[10-Q] GUIDED THERAPEUTICS INC Quarterly Earnings Report
Guided Therapeutics (GTHP) reported Q3 2025 results. Sales of devices and disposables were $60 thousand with gross profit of $35 thousand, while operating expenses reached $520 thousand. The company posted a net loss of $742 thousand for the quarter and $1.978 million for the nine months.
Liquidity remains tight with cash and cash equivalents of $87 thousand and total assets of $903 thousand against total liabilities of $6.549 million. Stockholders’ deficit was $5.646 million. The company disclosed a going concern uncertainty, citing a working capital deficit of about $5.7 million and ongoing operating losses.
To fund operations year-to-date, GTHP raised $260 thousand via private placements and $623 thousand in notes (including related parties), and issued 18.47 million shares from conversions, financing, and interest/dividends paid in stock. Deferred revenue stood at $689 thousand, short-term convertible debt in default was $1.130 million, and 83,599,156 common shares were outstanding as of November 10, 2025.
- None.
- Going concern uncertainty disclosed with ~
$5.7 million working capital deficit - Low liquidity: cash
$87,000 vs. total liabilities$6.549 million - Debt stress: short-term convertible debt in default of
$1.130 million
Insights
Low cash, high liabilities, and a going concern warning elevate risk.
Guided Therapeutics ended the quarter with cash of
Management disclosed substantial doubt about continuing as a going concern, citing a working capital deficit of approximately
Financing activity included private placements of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
Commission File No.
(Exact Name of Registrant as Specified in Its Charter) |
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(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
(
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:
Indicate by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):
Large Accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act. Yes
As of November 10, 2025, the registrant had
PART I — FINANCIAL INFORMATION |
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Item 1. | Financial Statements |
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| Unaudited Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 |
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| Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025 and 2024 |
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| Unaudited Condensed Consolidated Statements of Stockholders' Deficit for the Three and Nine Months Ended September 30, 2025 and 2024 |
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| Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 |
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| Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
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Item 4. | Controls and Procedures |
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PART II — OTHER INFORMATION |
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Item 1. | Legal Proceedings |
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Item 1A. | Risk Factors |
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
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Item 3. | Defaults Upon Senior Securities |
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Item 4. | Mine Safety Disclosures |
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Item 5. | Other Information |
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Item 6. | Exhibits |
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Signatures |
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| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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Trade receivables, net of allowance for credit losses of $ |
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Inventory, net of reserves of $ |
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Other current assets |
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Total current assets |
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Non-Current Assets: |
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Property and equipment, net |
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Operating lease right-of-use assets, net of amortization |
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Other assets |
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Total non-current assets |
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TOTAL ASSETS |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
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Current Liabilities: |
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Accounts payable |
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Accounts payable, related parties |
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Accrued liabilities |
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Deferred revenue |
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Current portion of lease liability |
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Short-term notes payable due to related parties |
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Current portion of long-term debt, related parties |
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Current portion of notes payable |
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Short-term convertible debt, net of discounts |
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Short-term convertible debt in default |
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Derivative liability at fair value |
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Total current liabilities |
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Long-Term Liabilities |
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Long-term lease liability |
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Long-term notes payable |
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Long-term convertible debt, net of discounts |
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Long-term debt, related parties |
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Total long-term liabilities |
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Total liabilities |
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COMMITMENTS AND CONTINGENCIES (Note 6) |
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| Table of Contents |
STOCKHOLDERS’ DEFICIT: |
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Series C convertible preferred stock, $ |
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Series C1 convertible preferred stock, $ |
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Series C2 convertible preferred stock, $ |
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Series D convertible preferred stock, $ |
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Series E convertible preferred stock, $ |
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Series F convertible preferred stock, $ |
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Series F-2 convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Treasury stock at cost |
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Accumulated deficit |
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Total stockholders’ deficit |
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TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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The accompanying notes are an integral part of these condensed consolidated statements.
| 4 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share data)
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| Three Months Ended |
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Sales - devices and disposables |
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Cost of goods sold |
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Gross profit |
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Operating expenses: |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other income (expenses): |
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Interest expense |
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Interest income |
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Change in fair value of derivative liability |
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Gain from forgiveness of debt |
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Loss from extinguishment of debt |
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Other income |
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Total other income (expense) |
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Loss before income taxes |
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Provision for income taxes |
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Net loss |
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Preferred stock dividends |
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NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
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NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS |
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Basic |
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Diluted |
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Weighted average shares outstanding |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
| 5 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2025
(unaudited, in thousands)
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| Preferred Stock |
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| Preferred Stock |
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| Preferred Stock |
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| Preferred Stock |
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| Series C |
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| Amount |
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Balance at June 30, 2025 |
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Issuance of common stock and warrants in private placement offering |
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Issuance of common stock for payment of Series E preferred dividends |
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Conversion of Preferred Stock Series D to common stock |
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Conversion of Preferred Stock Series E to common stock |
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Conversion of debt and accrued interest to common stock and warrants |
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Issuance of common stock for payment of interest |
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Stock-based compensation |
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Accrued preferred dividends |
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Net loss |
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Balance at September 30, 2025 |
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| Preferred Stock |
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| Preferred Stock |
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Balance at June 30, 2025 |
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Issuance of common stock and warrants in private placement offering |
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Issuance of common stock for payment of Series E preferred dividends |
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Conversion of Preferred Stock Series D to common stock |
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Conversion of Preferred Stock Series E to common stock |
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Conversion of debt and accrued interest to common stock and warrants |
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Issuance of common stock for payment of interest |
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Stock-based compensation |
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Accrued preferred dividends |
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Net loss |
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Balance at September 30, 2025 |
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| 6 |
| Table of Contents |
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| Additional |
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| Common Stock |
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| Shares |
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| Amount |
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| Capital |
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| Stock |
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| Deficit |
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| Total |
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Balance at June 30, 2025 |
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Issuance of common stock and warrants in private placement offering |
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Issuance of common stock for payment of Series E preferred dividends |
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Conversion of Preferred Stock Series D to common stock |
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Conversion of Preferred Stock Series E to common stock |
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Conversion of debt and accrued interest to common stock and warrants |
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Issuance of common stock for payment of interest |
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Stock-based compensation |
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| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at September 30, 2025 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these condensed consolidated statements.
| 7 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025
(unaudited, in thousands)
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| ||||||||||||||||||||
|
| Series C |
|
| Series C1 |
|
| Series C2 |
|
| Series D |
| ||||||||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||||
Balance at December 31, 2024 |
|
| - |
|
| $ |
|
|
| 1 |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| ||||||
Issuance of common stock and warrants in private placement offering |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series F preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Preferred Stock Series C to common stock |
|
| - |
|
| ( | ) |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Preferred Stock Series C1 to common stock |
|
| - |
|
|
|
|
|
| ( | ) |
| ( | ) |
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Preferred Stock Series C2 to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| ( | ) |
| ( | ) |
|
| - |
|
|
|
| ||||
Conversion of Preferred Stock Series D to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Conversion of Preferred Stock Series E to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Preferred Stock Series F-2 to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of debt and accrued interest to common stock and warrants |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Balance at September 30, 2025 |
|
| - |
|
| $ |
|
|
| - |
|
| $ |
|
|
| - |
|
| $ |
|
|
| - |
|
| $ |
| ||||
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| |||||||||||||||
|
| Series E |
|
| Series F |
|
| Series F2 |
| |||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||
Balance at December 31, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
Issuance of common stock and warrants in private placement offering |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series F preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Preferred Stock Series C to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Preferred Stock Series C1 to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Preferred Stock Series C2 to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Preferred Stock Series D to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Preferred Stock Series E to common stock |
|
| ( | ) |
|
| ( | ) |
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||
Conversion of Preferred Stock Series F-2 to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
| ( | ) | ||
Conversion of debt and accrued interest to common stock and warrants |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Balance at September 30, 2025 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| ||||
| 8 |
| Table of Contents |
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
|
| |||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
|
| |||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2024 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Issuance of common stock and warrants in private placement offering |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series D preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series E preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series F preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series C to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series C1 to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series C2 to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series D to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series E to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Preferred Stock Series F-2 to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of debt and accrued interest to common stock and warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Accrued preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at September 30, 2025 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these condensed consolidated statements.
| 9 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024
(unaudited, in thousands)
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| ||||||||||||||||||||
|
| Series C |
|
| Series C1 |
|
| Series C2 |
|
| Series D |
| ||||||||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||||
Balance at June 30, 2024 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Balance at September 30, 2024 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| |||||||||||||||
|
| Series E |
|
| Series F |
|
| Series F2 |
| |||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||
Balance at June 30, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Balance at September 30, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
| 10 |
| Table of Contents |
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
|
| |||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at June 30, 2024 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series D preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series E preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at September 30, 2024 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these condensed consolidated statements.
