2024[12] - The company had a working capital deficit of $(13.0) million as of September 30, 2025, compared to $(6.5) million as of December 31, 2024, driven by a $2.2 million increase in accounts payable and a $3.8 million increase in notes payable[69] - As of September 30, 2025, the company had approximately $13.3 million in current liabilities, including $4.9 million owed to vendors and $3.8 million in notes payable[71] Capital Needs and Financing - The company plans to raise additional capital through the issuance of financial instruments, including both debt and equity, to address its financial challenges[30] - The estimated capital needs for the next 12 months are approximately $5.0 million, with $3.6 million allocated for employees and related expenses[70] - The company anticipates needing to raise additional capital to fund future operations, which may not be achievable on favorable terms[72] Operational Challenges - The company has substantial doubt about its ability to continue as a going concern for the next twelve months, primarily due to expected operating losses and cash outflows[30] - The company has identified material weaknesses in its internal control over financial reporting, which could lead to misstatements in financial results[82] - Inflation had a material impact on operating results for the nine months ended September 30, 2025, particularly affecting staffing and supply costs[76] Shareholder Information - Preferred dividends declared in Q3 2025 amounted to $(1.3) million, compared to $(1.2) million in Q3 2024, indicating a 9.6% increase[14] - The number of common shares outstanding increased to 3,784,934 as of September 30, 2025, from 2,029,864 at December 31, 2024[12] - The company reported a loss per share of $(1.15) for Q3 2025, compared to $(1.71) for Q3 2024, reflecting a 32.8% improvement in loss per share[14] Impairment and Acquisitions - The company recognized an impairment loss of $748,101 on laboratory equipment acquired from Theralink Technologies, Inc., due to minimal cash flows generated from its use[33] - The company has acquired laboratory capabilities from Theralink Technologies, Inc., enhancing its technical capabilities in precision medicine for cancer treatment[23] - Operating expenses for the three months ended September 30, 2025, were $2.5 million, an increase from $1.9 million for the same period in 2024, primarily due to costs associated with the operation of a newly acquired laboratory[66] - Operating expenses for the nine months ended September 30, 2025, were $6.4 million, up from $3.7 million for the same period in 2024, primarily due to costs from the acquired laboratory[67] Revenue and Patient Revenue - The Company reported patient revenue of $21.2 million for the three months ended September 30, 2025, compared to $22.7 million for the same period in 2024[51] - The cost of revenues for the three months ended September 30, 2025, was $123.9 million, compared to $122.1 million for the same period in 2024[51] - The net revenue for the nine months ended September 30, 2025, was approximately $23,000, reflecting the company's ongoing challenges in generating revenue[33]

Utilities Sector - Utilities Select Sector SPDR Fund (NYSE:XLU) experienced a dramatic drop of over 50%, with its price falling to $43.54 from a year high of $93.77, indicating volatility in a sector typically considered stable [1][7] - Despite the decline, utility ETFs like XLU are gaining traction due to rising demand for AI-driven data centers and expectations of falling interest rates, which could enhance the sector's attractiveness [1] Healthcare Sector - IMAC Holdings, Inc. (NASDAQ:BACK) faced a steep decline of 42.55%, with its price dropping to $0.1149, significant for a company involved in regenerative and orthopedic therapies [2] - Quoin Pharmaceuticals, Ltd. (NASDAQ:QNRX) saw its price decrease by 41.88% to $10.99, highlighting challenges in the biotechnology industry where product development and regulatory approval are critical [3] - Ignite Proteomics' collaboration with Inova Health for a biomarker study in late-stage cancers indicates ongoing advancements in precision oncology, which could influence the healthcare landscape [2] Travel Services Sector - Ambitions Enterprise Management Co. L.L.C (NASDAQ:AHMA) experienced a 37.35% decrease in its price to $8.27, reflecting challenges faced by the travel services sector, possibly due to global travel restrictions or economic downturns [4] - The company's subsidiary, MULTIPLE EVENTS L.L.C, has been appointed as the preferred executive service partner for the 19th World Chinese Entrepreneurs Convention, which could enhance its future prospects [4] E-commerce Sector - Jeffs' Brands Ltd (NASDAQ:JFBR) saw its price fall by 36.6% to $1.58, indicating potential challenges in e-commerce or operational issues [5] - The company has entered into a definitive distribution agreement with Scanary Ltd, marking its strategic entry into the global homeland security market, which could open new revenue streams [5] Overall Market Volatility - Significant price movements across various sectors highlight the volatility and challenges faced by companies, with investors closely monitoring developments that may influence future performance [6][7]

Core Insights - Ignite Proteomics LLC has entered a research collaboration with Inova Health to utilize its Reverse Phase Protein Array (RPPA) technology for analyzing tumor samples from patients with late-stage gastrointestinal cancers [1][2] - The collaboration aims to generate actionable biomarker data from up to 600 tumor samples, focusing on various cancer-relevant drug target proteins [2][3] - This partnership is expected to enhance precision medicine approaches and contribute significantly to Ignite's revenue in 2025 [3] Company Overview - Ignite Proteomics is a subsidiary of IMAC Holdings, specializing in pathway-level protein analytics to guide precision oncology [4] - The company operates a CLIA-certified, CAP-accredited laboratory and its clinical RPPA assay quantifies 32 phospho- and total-protein biomarkers from small biopsy samples [4] Collaboration Details - The results from the RPPA analysis will be provided to Inova's Molecular Tumor Board to assess therapy response and resistance based on specific protein or phosphor-protein levels [2][3] - The collaboration is seen as a significant advancement in providing direct measures of protein drug target activity, which is not obtainable through genomic analysis [3]

