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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT 1934
For the quarterly period ended September 30, 2024
Commission File No. 000-22179
GUIDED THERAPEUTICS, INC. |
(Exact Name of Registrant as Specified in Its Charter) |
Delaware | | 58-2029543 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
5835 Peachtree Corners East, Suite B Peachtree Corners, Georgia 30092 (Address of principal executive offices) (Zip Code) |
(770) 242-8723
(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: Yes ☒ No ☐
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). Yes ☒ No ☐
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 | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | 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 ☐ No ☒
As of November 11, 2024, the registrant had 61,015,237 shares of Common Stock, $0.001 par value per share, outstanding.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY | |
CONDENSED CONSOLIDATED BALANCE SHEETS | |
(unaudited, in thousands) | |
| | | | | | |
| | September 30, | | | December 31, | |
| | 2024 | | | 2023 | |
ASSETS | |
| | | | | | |
Current Assets: | | | | | | |
Cash and cash equivalents | | $ | 194 | | | $ | 591 | |
Trade receivables, net of allowance for doubtful accounts of nil and $2 at September 30, 2024 and December 31, 2023, respectively. | | | 2 | | | | 7 | |
Inventory, net of reserves of $818 at September 30, 2024 and December 31, 2023 | | | 636 | | | | 632 | |
Other current assets | | | 211 | | | | 163 | |
Total current assets | | | 1,043 | | | | 1,393 | |
| | | | | | | | |
Non-Current Assets: | | | | | | | | |
Property and equipment, net | | | 25 | | | | 32 | |
Operating lease right-of-use assets, net of amortization | | | 164 | | | | 227 | |
Other assets | | | 17 | | | | 17 | |
Total non-current assets | | | 206 | | | | 276 | |
| | | | | | | | |
TOTAL ASSETS | | $ | 1,249 | | | $ | 1,669 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
| | | | | | | | |
Current Liabilities: | | | | | | | | |
Accounts payable | | $ | 2,100 | | | $ | 1,991 | |
Accounts payable, related parties | | | 32 | | | | 32 | |
Accrued liabilities | | | 923 | | | | 1,068 | |
Deferred revenue | | | 748 | | | | 424 | |
Current portion of lease liability | | | 102 | | | | 91 | |
Short-term notes payable due to related parties | | | 68 | | | | - | |
Current portion of long-term debt, related parties | | | 525 | | | | 39 | |
Short-term notes payable | | | 228 | | | | 59 | |
Short-term convertible debt | | | 149 | | | | 1,105 | |
Short-term convertible debt in default | | | 1,130 | | | | - | |
Derivative liability at fair value | | | 20 | | | | - | |
Total current liabilities | | | 6,025 | | | | 4,809 | |
| | | | | | | | |
Long-Term Liabilities, Net of Current Portion | | | | | | | | |
Long-term lease liability | | | 76 | | | | 155 | |
Long-term notes payable | | | 53 | | | | - | |
Long-term debt, related parties | | | 13 | | | | 511 | |
Total long-term liabilities | | | 142 | | | | 666 | |
| | | | | | | | |
Total liabilities | | | 6,167 | | | | 5,475 | |
| | | | | | | | |
COMMITMENTS AND CONTINGENCIES (Note 6) | | | | | | | | |
STOCKHOLDERS’ DEFICIT: | | | | | | |
| | | | | | |
Series C convertible preferred stock, $0.001 par value; 9.0 shares authorized, 0.3 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $286 at September 30, 2024 and December 31, 2023. | | | 105 | | | | 105 | |
Series C1 convertible preferred stock, $0.001 par value; 20.3 shares authorized, 1.0 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $1,049 at September 30, 2024 and December 31, 2023. | | | 170 | | | | 170 | |
Series C2 convertible preferred stock, $0.001 par value; 5,000 shares authorized, 2.7 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $2,700 at September 30, 2024 and December 31, 2023. | | | 439 | | | | 439 | |
Series D convertible preferred stock, $0.001 par value; 6.0 shares authorized, 0.4 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $438 at September 30, 2024 and December 31, 2023. | | | 159 | | | | 159 | |
Series E convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.9 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $883 at September 30, 2024 and December 31, 2023. | | | 834 | | | | 834 | |
Series F convertible preferred stock, $0.001 par value; 1.5 shares authorized, 1.1 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $1,006 at September 30, 2024 and December 31, 2023. | | | 838 | | | | 838 | |
Series F-2 convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.5 shares issued and outstanding as of September 30, 2024 and December 31, 2023. Liquidation preference of $520 at September 30, 2024 and December 31, 2023. | | | 475 | | | | 475 | |
Common stock, $0.001 par value; 500,000 shares authorized, 60,457 and 54,105 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. | | | 3,446 | | | | 3,441 | |
Additional paid-in capital | | | 141,757 | | | | 140,983 | |
Treasury stock at cost | | | (132 | ) | | | (132 | ) |
Accumulated deficit | | | (153,009 | ) | | | (151,118 | ) |
| | | | | | | | |
Total stockholders’ deficit | | | (4,918 | ) | | | (3,806 | ) |
| | | | | | | | |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | | $ | 1,249 | | | $ | 1,669 | |
The accompanying notes are an integral part of these condensed consolidated statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(unaudited, in thousands, except per share data) |
| | | | | | | | | | | | |
| | Three Months Ended | | | Nine Months Ended | |
| | September 30, | | | September 30, | |
| | 2024 | | | 2023 | | | 2024 | | | 2023 | |
| | | | | | | | | | | | |
Sales - devices and disposables | | $ | - | | | $ | - | | | $ | 6 | | | | 66 | |
Cost of goods sold | | | - | | | | 4 | | | | 2 | | | | 46 | |
Gross profit | | | - | | | | (4 | ) | | | 4 | | | | 20 | |
| | | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 111 | | | | 69 | | | | 386 | | | | 142 | |
Sales and marketing | | | 76 | | | | 69 | | | | 218 | | | | 203 | |
General and administrative | | | 374 | | | | 481 | | | | 974 | | | | 2,647 | |
Total operating expenses | | | 561 | | | | 619 | | | | 1,578 | | | | 2,992 | |
| | | | | | | | | | | | | | | | |
Loss from operations | | | (561 | ) | | | (623 | ) | | | (1,574 | ) | | | (2,972 | ) |
| | | | | | | | | | | | | | | | |
Other income (expenses): | | | | | | | | | | | | | | | | |
Interest expense | | | (108 | ) | | | (71 | ) | | | (247 | ) | | | (206 | ) |
Interest income | | | - | | | | - | | | | 3 | | | | - | |
Change in fair value of derivative liability | | | (1 | ) | | | - | | | | (8 | ) | | | 5 | |
Gain from extinguishment of debt | | | 16 | | | | 17 | | | | 49 | | | | 69 | |
Other income | | | - | | | | - | | | | 12 | | | | 1 | |
Total other income (expense) | | | (93 | ) | | | (54 | ) | | | (191 | ) | | | (131 | ) |
| | | | | | | | | | | | | | | | |
Loss before income taxes | | | (654 | ) | | | (677 | ) | | | (1,765 | ) | | | (3,103 | ) |
Provision for income taxes | | | - | | | | - | | | | - | | | | - | |
| | | | | | | | | | | | | | | | |
Net loss | | | (654 | ) | | | (677 | ) | | | (1,765 | ) | | | (3,103 | ) |
Deemed dividend for warrant exchanges | | | - | | | | - | | | | - | | | | (65 | ) |
Preferred stock dividends | | | (38 | ) | | | (40 | ) | | | (126 | ) | | | (122 | ) |
| | | | | | | | | | | | | | | | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | | $ | (692 | ) | | $ | (717 | ) | | $ | (1,891 | ) | | $ | (3,290 | ) |
| | | | | | | | | | | | | | | | |
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS | | | | | | | | | | | | | | | | |
Basic | | $ | (0.01 | ) | | $ | (0.01 | ) | | $ | (0.03 | ) | | $ | (0.07 | ) |
Diluted | | $ | (0.01 | ) | | $ | (0.01 | ) | | $ | (0.03 | ) | | $ | (0.07 | ) |
| | | | | | | | | | | | | | | | |
Weighted average shares outstanding | | | | | | | | | | | | | | | | |
Basic | | | 57,039 | | | | 51,473 | | | | 55,929 | | | | 50,588 | |
Diluted | | | 57,039 | | | | 51,473 | | | | 55,929 | | | | 50,588 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT |
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 |
(unaudited, in thousands) |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series C | | | Series C1 | | | Series C2 | | | Series D | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at June 30, 2024 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
Issuance of common stock and warrants in private placement offering, net of expenses | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of warrants with debt | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2024 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series E | | | Series F | | | Series F2 | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at June 30, 2024 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | - | | | $ | 475 | |
Issuance of common stock and warrants in private placement offering, net of expenses | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of warrants with debt | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2024 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | - | | | $ | 475 | |
| | | | | Additional | | | | | | | | | | |
| | Common Stock | | | Paid-In | | | Treasury | | | Accumulated | | | | |
| | Shares | | | Amount | | | Capital | | | Stock | | | Deficit | | | Total | |
Balance at June 30, 2024 | | | 56,267 | | | $ | 3,442 | | | $ | 141,320 | | | $ | (132 | ) | | $ | (152,317 | ) | | $ | (4,667 | ) |
Issuance of common stock and warrants in private placement offering, net of expenses | | | 3,333 | | | | 3 | | | | 297 | | | | - | | | | - | | | | 300 | |
Issuance of common stock for payment of Series D preferred dividends | | | 71 | | | | - | | | | 9 | | | | - | | | | - | | | | 9 | |
Issuance of common stock for payment of Series E preferred dividends | | | 573 | | | | 1 | | | | 54 | | | | - | | | | - | | | | 55 | |
Issuance of common stock for payment of interest | | | 213 | | | | - | | | | 21 | | | | - | | | | - | | | | 21 | |
Issuance of warrants with debt | | | - | | | | - | | | | 15 | | | | - | | | | - | | | | 15 | |
Stock-based compensation | | | - | | | | - | | | | 41 | | | | - | | | | - | | | | 41 | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | (38 | ) | | | (38 | ) |
Net loss | | | - | | | | - | | | | - | | | | - | | | | (654 | ) | | | (654 | ) |
Balance at September 30, 2024 | | | 60,457 | | | $ | 3,446 | | | $ | 141,757 | | | $ | (132 | ) | | $ | (153,009 | ) | | $ | (4,918 | ) |
The accompanying notes are an integral part of these condensed consolidated statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT |
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 |
(unaudited, in thousands) |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series C | | | Series C1 | | | Series C2 | | | Series D | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at December 31, 2023 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
Issuance of common stock and warrants in private placement offering, net of expenses | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series F preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series F-2 preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of warrants with debt | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2024 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series E | | | Series F | | | Series F2 | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at December 31, 2023 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | - | | | $ | 475 | |
Issuance of common stock and warrants in private placement offering, net of expenses | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series F preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series F-2 preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of warrants with debt | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2024 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | - | | | $ | 475 | |
| | | | | Additional | | | | | | | | | | |
| | Common Stock | | | Paid-In | | | Treasury | | | Accumulated | | | | |
| | Shares | | | Amount | | | Capital | | | Stock | | | Deficit | | | Total | |
Balance at December 31, 2023 | | | 54,105 | | | $ | 3,441 | | | $ | 140,983 | | | $ | (132 | ) | | $ | (151,118 | ) | | $ | (3,806 | ) |
Issuance of common stock and warrants in private placement offering, net of expenses | | | 3,333 | | | | 3 | | | | 297 | | | | - | | | | - | | | | 300 | |
Issuance of common stock for payment of Series D preferred dividends | | | 196 | | | | - | | | | 24 | | | | - | | | | - | | | | 24 | |
Issuance of common stock for payment of Series E preferred dividends | | | 625 | | | | 1 | | | | 62 | | | | - | | | | - | | | | 63 | |
Issuance of common stock for payment of Series F preferred dividends | | | 445 | | | | - | | | | 54 | | | | - | | | | - | | | | 54 | |
Issuance of common stock for payment of Series F-2 preferred dividends | | | 236 | | | | - | | | | 27 | | | | - | | | | - | | | | 27 | |
Issuance of common stock for payment of interest | | | 1,117 | | | | 1 | | | | 125 | | | | - | | | | - | | | | 126 | |
Settlement of previously accrued professional fees through common stock issuance | | | 400 | | | | - | | | | 57 | | | | - | | | | - | | | | 57 | |
Issuance of warrants with debt | | | - | | | | - | | | | 27 | | | | - | | | | - | | | | 27 | |
Stock-based compensation | | | - | | | | - | | | | 101 | | | | - | | | | - | | | | 101 | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | (126 | ) | | | (126 | ) |
Net loss | | | - | | | | - | | | | - | | | | - | | | | (1,765 | ) | | | (1,765 | ) |
Balance at September 30, 2024 | | | 60,457 | | | $ | 3,446 | | | $ | 141,757 | | | $ | (132 | ) | | $ | (153,009 | ) | | $ | (4,918 | ) |
The accompanying notes are an integral part of these condensed consolidated statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT |
FOR THE THREE MONTHS ENDED SEPTEMBER 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 June 30, 2023 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2023 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series E | | | Series F | | | Series F2 | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at June 30, 2023 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | 3 | | | $ | 475 | |
Issuance of common stock for payment of Series D preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of Series E preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2023 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | 3 | | | $ | 475 | |
| | | | | Additional | | | | | | | | | | |
| | Common Stock | | | Paid-In | | | Treasury | | | Accumulated | | | | |
| | Shares | | | Amount | | | Capital | | | Stock | | | Deficit | | | Total | |
Balance at June 30, 2023 | | | 51,011 | | | $ | 3,438 | | | $ | 140,291 | | | $ | (132 | ) | | $ | (149,932 | ) | | $ | (3,315 | ) |
Issuance of common stock for payment of Series D preferred dividends | | | 38 | | | | - | | | | 8 | | | | - | | | | - | | | | 8 | |
Issuance of common stock for payment of Series E preferred dividends | | | 353 | | | | - | | | | 53 | | | | - | | | | - | | | | 53 | |
Issuance of common stock for payment of interest | | | 240 | | | | - | | | | 60 | | | | - | | | | - | | | | 60 | |
Settlement of previously accrued professional fees through common stock issuance | | | 400 | | | | 1 | | | | 50 | | | | - | | | | - | | | | 51 | |
Stock-based compensation | | | - | | | | - | | | | 210 | | | | - | | | | - | | | | 210 | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | (40 | ) | | | (40 | ) |
Net loss | | | - | | | | - | | | | - | | | | - | | | | (677 | ) | | | (677 | ) |
Balance at September 30, 2023 | | | 52,042 | | | $ | 3,439 | | | $ | 140,672 | | | $ | (132 | ) | | $ | (150,649 | ) | | $ | (3,650 | ) |
The accompanying notes are an integral part of these condensed consolidated statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT |
FOR THE NINE MONTHS ENDED SEPTEMBER 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 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
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 | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Impact of warrant exchanges | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2023 | | | - | | | $ | 105 | | | | 1 | | | $ | 170 | | | | 2 | | | $ | 439 | | | | 1 | | | $ | 159 | |
| | Preferred Stock | | | Preferred Stock | | | Preferred Stock | |
| | Series E | | | Series F | | | Series F2 | |
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | |
Balance at December 31, 2022 | | | 1 | | | $ | 839 | | | | 1 | | | $ | 880 | | | | 3 | | | $ | 489 | |
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 | | | - | | | | (5 | ) | | | - | | | | - | | | | - | | | | - | |
Conversion of Series F preferred stock to common stock | | | - | | | | - | | | | - | | | | (42 | ) | | | - | | | | - | |
Conversion of Series F-2 preferred stock to common stock | | | - | | | | - | | | | - | | | | - | | | | - | | | | (14 | ) |
Issuance of common stock for payment of interest | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Settlement of previously accrued professional fees through common stock issuance | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Stock-based compensation | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Impact of warrant exchanges | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Net loss | | | - | | | | - | | | | - | | | | - | | | | - | | | | - | |
Balance at September 30, 2023 | | | 1 | | | $ | 834 | | | | 1 | | | $ | 838 | | | | 3 | | | $ | 475 | |
| | | | | Additional | | | | | | | | | | |
| | Common Stock | | | Paid-In | | | Treasury | | | Accumulated | | | | |
| | Shares | | | Amount | | | Capital | | | Stock | | | Deficit | | | Total | |
Balance at December 31, 2022 | | | 48,596 | | | $ | 3,437 | | | $ | 138,090 | | | $ | (132 | ) | | $ | (147,359 | ) | | $ | (2,883 | ) |
Common stock warrants exercised | | | 1,120 | | | | 1 | | | | 230 | | | | - | | | | - | | | | 231 | |
Issuance of common stock for payment of Series D preferred dividends | | | 97 | | | | - | | | | 22 | | | | - | | | | - | | | | 22 | |
Issuance of common stock for payment of Series E preferred dividends | | | 379 | | | | - | | | | 61 | | | | - | | | | - | | | | 61 | |
Issuance of common stock for payment of Series F preferred dividends | | | 233 | | | | - | | | | 53 | | | | - | | | | - | | | | 53 | |
Issuance of common stock for payment of Series F-2 preferred dividends | | | 121 | | | | - | | | | 29 | | | | - | | | | - | | | | 29 | |
Conversion of Series E preferred stock to common stock | | | 20 | | | | - | | | | 5 | | | | - | | | | - | | | | - | |
Conversion of Series F preferred stock to common stock | | | 200 | | | | - | | | | 42 | | | | - | | | | - | | | | - | |
Conversion of Series F-2 preferred stock to common stock | | | 60 | | | | - | | | | 14 | | | | - | | | | - | | | | - | |
Issuance of common stock for payment of interest | | | 418 | | | | - | | | | 119 | | | | - | | | | - | | | | 119 | |
Settlement of previously accrued professional fees through common stock issuance | | | 800 | | | | 1 | | | | 167 | | | | - | | | | - | | | | 168 | |
Stock-based compensation | | | - | | | | - | | | | 1,776 | | | | - | | | | - | | | | 1,776 | |
Impact of warrant exchanges | | | - | | | | - | | | | 65 | | | | - | | | | (65 | ) | | | - | |
Accrued preferred dividends | | | - | | | | - | | | | (1 | ) | | | - | | | | (122 | ) | | | (123 | ) |
Net loss | | | - | | | | - | | | | - | | | | - | | | | (3,103 | ) | | | (3,103 | ) |
Balance at September 30, 2023 | | | 52,042 | | | $ | 3,439 | | | $ | 140,672 | | | $ | (132 | ) | | $ | (150,649 | ) | | $ | (3,650 | ) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
(unaudited, in thousands) |
| | | | | | |
| | Nine Months Ended | |
| | September 30, | |
| | 2024 | | | 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | | | | | | |
Net loss | | $ | (1,765 | ) | | $ | (3,103 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | |
Bad debt expense | | | 1 | | | | 2 | |
Depreciation | | | 7 | | | | 7 | |
Amortization of debt issuance costs and discounts | | | 72 | | | | 97 | |
Stock-based compensation | | | 133 | | | | 1,860 | |
Change in fair value of derivative liability | | | 8 | | | | (5 | ) |
Amortization of lease right-of-use-asset | | | 64 | | | | 56 | |
Gain from forgiveness of debt | | | (49 | ) | | | (69 | ) |
Other non-cash expenses | | | 14 | | | | 20 | |
Change in operating assets and liabilities: | | | | | | | | |
Accounts receivable | | | 4 | | | | (3 | ) |
Inventory | | | (4 | ) | | | (99 | ) |
Other current assets | | | 82 | | | | 74 | |
Accounts payable and accrued liabilities | | | 389 | | | | (130 | ) |
Lease liabilities | | | (67 | ) | | | (58 | ) |
Deferred revenue | | | 324 | | | | (59 | ) |
NET CASH USED IN OPERATING ACTIVITIES | | | (787 | ) | | | (1,410 | ) |
| | | | | | | | |
CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | | | | |
Proceeds from the issuance of notes payable | | | 312 | | | | - | |
Proceeds from the issuance of notes payable issued to related parties | | | 75 | | | | - | |
Payments made on notes payable | | | (239 | ) | | | (367 | ) |
Payments made on notes payable issued to related parties | | | (29 | ) | | | - | |
Payments of debt issuance costs | | | (29 | ) | | | - | |
Proceeds from issuance of common stock, net of costs | | | 300 | | | | - | |
Proceeds from warrant exercises | | | - | | | | 195 | |
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES | | | 390 | | | | (172 | ) |
| | | | | | | | |
NET CHANGE IN CASH | | | (397 | ) | | | (1,582 | ) |
| | | | | | | | |
Cash at beginning of period | | | 591 | | | | 2,313 | |
| | | | | | | | |
CASH AT END OF PERIOD | | $ | 194 | | | $ | 731 | |
| | | | | | | | |
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES: | | | | | | | | |
Cash paid for interest | | $ | 25 | | | $ | 97 | |
| | | | | | | | |
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES: | | | | | | | | |
| | | | | | | | |
Dividends on preferred stock | | $ | 126 | | | $ | 122 | |
Deemed dividends for warrant exchanges | | $ | - | | | $ | 65 | |
Warrants issued with debt | | $ | 27 | | | $ | - | |
Fair value of beneficial conversion features | | $ | 12 | | | $ | - | |
Settlement of interest through common stock issuance | | $ | 126 | | | $ | 119 | |
Settlement of dividends through common stock issuance | | $ | 168 | | | $ | 166 | |
Settlement of previously accrued professional fees through common stock issuance | | $ | 57 | | | $ | 167 | |
Accrued payroll liability exchanged for promissory note | | $ | 87 | | | $ | - | |
Directors and Officers Insurance obtained with Financing | | $ | 130 | | | $ | 119 | |
Conversion of Series E preferred shares into common stock | | $ | - | | | $ | 5 | |
Conversion of Series F preferred shares into common stock | | $ | - | | | $ | 42 | |
Conversion of Series F-2 preferred shares into common stock | | $ | - | | | $ | 14 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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 September 30, 2024 and December 31, 2023, and the consolidated results of operations and cash flows for the three and nine-month periods ended September 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 September 30, 2024, it had an accumulated deficit of approximately $153.0 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.