| 11 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024
(unaudited, in thousands)
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| ||||||||||||||||||||
|
| Series C |
|
| Series C1 |
|
| Series C2 |
|
| Series D |
| ||||||||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||||
Balance at December 31, 2023 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series F preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Settlement of previously accrued professional fees through common stock issuance |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Balance at September 30, 2024 |
|
| - |
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| |||||||
| 12 |
| Table of Contents |
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| |||||||||||||||
|
| Series E |
|
| Series F |
|
| Series F2 |
| |||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||
Balance at December 31, 2023 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series E preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series F preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Settlement of previously accrued professional fees through common stock issuance |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Balance at September 30, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||||
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
|
| |||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2023 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Issuance of common stock and warrants in private placement offering, net of expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series D preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series E preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series F preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Settlement of previously accrued professional fees through common stock issuance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of warrants with debt |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at September 30, 2024 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 13 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
|
| Nine Months Ended |
| |||||
|
| September 30, |
| |||||
|
| 2025 |
|
| 2024 |
| ||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
| ||
Net loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Bad debt expense |
|
|
|
|
|
| ||
Depreciation |
|
|
|
|
|
| ||
Amortization of debt issuance costs and discounts |
|
|
|
|
|
| ||
Stock-based compensation |
|
|
|
|
|
| ||
Change in fair value of derivative liability |
|
| ( | ) |
|
|
| |
Amortization of lease right-of-use-asset |
|
|
|
|
|
| ||
Loss on extinguishment of debt |
|
|
|
|
|
| ||
Gain from forgiveness of debt |
|
| ( | ) |
|
| ( | ) |
Other non-cash expenses |
|
|
|
|
|
| ||
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
| ( | ) |
|
|
| |
Inventory |
|
|
|
|
| ( | ) | |
Other current assets |
|
|
|
|
|
| ||
Accounts payable and accrued liabilities |
|
|
|
|
|
| ||
Lease liabilities |
|
| ( | ) |
|
| ( | ) |
Deferred revenue |
|
| ( | ) |
|
|
| |
NET CASH USED IN OPERATING ACTIVITIES |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
| ( | ) |
|
|
| |
NET CASH USED FOR INVESTING ACTIVITIES |
|
| ( | ) |
|
|
| |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from private placement offerings |
|
|
|
|
|
| ||
Proceeds from the issuance of notes payable |
|
|
|
|
|
| ||
Proceeds from the issuance of notes payable issued to related parties |
|
|
|
|
|
| ||
Payments made on notes payable |
|
| ( | ) |
|
| ( | ) |
Payments made on notes payable issued to related parties |
|
| ( | ) |
|
| ( | ) |
Payments of debt issuance costs |
|
| ( | ) |
|
| ( | ) |
NET CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
NET CHANGE IN CASH |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
Cash at beginning of period |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Cash paid for interest |
| $ |
|
| $ |
| ||
| 14 |
| Table of Contents |
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
| ||
|
|
|
|
|
|
| ||
Dividends on preferred stock |
| $ |
|
| $ |
| ||
Common stock issued for payment of interest |
| $ |
|
| $ |
| ||
Common stock issued for payment of accrued dividends |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series C to common stock |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series C1 to common stock |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series C2 to common stock |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series D to common stock |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series E to common stock |
| $ |
|
| $ |
| ||
Conversion of Preferred Stock Series F-2 to common stock |
| $ |
|
| $ |
| ||
Conversion of debt and accrued interest into common stock |
| $ |
|
| $ |
| ||
Directors and Officers insurance obtained with financing |
| $ |
|
| $ |
| ||
Warrants issued with debt |
| $ |
|
| $ |
| ||
Inception of derivative liability |
| $ |
|
| $ |
| ||
Settlement of previously accrued professional fees through common stock issuance |
| $ |
|
| $ |
| ||
Accrued payroll liability exchanged for promissory note |
| $ |
|
| $ |
| ||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 15 |
| Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. ORGANIZATION, BACKGROUND, AND BASIS OF PRESENTATION
Guided Therapeutics, Inc. (formerly SpectRx, Inc.), together with its wholly owned subsidiary, InterScan, Inc. (formerly Guided Therapeutics, Inc.), collectively referred to herein as the “Company”, is a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. The Company’s primary focus is the continued commercialization of its LuViva non-invasive cervical cancer detection device and extension of its cancer detection technology into other cancers, including esophageal. The Company’s technology, including products in research and development, primarily relates to biophotonics technology for the non-invasive detection of cancers.
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) pursuant to Section 13 or 15(d) under the Securities Exchange Act of 1934. The December 31, 2024 balances reported herein are derived from the audited consolidated financial statements for the year ended December 31, 2024. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.
All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company as of September 30, 2025 and December 31, 2024, and the consolidated results of operations and cash flows for the three and nine-month periods ended September 30, 2025 and 2024 have been included.
The Company’s prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced net losses since its inception and, as of September 30, 2025, it had an accumulated deficit of approximately $155.8 million. To date, the Company has engaged primarily in research and development efforts and the early stages of marketing its products. The Company may not be successful in growing sales for its products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. The Company’s products may not ever gain market acceptance and the Company may not ever generate significant revenues or achieve profitability. The development and commercialization of the Company’s products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. The Company expects operating losses to continue for the foreseeable future as it continues to expend substantial resources to complete development of its products, obtain regulatory clearances or approvals, build its marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
Going Concern
The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.
At September 30, 2025, the Company had a negative working capital of approximately $
| 16 |
| Table of Contents |
During the nine months ended September 30, 2025, the Company received $
2. SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the inventory valuation, valuation of share-based compensation and the valuation of the convertible note payable derivative liability. Management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to the Company’s financial statements.
Recently Issued Accounting Standard Updates (“ASUs”) Not Yet Adopted
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). The ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. The ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. This guidance will be effective for the annual periods beginning the year ended December 31, 2025. This ASU will result in the required additional disclosures being included in the Company’s consolidated financial statements once adopted.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. All public business entities, including those with non-calendar year ends, are required to adopt the new disclosure requirements in their first annual reporting period beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact that adoption of ASU 2025-01 will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU No. 2024-04, Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments (“ASU 2024-04”). ASU 2024-04 clarifies the accounting guidance for determining whether a settlement of a convertible debt instrument should be accounted for as an induced conversion or as a debt extinguishment. Specifically, the amendments require that an inducement offer include, at a minimum, the form and amount of consideration that would have been issuable under the original conversion privileges and provide additional guidance for instruments with cash conversion features and volume-weighted average price (VWAP) formulas. The amendments also clarify that the induced conversion guidance can apply to convertible debt instruments that are not currently convertible, provided they contain a substantive conversion feature at issuance and at the date of the inducement offer.
ASU 2024-04 is effective for all entities for annual reporting periods beginning after December 15, 2025, and interim periods within those annual periods. Early adoption is permitted for entities that have adopted ASU 2020-06. The amendments may be applied either prospectively to settlements occurring after the effective date or retrospectively to the beginning of the earliest period presented, provided such settlements occurred after the adoption of ASU 2020-06.
The Company is currently evaluating the impact that the adoption of ASU 2024-04 will have on its consolidated financial statements.
| 17 |
| Table of Contents |
A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s consolidated financial statements.
Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be a cash equivalent.
Concentrations of Credit Risk
The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was nil and $
Inventory Valuation
All inventories are stated at the lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred. Inventories consisted of the following as of September 30, 2025 and December 31, 2024:
|
| (in thousands) |
| |||||
|
| September 30, |
|
| December 31, |
| ||
|
| 2025 |
|
| 2024 |
| ||
|
|
|
|
|
|
| ||
Raw materials |
| $ |
|
| $ |
| ||
Work-in-progress |
|
|
|
|
|
| ||
Finished goods |
|
|
|
|
|
| ||
Inventory reserve |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
Total inventory |
| $ |
|
| $ |
| ||
The company periodically reviews the value of items in inventory and provides write-downs or write-offs of inventory based on its assessment of market conditions. Write-downs and write-offs are charged to cost of goods sold.
| 18 |
| Table of Contents |
Property and Equipment
Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over estimated useful lives of three to seven years. Depreciation and amortization expense are included in general and administrative expense on the statements of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment consisted of the following as of September 30, 2025 and December 31, 2024:
|
| (in thousands) |
| |||||
|
| September 30, |
|
| December 31, |
| ||
|
| 2025 |
|
| 2024 |
| ||
|
|
|
|
|
|
| ||
Equipment |
| $ |
|
| $ |
| ||
Software |
|
|
|
|
|
| ||
Furniture and fixtures |
|
|
|
|
|
| ||
Leasehold improvements |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Subtotal |
|
|
|
|
|
| ||
Less accumulated depreciation |
|
| ( | ) |
|
| ( | ) |
Property, equipment and leasehold improvements, net |
| $ |
|
| $ |
| ||
Depreciation expense related to property and equipment for the three and nine months ended September 30, 2025 and 2024 was not material.
Debt Issuance Costs
Debt issuance costs are capitalized and amortized over the term of the associated debt. Debt issuance costs are presented in the balance sheet as a direct deduction from the carrying amount of the debt liability consistent with the debt discount.
Patent Costs (Principally Legal Fees)
Costs incurred in filing, prosecuting, and maintaining patents are recurring, and expensed as incurred. Costs for maintaining patents are expensed as incurred as the Company has not yet received U.S. FDA approval and recovery of these costs is uncertain. Such costs were not material for the three and nine months ended September 30, 2025 and 2024.
Leases
A lease provides the lessee the right to control the use of an identified asset for a period of time in exchange for consideration. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company determines if an arrangement is a lease at inception. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.
Where an operating lease contains extension options that the Company is reasonably certain to exercise, the extension period is included in the calculation of the right-of-use assets and lease liabilities.
The discount rate used to determine the commencement date present value of lease payments is the interest rate implicit in the lease, or when that is not readily determinable, the Company utilizes its secured borrowing rate. Right-of-use assets include any lease payments required to be made prior to commencement and exclude lease incentives. Both right-of-use assets and lease liabilities exclude variable payments not based on an index or rate, which are treated as period costs. The Company’s lease agreements do not contain significant residual value guarantees, restrictions or covenants. See Note 6 – “Commitments and Contingencies.”
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Accrued Liabilities
Accrued liabilities as of September 30, 2025 and December 31, 2024 are summarized as follows:
|
| (in thousands) |
| |||||
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
|
|
|
|
|
|
| ||
Compensation |
| $ |
|
| $ |
| ||
Professional fees |
|
|
|
|
|
| ||
Interest |
|
|
|
|
|
| ||
Vacation |
|
|
|
|
|
| ||
Preferred dividends |
|
|
|
|
|
| ||
Other accrued expenses |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Total |
| $ |
|
| $ |
| ||
Revenue Recognition
ASC 606, Revenue from Contracts with Customers, establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue will now be recognized by a vendor when control over the goods or services is transferred to the customer. The application of the core principle in ASC 606 is carried out in five steps:
| · | Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties, that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled. |
|
|
|
| · | Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract. |
|
|
|
| · | Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties. |
|
|
|
| · | Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach in limited circumstances. Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and reallocation of changes in standalone selling prices after inception is not permitted. |
|
|
|
| · | Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date. |
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The Company’s revenues do not require significant estimates or judgments and are recognized when control of the promised goods or services is transferred to the Company’s customers, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. Revenue is measured as the amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The Company does not offer returns, discounts, loyalty programs or other sales incentive programs that are material to revenue recognition. The Company is not party to contracts that include multiple performance obligations or material variable consideration.
Contract Balances
The Company defers payments received as revenue until earned based on the related contracts and applying ASC 606 as required. Deferred revenue totaled $
Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of September 30, 2025 and December 31, 2024.
Research and Development
Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred.
Income Taxes
The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company has filed its 2024 federal and state corporate tax returns. Although the Company has been experiencing recurring losses, it is obligated to file tax returns for compliance with IRS regulations and that of applicable state jurisdictions. At September 30, 2025, the Company had approximately $
The Company recognizes uncertain tax positions based on a benefit recognition model. Provided that the tax position is deemed more likely than not of being sustained, the Company recognizes the largest amount of tax benefit that is greater than
Warrants
The Company has issued warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including warrants based on the fair value at the date of issue. The fair value of warrants classified as equity instruments at the date of issuance is estimated using the Black-Scholes or binomial option pricing models.
