UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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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 August 10, 2024, the registrant had
PART I — FINANCIAL INFORMATION | ||||
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| Unaudited Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 |
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| Notes to Unaudited Condensed Consolidated Financial Statements |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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2 |
Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(unaudited, in thousands) | ||||||||
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June 30, | December 31, | |||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | $ | ||||||
Trade receivables, net of allowance for doubtful accounts of nil and $ | ||||||||
Inventory, net of reserves of $ | ||||||||
Other current assets | ||||||||
Total current assets | ||||||||
Non-Current Assets: | ||||||||
Property and equipment, net | ||||||||
Operating lease right-of-use assets, net of amortization | ||||||||
Other assets | ||||||||
Total non-current assets | ||||||||
TOTAL ASSETS | $ | $ | ||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | $ | ||||||
Accounts payable, related parties | ||||||||
Accrued liabilities | ||||||||
Deferred revenue | ||||||||
Current portion of lease liability | ||||||||
Current portion of long-term debt, related parties | ||||||||
Short-term notes payable | ||||||||
Short-term convertible debt | ||||||||
Short-term convertible debt in default | ||||||||
Derivative liability at fair value | ||||||||
Total current liabilities | ||||||||
Long-Term Liabilities | ||||||||
Long-term lease liability | ||||||||
Long-term notes payable | ||||||||
Long-term debt, related parties | ||||||||
Total long-term liabilities | ||||||||
Total liabilities | ||||||||
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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| Six Months Ended |
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| June 30, |
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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 extinguishment of debt |
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Other income (expenses) |
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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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Deemed dividend for warrant exchanges |
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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 JUNE 30, 2024 | ||||||||||||||||||||||||||||||||
(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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Series C | Series C1 | Series C2 | Series D |
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Balance at March 31, 2024 |
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Issuance of common stock for payment of Series D preferred dividends |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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Issuance of common stock for payment of interest |
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Issuance of warrants with debt |
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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 June 30, 2024 |
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| Preferred Stock |
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Series E | Series F | Series F2 |
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Balance at March 31, 2024 |
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Issuance of common stock for payment of Series D preferred dividends |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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Issuance of common stock for payment of interest |
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Issuance of warrants with debt |
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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 June 30, 2024 |
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| Additional |
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| Common Stock |
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| Capital |
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| Stock |
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| Total |
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Balance at March 31, 2024 |
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Issuance of common stock for payment of Series D preferred dividends |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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Issuance of common stock for payment of interest |
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Issuance of warrants with debt |
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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 June 30, 2024 |
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The accompanying notes are an integral part of these condensed consolidated statements.
6 |
Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | ||||||||||||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT | ||||||||||||||||||||||||||||||||
FOR THE THREE MONTHS ENDED JUNE 30, 2023 | ||||||||||||||||||||||||||||||||
(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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| Series C1 |
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| Series C2 |
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| Series D |
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| Amount |
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| Shares |
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| Amount |
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| Shares |
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| Amount |
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| Shares |
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| Amount |
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Balance at March 31, 2023 |
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Common stock warrants exercised |
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Issuance of common stock for payment of Series D preferred dividends |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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Conversion of Series F preferred stock to common stock |
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Stock-based compensation |
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| - |
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Accrued preferred dividends |
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Net loss |
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| - |
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| - |
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| - |
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Balance at June 30, 2023 |
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| Preferred Stock |
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| Preferred Stock |
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| Preferred Stock |
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| Series E |
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| Series F |
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| Series F2 |
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| Shares |
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| Amount |
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| Shares |
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| Amount |
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| Shares |
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| Amount |
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Balance at March 31, 2023 |
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Common stock warrants exercised |
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| - |
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|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series D preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Conversion of Series F preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
| ( | ) |
|
| - |
|
|
|
| ||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Balance at June 30, 2023 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
| |||||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
|
| |||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at March 31, 2023 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Common stock warrants exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series D preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series F-2 preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Conversion of Series F preferred stock to common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
| ( | ) |
|
| ( | ) | ||
Net loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at June 30, 2023 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
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 SIX MONTHS ENDED JUNE 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 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 June 30, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| 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 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 June 30, 2024 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
| |||||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
|
| |||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2023 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
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 June 30, 2024 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
8 |
Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | ||||||||||||||||||||||||||||||||
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT | ||||||||||||||||||||||||||||||||
