[Explanatory Note](index=3&type=section&id=Explanatory%20Note) [Restatement of Financial Statements](index=3&type=section&id=Restatement%20of%20Financial%20Statements) The company restated 2023 and 2024 financial statements due to incorrect royalty accruals, identifying a material weakness in internal controls - The company determined it should not have been accruing royalty expense for certain agreements, leading to a reversal of accruals from 2016-2023[11](index=11&type=chunk) - Previously issued financial statements for the year ended December 31, 2023, and quarterly reports for 2023 and 2024, are no longer reliable and have been restated in this Form 10-K[12](index=12&type=chunk)[14](index=14&type=chunk) - A material weakness in internal control over financial reporting was identified, attributed to a lack of communication between the accounting and science teams regarding the technology used in revenue-generating products (ThyraMIR and ThyGeNEXT)[13](index=13&type=chunk) - The company does not plan to amend previously filed Annual or Quarterly reports for the affected periods; this Form 10-K supersedes that information[16](index=16&type=chunk) [PART I](index=6&type=section&id=PART%20I) [Business](index=6&type=section&id=Item%201.%20Business) Interpace Biosciences offers specialized molecular diagnostic and pathology services for cancer risk assessment via five commercialized genomic tests [Company and Market Overview](index=6&type=section&id=Company%20and%20Market%20Overview) The company offers esoteric molecular diagnostic tests for cancer risk, operating in a global market projected for substantial growth - The company provides molecular diagnostic testing and pathology services to aid in cancer risk evaluation for patients with indeterminate biopsies[24](index=24&type=chunk) - The global esoteric molecular diagnostics market is expected to grow at a CAGR of **8.5%** from 2023 to 2029, reaching **$48.3 billion**[27](index=27&type=chunk) - In 2024, Laboratory Corporation of America (LabCorp) was the largest customer for the company's ThyGeNEXT and ThyraMIRv2 products[25](index=25&type=chunk) [Our Service Offerings](index=8&type=section&id=Our%20Service%20Offerings) The company commercializes five molecular diagnostic tests for cancer risk stratification, performed in its accredited laboratory - The company has five commercialized molecular diagnostic tests: PancraGEN, PanDNA, ThyGeNEXT, ThyraMIRv2, and RespriDx[39](index=39&type=chunk) - The addressable market for PancraGEN is estimated at approximately **$200 million** annually, and for endocrine (thyroid) cancer assays, it is about **$300 million** annually[41](index=41&type=chunk)[46](index=46&type=chunk) - All testing is performed in the company's CLIA-certified and CAP-accredited laboratory in Pittsburgh, Pennsylvania[50](index=50&type=chunk) [Competition](index=11&type=section&id=Competition) The company faces competition from established diagnostic firms, with its PancraGEN test having fewer direct integrated competitors - In the thyroid diagnostic market, key competitors include Veracyte (Afirma), Quest Diagnostics, and Sonic (ThyroSeq)[56](index=56&type=chunk) - The company is not aware of any direct competitors to PancraGEN that fully integrate clinical, imaging, cytology, and molecular data, although the University of Pittsburgh Medical Center offers a competitive gene sequencing panel (PancreaSeq)[57](index=57&type=chunk) [Government Regulations and Industry Guidelines](index=14&type=section&id=Government%20Regulations%20and%20Industry%20Guidelines) The company faces extensive regulation and significant revenue risk from a pending Medicare non-coverage decision for PancraGEN - The FDA published a final rule on April 29, 2024, to phase out enforcement discretion for many LDTs over a four-year period, which could subject the company's tests to additional, costly regulatory requirements[76](index=76&type=chunk) - Reimbursement from Medicare and Medicare Advantage programs constituted approximately **53%** of consolidated net revenues in 2024[118](index=118&type=chunk) - A new LCD from Novitas established non-coverage for the PancraGEN test. Implementation has been delayed to April 24, 2025, but if it takes effect, it could negatively impact the company's liquidity[123](index=123&type=chunk) [Business Development](index=24&type=section&id=Business%20Development) The company exchanged Series B for Series C Preferred Stock with investors, lowering the conversion price and reducing investor protections - The company exchanged all 47,000 shares of Series B Preferred