The Company evaluates all warrants to determine whether they should be classified as equity or liabilities in accordance with ASC 815-40. Warrants that are not indexed to the Company's own stock or that require net cash settlement are classified as liabilities and remeasured at fair value each reporting period. As of the periods presented, the Company had no liability-classified warrants outstanding.
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Stock Based Compensation
The Company accounts for its stock-based awards in accordance with ASC Subtopic 718, “Compensation – Stock Compensation”, which requires fair value measurement on the grant date and recognition of compensation expense for all stock-based payment awards made to employees and directors. The Company determines the fair value of stock options using the Black-Scholes model. The fair value of restricted stock awards is based upon the quoted market price of the shares of common stock on the date of grant. The fair value of stock-based awards is expensed over the requisite service periods of the awards. The Company accounts for forfeitures of stock-based awards as they occur.
The Black-Scholes option pricing model requires the input of certain assumptions that require the Company’s judgment, including the expected term and the expected stock price volatility of the underlying stock. The assumptions used in calculating the fair value of stock-based compensation represent management’s best estimates, but these estimates involve inherent uncertainties and the application of judgment. As a result, if factors change resulting in the use of different assumptions, stock-based compensation expense could be materially different in the future.
During the nine months ended September 30, 2025, the Company recognized $
Derivatives
The Company reviews the terms of convertible debt issued to determine whether there are embedded derivative instruments, including embedded conversion options, which are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrument contains more than one embedded derivative instrument, including the conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.
Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense.
Fair Value Measurements
ASC 820, “Fair Value Measurements and Disclosures,” clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that should be determined based upon assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
| · | Level 1: Quoted prices for identical assets or liabilities in active markets that the Company can access at the measurement date. |
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| Table of Contents |
| · | Level 2: Significant other observable inputs other than level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data. |
|
|
|
| · | Level 3: Significant unobservable inputs that reflect the Company’s judgment about the assumptions that market participants would use in pricing an asset or liability. |
An asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.
Assets and liabilities measured at fair value are based on one or more of the following three valuation techniques noted in ASC 820:
| · | Market approach: Prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. |
|
|
|
| · | Cost approach: Amount that would be required to replace the service capacity of an asset (replacement cost). |
|
|
|
| · | Income approach: Techniques to convert future amounts to a single present value amount |
The Company believes its valuation methods are appropriate and consistent with other market participants, however the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.
3. STOCKHOLDERS’ DEFICIT
August 2025 Private Placement Offering
On August 29, 2025, the Company entered into a Securities Purchase Agreement (the “August Purchase Agreement”) with certain institutional investors, including Dr. John Imhoff and Michael James, members of the Company’s board of directors, for the purpose of raising $
In connection with the August Purchase Agreement, the Company entered into an exchange agreement with Alan Grujic, a member of the Company’s board of directors, whereby
March 2025 Private Placement Offering
On March 18, 2025, the Company entered into a Securities Purchase Agreement (the “March Purchase Agreement”) with certain institutional investors, including Dr. Imhoff and Mr. James, for the purpose of raising $
| 23 |
| Table of Contents |
In connection with the March Purchase Agreement, the Company entered into an exchange agreement with Dr. Imhoff, whereby
C-1 and C-2 Preferred Stock Exchanges
On March 3, 2025, the Company entered into exchange agreements with certain accredited investors, including Mark Faupel and John Imhoff, members of the Company’s board of directors, to exchange
Common Stock
The Company has authorized
During the nine months ended September 30, 2025, the Company issued
|
| Number of Shares |
| |
| ||||
Issuance of common stock in private placement offering |
|
|
| |
Issuance of common stock for payment of Preferred Series D dividends |
|
|
| |
Issuance of common stock for payment of Preferred Series E dividends |
|
|
| |
Issuance of common stock for payment of Preferred Series F dividends |
|
|
| |
Issuance of common stock for payment of Preferred Series F-2 dividends |
|
|
| |
Conversion of Preferred Series C stock to common stock |
|
|
| |
Conversion of Preferred Series C-1 stock to common stock |
|
|
| |
Conversion of Preferred Series C-2 stock to common stock |
|
|
| |
Conversion of Preferred Series D stock to common stock |
|
|
| |
Conversion of Preferred Series E stock to common stock |
|
|
| |
Conversion of Preferred Series F-2 stock to common stock |
|
|
| |
Issuance of common stock for payment of interest |
|
|
| |
Conversion of debt and accrued interest to common stock |
|
|
| |
Total shares of common stock issued during the nine months ended September 30, 2025 |
|
|
| |
Preferred Stock
The Company has authorized
Series C Convertible Preferred Stock
The board designated
| 24 |
| Table of Contents |
Holders of the Series C Preferred Stock were entitled to quarterly cumulative dividends at an annual rate of
Series C1 Convertible Preferred Stock
The board designated
The Series C1 Preferred Stock has terms that are substantially the same as the Series C Preferred Stock, except that the Series C1 Preferred Stock does not pay dividends (unless and to the extent declared on the common stock) or at-the-market “make-whole payments” and, while it has the same anti-dilution protections afforded the Series C Preferred Stock, it does not automatically reset in connection with a reverse stock split or conversion of our outstanding convertible debt.
Series C2 Convertible Preferred Stock
On August 31, 2018, the Company entered into agreements with certain holders of the Company’s Series C1 Convertible Preferred Stock, including the chairman of the Company’s board of directors, the former Chief Operating Officer (now the Chief Executive Officer) and a director of the Company pursuant to which those holders separately agreed to exchange each share of the Series C1 Preferred Stock held for one (1) share of the Company’s newly created Series C2 Convertible Preferred Stock. In total, for
Series D Convertible Preferred Stock
The board designated
Initially, each share of Series D Preferred Stock was convertible, at the option of the holder, at any time during the five-year period following issuance, into that number of shares of common stock determined by dividing the stated value by $
During the nine months ended September 30, 2025, the Company issued
| 25 |
| Table of Contents |
Series E Convertible Preferred Stock
The Board designated
Each share of Series E Preferred was convertible, at any time for a period of
Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of
During the nine months ended September 30, 2025, the Company issued
Series F Convertible Preferred Stock
The Board designated
Each share of Series F Preferred Stock is convertible, at any time for a period of
| 26 |
| Table of Contents |
During the nine months ended September 30, 2025, the Company issued
Series F-2 Convertible Preferred Stock
The Company was oversubscribed for its Series F Preferred Stock, resulting in the requirement to file an additional Certificate of Designation for Series F-2 Preferred Stock with substantially the same terms as the Series F Preferred Stock. The Board designated
Each share of Series F-2 Preferred Stock is convertible, at any time for a period of
During the nine months ended September 30, 2025, the Company issued
Series G Convertible Preferred Stock
During January 2021, the board designated
Warrants
The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the nine months ended September 30, 2025 and 2024:
|
| Warrants (Underlying Shares) |
|
| Weighted-Average Exercise Price Per Share |
| ||
|
|
|
|
| ||||
Outstanding, December 31, 2024 |
|
|
|
| $ |
| ||
Warrants issued |
|
|
|
|
|
| ||
Outstanding, September 30, 2025 |
|
|
|
| $ |
| ||
|
| Warrants (Underlying Shares) |
|
| Weighted-Average Exercise Price Per Share |
| ||
|
|
|
|
| ||||
Outstanding, December 31, 2023 |
|
|
|
| $ |
| ||
Warrants issued |
|
|
|
|
|
| ||
Warrants expired |
|
| ( | ) |
|
|
| |
Outstanding, September 30, 2024 |
|
|
|
| $ |
| ||
| 27 |
| Table of Contents |
Warrants Issued in 2025
Private Placement Offerings
On August 29, 2025, the Company issued
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The offering proceeds were allocated between common stock and the warrants based on their relative fair values. The estimated fair value of warrants issued in connection with the exchange agreements was included in the calculation of the loss on extinguishment of debt.
On March 18, 2025, the Company issued
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The offering proceeds were allocated between common stock and the warrants based on their relative fair values. The estimated fair value of warrants issued in connection with the exchange agreements was included in the calculation of the loss on extinguishment of debt.
Warrants Issued with Debt
During the nine months ended September 30, 2025, the Company issued
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
| 28 |
| Table of Contents |
Warrants Issued in 2024
During the nine months ended September 30, 2024, the Company issued
Warrants Issued with Debt
During the nine months ended September 30, 2024, the Company issued
On June 28, 2024, the Company issued
Management estimated the fair value of the warrants issued with debt utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
Private Placement Offerings
On September 23, 2024, the Company issued
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
4. STOCK OPTIONS
The Company’s Stock Plan (the “Plan”) allows for the issuance of incentive stock options, nonqualified stock options, and stock purchase rights. The exercise price of options was determined by the Company’s board of directors, but incentive stock options were granted at an exercise price equal to the fair market value of the Company’s common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The aggregate number of common shares that may be issued or reserved pursuant to stock option or other awards under the plan may not exceed
| 29 |
| Table of Contents |
The following tables summarize the Company’s stock option activity and related information for the nine months ended September 30, 2025 and 2024:
|
| Number of Shares |
|
| Weighted-Average Exercise Price Per Share |
|
| Weighted-Average Remaining Contractual Life |
| Aggregate Intrinsic Value of In-the-Money Options (in thousands) |
| |||
|
|
|
|
|
|
| ||||||||
Options outstanding as of December 31, 2024 |
|
|
|
| $ |
|
|
| $ |
| ||||
Options granted |
|
|
|
| $ |
|
|
|
|
|
|
| ||
Options forfeited |
|
| ( | ) |
| $ |
|
|
|
|
|
|
| |
Options expired |
|
| ( | ) |
|
|
|
|
|
|
|
|
| |
Options outstanding as of September 30, 2025 |
|
|
|
| $ |
|
| |
| $ |
| |||
Options exercisable as of September 30, 2025 |
|
|
|
| $ |
|
| |
| $ |
| |||
|
| Number of Shares |
|
| Weighted-Average Exercise Price Per Share |
|
| Weighted-Average Remaining Contractual Life |
| Aggregate Intrinsic Value of In-the-Money Options (in thousands) |
| |||
|
|
|
|
|
|
| ||||||||
Options outstanding as of December 31, 2023 |
|
|
|
| $ |
|
|
| $ |
| ||||
Options granted |
|
|
|
| $ |
|
|
|
|
|
|
| ||
Options outstanding as of September 30, 2024 |
|
|
|
| $ |
|
| |
| $ |
| |||
Options exercisable as of September 30, 2024 |
|
|
|
| $ |
|
| |
| $ |
| |||
The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of September 30, 2025 and the exercise price, multiplied by the number of options. As of September 30, 2025, there was $
The Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period. During the nine months ended September 30, 2025 and 2024, the Company recognized expense for stock options of $
5. LITIGATION AND CLAIMS
From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular year.