Going Concern
The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.
At September 30, 2024, the Company had a negative working capital of approximately $5.0 million, accumulated deficit of $153.0 million, and incurred a net loss including preferred dividends of $1.9 million for the nine months then ended. Stockholders’ deficit totaled approximately $4.9 million at September 30, 2024, primarily due to recurring net losses from operations.
During the year ended December 31, 2023, the Company received $0.4 million of proceeds from warrant exercises. During the nine months ended September 30, 2024, the Company received $0.4 million of proceeds from the issuance of promissory notes payable and $0.3 million of proceeds from the sale of common stock. The Company will need to continue to raise capital in order to provide funding for its operations and FDA/NMPA 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.
Reclassifications
Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications did not affect net loss, revenues and 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 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
The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was nil and $156,112 as of September 30, 2024 and December 31, 2023, respectively.
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 September 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 September 30, 2024 and December 31, 2023:
| | (in thousands) | |
| | September 30, | | | December 31, | |
| | 2024 | | | 2023 | |
| | | | | | |
Raw materials | | $ | 1,364 | | | $ | 1,360 | |
Work-in-progress | | | 46 | | | | 46 | |
Finished goods | | | 44 | | | | 44 | |
Inventory reserve | | | (818 | ) | | | (818 | ) |
| | | | | | | | |
Total inventory | | $ | 636 | | | $ | 632 | |
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 September 30, 2024 and December 31, 2023:
| | (in thousands) | |
| | September 30, | | | December 31, | |
| | 2024 | | | 2023 | |
| | | | | | |
Equipment | | $ | 951 | | | $ | 951 | |
Software | | | 634 | | | | 634 | |
Furniture and fixtures | | | 17 | | | | 17 | |
Leasehold improvements | | | 12 | | | | 12 | |
| | | | | | | | |
Subtotal | | | 1,614 | | | | 1,614 | |
Less accumulated depreciation | | | (1,589 | ) | | | (1,582 | ) |
Property, equipment and leasehold improvements, net | | $ | 25 | | | $ | 32 | |
Depreciation expense related to property and equipment for the three and nine months ended September 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 nine months ended September 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.”
Accrued Liabilities
Accrued liabilities as of September 30, 2024 and December 31, 2023 are summarized as follows:
| | (in thousands) | |
| | September 30, 2024 | | | December 31, 2023 | |
| | | | | | |
Compensation | | $ | 383 | | | $ | 401 | |
Professional fees | | | 126 | | | | 216 | |
Interest | | | 188 | | | | 188 | |
Vacation | | | 31 | | | | 27 | |
Preferred dividends | | | 188 | | | | 228 | |
Other accrued expenses | | | 7 | | | | 8 | |
| | | | | | | | |
Total | | $ | 923 | | | $ | 1,068 | |
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 must be 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. |
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 $747,780, $424,225, and $509,101 as of September 30, 2024, December 31, 2023 and December 31, 2022, respectively.
Significant Customers
As of September 30, 2024, trade receivables of $2,047 (net of the allowance for credit losses of $450) were attributed to one customer. As of December 31, 2023, accounts receivable of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers.
Research and Development
Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred.
Income Taxes
The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company has filed its 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 September 30, 2024, the Company had approximately $66.4 million of net operating losses carryforward available, $3.8 million of which will expire on December 31, 2024. The remaining net operating loss will be eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related to the deferred tax assets generated from the net operating losses.
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 50.0% likely of being ultimately realized upon settlement. The tax position is derecognized when it is no longer more likely than not of being sustained. The Company classifies income tax related interest and penalties as interest expense and selling, general and administrative expense, respectively, on the consolidated statements of operations.
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 nine months ended September 30, 2024, the Company recognized $60,860 of expense for stock options and $41,242 of expense for warrants issued to a director. Additionally, during the nine months ended September 30, 2024, the Company accrued $30,889 of expense for common stock owed to a director, pursuant to his consulting agreement. During the nine months ended September 30, 2023, the Company recognized $221,143 of expense related to stock options, $9,333 of expense for stock issued to consultants and executives and $1,546,089 of expense for warrants issued to consultants and executives. Additionally, during the nine months ended September 30, 2023, the Company accrued $83,301 of expense for common stock owed to a director, pursuant to his consulting agreement.
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, which is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.
Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense.
Fair Value Measurements
ASC 820, “Fair Value Measurements and Disclosures,” clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that should be determined based upon assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
| · | Level 1: Quoted prices for identical assets or liabilities in active markets that the Company can access at the measurement date. |
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| · | 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. |
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| · | 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
September Private Placement Offering
On September 23, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors, including John Imhoff a member of the Company’s Board of Directors, for the purpose of raising $300,000 in gross proceeds for the Company. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell, in a private placement offering, an aggregate of 3,333,335 units, each unit consisting of one share of common stock and one warrant to purchase up to 3,333,335 shares of common stock (the “Warrants”). The purchase price per unit was $0.09. The Warrants were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.12 per share.
Common Stock
The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of September 30, 2024 and December 31, 2023, 60,456,884 and 54,105,101 shares of common stock were issued and outstanding, respectively.
During the nine months ended September 30, 2024, the Company issued 6,351,783 shares of common stock, as summarized below:
| | Number of Shares | |
Issuance of common stock in private placement offering | | | 3,333,335 | |
Issuance of common stock for payment of Series D preferred dividends | | | 196,063 | |
Issuance of common stock for payment of Series E preferred dividends | | | 625,511 | |
Issuance of common stock for payment of Series F preferred dividends | | | 444,621 | |
Issuance of common stock for payment of Series F-2 preferred dividends | | | 235,544 | |
Issuance of common stock for payment of interest | | | 1,116,709 | |
Issuance of common stock to consultants | | | 400,000 | |
Total common stock issued during the nine months ended September 30, 2024 | | | 6,351,783 | |
| | | | |
Summary table of common stock transactions: | | | | |
Shares outstanding at December 31, 2023 | | | 54,105,101 | |
Common shares issued during the nine months ended September 30, 2024 | | | 6,351,783 | |
Shares outstanding at September 30, 2024 | | | 60,456,884 | |
Preferred Stock
The Company has authorized 5,000,000 shares of preferred stock with a $0.001 par value. The board of directors has the authority to issue these shares and to set dividends, voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions.
Series C Convertible Preferred Stock
The board designated 9,000 shares of preferred stock as Series C Convertible Preferred Stock, (the “Series C Preferred Stock”). Pursuant to the Series C certificate of designations, shares of Series C Preferred Stock are convertible into common stock by their holder at any time and may be mandatorily convertible upon the achievement of specified average trading prices for the Company’s common stock. At September 30, 2024 and December 31, 2023, there were 286 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock for a total of 572,000 shares, subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt.
Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in cash or, subject to certain conditions, the Company’s common stock. Unpaid accrued dividends were $120,120 as of September 30, 2024 and December 31, 2023. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At September 30, 2024 and December 31, 2023, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock.
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 $1,000, plus any accrued but unpaid dividends.
Series C1 Convertible Preferred Stock
The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at September 30, 2024 and December 31, 2023. The C1 Convertible Preferred Stock has a conversion price of $0.50 per share, such that each share would convert into approximately 2,000 shares of the Company’s common stock, for a total of 2,098,500 shares of common stock.
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 3,262.25 shares of Series C1 Convertible Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Convertible Preferred Stock.
At September 30, 2024 and December 31, 2023, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C2 preferred stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares.
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 ($1,000 per share) of such share of Series C2 Preferred Stock by the purchase price of the securities sold in the Qualified Financing.
Series D Convertible Preferred Stock
The board designated 6,000 shares of preferred stock as Series D Preferred Stock, 438 of which remained outstanding as of September 30, 2024 and December 31, 2023. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer (now the Chief Executive Officer) and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock, 1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. Each Series D Preferred Stock is convertible into 3,000 shares of common stock. The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750.
Each share of Series D Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series D Certificate of Designation (the “Series D Conversion Price”). The conversion of Series D Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series D Preferred. If the average of the VWAPs (as defined in the Series D Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series D Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series D Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. During the nine months ended September 30, 2024, the Company issued 196,063 shares of common stock for payment of accrued Series D Preferred Stock dividends. As of September 30, 2024, and December 31, 2023, the Company had accrued dividends for the Series D Preferred Stock of $8,360.
Series E Convertible Preferred Stock
The Board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 of which remained outstanding as of September 30, 2024 and December 31, 2023. During year ended December 31, 2020, the Company entered into a Security Agreement with the Series E Investors (the “Series E Security Agreement”) pursuant to which all obligations under the Series E Certificate of Designation are secured by all of the Company’s assets and personal properties, with certain accredited investors. In total, for $1,736,000 the Company issued 1,736 shares of Series E Preferred Stock. Each Series E Preferred Stock is convertible into 4,000 common stock shares. The stated value and liquidation preference on the Series E Preferred Stock is $1,736.
Each share of Series E Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series E Certificate of Designation (the “Series E Conversion Price”). The conversion of Series E Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series E Preferred. If the average of the VWAPs (as defined in the Series E Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series E Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series E Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. Each share of Series E Preferred Stock has a par value of $0.001 per share and a stated value equal to $1,000, subject to the increase set forth in its Certificate of Designation.
Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of 8% per annum, payable annually in cash or, at the option of the Company, shares of common stock.
During the nine months ended September 30, 2024, the Company issued 625,511 shares of common stock for payment of accrued Series E Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends of $12,612 and $30,272 for the Series E Preferred Stock, respectively.
Series F Convertible Preferred Stock
The Board designated 1,500 shares of preferred stock as Series F Preferred Stock, 1,006 of which remained outstanding as of September 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series F Investors”). In total, for $1,436,000 the Company issued 1,436 shares of Series F Preferred Stock. Each Series F Preferred Stock is convertible into 4,000 shares of common stock. The Series F Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Preferred Stock is $1,000.
Each share of Series F Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F Certificate of Designation (the “Series F Conversion Price”). The conversion of Series F Preferred Stock is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends.
During the nine months ended September 30, 2024, the Company issued 444,621 shares of common stock for the payment of annual Series F Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F preferred shares of $30,851 and $46,108, respectively.
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 3,500 shares of preferred stock as Series F-2 Preferred Stock, 520 of which were issued and outstanding as of September 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. Each Series F-2 Preferred share is convertible into 4,000 shares of common stock. The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000.
Each share of Series F-2 Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F-2 Certificate of Designation (the “Series F-2 Conversion Price”). The conversion of Series F-2 Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F-2 Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F-2 Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F-2 Preferred Stock, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends.
During the nine months ended September 30, 2024, the Company issued 235,544 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F-2 preferred shares of $15,718 and $23,579, respectively.
Warrants
The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the nine months ended September 30, 2024 and 2023:
| | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | |
| | | | |
Outstanding, December 31, 2023 | | | 28,584,580 | | | $ | 0.50 | |
Warrants issued | | | 5,368,335 | | | | 0.19 | |
Warrants expired | | | (1,561,500 | ) | | | 0.44 | |
Outstanding, September 30, 2024 | | | 32,391,415 | | | $ | 0.46 | |
| | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | |
| | | | |
Outstanding, December 31, 2022 | | | 35,586,980 | | | $ | 0.46 | |
Warrants issued | | | 6,773,750 | | | | 0.26 | |
Warrants exchanged | | | (1,025,000 | ) | | | 0.25 | |
Warrants expired | | | (9,545,200 | ) | | | 0.30 | |
Warrants exercised | | | (973,750 | ) | | | 0.20 | |
Outstanding, September 30, 2023 | | | 30,816,780 | | | $ | 0.49 | |
Warrants Issued in 2024
During the nine months ended September 30, 2024, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information.
During the nine months ended September 30, 2024, the Company issued 160,000 warrants in conjunction with the issuance of $150,000 in notes payable to unaffiliated third parties and 75,000 warrants in conjunction with issuances of $75,000 of notes payable to board members. See Note 7, “Short-Term Notes Payable” and Note 9, “Related Party Debt” for additional details on the warrants issued with debt.
During the nine months ended September 30, 2024, the Company issued 3,333,335 warrants in connection with the private placement offering that closed on September 23, 2024, 1,666,677 of which were issued to one of our board members, a related party. Management estimated the fair value of the warrants utilizing the Black-Scholes Option Pricing model with the following assumptions before allocating the total proceeds from the offering to the common stock and warrants issued:
Expected term (years) | | | 4.0 | |
Volatility | | | 397.3 | % |
Risk-free interest rate | | | 3.5 | % |
Dividend yield | | | 0.0 | % |
Warrants Issued in 2023
On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, were fully vested on the issuance date and will expire on May 13, 2028. During the nine months ended September 30, 2023, the Company recorded approximately $679,959 of stock-based compensation expense attributed to the warrants.