[Important Information Regarding Forward-Looking Statements](index=4&type=section&id=Important%20Information%20Regarding%20Forward-Looking%20Statements) This section highlights that the report contains forward-looking statements subject to risks and uncertainties - This report contains forward-looking statements based on current beliefs, expectations, and projections, subject to risks and uncertainties that could cause actual results to differ materially. Significant risks are detailed in the Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023[8](index=8&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and related disclosures for interim periods [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Presents the company's condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------------- | :------------ | :------------------ | | Cash | $42,665 | $504,189 | | Total current assets | $277,096 | $684,341 | | Total assets | $1,077,390 | $1,589,021 | | Accounts payable and accrued expenses | $4,498,691 | $2,714,105 | | Total current liabilities | $10,903,336 | $7,227,546 | | Total stockholders' deficit | $(9,825,946) | $(5,638,525) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Presents the company's condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenues, net | $0 | $15,750 | $1,500 | $15,750 | | Gross profit | $(102,328) | $(56,252) | $(204,015) | $(56,252) | | Operating loss | $(1,972,113) | $(1,401,944) | $(4,161,014) | $(1,810,574) | | Net loss from continuing operations | $(2,120,265) | $(1,413,106) | $(4,320,447) | $(1,862,005) | | Net loss | $(2,120,265) | $(1,383,404) | $(4,320,133) | $(1,790,623) | | Net loss available to common stockholders | $(3,363,656) | $(2,031,520) | $(6,777,861) | $(2,518,104) | | Net loss per share – Basic and diluted | $(0.89) | $(1.72) | $(1.95) | $(2.16) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20STOCKHOLDERS%27%20EQUITY%20(DEFICIT)) Details changes in stockholders' equity (deficit) for the six months ended June 30, 2025, reflecting stock transactions and net loss Changes in Stockholders' Equity (Deficit) - Six Months Ended June 30, 2025 | Metric | January 31, 2025 Balance (USD) | Dividends Declared (USD) | Capitalized Dividends (USD) | Preferred Stock Conversion (USD) | Common Stock Issuance (USD) | Net Loss (USD) | June 30, 2025 Balance (USD) | | :-------------------------- | :----------------------- | :----------------- | :-------------------- | :------------------------- | :-------------------- | :--------- | :---------------------- | | Preferred Stock (Par) | $51 | - | - | $(4) | - | - | $47 | | Common Stock (Par) | $1,168 | - | - | $4 | $165 | - | $1,337 | | Additional Paid-In Capital | $59,344,408 | $(2,457,728) | $2,312,108 | $178,332 | $99,835 | - | $59,476,955 | | Accumulated Deficit | $(64,984,152) | - | - | - | - | $(4,320,133) | $(69,304,285) | | Total | $(5,638,525) | $(2,457,728) | $2,312,108 | $178,332 | $100,000 | $(4,320,133) | $(9,825,946) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Presents the company's condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows Highlights | Cash Flow Activity | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (As Restated) (USD) | | :------------------------------------------ | :----------------------------- | :------------------------------------------- | | Net cash used in operating activities | $(2,328,451) | $(930,128) | | Net cash used in investing activities | $0 | $(375,000) | | Net cash provided in financing activities | $1,866,927 | $1,974,227 | | Net increase (decrease) in cash | $(461,524) | $669,099 | | Cash, end of period | $42,665 | $890,610 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) Provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1 – Description of Business](index=10&type=section&id=Note%201%20%E2%80%93%20Description%20of%20Business) Describes the company's continuing operations in precision medicine for cancer treatment and its discontinued operations - The Company's continuing operations focus on precision medicine in cancer treatment, utilizing activated protein analysis for clinical testing of breast cancer patients and collaborations with biopharmaceutical companies for drug target identification[24](index=24&type=chunk) - Discontinued operations include IMAC Regeneration Centers, The BackSpace retail stores, and the Investigational New Drug division, with patient care at all locations sold or discontinued as of December 31, 2023[25](index=25&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=10&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the significant accounting policies used in preparing the unaudited condensed financial statements and impact of new standards - The unaudited condensed financial statements are prepared in accordance with GAAP for interim financial information and Article 8 of Regulation S-X, including only normal recurring adjustments[26](index=26&type=chunk) - Management makes estimates and assumptions affecting reported amounts, with actual results potentially differing materially[28](index=28&type=chunk) - The Company is evaluating the impact of recently issued accounting standards: ASU 2023-09 (Income Taxes) effective after December 15, 2024, and ASU 2024-03 (Expense Disaggregation Disclosures) effective after December 15, 2026[29](index=29&type=chunk)[30](index=30&type=chunk) [Note 3 – Going Concern Considerations](index=11&type=section&id=Note%203%20%E2%80%93%20Going%20Concern%20Considerations) Addresses the company's ability to continue as a going concern, citing expected operating losses and plans for capital raises - The Company expects to incur operating losses and cash outflows, leading to substantial doubt about its ability to continue as a going concern within twelve months from the statements' issuance[31](index=31&type=chunk) - Management plans to raise additional capital through debt and equity to mitigate going concern risks[31](index=31&type=chunk) [Note 4 – Property and Equipment](index=11&type=section&id=Note%204%20%E2%80%93%20Property%20and%20Equipment) Details the company's property and equipment, net of accumulated depreciation, and related depreciation expense Property and Equipment, Net | Category | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------- | :------------ | :------------------ | | Equipment | $1,044,000 | $1,044,000 | | Less: accumulated depreciation | $(244,000) | $(139,000) | | Total property and equipment, net | $800,000 | $905,000 | - Depreciation expense for the six months ended June 30, 2025, was approximately **$0.10 million**, significantly higher than **$0.04 million** for the same period in 2024[33](index=33&type=chunk) [Note 5 – Note Payable](index=12&type=section&id=Note%205%20%E2%80%93%20Note%20Payable) Summarizes the company's notes payable, including new issuances and unamortized debt discounts Notes Payable Summary | Note Type | June 30, 2025 (USD) | December 31, 2024 (USD) | | :------------------------ | :------------ | :------------------ | | 40% OID promissory note | $2,278,000 | $0 | | 10% OID promissory note | $154,000 | $0 | | Total notes payable | $2,432,000 | $0 | | Less: unamortized debt discounts | $(505,000) | $0 | | Notes payable, net | $1,927,000 | $0 | - During the six months ended June 30, 2025, the Company issued promissory notes totaling **$2.43 million** in principal for an aggregate purchase price of **$1.77 million**[34](index=34&type=chunk) [Note 6 – Shareholders' Deficit](index=12&type=section&id=Note%206%20%E2%80%93%20Shareholders%27%20Deficit) Details changes in shareholders' deficit, including preferred stock conversions and common stock issuances - **4,455 shares** of preferred stock were converted into **1,425,170 shares** of common stock during the six months ended June 30, 2025[35](index=35&type=chunk) Preferred Stock Liquidation Preference as of June 30, 2025 | Series | Shares Outstanding | Stated Value (USD) | Liquidation Preference (USD) | | :------- | :----------------- | :----------- | :--------------------- | | Series C-1 | 2,020 | $1,000 | $2,578,000 | | Series C-2 | 876 | $1,000 | $1,071,000 | | Series D | 14,003 | $1,090 | $17,177,000 | | Series E | 24,172 | $1,090 | $29,650,000 | | Series F | 300 | $1,091 | $368,000 | | Series G | 4,676 | $1,038 | $5,462,000 | | Total | 46,047 | | $56,306,000 | - Shareholders approved an increase in authorized common stock to **120,000,000 shares** from **60,000,000 shares** on March 26, 2025. The Company issued **329,932 common shares** for **$0.10 million** cash in the six months ended June 30, 2025[37](index=37&type=chunk) [Note 7 – Net Loss Per Share](index=13&type=section&id=Note%207%20%E2%80%93%20Net%20Loss%20Per%20Share) Explains the calculation of basic and diluted net loss per share and lists dilutive instruments excluded due to anti-dilutive effects - Basic and diluted net loss per common share are computed by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding. Dilutive common stock equivalents are excluded due to their anti-dilutive effect from the Company's net loss[38](index=38&type=chunk) Dilutive Shares Not Included in EPS Calculation | Instrument | June 30, 2025 | June 30, 2024 | | :-------------------------- | :------------ | :------------ | | Common Stock Purchase Warrants | 5,905,946 | 2,928,231 | | Preferred shares C-1 | 927,857 | 1,043,388 | | Preferred shares C-2 | 383,860 | 509,318 | | Preferred shares D | 4,298,245 | 4,828,637 | | Preferred shares E | 7,419,643 | 6,721,844 | | Preferred shares F | 98,639 | 134,043 | | Preferred shares G | 3,169,988 | - | | Stock options | 11,306 | 1,312 | | Total | 22,215,484 | 16,166,773 | [Note 8 – Commitments and Contingencies](index=13&type=section&id=Note%208%20%E2%80%93%20Commitments%20and%20Contingencies) Outlines the company's commitments and contingencies, primarily related to governmental program audits and potential overpayments - The Company is subject to audits under governmental programs, with CMS contractors recommending overpayments for discontinued operations[40](index=40&type=chunk) - For Progressive Health, CMS recommended an overpayment of approximately **$2.7 million**. The Company has appealed through multiple levels, including filing a lawsuit in federal court on May 14, 2025, and has reserved this amount[41](index=41&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - For Advantage Therapy, CMS recommended an overpayment of approximately **$0.5 million**. The Company received a partially favorable reconsideration decision and awaits a response from an Administrative Law Judge hearing[45](index=45&type=chunk)[46](index=46&type=chunk) - For IMAC St. Louis, CMS estimated an overpayment of approximately **$1.1 million** for the period February 26, 2020, through January 2, 2024[47](index=47&type=chunk) [Note 9 – Segment Reporting](index=14&type=section&id=Note%209%20%E2%80%93%20Segment%20Reporting) Identifies the company's single operating segment in precision medicine and presents segment expenses from continuing operations - The Company operates in a single segment: precision medicine in cancer treatment, located in the United States[48](index=48&type=chunk) Segment Expenses from Continuing Operations | Expense Category | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :----------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Employee expense | $1,144,984 | $431,207 | $1,947,025 | $581,409 | | Professional fees | $372,074 | $752,799 | $1,435,279 | $910,535 | | Occupancy | $71,569 | $34,257 | $137,555 | $36,334 | | Insurance | $69,091 | $85,408 | $139,597 | $167,248 | | Other | $212,067 | $42,021 | $297,543 | $58,796 | | Total operating expenses | $1,869,785 | $1,345,692 | $3,956,999 | $1,754,322 | | Operating loss | $(1,972,113) | $(1,401,944) | $(4,161,014) | $(1,810,574) | [Note 10 – Subsequent Events](index=15&type=section&id=Note%2010%20%E2%80%93%20Subsequent%20Events) Reports significant events occurring after June 30, 2025, including the issuance of additional unsecured promissory notes - Subsequent to June 30, 2025, the Company issued unsecured promissory notes (Q3 2025 Notes) with an aggregate principal amount of **$1.2 million** for a purchase price of **$0.9 million**, maturing by December 24, 2025, or upon a qualifying securities offering[50](index=50&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on the company's financial condition, operating results, liquidity, and capital resources for interim periods [Special Note Regarding Forward-Looking Information](index=16&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Information) Highlights that this discussion contains forward-looking statements subject to