FOR THE SIX MONTHS ENDED JUNE 30, 2023 | ||||||||||||||||||||||||||||||||
(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, 2022 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| ||||||||
Common stock warrants exercised |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
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 Series E preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Series F preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Conversion of Series F-2 preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Impact of warrant exchanges |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||||
Balance at June 30, 2023 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
| Preferred Stock |
|
| Preferred Stock |
|
| Preferred Stock |
| |||||||||||||||
|
| Series E |
|
| Series F |
|
| Series F2 |
| |||||||||||||||
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
|
| Shares |
|
| Amount |
| ||||||
Balance at December 31, 2022 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
| ||||||
Common stock warrants exercised |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
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 Series E preferred stock to common stock |
|
| - |
|
|
| ( | ) |
|
| - |
|
|
|
|
|
| - |
|
|
|
| ||
Conversion of Series F preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
| ( | ) |
|
| - |
|
|
|
| ||
Conversion of Series F-2 preferred stock to common stock |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
| ( | ) | ||
Issuance of common stock for payment of interest |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Stock-based compensation |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Impact of warrant exchanges |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Accrued preferred dividends |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Net loss |
|
| - |
|
|
|
|
|
| - |
|
|
|
|
|
| - |
|
|
|
| |||
Balance at June 30, 2023 |
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| $ |
|
|
|
|
| Additional |
|
|
|
|
|
|
|
|
| |||||||||||
|
| Common Stock |
|
| Paid-In |
|
| Treasury |
|
| Accumulated |
|
|
|
| |||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Stock |
|
| Deficit |
|
| Total |
| ||||||
Balance at December 31, 2022 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
Common stock warrants exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series D preferred dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Issuance of common stock for payment of Series E preferred dividends |
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Issuance of common stock for payment of Series F preferred dividends |
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Issuance of common stock for payment of Series F-2 preferred dividends |
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| ||||||
Conversion of Series E preferred stock to common stock |
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| ||||||
Conversion of Series F preferred stock to common stock |
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| ||||||
Conversion of Series F-2 preferred stock to common stock |
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Issuance of common stock for payment of interest |
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Stock-based compensation |
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| ||||||
Impact of warrant exchanges |
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| - |
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|
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|
| ( | ) |
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| ||||
Accrued preferred dividends |
|
| - |
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|
|
|
| ( | ) |
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|
|
| ( | ) |
|
| ( | ) | ||
Net loss |
|
| - |
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|
|
|
|
| ( | ) |
|
| ( | ) | |||
Balance at June 30, 2023 |
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| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
9 |
Table of Contents |
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(unaudited, in thousands) | ||||||||
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| Six Months Ended |
| |||||
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| June 30, |
| |||||
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| 2024 |
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| 2023 |
| ||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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| ||
Net loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Bad debt expense |
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Depreciation |
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| ||
Amortization of debt issuance costs and discounts |
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| ||
Stock-based compensation |
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Change in fair value of derivative liability |
|
|
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|
| ( | ) | |
Amortization of lease right-of-use-asset |
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| ||
Gain from forgiveness of debt |
|
| ( | ) |
|
| ( | ) |
Other non-cash expenses |
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| ||
Change in operating assets and liabilities: |
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Accounts receivable |
|
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| ( | ) | |
Inventory |
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| ( | ) | |
Other current assets |
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| ||
Accounts payable and accrued liabilities |
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|
| ( | ) | |
Lease liabilities |
|
| ( | ) |
|
| ( | ) |
Deferred revenue |
|
|
|
|
| ( | ) | |
NET CASH USED IN OPERATING ACTIVITIES |
|
| ( | ) |
|
| ( | ) |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from notes payable |
|
|
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| ||
Payments of debt issuance costs |
|
| ( | ) |
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| |
Payments made on notes payable |
|
| ( | ) |
|
| ( | ) |
Proceeds from warrant exercises |
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| ||
NET CASH USED IN FINANCING ACTIVITIES |
|
| ( | ) |
|
| ( | ) |
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NET CHANGE IN CASH |
|
| ( | ) |
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| ( | ) |
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Cash at beginning of period |
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| ||
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CASH AT END OF PERIOD |
| $ |
|
| $ |
| ||
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SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES: |
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Cash paid for interest |
| $ |
|
| $ |
|
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: |
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| ||
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| ||
Dividends on preferred stock |
| $ |
|
| $ |
| ||
Deemed dividends for warrant exchanges |
| $ |
|
| $ |
| ||
Warrants issued with debt |
| $ |
|
| $ |
| ||
Beneficial conversion feature |
| $ |
|
| $ |
| ||
Common stock issued for payment of interest |
| $ |
|
| $ |
| ||
Common stock issued for payment of accrued dividends |
| $ |
|
| $ |
| ||
Settlement of previously accrued professional fees through common stock issuance |
| $ |
|
| $ |
| ||
Accrued payroll liability exchanged for promissory note |
| $ |
|
| $ |
| ||
Conversion of Series E preferred shares into common stock |
| $ |
|
| $ |
| ||
Conversion of Series F preferred shares into common stock |
| $ |
|
| $ |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
10 |
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, 2023 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, 2023 balances reported herein are derived from the audited consolidated financial statements for the year ended December 31, 2023. 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 June 30, 2024 and December 31, 2023, and the consolidated results of operations and cash flows for the three and six-month periods ended June 30, 2024 and 2023 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 June 30, 2024, it had an accumulated deficit of approximately $152.1 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.
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 makers do 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.
11 |
Table of Contents |
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 June 30, 2024, the Company had a negative working capital of approximately $
During the year ended December 31, 2023, the Company received $
Reclassifications
Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications did not affect net loss, revenues or stockholders’ equity.
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 allowance for doubtful accounts, 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.
Accounting Standard Updates
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
12 |
Table of Contents |
Trade Receivables
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 June 30, 2024 and December 31, 2023.
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 June 30, 2024 and December 31, 2023:
|
| (in thousands) |
| |||||
|
| June 30, |
|
| December 31, |
| ||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
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.
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 June 30, 2024 and December 31, 2023:
13 |
Table of Contents |
|
| (in thousands) |
| |||||
|
| June 30, |
|
| December 31, |
| ||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
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 six months ended June 30, 2024 and 2023 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. 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 six months ended June 30, 2024 and 2023.
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.”