As of September 30, 2025, and December 31, 2024, there was no accrual recorded for any potential losses related to pending litigation.
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| Table of Contents |
6. COMMITMENTS AND CONTINGENCIES
Operating Leases
Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located on a 12,835 square foot leased property. The lease for our corporate offices, which will terminate on May 31, 2026, includes a renewal option that allows the Company to extend the term for an additional five years through May 31, 2031; however, at the time of lease commencement, the renewal option was not reasonably certain to be exercised and, therefore, is not included in the measurement of the lease liability or right‑of‑use asset. Total operating lease cost recognized for this lease was $
|
| (in thousands) |
| |||||
|
| September 30, |
|
| December 31 |
| ||
|
| 2025 |
|
| 2024 |
| ||
Operating lease right-of-use assets |
| $ |
|
| $ |
| ||
Operating lease liabilities |
| $ |
|
| $ |
| ||
The table below presents the maturities of operating lease liabilities as of September 30, 2025:
|
| (in thousands) |
| |
|
| Operating |
| |
|
| Lease Payments |
| |
|
|
|
| |
2025 (remaining) |
|
|
| |
2026 |
|
|
| |
Total future lease payments |
|
|
| |
Less: discount |
|
| ( | ) |
Total lease liabilities |
| $ |
| |
The table below presents the weighted-average remaining lease term and discount rate used in the calculation of operating lease right-of-use assets and lease liabilities as of September 30, 2025 and December 31, 2024
|
| (in thousands) |
| |||||
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
Weighted average remaining lease term (years) |
|
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
|
| % | ||
Related Party Contracts
Executive Compensation Agreement
On June 3, 2025, the Company's Board of Directors approved a revised compensation agreement for the Company’s Chief Executive Officer (“CEO”), Dr. Mark Faupel. As of September 30, 2025, Dr. Faupel is entitled to:
| 1. | Warrants to purchase an additional |
| · | |
| · | 1,500,000 warrants upon receipt of an Approvable Letter or equivalent approval from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. |
| · | These warrants have an exercise price of $ |
| 2. | An additional warrant to purchase |
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| Table of Contents |
Additionally, deferred salary of $373,783 accrued as of May 23, 2025, will continue accruing interest at an annual rate of 6%, and Mr. Faupel’s annual compensation was increased to $240,000 effective June 1, 2025. Up to $100,000 of this salary may be deferred at Mr. Faupel's discretion, accruing interest at 6%. As of December 31, 2025, all accrued and future deferred compensation amounts will be convertible at Mr. Faupel’s option into common shares at a conversion price of $0.25 per share. All amounts owed to Mr. Faupel will be due within ten business days if his position as CEO is terminated by the Board.
Related Party Debt
See Note 9, “Related Party Debt” for details regarding debt issued to related parties.
License Agreement with Shenghuo Medical, LLC
On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or
Royalty Agreement
On September 6, 2016, the Company entered into a royalty agreement with one of its directors, Dr. John Imhoff, and another stockholder, Dolores Maloof, pursuant to which the Company sold to them a royalty of future sales of single-use cervical guides for LuViva. Under the terms of the royalty agreement, and for consideration of $
Director Consulting Agreement
On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided a non-refundable payment of $
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
During the nine months ended September 30, 2025 and 2024, the Company issued nil and
| 32 |
| Table of Contents |
On August 24, 2022, the Company entered into an agreement with Ironstone Capital Corp. and Alan Grujic (the “Advisory Group”) whereby the Advisory Group agreed to perform marketing and investor relations services over a term of twelve months, commencing on the closing of a financing of at least $2.5 million. In consideration for these services, the Company issued
The agreement also provided for monthly payments of $
The Company estimated the fair value of the first tranche warrants issued in September 2022 using the Black-Scholes option pricing model with the following assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
Expense related to the first tranche of warrants was recognized in prior years. Unrecognized expense related to the first tranche warrants was nil as of September 30, 2025.
The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
Expense related to the second tranche of warrants was recognized in prior years. Unrecognized expense related to the first tranche warrants was nil as of September 30, 2025.
The Company estimated the fair value of the third tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The Company recognized nil expense for the third tranche of warrants during the three and nine months ended September 30, 2025. The Company recognized $
| 33 |
| Table of Contents |
Other Commitments
On July 24, 2019, the Company entered into an agreement with Shandong Yaohua Medical Instrument Corporation (“SMI”) under which SMI received exclusive rights to manufacture and distribute the Company’s LuViva® device and related disposables in China and certain other jurisdictions, subject to SMI achieving defined commercialization and regulatory milestones. In connection with the agreement, the Company received $
The parties subsequently amended the agreement multiple times to extend deadlines for SMI to obtain NMPA approval and to establish manufacturing capabilities in China. Under an amendment executed on February 17, 2024,
On October 21, 2024, the parties entered into a new agreement that superseded the prior agreements (other than certain existing purchase orders). The new agreement provided for the purchase of device instrumentation packages and RFID chips and required SMI to submit the LuViva device for NMPA approval. SMI submitted the NMPA application on October 16, 2024. The agreement also required SMI to meet defined sales and manufacturing milestones to retain exclusive rights.
On May 8, 2025, the Company and SMI executed an extension under which exclusivity would continue if SMI or its affiliates made required payments. During the nine months ended September 30, 2025, SMI made a required $
As of September 30, 2025, SMI did not achieve required commercialization milestones or obtain NMPA approval within the agreed timeframe and did not cure such breaches. Accordingly, SMI no longer retains rights to manufacture, market, or distribute LuViva. SMI has entered discussions with third parties to transition commercialization efforts in China. One such entity, Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”), entered into a contract to purchase 35 LuViva devices for $
Contingencies
The conflict in Ukraine, which has already affected global financial markets, continues to create uncertainty that could impact the Company’s operating business. Although approval to market and sell the Company’s products in Russia was granted on August 11, 2025, ongoing geopolitical tensions could still disrupt supply chains, distribution activities, or future regulatory interactions within the region. The ultimate impact of the conflict remains highly uncertain, and the Company cannot provide assurance that it will not have a material adverse effect on its operations, financial condition, or future regulatory matters.
Tariffs imposed and/or publicly contemplated by the U.S. government in 2025, particularly those affecting imports from China, create significant uncertainty with respect to future tax and trade regulations and the potential competitive effects of such actions. Although the countries in which our products are manufactured or imported may from time to time impose additional quotas, duties, tariffs, or other restrictions, or adversely modify existing ones, we have established an auxiliary manufacturing site in Hungary. This strategic initiative helps mitigate our exposure to currently imposed tariffs, particularly those targeting Chinese imports, and limits the overall impact on our operations. Nevertheless, it remains unclear what the U.S. administration or foreign governments specifically will or will not do with respect to tariffs, tax policies, or other international trade agreements, regulations, and policies. A trade war, other governmental actions related to tariffs or international trade agreements, or changes in U.S. or foreign social, political, regulatory and economic conditions—especially as they relate to manufacturing and investment—could still materially adversely affect the Company’s business, financial condition, operating results, and cash flows.
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| Table of Contents |
7. NOTES PAYABLE
Short-term Promissory Notes
On July 23, 2024, the Company issued a promissory note totaling $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
On July 4, 2024, the Company entered into a premium finance agreement to finance its insurance policies totaling $
On July 4, 2025, the Company entered into a premium finance agreement to finance its insurance policies totaling $
Long-term Promissory Notes
On April 15, 2024, the Company entered into an exchange agreement with a former employee, whereby the former employee agreed to exchange outstanding amounts due to him for deferred compensation in the amount of $
| 35 |
| Table of Contents |
The following tables summarize notes payable (in thousands):
|
| Notes Payable (in thousands) |
| |||||
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
Short-term promissory notes |
| $ |
|
| $ |
| ||
Deferred compensation note |
|
|
|
|
|
| ||
Insurance policy financing |
|
|
|
|
|
| ||
Debt discount |
|
|
|
|
| ( | ) | |
Total |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Less: Current portion of notes payable |
|
| ( | ) |
|
| ( | ) |
Total long-term notes payable |
| $ |
|
| $ |
| ||
Future debt obligations at September 30, 2025 for notes payable are as follows:
Year |
| Amount (thousands) |
| |
2025 (remaining) |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
Total |
| $ |
| |
8. CONVERTIBLE DEBT
10% Senior Unsecured Convertible Debenture
On May 17, 2021, the Company issued
| 36 |
| Table of Contents |
At September 30, 2025 and December 31, 2024, the balance due on the 10% Senior Secured Convertible Debenture was $
Convertible Promissory Notes
The following table summarizes convertible promissory notes outstanding as of September 30, 2025 and December 31, 2024:
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
Convertible promissory notes |
| $ |
|
| $ |
| ||
Unamortized debt issuance costs |
|
| ( | ) |
|
| ( | ) |
Debt discount |
|
| ( | ) |
|
| ( | ) |
Convertible promissory notes |
| $ |
|
| $ |
| ||
1800 Diagonal Lending LLC Notes
On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending LLC (“Diagonal Lending”). The convertible note issued to Diagonal Lending had a total principal balance of $
On July 22, 2024, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending. The convertible note had a total principal balance of $
On April 1, 2025, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending. The convertible note issued to Diagonal Lending had a total principal balance of $
On May 1, 2025, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending (together with the previously issued notes, the “Notes”). The convertible note issued to Diagonal Lending had a total principal balance of $
| 37 |
| Table of Contents |
In the event of default, the unpaid portion of the Notes and accrued interest is convertible into shares of common stock at a conversion rate equal to the variable conversion price. The variable conversion price is equal to the lowest closing price of our common stock during the ten days prior to the conversion date multiplied by 65.0%. The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host notes and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the issuance dates of the Notes and recorded them as discounts that net against the convertible notes. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).