uncertainties and risks that could materially affect actual results - This discussion contains forward-looking statements subject to uncertainties, risks, and other influences, many beyond the company's control, which could materially affect actual results. The company does not undertake to update these statements[51](index=51&type=chunk)[52](index=52&type=chunk) [Overview](index=16&type=section&id=Overview) Provides an overview of IMAC Holdings, Inc.'s primary operations through Ignite Proteomics, LLC, and key financial highlights - IMAC Holdings, Inc. primarily operates through Ignite Proteomics, LLC, which uses a patented RPPA technology platform for oncology clinical treatment decisions and biopharmaceutical drug development[54](index=54&type=chunk) Key Financials for Q2 and H1 2025 | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------------------- | :------------------------------- | :----------------------------- | | Net revenue | $0 | $0.002 million | | Net loss | $2.1 million | $4.3 million | | Net loss from continuing operations | $(2.1 million) | $(4.3 million) | | Net loss from discontinued operations | $0 | $0 | | Legal fees (H1 only) | N/A | $0.6 million | [Matters that May or Are Currently Affecting Our Business](index=17&type=section&id=Matters%20that%20May%20or%20Are%20Currently%20Affecting%20Our%20Business) Discusses factors impacting the business, including the need for additional financing and attracting skilled personnel - Future success depends on the ability to obtain additional financing for the recently acquired laboratory's growth and to attract competent, skilled laboratory and sales personnel at acceptable prices[57](index=57&type=chunk) [Critical Accounting Estimates](index=18&type=section&id=Critical%20Accounting%20Estimates) Explains the role of management estimates and assumptions in financial statements and the impact of critical accounting estimates - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts, with material differences potentially impacting financial condition or results of operations[58](index=58&type=chunk) - A critical accounting estimate involves highly uncertain assumptions and changes that could materially impact financial condition or results[59](index=59&type=chunk) [Results of Operations for the Three and Six Months Ended June 30, 2025 Compared to the Three and Six Months Ended June 30, 2024](index=18&type=section&id=Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20Compared%20to%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202024) Analyzes the company's operating results for the three and six months ended June 30, 2025, compared to the same periods in 2024 - Cost of revenues increased for both the three and six months ended June 30, 2025, primarily due to costs incurred in the operation of the laboratory acquired in May 2024[61](index=61&type=chunk)[62](index=62&type=chunk) - Operating expenses increased to **$1.9 million** (Q2 2025) from **$1.3 million** (Q2 2024) and to **$4.0 million** (H1 2025) from **$1.8 million** (H1 2024), mainly attributable to the acquired laboratory's operations, including higher salaries and benefits[63](index=63&type=chunk)[64](index=64&type=chunk) - Other expenses, primarily interest expense, significantly increased to **$0.1 million** (Q2 2025) from **$0.01 million** (Q2 2024) and to **$0.2 million** (H1 2025) from **$0.05 million** (H1 2024)[65](index=65&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's liquidity position, working capital, and capital resources, including the need for additional funding Liquidity Position | Metric | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :------------------ | | Cash | $0.04 million | $0.5 million | | Working capital deficit | $(10.6) million | $(6.5) million | | Total current liabilities | $10.9 million | N/A | - The decrease in working capital was primarily due to a **$1.8 million** increase in accounts payable and a **$1.8 million** increase in notes payable[66](index=66&type=chunk) - The Company had an accumulated deficit of **$69.3 million** as of June 30, 2025, and anticipates needing to raise additional capital to fund future operations. Management has determined that the financial condition raises substantial doubt about the ability to continue as a going concern[68](index=68&type=chunk) [Cash Flows](index=19&type=section&id=Cash%20Flows) Analyzes the company's cash flows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 - Net cash used in operating activities increased to **$2.3 million** for the six months ended June 30, 2025, compared to **$0.9 million** for the same period in 2024, primarily due to an increase in accounts payable[69](index=69&type=chunk) - Net cash provided by financing activities was **$1.9 million** for the six months ended June 30, 2025, mainly from common stock sales and promissory note issuances, compared to **$2.0 million** in the prior year[70](index=70&type=chunk) [Impact of Inflation](index=19&type=section&id=Impact%20of%20Inflation) Discusses the material impact of inflation on the company's results of operations, particularly on staffing and supply costs - Inflation had a material impact on the Company's results of operations for the six months ended June 30, 2025, particularly affecting staffing and supply costs related to patient care[71](index=71&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) States that there are no quantitative and qualitative disclosures about market risk applicable to the Company - This item is not applicable to the Company[73](index=73&type=chunk) [Item 4. Controls and Procedures](index=20&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting [Disclosure Controls and Procedures](index=20&type=section&id=Disclosure%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025 - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were not effective as of March 31, 2025, and June 30, 2025, due to material weaknesses in internal control over financial reporting[75](index=75&type=chunk)[77](index=77&type=chunk) [Material Weaknesses](index=20&type=section&id=Material%20Weaknesses) Identifies material weaknesses in internal control over financial reporting, including insufficient accounting resources and lack of segregation of duties - Insufficient resources in the accounting department, limiting the ability to gather, analyze, and properly review financial reporting