Stock for 47,000 shares of new Series C Preferred Stock with investors Ampersand and 1315 Capital[127](index=127&type=chunk) - The new Series C Preferred Stock has a conversion price of **$2.02** per share, significantly lower than the Series B's **$6.00** price, and removes certain investor protections like liquidation preference and director designation rights[128](index=128&type=chunk)[132](index=132&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from CMS reliance, PancraGEN non-coverage, concentrated ownership, FDA LDT regulation, and internal control weaknesses - A significant risk is the dependence on CMS reimbursement, particularly for the PancraGEN test, which faces non-coverage under a new LCD, potentially impacting liquidity[142](index=142&type=chunk)[149](index=149&type=chunk) - Two private equity firms, Ampersand and 1315 Capital, control an aggregate of **84%** of the company's outstanding common stock on an as-converted basis through their Series C Preferred Stock holdings[142](index=142&type=chunk)[167](index=167&type=chunk) - The FDA's final rule to regulate LDTs could impose substantial costs and delays for obtaining pre-market clearance for the company's tests[142](index=142&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) - The restatement of prior financial statements and the identification of a material weakness in internal controls as of December 31, 2024, pose risks to investor confidence and company reputation[145](index=145&type=chunk)[274](index=274&type=chunk) - The company's common stock was delisted from Nasdaq and now trades on the OTCQX, which has adversely affected liquidity and stock price[145](index=145&type=chunk)[259](index=259&type=chunk) [Cybersecurity](index=62&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cybersecurity risk management program overseen by its IT team and Board, with no material incidents reported - The company maintains processes to assess, identify, and manage cybersecurity risks, overseen by a dedicated IT team and the Board's Compliance Committee[283](index=283&type=chunk)[285](index=285&type=chunk) - The Vice President of Information Technology, with over 15 years of experience, leads the cybersecurity efforts[286](index=286&type=chunk) - No cybersecurity incidents have materially affected the company in the last fiscal year, but ongoing risks are acknowledged[284](index=284&type=chunk) [Properties](index=62&type=section&id=Item%202.%20Properties) The company's corporate headquarters are in Parsippany, NJ, and its main diagnostic laboratory is in Pittsburgh, PA - Corporate headquarters are in Parsippany, NJ on a month-to-month lease[287](index=287&type=chunk) - The diagnostic laboratory is a 21,400 sq. ft. facility in Pittsburgh, PA, with a lease running through June 30, 2028[287](index=287&type=chunk) [PART II](index=63&type=section&id=PART%20II) [Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=63&type=section&id=Item%205.%20Market%20for%20our%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock was delisted from Nasdaq and now trades on OTCQX, with a recent unregistered preferred stock exchange - The company's common stock was delisted from Nasdaq and now trades on the OTCQX under the symbol "IDXG"[291](index=291&type=chunk) - The company received a notice of non-compliance from OTCQX in December 2023 for its market capitalization falling below **$5 million**, but regained compliance in March 2024[292](index=292&type=chunk) - An unregistered exchange of 47,000 shares of Series B Preferred Stock for new Series C Preferred Stock occurred on October 10, 2024[296](index=296&type=chunk)[297](index=297&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=64&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In FY2024, revenue increased **17%** to **$46.9 million**, but liquidity is uncertain due to a pending Medicare non-coverage decision for PancraGEN [Consolidated Results of Operations](index=69&type=section&id=Consolidated%20Results%20of%20Operations) For FY2024, net revenue increased **17%** to **$46.9 million**, driving a **104%** increase in operating income to **$8.1 million** Consolidated Results of Operations (Years Ended December 31) | Metric | 2024 | 2023 (as restated) | % Change | | :--- | :--- | :--- | :--- | | **Revenue, net** | $46.9 million | $40.0 million | 17% | | **Gross Profit** | $29.9 million | $25.1 million | 19% | | **Operating Income** | $8.1 million | $4.0 million | 104% | | **Net Income** | $6.7 million | $2.0 million | 243% | - The increase in net revenue was largely driven by increased test volumes compared to the