On May 14, 2023, the Compensation Committee of the Company’s Board of Directors also approved the issuance of 4,000,000 common stock warrants to Mark Faupel, 2,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter from the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan and 1,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter or equivalent from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. The warrants, which have a strike price of $0.40, will expire five years after they are exercisable with a maximum term of 10 years from issuance. As of September 30, 2024, the Company has concluded it is not probable that the performance conditions related to the warrants will be achieved, and as a result no compensation expense related to the warrants has been recorded.
During the nine months ended September 30, 2023, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information.
During the nine months ended September 30, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants, pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. The Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296.
During the nine months ended September 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) | 3.8 |
Volatility | | 266.4% |
Risk-free interest rate | 3.8% |
Dividend yield | 0.0% |
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 2,500,000 common shares. As of September 30, 2024, shares available for issuance under the Plan were 116,364.
The following tables summarize the Company’s stock option activity and related information for the nine months ended September 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 | | | 2,338,636 | | | $ | 0.41 | | | 6.5 years | | $ | - | |
Options granted | | | 545,000 | | | $ | 0.12 | | | | | | | |
Options outstanding as of September 30, 2024 | | | 2,883,636 | | | $ | 0.35 | | | 6.6 years | | $ | 29,975 | |
Options exercisable as of September 30, 2024 | | | 2,172,614 | | | $ | 0.41 | | | 5.7 years | | $ | 7,494 | |
| | 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 | | | 1,500,000 | | | $ | 0.49 | | | 7.5 years | | $ | - | |
Options granted | | | 1,025,000 | | | $ | 0.26 | | | | | | | |
Options forfeited | | | (186,364 | ) | | $ | 0.31 | | | | | | | |
Options outstanding as of September 30, 2023 | | | 2,338,636 | | | $ | 0.41 | | | 6.8 years | | $ | - | |
Options exercisable as of September 30, 2023 | | | 1,811,364 | | | $ | 0.45 | | | 6.0 years | | $ | - | |
The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of September 30, 2024 and the exercise price, multiplied by the number of options. As of September 30, 2024, there was $128,792 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately 2.0 years. The weighted-average fair value of awards granted was $0.12 and $0.26 during the nine months ended September 30, 2024 and 2023, respectively.
The Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period. During the nine months ended September 30, 2024 and 2023, the Company recognized expense for stock options of $60,860 and $221,143, respectively.
2024 Stock Option Activity
On July 9, 2024, the Company granted 45,000 stock options to employees under the Plan and 500,000 stock options to executives and directors of the Company outside of the Plan. The stock options, which have exercise prices of $0.12, will expire on July 8, 2034. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on October 9, 2024.
The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the nine months ended September 30, 2024:
Expected term (years) | | | 6.1 | |
Volatility | | | 797.4 | % |
Risk-free interest rate | | | 4.2 | % |
Dividend yield | | | - | |
2023 Stock Option Activity
On February 10, 2023, the Company granted 925,000 stock options to employees, executives and directors of the Company. The stock options, which have exercise prices of $0.2629, will expire on February 9, 2033. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on May 10, 2023.
On March 7, 2023, the Company granted 100,000 stock options, which have exercise prices of $0.27 and will expire on March 6, 2033, to Alan Grujic, upon appointing him to the Board of Directors. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on June 7, 2023.
The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the nine months ended September 30, 2023:
Expected term (years) | | | 10.0 | |
Volatility | | | 366.4 | % |
Risk-free interest rate | | | 3.8 | % |
Dividend yield | | | 0.00 | |
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 186,364 unvested stock options. On May 2, 2023, the Company’s Board of Directors approved an extension of the expiration date of Mr. Cartwright’s vested options to June 1, 2025. Management measured the modified stock option award using the Black-Scholes option pricing model and recorded expense of $59,216 during the nine months ended September 30, 2023, representing the excess fair value of the modified award over the original award. Management estimated the fair value of the modified award using the Black-Scholes option pricing model and the following assumptions:
Expected term (years) | | | 2.0 | |
Volatility | | | 182.8 | % |
Risk-free interest rate | | | 4.0 | % |
Dividend yield | | | 0.0 | % |
5. LITIGATION AND CLAIMS
From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular year.
As of September 30, 2024, and December 31, 2023, there was no accrual recorded for any potential losses related to pending litigation.
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 year and was $27,351 and $82,053 for the three and nine months ended September 30, 2024, respectively. The below table presents total operating lease right-of-use assets and lease liabilities as of September 30, 2024 and December 31, 2023:
| | (in thousands) | |
| | September 30, | | | December 31 | |
| | 2024 | | | 2023 | |
Operating lease right-of-use assets | | $ | 164 | | | $ | 227 | |
Operating lease liabilities | | $ | 178 | | | $ | 246 | |
The table below presents the maturities of operating lease liabilities as of September 30, 2024:
| | (in thousands) | |
| | Operating | |
| | Lease Payments | |
2024 (remaining) | | | 29 | |
2025 | | | 118 | |
2026 | | | 50 | |
Total future lease payments | | | 197 | |
Less: discount | | | (19 | ) |
Total lease liabilities | | $ | 178 | |
The table below presents the weighted-average remaining lease term and discount rate used in the calculation of operating lease right-of-use assets and lease liabilities as of September 30, 2024 and December 31, 2023
| | (in thousands) | |
| | September 30, 2024 | | | December 31, 2023 | |
Weighted average remaining lease term (years) | | | 1.7 | | | | 2.4 | |
Weighted average discount rate | | | 11.4 | % | | | 11.4 | % |
Related Party Contracts
During the nine months ended September 30, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. See Note 9, “Related Party Debt” for additional details.
On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or 20% of the distributor price (subject to a discount under certain circumstances), whichever is higher, per disposable distributed within Shenghuo’s exclusive territories. Pursuant to the license agreement, Shenghuo had the option to have a designee appointed to the Company’s board of directors (current director Richard Blumberg is the designee).
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 $50,000, the Company will pay them an aggregate perpetual royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20, for each cervical guide that the Company sells (or that is sold by a third party pursuant to a licensing arrangement with the Company).
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 5,000,000 warrants, broken into four tranches of 1,250,000. The warrants have a strike price of $0.25 and were subject to vesting based upon the close of the Series D offering and a minimum share price based on the 30-day VWAP. If the minimum share price per the terms of the agreement is not achieved, the warrants will expire three years after the scheduled issuance date. The warrants were valued using the Black Scholes model on the grant date of January 22, 2020. As of September 30, 2024, unrecognized consulting expense associated with the agreement was nil and 2,500,000 of the warrants had been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties.
During the nine months ended September 30, 2023, the Company entered into an agreement with Mr. Blumberg to exchange 875,000 of his outstanding warrants for 831,250 warrants with a strike price of $0.20, which were exercised during the first quarter of 2023.
On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided a non-refundable payment of $350,000 to the Company in exchange for the following: (1) 3,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on Mr. Blumberg’s assistance in helping the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million. Upon receipt of the funds, the Company agreed to issue the common shares and warrants owed to Mr. Blumberg in four equal tranches, to be issued every six months, beginning six months after the financing transaction. On November 11, 2022, the Company and Mr. Blumberg entered into an amended agreement, upon which the exercise prices of the warrants were changed to $0.30. The Company estimated the fair value of the modified warrants using the Black-Scholes option pricing model and the following assumptions:
Expected term (years) | | | 3.0 | |
Volatility | | | 108.7 | % |
Risk-free interest rate | | | 4.3 | % |
Dividend yield | | | 0.0 | % |
During the nine months ended September 30, 2024 and 2023, the Company issued 1,800,000 warrants to Mr. Blumberg pursuant to the agreement, and recognized expense of nil and $740,517, respectively. Total unrecognized expense for the warrants was nil as of September 30, 2024. During the nine months ended September 30, 2024 and 2023, the Company recognized $31,889 and $151,933 of expense for the shares of common stock due to Mr. Blumberg, respectively. As 400,000 shares had not been issued as of September 30, 2024, the Company estimated the total amount of expense for the future issuances using the closing price of the Company’s stock as of September 30, 2024.
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 800,000 warrants (“first tranche of warrants”) with an exercise price of $0.50 to Mr. Grujic, which were due within 10 business days of closing the financing transaction (the “Transaction”) that took place in September 2022. In the event the Company’s 20 trading day variable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing, the Company would have issued 600,000 warrants (“second tranche of warrants”) with an exercise price of $0.75 to Mr. Grujic. In the event the Company’s 20 trading day VWAP exceeds $1.50 within two years of the closing of the financing, the Company will issue an additional 600,000 warrants (“third tranche of warrants”) to Mr. Grujic. Once issued, the warrants vest immediately and will expire two years from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with the U.S. FDA or if the Chinese NMPA (formerly Chinese FDA) approval is not granted by each due date for reaching each respective pricing milestone, then the due date for reaching each milestone shall be extended by six months. As of June 30, 2024, the deadline to achieve the stock price of $1.50 has passed and the second tranche warrants will therefore not be issued.
Pursuant to the agreement, the Company also agreed to pay the Advisory Group $2,000 per month for 12 months, starting the month after the closing of the Transaction. Subsequently, the agreement was amended to extend the term of the agreement to September of 2024.
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) | | | 2.0 | |
Volatility | | | 173.0 | % |
Risk-free interest rate | | | 3.4 | % |
Dividend yield | | | 0.0 | % |
Expense related to the first tranche of warrants was recognized in prior years. Unrecognized expense related to the first tranche warrants was nil as of September 30, 2024.
The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) | | | 1.0 | |
Volatility | | | 144.4 | % |
Risk-free interest rate | | | 3.6 | % |
Dividend yield | | | 0.0 | % |
The Company recognized expense for the second tranche of warrants of nil and $29,706 during the three months ended September 30, 2024 and 2023, respectively. The Company recognized expense for the second tranche of warrants of nil and $79,216 during the nine months ended September 30, 2024 and 2023, respectively. Unrecognized expense for the third tranche of warrants was nil as of September 30, 2024.
The Company estimated the fair value of the third tranche warrants using the Binomial Lattice model with the following assumptions:
Expected term (years) | | | 2.0 | |
Volatility | | | 172.1 | % |
Risk-free interest rate | | | 3.6 | % |
Dividend yield | | | 0.0 | % |
The Company recognized expense for the third tranche of warrants of $10,311 and $15,466 during the three months ended September 30, 2024 and 2023, respectively. The Company recognized expense for the third tranche of warrants of $41,242 and $46,397 during the nine months ended September 30, 2024 and 2023, respectively. Unrecognized expense for the third tranche of warrants was nil as of September 30, 2024.
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.
First, SMI shall complete the payment for parts, per the purchase order, for five additional LuViva devices. Second, in consideration for the $885,144 that the Company received, SMI will receive 12,147 shares of common stock. Third, SMI shall honor all existing purchase orders it has executed to date with the Company, in order to maintain jurisdiction sales and distribution rights. If SMI needs to purchase cervical guides, then it will do so at a cost including labor, plus ten percent markup. The Company will provide 200 cervical guides at no cost for the clinical trials. Fourth, the Company and SMI will make their best efforts to sell devices after NMPA approval. With an initial estimate of year one sales of 200 LuViva devices; year two sales of 500 LuViva devices; year three sales of 1,000 LuViva devices; and year four sales of 1,250 LuViva devices. Fifth, SMI shall pay for entire costs of securing approval of LuViva with the Chinese FDA. Sixth, SMI shall arrange, at its sole cost, for a manufacturer in China to build tooling to support manufacturing. In addition, SMI retains the right to manufacture for China, Hong Kong, Macau and Taiwan, where SMI has distribution and sales rights. For each single-use cervical guide sold by SMI in the jurisdictions, SMI shall transfer funds to escrow agent at a rate of $1.90 per device chip. If within 18 months of the license’s effective date, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. Commercialization is defined as: filing an application with the Chinese FDA for the approval of LuViva; any assembly or manufacture of the devices or disposables that begins in China; and purchase of at least 10 devices and disposables for clinical evaluations and regulatory use and or sales in the jurisdictions.
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 $531,100 on or prior to March 15, 2024. On March 18, 2024, SMI, through SMI’s authorized distribution partner, initiated a wire payment of $330,000 in partial satisfaction of $531,100 owed to the Company. The payment was received by the Company on March 20, 2024. As the full payment was not received by March 15, 2024, the Company had the right to terminate the agreement with two weeks’ notice to SMI, however the Company did not exercise this option.
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 $4.4 million during 2024, including the payment due on March 15, 2024.
On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”). The parties agreed that SMI will make a nonrefundable payment of $100,000 to the Company prior to March 31, 2024. In exchange, the Company will not initiate any legal proceedings, including but not limited to filing a lawsuit, obtaining a judgement, or enforcing any security interest, as related to the March shortfall in payments of $201,100, until April 30, 2024. Upon paying $100,000, SMI will have the option to extend the Standstill Agreement until June 15, 2024 by making a nonrefundable payment to the Company of $150,000. One additional payment of $150,000 may be made to extend the standstill rights until July 30, 2024, if mutually agreed upon. If SMI is unable to make the payments pursuant to the Standstill Agreement, the Company agreed to seek loans on behalf of SMI to cover the payments. SMI agreed to reimburse the Company for these loans along with all expenses associated with them within three months of the loans being issued as long as the loans are used solely for (1) parts for LuViva devices to be used by SMI for marketing and promotional activities, or (2) labor or consulting fees connected to providing parts, assemblies of devices or disposables to SMI. Additionally, SMI confirmed its commitment to make payments to GTI of at least $4.0 million during 2024 and as part of this commitment will make payments of $200,000 and $500,000 by the end of May 2024 and July 2024, respectively, to ensure that the program commercialization proceeds according to schedule.
On April 26, 2024, the parties extended the Standstill Agreement (“Standstill Extension”) until July 30, 2024, contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can place a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545. The other terms from the Amendment and Standstill Agreement remained intact.
On July 31, 2024, the parties extended the Standstill Agreement until August 16, 2024. A long-term agreement was reached subsequent to September 30, 2024 (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.
7. SHORT-TERM NOTES PAYABLE
On July 23, 2024, the Company issued a promissory note totaling $50,000 to an unaffiliated third party. The promissory note matures on February 1, 2025 and will accrue total interest of $5,000. Monthly payments of $10,000 are due on the note, beginning September 1, 2024 until January 1, 2025, while the interest payment is due on or before February 1, 2025. The promissory note may be prepaid in full or in part without penalty or premium. The holder of the promissory note also received 60,000 common stock purchase warrants, which have an exercise price of $0.25 and will expire on August 1, 2028. The warrants, which had an estimated fair value of $6,329, were recorded as a discount on the note payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:
Expected term (years) | | | 4.0 | |
Volatility | | | 397.3 | % |
Risk-free interest rate | | | 3.9 | % |
Dividend yield | | | 0.0 | % |
On June 28, 2024, the Company issued a promissory note totaling $100,000 to an unaffiliated third party. The promissory note matures on January 1, 2025 and will accrue total interest of $10,000. Monthly payments of $20,000 are due on the note, beginning August 1, 2024 until December 1, 2024, while the interest payment is due on or before January 1, 2025. The promissory note may be prepaid in full or in part without penalty or premium. The holder of the promissory note also received 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. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:
Expected term (years) | | | 4.0 | |
Volatility | | | 389.2 | % |
Risk-free interest rate | | | 4.4 | % |
Dividend yield | | | 0.0 | % |
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 $81,768 for an $87,162 promissory note dated April 15, 2024. Beginning on May 5, 2024, monthly payments of $2,000 are due on the note until its maturity date. The promissory note, which accrues interest at a rate of 6.0% per annum, matures on May 5, 2028. The total balance of the promissory note was $77,162 as of September 30, 2024, of which $24,000 is included in “Short-term notes payable” on the consolidated balance sheets and $53,162 is included in “Long-term notes payable.”
On July 4, 2024, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,556. Monthly payments of $12,025 are due on the note, including interest incurred at a rate of 8.8%. The note, which matures on May 4, 2025, had an outstanding balance of $93,784 and nil as of September 30, 2024 and December 31, 2023, respectively.
On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,073. Monthly payments of $12,041 are due on the note, including interest incurred at a rate of 7.9%. The note, which matured on May 4, 2024, had an outstanding balance of nil and $59,422 as of September 30, 2024 and December 31, 2023, respectively.