information, including complex accounting principles - Lack of segregation of duties, where conflicting duties may not always be possible to separate due to the Company's size and nature - Insufficiently designed and implemented operating controls surrounding accounting policies to ensure books and records are recorded in accordance with US GAAP[78](index=78&type=chunk) [Changes in Internal Control over Financial Reporting](index=21&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Reports no material changes in internal control over financial reporting during the most recent fiscal quarter - No change in internal control over financial reporting occurred during the most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting[79](index=79&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings and risk factors [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The Company may be involved in various lawsuits and legal proceedings, but management is not aware of any material adverse effects - The Company is not currently aware of any legal proceedings or claims that are believed to have a material adverse effect on the business[81](index=81&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the Company's Risk Factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to Risk Factors have occurred since the Annual Report on Form 10-K for the year ended December 31, 2024[82](index=82&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of equity securities or use of proceeds to disclose - None to report[82](index=82&type=chunk) [Item 3. Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities - None to report[83](index=83&type=chunk) [Item 4. Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the Company - Not applicable[84](index=84&type=chunk) [Item 5. Other Information](index=22&type=section&id=Item%205.%20Other%20Information) This section reports that there is no other information to disclose - None to report[85](index=85&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate organizational documents and certifications - Includes Certificate of Incorporation, Bylaws, Specimen Common Stock Certificate, various Forms of Warrants, Form of Promissory Note, Credit Agreement, and Security and Pledge Agreement[87](index=87&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002 are filed herewith[88](index=88&type=chunk) [SIGNATURES](index=25&type=section&id=SIGNATURES) This section confirms the report was duly signed by the Chief Executive Officer and Chief Financial Officer on August 14, 2025 - The report was duly caused to be signed on behalf of IMAC Holdings, Inc. by Faith Zaslavsky, Chief Executive Officer, and Sheri Gardzina, Chief Financial Officer, on August 14, 2025[90](index=90&type=chunk)[91](index=91&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2025 financials show a **$2.2 million** net loss and **$7.6 million** stockholders' deficit, following a business shift [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$1.14 million** by March 2025, liabilities increased to **$8.77 million**, and stockholders' deficit worsened to **$7.63 million** Condensed Consolidated Balance Sheet Summary | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $30,880 | $504,189 | | Total Current Assets | $287,643 | $684,341 | | Total Assets | $1,140,130 | $1,589,021 | | **Liabilities & Stockholders' Deficit** | | | | Total Current Liabilities | $8,772,592 | $7,227,546 | | Total Stockholders' Deficit | $(7,632,462) | $(5,638,525) | | Total Liabilities and Stockholders' Deficit | $1,140,130 | $1,589,021 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 reported minimal revenue, a **$0.1 million** gross loss, **$2.09 million** operating expenses, and a **$3.41 million** net loss or **$(1.08) per share** Q1 2025 vs. Q1 2024 Statement of Operations | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues, net | $1,500 | $- | | Gross loss | $(101,687) | $- | | Operating expenses | $2,087,214 | $408,630 | | Operating loss | $(2,188,901) | $(408,630) | | Net loss from continuing operations | $(2,200,182) | $(448,899) | | Net loss available to common stockholders | $(3,414,205) | $(616,584) | | Net loss per share – Basic and diluted | $(1.08) | $(0.35) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 net cash used in operations increased to **$1.03 million**, financing provided **$0.56 million**, resulting in a **$0.47 million** cash decrease, ending at **$30,880** Q1 2025 vs. Q1 2024 Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,033,309) | $(202,252) | | Net cash provided by financing activities | $560,000 | $(1,724) | | Net decrease in cash | $(473,309) | $(203,976) | | Cash, end of period | $30,880 | $17,535 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's shift to precision medicine, express substantial doubt about going concern, and highlight new promissory notes and significant Medicare liabilities - The company's continuing operations are focused on precision medicine in cancer treatment, leveraging technology from Theralink Technologies, Inc. Previous operations, including IMAC Regeneration Centers, are now classified as discontinued[21](index=21&type=chunk)[22](index=22&type=chunk)[24](index=24&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for the next twelve months due to historical operating losses and cash outflows. The company plans to raise additional capital to mitigate this risk[30](index=30&type=chunk) - The company is appealing an alleged Medicare overpayment of approximately **$2.7 million** related to its discontinued Progressive Health operations and has reserved this amount. A lawsuit was filed in federal court in May 2025 after an unfavorable appeal result[40](index=40&type=chunk)[43](index=43&type=chunk) - Subsequent to the quarter's end, the company issued additional promissory notes for an aggregate principal amount of **$1.7 million** to raise **$1.2 million** in cash[50](index=50&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the operational shift to Ignite Proteomics, highlighting a **$2.2 million** net loss, **$8.5 million** working capital deficit, and substantial doubt about going concern [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Q1 2025 saw minimal revenue, **$0.1 million** in cost of revenues, and **$2.1 million** in operating expenses, primarily driven by salaries, legal, and professional fees - Operating expenses