14 |
Table of Contents |
Accrued Liabilities
Accrued liabilities as of June 30, 2024 and December 31, 2023 are summarized as follows:
|
| (in thousands) |
| |||||
|
| June 30, 2024 |
|
| December 31, 2023 |
| ||
|
|
|
|
|
|
| ||
Compensation |
| $ |
|
| $ |
| ||
Professional fees |
|
|
|
|
|
| ||
Interest |
|
|
|
|
|
| ||
Vacation |
|
|
|
|
|
| ||
Preferred dividends |
|
|
|
|
|
| ||
Other accrued expenses |
|
|
|
|
|
| ||
Total |
| $ |
|
| $ |
|
Stock Subscription Payable
Cash received from investors for shares of common stock that have not yet been issued is recorded as a liability, which is presented within Accrued Liabilities on the consolidated balance sheet.
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. |
15 |
Table of Contents |
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 $
Significant Customers
As of June 30, 2024, trade receivables of $
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 for an extension for its 2023 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 June 30, 2024, 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
16 |
Table of Contents |
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.
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 six months ended June 30, 2024, 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:
17 |
Table of Contents |
| · | 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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|
|
| · | 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. |
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|
|
| · | 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). |
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|
|
| · | 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
Common Stock
The Company has authorized
During the six months ended June 30, 2024, the Company issued 2,161,560 shares of common stock, as summarized below:
|
| Number of Shares |
| |
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 |
|
|
| |
Issuance of common stock to consultants |
|
|
| |
Total common stock issued during the six months ended June 30, 2024 |
|
|
| |
|
|
|
|
|
Summary table of common stock transactions: |
|
|
|
|
Shares outstanding at December 31, 2023 |
|
|
| |
Common shares issued during the six months ended June 30, 2024 |
|
|
| |
Shares outstanding at June 30, 2024 |
|
|
|
18 |
Table of Contents |
Preferred Stock
The Company has authorized
Series C Convertible Preferred Stock
The board designated
Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of
The Series C Preferred Stock generally has no voting rights except as required by Delaware law. Upon the Company’s liquidation or sale to or merger with another corporation, each share will be entitled to a liquidation preference 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
19 |
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At June 30, 2024 and December 31, 2023, there were
The terms of the Series C2 Convertible Preferred Stock are substantially the same as the Series C1 shares, except that (i) shares of Series C1 Convertible Preferred Stock were not convertible into the Company’s common stock by their holder for a period of 180 days following the date of the filing of the Certificate of Designation (the “Lock-Up Period”); (ii) the Series C2 Convertible Preferred Stock has the right to vote as a single class with the Company’s common stock on an as-converted basis, notwithstanding the Lock-Up Period; and (iii) the Series C2 Convertible Preferred Stock will automatically convert into that number of securities sold in the next Qualified Financing (as defined in the Exchange Agreement) determined by dividing the stated value ($
Series D Convertible Preferred Stock
The board designated
Each share of Series D Preferred is convertible, at any time for a period of
During the six months ended June 30, 2024, the Company issued
Series E Convertible Preferred Stock
The Board designated
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Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of
During the six months ended June 30, 2024, 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
During the six months ended June 30, 2024, 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 six months ended June 30, 2024, the Company issued
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Warrants
The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the six months ended June 30, 2024 and 2023:
|
| Warrants (Underlying Shares) |
|
| Weighted-Average Exercise Price Per Share |
| ||
|
| |||||||
Outstanding, December 31, 2023 |
|
|
|
| $ |
| ||
Warrants issued |
|
|
|
|
|
| ||
Warrants expired |
|
| ( | ) |
|
|
| |
Outstanding, June 30, 2024 |
|
|
|
| $ |
|
|
| Warrants (Underlying Shares) |
|
| Weighted-Average Exercise Price Per Share |
| ||
|
|
|
|
|
|
| ||
Outstanding, December 31, 2022 |
|
|
|
| $ |
| ||
Warrants issued |
|
|
|
|
|
| ||
Warrants exchanged |
|
| ( | ) |
|
|
| |
Warrants expired |
|
| ( | ) |
|
|
| |
Warrants exercised |
|
| ( | ) |
|
|
| |
Outstanding, June 30, 2023 |
|
|
|
| $ |
|
During the six months ended June 30, 2024 and 2023, the Company issued
During the six months ended June 30, 2024, the Company issued
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of
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On May 14, 2023, the Compensation Committee of the Company’s Board of Directors also approved the issuance of
During the six months ended June 30, 2023, the Company entered into various agreements with holders of the Company’s $
During the six months ended June 30, 2023, management estimated the fair value of the warrants issued utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:
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
During the six months ended June 30, 2024 and 2023, the Company recognized expense for stock options of $
On February 10, 2023, the Company granted
On March 7, 2023, the Company granted
23 |
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The following tables summarize the Company’s stock option activity and related information for the six months ended June 30, 2024 and 2023:
|
| 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 outstanding as of June 30, 2024 |
|
|
|
| $ |
|
|
| $ |
| ||||
Options exercisable as of June 30, 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, 2022 |
|
|
|
| $ |
|
|
| $ | - |
| |||
Options granted |
|
|
|
| $ |
|
|
|
|
|
|
| ||
Options forfeited |
|
| ( | ) |
| $ |
|
|
|
|
|
|
| |
Options outstanding as of June 30, 2023 |
|
|
|
| $ |
|
|
| $ | - |
| |||
Options exercisable as of June 30, 2023 |
|
|
|
| $ |
|
| |
| $ |
|
The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of June 30, 2024 and the exercise price, multiplied by the number of options. As of June 30, 2024, 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. The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the six months ended June 30, 2023:
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
|
|
On March 3, 2023, Dr. Gene Cartwright retired from his position as President and Chief Executive Officer of the Company and as a member of the Board. Upon his departure, Mr. Cartwright forfeited
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
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 June 30, 2024, and December 31, 2023, there was no accrual recorded for any potential losses related to pending litigation.