The following table summarizes short-term notes payable (in thousands):
| | Short-Term Notes Payable | |
| | September 30, 2024 | | | December 31, 2023 | |
Short-term promissory notes | | $ | 121 | | | $ | - | |
Current portion of long-term promissory note | | | 24 | | | | - | |
Premium Finance (insurance) | | | 93 | | | | 59 | |
Debt discount | | | (10 | ) | | | - | |
Short-term notes payable | | $ | 228 | | | $ | 59 | |
8. CONVERTIBLE DEBT
10% Senior Unsecured Convertible Debentures
On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which matured on May 17, 2024 (the “Maturity Date”). The Company subscribed $1,130,000 of the $1,000 convertible debentures. The terms of the debentures are as follows: 1) the principal amount of some or all of the convertible debentures and accrued interest are convertible into shares of common stock at the holder’s option, at a price of $0.50 per common stock share (the “conversion price”), subject to adjustment in certain events, at any time prior to maturity date; 2) upon successful uplist to a U.S. National Exchange, the note will automatically convert into the uplisting financing; 3) each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023; 4) if a Change of Control (as defined in the Convertible Debenture Certificate) occurs prior to the Maturity Date, unless the holder elects in writing to convert the Convertible Debentures into shares of common stock, the Company will repay in cash upon the closing of such Change of Control all outstanding principal and accrued interest under each Convertible Debenture plus a Change of Control premium equal to an additional 3% of the outstanding principal sum under such Convertible Debenture. Prior to the closing of an Change of Control, in lieu of repayment as set forth in the preceding sentence, the holder has the right to elect in writing to convert, effective immediately prior to the effective date of such Change of Control, all outstanding principal and accrued Interest under the Convertible Debentures into shares of common stock at the Conversion Price; 5) Subject to a holder’s option of electing conversion prior to the Redemption Date (as such term is defined below), on or after the date that is 24 months from the Closing Date if the daily volume weighted average trading price of the shares of common stock is $1.50 per share of common stock or more for each trading day over a 30 consecutive trading day period, the Company may, at any time (the “Redemption Date”), at its option, redeem all, or any portion of the Convertible Debentures for either: (i) a cash payment (in the form of a certified cheque or bank draft) that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date; or (ii) by issuing and delivering shares of common stock to the holders of Convertible Debentures at a deemed price of $0.50 per share of common stock that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date, or any combination of (i) or (ii), upon not less than 30 days and not more than 60 days prior written notice in the manner provided in the Debenture Certificate, to the holder of Convertible Debentures.
At September 30, 2024 and December 31, 2023, the balance due on the 10% Senior Secured Convertible Debentures was $1,130,000 and total accrued interest was $51,980 and $58,494, respectively. After the May 17, 2024 maturity date, the debt went into default and the interest rate increased to the default rate of 18.0%. The bond payable discount and unamortized debt issuance costs as of September 30, 2024 and December 31, 2023 are presented below (in thousands):
| | Senior Secured Convertible Debenture | |
| | September 30, 2024 | | | December 31, 2023 | |
10% Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,130 | |
Unamortized debt issuance costs | | | - | | | | (12 | ) |
Debt discount | | | - | | | | (38 | ) |
Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,080 | |
As of September 30, 2024, the balance of the Senior Unsecured Convertible Debentures 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 Debentures is included in “Short-term convertible notes payable” within the condensed consolidated balance sheets.
1800 Diagonal Lending LLC Notes
On July 22, 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 $62,100 and an original issue discount of $8,100. The note, which will accrue total interest of $8,694, will mature on May 30, 2025. A payment of $35,397 is due on the note on January 30, 2025. The remaining balance due, including accrued interest, will be paid in monthly payments of $8,849 from February 28, 2025 through May 30, 2025. The note may be prepaid at any time with no prepayment penalty. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22.0% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest.
On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending (together with the July 22, 2024 note, the “Notes”). 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. The note may be prepaid within 120 days of issuance for a discount of 2.0 -3.0 % of the principal and accrued interest due. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest.
In the event of default, the unpaid portion of the Notes and accrued interest is convertible into shares of common stock at a conversion rate equal to the variable conversion price. The variable conversion price is equal to the lowest closing price of our common stock during the ten days prior to the conversion date multiplied by 65.0%. The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host notes, and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the issuance dates of the Notes and recorded them as discounts that net against the convertible notes. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).
At September 30, 2024, the balance due on the Notes was $162,150 and total accrued interest was $9,438. The associated debt discounts and unamortized debt issuance costs as of September 30, 2024 and December 31, 2023 are included in “Short-term convertible debt” on the condensed consolidated balance sheets and are presented below (in thousands):
| | September 30, 2024 | | | December 31, 2023 | |
Short-term convertible promissory notes | | $ | 162 | | | $ | - | |
Unamortized debt issuance costs | | | (5 | ) | | | - | |
Debt discount | | | (23 | ) | | | - | |
1800 Diagonal Lending Convertible Note | | $ | 134 | | | $ | - | |
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 $2.4 million. The note may not have been prepaid in whole or in part except as otherwise explicitly allowed. Any amount of principal or interest on the note which was not paid when due shall bore interest at the rate of the lessor of 24% or the maximum permitted by law (the “default interest”). The variable conversion prices equaled the lesser of: (i) the lowest trading price on the issue date, and (ii) the variable conversion price. The variable conversion price was 95% multiplied by the market price (the market price means the average of the five lowest trading prices during the period beginning on the issue date and ending on the maturity date), minus $0.04 per share, provided however that in no event could the variable conversion price be less than $0.15. If an event of default under this note occurred and/or the note was not extinguished in its entirety prior to December 17, 2020, the $0.15 price floor no longer applied.
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 $1,228,183 of debt, including an early prepayment penalty of $350,000, default premiums of $281,256, and $91,555 in interest payable. Auctus agreed to reduce the amount owed to $710,911 and to revert the May 27, 2020 note to its original term. Additionally, Auctus agreed to exchange 8,775,000 warrants that were priced between $0.15 and $0.20 and the $350,000 prepayment penalty for 3,900,000 shares of common stock, warrants to purchase 3,900,000 shares of common stock at $0.50 per share and warrants to purchase 3,900,000 shares of common stock at $0.65 per share (the “Exchange”). As a result of the Exchange Agreement, Auctus forgave a default penalty of $225,444. Following the Exchange and Repayment, the Company will make payments to Auctus in four installments, over an 18-month period. During 2024, Auctus agreed to apply the payments to the principal portion of the debt before applying the funds to the accrued interest. As a result, management has reclassified a portion of the current and prior period outstanding debt to the accrued interest.
The total outstanding balance of the convertible note was $15,000 and $25,000 as of September 30, 2024 and December 31, 2023, respectively. The balances are included within “Short-term convertible debt” on the condensed consolidated balance sheets. Total accrued interest on the Auctus convertible note was $116,029 and $121,995 as of September 30, 2024 and December 31, 2023, respectively.
9. RELATED PARTY DEBT
Short-Term Notes Payable Due to Related Parties
During the nine months ended September 30, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. The promissory notes mature in the third quarter of 2025, at which time the principal and accrued interest payments are due in full. The promissory notes accrue interest at a rate of 9.0%. The holders of the promissory notes also received 75,000 common stock purchase warrants, which have exercise prices of $0.25 and will expire four years after issuance. The warrants, which had an estimated fair value of $8,800, were recorded as a discount on the notes payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following weighted-average assumptions:
Expected term (years) | | | 4.0 | |
Volatility | | | 397.1 | % |
Risk-free interest rate | | | 3.9 | % |
Dividend yield | | | 0.0 | % |
The outstanding principal and associated debt discounts as of September 30, 2024 and December 31, 2023 are presented below (in thousands):
| | Short-Term Notes Payable Due to Related Parties | |
| | September 30, 2024 | | | December 31, 2023 | |
Short-term promissory notes | | $ | 75 | | | $ | - | |
Debt discount | | | (7 | ) | | | - | |
Short-term notes payable due to related parties | | $ | 68 | | | $ | - | |
Current Portion of Long-Term Debt, Related Parties
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 $660,895 for a $207,111 promissory note dated September 4, 2018. On July 20, 2018, the Company entered into an exchange agreement with Dr. Cartwright, whereby Dr. Cartwright agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $1,621,499 for a $319,000 promissory note dated September 4, 2018 that incurs interest at a rate of 6.0% per annum.
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 $267,085, the maturity date was February 18, 2023, and the interest rate was 6.0%. For Dr. Faupel the principal amount on the new note was $153,178, the maturity date was February 18, 2023, and the interest rate was 6.0%. Additionally, the Company exchanged $100,000 and $85,000 of the balances owed to Dr. Cartwright and Dr. Faupel for 100 and 85 shares of Series F-2 Preferred Stock, respectively.
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 debt owed to Dr. Faupel and Dr. Cartwright (in thousands):
For Dr. Faupel:
Salary | | $ | 134 | |
Bonus | | | 20 | |
Vacation | | | 95 | |
Interest on compensation | | | 67 | |
Loans to Company | | | 196 | |
Interest on loans | | | 149 | |
Total outstanding prior to exchange | | | 661 | |
| | | | |
Amount forgiven in prior years | | | (454 | ) |
Amount exchanged for Series F-2 Preferred Stock | | | (85 | ) |
Total interest accrued through December 31, 2023 | | | 57 | |
Balance outstanding at December 31, 2023 | | $ | 179 | |
| | | | |
Interest accrued through September 30, 2024 | | | 7 | |
Balance outstanding at September 30, 2024 | | $ | 186 | |
For Dr. Cartwright
Salary | | $ | 337 | |
Bonus | | | 675 | |
Loans to Company | | | 528 | |
Interest on loans | | | 81 | |
Total outstanding prior to exchange | | | 1,621 | |
| | | | |
Amount forgiven in prior years | | | (1,302 | ) |
Amount exchanged for Series F-2 Preferred Stock | | | (100 | ) |
Total interest accrued through December 31, 2023 | | | 93 | |
Payments on outstanding debt | | | (25 | ) |
Balance outstanding at December 31, 2023 | | $ | 287 | |
| | | | |
Interest accrued through September 30, 2024 | | | 11 | |
Balance outstanding at September 30, 2024 | | $ | 298 | |
On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler. As of December 31, 2020, the Company owed Mr. Fowler $546,214 ($412,624 in deferred salary and $133,590 in accrued interest). The Company exchanged $50,000 of the amount owed of $546,214 for 50 shares of Series F-2 Preferred Stock (convertible into 200,000 shares of common stock), and a $150,000 unsecured note. The note accrues interest at the rate of 6.0% (18.0% in the event of default) beginning on March 22, 2022 and is payable in monthly installments of $3,600 for four years, with the first payment due on March 15, 2022. The effective interest rate of the note is 6.18%.
During the three and nine months ended September 30, 2024, Mr. Fowler forgave $16,145 and $49,205 of the outstanding balance of deferred compensation, respectively. During the three and nine months ended September 30, 2023, Mr. Fowler forgave $17,183 and $52,354 of the outstanding balance of deferred compensation, respectively. As of September 30, 2024, Mr. Fowler may forgive up to $80,131 of the remaining deferred compensation if the Company complies with the repayment plan described above. The reductions in the outstanding balance met the criteria for troubled debt. The basic criteria are that the borrower is troubled, i.e., they are having financial difficulties, and a concession is granted by the creditor. As of September 30, 2024, the outstanding principal amount owed on the note was $53,886, of which $40,875 is included in “Current portion of long-term debt, related parties” and $13,011 is included in “Long-term debt, related parties.” As of December 31, 2023, the outstanding principal amount owed on the note was $82,945, of which $39,090 is included in “Current portion of long-term debt, related parties” and $43,855 is included in “Long-term debt, related parties.”
Future debt obligations at September 30, 2024 for debt owed to related parties is as follows:
Year | | Amount (in thousands) | |
2024 (remaining) | | | 10 | |
2025 | | | 600 | |
2026 | | | 3 | |
Total | | $ | 613 | |
10. INCOME (LOSS) PER SHARE OF COMMON STOCK
Basic net income (loss) per share attributable to common stockholders, amounts are computed by dividing the net income (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the year.
Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the year, plus Series C, Series C-1, Series C-2, Series 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 nine months ended September 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 September 30, 2024 and 2023, these instruments were convertible into 57,954,585 and 54,457,934 common shares, respectively.
The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders (in thousands, except for per-share data):
| | September 30, | |
| | 2024 | | | 2023 | |
| | | | | | |
Net loss | | $ | (1,891 | ) | | $ | (3,290 | ) |
Basic weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | |
Net loss per share (basic) | | $ | (0.03 | ) | | $ | (0.07 | ) |
Diluted weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | |
Net loss per share (diluted) | | $ | (0.03 | ) | | $ | (0.07 | ) |
11. FAIR VALUE MEASUREMENTS
The convertible notes payable derivative liabilities are considered Level 3 measurements, due to the significant unobservable inputs in the valuation, which are based on a forecast of the Company’s future stock performance and, as the note payable is contingently convertible upon an event of default, management’s estimate of the likelihood and timing of conversion.
Based on the terms and provisions of the Diagonal Lending notes 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 notes 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. |
The following tables present the fair value of the bifurcated conversion options:
| | Fair Value at September 30, 2024 (in thousands) | |
| | Level 1 | | | Level 2 | | | Level 3 | | | Total | |
| | | | | | | | | | | | |
Derivative liability/bifurcated conversion options in connection with Diagonal Lending promissory notes | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | |
| | | | | | | | | | | | | | | | |
Total short-term liabilities at fair value | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | |
Derivative financial instruments and changes thereto recorded in the three and nine months ended September 30, 2024 and 2023 include the following:
| | Three Months Ended September 30, | |
| | 2024 | | | 2023 | |
| | | | | | |
Fair value, beginning of period | | $ | 13 | | | $ | - | |
Inception of derivative liability | | | 6 | | | | - | |
Change in fair value of beneficial conversion features | | | 1 | | | | - | |
| | | | | | | | |
Fair value, end of period | | $ | 20 | | | $ | - | |
| | Nine Months Ended September 30, | |
| | 2024 | | | 2023 | |
| | | | | | |
Fair value, beginning of period | | $ | - | | | $ | (5 | ) |
Inception of derivative liability | | | 12 | | | | - | |
Change in fair value of beneficial conversion features | | | 8 | | | | 5 | |
| | | | | | | | |
Fair value, end of period | | $ | 20 | | | $ | - | |
12. SUBSEQUENT EVENTS
Promissory Note
On October 10, 2024, the Company issued a promissory note totaling $200,000 to an unaffiliated third party (the “Holder”). The promissory note matures on October 10, 2025 and will accrue interest at a rate of 12.0% per annum. Monthly payments of $20,000 are due on the note, beginning November 30, 2024 until August 31, 2025, while the interest payment is due on or before October 10, 2025. If not repaid by the maturity date, the unpaid balance of the note will accrue interest at a rate of 16.0% per annum. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. The Holder also received 667,667 common stock purchase warrants, which have an exercise price of $0.25 and will expire on October 9, 2028.
Agreement with SMI
On October 21, 2024, the Company executed an agreement with SMI (the “Agreement”), which supersedes all previous agreements, other than existing purchase orders (except those as modified and summarized below). Pursuant to the Agreement, the Company plans to execute a purchase agreement with a distributor of SMI for 35 base units, connected, aligned, calibrated and tested (“Completed Instrumentation Packages”). SMI, to obtain the license for global manufacturing rights and exclusive distribution of LuViva within certain jurisdictions, agreed to:
| 1. | Meet an established schedule for minimum sales of the product in China. |
| 2. | Establish a manufacturing capability for the manufacture of LuViva and its accessories including the single use disposable Cervical Guide “Disposables” or “Accessories”). |
| 3. | Apply for NMPA approval for LuViva no later than October 30, 2024. Said application was filed by SMI with NMPA on October 16, 2024. |
Under the terms of the agreement, the Handheld Unit and Base Unit constitute an Instrumentation Package or “IP”. An IP and mobile cart with a monitor constitute a fully functional LuViva device ready for sale. SMI will be responsible for the manufacture of the mobile carts that house the IPs and the display monitor. All active purchase orders will be revised to include 100 IPs to be provided by GTI to SMI and/or its distribution partners to meet expected demand for the end of 2024 and 2025, as summarized below:
| 1. | Forty-seven (47) of the 100 IPs will be provided by GTI to SMI, at an approximate price of $1,351,250; The number of IPs may be reduced if the full payment is delayed beyond the end of 2024. |
| 2. | Thirty-five (35) of the 100 IPs will be provided by GTI to SMI or to one of SMI’s distributors, at a total price of $700,000. |
| 3. | Eighteen (18) of the 100 IPs will be provided to SMI at no additional charge, beyond what has already been paid by SMI. |
To meet demand for the remainder of 2024 and for the first half of 2025, SMI agreed to purchase a minimum of 500,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. To meet demand for the second half of 2025, SMI agreed to purchase an additional 100 IPs and 1,000,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. SMI agreed to pay a minimum of $400,000 to the Company prior to December 31, 2024, to cover additional components, devices and costs incurred by the Company.
Beginning in 2026 and extending into 2030, to preserve its licensing rights, SMI shall be committed to the minimum LuViva Cervical Guide Radio Frequency Identification Chips and Royalty Sales (“RFID Chips”) of the single-use Cervical Guide Chip, at a sale price to SMI at $1.00, as specified in the table below:
Year | | Cumulative Number of Devices Placed or Sold | | | Cumulative Resulting Minimum Tests | | | Cumulative Minimum Cervical Guide Royalty Payments to GTI | |
2026 | | | 300 | | | | 1,440,000 | | | $ | 1,440,000 | |
2027 | | | 400 | | | | 5,040,000 | | | $ | 4,480,000 | |
2028 | | 1500 | | | | 15,840,000 | | | $ | 15,840,000 | |
2029 | | 3000 | | | | 37,440,000 | | | $ | 37,440,000 | |
2030 | | 4000 | | | | 66,240,000 | | | $ | 66,240,000 | |
If by April 30, 2025, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva.
Issuances of Common Stock
Subsequent to September 30, 2024, we issued 400,000 common shares to Mr. Blumberg, pursuant to his consulting agreement. Additionally, we issued 52,795 common shares for Series D preferred stock dividends, 5,558 common shares for Series F preferred stock dividends, and 100,000 common shares for the conversion of 25 shares of Series F preferred stock.