for Q1 2025 totaled **$2.1 million**, primarily composed of salaries and benefits (**$0.8 million**), legal fees (**$0.5 million**), and professional/consulting fees (**$0.5 million**)[61](index=61&type=chunk) - Cost of revenues in Q1 2025 was **$0.1 million**, split between **$0.05 million** for laboratory supplies and **$0.05 million** for depreciation expense[60](index=60&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity deteriorated with cash at **$0.03 million** and working capital deficit widening to **$(8.5) million**, raising substantial doubt about going concern Working Capital and Cash Position | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $0.03 million | $0.5 million | | Working Capital | $(8.5) million | $(7.3) million | - Current liabilities stood at approximately **$8.8 million**, including **$3.8 million** to vendors, **$0.4 million** in dividends payable, **$0.5 million** in notes payable, and **$4.0 million** for liabilities of discontinued operations[63](index=63&type=chunk) - Management has concluded that the company's financial condition raises substantial doubt about its ability to continue as a going concern and anticipates the need to raise additional capital to fund future operations[64](index=64&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company - This item is not applicable to the company[68](index=68&type=chunk) [Item 4. Controls and Procedures](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of March 31, 2025, due to material weaknesses including insufficient accounting resources and lack of segregation of duties - The CEO and CFO concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to material weaknesses in internal control over financial reporting[70](index=70&type=chunk) - Identified material weaknesses include: 1. Insufficient resources in the accounting department, hindering timely and proper financial reporting 2. Lack of segregation of conflicting duties due to the company's small size[74](index=74&type=chunk) - No changes were made to the internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, these controls[75](index=75&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=20&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any legal proceedings with a material adverse effect on its business - The company is not currently aware of any legal proceedings that are believed to have a material adverse effect on the business[77](index=77&type=chunk) [Item 1A. Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) No material changes to Risk Factors from the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have been made to the Risk Factors from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[78](index=78&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=20&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None reported[79](index=79&type=chunk) [Item 6. Exhibits](index=21&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and officer certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002[84](index=84&type=chunk)

PART I [Item 1. Business](index=4&type=section&id=Item%201.%20Business) IMAC Holdings shifted to oncology proteomic products via Ignite Proteomics, facing Nasdaq delisting and evolving LDT regulations - IMAC Holdings, Inc. transitioned its business focus to proteomic products for oncology clinical treatment and biopharmaceutical drug development, effective May 2024[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) - The company acquired assets and rights from Theralink Technologies, Inc., including a CLIA-certified, CAP-accredited, and NYS-CLEP certified laboratory, and licenses for proteomics technology[19](index=19&type=chunk)[20](index=20&type=chunk) - A new wholly-owned subsidiary, Ignite Proteomics LLC, was formed to operate the acquired medical lab and deliver proteomic services, with credentials to bill Medicare and other third-party payors[20](index=20&type=chunk) - The core product is a patented RPPA technology platform quantifying protein signaling for oncology treatment decisions and drug development, initially for breast cancer with plans to expand to pan-tumor assays in 2025-2026[31](index=31&type=chunk)[35](index=35&type=chunk) - The company's common stock was delisted from Nasdaq on March 26, 2025, due to non-compliance with the Minimum Equity Rule and now trades on the OTC Pink Market[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - As a smaller reporting company, IMAC Holdings benefits from scaled disclosures, including presenting only two years of audited financial statements and reduced executive compensation disclosures[45](index=45&type=chunk) - The company is subject to evolving government regulations regarding Laboratory Developed Tests (LDTs) by the FDA, which could lead to increased regulatory burdens and costs[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) [Overview](index=4&type=section&id=Overview) This section provides a general introduction to IMAC Holdings' business transformation and current operational status [Intellectual Property](index=4&type=section&id=Intellectual%20Property) The company's intellectual property includes patented proteomics technology licensed from Vanderbilt University and George Mason University [Strategy](index=6&type=section&id=Strategy) The company's strategy focuses on commercializing its proteomic platform for oncology, expanding test offerings, and securing payor coverage [Product Portfolio](index=6&type=section&id=Product%20Portfolio) The product portfolio centers on the RPPA technology platform for breast cancer, with plans for broader oncology applications [Corporate Information](index=9&type=section&id=Corporate%20Information) This section details the company's legal structure and operational headquarters [Listing of Company Securities](index=9&type=section&id=Listing%20of%20Company%20Securities) Information regarding the trading status of the company's common stock, including its delisting from Nasdaq [Implications of Being a Smaller Reporting Company](index=10&type=section&id=Implications%20of%20Being%20a%20Smaller%20Reporting%20Company) This section outlines the reduced disclosure requirements and other benefits afforded to smaller reporting companies [Government Regulation](index=10&type=section&id=Government%20Regulation) The company operates under various government regulations, particularly those impacting Laboratory Developed Tests (LDTs) [Employees and Human Capital Management](index=12&type=section&id=Employees%20and%20Human%20Capital%20Management) This section provides information on the company's workforce and human resources strategies [Available Information](index=12&type=section&id=Available%20Information) Details on where to access the company's public filings and other relevant information [Item 1A. Risk Factors](index=12&type=section&id=Item%201A.