At September 30, 2025, the balance due on the Notes was $
Flynn D. Case Living Trust Convertible Note
On October 10, 2024, the Company issued a promissory note totaling $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
On December 5, 2024, the Company amended the payment terms of the convertible promissory note. In accordance with the amended agreement, the note will mature on June 4, 2026, upon which payment of the full principal balance and accrued interest is due. The Holder will have an option to convert the principal and accrued interest due on each payment date to common stock at the following conversion prices:
| · | $ |
|
|
|
| · | $ |
|
|
|
| · | $ |
| 38 |
| Table of Contents |
The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host note and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the date the amendment was executed and recorded them as discounts that net against the convertible note. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).
During the nine months ended September 30, 2025, the Holder converted $
At September 30, 2025, the balance due on the convertible promissory note was $
Labrys Fund II Convertible Note
On August 27, 2025, the Company issued a promissory note totaling $
Labrys may convert all or any portion of the outstanding principal and accrued interest upon the occurrence of an event of default or missed amortization payment at a conversion price equal to 75% of the average of the two lowest closing prices of the Company’s common stock during the ten trading days preceding the conversion date, subject to customary adjustments.
The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host note and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the date the amendment was executed and recorded them as discounts that net against the convertible note. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).
A payment of $
Auctus Convertible Note
On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with Auctus Fund, LLC (“Auctus’).
| 39 |
| Table of Contents |
On September 1, 2022, the Company agreed to exchange certain debt and equity owned by Auctus pursuant to an Exchange Agreement between the Company and Auctus (the “Exchange Agreement”). Immediately prior to the Exchange Agreement, Auctus held $
The total outstanding balance of the convertible note was $
Other Convertible Promissory Notes
On May 2, 2025, the Company issued a promissory note totaling $
On May 22, 2025, the Company issued a promissory note totaling $
| 40 |
| Table of Contents |
9. RELATED PARTY DEBT
Short-Term Notes Payable Due to Related Parties
During the year ended December 31, 2024, the Company issued promissory notes totaling $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
On August 21, 2025, the Company entered into an exchange agreement with Mr. Alan Grujic, a member of the Board of Directors, to exchange $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
During the nine months ended September 30, 2025, the Company entered into exchange agreements with members of the Board of Directors to exchange $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
The outstanding principal and associated debt discounts as of September 30, 2025 and December 31, 2024 are presented below (in thousands):
|
| Short-Term Notes Payable Due to Related Parties |
| |||||
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
Short-term promissory notes |
| $ |
|
| $ |
| ||
Debt discount |
|
|
|
|
| ( | ) | |
Short-term notes payable due to related parties |
| $ |
|
| $ |
| ||
| 41 |
| Table of Contents |
Long-Term Notes Payable Due to Related Parties
Executive Deferred Compensation Notes Payable
On July 14 and July 20, 2018, the Company entered into exchange agreements with Dr. Mark Faupel and Dr. Gene Cartwright, the Company’s former Chief Executive Officer, to settle outstanding amounts due for loans, interest, bonuses, salary, and vacation pay totaling $
On July 24, 2019, the parties agreed to extend the maturity of these notes to the third anniversary of the modification date.
On February 19, 2021, the Company replaced the 2018 notes with new promissory notes totaling $
On February 18, 2023, the Company amended and extended both promissory notes to mature on February 18, 2025. On March 7, 2025, the Company amended the terms of the promissory note held by Mark Faupel. Under the terms of the new agreement, the promissory note will mature on February 18, 2026. The balance owed to Mr. Cartwright was overdue as of September 30, 2025.
On August 27, 2025,
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
| 42 |
| Table of Contents |
The tables below summarize the outstanding balance of debt owed to Dr. Faupel and Dr. Cartwright (in thousands):
For Dr. Faupel: |
|
|
| |
|
|
|
| |
Salary |
| $ |
| |
Bonus |
|
|
| |
Vacation |
|
|
| |
Interest on compensation |
|
|
| |
Loans to Company |
|
|
| |
Interest on loans |
|
|
| |
Total outstanding prior to exchange |
|
|
| |
|
|
|
|
|
Amount forgiven in prior years |
|
| ( | ) |
Amount exchanged for Series F-2 Preferred Stock |
|
| ( | ) |
Total interest accrued through December 31, 2024 |
|
|
| |
Balance outstanding at December 31, 2024 |
| $ |
| |
|
|
|
|
|
Interest accrued through September 30, 2025 |
|
|
| |
Amount exchanged for common stock and warrants |
|
| ( | ) |
Balance outstanding at September 30, 2025 |
| $ |
| |
For Dr. Cartwright |
|
|
| |
|
|
|
| |
Salary |
| $ |
| |
Bonus |
|
|
| |
Loans to Company |
|
|
| |
Interest on loans |
|
|
| |
Total outstanding prior to exchange |
|
|
| |
|
|
|
|
|
Amount forgiven in prior years |
|
| ( | ) |
Amount exchanged for Series F-2 Preferred Stock |
|
| ( | ) |
Total interest accrued through December 31, 2024 |
|
|
| |
Payments on outstanding debt |
|
| ( | ) |
Balance outstanding at December 31, 2024 |
| $ |
| |
|
|
|
|
|
Interest accrued through September 30, 2025 |
|
|
| |
Balance outstanding at September 30, 2025 |
| $ |
| |
On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler, a former executive of the Company. As of December 31, 2020, the Company owed Mr. Fowler $
During the three and nine months ended September 30, 2025, Mr. Fowler forgave $
| 43 |
| Table of Contents |
Other Notes Payable Issued to Related Parties
On September 25, 2025, the Company issued a $
The Company may prepay the note at any time without penalty with the holder’s written consent. As of September 30, 2025, no payments or conversions had occurred, and the full principal balance of $
The following tables summarize long-term notes payable due to related parties:
|
| Notes Payable Due to Related Parties (in thousands) |
| |||||
|
| September 30, 2025 |
|
| December 31, 2024 |
| ||
Executive deferred compensation notes |
| $ |
|
| $ |
| ||
Contingently convertible promissory note |
|
|
|
|
|
| ||
Total |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Less: Current portion of notes payable due to related parties |
|
| ( | ) |
|
| ( | ) |
Total long-term notes payable due to related parties |
| $ |
|
| $ |
| ||
Future debt obligations at September 30, 2025 for debt owed to related parties are as follows:
Year |
| Amount (in thousands) |
| |
|
|
|
| |
2025 (remaining) |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
Total |
| $ |
| |
| 44 |
| Table of Contents |
10. INCOME (LOSS) PER SHARE OF COMMON STOCK
Basic net income (loss) per share attributable to common stockholders, amounts are computed by dividing the net income (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the year.
Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the year, plus Series C, Series C-1, Series C-2, Series F and Series F-2 convertible preferred stock, convertible debt, convertible preferred dividends, warrants and stock options convertible into common stock shares.
During a period of net loss, basic and diluted earnings per share are the same as the assumed exercise of warrants and the conversion of convertible debt and preferred stock are anti-dilutive. For the three and nine months ended September 30, 2025 and 2024, all stock options, convertible preferred stock, convertible debt and warrants were anti-dilutive and were therefore excluded from the computation of diluted loss per share. At September 30, 2025 and 2024, these instruments were convertible into
The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders (in thousands, except for per-share data):
|
| September 30, |
| |||||
|
| 2025 |
|
| 2024 |
| ||
|
|
|
|
|
|
| ||
Net loss attributable to common stockholders |
|
| ( | ) |
|
| ( | ) |
Basic weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss attributable to common stockholders per share (basic) |
|
| ( | ) |
|
| ( | ) |
Diluted weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss attributable to common stockholders per share (diluted) |
|
| ( | ) |
|
| ( | ) |
11. FAIR VALUE MEASUREMENTS
The convertible notes payable derivative liabilities are considered Level 3 measurements, due to the significant unobservable inputs in the valuation, which are based on a forecast of the Company’s future stock performance and, as the note payable is contingently convertible upon an event of default, management’s estimate of the likelihood and timing of conversion.
Management utilized a pricing model simulation based on the terms of the bifurcated conversion features, which projects potential future stock prices using the Company’s historical volatility. The model estimates a variable conversion price as of an assumed future conversion date, based on management’s best estimate of the timing and probability of conversion.
The key inputs to the valuation model that was utilized to estimate the fair value of the bifurcated conversion option included:
| · | The forecasted future stock prices were determined using historical stock prices and the Company’s equity volatility. |
|
|
|
| · | The expected conversion price was determined using the forecast and the contractual term of the convertible note agreement. |
|
|
|
| · | The probability of an event of default and timing of a future conversion are based on management’s best estimate of the future settlement of the convertible note. |
| 45 |
| Table of Contents |
The following tables present the fair value of the bifurcated conversion options as of September 30, 2025 and December 31, 2024:
|
| Fair Value at September 30, 2025 (in thousands) |
| |||||||||||||
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
|
| Total |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Derivative liability/bifurcated conversion options in connection with convertible promissory notes |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivative liabilities at fair value |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
|
| Fair Value at December 31, 2024 (in thousands) |
| |||||||||||||
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
|
| Total |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Derivative liability/bifurcated conversion options in connection with convertible promissory notes |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total derivative liabilities at fair value |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
Derivative financial instruments and changes thereto recorded in the three and nine months ended September 30, 2025 and 2024 include the following:
|
| Three Months Ended September 30, |
| |||||
|
| 2025 |
|
| 2024 |
| ||
|
|
|
|
|
|
| ||
Fair value, beginning of period |
| $ |
|
| $ |
| ||
Inception of derivative liability |
|
|
|
|
|
| ||
Settlements (upon conversion) |
|
| ( | ) |
|
|
| |
Change in fair value of beneficial conversion features |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Fair value, end of period |
| $ |
|
| $ |
| ||
|
| Nine Months Ended September 30, |
| |||||
|
| 2025 |
|
| 2024 |
| ||
|
|
|
|
|
|
| ||
Fair value, beginning of period |
| $ |
|
| $ |
| ||
Inception of derivative liability |
|
|
|
|
|
| ||
Settlements (upon conversion) |
|
| ( | ) |
|
|
| |
Change in fair value of beneficial conversion features |
|
| ( | ) |
|
|
| |
|
|
|
|
|
|
|
|
|
Fair value, end of period |
| $ |
|
| $ |
| ||
12. SEGMENT REPORTING
The Company is not organized by multiple operating segments for the purpose of making operating decisions or assessing performance. Accordingly, the Company operates in one reportable operating segment. The Company’s principal decision maker is the Chief Executive Officer and acting Chief Financial Officer. Management believes that its business operates as one reportable segment because: a) the Company measures profit and loss as a whole; b) the principal decision maker does not review information based on any operating segment; c) the Company does not maintain discrete financial information on any specific segment; d) the Company has not chosen to organize its business around different products and services, and e) the Company has not chosen to organize its business around geographic areas. Since the Company operates as one operating segment, financial segment information, including profit or loss and asset information, can be found in the consolidated financial statements.