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:
| · | Notes in the amount of $1.13 million in default 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. |
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 made that we will make additional updates with respect thereto or with respect to other forward-looking statements.
The following discussion should be read in conjunction with our financial statements and notes thereto included elsewhere in this report.
OVERVIEW
We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.
LuViva provides a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva improves patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.
We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants.
Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception in 1992 as SpectRx, Inc. and, as of September 30, 2024, we have an accumulated deficit of approximately $153.0 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.
Our product revenues to date have been limited. Our historical and expected future revenue has been and will be derived from sales of LuViva devices and disposables.
Current Demand for LuViva
Based on written agreements and ongoing discussions with SMI, we currently hold and expect to generate additional purchase orders which we expect to result in actual sales of approximately $2.4 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 conducting a clinical trial involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The study protocol was drafted with input from FDA and physicians at the clinical centers that are participating in the study. In 2023, FDA completed its review of the protocol and had no further recommendations or questions. Also in 2023, four clinical sites agreed to participate in the study and all four of the study sites were fully IRB approved. The protocol was also approved by an independent, nationally recognized institutional review board. All four sites have received LuViva devices and have been trained in their use. All four sites have undergone one or more clinical study monitoring visits by the Company’s clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol. Findings from the ongoing clinical study monitoring visits include:
| 1) | Approximately 255 patients have been enrolled and tested, which represents approximately sixty-four percent of the 400 anticipated patients needed to complete the study. |
| 2) | There have not been any adverse events reported related to the use of LuViva. |
| | |
| 3) | All four 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 near the end of 2024 or early in 2025, depending in part by how many women are diagnosed with cervical disease, along with other factors such as potential slowdowns during the fall and winter holidays. However, there can be no assurance that the study will progress within the expected timeline, or ever.
Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, filed the application with NMPA for approval of LuViva as a Class 3 medical device in China on October 16, 2024. The results for the 449 women tested by LuViva were better than required by NMPA with a sensitivity of 83% and a specificity of 54%. There were no adverse events reported during the use of LuViva in the study, adding further evidence as to the safety of the technology. SMI believes NMPA approval could happen within six months, although there can be no assurance that NMPA approval will occur within the projected time frame.
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. In addition, an application for approval has been filed in Russia, although current geopolitics presents uncertainty as to the ability to sell and market new medical technology in that country.
In Turkey, we have been in contact with three different medical groups representing over 60 individual hospitals and clinics. We have entered contract discussions with ORA Medical of Ankara, Turkey for distribution rights in Turkey.
In Indonesia, our contracted distributors are in discussions with the local government hospital system of Sulawesi, one of the nation’s most populous islands.
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.
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 must be 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 Employees, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using the Black-Scholes or binomial option pricing models.
Allowance for Credit Losses: Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of September 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 purchased.
RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
Sales Revenue and Cost of Goods Sold: Revenues and cost of goods sold from the sale of LuViva devices and disposables for the three months ended September 30, 2024 and 2023 were not material. As of September 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 or early in 2025, upon receiving NMPA approval.
Research and Development Expenses: Research and development expenses were $111,298 and $69,140 during the three months ended September 30, 2024 and 2023, respectively. The increase of $42,158 or 61.0%, was primarily due to additional costs of $59,201 for sponsored research related to our U.S. clinical trials during the three months ended September 30, 2024. The increase in sponsored research costs was partially offset by a decline in patent maintenance fees of $12,208 and a decline in clinical research-related travel expenses of $3,818.
Sales and Marketing Expenses: Sales and marketing expenses were $75,850 and $69,359 during the three months ended September 30, 2024 and 2023, respectively. The increase of $6,491, or 9.4%, was primarily due to $2,678 of additional rent expense allocated to our sales & marketing department and $2,240 of additional travel expenses for sales trips.
General and Administrative Expense: General and administrative expenses were $374,190 and $480,550 during the three months ended September 30, 2024 and 2023, respectively. The decrease of $106,360, or 22.1%, was primarily driven by a decrease of $138,906 in consulting fees, of which $104,543 was due to less expense recognized in the current period for the shares of common stock and warrants issued to Mr. Blumberg and $24,959 was due to less expense recognized for warrants issued to Mr. Grujic, pursuant to their respective agreements. The decrease was also due to an $18,830 decline in property taxes. These decreases were offset by a $42,999 increase in attorney and other professional fees paid to outside service providers and a $16,350 increase in stock option expense.
Interest Expense: Interest expense was $107,500 and $71,481 during the three months ended September 30, 2024 and 2023, respectively. The increase of $36,019, or 50.4%, was due to an increase in debt in the current period versus the prior.
Change in fair value of derivative liability: The change in the fair value of our derivative liability resulted in a loss of $585 during the three months ended September 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 $16,145 and $17,184 during the three months ended September 30, 2024 and 2023, respectively, was materially consistent over the two periods and was due to forgiveness of debt from our creditors.
Preferred Stock Dividends: Expense related to preferred stock dividends of $38,194 and $40,073 for the three months ended September 30, 2024 and 2023, respectively, was materially consistent over the two periods.
Net Loss: Net loss attributable to common stockholders was $691,417 and $718,777 during the three months ended September 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 September 30, 2024 or 2023, due to recurring net operating losses.
RESULTS OF OPERATIONS
COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the nine months ended September 30, 2024, were $5,720, compared to $66,287 for the nine months ended September 30, 2023. Cost of goods sold was $1,879 during the nine months ended September 30, 2024, compared to $45,570 during the nine months ended September 30, 2023. As of September 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 or early in 2025, upon receiving NMPA approval. In the prior period, the majority of our sales were related to four IPs sold to SMI.
Research and Development Expenses: Research and development expenses were $386,417 and $142,450 during the nine months ended September 30, 2024 and 2023, respectively. The increase of $243,967 or 171.3%, was primarily due to a $245,274 increase in sponsored research costs, a $5,775 increase in clinical travel expenses and an increase of $5,394 in engineering staff salaries. These increases were offset by a decline of $18,695 in patent maintenance fees.
Sales and Marketing Expenses: Sales and marketing expenses were $217,653 and $203,334 during the nine months ended September 30, 2024 and 2023, respectively. The increase of $14,319, or 7.0% was primarily due to an increase of $10,002 in rent expense allocated to our sales & marketing department.
General and Administrative Expense: General and administrative expenses were $974,406 and $2,647,017 during the nine months ended September 30, 2024 and 2023, respectively. The decrease of $1,672,611, or 63.2%, was primarily driven by a decline of $903,676 of expense for consulting fees, which was caused by (1) $801,327 less expense recognized for shares of common stock and warrants issued to Mr. Blumberg, (2) $84,371 less expense for warrants issued to Mr. Grujic and (3) a decline of $18,014 in fees paid to other outside consultants. The decrease in our current year general and administrative expenses was also due to a $602,689 decline in payroll and benefits expenses (including payroll taxes), which was primarily caused by 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, expense for stock options decreased $160,283 in the current period due to (1) a one-time charge of $59,216 in the prior year for the modification of a stock option award and (2) fewer stock option awards vesting in the current period versus the prior. These decreases were partially offset by an increase in rent and utilities of $7,525 and an increase of $6,805 in fees for outside services in the current period versus the prior.
Interest Expense: Interest expense was $246,990 and $205,872 during the nine months ended September 30, 2024 and 2023, respectively. The increase of $41,118, or 20.0%, was due to an increase in debt in the current period versus the prior.
Change in Fair Value of Derivative Liability: The change in the fair value of our derivative liability resulted in a loss of $7,935 in the nine months ended September 30, 2024, versus a gain of $5,104 during the nine months ended September 30, 2024. The change in the fair value in the current period was attributed to changes in our forecasted stock price. The gain due to the change in fair value of the derivative liability during the nine months ended September 30, 2023 was due to changes in our stock price.
Gain from Extinguishment of Debt: The gain from extinguishment of debt was $49,205 and $69,407 during the nine months ended September 30, 2024 and 2023, respectively. The decrease of $20,202, or 29.1%, 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 $568 during the nine months ended September 30, 2024 and 2023, respectively. The change in other income was primarily due to an adjustment of a liability recorded during the nine months ended September 30, 2024.
Deemed Dividend for Warrant Exchanges: Expense for deemed dividends was nil and $65,296 in the nine months ended September 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 of $126,030 and $122,328 for the nine months ended September 30, 2024 and 2023, respectively, was materially consistent over the two periods.
Net Loss: Net loss attributable to common stockholders was $1,890,970 and $3,289,502 during the nine months ended September 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 nine months ended September 30, 2024 or 2023, due to recurring net operating losses.
LIQUIDITY AND CAPITAL RESOURCES
Going Concern Considerations
We have incurred significant losses since our inception. At September 30, 2024, the Company had negative working capital of approximately $5.0 million, accumulated deficit of $153.0 million, and incurred a net loss including preferred dividends of $1.9 million for the nine months then ended. Stockholders’ deficit totaled approximately $4.9 million at September 30, 2024, primarily due to recurring net losses from operations.
The risks and uncertainties surrounding our ability to continue our business with limited capital resources raise substantial doubt as to our ability to continue as a going concern for twelve months from the issuance of these financial statements. Our consolidated financial statements do not include any adjustments that might result if we are unable to continue as a going concern. If we are unable to continue as a going concern, the holders of our securities might lose their entire investment. These factors, among others, may make it difficult to raise any additional capital and may cause us to be unable to continue to operate our business.
The Company will need to continue to raise capital in order to provide funding for its operations and the 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 $1.5 million to $1.8 million of funds to operate our business over the next twelve months, including approximately $512 thousand 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 September 30, 2024, we had cash of approximately $194 thousand and negative working capital of $5.0 million. During the nine months ended September 30, 2024, our $1,13 million of 10% Senior Secured Convertible Debentures (the “Debentures”) went into default. After the May 17, 2024 maturity date, the interest rate on the Debentures increased to the default rate of 18.0%.
Our major cash flows for the nine months ended September 30, 2024 consisted of cash used for operating activities of $787 thousand, proceeds from the issuance of notes payable and common stock of $387 thousand and $300 thousand, respectively, and payments of debt and debt issuance costs of $297 thousand.
Our major cash flows for the nine months ended September 30, 2023 consisted of cash used for operating activities of $1.4 million, payments of debt of $367 thousand and proceeds from warrant exercises of $195 thousand.
The reduction in cash used in operating activities was primarily attributable to the timing of payments associated with our accounts payable and accrued liabilities and a $324 thousand increase to deferred revenue in the current period. The $562 thousand increase in cash provided by financing activities was attributed to a $358 increase in proceeds from issuance of notes payable, net of debt issuance costs, a $300 thousand increase in proceeds from the issuance of common stock, and a $99 thousand reduction in payments made on notes payable in the current year versus the prior.
On October 10, 2024, we issued a promissory note totaling $0.2 million to an unaffiliated third party (the “Holder”). The promissory note matures on October 10, 2025 and will accrue interest at a rate of 12.0% per annum. Monthly payments of $20 thousand are due on the note, beginning November 30, 2024 until August 31, 2025, while the interest payment is due on or before October 10, 2025. If not repaid by the maturity date, the unpaid balance of the note will accrue interest at a rate of 16.0% per annum. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium.
On October 21, 2024, we executed an agreement with SMI (the “Agreement”), which supersedes all previous agreements, other than existing purchase orders. Pursuant to the Agreement, the Company plans to execute a purchase agreement with a distributor of SMI for 35 base units, connected, aligned, calibrated and tested (“Completed Instrumentation Packages”). Under the terms of the agreement, the Handheld Unit and Base Unit constitute an Instrumentation Package or “IP”. An IP and mobile cart with a monitor constitute a fully functional LuViva device ready for sale. SMI will be responsible for the manufacture of the mobile carts that house the IPs and the display monitor. All active purchase orders will be revised to include 100 IPs to be provided by GTI to SMI and/or its distribution partners to meet expected demand for the end of 2024 and 2025, as summarized below:
| 1. | Forty-seven (47) of the 100 IPs will be provided by GTI to SMI, at an approximate price of $1,351,250; The number of IPs may be reduced if the full payment is delayed beyond the end of 2024. |
| 2. | Thirty-five (35) of the 100 IPs will be provided by GTI to SMI or to one of SMI’s distributors, at a total price of $700,000. |
| 3. | Eighteen (18) of the 100 IPs will be provided to SMI at no additional charge, beyond what has already been paid by SMI. |
Beginning in 2026 and extending into 2030, to preserve its licensing rights, SMI shall be committed to the minimum LuViva Cervical Guide Radio Frequency Identification Chips and Royalty Sales (“RFID Chips”) of the single-use Cervical Guide Chip, at a sale price to SMI at $1.00, as specified in the table below:
Year | | Cumulative Number of Devices Placed or Sold | | | Cumulative Resulting Minimum Tests | | | Cumulative Minimum Cervical Guide Royalty Payments to GTI | |
2026 | | | 300 | | | | 1,440,000 | | | $ | 1,440,000 | |
2027 | | | 400 | | | | 5,040,000 | | | $ | 4,480,000 | |
2028 | | 1500 | | | | 15,840,000 | | | $ | 15,840,000 | |
2029 | | 3000 | | | | 37,440,000 | | | $ | 37,440,000 | |
2030 | | 4000 | | | | 66,240,000 | | | $ | 66,240,000 | |
If by April 30, 2025, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva.
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 September 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 September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
On July 9, 2024, the Company granted 45,000 stock options to employees under the Plan and 500,000 stock options to executives and directors of the Company outside of the Plan. The stock options, which have exercise prices of $0.12, will expire on July 8, 2034. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on October 9, 2024.
On July 23, 2024, the Company issued a promissory note totaling $50,000 to an unaffiliated third party. The promissory note matures on February 1, 2025 and will accrue total interest of $5,000. The holder of the promissory note also received 60,000 common stock purchase warrants, which have an exercise price of $0.25 and will expire on August 1, 2028.
During the three months ended September 30, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. The promissory notes mature in the third quarter of 2025, at which time the principal and accrued interest payments are due in full. The promissory notes accrue interest at a rate of 9.0%. The holders of the promissory notes also received 75,000 common stock purchase warrants, which have exercise prices of $0.25 and will expire four years after issuance.
On September 1, 2024, the Company issued 900,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. The warrants, which will expire on September 1, 2027, have a strike price of $0.30.
On September 23, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors, including John Imhoff a member of the Company’s Board of Directors, for the purpose of raising $300,000 in gross proceeds for the Company. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell, in a private placement offering, an aggregate of 3,333,335 units, each unit consisting of one share of common stock and one warrant to purchase up to 3,333,335 shares of common stock (the “Warrants”). The purchase price per unit was $0.09. The Warrants were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.12 per share.
ITEM 3: DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4: MINE SAFETY DISCLOSURES.
Not applicable
ITEM 5: OTHER INFORMATION.
None.