%20Risk%20Factors) The company faces recurring losses, going concern issues, integration challenges, intense competition, LDT regulatory uncertainty, internal control weaknesses, and reduced liquidity post-Nasdaq delisting - The company recorded a net loss of approximately **$6.3 million** from continuing operations for the year ended December 31, 2024, and has a going concern qualification, indicating substantial doubt about its ability to continue operations without additional funding[57](index=57&type=chunk)[58](index=58&type=chunk) - Successful integration of assets acquired from Theralink, obtaining Medicare and third-party payor credentials, and securing additional funding are critical for revenue generation and financial stability[60](index=60&type=chunk)[61](index=61&type=chunk) - Competition in the cancer information field is intense, with larger competitors possessing greater R&D, marketing, and financial resources, posing a risk to the commercial success of the company's services[65](index=65&type=chunk)[66](index=66&type=chunk)[68](index=68&type=chunk) - Regulatory changes, particularly concerning Laboratory Developed Tests (LDTs) by the FDA, could impose additional clinical trials, delays, increased costs, or failure to obtain necessary approvals[73](index=73&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - The company has identified material weaknesses in internal controls over financial reporting, including insufficient accounting personnel for complex transactions and lack of segregation of duties, which could lead to material misstatements and affect stock price[98](index=98&type=chunk)[99](index=99&type=chunk) - The company's common stock was suspended from trading on Nasdaq and now trades on the OTC Pink Market, which may adversely affect liquidity and the ability to raise capital[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) [Risks Relating to Our Business](index=12&type=section&id=Risks%20Relating%20to%20Our%20Business) This section details operational and financial risks specific to the company's business model and market [Risks Related to Our Securities](index=21&type=section&id=Risks%20Related%20to%20Our%20Securities) This section outlines risks associated with the company's common stock, including liquidity and capital raising challenges [General Risk Factors](index=24&type=section&id=General%20Risk%20Factors) This section covers broader risks that could impact the company's overall operations and financial performance [Item 1B. Unresolved Staff Comments](index=25&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[124](index=124&type=chunk) [Item 1C. Cybersecurity](index=25&type=section&id=Item%201C.%20Cybersecurity) IMAC Holdings has established processes for assessing, identifying, and managing material cybersecurity risks, integrating them into overall risk management - The company has established processes for assessing, identifying, and managing material cybersecurity threats, integrated into its overall risk management systems[125](index=125&type=chunk) - Periodic risk assessments are conducted to identify threats, evaluate potential damage, and assess the sufficiency of existing safeguards, with an IT consultant reporting to the CEO[126](index=126&type=chunk)[127](index=127&type=chunk) - The Board is periodically informed of risk management processes, including cybersecurity threats, with the CEO and CFO primarily responsible for oversight[131](index=131&type=chunk)[132](index=132&type=chunk) - The company has not encountered cybersecurity challenges that have materially impaired its operations or financial standing[130](index=130&type=chunk) [Risk Management and Strategy](index=25&type=section&id=Risk%20Management%20and%20Strategy) This section describes the company's approach to identifying, assessing, and mitigating cybersecurity risks [Governance](index=26&type=section&id=Governance) This section outlines the oversight structure for cybersecurity risks, including roles of management and the Board of Directors [Item 2. Properties](index=26&type=section&id=Item%202.%20Properties) IMAC Holdings operates from a principal executive office in Franklin, Tennessee, and a laboratory in Golden, Colorado, both on month-to-month leases - The company's principal executive office is in Franklin, Tennessee, and its laboratory is in Golden, Colorado[133](index=133&type=chunk) - Both the executive office and laboratory leases are on a month-to-month basis[133](index=133&type=chunk) Rent Expense | Year | Rent Expense | | :--- | :--- | | 2024 | $0.1 million | [Item 3. Legal Proceedings](index=26&type=section&id=Item%203.%20Legal%20Proceedings) IMAC Holdings is involved in a legal proceeding regarding an alleged lease default for a former clinic location in Tampa, Florida, with the landlord claiming approximately $0.15 million - A complaint was filed against the company for an alleged default in a foreclosure action related to a former clinic lease in Tampa, Florida[135](index=135&type=chunk) Alleged Lease Default Amount | Item | Amount | | :--- | :--- | | Alleged Lease Payments, Commissions, Costs, and Interest | ~$0.15 million | - The company is in discussions with the landlord for a potential settlement[135](index=135&type=chunk) - Management is not aware of any other legal proceedings or claims that would have a material adverse effect[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to IMAC Holdings, Inc PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=27&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purch