prior year[335](index=335&type=chunk) [Non-GAAP Financial Measures](index=71&type=section&id=Non-GAAP%20Financial%20Measures) Adjusted EBITDA, a key non-GAAP measure, increased **56%** to **$8.7 million** in 2024, reflecting improved operational performance Reconciliation of Adjusted EBITDA (Unaudited, in thousands) | | Years Ended December 31, | | :--- | :--- | :--- | | | **2024** | **2023 (as restated)** | | **Income from continuing operations (GAAP Basis)** | $6,946 | $2,264 | | Depreciation and amortization | 300 | 1,026 | | Stock-based compensation | 291 | 630 | | Tax expense | 4 | 17 | | Interest accretion expense | 34 | 112 | | Financing interest and related costs | 625 | 896 | | Interest income | (48) | (53) | | Change in fair value of note payable | 547 | 678 | | Change in fair value of contingent consideration | - | 7 | | **Adjusted EBITDA** | **$8,699** | **$5,577** | [Liquidity and Capital Resources](index=72&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2024, the company had **$1.5 million** in cash, with liquidity facing significant risk from potential Medicare non-coverage for PancraGEN - As of December 31, 2024, the company had **$1.5 million** in cash and cash equivalents and current liabilities of **$10.6 million**[355](index=355&type=chunk) - The maturity date of the BroadOak term loan, with a balance of **$4.4 million** at year-end, was extended to December 31, 2025[352](index=352&type=chunk)[354](index=354&type=chunk) - Net cash provided by operating activities was **$4.6 million** in 2024, compared to **$3.8 million** in 2023[356](index=356&type=chunk) - A significant liquidity risk remains due to the potential non-coverage of the PancraGEN test by Medicare, with a final decision delayed until April 24, 2025[361](index=361&type=chunk)[364](index=364&type=chunk)[366](index=366&type=chunk) [Controls and Procedures](index=75&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were ineffective as of December 31, 2024, due to a material weakness - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024[372](index=372&type=chunk) - A material weakness in internal control over financial reporting was identified related to an incorrect royalty accrual, stemming from a lack of communication between the science and accounting teams[372](index=372&type=chunk) - A remediation plan is being implemented, including updated procedures for reviewing significant agreements with outside experts and establishing quarterly meetings between management and the science team[373](index=373&type=chunk) - Management also concluded that internal control over financial reporting was not effective as of December 31, 2024[375](index=375&type=chunk) [PART IV](index=77&type=section&id=PART%20IV) [Financial Statements and Exhibits](index=77&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section presents the company's consolidated financial statements for 2024 and 2023, including notes on the significant restatement and liquidity risks [Note 2. Restatement of Previously Issued Consolidated Financial Statements](index=93&type=section&id=Note%202.%20Restatement%20of%20Previously%20Issued%20Consolidated%20Financial%20Statements) The company restated 2023 and 2024 financial statements due to incorrect royalty expense accruals, reducing accumulated deficit by **$6.1 million** - Financial statements were restated due to the incorrect accrual of royalty expenses and adjustments to revenue recognition timing[445](index=445&type=chunk)[447](index=447&type=chunk) Impact of Restatement on 2023 Consolidated Statement of Operations (in thousands) | Account | As Previously Reported | Restatement Amount | As Restated | | :--- | :--- | :--- | :--- | | **Revenue, net** | $40,214 | $(178) | $40,036 | | **Cost of revenue** | $16,310 | $(1,330) | $14,980 | | **Gross profit** | $23,904 | $1,152 | $25,056 | | **Operating income** | $2,804 | $1,152 | $3,956 | | **Net income** | $802 | $1,152 | $1,954 | Impact of Restatement on Dec 31, 2023 Consolidated Balance Sheet (in thousands) | Account | As Previously Reported | Restatement Amount | As Restated | | :--- | :--- | :--- | :--- | | **Total current liabilities** | $17,474 | $(6,038) | $11,436 | | **Total liabilities** | $28,157 | $(6,038) | $22,119 | | **Accumulated deficit** | $(248,215) | $6,133 | $(242,082) | | **Total stockholders' deficit** | $(61,672) | $6,133 | $(55,539) |