ITEM 6. EXHIBITS
Exhibit Number | | Exhibit Description |
| | |
3.1 | | Restated Certificate of Incorporation, as amended through November 3, 2016 (incorporated by reference to Exhibit 3.1 to the annual report on Form 10-K filed March 15, 2016) |
3.2 | | Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed March 23, 2012) |
3.3 | | Amended and Restated Certificate of Incorporation, (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed November 15, 2018) |
3.4 | | Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.4 to the annual report on Form 10-K, filed April 20, 2020) |
3.5 | | Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the annual report on Form 10-K filed April 5, 2021) |
3.6 | | Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock (incorporated by reference to Exhibit 3.6 to the annual report on Form 10-K filed April 5, 2021) |
3.7 | | Certificate of Designation of Preferences, Rights and Limitations of Series F-2 Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on June 10, 2021) |
3.8 | | Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock (incorporated by reference to Exhibit 3.8 to the annual report on Form 10-K filed March 30, 2022) |
3.9 | | Certificate of Amendment to the Certificate of Incorporation of Guided Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on January 7, 2022) |
10.1 | | Form of Promissory Note issued to Directors |
10.2 | | Promissory Note, dated July 23, 2024, in the amount of $50,000 |
10.3 | | Common Stock Purchase Warrant, dated August 1, 2024 |
10.4 | | Form of Common Stock Purchase Warrants issued to Directors |
31* | | Rule 13a-14(a)/15d-14(a) Certification |
32* | | Section 1350 Certification |
101.1* | | Interactive data files for Guided Therapeutics, Inc. 's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL: (i) the Unaudited Condensed Consolidated Balance Sheets; (ii) the Unaudited Condensed Consolidated Statements of Income; (iii) the Unaudited Condensed Consolidated Statements in Stockholders' Deficit; (iv) the Unaudited Condensed Consolidated Statements of Cash Flows; and (v) the Notes to the Unaudited Condensed Consolidated Financial Statements. |
104 | | The cover page from Guided Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (formatted in Inline XBRL and included in Exhibit 101) |
______________
*Filed herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GUIDED THERAPEUTICS, INC. | |
| | |
By: | /s/ Mark Faupel | |
| Mark Faupel | |
| President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer | |
Date: November 14, 2024
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v3.24.3
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 194
|
$ 591
|
Trade receivables, net of allowance for doubtful accounts of nil and $2 at September 30, 2024 and December 31, 2023, respectively. |
2
|
7
|
Inventory, net of reserves of $818 at September 30, 2024 and December 31, 2023 |
636
|
632
|
Other current assets |
211
|
163
|
Total current assets |
1,043
|
1,393
|
Non-Current Assets: |
|
|
Property and equipment, net |
25
|
32
|
Operating lease right-of-use assets, net of amortization |
164
|
227
|
Other assets |
17
|
17
|
Total non-current assets |
206
|
276
|
TOTAL ASSETS |
1,249
|
1,669
|
Current Liabilities: |
|
|
Accounts payable |
2,100
|
1,991
|
Accounts payable, related parties |
32
|
32
|
Accrued liabilities |
923
|
1,068
|
Deferred revenue |
748
|
424
|
Current portion of lease liability |
102
|
91
|
Short-term notes payable due to related parties |
68
|
0
|
Current portion of long-term debt, related parties |
525
|
39
|
Short-term notes payable |
228
|
59
|
Short-term convertible debt |
149
|
1,105
|
Short-term convertible debt in default |
1,130
|
0
|
Derivative liability at fair value |
20
|
0
|
Total current liabilities |
6,025
|
4,809
|
Long-Term Liabilities, Net of Current Portion |
|
|
Long-term lease liability |
76
|
155
|
Long-term notes payable |
53
|
0
|
Long-term debt, related parties |
13
|
511
|
Total long-term liabilities |
142
|
666
|
Total liabilities |
6,167
|
5,475
|
STOCKHOLDERS' DEFICIT: |
|
|
Common stock, $.001 par value; 500,000 shares authorized, 60,457 and 54,105 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. |
3,446
|
3,441
|
Additional paid-in capital |
141,757
|
140,983
|
Treasury stock at cost |
(132)
|
(132)
|
Accumulated deficit |
(153,009)
|
(151,118)
|
Total stockholders' deficit |
(4,918)
|
(3,806)
|
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT |
1,249
|
1,669
|
Series C Convertible Preferred Shares [Member] |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
105
|
105
|
Series C1 Convertible Preferred Shares [Member] |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
170
|
170
|
Series C2 Convertible Preferred Shares [Member] |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
439
|
439
|
Series F-2 Convertible Preferred Shares [Member] |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
475
|
475
|
Series D Convertible Preferred Shares |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
159
|
159
|
Series E Convertible Preferred Shares |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
834
|
834
|
Series F Convertible Preferred Shares |
|
|
STOCKHOLDERS' DEFICIT: |
|
|
Preferred stock, value |
$ 838
|
$ 838
|
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v3.24.3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Accounts receivable, net of allowance |
$ 0
|
$ 2,000
|
Inventory, net of reserves |
$ 818,000
|
$ 818,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, authorized |
500,000,000
|
500,000,000
|
Common stock, issued |
60,457,000
|
54,105,000
|
Common stock, outstanding |
60,457,000
|
54,105,000
|
Series C Convertible Preferred Shares [Member] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
9,000.0
|
9,000.0
|
Preferred stock, liquidation preference |
$ 286,000
|
$ 286,000
|
Preferred stock, issued |
300
|
300.0
|
Preferred stock, outstanding |
300.0
|
300.0
|
Series F-2 Convertible Preferred Shares [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
5,000.0
|
5,000.0
|
Preferred stock, liquidation preference |
$ 520,000
|
$ 520,000
|
Preferred stock, issued |
500
|
500.0
|
Preferred stock, outstanding |
500.0
|
500.0
|
Series D Convertible Preferred Shares |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
6,000.0
|
6,000.0
|
Preferred stock, liquidation preference |
$ 438,000
|
$ 438,000
|
Preferred stock, issued |
400
|
400.0
|
Preferred stock, outstanding |
400.0
|
400.0
|
Series E Convertible Preferred Shares |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
5,000.0
|
5,000.0
|
Preferred stock, liquidation preference |
$ 883,000
|
$ 883,000
|
Preferred stock, issued |
900
|
900.0
|
Preferred stock, outstanding |
900.0
|
900.0
|
Series F Convertible Preferred Shares |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
1,500
|
1,500.0
|
Preferred stock, liquidation preference |
$ 1,006,000
|
$ 1,006,000
|
Preferred stock, issued |
1,100
|
1,100.0
|
Preferred stock, outstanding |
1,100.0
|
1,100.0
|
Series C-1 Convertible Preferred Shares |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
20,300
|
20,300.0
|
Preferred stock, liquidation preference |
$ 1,049,000
|
$ 1,049,000
|
Preferred stock, issued |
1,000.0
|
1,000.0
|
Preferred stock, outstanding |
1,000.0
|
1,000.0
|
Series C-2 Convertible Preferred Shares |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
5,000,000
|
5,000,000
|
Preferred stock, liquidation preference |
$ 2,700,000
|
$ 2,700,000
|
Preferred stock, issued |
2,700
|
2,700.0
|
Preferred stock, outstanding |
2,700.0
|
2,700.0
|
X |
- DefinitionThe per share liquidation preference (or restrictions) of nonredeemable preferred stock (or preferred stock redeemable solely at the option of the issuer) that has a preference in involuntary liquidation considerably in excess of the par or stated value o
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v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) |
|
|
|
|
Sales - devices and disposables |
$ 0
|
$ 0
|
$ 6
|
$ 66
|
Cost of goods sold |
0
|
4
|
2
|
46
|
Gross profit |
0
|
(4)
|
4
|
20
|
Operating expenses: |
|
|
|
|
Research and development |
111
|
69
|
386
|
142
|
Sales and marketing |
76
|
69
|
218
|
203
|
General and administrative |
374
|
481
|
974
|
2,647
|
Total operating expenses |
561
|
619
|
1,578
|
2,992
|
Loss from operations |
(561)
|
(623)
|
(1,574)
|
(2,972)
|
Other income (expenses): |
|
|
|
|
Interest expense |
(108)
|
(71)
|
(247)
|
(206)
|
Interest income |
0
|
0
|
3
|
0
|
Change in fair value of derivative liability |
(1)
|
0
|
(8)
|
5
|
Gain from extinguishment of debt |
16
|
17
|
49
|
69
|
Other income |
0
|
0
|
12
|
1
|
Total other income (expense) |
(93)
|
(54)
|
(191)
|
(131)
|
Loss before income taxes |
(654)
|
(677)
|
(1,765)
|
(3,103)
|
Provision for income taxes |
0
|
0
|
0
|
0
|
Net loss |
(654)
|
(677)
|
(1,765)
|
(3,103)
|
Deemed dividend for warrant exchanges |
0
|
0
|
0
|
(65)
|
Preferred stock dividends |
(38)
|
(40)
|
(126)
|
(122)
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ (692)
|
$ (717)
|
$ (1,891)
|
$ (3,290)
|
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS |
|
|
|
|
Basic |
$ (0.01)
|
$ (0.01)
|
$ (0.03)
|
$ (0.07)
|
Diluted |
$ (0.01)
|
$ (0.01)
|
$ (0.03)
|
$ (0.07)
|
Weighted average shares outstanding |
|
|
|
|
Weighted average shares outstanding - Basic |
57,039
|
51,473
|
55,929
|
50,588
|
Weighted average shares outstanding - Diluted |
57,039
|
51,473
|
55,929
|
50,588
|
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v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS DEFICIT (unaudited) - USD ($) shares in Thousands |
Total |
Preferred Stock Series C [Member] |
Preferred Stock Series C1 [Member] |
Preferred Stock Series C2 [Member] |
Preferred Stock Series D [Member] |
Preferred Stock Series E [Member] |
Preferred Stock Series F [Member] |
Preferred Stock Series F2 [Member] |
Common Stock |
Additional Paid-In Capital |
Retained Earnings (Accumulated Deficit) |
Treasury Stock |
Balance, shares at Dec. 31, 2022 |
|
|
1
|
2
|
1
|
1
|
1
|
3
|
48,596
|
|
|
|
Balance, amount at Dec. 31, 2022 |
$ (2,883,000)
|
$ 105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 839,000
|
$ 880,000
|
$ 489,000
|
$ 3,437,000
|
$ 138,090,000
|
$ (147,359,000)
|
$ (132,000)
|
Common stock warrants exercised, shares |
|
|
|
|
|
|
|
|
1,120
|
|
|
|
Common stock warrants exercised, amount |
231,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
230,000
|
0
|
0
|
Issuance of common stock for payment of Series D preferred dividends, shares |
|
|
|
|
|
|
|
|
97
|
|
|
|
Issuance of common stock for payment of Series D preferred dividends, amount |
22,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
22,000
|
0
|
0
|
Issuance of common stock for payment of Series E preferred dividends, shares |
|
|
|
|
|
|
|
|
379
|
|
|
|
Issuance of common stock for payment of Series E preferred dividends, amount |
61,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
61,000
|
0
|
0
|
Issuance of common stock for payment of Series F preferred dividends, shares |
|
|
|
|
|
|
|
|
233
|
|
|
|
Issuance of common stock for payment of Series F preferred dividends, amount |
53,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
53,000
|
0
|
0
|
Issuance of common stock for payment of Series F-2 preferred dividends, shares |
|
|
|
|
|
|
|
|
121
|
|
|
|
Issuance of common stock for payment of Series F-2 preferred dividends, amount |
29,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
29,000
|
0
|
0
|
Conversion of Series E preferred stock to common stock, shares |
|
|
|
|
|
|
|
|
20
|
|
|
|
Conversion of Series E preferred stock to common stock, amount |
0
|
0
|
0
|
0
|
0
|
(5,000)
|
0
|
0
|
$ 0
|
5,000
|
0
|
0
|
Conversion of Series F preferred stock to common stock, shares |
|
|
|
|
|
|
|
|
200
|
|
|
|
Conversion of Series F preferred stock to common stock, amount |
0
|
0
|
0
|
0
|
0
|
0
|
(42,000)
|
0
|
$ 0
|
42,000
|
0
|
0
|
Conversion of Series F-2 preferred stock to common stock, shares |
|
|
|
|
|
|
|
|
60
|
|
|
|
Conversion of Series F-2 preferred stock to common stock, amount |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
(14,000)
|
$ 0
|
14,000
|
0
|
0
|
Issuance of common stock for payment of interest, shares |
|
|
|
|
|
|
|
|
418
|
|
|
|
Issuance of common stock for payment of interest, amount |
119,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
119,000
|
0
|
0
|
Settlement of previously accrued professional fees through common stock issuance, shares |
|
|
|
|
|
|
|
|
800
|
|
|
|
Settlement of previously accrued professional fees through common stock issuance, amount |
168,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
167,000
|
0
|
0
|
Stock-based compensation |
1,776,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1,776,000
|
0
|
0
|
Impact of warrant exchanges |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
65,000
|
(65,000)
|
0
|
Accrued preferred dividends |
(123,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
(1,000)
|
(122,000)
|
0
|
Net loss |
(3,103,000)
|
0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
0
|
(3,103,000)
|
0
|
Balance, shares at Sep. 30, 2023 |
|
|
1
|
2
|
1
|
1
|
1
|
3
|
52,042
|
|
|
|
Balance, amount at Sep. 30, 2023 |
(3,650,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
$ 475,000
|
$ 3,439,000
|
140,672,000
|
(150,649,000)
|
(132,000)
|
Balance, shares at Jun. 30, 2023 |
|
|
1
|
2
|
1
|
1
|
1
|
3
|
51,011
|
|
|
|
Balance, amount at Jun. 30, 2023 |
(3,315,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
$ 475,000
|
$ 3,438,000
|
140,291,000
|
(149,932,000)
|
(132,000)
|
Issuance of common stock for payment of Series D preferred dividends, shares |
|
|
|
|
|
|
|
|
38
|
|
|
|
Issuance of common stock for payment of Series D preferred dividends, amount |
8,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
8,000
|
0
|
0
|
Issuance of common stock for payment of Series E preferred dividends, shares |
|
|
|
|
|
|
|
|
353
|
|
|
|
Issuance of common stock for payment of Series E preferred dividends, amount |
53,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
53,000
|
0
|
0
|
Issuance of common stock for payment of interest, shares |
|
|
|
|
|
|
|
|
240
|
|
|
|
Issuance of common stock for payment of interest, amount |
60,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
60,000
|
0
|
0
|
Settlement of previously accrued professional fees through common stock issuance, shares |
|
|
|
|
|
|
|
|
400
|
|
|
|
Settlement of previously accrued professional fees through common stock issuance, amount |
51,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
50,000
|
0
|
0
|
Stock-based compensation |
210,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
210,000
|
0
|
0
|
Accrued preferred dividends |
(40,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
(40,000)
|
0
|
Net loss |
(677,000)
|
0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
0
|
(677,000)
|
0
|
Balance, shares at Sep. 30, 2023 |
|
|
1
|
2
|
1
|
1
|
1
|
3
|
52,042
|
|
|
|
Balance, amount at Sep. 30, 2023 |
(3,650,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
$ 475,000
|
$ 3,439,000
|
140,672,000
|
(150,649,000)
|
(132,000)
|
Balance, shares at Dec. 31, 2023 |
|
|
1
|
2
|
1
|
1
|
1
|
|
54,105
|
|
|
|
Balance, amount at Dec. 31, 2023 |
(3,806,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
475,000
|
$ 3,441,000
|
140,983,000
|
(151,118,000)
|
(132,000)
|
Issuance of common stock for payment of Series D preferred dividends, shares |
|
|
|
|
|
|
|
|
196
|
|
|
|
Issuance of common stock for payment of Series D preferred dividends, amount |
24,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
24,000
|
0
|
0
|
Issuance of common stock for payment of Series E preferred dividends, shares |
|
|
|
|
|
|
|
|
625
|
|
|
|
Issuance of common stock for payment of Series E preferred dividends, amount |
63,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
62,000
|
0
|
0
|
Issuance of common stock for payment of Series F preferred dividends, shares |
|
|
|
|
|
|
|
|
445
|
|
|
|
Issuance of common stock for payment of Series F preferred dividends, amount |
54,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
54,000
|
0
|
0
|
Issuance of common stock for payment of Series F-2 preferred dividends, shares |
|
|
|
|
|
|
|
|
236
|
|
|
|
Issuance of common stock for payment of Series F-2 preferred dividends, amount |
27,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
27,000
|
0
|
0
|
Issuance of common stock for payment of interest, shares |
|
|
|
|
|
|
|
|
1,117
|
|
|
|
Issuance of common stock for payment of interest, amount |
126,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
125,000
|
0
|
0
|
Settlement of previously accrued professional fees through common stock issuance, shares |
|
|
|
|
|
|
|
|
400
|
|
|
|
Settlement of previously accrued professional fees through common stock issuance, amount |
57,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
57,000
|
0
|
0
|
Stock-based compensation |
101,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
101,000
|
0
|
0
|
Accrued preferred dividends |
(126,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
(126,000)
|
0
|
Net loss |
(1,765,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
0
|
(1,765,000)
|
0
|
Issuance of common stock and warrants in private placement offering, net of expenses, shares |
|
|
|
|
|
|
|
|
3,333
|
|
|
|
Issuance of common stock and warrants in private placement offering, net of expenses, amount |
300,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 3,000
|
297,000
|
0
|
0
|
Issuance of warrants with debt |
27,000
|
0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
0
|
$ 0
|
27,000
|
0
|
0
|
Balance, shares at Sep. 30, 2024 |
|
|
1
|
2
|
1
|
1
|
1
|
|
60,457
|
|
|
|
Balance, amount at Sep. 30, 2024 |
(4,918,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
475,000
|
$ 3,446,000
|
141,757,000
|
(153,009,000)
|
(132,000)
|
Balance, shares at Jun. 30, 2024 |
|
|
1
|
2
|
1
|
1
|
1
|
|
56,267
|
|
|
|
Balance, amount at Jun. 30, 2024 |
(4,667,000)
|
105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
475,000
|
$ 3,442,000
|
141,320,000
|
(152,317,000)
|
(132,000)
|
Issuance of common stock for payment of Series D preferred dividends, shares |
|
|
|
|
|
|
|
|
71
|
|
|
|
Issuance of common stock for payment of Series D preferred dividends, amount |
9,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
9,000
|
0
|
0
|
Issuance of common stock for payment of Series E preferred dividends, shares |
|
|
|
|
|
|
|
|
573
|
|
|
|
Issuance of common stock for payment of Series E preferred dividends, amount |
55,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 1,000
|
54,000
|
0
|
0
|
Issuance of common stock for payment of interest, shares |
|
|
|
|
|
|
|
|
213
|
|
|
|
Issuance of common stock for payment of interest, amount |
21,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
21,000
|
0
|
0
|
Stock-based compensation |
41,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
41,000
|
0
|
0
|
Accrued preferred dividends |
(38,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
(38,000)
|
0
|
Net loss |
(654,000)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 0
|
0
|
(654,000)
|
0
|
Issuance of common stock and warrants in private placement offering, net of expenses, shares |
|
|
|
|
|
|
|
|
3,333
|
|
|
|
Issuance of common stock and warrants in private placement offering, net of expenses, amount |
300,000
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
$ 3,000
|
297,000
|
0
|
0
|
Issuance of warrants with debt |
15,000
|
0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
0
|
$ 0
|
15,000
|
0
|
0
|
Balance, shares at Sep. 30, 2024 |
|
|
1
|
2
|
1
|
1
|
1
|
|
60,457
|
|
|
|
Balance, amount at Sep. 30, 2024 |
$ (4,918,000)
|
$ 105,000
|
$ 170,000
|
$ 439,000
|
$ 159,000
|
$ 834,000
|
$ 838,000
|
$ 475,000
|
$ 3,446,000
|
$ 141,757,000
|
$ (153,009,000)
|
$ (132,000)
|
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v3.24.3
ORGANIZATION BACKGROUND AND BASIS OF PRESENTATION
|
9 Months Ended |
Sep. 30, 2024 |
ORGANIZATION BACKGROUND AND BASIS OF PRESENTATION |
|
ORGANIZATION, BACKGROUND, AND BASIS OF PRESENTATION |
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 September 30, 2024 and December 31, 2023, and the consolidated results of operations and cash flows for the three and nine-month periods ended September 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 September 30, 2024, it had an accumulated deficit of approximately $153.0 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. Going Concern The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty. At September 30, 2024, the Company had a negative working capital of approximately $5.0 million, accumulated deficit of $153.0 million, and incurred a net loss including preferred dividends of $1.9 million for the nine months then ended. Stockholders’ deficit totaled approximately $4.9 million at September 30, 2024, primarily due to recurring net losses from operations. During the year ended December 31, 2023, the Company received $0.4 million of proceeds from warrant exercises. During the nine months ended September 30, 2024, the Company received $0.4 million of proceeds from the issuance of promissory notes payable and $0.3 million of proceeds from the sale of common stock. The Company will need to continue to raise capital in order to provide funding for its operations and FDA/NMPA 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. Reclassifications Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications did not affect net loss, revenues and stockholders’ equity.