Core Insights - Ignite Proteomics has demonstrated that MHC-II protein expression is a superior predictor of response to pembrolizumab (Keytruda) compared to PD-L1, with data to be presented at the NCCN Annual Conference [1][6] - The analysis indicates that measuring MHC-II levels can better identify breast cancer patients who will respond to Keytruda, potentially leading to more effective treatment decisions [2][6] I-SPY 2 Trial Context - The I-SPY 2 trial is a multicenter, adaptive platform trial focused on high-risk stage II and III breast cancer patients undergoing neoadjuvant treatment, evaluating new agents based on interim outcomes [2] - MHC-II expression outperformed PD-L1 measurements in predicting patient outcomes within this significant research setting [2] Key Findings - Among five tested PD-L1 antibodies, only MHC-II showed a statistically significant correlation with response to pembrolizumab, while none of the PD-L1 measurements reached statistical significance [7] - Patients with higher MHC-II protein levels exhibited nearly double the response rate compared to unselected patient cohorts [7] - There is an unmet need for biomarker testing in certain cancer types, where a significant number of patients do not respond to checkpoint inhibitors; MHC-II testing could enhance the identification of those likely to benefit [7] About Ignite Proteomics - Ignite Proteomics utilizes a multi-analyte proteomic assay to assist oncologists in identifying the most effective targeted therapies for patients, moving beyond single-gene tests to evaluate entire protein pathways [4] - The company is expanding its focus from advanced breast cancer to other solid tumors and therapies reliant on protein function, aiming to improve treatment outcomes and reduce costs [4]

Core Insights - Ignite Proteomics LLC has successfully transferred the Proprietary Laboratory Analyses (PLA) code 0249U from Theralink Technologies, enhancing its capabilities in proteomic diagnostics for breast cancer [1][10] - The PLA code 0249U is recognized in the Medicare Clinical Laboratory Fee Schedule and is reimbursed at $2,219.13, indicating its significance among high-complexity diagnostic assays [2][10] - The integration of the PLA code positions Ignite Proteomics to lead in proteomic diagnostics and accelerate innovation in precision oncology [3] Company Overview - Ignite Proteomics specializes in advanced Reverse Phase Protein Array (RPPA) technology for cancer diagnostics, operating under a CLIA-certified, CAP-accredited, and NY State-approved laboratory [7] - The company aims to bridge the gap left by gene-focused methods by helping physicians match patients with suitable targeted therapies [7] - IMAC Holdings, the parent company, is committed to improving patient outcomes through innovative healthcare solutions and is in the process of rebranding to IMAC Holdings, Inc., DBA Ignite Sciences, Inc. [8] Diagnostic Methodology - Ignite's proteomic assay measures functional protein activity in breast tumors, providing oncologists with data on how patients might respond to targeted therapies [3] - This method differs from standard genomic tests by identifying active proteins, potentially improving treatment outcomes for patients [6][12] - The establishment of a dedicated PLA code allows for clearer reimbursement pathways, avoiding confusion associated with generic billing codes [5][10]

Core Insights - The study emphasizes the importance of measuring activated proteins in the AKT–mTOR signaling pathway for predicting patient responses to targeted cancer therapies [2][3][11] Group 1: Study Overview - Ignite Proteomics LLC published a significant study in the British Journal of Cancer, highlighting the functional activation of the AKT–mTOR signaling axis in metastatic breast cancer [2] - The research indicates that direct assessment of protein activation is a superior method for predicting therapeutic outcomes compared to genomic profiling alone [3][6] Group 2: Key Findings - Enhanced clinical outcomes were observed through proteomic profiling, allowing for better identification of patients likely to benefit from endocrine therapy combined with a CDK4/6 inhibitor [5] - The study found that patients with functional activation of the AKT–mTOR signaling axis had significantly worse responses to standard first-line treatment with a CDK4/6 inhibitor [8] - There was no correlation between genomic mutations in key genes (PIK3CA, PTEN, AKT) and the activation status of corresponding proteins, indicating that genomic alterations do not reflect protein activity [8][9] Group 3: Implications for Cancer Treatment - The AKT–mTOR pathway is crucial for cell growth and survival, and its dysregulation is linked to various cancers, including metastatic breast cancer [6] - The findings support the integration of proteomic analysis into clinical practice to personalize cancer treatment based on functional protein activity [10][12] Group 4: Technological Advancements - Ignite Proteomics offers a clinically validated assay that measures both expression and activation levels of drug targets in breast tumors, providing actionable insights for oncologists [13][14] - The Reverse Phase Protein Array (RPPA)-based assay quantifies the phosphorylation status of proteins, focusing on protein function rather than genetic mutations [9][10]

Core Insights - IMAC Holdings has launched Ignite Proteomics LLC, a subsidiary focused on personalized cancer treatment through protein-level insights, addressing the need for improved therapy selection in breast cancer and other cancers [1][2] Group 1: Market Opportunity - The genomic testing market has not fully delivered on personalized care, as genetics reveal potential but proteins indicate current tumor behavior, positioning Ignite to disrupt the multi-billion-dollar genomic testing market [2][3] - The current clinically approved indication for Ignite's test represents a market opportunity of $600 million [2] Group 2: Product Offering - Ignite's multi-protein test measures a range of proteins in a single sample, providing a comprehensive view of tumor activity and therapy vulnerability, with several biomarkers protected by licensed patents [4][9] - The test aims to improve therapy selection by identifying drug targets that standard genomic tests may overlook, thus avoiding the trial-and-error approach in treatment [8] Group 3: Strategic Vision - Ignite Proteomics is collaborating with leading cancer centers to expand clinical evidence and integrate its test into routine care, enhancing the standard of care for breast cancer [8] - The focus on antibody-drug conjugates (ADCs) and immunotherapy reflects the need for deeper insights into tumor behavior as more complex therapies are introduced [8]