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section covers the unaudited interim financial statements, management's analysis, market risk, and internal controls [Item 1. Unaudited Interim Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Unaudited interim financial statements show improved performance and a strategic preferred stock exchange [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheet reflects increased assets, decreased liabilities, and an improved stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2024 (unaudited) | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,113 | $3,498 | | Total current assets | $11,110 | $10,322 | | Total assets | $14,039 | $13,021 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $18,769 | $17,474 | | Total liabilities | $25,185 | $28,157 | | Total stockholders' deficit | $(57,682) | $(61,672) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of operations show significant revenue growth and a shift to net income Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2024 | Q3 2023 | Nine Months 2024 | Nine Months 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenue, net | $12,295 | $9,078 | $34,610 | $29,931 | | Gross profit | $7,506 | $4,954 | $21,008 | $17,768 | | Operating income (loss) | $1,905 | $(16) | $5,036 | $1,491 | | Net income (loss) | $1,280 | $(614) | $3,810 | $(88) | | Diluted EPS | $0.29 | $(0.14) | $0.87 | $(0.02) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements indicate positive operating cash flow, offset by financing activities Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Category | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $3,462 | $2,649 | | Net cash (used in) provided by investing activities | $(747) | $55 | | Net cash used in financing activities | $(4,100) | $(2,500) | | **Net (decrease) increase in cash** | **$(1,385)** | **$204** | | Cash and cash equivalents – ending | $2,113 | $5,032 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity concerns, Medicare coverage risks, and a strategic preferred stock exchange - The company faces a potential negative impact on liquidity if the Proposed Local Coverage Determination (LCD) by Novitas restricts Medicare coverage for its PancraGEN test. A final decision has been granted an undefined extension by CMS as of July 29, 2024[21](index=21&type=chunk) - As of September 30, 2024, the company had **$2.1 million** in cash and cash equivalents, with current liabilities of **$18.8 million** exceeding current assets of **$11.1 million**. Management believes current cash and forecasted receipts are sufficient for the next twelve months[22](index=22&type=chunk)[26](index=26&type=chunk) - On October 10, 2024, the company exchanged all **47,000 shares** of its Series B Preferred Stock for **47,000 shares** of newly created Series C Preferred Stock. The new series has a lower conversion price (**$2.02** vs. **$6.00**) and fewer restrictive provisions, which is considered a significant step towards a potential Nasdaq uplisting[88](index=88&type=chunk)[89](index=89&type=chunk) - The BroadOak term loan maturity was extended to June 30, 2025, with monthly payments of **$500,000** beginning April 1, 2024. The outstanding balance was **$5.9 million** as of September 30, 2024[68](index=68&type=chunk)[69](index=69&type=chunk)[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong financial performance driven by increased test volumes, alongside key regulatory risks [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Operational results show significant revenue growth and improved profitability Q3 2024 vs Q3 2023 Performance (in thousands) | Metric | Q3 2024 | Q3 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue, net | $12,295 | $9,078 | 35% | | Gross profit | $7,506 | $4,954 | 51.5% | | Gross Margin | 61.0% | 54.6% | +6.4 p.p. | | Operating income (loss) | $1,905 | $(16) | N/A | Nine Months 2024 vs 2023 Performance (in thousands) | Metric | Nine Months 2024 | Nine Months 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue, net | $34,610 | $29,931 | 16% | | Gross profit | $21,008 | $17,768 | 18.2% | | Gross Margin | 60.7% | 59.4% | +1.3 p.p. | | Operating income | $5,036 | $1,491 | 237.8% | - Adjusted EBITDA, a non-GAAP measure, increased to **$2.1 million** in Q3 2024 from **$0.4 million** in Q3 2023. For the nine-month period, it rose to **$5.5 million** from **$2.9 million** year-over-year[137](index=137&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity strategy focuses on operational cash flow and a preferred stock exchange for Nasdaq uplisting - Cash provided by operating activities was **$3.5 million** for the first nine months of 2024, compared to **$2.6 million** in the prior year period[142](index=142&type=chunk) - Cash used in financing activities was **$4.1 million** for