24 |
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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. Total operating lease cost recognized for this lease was unchanged from the prior period and was $
|
| (in thousands) |
| |||||
|
| June 30, |
|
| December 31 |
| ||
|
| 2024 |
|
| 2023 |
| ||
Operating lease right-of-use assets |
| $ |
|
| $ |
| ||
Operating lease liabilities |
| $ |
|
| $ |
|
The table below presents the maturities of operating lease liabilities as of June 30, 2024:
|
| (in thousands) |
| |
|
| Operating |
| |
|
| Lease Payments |
| |
2024 (remaining) |
|
|
| |
2025 |
|
|
| |
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 June 30, 2024 and December 31, 2023
|
| (in thousands) |
| |||||
|
| June 30, 2024 |
|
| December 31, 2023 |
| ||
Weighted average remaining lease term (years) |
|
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
|
| % |
Related Party Contracts
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. Shenghuo was already the Company’s exclusive distributor in China, Macau and Hong Kong, and the license extended to manufacturing in those countries as well. 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
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On September 6, 2016, the Company entered into a royalty agreement with one of its directors, 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 $
On January 22, 2020, the Company entered into a promotional agreement with a related party, which is partially owned by Mr. Blumberg, to provide investor and public relations services for a period of two years. As compensation for these services, the Company agreed to issue a total of
During the six months ended June 30, 2023, the Company entered into an agreement with Mr. Blumberg to exchange
On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided $
Expected term (years) |
|
|
| |
Volatility |
|
| % | |
Risk-free interest rate |
|
| % | |
Dividend yield |
|
| % |
During the six months ended June 30, 2024 and 2023, the Company issued
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
26 |
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Pursuant to the agreement, the Company also agreed to pay the Advisory Group $
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 June 30, 2024.
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 |
|
| % |
The Company recognized expense for the second tranche of warrants of nil and $
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 expense for the third tranche of warrants of $
Other Commitments
On July 24, 2019, the Company agreed to grant Shandong Yaohua Medical Instrument Corporation (“SMI”) (1) exclusive manufacturing rights, excepting the disposable cervical guides for the Republic of Turkey, and the final assembly rights for Hungary, and (2) exclusive distribution and sales for LuViva in jurisdictions, subject to the terms and conditions described below.
27 |
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First, SMI shall complete the payment for parts, per the purchase order, for five additional LuViva devices. Second, in consideration for the $
On August 12, 2021, the Company executed an amendment to its agreement with SMI. Under the terms of the amended agreement, the parties agreed that if by October 30, 2022, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. On March 3, 2023, the Company entered into a third amendment with SMI pursuant to which the Company extended the deadline for SMI to achieve commercialization of LuViva in China to April 30, 2024.
On February 17, 2024, the Company entered into a fourth amendment to the agreement with SMI. Under the terms of the amended agreement, SMI agreed to pay the Company $
The amended agreement also provides for a timeline for the Company to deliver inventory during 2024, including LuViva devices and components, as well as approximately 1,640,000 RFID chips. In consideration, SMI agreed to pay a total of $
On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”).
On April 26, 2024, the parties extended the Standstill Agreement (“Standstill Extension”) until July 30, 2024,
The Company and SMI executed an extension to the Standstill Agreement (the “Second Standstill Extension”) subsequent to June 30, 2024. Please see Note 12, “Subsequent Events” for details.
Contingencies
The conflict in Ukraine, which has already had an impact on financial markets, could result in additional repercussions in our operating business, including delays in obtaining regulatory approval to market our products in Russia. The future impact of the conflict is highly uncertain and cannot be predicted, and we cannot provide any assurance that the conflict will not have a material adverse impact on our operations or future results or filings with regulatory health authorities.
28 |
Table of Contents |
7. NOTES PAYABLE
On June 28, 2024, the Company issued a promissory note totaling $
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 $
On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $
The following table summarizes short-term notes payable (in thousands):
|
| Short-term notes payable |
| |||||
|
| June 30, 2024 |
|
| December 31, 2023 |
| ||
Short-term promissory note |
| $ |
|
| $ |
| ||
Current portion of long-term promissory note |
|
|
|
|
|
| ||
Premium Finance (insurance) |
|
|
|
|
|
| ||
Debt Discount |
|
| ( | ) |
|
|
| |
Short-term notes payable |
| $ |
|
| $ |
|
8. CONVERTIBLE DEBT
10% Senior Unsecured Convertible Debenture
On May 17, 2021, the Company issued
29 |
Table of Contents |
At June 30, 2024 and December 31, 2023, the balance due on the 10% Senior Secured Convertible Debenture was $
|
| Senior Secured Convertible Debenture |
| |||||
|
| June 30, 2024 |
|
| December 31, 2023 |
| ||
10% Senior Unsecured Convertible Debentures |
| $ |
|
| $ |
| ||
Unamortized debt issuance costs |
|
|
|
|
| ( | ) | |
Debt Discount |
|
|
|
|
| ( | ) | |
Senior Unsecured Convertible Debenture |
| $ |
|
| $ |
|
As of June 30, 2024, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible notes payable in default” within the condensed consolidated balance sheets. As of December 31, 2023, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible notes payable” within the condensed consolidated balance sheets.