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v3.24.3
SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 30, 2024 |
SIGNIFICANT ACCOUNTING POLICIES |
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SIGNIFICANT ACCOUNTING POLICIES |
2. SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the inventory valuation, valuation of share-based compensation and the valuation of the convertible note payable derivative liability. Management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to the Company’s financial statements. 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 The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was nil and $156,112 as of September 30, 2024 and December 31, 2023, respectively. 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 September 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 September 30, 2024 and December 31, 2023: | | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Raw materials | | $ | 1,364 | | | $ | 1,360 | | Work-in-progress | | | 46 | | | | 46 | | Finished goods | | | 44 | | | | 44 | | Inventory reserve | | | (818 | ) | | | (818 | ) | | | | | | | | | | Total inventory | | $ | 636 | | | $ | 632 | |
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 September 30, 2024 and December 31, 2023: | | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Equipment | | $ | 951 | | | $ | 951 | | Software | | | 634 | | | | 634 | | Furniture and fixtures | | | 17 | | | | 17 | | Leasehold improvements | | | 12 | | | | 12 | | | | | | | | | | | Subtotal | | | 1,614 | | | | 1,614 | | Less accumulated depreciation | | | (1,589 | ) | | | (1,582 | ) | Property, equipment and leasehold improvements, net | | $ | 25 | | | $ | 32 | |
Depreciation expense related to property and equipment for the three and nine months ended September 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 nine months ended September 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.” Accrued Liabilities Accrued liabilities as of September 30, 2024 and December 31, 2023 are summarized as follows: | | (in thousands) | | | | September 30, 2024 | | | December 31, 2023 | | | | | | | | | Compensation | | $ | 383 | | | $ | 401 | | Professional fees | | | 126 | | | | 216 | | Interest | | | 188 | | | | 188 | | Vacation | | | 31 | | | | 27 | | Preferred dividends | | | 188 | | | | 228 | | Other accrued expenses | | | 7 | | | | 8 | | | | | | | | | | | Total | | $ | 923 | | | $ | 1,068 | |
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 must be 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. |
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 $747,780, $424,225, and $509,101 as of September 30, 2024, December 31, 2023 and December 31, 2022, respectively. Significant Customers As of September 30, 2024, trade receivables of $2,047 (net of the allowance for credit losses of $450) were attributed to one customer. As of December 31, 2023, accounts receivable of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers. Research and Development Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred. Income Taxes The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company has filed its 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 September 30, 2024, the Company had approximately $66.4 million of net operating losses carryforward available, $3.8 million of which will expire on December 31, 2024. The remaining net operating loss will be eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related to the deferred tax assets generated from the net operating losses. 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 50.0% likely of being ultimately realized upon settlement. The tax position is derecognized when it is no longer more likely than not of being sustained. The Company classifies income tax related interest and penalties as interest expense and selling, general and administrative expense, respectively, on the consolidated statements of operations. 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 nine months ended September 30, 2024, the Company recognized $60,860 of expense for stock options and $41,242 of expense for warrants issued to a director. Additionally, during the nine months ended September 30, 2024, the Company accrued $30,889 of expense for common stock owed to a director, pursuant to his consulting agreement. During the nine months ended September 30, 2023, the Company recognized $221,143 of expense related to stock options, $9,333 of expense for stock issued to consultants and executives and $1,546,089 of expense for warrants issued to consultants and executives. Additionally, during the nine months ended September 30, 2023, the Company accrued $83,301 of expense for common stock owed to a director, pursuant to his consulting agreement. 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, which is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense. Fair Value Measurements ASC 820, “Fair Value Measurements and Disclosures,” clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that should be determined based upon assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: | · | Level 1: Quoted prices for identical assets or liabilities in active markets that the Company can access at the measurement date. | | | | | · | Level 2: Significant other observable inputs other than level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data. | | | | | · | Level 3: Significant unobservable inputs that reflect the Company’s judgment about the assumptions that market participants would use in pricing an asset or liability. |
An asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. Assets and liabilities measured at fair value are based on one or more of the following three valuation techniques noted in ASC 820: | · | Market approach: Prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. | | | | | · | Cost approach: Amount that would be required to replace the service capacity of an asset (replacement cost). | | | | | · | Income approach: Techniques to convert future amounts to a single present value amount |
The Company believes its valuation methods are appropriate and consistent with other market participants, however the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.3
STOCKHOLDERS DEFICIT
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9 Months Ended |
Sep. 30, 2024 |
STOCKHOLDERS' DEFICIT: |
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STOCKHOLDERS' DEFICIT |
3. STOCKHOLDERS’ DEFICIT September Private Placement Offering On September 23, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors, including John Imhoff a member of the Company’s Board of Directors, for the purpose of raising $300,000 in gross proceeds for the Company. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell, in a private placement offering, an aggregate of 3,333,335 units, each unit consisting of one share of common stock and one warrant to purchase up to 3,333,335 shares of common stock (the “Warrants”). The purchase price per unit was $0.09. The Warrants were immediately exercisable upon issuance, expire four years following the issuance date and have an exercise price of $0.12 per share. Common Stock The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of September 30, 2024 and December 31, 2023, 60,456,884 and 54,105,101 shares of common stock were issued and outstanding, respectively. During the nine months ended September 30, 2024, the Company issued 6,351,783 shares of common stock, as summarized below: | | Number of Shares | | Issuance of common stock in private placement offering | | | 3,333,335 | | Issuance of common stock for payment of Series D preferred dividends | | | 196,063 | | Issuance of common stock for payment of Series E preferred dividends | | | 625,511 | | Issuance of common stock for payment of Series F preferred dividends | | | 444,621 | | Issuance of common stock for payment of Series F-2 preferred dividends | | | 235,544 | | Issuance of common stock for payment of interest | | | 1,116,709 | | Issuance of common stock to consultants | | | 400,000 | | Total common stock issued during the nine months ended September 30, 2024 | | | 6,351,783 | | | | | | | Summary table of common stock transactions: | | | | | Shares outstanding at December 31, 2023 | | | 54,105,101 | | Common shares issued during the nine months ended September 30, 2024 | | | 6,351,783 | | Shares outstanding at September 30, 2024 | | | 60,456,884 | |
Preferred Stock The Company has authorized 5,000,000 shares of preferred stock with a $0.001 par value. The board of directors has the authority to issue these shares and to set dividends, voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions. Series C Convertible Preferred Stock The board designated 9,000 shares of preferred stock as Series C Convertible Preferred Stock, (the “Series C Preferred Stock”). Pursuant to the Series C certificate of designations, shares of Series C Preferred Stock are convertible into common stock by their holder at any time and may be mandatorily convertible upon the achievement of specified average trading prices for the Company’s common stock. At September 30, 2024 and December 31, 2023, there were 286 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock for a total of 572,000 shares, subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt. Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in cash or, subject to certain conditions, the Company’s common stock. Unpaid accrued dividends were $120,120 as of September 30, 2024 and December 31, 2023. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At September 30, 2024 and December 31, 2023, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock. 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 $1,000, plus any accrued but unpaid dividends. Series C1 Convertible Preferred Stock The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at September 30, 2024 and December 31, 2023. The C1 Convertible Preferred Stock has a conversion price of $0.50 per share, such that each share would convert into approximately 2,000 shares of the Company’s common stock, for a total of 2,098,500 shares of common stock. 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 3,262.25 shares of Series C1 Convertible Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Convertible Preferred Stock. At September 30, 2024 and December 31, 2023, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C2 preferred stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares. 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 ($1,000 per share) of such share of Series C2 Preferred Stock by the purchase price of the securities sold in the Qualified Financing. Series D Convertible Preferred Stock The board designated 6,000 shares of preferred stock as Series D Preferred Stock, 438 of which remained outstanding as of September 30, 2024 and December 31, 2023. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer (now the Chief Executive Officer) and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock, 1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. Each Series D Preferred Stock is convertible into 3,000 shares of common stock. The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750. Each share of Series D Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series D Certificate of Designation (the “Series D Conversion Price”). The conversion of Series D Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series D Preferred. If the average of the VWAPs (as defined in the Series D Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series D Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series D Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. During the nine months ended September 30, 2024, the Company issued 196,063 shares of common stock for payment of accrued Series D Preferred Stock dividends. As of September 30, 2024, and December 31, 2023, the Company had accrued dividends for the Series D Preferred Stock of $8,360. Series E Convertible Preferred Stock The Board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 of which remained outstanding as of September 30, 2024 and December 31, 2023. During year ended December 31, 2020, the Company entered into a Security Agreement with the Series E Investors (the “Series E Security Agreement”) pursuant to which all obligations under the Series E Certificate of Designation are secured by all of the Company’s assets and personal properties, with certain accredited investors. In total, for $1,736,000 the Company issued 1,736 shares of Series E Preferred Stock. Each Series E Preferred Stock is convertible into 4,000 common stock shares. The stated value and liquidation preference on the Series E Preferred Stock is $1,736. Each share of Series E Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series E Certificate of Designation (the “Series E Conversion Price”). The conversion of Series E Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series E Preferred. If the average of the VWAPs (as defined in the Series E Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series E Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series E Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. Each share of Series E Preferred Stock has a par value of $0.001 per share and a stated value equal to $1,000, subject to the increase set forth in its Certificate of Designation. Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of 8% per annum, payable annually in cash or, at the option of the Company, shares of common stock. During the nine months ended September 30, 2024, the Company issued 625,511 shares of common stock for payment of accrued Series E Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends of $12,612 and $30,272 for the Series E Preferred Stock, respectively. Series F Convertible Preferred Stock The Board designated 1,500 shares of preferred stock as Series F Preferred Stock, 1,006 of which remained outstanding as of September 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series F Investors”). In total, for $1,436,000 the Company issued 1,436 shares of Series F Preferred Stock. Each Series F Preferred Stock is convertible into 4,000 shares of common stock. The Series F Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Preferred Stock is $1,000. Each share of Series F Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F Certificate of Designation (the “Series F Conversion Price”). The conversion of Series F Preferred Stock is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends. During the nine months ended September 30, 2024, the Company issued 444,621 shares of common stock for the payment of annual Series F Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F preferred shares of $30,851 and $46,108, respectively. 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 3,500 shares of preferred stock as Series F-2 Preferred Stock, 520 of which were issued and outstanding as of September 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. Each Series F-2 Preferred share is convertible into 4,000 shares of common stock. The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000. Each share of Series F-2 Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F-2 Certificate of Designation (the “Series F-2 Conversion Price”). The conversion of Series F-2 Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F-2 Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F-2 Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F-2 Preferred Stock, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. During the nine months ended September 30, 2024, the Company issued 235,544 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. As of September 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F-2 preferred shares of $15,718 and $23,579, respectively. Warrants The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the nine months ended September 30, 2024 and 2023: | | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | | | | | | | Outstanding, December 31, 2023 | | | 28,584,580 | | | $ | 0.50 | | Warrants issued | | | 5,368,335 | | | | 0.19 | | Warrants expired | | | (1,561,500 | ) | | | 0.44 | | Outstanding, September 30, 2024 | | | 32,391,415 | | | $ | 0.46 | |
| | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | | | | | | | Outstanding, December 31, 2022 | | | 35,586,980 | | | $ | 0.46 | | Warrants issued | | | 6,773,750 | | | | 0.26 | | Warrants exchanged | | | (1,025,000 | ) | | | 0.25 | | Warrants expired | | | (9,545,200 | ) | | | 0.30 | | Warrants exercised | | | (973,750 | ) | | | 0.20 | | Outstanding, September 30, 2023 | | | 30,816,780 | | | $ | 0.49 | |
Warrants Issued in 2024 During the nine months ended September 30, 2024, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information. During the nine months ended September 30, 2024, the Company issued 160,000 warrants in conjunction with the issuance of $150,000 in notes payable to unaffiliated third parties and 75,000 warrants in conjunction with issuances of $75,000 of notes payable to board members. See Note 7, “Short-Term Notes Payable” and Note 9, “Related Party Debt” for additional details on the warrants issued with debt. During the nine months ended September 30, 2024, the Company issued 3,333,335 warrants in connection with the private placement offering that closed on September 23, 2024, 1,666,677 of which were issued to one of our board members, a related party. Management estimated the fair value of the warrants utilizing the Black-Scholes Option Pricing model with the following assumptions before allocating the total proceeds from the offering to the common stock and warrants issued: Expected term (years) | | | 4.0 | | Volatility | | | 397.3 | % | Risk-free interest rate | | | 3.5 | % | Dividend yield | | | 0.0 | % |
Warrants Issued in 2023 On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, were fully vested on the issuance date and will expire on May 13, 2028. During the nine months ended September 30, 2023, the Company recorded approximately $679,959 of stock-based compensation expense attributed to the warrants. On May 14, 2023, the Compensation Committee of the Company’s Board of Directors also approved the issuance of 4,000,000 common stock warrants to Mark Faupel, 2,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter from the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan and 1,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter or equivalent from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. The warrants, which have a strike price of $0.40, will expire five years after they are exercisable with a maximum term of 10 years from issuance. As of September 30, 2024, the Company has concluded it is not probable that the performance conditions related to the warrants will be achieved, and as a result no compensation expense related to the warrants has been recorded. During the nine months ended September 30, 2023, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information. During the nine months ended September 30, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants, pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. The Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296. During the nine months ended September 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) | 3.8 | Volatility | | 266.4% | Risk-free interest rate | 3.8% | Dividend yield | 0.0% |
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- DefinitionThe entire disclosure for equity.
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v3.24.3
STOCK OPTIONS
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9 Months Ended |
Sep. 30, 2024 |
STOCK OPTIONS |
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STOCK OPTIONS |
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 2,500,000 common shares. As of September 30, 2024, shares available for issuance under the Plan were 116,364. The following tables summarize the Company’s stock option activity and related information for the nine months ended September 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 | | | 2,338,636 | | | $ | 0.41 | | | 6.5 years | | $ | - | | Options granted | | | 545,000 | | | $ | 0.12 | | | | | | | | Options outstanding as of September 30, 2024 | | | 2,883,636 | | | $ | 0.35 | | | 6.6 years | | $ | 29,975 | | Options exercisable as of September 30, 2024 | | | 2,172,614 | | | $ | 0.41 | | | 5.7 years | | $ | 7,494 | |
| | 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 | | | 1,500,000 | | | $ | 0.49 | | | 7.5 years | | $ | - | | Options granted | | | 1,025,000 | | | $ | 0.26 | | | | | | | | Options forfeited | | | (186,364 | ) | | $ | 0.31 | | | | | | | | Options outstanding as of September 30, 2023 | | | 2,338,636 | | | $ | 0.41 | | | 6.8 years | | $ | - | | Options exercisable as of September 30, 2023 | | | 1,811,364 | | | $ | 0.45 | | | 6.0 years | | $ | - | |
The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of September 30, 2024 and the exercise price, multiplied by the number of options. As of September 30, 2024, there was $128,792 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately 2.0 years. The weighted-average fair value of awards granted was $0.12 and $0.26 during the nine months ended September 30, 2024 and 2023, respectively. The Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period. During the nine months ended September 30, 2024 and 2023, the Company recognized expense for stock options of $60,860 and $221,143, respectively. 2024 Stock Option Activity On July 9, 2024, the Company granted 45,000 stock options to employees under the Plan and 500,000 stock options to executives and directors of the Company outside of the Plan. The stock options, which have exercise prices of $0.12, will expire on July 8, 2034. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on October 9, 2024. The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the nine months ended September 30, 2024: Expected term (years) | | | 6.1 | | Volatility | | | 797.4 | % | Risk-free interest rate | | | 4.2 | % | Dividend yield | | | - | |
2023 Stock Option Activity On February 10, 2023, the Company granted 925,000 stock options to employees, executives and directors of the Company. The stock options, which have exercise prices of $0.2629, will expire on February 9, 2033. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on May 10, 2023. On March 7, 2023, the Company granted 100,000 stock options, which have exercise prices of $0.27 and will expire on March 6, 2033, to Alan Grujic, upon appointing him to the Board of Directors. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on June 7, 2023. The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the nine months ended September 30, 2023: Expected term (years) | | | 10.0 | | Volatility | | | 366.4 | % | Risk-free interest rate | | | 3.8 | % | Dividend yield | | | 0.00 | |
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 186,364 unvested stock options. On May 2, 2023, the Company’s Board of Directors approved an extension of the expiration date of Mr. Cartwright’s vested options to June 1, 2025. Management measured the modified stock option award using the Black-Scholes option pricing model and recorded expense of $59,216 during the nine months ended September 30, 2023, representing the excess fair value of the modified award over the original award. Management estimated the fair value of the modified award using the Black-Scholes option pricing model and the following assumptions: Expected term (years) | | | 2.0 | | Volatility | | | 182.8 | % | Risk-free interest rate | | | 4.0 | % | Dividend yield | | | 0.0 | % |
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.3
LITIGATION AND CLAIMS
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9 Months Ended |
Sep. 30, 2024 |
LITIGATION AND CLAIMS |
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LITIGATION AND CLAIMS |
5. LITIGATION AND CLAIMS From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular year. As of September 30, 2024, and December 31, 2023, there was no accrual recorded for any potential losses related to pending litigation.