the nine months ended September 30, 2024, due to payments on the BroadOak Term Loan[144](index=144&type=chunk) - The company is pursuing an uplisting of its common stock to Nasdaq, believing it will assist in raising additional capital. The exchange of preferred stock in October 2024 is described as the 'first significant step' in this process[147](index=147&type=chunk) [Regulatory and Market Risks](index=24&type=section&id=Regulatory%20and%20Market%20Risks) Key risks include Medicare coverage restrictions and new FDA regulations impacting LDTs - The company's liquidity could be negatively impacted if Novitas, its Medicare administrative contractor, ultimately restricts coverage for the PancraGEN test following its ongoing review of the relevant LCD[98](index=98&type=chunk)[149](index=149&type=chunk) - The FDA published a final rule on April 29, 2024, to phase out enforcement discretion for many LDTs over a four-year period. This will require compliance with medical device reporting, quality systems, and potentially premarket review, which could be expensive and time-consuming[101](index=101&type=chunk)[103](index=103&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective due to a material weakness in revenue recognition, with remediation underway - A material weakness in internal control over financial reporting related to the timing of revenue recognition was identified in Q1 2024[158](index=158&type=chunk) - Due to this material weakness, the principal executive officer and principal financial officer concluded that disclosure controls and procedures were not effective as of September 30, 2024[158](index=158&type=chunk) - The company has adopted a remediation plan to amend its internal controls, including updating procedures for testing revenue recognition[159](index=159&type=chunk) [PART II - OTHER INFORMATION](index=36&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, unregistered equity sales, and a list of exhibits [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal proceedings as of the filing date - There are no legal proceedings to report[161](index=161&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) This section is not applicable as the company is a smaller reporting company - Not applicable as the company is a smaller reporting company[162](index=162&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds during the period - None reported[163](index=163&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) Exhibits filed with the Form 10-Q include documents related to the Series C Preferred Stock exchange - Key exhibits filed include documents related to the Series C Preferred Stock exchange, such as the Exchange Agreement (10.1) and the Certificate of Designation (part of 3.1)[167](index=167&type=chunk)

[Financial and Business Highlights](index=1&type=section&id=Financial%20and%20Business%20Highlights) Interpace Biosciences reported record financial results for the third quarter of 2024, achieving all-time highs in test volume, revenue, and profitability Summary of Key Financial Metrics | Metric | Q3 2024 | Q3 2023 | Change | | :--- | :--- | :--- | :--- | | **Net Revenue** | $12.3 million | $9.1 million | +35% | | **Test Volume** | N/A | N/A | +26% | | **Cash Collections** | $11.3 million | $9.8 million | +15% | | **Income from Continuing Operations** | $1.4 million | ($0.5) million | +$1.9M | | **Adjusted EBITDA** | $2.1 million | $0.4 million | +$1.7M | - The company's proprietary molecular diagnostics tests, ThyGeNEXT+ ThyraMIRv2 and PancraGEN, continued to experience double-digit growth in Q3 2024 over Q3 2023[3](index=3&type=chunk) - Q3 2024 marked the eighteenth consecutive quarter of year-over-year volume growth for the company[3](index=3&type=chunk) - Interpace is actively interviewing equity research partners and investment bankers to raise additional capital to fund its growth strategy and pursue a potential uplisting to the Nasdaq stock exchange[3](index=3&type=chunk) [Business Overview](index=2&type=section&id=About%20Interpace%20Biosciences) Interpace Biosciences focuses on personalized medicine, offering molecular diagnostic tests and services for cancer diagnosis and risk assessment, with a portfolio of five commercialized tests - The company offers specialized services along the therapeutic value chain, from early diagnosis and prognostic planning to targeted therapeutic applications[6](index=6&type=chunk) - Interpace has five commercialized molecular tests: PancraGEN and PanDNA (pancreatic cancer), ThyGeNEXT and ThyraMIRv2 (thyroid cancer), and RespriDX (lung