1800 Diagonal Lending Note
On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with 1800 Diagonal Lending LLC (“Diagonal Lending”). The convertible note issued to Diagonal Lending had a total principal balance of $
In an event of default, the unpaid portion of the note 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 this embedded conversion feature and determined that it is not considered clearly and closely related to the host note, and therefore meets the definition of a derivative. Therefore, this embedded conversion feature is required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the combined derivative liability as of June 11, 2024, which was recorded as a liability and as a discount net against the subordinated convertible notes. The Company is required to remeasure the combined derivative liability to its then fair value 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).
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Table of Contents |
At June 30, 2024, the balance due on the note was $
|
| June 30, 2024 |
|
| December 31, 2023 |
| ||
Short-term convertible promissory note |
| $ |
|
| $ |
| ||
Unamortized debt issuance costs |
|
| ( | ) |
|
|
| |
Debt Discount |
|
| ( | ) |
|
|
| |
Beneficial conversion feature |
|
| ( | ) |
|
|
| |
1800 Diagonal Lending Convertible Note |
| $ |
|
| $ |
|
Auctus Convertible Note
On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with Auctus Fund, LLC (“Auctus’). The convertible note issued to Auctus was for a total of $
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 $
9. RELATED PARTY DEBT
On July 14, 2018, the Company entered into an exchange agreement with Dr. Faupel, whereby Dr. Faupel agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $
31 |
Table of Contents |
On July 24, 2019, Dr. Faupel and Mr. Cartwright agreed to an addendum to the debt restructuring exchange agreement. Pursuant to this modification Dr. Faupel and Mr. Cartwright agreed to extend the note to be due in full on the third anniversary of that agreement.
On February 19, 2021, the Company entered into new promissory notes replacing the original notes from September 4, 2018, with Mark Faupel and Gene Cartwright. For Dr. Cartwright the principal amount on the new note was $
On February 18, 2023, the Company amended the terms of the promissory notes held by Mark Faupel and Gene Cartwright. Under the terms of the new agreements, the promissory notes will mature on February 18, 2025.
The tables below summarize the outstanding balance of long-term 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, 2023 |
|
|
| |
Balance outstanding at December 31, 2023 |
| $ |
| |
|
|
|
|
|
Interest accrued through June 30, 2024 |
|
|
| |
Balance outstanding at June 30, 2024 |
| $ |
|
32 |
Table of Contents |
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, 2023 |
|
|
| |
Payments on outstanding debt |
|
| ( | ) |
Balance outstanding at December 31, 2023 |
| $ |
| |
|
|
|
|
|
Interest accrued through June 30, 2024 |
|
|
| |
Balance outstanding at June 30, 2024 |
| $ |
|
On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler. As of December 31, 2020, the Company owed Mr. Fowler $
During the three and six months ended June 30, 2024, Mr. Fowler forgave $
Future debt obligations at June 30, 2024 for debt owed to related parties is as follows:
Year |
| Amount (in thousands) |
| |
2024 (remaining) |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
Total |
| $ |
|
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.
33 |
Table of Contents |
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 D, Series E, 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 six months ended June 30, 2024 and 2023, 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 June 30, 2024 and 2023, 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):
|
| June 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
Net loss |
|
| ( | ) |
|
| ( | ) |
Basic weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss per share (basic) |
|
| ( | ) |
|
| ( | ) |
Diluted weighted average number of shares outstanding |
|
|
|
|
|
| ||
Net loss per share (diluted) |
|
| ( | ) |
|
| ( | ) |
11. FAIR VALUE MEASUREMENTS
The convertible notes payable derivative liability is considered a Level 3 measurement, 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.
Based on the terms and provisions of the Diagonal Lending note payable, management built a pricing simulation that predicts the Company’s future stock prices using historical volatility. Our model is designed to utilize the Company’s best estimates of the timing and likelihood of a conversion of the note payable to calculate the variable conversion price as of the future conversion date.
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. |
34 |
Table of Contents |
The following tables present the fair value of the bifurcated conversion option:
|
| Fair Value at June 30, 2024 (in thousands) |
| |||||||||||||
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
|
| Total |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Derivative liability/bifurcated conversion option in connection with Diagonal Lending $100,050 promissory note |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term liabilities at fair value |
| $ |
|
| $ |
|
| $ |
|
| $ |
|
Derivative financial instruments and changes thereto recorded in the six months ended June 30, 2024 and 2023 include the following:
|
| Six Months Ended June 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
|
|
|
|
|
|
| ||
Balance, beginning of period |
| $ |
|
| $ | ( | ) | |
Inception of derivative liability |
|
|
|
|
|
|
| |
Change in fair value during the period |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Balance, end of period |
| $ |
|
| $ |
|
12. SUBSEQUENT EVENTS
Issuances of Promissory Notes and Related Warrants
On July 22, 2024, we issued a $
On July 23, 2024, we issued a $
Subsequent to June 30, 2024, we issued three $
Issuances of Common Stock
Subsequent to June 30, 2024,
Second Extension of Standstill Amendment with SMI
Subsequent to June 30, 2024, SMI payments due on July 31, 2024 remained unpaid. On July 31, 2024, the Company and SMI jointly agreed to extend the Standstill Agreement until August 16, 2024, upon which a longer-term agreement is expected to be executed.