13. SUBSEQUENT EVENTS
On October 3, 2025, the Company entered into a securities purchase agreement and contingent convertible note with Diagonal Lending. The convertible note, which had a total principal balance of $
Subsequent to September 30, 2025, the Company received cash proceeds of approximately $
| 46 |
| Table of Contents |
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FORWARD-LOOKING STATEMENTS
In addition to historical information, this Quarterly Report on Form 10-Q may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act), which provides a “safe harbor” for forward-looking statements made by us. All statements, other than statements of historical facts, including statements concerning our plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook, business trends, and other information, may be forward-looking statements. Words such as “might,” “will,” “may,” “should,” “estimates,” “expects,” “continues,” “contemplates,” “anticipates,” “projects,” “plans,” “potential,” “predicts,” “intends,” “believes,” “forecasts,” “future,” and variations of such words or similar expressions are intended to identify forward-looking statements. The forward-looking statements are not historical facts, and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by their nature, are inherently uncertain and beyond our control. Our expectations, beliefs, estimates, and projections are expressed in good faith and we believe there is a reasonable basis for them. However, there can be no assurance that management’s expectations, beliefs, estimates, and projections will occur or can be achieved and actual results may vary materially from what is expressed in or indicated by the forward-looking statements.
These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results, including those that may be set forth under "Risk Factors" below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 2024 and this quarterly report on Form 10-Q. Examples of these uncertainties and risks include, but are not limited to:
| · | access to sufficient debt or equity capital to meet our operating and financial needs; |
| · | the extent of dilution of the holdings of our existing stockholders upon the issuance, conversion or exercise of securities issued as part of our capital raising efforts; |
| · | the extent to which certain debt holders may call the notes to be paid; |
| · | the effectiveness and ultimate market acceptance of our products and our ability to generate sufficient sales revenues to sustain our growth and strategy plans; |
| · | whether our products in development will prove safe, feasible and effective; |
| · | whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate; |
| · | our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products; |
| · | the lack of immediate alternate sources of supply for some critical components of our products; |
| · | our ability to establish and protect the proprietary information on which we base our products, including our patent and intellectual property position; |
| · | The impact of the conflict between Russia and Ukraine on economic conditions in general and on our business operations; |
| · | the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines; |
| · | results related with the termination of the license agreement with SMI and potential partnership agreement with other parties; |
| · | the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and |
| · | other risks and uncertainties described from time to time in our reports filed with the SEC. |
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| Table of Contents |
These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this filing and are subject to risks and uncertainties. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Forward-looking statements speak only as of the date the statements are made. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect thereto or with respect to other forward-looking statements.
The following discussion should be read in conjunction with our financial statements and notes thereto included elsewhere in this report.
OVERVIEW
We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.
LuViva provides a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva improves patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.
We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants.
Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception in 1992 as SpectRx, Inc. and, as of September 30, 2025, we have an accumulated deficit of approximately $155.8 million. To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue for the foreseeable future as we continue to expend substantial resources to complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance capabilities, and conduct further research and development.
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Our product revenues to date have been limited. Our historical and expected future revenue has been and will be derived from sales of LuViva devices and disposables.
Current Demand for LuViva
Based on written agreements and ongoing discussions with SMI and its Chinese partners, we currently hold and expect to generate additional purchase orders which we expect to result in actual sales of approximately $1.0 million within the next twelve months. We cannot be assured that we will generate all or any of these additional purchase orders, or that existing orders will not be canceled by the distributors or that parts to build product will be available to meet demand, such that existing orders will result in actual sales, in part because demand for LuViva is contingent upon Chinese regulatory approval which has not yet been achieved. Because we have a short history of sales of our products, we cannot confidently predict future sales of our products beyond this time frame and cannot be assured of any particular number of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, we are focused on three primary markets: the United States, China and Europe. In addition, we have recently received sales orders from Turkey and Indonesia, for which we have received the necessary regulatory approvals and are preparing to fulfill. These orders are expected to result in approximately $200,000 in revenue for 2025. When combined with sales to our Chinese partner, these constitute what we view as the current demand for our products.
In the United States, the Company is actively pursuing FDA approval by conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with input from FDA and physicians at the clinical centers that are participating in the study. In 2023, FDA completed its review of the protocol and had no further recommendations or questions. Also in 2023, four clinical sites agreed to participate in the study and all four of the study sites were fully IRB approved. The protocol was also approved by an independent, nationally recognized institutional review board. All four sites have received LuViva devices and were trained in their use. All four sites have undergone multiple clinical study monitoring visits by the Company’s clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol.
On August 13, 2025 the Company announced that it had surpassed the minimum number of enrolled subjects, both for each individual site and for the entire study. Based on this achievement, data analysis has begun. The initial analysis will focus on determining the number of study subjects with and without significant cervical disease to ensure that adequate numbers of both have been enrolled and tested. While this is occurring, study site close-out and monitoring visits are being scheduled. Below is a summary of the status of the study:
| 1. | As of November 1, 2025, approximately 460 patients have been enrolled and tested, which is above the target minimum number needed to file the application with the FDA. Analysis of these data indicate that enough women both with and without cervical disease have been enrolled and tested. |
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| 2. | There have not been any adverse events reported related to the use of LuViva. |
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| 3. | All four monitored clinical study sites adhered to the study protocol and have completed the necessary case report forms according to FDA standards. |
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| 4. | Two of the four clinical sites have completed close-out monitoring visits. Study supplies and LuViva devices have been retrieved from these sites. The remaining two sites are expected to complete their close out monitoring visits in November, 2025. |
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We expect the study and data analysis to be completed in 2025. However, there can be no assurance that the study will progress and be completed within the expected timeframe, or ever.
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, filed the application with NMPA for approval of LuViva as a Class 3 medical device in China on October 16, 2024. The results for the 449 women tested by LuViva were better than required by NMPA with a sensitivity of 83% and a specificity of 54%. There were no adverse events reported during the use of LuViva in the study, adding further evidence as to the safety of the technology. The NMPA application was accepted as complete and is under review. SMI has informed us that a mandatory inspection of their manufacturing site has delayed until of 2026, which is consistent with NMPA approval in the first half of 2026, although there can be no assurance that NMPA approval will occur within the projected time frame, or ever.
As of August 1, 2025, SMI was in contractual default due to late payments totaling $200,000 and failure to provide certain data to the Company as set forth in its agreements with the Company.
As of October 31, 2025, SMI had not cured the defaults and had not achieved NMPA approval, resulting in SMI’s loss of rights to sell and market LuViva in China. Guided Therapeutics is currently in discussions with a new partner that works with SMI to assume the responsibilities formerly under the purview of SMI. In addition, during the nine months ended September 30, 2025, we entered into a supply agreement with Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”), the exclusive provider of gynecology products for 42 hospitals in China, for the purchase of 35 LuViva devices totaling $700,000. As of September 30, 2025, we have received $100,000 in payments and shipped three devices, resulting in the recognition of $60,000 in revenue for the quarter ended September 30, 2025.
Based on regulatory approval of LuViva in Russia granted on August 11, 2025, our distribution partner, Newmars Medical Technologies (“Newmars”), is shifting its emphasis from smaller East European countries to the larger Russian market,
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions for supplying LuViva to the Turkish Ministry of Health (“MOH”). The current plan involves a collaboration with MOH to conduct a clinical study in Turkey to support the use of LuViva for primary screening of cervical cancer as a replacement for the Pap test under the public health system. The MOH has informed us that this would potentially involve up to 20 million tests annually in Turkey paid for by the Turkish national healthcare system. The clinical study is expected to involve about 800 patients, take less than six months to complete and will be funded by the MOH. As of October 31, 2025, MOH had approved the study and budget, including paying for LuViva devices and single use Cervical Guides. Funds are expected to be released in 2025 and the study concluded in the first half of 2026.
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands. During the fourth quarter of 2024, we received an order and full payment for four devices from Indonesia. We have delayed shipment pending final payment for shipping and additional services requested by the customer. We expect to ship these devices in the fourth quarter of this year.
CRITICAL ACCOUNTING POLICIES
Our material accounting policies, which we believe are the most critical to investors’ understanding of our financial results and condition, are discussed below. Because we are still early in our enterprise development, the number of these policies requiring explanation is limited. As we begin to generate increased revenue from different sources, we expect that the number of applicable policies and complexity of the judgments required will increase.
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Revenue Recognition: ASC 606, Revenue from Contracts with Customers establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue is now recognized when control over the goods or services is transferred to the customer. The application of the core principle in ASC 606 is carried out in five steps:
Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled.
Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.
Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.
Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach (in limited circumstances). Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and the reallocation of changes in standalone selling prices after inception is not permitted.
Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.
Valuation of Deferred Taxes: We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.
Valuation of Equity Instruments Granted to Employee, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial lattice valuation models.
Allowance for Credit Losses: Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The allowance for credit losses was immaterial as of September 30, 2025 and December 31, 2024.
Inventory Valuation: All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred.
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RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
Sales Revenue and Cost of Goods Sold: Revenue from the sale of LuViva devices and disposables was $60,000 for the three months ended September 30, 2025, compared to none in the prior-year period. The current period revenue was derived from the shipment of three instrumentation packages to Hangzhou Dongye Medical Technology Company, Ltd. (“HDMT”). Cost of goods sold totaled $25,288, of which $22,693 related to the devices shipped to HDMT, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Research and Development Expenses: Research and development expenses were $135,549 and $111,298 during the three months ended September 30, 2025 and 2024, respectively. The increase of $24,251, or 21.8%, was primarily due to $24,240 in additional sponsored research costs related to clinical trials.
Sales and Marketing Expenses: Sales and marketing expenses were $22,500 and $75,850 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $53,350, or 70.3%, was primarily due to reductions of $39,929 in salaries and benefits, $9,474 in allocated rent expense, and $4,439 in travel expenses.
General and Administrative Expense: General and administrative expenses were $361,898 and $374,190 during the three months ended September 30, 2025 and 2024, respectively. The decrease of $12,292, or 3.3%, was primarily driven by a decrease of $23,917 for consulting and professional fees, a decrease of $10,658 for taxes and a decrease of $7,481 for stock option expense. These increases were offset by an increase of $21,211 in salaries & benefits, $7,207 of additional rent expense allocated to general use purposes and a $1,346 increase in other miscellaneous expenses.