cancer)[7](index=7&type=chunk) - A sixth test, BarreGEN, for assessing the progression risk of Barrett's Esophagus to esophageal cancer, is currently in a clinical evaluation program (CEP) to gather clinical evidence and support potential payer reimbursement[7](index=7&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-looking%20Statements) This section contains standard legal disclaimers regarding forward-looking statements, highlighting risks such as reimbursement policies, financing capabilities, and the ability to uplist to Nasdaq - The press release contains forward-looking statements concerning future financial and operating performance, which are subject to risks and uncertainties[9](index=9&type=chunk) - Identified risks include, but are not limited to, reimbursement challenges (including CMS review), historical operating losses, ability to finance the business, dependence on sales and reimbursements, and the ability to uplist common stock to Nasdaq[9](index=9&type=chunk) [Financial Performance Analysis](index=3&type=section&id=Financial%20Performance%20Analysis) This section provides a detailed breakdown of Interpace's financial statements for the third quarter and nine months ended September 30, 2024, including statements of operations, balance sheet, cash flow, and Adjusted EBITDA reconciliation [Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2024, net revenue increased by 35% to $12.3 million, and gross profit rose to $7.5 million, resulting in an operating income of $1.9 million and net income of $1.4 million Condensed Consolidated Statements of Operations | Metric (in thousands, except per share) | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Revenue, net** | $12,295 | $9,078 | $34,610 | $29,931 | | **Gross Profit** | $7,506 | $4,954 | $21,008 | $17,768 | | **Operating income (loss)** | $1,905 | $(16) | $5,036 | $1,491 | | **Income (loss) from continuing operations** | $1,362 | $(528) | $4,070 | $297 | | **Net income (loss)** | $1,280 | $(614) | $3,810 | $(88) | | **Diluted EPS from continuing operations** | $0.31 | $(0.12) | $0.92 | $0.07 | [Balance Sheet](index=4&type=section&id=Selected%20Balance%20Sheet%20Data) As of September 30, 2024, cash and cash equivalents decreased to $2.1 million due to debt paydown, while total liabilities decreased to $25.2 million, improving stockholders' deficit Selected Balance Sheet Data | Metric (in thousands) | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $2,113 | $3,498 | | **Total assets** | $14,039 | $13,021 | | **Total liabilities** | $25,185 | $28,157 | | **Total stockholders' deficit** | $(57,682) | $(61,672) | - The cash balance decreased from **$5.0 million** as of September 30, 2023, primarily driven by a **$6.6 million** additional paydown of debt[5](index=5&type=chunk) [Cash Flow Statement](index=4&type=section&id=Selected%20Cash%20Flow%20Data) For the first nine months of 2024, operating cash flow increased to $3.5 million, with significant cash used in financing activities, resulting in a net decrease in cash of $1.4 million Selected Cash Flow Data | Metric (in thousands) | For the Nine Months Ended Sep 30, 2024 | For the Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $3,462 | $2,649 | | **Net cash (used in) provided by investing activities** | $(747) | $55 | | **Net cash used in financing activities** | $(4,100) | $(2,500) | | **Change in cash and cash equivalents** | $(1,385) | $204 | [Non-GAAP Measures (Adjusted EBITDA)](index=5&type=section&id=Reconciliation%20of%20Adjusted%20EBITDA) Adjusted EBITDA significantly improved to $2.1 million for Q3 2024 and $5.5 million for the nine-month period, reflecting strong operational performance Reconciliation of Adjusted EBITDA | Metric (in thousands) | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Income (loss) from continuing operations (GAAP)** | $1,362 | $(528) | $4,070 | $297 | | **Adjusted EBITDA (Non-GAAP)** | $2,076 | $363 | $5,458 | $2,904 | - Adjusted EBITDA is defined as income or loss from continuing operations, adjusted for depreciation and amortization, stock-based compensation, interest, taxes, and other non-cash expenses like the change in fair value of notes payable[21](index=21&type=chunk)