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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, 2023 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; |
| · | 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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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 and, as of June 30, 2024, we have an accumulated deficit of approximately $152.1 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 our distributors, we currently hold and expect to generate additional purchase orders for approximately $4.2 million in LuViva devices and disposables and expect those purchase orders to result in actual sales of $1.5 to $2.5 million within the next twelve months, representing what we view as current demand for our products. 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. 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 the United States, the Company is actively pursuing FDA approval by initiating a clinical trial protocol 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 protocol was drafted with input from FDA and at least two prestigious 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 are fully IRB approved. All four sites have received LuViva devices and have been trained on their use. One site unexpectedly needed additional approvals from the local hospital that is contributing subjects to the study, but that approval was granted on March 28, 2024. All of the four sites have undergone one or more clinical study monitoring visits by Company 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. Findings from the initial clinical study monitoring visits include:
| 1) | Approximately 200 patients have been enrolled and tested, which represents approximately half of the patients needed to complete the study. |
| 2) | There have not been any adverse events reported related to the use of LuViva. |
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| 3) | All three monitored clinical study sites are adhering to the study protocol and are completing the necessary case report forms according to FDA standards. |
Based on current and expected enrollment rates, we expect the study to be completed in 2024, however there can be no assurance that the study will progress within the expected timeline.
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, has reported to us that as of June 30, 2024, all study subjects needed for Chinese National Medical Products Administration (NMPA) approval have been enrolled and tested. There have been no reports of any adverse events from the study associated with the LuViva device. Filing with the NMPA was temporarily delayed during the second quarter of 2024 due to an unexpected medical leave taken by a clinical medical administrator at one of the clinical sites. SMI believes that they can file the clinical report with NMPA during 2024 and that approval could occur in 2024, although there can be no assurance that NMPA filing and approval will be completed within the projected time frames.
In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), reported that sales efforts have restarted after delays caused by Covid-19. They are now actively pursuing potential customers in Poland, Hungary and Romania, where we have obtained the required approvals to sell our products though Newmars.
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. When we begin to generate 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 will now be recognized by a vendor when control over the goods or services is transferred to the customer. In contrast, Revenue based revenue recognition around an analysis of the transfer of risks and rewards; this now forms one of a number of criteria that are assessed in determining whether control has been transferred. 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.
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 valuation model.
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 credit loss allowance was immaterial as of June 30, 2024 and December 31, 2023.
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 purchased.
RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED JUNE 30, 2024 AND 2023
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the three months ended June 30, 2024, were nil, compared to $44,238 for the three months ended June 30, 2023. Cost of goods sold was nil during the three months ended June 30, 2024, compared to $33,038 during the three months ended June 30, 2023. As of June 30, 2024, we have a deferred revenue balance of $747,780, which will be recognized as revenue when our products are shipped, which is expected to occur late in 2024 upon receiving NMPA approval.
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Research and Development Expenses: Research and development expenses were $221,565 and $66,164 during the three months ended June 30, 2024 and 2023, respectively. The increase of $155,401 or 234.9%, was primarily due to additional $153,764 of costs for sponsored research related to our clinical trials during the three months ended June 30, 2024.
Sales and Marketing Expenses: Sales and marketing expenses were $69,231 and $60,930 during the three months ended June 30, 2024 and 2023, respectively. The increase of $8,300, or 13.6%, was primarily due to $5,008 of additional rent expense allocated to our sales & marketing department and $2,663 of additional travel expenses for sales trips.
General and Administrative Expense: General and administrative expenses were $363,989 and $1,389,034 during the three months ended June 30, 2024 and 2023, respectively. The decrease of $1,025,045, or 73.8%, was primarily driven by a decrease of $697,338 in payroll and benefits (including payroll taxes), which was primarily due to a one-time charge of $679,959 recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the prior year period. Additionally, the Company recognized $59,216 of additional stock-based compensation expense during the prior year period due to the modification of a stock option award and $30,745 of additional expense for stock options for which the related expense was fully recognized as of the end of the prior period. The decrease in general and administrative expenses was also due to a decline of $326,502 of expense for consulting and legal fees, which was primarily driven by $336,745 less expense recognized for shares of common stock and warrants issued to Mr. Blumberg and $29,706 less expense for warrants issued to Mr. Grujic. These decreases were offset by an increase of $39,949 in fees paid to consultants and other third-party professional services providers.
Interest Expense: Interest expense was $75,372 and $68,711 during the three months ended June 30, 2024 and 2023, respectively. The increase of $6,661, or 9.7%, was primarily due to an $8,127 increase in interest due on a local tax liability and $2,019 of additional interest incurred for the promissory note issued to Diagonal Lending during the three months ended June 30, 2024. These increases were offset by decreases in interest expense due to declining balances in other notes payable outstanding.
Change in fair value of derivative liability: The change in the fair value of our derivative liability resulted in a loss of $7,350 during the three months ended June 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price.
Gain from Extinguishment of Debt: The gain from extinguishment of debt of $16,401 and $17,450 during the three months ended June 30, 2024 and 2023, respectively, was materially consistent period over period and was due to forgiveness of debt from our creditors.