Interest Expense: Interest expense was $129,304 and $107,500 during the three months ended September 30, 2025 and 2024, respectively. The increase of $21,804, or 20.3%, was primarily due to a higher level of outstanding debt.
Change in fair value of derivative liability: The change in the fair value of our derivative liabilities resulted in a loss of $37,033 and $585 during the three months ended September 30, 2025 and 2024, respectively. The increase in the derivative liability was primarily attributable to accrued interest, which increased the amount subject to conversion features accounted for as derivative liabilities.
Gain from Forgiveness of Debt: The gain from forgiveness of debt of $15,118 and $16,145 during the three months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Loss from Extinguishment of Debt: During the three months ended September 30, 2025, we recognized a loss on extinguishment of debt of $106,200 related to exchanges of debt for common stock and warrants.
Preferred Stock Dividends: Preferred stock dividend expense was $42,837 for the three months ended September 30, 2025, compared to $38,194 in the prior-year period, and was materially consistent between periods.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $785,445 and $692,417 during the three months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
There was no income tax benefit recorded for the three months ended September 30, 2025 or 2024, due to recurring net operating losses.
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RESULTS OF OPERATIONS
COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the nine months ended September 30, 2025 were $177,462, compared to $5,720 for the nine months ended September 30, 2024. Revenue in the current period was attributed to the shipment of six instrumentation packages and 49,031 RFID chips to our customers in China. Cost of goods sold was $63,500 during the nine months ended September 30, 2025, of which $60,911 related to the devices and RFID chips shipped to China, with the remainder attributable to inventory adjustments. As of September 30, 2025, we have a deferred revenue balance of $689,318 which will be recognized as revenue upon shipment of devices pending NMPA approval.
Research and Development Expenses: Research and development expenses were $342,359 and $386,417 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $44,058, or 11.4%, was primarily due to a $29,614 decrease in sponsored research costs, a $10,432 decrease in clinical travel expenses and a decrease of $5,394 in engineering staff salaries.
Sales and Marketing Expenses: Sales and marketing expenses were $146,011 and $217,653 during the nine months ended September 30, 2025 and 2024, respectively. The decrease of $71,642, or 32.9% was primarily due to reductions of $49,503 in salaries & benefits, $15,312 in rent expense (due to a decline in allocated rent expense and a decline in ancillary charges from the landlord), and $7,577 in travel expenses.
General and Administrative Expense: General and administrative expenses were $1,286,930 and $974,406 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $312,524, or 32.1%, was primarily driven by an increase of $300,672 in payroll & benefits (including payroll taxes), which was primarily due to a one-time charge of $270,389 for warrants included in a board-approved compensation package for Dr. Faupel during the current period. Additionally, the Company recognized $20,009 of additional expense for stock options in the current period versus the prior and $4,464 of additional credit loss expense. These increases were offset by a decrease of $15,658 in taxes.
Interest Expense: Interest expense was $432,752 and $246,990 during the nine months ended September 30, 2025 and 2024, respectively. The increase of $185,762, or 75.2%, was due to an increase in debt in the current period versus the prior.
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liabilities resulted in a gain of $46,227 during the nine months ended September 30, 2025 versus a loss of $7,935 during the nine months ended September 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price. In addition, a greater number of derivative liabilities were recorded in the current year due to additional bifurcated conversion features associated with new debt issuances.
Gain from Extinguishment of Debt: The gain from forgiveness of debt of $46,136 and $49,205 during the nine months ended September 30, 2025 and 2024, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Loss from Extinguishment of Debt: During the nine months ended September 30, 2025, we recognized a loss on extinguishment of debt of $138,148 related to exchanges of debt for common stock and warrants.
Other Income: Other income was $161,087 and $12,372 during the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025, we reached an agreement with SMI to apply their payment of $180,000 towards reimbursement of certain expenses incurred during the years ended December 31, 2024 and 2023. As a result of this agreement, we recognized $180,000 of deferred revenue in other income during the current period. Additionally, we recorded other income of $52,400 in the current period to account for funds received from the Internal Revenue Service related to refundable payroll tax credits under the Employee Retention Credit program. This income was offset by a $84,000 loss recorded for the write-off of a long-term asset in the current period. Other income in the prior year period primarily reflected an adjustment to a previously recorded liability.
Preferred Stock Dividends: Expense related to preferred stock dividends of $125,875 and $126,030 for the nine months ended September 30, 2025 and 2024, respectively, was materially consistent over the two periods.
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Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $2,103,663 and $1,890,970 during the nine months ended September 30, 2025 and 2024, respectively. The change reflects the factors discussed above.
There was no income tax benefit recorded for the nine months ended September 30, 2025 or 2024, due to recurring net operating losses.
LIQUIDITY AND CAPITAL RESOURCES
Going Concern Considerations
We have incurred significant losses since our inception. At September 30, 2025, the Company had negative working capital of approximately $5.7 million, accumulated deficit of $155.8 million, and incurred a net loss including preferred dividends of $2.1 million for the nine months then ended. Stockholders’ deficit totaled approximately $5.7 million at September 30, 2025, primarily due to recurring net losses from operations.
The Company will need to continue to raise capital in order to provide funding for its operations and FDA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.
Liquidity
Over the next 12 months we expect our burn rate to increase as we increase headcount, especially for meeting manufacturing demand. In addition, although we have significant inventory, we will need to order additional parts and services for production. Finally, we expect to spend another $425 thousand to complete and file our FDA study. Thus, we estimate that approximately $2.3 million will be needed to fund the business over the next 12 months. However, other than completing and filing the US FDA study results, additional expenditures for manufacturing production will be needed only if significant product is ordered and paid for in advance by customers, which is our current policy.
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of September 30, 2025, we had cash of approximately $87 thousand and negative working capital of $5.7 million. Our outstanding debt obligations include a combination of short- and long-term promissory notes, insurance premium financing, and several convertible notes with varying maturities, interest rates, and terms.
Subsequent to September 30, 2025, the Company received approximately $200,000 in proceeds from an ongoing private placement offering of units consisting of one share of common stock, one three-year warrant exercisable at $0.26 per share, and one four-year warrant exercisable at $0.52 per share, sold at a price of $0.19 per unit. The Company expects to complete the issuance of the related securities during the fourth quarter of 2025, and intends to use the proceeds for general working capital and corporate purposes.
Promissory Notes
As of September 30, 2025, we have a long-term note issued to a former employee with a remaining principal balance of $53,162, of which $24,000 is classified as short-term. This note accrues interest at 6% per annum and matures on May 5, 2028. Scheduled monthly payments of $2,000 are being made in accordance with the agreement.
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Convertible Debt:
Our convertible debt obligations as of September 30, 2025 include the following:
| · | A $1.13 million 10% Senior Unsecured Convertible Debenture, which matured on May 17, 2024, is currently in default and accruing interest at the default rate of 18%. Total accrued interest on this note was $51,980 as of September 30, 2025. The balance is classified as short-term convertible debt in default. |
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| · | Two convertible notes with Diagonal Lending LLC totaling $198,519 in principal, presented net of $31,382 in unamortized discounts and issuance costs. These notes carry embedded conversion features that have been bifurcated and recorded as derivative liabilities. The notes, which accrue interest at an effective rate of approximately 18.1%, have initial lump-sum payments followed by monthly payments due through the first quarter of 2026. As of September 30, 2025, $11,308 of interest has accrued on the notes. |
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| · | A convertible note issued to Flynn D. Case Living Trust, amended in December 2024, has an outstanding balance of $125,000 and is presented net of $49,470 of unamortized debt discounts. A payment of $75,000 is due on December 4, 2025, while the remaining balance of $50,000 and all accrued interest is due on June 4, 2026. The note includes multiple embedded conversion options with variable pricing terms, which have been bifurcated and accounted for as derivative liabilities. As of September 30, 2025, $3,858 of interest has accrued on the note. |
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| · | A $107,800 unsecured convertible promissory note issued on August 27, 2025 to Labrys Fund II, L.P., an unaffiliated institutional investor, was issued at a purchase price of $98,000, reflecting an original issue discount of $9,800, and bears total interest of $10,780. The note matures on August 27, 2026 and may not be prepaid except as provided in its terms. In the event of default or a missed amortization payment, the holder may convert the outstanding balance, including accrued interest, into common stock at a conversion price equal to 75% of the average of the two lowest closing prices over the ten trading days preceding conversion. The embedded conversion features were bifurcated and recorded as derivative liabilities, which are remeasured at each reporting date. A payment of $59,290 is due on February 27, 2026, followed by monthly payments of $9,882 through maturity. As of September 30, 2025, the full balance remained outstanding. The note is presented net of unamortized discounts of $22,607. |
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| · | A convertible note held by Auctus Fund LLC had an outstanding balance of $15,000 as of September 30, 2025. The note has accrued interest of $117,550 and is classified as short-term debt. |
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| · | A $75,000 convertible promissory note issued on May 2, 2025 to an unaffiliated third party accrues interest at 12% per annum and matures on May 2, 2026. On the maturity date, the Company may elect to convert the outstanding balance into common shares at $0.20 per share. The note was issued with 75,000 warrants exercisable at $0.20 per share, expiring on May 1, 2028. As of September 30, 2025, the note had $4,146 in unamortized discount and $3,723 in accrued interest. |
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| · | A $10,000 convertible promissory note issued on May 22, 2025 to an unaffiliated third party accrues interest at 12% per annum and matures on May 22, 2026. On the maturity date, the Company may elect to convert the outstanding balance into common shares at $0.20 per share. The note was issued with 10,000 warrants exercisable at $0.20 per share, expiring on May 21, 2028. As of September 30, 2025, the note had $727 in unamortized discount and $219 in accrued interest. |
These convertible instruments, especially those with variable conversion pricing or embedded features, may result in significant dilution to existing stockholders if converted to equity. Additionally, several of the notes include default provisions or change of control clauses that may accelerate repayment obligations or increase total amounts due.