PART I - FINANCIAL INFORMATION [Item 1. Unaudited Interim Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) The unaudited interim financial statements for June 30, 2024, reveal revenue growth, a substantial increase in net income, and positive operating cash flow, despite a net cash decrease driven by debt repayment and a persistent stockholders' deficit [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, total assets slightly decreased to **$13.0 million**, while total liabilities reduced to **$25.5 million**, resulting in an improved yet significant stockholders' deficit of **$59.0 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,019 | $3,498 | | Total current assets | $10,166 | $10,322 | | Total assets | $12,972 | $13,021 | | Total current liabilities | $19,030 | $17,474 | | Total liabilities | $25,462 | $28,157 | | Total stockholders' deficit | $(59,026) | $(61,672) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and six months ended June 30, 2024, the company achieved significant year-over-year profitability growth, with substantial increases in net revenue and net income driven by higher sales and reduced general and administrative expenses Key Performance Indicators (in thousands, except per share data) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenue, net | $12,042 | $11,026 | $22,314 | $20,853 | | Gross profit | $7,431 | $6,835 | $13,502 | $12,814 | | Operating income | $2,257 | $832 | $3,131 | $1,508 | | Net income | $2,062 | $175 | $2,530 | $526 | | Net income per diluted share | $0.47 | $0.04 | $0.58 | $0.12 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2024, the company generated **$1.3 million** in operating cash flow, but a **$2.6 million** outflow from financing activities, primarily debt repayment, led to a net cash decrease of **$1.5 million** Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $1,346 | $1,544 | | Net cash used in investing activities | $(225) | $(293) | | Net cash used in financing activities | $(2,600) | $(1,000) | | **Net (decrease) increase in cash** | **$(1,479)** | **$251** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's liquidity, debt, and regulatory risks, including a proposed Medicare LCD impacting its PancraGEN test, while management asserts sufficient liquidity despite current liabilities exceeding assets, following a term loan amendment and credit facility termination - The company faces significant risk from a Proposed Local Coverage Determination (LCD) by Novitas, potentially leading to **non-coverage for its PancraGEN test** and impacting liquidity, with a final decision granted an undefined extension by CMS[23](index=23&type=chunk) - As of June 30, 2024, the company held **$2.0 million in cash**, with current assets of **$10.2 million** and current liabilities of **$19.0 million**, yet management expects sufficient liquidity for the next twelve months[24](index=24&type=chunk)[27](index=27&type=chunk) - In March 2024, the BroadOak Term Loan was amended, extending maturity to **June 30, 2025**, with monthly payments of **$500,000** and an outstanding balance of **$7.4 million** as of June 30, 2024[68](index=68&type=chunk)[69](index=69&type=chunk)[74](index=74&type=chunk) - The company terminated its **$7.5 million** revolving credit facility with Comerica Bank in February 2024, with no outstanding balance at termination[22](index=22&type=chunk)[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights improved financial performance with increased revenue and operating income driven by higher test volumes and reduced G&A expenses, while acknowledging significant risks from potential Medicare non-coverage and new FDA LDT regulations, yet expressing confidence in future liquidity [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Revenue increased by **9%** in Q2 2024 and **7%** in H1 2024, reaching **$12.0 million** and **$22.3 million** respectively, with operating income significantly growing to **$2.3 million** and **$3.1 million** due to higher test volumes and reduced general and administrative expenses Comparison of Operations for the Three Months Ended June 30 (in thousands) | Metric | 2024 | 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue, net | $12,042 | $11,026 | 9.2% | | Gross profit | $7,431 | $6,835 | 8.7% | | General and administrative | $2,141 | $2,894 | (26.0%) | | Operating income | $2,257 | $832 | 171.3% | Comparison of Operations for the Six Months Ended June 30 (in thousands) | Metric | 2024 | 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue, net | $22,314 | $20,853 | 7.0% | | Gross profit | $13,502 | $12,814 | 5.4% | | General and administrative | $4,381 | $5,389 | (18.7%) | | Operating income | $3,131 | $1,508 | 107.6% | [Non-GAAP Financial Measures](index=28&type=section&id=Non-GAAP%20Financial%20Measures) The company utilizes Adjusted EBITDA as a non-GAAP measure, reporting **$2.4 million** for Q2 2024 and **$3.4 million** for H1 2024, reflecting improved operational cash flow compared to