Other Income: Other income was $11,515 and $248 during the three months ended June 30, 2024 and 2023, respectively. The change in other income was primarily due to an adjustment of a liability during the three months ended June 30, 2024.
Preferred Stock Dividends: Expense related to preferred stock dividends of $48,929 and $47,497 for the three months ended June 30, 2024 and 2023, respectively, was materially consistent over the two periods.
Net Loss: Net loss attributable to common stockholders was $758,180 and $1,603,219 during the three months ended June 30, 2024 and 2023, respectively. The reasons for the decrease in our net loss are outlined above.
There was no income tax benefit recorded for the three months ended June 30, 2024 or 2023, due to recurring net operating losses.
RESULTS OF OPERATIONS
COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the six months ended June 30, 2024, were $5,720, compared to $66,287 for the six months ended June 30, 2023. Cost of goods sold was $1,875 during the six months ended June 30, 2024, compared to $41,827 during the six months ended June 30, 2023. As of June 30, 2024, we have a deferred revenue balance of $747,780, which will be recognized as revenue when our products are shipped, which is expected to occur late in 2024 upon receiving NMPA approval.
Research and Development Expenses: Research and development expenses were $275,119 and $73,310 during the six months ended June 30, 2024 and 2023, respectively. The increase of $201,809 or 275.3%, was primarily due to an increase in costs for clinical trials, including a $186,074 increase in sponsored research costs and $9,593 additional travel expenses for trials during the in the six months ended June 30, 2024.
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Sales and Marketing Expenses: Sales and marketing expenses were $141,803 and $133,975 during the six months ended June 30, 2024 and 2023, respectively. The increase of $7,827, or 5.8% was primarily due to an increase of $7,324 in rent expense allocated to our sales & marketing department.
General and Administrative Expense: General and administrative expenses were $600,216 and $2,165,467 during the six months ended June 30, 2024 and 2023, respectively. The decrease of $1,565,251, or 72.3%, was primarily driven by a decrease of $771,892 in payroll and benefits (including payroll taxes), which was primarily due to a one-time charge of $679,959 recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the prior year period. Additionally, the Company recognized $59,216 of additional stock-based compensation expense during the prior year period due to the modification of a stock option award. The decrease in general and administrative expenses was also due to a decline of $800,040 of expense for consulting and legal fees, which was primarily driven by (1) $696,784 less expense recognized for shares of common stock and warrants issued to Mr. Blumberg, (2) $59,412 less expense for warrants issued to Mr. Grujic and (3) a decline of $43,879 in fees paid to consultants and other third party professional service providers. These decreases were offset by an overall increase of $6,682 in other general and miscellaneous expenses.
Interest Expense: Interest expense was $139,490 and $134,391 during the six months ended June 30, 2024 and 2023, respectively. The increase of $5,099, or 3.8%, was primarily due to a $9,345 increase in interest due on a local tax liability and $2,019 of additional interest incurred for the promissory note issued to Diagonal Lending during the three months ended June 20, 2024. These increases were offset by decreases in interest expense due to declining balances in other notes payable outstanding.
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a loss of $7,350 during the six months ended June 30, 2024. The change in the fair value was attributed to changes in our forecasted stock price. The gain due to the change in fair value of the derivative liability during the six months ended June 30, 2023 was $5,038 and was attributed to changes in our stock price.
Gain from Extinguishment of Debt: The gain from extinguishment of debt was $33,060 and $52,223 during the six months ended June 30, 2024 and 2023, respectively. The decrease of $19,163, or 36.7% was due to a lower amount of debt forgiven in the current period, as the balances owed to our creditors have declined.
Other Income: Other income was $12,372 and $248 during the six months ended June 30, 2024 and 2023, respectively. The change in other income was primarily due to an adjustment of a liability during the six months ended June 30, 2024.
Deemed Dividend for Warrant Exchanges: Expense for deemed dividends was nil and $65,296 in the six months ended June 30, 2024 and 2023, respectively. The expense in the prior period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.
Preferred Stock Dividends: Expense related to preferred stock dividends was $87,836 and $82,255 for the six months ended June 30, 2024 and 2023, respectively. The increase of $5,581, or 6.8%, was due to changes in the value of the common shares used to settle preferred stock dividends in each period.
Net Loss: Net loss attributable to common stockholders was $1,199,452 and $2,572,726 during the six months ended June 30, 2024 and 2023, respectively. The reasons for the decrease in our net loss are outlined above.
There was no income tax benefit recorded for the three months ended June 30, 2024 or 2023, due to recurring net operating losses.
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LIQUIDITY AND CAPITAL RESOURCES
Going Concern Considerations
We have incurred significant losses since our inception. At June 30, 2024, the Company had negative working capital of approximately $4.7 million, accumulated deficit of $152.3 million, and incurred a net loss including preferred dividends of $1.2 million for the six months then ended. Stockholders’ deficit totaled approximately $4.7 million at June 30, 2024, 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
The Company’s primary liquidity requirements are for working capital, funding clinical studies, and other costs associated with achieving regulatory approval to sell our products. Although income taxes are not currently a significant use of funds, after the benefits of our net operating loss carryforwards are fully recognized, they could become a material use of funds, depending on our future profitability and future tax rates. We anticipate we will require approximately $1.8 million to $2.2 million of funds to operate our business over the next twelve months, including approximately $0.4 million of funds to complete our ongoing clinical studies.