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Related Party Debt
As of September 30, 2025, we also had multiple outstanding obligations to related parties, including current and former directors and executives:
| · | On September 25, 2025, the Company issued a $160,000 contingently convertible promissory note to Dr. John Imhoff. The note bears interest at 10% per annum and matures on February 28, 2027. Beginning November 30, 2025, the Company is required to make monthly payments of $10,000 plus accrued interest. If any payment is missed, the holder may elect to convert the unpaid balance, including accrued interest, into common stock at $0.07 per share when the 10-day VWAP is below $0.50, or $0.14 per share when the 10-day VWAP is $0.50 or higher. The Company may prepay the note at any time with the holder’s consent. As of September 30, 2025, no payments or conversions had occurred, and the full $160,000 principal remained outstanding. | ||
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| · | Dr. Mark Faupel and Dr. Gene Cartwright hold promissory notes originally issued in 2018 and most recently amended in 2023 and 2025. On August 27, 2025, the Company entered into an agreement with Dr. Faupel to exchange $25,000 of note principal for 138,889 shares of common stock and 138,889 warrants to purchase up to 138,889 shares of common stock. The warrants, which were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.25 per share. During the nine months ended September 30, 2025, the Company recorded a loss on extinguishment of debt of $50,697 for the exchange agreement, equal to the excess of fair value of the common stock and warrants over the value of the debt. As of September 30, 2025, Dr. Cartwright’s $312,816 note was overdue, while Dr. Faupel’s $170,471 note will mature on February 18, 2026. | ||
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| · | A note issued to Richard Fowler in 2021 had a remaining principal balance of $13,011 as of September 30, 2025. The note carries a 6% interest rate and is being repaid in monthly installments. Mr. Fowler has forgiven portions of the deferred compensation related to this note, which was accounted for as a troubled debt restructuring. | ||
Summary of our Cash Flows
Net cash used in operating activities was $776,689 for the nine months ended September 30, 2025, compared to $786,783 in the prior-year period, and remained relatively consistent year over year. The change reflects a higher net loss of $213,848 and unfavorable working capital changes of $216,859, offset by higher non-cash adjustments, including increases in stock-based compensation ($219,267), loss on extinguishment of debt ($138,148), and amortization of debt discounts and issuance costs ($117,108). These increases were partially offset by a $46,227 gain from the change in fair value of derivative liabilities compared to a $7,935 loss in the prior period.
For the nine months ended September 30, 2025, $1,797 of cash used for investing activities was for the purchase of computer equipment.
Net cash provided by financing activities was $477,832 in the nine months ended September 30, 2025, compared to $390,100 in the prior-year period. The increase of $87,732 was due to $235,900 of additional proceeds from the issuance of notes payable, offset by an increase in debt payments of $74,519, a decrease in proceeds from issuances of equity instruments of $40,499 and an increase in debt issuance costs of $33,150.
As a result, our total cash decreased by $300,654 during the nine months ended September 30, 2025, compared to a $396,683 decrease during the same period in 2024.
Off-Balance Sheet Arrangements
We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide the information required by this item.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain a set of disclosure controls and procedures designed to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized, and reported, within the time periods specified in Securities and Exchange Commission (“Commission”) rules and forms. We carried out an evaluation under the supervision and with the participation of our management, including the Chief Executive Officer/Acting Chief Financial Officer, Mark Faupel, of the effectiveness of its disclosure controls and procedures. Based on that evaluation, the Chief Executive Officer/Acting Chief Financial Officer has concluded that our disclosure controls and procedures were ineffective as of September 30, 2025, due to the existence of material weaknesses in our internal control over financial reporting. The material weaknesses identified arose from a lack of recourses to properly research and account for complex transactions and lack of oversight and approval by the Board of Directors and Audit Committee, including formally documented approval of significant transactions, including related party transactions. While management is currently in the early stages of developing a remediation plan, we have yet to fully remediate this material weakness.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the disposition of these matters, individually or in the aggregate, is not expected to have a material adverse effect on the Company’s financial condition.
ITEM 1A. RISK FACTORS
Except as noted below, there have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 31, 2025.
In October 2025, a partial shutdown of the U.S. federal government began, resulting in reduced staffing and limited operations at certain agencies, including the U.S. Food and Drug Administration (“FDA”). The Company is currently pursuing FDA clearance for the LuViva Advanced Cervical Scan, and a prolonged shutdown could delay the timing of regulatory reviews and approvals, which in turn could adversely affect product commercialization timelines, revenue opportunities, and cash flow forecasts. The duration and potential impacts of the shutdown are uncertain and could vary depending on the extent of agency operations and the resolution of the federal budget process.
Regarding the Chinese market, the ability of SMI to timely achieve NMPA approval and be able to successfully market LuViva in China is a risk factor of increasing magnitude, given repeated delays over the past year. While SMI has been able to bring new partners to the table which has resulted in increased sales to China in the past year, full NMPA approval will be necessary to achieve significant sales over the long term.
ITEM 2. UNREGISTERRED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
August 2025 Private Placement Offering
On August 29, 2025, the Company entered into a Securities Purchase Agreement (the “August Purchase Agreement”) with certain institutional investors, including Dr. John Imhoff and Michael James, members of the Company’s Board of Directors, to raise gross proceeds of $55,000. Under the agreement, the Company issued 305,557 units at a purchase price of $0.18 per unit, each consisting of one share of common stock and one warrant to purchase one share of common stock (the “August Warrants”). The August Warrants were immediately exercisable upon issuance, have an exercise price of $0.25 per share, and expire four years from the issuance date.
In connection with the August Purchase Agreement, the Company also entered into exchange agreements with two directors. Alan Grujic exchanged a $25,000 note payable and $2,379 of accrued interest for 152,108 units, and Dr. Mark Faupel, the Company’s President and Chief Executive Officer, exchanged a $25,000 note payable for 138,889 units. The Company recognized a loss on extinguishment of debt of $106,220 related to these exchanges during the nine months ended September 30, 2025.
The issuance of the foregoing securities was made in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506(b) of Regulation D promulgated thereunder, as the transactions did not involve any public offering. The $55,000 in cash proceeds from the offering were used for general corporate purposes.
Common Stock Issues as Payment of Dividends
During the three months ended September 30, 2025, the Company issued 272,611 shares of common stock for payment of dividends on its Series E Preferred Stock, The unregistered shares were issued in reliance on exemptions from registration under Section 4(a)(2) of the Securities Act and/or Regulation D.
Conversion of Debt and Interest into Common Stock
On July 1, 2025, the Company permitted the holder of the Flynn D. Case Living Trust promissory notes to convert $75,000 of principal and $13,800 of accrued interest outstanding into 498,752 shares of common stock. On the same date, the Company issued 813,916 shares of common stock as payment of interest on its 10% unsecured senior convertible debentures. The shares issued in these transactions were unregistered and issued in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Rule 506 of Regulation D promulgated thereunder.
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Conversion of Preferred Stock into Common Stock
The Company issued 1,200,000 shares of common stock to Dr. John Imhoff upon the conversion of 300 shares of Series E Convertible Preferred Stock in accordance with its certificate of designation.
The issuance of these securities was made in reliance upon the exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended, as the exchanges were made with existing security holders and no commission or other remuneration was paid. No cash proceeds were received by the Company in connection with these conversions.
ITEM 3: DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4: MINE SAFETY DISCLOSURES.
Not applicable
ITEM 5: OTHER INFORMATION.
None.
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ITEM 6. EXHIBITS
| Exhibit Number |
| Exhibit Description |
| ||
| 3.1 |
| Restated Certificate of Incorporation, as amended through November 3, 2016 (incorporated by reference to Exhibit 3.1 to the annual report on Form 10-K filed March 15, 2016) |
| 3.2 |
| Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed March 23, 2012) |
| 3.3 |
| Amended and Restated Certificate of Incorporation, (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed November 15, 2018) |
| 3.4 |
| Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.4 to the annual report on Form 10-K, filed April 20, 2020) |
| 3.5 |
| Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the annual report on Form 10-K filed April 5, 2021) |
| 3.6 |
| Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock (incorporated by reference to Exhibit 3.6 to the annual report on Form 10-K filed April 5, 2021) |
| 3.7 |
| Certificate of Designation of Preferences, Rights and Limitations of Series F-2 Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on June 10, 2021) |
| 3.8 |
| Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock (incorporated by reference to Exhibit 3.8 to the annual report on Form 10-K filed March 30, 2022) |
| 3.9 |
| Certificate of Amendment to the Certificate of Incorporation of Guided Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on January 7, 2022) |
| 10.1* |
| Exchange Agreement dated August 27, 2025, by and between the Company and Mark Faupel |
| 10.2* |
| Exchange Agreement dated August 27, 2025, by and between the Company and Alan Grujic |
| 10.3* |
| Form of Securities Purchase Agreement dated August 29, 2025, by and among the Company and the investors named therein. |
| 10.4* |
| Form of Warrant Agreement Dated August 29, 2025, by and among the Company and the investors named therein. |
| 10.5* |
| Convertible Promissory Note, dated September 25, 2025, issued by the Company to John Imhoff in the principal amount of $160,000. |
| 10.6* |
| Promissory Note, dated August 27, 2025, issued by the Company to Labrys Fund II, L.P., in the principal amount of $107,800. |
| 10.7* |
| Securities Purchase Agreement dated August 27, 2025, by and among the Company and Labrys Fund II, L.P. |
| 10.8* |
| Promissory Note, dated October 3, 2025, issued by the Company to 1800 Diagional Lending LLC, in the principal amount of $123,050. |
| 10.9* |
| Securities Purchase Agreement dated October 3, 2025, by and among the Company and 1800 Diagional Lending, LLC. |
| 31* |
| Rule 13a-14(a)/15d-14(a) Certification |
| 32* |
| Section 1350 Certification |
| 101.1* |
| Interactive data files for Guided Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, formatted in Inline XBRL: (i) the Unaudited Condensed Consolidated Balance Sheets; (ii) the Unaudited Condensed Consolidated Statements of Income; (iii) the Unaudited Condensed Consolidated Statements in Stockholders' Deficit; (iv) the Unaudited Condensed Consolidated Statements of Cash Flows; and (v) the Notes to the Unaudited Condensed Consolidated Financial Statements. |
104 |
| The cover page from Guided Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 (formatted in Inline XBRL and included in Exhibit 101) |
______________
*Filed herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GUIDED THERAPEUTICS, INC. | ||
| ||
By: | /s/ Mark Faupel | |
Mark Faupel | ||
President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer | ||
Date: November 13, 2025
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FAQ
What were GTHP’s Q3 2025 sales and profitability?
What is Guided Therapeutics’ cash position and leverage?
Did GTHP disclose a going concern risk?
How did GTHP finance operations year-to-date?
How many GTHP shares are outstanding?
What debt pressures exist near term?