prior periods Reconciliation of Adjusted EBITDA (in thousands) | Period | 2024 | 2023 | | :--- | :--- | :--- | | **Three Months Ended June 30** | | | | Income from continuing operations | $2,136 | $395 | | Adjusted EBITDA | $2,377 | $1,324 | | **Six Months Ended June 30** | | | | Income from continuing operations | $2,708 | $825 | | Adjusted EBITDA | $3,382 | $2,544 | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company held **$2.0 million** in cash, with **$1.3 million** net cash from operations for H1 2024, but a **$2.6 million** use in financing activities, yet management projects sufficient liquidity for the next twelve months despite regulatory risks - Cash and cash equivalents were **$2.0 million** as of June 30, 2024, and approximately **$1.8 million** as of August 2, 2024[136](index=136&type=chunk) - For the six months ended June 30, 2024, net cash provided by operating activities was **$1.3 million**, with **$2.6 million** primarily used for BroadOak Term Loan payments in financing activities[137](index=137&type=chunk)[138](index=138&type=chunk) - The company faces significant liquidity risk from a proposed Medicare LCD that could unfavorably impact coverage for its PancraGEN test[141](index=141&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company has elected scaled disclosure and is not required to provide information regarding market risk - The company is a smaller reporting company and is not required to provide the information requested by this item[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of June 30, 2024, due to a material weakness in internal control over financial reporting related to revenue recognition timing, for which a remediation plan has been adopted - A material weakness in internal control over financial reporting was identified concerning the timing of revenue recognition[147](index=147&type=chunk) - Consequently, disclosure controls and procedures were deemed **not effective** as of June 30, 2024[147](index=147&type=chunk) - A remediation plan has been adopted to amend internal controls, including updating procedures for testing and reviewing revenue recognition[148](index=148&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal proceedings at this time - There is no pending litigation involving the Company at this time[51](index=51&type=chunk)[150](index=150&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) A significant updated risk factor is the FDA's final rule regulating Laboratory Developed Tests (LDTs), which will phase out enforcement discretion, potentially imposing substantial compliance costs, requiring pre-market clearance, and risking penalties or test withdrawal - A primary risk is the FDA's final rule, published April 29, 2024, phasing out enforcement discretion for many LDTs over a **four-year period** starting **May 6, 2025**[153](index=153&type=chunk) - The new regulation may necessitate costly and time-consuming pre-market clearance or approval for tests, potentially leading to their withdrawal from the market[156](index=156&type=chunk) - Non-compliance with new FDA regulations could result in enforcement actions such as warning letters, fines, injunctions, recalls, or a total shutdown of operations[157](index=157&type=chunk) [Other Items (2, 3, 4, 5)](index=33&type=section&id=Other%20Items%20(2%2C%203%2C%204%2C%205)) The company reported no unregistered sales of equity securities, no defaults upon senior securities, no mine safety disclosures, and no other information for the period - The company reported 'None' for Unregistered Sales of Equity Securities and Use of Proceeds, Defaults Upon Senior Securities, Mine Safety Disclosures, and Other Information[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications required by the Sarbanes-Oxley Act

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 000-24249 Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) | Dela ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to_________________ Commission file Number: 000-24249 Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 22-29 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 000-24249 Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) | Delaware | 22-2919486 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 000-24249 Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) | Delaw ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 000-24249 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to_________________ Commission file Number: 000-24249 Interpace Biosciences, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2 ...