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 June 30, 2024, we had cash of approximately $275 thousand and negative working capital of $4.7 million.
Our major cash flows for the six months ended June 30, 2024 consisted of cash used for operating activities of $314 thousand, proceeds from the issuance of notes payable of $200 thousand and payments of debt and debt issuance costs of $202 thousand.
On July 22, 2024, we issued a $62,100 convertible promissory note to Diagonal Lending. The convertible promissory note, which had an original issue discount of $8,100, will mature on May 30, 2025 and will accrue total interest of $8,694. A payment of $35,397 will be due on January 30, 2025. The remaining balance, including the accrued interest, will be paid in monthly installments of $8,849 beginning February 28, 2024 and ending on the maturity date. The remaining terms of the convertible promissory note are identical to the June 11, 2024 convertible promissory note disclosed within Note 8, “Convertible Debt.”
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On July 23, 2024, we issued a $50,000 promissory note to an unaffiliated third party (the “Holder”). The promissory note, which will incur total interest of $5,000, will mature on February 1, 2025. Monthly payments of $10,000 are due beginning September 1, 2024 and ending January 1, 2025. The $5,000 interest payment is due on February 1, 2025. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. In connection with the promissory note, we issued 60,000 common stock warrants with a strike price of $025. The warrants will expire on July 31, 2028.
Our major cash flows for the six months ended June 30, 2023 consisted of cash used by operating activities of $937 thousand, payments of debt of $213 thousand and proceeds from warrant exercises of $195 thousand.
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.
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 June 30, 2024, 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 June 30, 2024 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
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 28, 2024.
ITEM 2. UNREGISTERRED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
During the six months ended June 30 2024, the Company issued 400,000 shares of common stock and 900,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. The warrants, which will expire on March 1, 2027, have a strike price of $0.30.
On June 11, 2024, 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 $100,050 and an original issue discount of $13,050. The note, which will accrue total interest of $14,007, will mature on April 15, 2025. A payment of $57,029 is due on the note on December 15, 2024. The remaining balance due, including accrued interest, will be paid in monthly payments of $14,257 from January 15, 2025 through April 15, 2025.
On June 28, 2024, in connection with the issuance of a promissory note, the Company issued the holder 100,000 common stock purchase warrants, which will have an exercise price of $0.25 and will expire on July 1, 2028. The warrants, which had an estimated fair value of $11,998, were recorded as a discount on the note payable.
ITEM 3: DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4: MINE SAFETY DISCLOSURES.
Not applicable
ITEM 5: OTHER INFORMATION.
Issuances of Promissory Notes and Related Warrants
On July 22, 2024, we issued a $62,100 convertible promissory note to Diagonal Lending. The convertible promissory note, which had an original issue discount of $8,100, will mature on May 30, 2025 and will accrue total interest of $8,694. A payment of $35,397 will be due on January 30, 2025. The remaining balance, including the accrued interest, will be paid in monthly installments of $8,849 beginning February 28, 2024 and ending on the maturity date. The remaining terms of the convertible promissory note are identical to the June 11, 2024 convertible promissory note disclosed within Note 8, “Convertible Debt,” with the exception that payments on the note may be accelerated or prepaid in full at any time with no prepayment penalty.
On July 23, 2024, we issued a $50,000 promissory note to an unaffiliated third party (the “Holder”). The promissory note, which will incur total interest of $5,000, will mature on February 1, 2025. Monthly payments of $10,000 are due beginning September 1, 2024 and ending January 1, 2025. The $5,000 interest payment is due on February 1, 2025. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. In connection with the promissory note, we issued 60,000 common stock warrants with a strike price of $025. The warrants will expire on July 31, 2028.
Subsequent to June 30, 2024, we issued three $25,000 promissory notes to our directors. The promissory notes mature in one year and accrue interest at an annual rate of 9.0%. In connection with the promissory notes, we issued 75,000 common stock warrants to our directors. The warrants, which have a strike price of $0.25, will expire four years after the issuance date.
Issuances of Common Stock
Subsequent to June 30, 2024, we issued 70,558 common shares for payment of Series D Preferred dividends and 213,151 common shares for payment of accrued interest expense.
Second Extension of Standstill Amendment with SMI
Subsequent to June 30, 2024, SMI payments due on July 31, 2024 remained unpaid. On July 31, 2024, the Company and SMI jointly agreed to extend the Standstill Agreement until August 16, 2024, upon which a longer-term agreement is expected to be executed.
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ITEM 6. EXHIBITS
Exhibit Number |
| Exhibit Description |
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| $100,000 Promissory Note Dated June 28, 2024 and Related Common Stock Purchase Warrant | |
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| $100,050 Promissory Note Dated June 11, 2024 with 1800 Diagonal Lending | |
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| Form of Promissory Notes Issued to Directors and Form of Related Common Stock Purchase Warrants | |
| Securities Purchase Agreement with 1800 Diagonal Lending, dated July 22, 2024 | |
| $62,100 Promissory Note Dated July 22, 2024 with 1800 Diagonal Lending | |
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101.1* |
| Interactive data files for Guided Therapeutics, Inc. 's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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 June 30, 2024 (formatted in Inline XBRL and included in Exhibit 101) |
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*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. | |||
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| By: | /s/ Mark Faupel | |
| Mark Faupel | ||
| President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer |
Date: August 14, 2024
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