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v3.24.3
COMMITMENTS AND CONTINGENCIES
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9 Months Ended |
Sep. 30, 2024 |
COMMITMENTS AND CONTINGENCIES |
|
COMMITMENTS AND CONTINGENCIES |
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 year and was $27,351 and $82,053 for the three and nine months ended September 30, 2024, respectively. The below table presents total operating lease right-of-use assets and lease liabilities as of September 30, 2024 and December 31, 2023: | | (in thousands) | | | | September 30, | | | December 31 | | | | 2024 | | | 2023 | | Operating lease right-of-use assets | | $ | 164 | | | $ | 227 | | Operating lease liabilities | | $ | 178 | | | $ | 246 | |
The table below presents the maturities of operating lease liabilities as of September 30, 2024: | | (in thousands) | | | | Operating | | | | Lease Payments | | 2024 (remaining) | | | 29 | | 2025 | | | 118 | | 2026 | | | 50 | | Total future lease payments | | | 197 | | Less: discount | | | (19 | ) | Total lease liabilities | | $ | 178 | |
The table below presents the weighted-average remaining lease term and discount rate used in the calculation of operating lease right-of-use assets and lease liabilities as of September 30, 2024 and December 31, 2023 | | (in thousands) | | | | September 30, 2024 | | | December 31, 2023 | | Weighted average remaining lease term (years) | | | 1.7 | | | | 2.4 | | Weighted average discount rate | | | 11.4 | % | | | 11.4 | % |
Related Party Contracts During the nine months ended September 30, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. See Note 9, “Related Party Debt” for additional details. On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or 20% of the distributor price (subject to a discount under certain circumstances), whichever is higher, per disposable distributed within Shenghuo’s exclusive territories. Pursuant to the license agreement, Shenghuo had the option to have a designee appointed to the Company’s board of directors (current director Richard Blumberg is the designee). 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 $50,000, the Company will pay them an aggregate perpetual royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20, for each cervical guide that the Company sells (or that is sold by a third party pursuant to a licensing arrangement with the Company). 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 5,000,000 warrants, broken into four tranches of 1,250,000. The warrants have a strike price of $0.25 and were subject to vesting based upon the close of the Series D offering and a minimum share price based on the 30-day VWAP. If the minimum share price per the terms of the agreement is not achieved, the warrants will expire three years after the scheduled issuance date. The warrants were valued using the Black Scholes model on the grant date of January 22, 2020. As of September 30, 2024, unrecognized consulting expense associated with the agreement was nil and 2,500,000 of the warrants had been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties. During the nine months ended September 30, 2023, the Company entered into an agreement with Mr. Blumberg to exchange 875,000 of his outstanding warrants for 831,250 warrants with a strike price of $0.20, which were exercised during the first quarter of 2023. On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided a non-refundable payment of $350,000 to the Company in exchange for the following: (1) 3,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on Mr. Blumberg’s assistance in helping the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million. Upon receipt of the funds, the Company agreed to issue the common shares and warrants owed to Mr. Blumberg in four equal tranches, to be issued every six months, beginning six months after the financing transaction. On November 11, 2022, the Company and Mr. Blumberg entered into an amended agreement, upon which the exercise prices of the warrants were changed to $0.30. The Company estimated the fair value of the modified warrants using the Black-Scholes option pricing model and the following assumptions: Expected term (years) | | | 3.0 | | Volatility | | | 108.7 | % | Risk-free interest rate | | | 4.3 | % | Dividend yield | | | 0.0 | % |
During the nine months ended September 30, 2024 and 2023, the Company issued 1,800,000 warrants to Mr. Blumberg pursuant to the agreement, and recognized expense of nil and $740,517, respectively. Total unrecognized expense for the warrants was nil as of September 30, 2024. During the nine months ended September 30, 2024 and 2023, the Company recognized $31,889 and $151,933 of expense for the shares of common stock due to Mr. Blumberg, respectively. As 400,000 shares had not been issued as of September 30, 2024, the Company estimated the total amount of expense for the future issuances using the closing price of the Company’s stock as of September 30, 2024. 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 800,000 warrants (“first tranche of warrants”) with an exercise price of $0.50 to Mr. Grujic, which were due within 10 business days of closing the financing transaction (the “Transaction”) that took place in September 2022. In the event the Company’s 20 trading day variable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing, the Company would have issued 600,000 warrants (“second tranche of warrants”) with an exercise price of $0.75 to Mr. Grujic. In the event the Company’s 20 trading day VWAP exceeds $1.50 within two years of the closing of the financing, the Company will issue an additional 600,000 warrants (“third tranche of warrants”) to Mr. Grujic. Once issued, the warrants vest immediately and will expire two years from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with the U.S. FDA or if the Chinese NMPA (formerly Chinese FDA) approval is not granted by each due date for reaching each respective pricing milestone, then the due date for reaching each milestone shall be extended by six months. As of June 30, 2024, the deadline to achieve the stock price of $1.50 has passed and the second tranche warrants will therefore not be issued. Pursuant to the agreement, the Company also agreed to pay the Advisory Group $2,000 per month for 12 months, starting the month after the closing of the Transaction. Subsequently, the agreement was amended to extend the term of the agreement to September of 2024. 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) | | | 2.0 | | Volatility | | | 173.0 | % | Risk-free interest rate | | | 3.4 | % | Dividend yield | | | 0.0 | % |
Expense related to the first tranche of warrants was recognized in prior years. Unrecognized expense related to the first tranche warrants was nil as of September 30, 2024. The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions: Expected term (years) | | | 1.0 | | Volatility | | | 144.4 | % | Risk-free interest rate | | | 3.6 | % | Dividend yield | | | 0.0 | % |
The Company recognized expense for the second tranche of warrants of nil and $29,706 during the three months ended September 30, 2024 and 2023, respectively. The Company recognized expense for the second tranche of warrants of nil and $79,216 during the nine months ended September 30, 2024 and 2023, respectively. Unrecognized expense for the third tranche of warrants was nil as of September 30, 2024. The Company estimated the fair value of the third tranche warrants using the Binomial Lattice model with the following assumptions: Expected term (years) | | | 2.0 | | Volatility | | | 172.1 | % | Risk-free interest rate | | | 3.6 | % | Dividend yield | | | 0.0 | % |
The Company recognized expense for the third tranche of warrants of $10,311 and $15,466 during the three months ended September 30, 2024 and 2023, respectively. The Company recognized expense for the third tranche of warrants of $41,242 and $46,397 during the nine months ended September 30, 2024 and 2023, respectively. Unrecognized expense for the third tranche of warrants was nil as of September 30, 2024. 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. First, SMI shall complete the payment for parts, per the purchase order, for five additional LuViva devices. Second, in consideration for the $885,144 that the Company received, SMI will receive 12,147 shares of common stock. Third, SMI shall honor all existing purchase orders it has executed to date with the Company, in order to maintain jurisdiction sales and distribution rights. If SMI needs to purchase cervical guides, then it will do so at a cost including labor, plus ten percent markup. The Company will provide 200 cervical guides at no cost for the clinical trials. Fourth, the Company and SMI will make their best efforts to sell devices after NMPA approval. With an initial estimate of year one sales of 200 LuViva devices; year two sales of 500 LuViva devices; year three sales of 1,000 LuViva devices; and year four sales of 1,250 LuViva devices. Fifth, SMI shall pay for entire costs of securing approval of LuViva with the Chinese FDA. Sixth, SMI shall arrange, at its sole cost, for a manufacturer in China to build tooling to support manufacturing. In addition, SMI retains the right to manufacture for China, Hong Kong, Macau and Taiwan, where SMI has distribution and sales rights. For each single-use cervical guide sold by SMI in the jurisdictions, SMI shall transfer funds to escrow agent at a rate of $1.90 per device chip. If within 18 months of the license’s effective date, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. Commercialization is defined as: filing an application with the Chinese FDA for the approval of LuViva; any assembly or manufacture of the devices or disposables that begins in China; and purchase of at least 10 devices and disposables for clinical evaluations and regulatory use and or sales in the jurisdictions. 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 $531,100 on or prior to March 15, 2024. On March 18, 2024, SMI, through SMI’s authorized distribution partner, initiated a wire payment of $330,000 in partial satisfaction of $531,100 owed to the Company. The payment was received by the Company on March 20, 2024. As the full payment was not received by March 15, 2024, the Company had the right to terminate the agreement with two weeks’ notice to SMI, however the Company did not exercise this option. 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 $4.4 million during 2024, including the payment due on March 15, 2024. On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”). The parties agreed that SMI will make a nonrefundable payment of $100,000 to the Company prior to March 31, 2024. In exchange, the Company will not initiate any legal proceedings, including but not limited to filing a lawsuit, obtaining a judgement, or enforcing any security interest, as related to the March shortfall in payments of $201,100, until April 30, 2024. Upon paying $100,000, SMI will have the option to extend the Standstill Agreement until June 15, 2024 by making a nonrefundable payment to the Company of $150,000. One additional payment of $150,000 may be made to extend the standstill rights until July 30, 2024, if mutually agreed upon. If SMI is unable to make the payments pursuant to the Standstill Agreement, the Company agreed to seek loans on behalf of SMI to cover the payments. SMI agreed to reimburse the Company for these loans along with all expenses associated with them within three months of the loans being issued as long as the loans are used solely for (1) parts for LuViva devices to be used by SMI for marketing and promotional activities, or (2) labor or consulting fees connected to providing parts, assemblies of devices or disposables to SMI. Additionally, SMI confirmed its commitment to make payments to GTI of at least $4.0 million during 2024 and as part of this commitment will make payments of $200,000 and $500,000 by the end of May 2024 and July 2024, respectively, to ensure that the program commercialization proceeds according to schedule. On April 26, 2024, the parties extended the Standstill Agreement (“Standstill Extension”) until July 30, 2024, contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can place a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545. The other terms from the Amendment and Standstill Agreement remained intact. On July 31, 2024, the parties extended the Standstill Agreement until August 16, 2024. A long-term agreement was reached subsequent to September 30, 2024 (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.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.3
SHORT-TERM NOTES PAYABLE
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9 Months Ended |
Sep. 30, 2024 |
SHORT-TERM NOTES PAYABLE |
|
NOTES PAYABLE |
7. SHORT-TERM NOTES PAYABLE On July 23, 2024, the Company issued a promissory note totaling $50,000 to an unaffiliated third party. The promissory note matures on February 1, 2025 and will accrue total interest of $5,000. Monthly payments of $10,000 are due on the note, beginning September 1, 2024 until January 1, 2025, while the interest payment is due on or before February 1, 2025. The promissory note may be prepaid in full or in part without penalty or premium. The holder of the promissory note also received 60,000 common stock purchase warrants, which have an exercise price of $0.25 and will expire on August 1, 2028. The warrants, which had an estimated fair value of $6,329, were recorded as a discount on the note payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions: Expected term (years) | | | 4.0 | | Volatility | | | 397.3 | % | Risk-free interest rate | | | 3.9 | % | Dividend yield | | | 0.0 | % |
On June 28, 2024, the Company issued a promissory note totaling $100,000 to an unaffiliated third party. The promissory note matures on January 1, 2025 and will accrue total interest of $10,000. Monthly payments of $20,000 are due on the note, beginning August 1, 2024 until December 1, 2024, while the interest payment is due on or before January 1, 2025. The promissory note may be prepaid in full or in part without penalty or premium. The holder of the promissory note also received 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. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions: Expected term (years) | | | 4.0 | | Volatility | | | 389.2 | % | Risk-free interest rate | | | 4.4 | % | Dividend yield | | | 0.0 | % |
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 $81,768 for an $87,162 promissory note dated April 15, 2024. Beginning on May 5, 2024, monthly payments of $2,000 are due on the note until its maturity date. The promissory note, which accrues interest at a rate of 6.0% per annum, matures on May 5, 2028. The total balance of the promissory note was $77,162 as of September 30, 2024, of which $24,000 is included in “Short-term notes payable” on the consolidated balance sheets and $53,162 is included in “Long-term notes payable.” On July 4, 2024, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,556. Monthly payments of $12,025 are due on the note, including interest incurred at a rate of 8.8%. The note, which matures on May 4, 2025, had an outstanding balance of $93,784 and nil as of September 30, 2024 and December 31, 2023, respectively. On July 4, 2023, the Company entered into a premium finance agreement to finance its insurance policies totaling $129,073. Monthly payments of $12,041 are due on the note, including interest incurred at a rate of 7.9%. The note, which matured on May 4, 2024, had an outstanding balance of nil and $59,422 as of September 30, 2024 and December 31, 2023, respectively. The following table summarizes short-term notes payable (in thousands): | | Short-Term Notes Payable | | | | September 30, 2024 | | | December 31, 2023 | | Short-term promissory notes | | $ | 121 | | | $ | - | | Current portion of long-term promissory note | | | 24 | | | | - | | Premium Finance (insurance) | | | 93 | | | | 59 | | Debt discount | | | (10 | ) | | | - | | Short-term notes payable | | $ | 228 | | | $ | 59 | |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.3
CONVERTIBLE DEBT
|
9 Months Ended |
Sep. 30, 2024 |
CONVERTIBLE DEBT |
|
CONVERTIBLE DEBT |
8. CONVERTIBLE DEBT 10% Senior Unsecured Convertible Debentures On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which matured on May 17, 2024 (the “Maturity Date”). The Company subscribed $1,130,000 of the $1,000 convertible debentures. The terms of the debentures are as follows: 1) the principal amount of some or all of the convertible debentures and accrued interest are convertible into shares of common stock at the holder’s option, at a price of $0.50 per common stock share (the “conversion price”), subject to adjustment in certain events, at any time prior to maturity date; 2) upon successful uplist to a U.S. National Exchange, the note will automatically convert into the uplisting financing; 3) each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023; 4) if a Change of Control (as defined in the Convertible Debenture Certificate) occurs prior to the Maturity Date, unless the holder elects in writing to convert the Convertible Debentures into shares of common stock, the Company will repay in cash upon the closing of such Change of Control all outstanding principal and accrued interest under each Convertible Debenture plus a Change of Control premium equal to an additional 3% of the outstanding principal sum under such Convertible Debenture. Prior to the closing of an Change of Control, in lieu of repayment as set forth in the preceding sentence, the holder has the right to elect in writing to convert, effective immediately prior to the effective date of such Change of Control, all outstanding principal and accrued Interest under the Convertible Debentures into shares of common stock at the Conversion Price; 5) Subject to a holder’s option of electing conversion prior to the Redemption Date (as such term is defined below), on or after the date that is 24 months from the Closing Date if the daily volume weighted average trading price of the shares of common stock is $1.50 per share of common stock or more for each trading day over a 30 consecutive trading day period, the Company may, at any time (the “Redemption Date”), at its option, redeem all, or any portion of the Convertible Debentures for either: (i) a cash payment (in the form of a certified cheque or bank draft) that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date; or (ii) by issuing and delivering shares of common stock to the holders of Convertible Debentures at a deemed price of $0.50 per share of common stock that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date, or any combination of (i) or (ii), upon not less than 30 days and not more than 60 days prior written notice in the manner provided in the Debenture Certificate, to the holder of Convertible Debentures. At September 30, 2024 and December 31, 2023, the balance due on the 10% Senior Secured Convertible Debentures was $1,130,000 and total accrued interest was $51,980 and $58,494, respectively. After the May 17, 2024 maturity date, the debt went into default and the interest rate increased to the default rate of 18.0%. The bond payable discount and unamortized debt issuance costs as of September 30, 2024 and December 31, 2023 are presented below (in thousands): | | Senior Secured Convertible Debenture | | | | September 30, 2024 | | | December 31, 2023 | | 10% Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,130 | | Unamortized debt issuance costs | | | - | | | | (12 | ) | Debt discount | | | - | | | | (38 | ) | Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,080 | |
As of September 30, 2024, the balance of the Senior Unsecured Convertible Debentures 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 Debentures is included in “Short-term convertible notes payable” within the condensed consolidated balance sheets. 1800 Diagonal Lending LLC Notes On July 22, 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 $62,100 and an original issue discount of $8,100. The note, which will accrue total interest of $8,694, will mature on May 30, 2025. A payment of $35,397 is due on the note on January 30, 2025. The remaining balance due, including accrued interest, will be paid in monthly payments of $8,849 from February 28, 2025 through May 30, 2025. The note may be prepaid at any time with no prepayment penalty. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22.0% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest. On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with Diagonal Lending (together with the July 22, 2024 note, the “Notes”). 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. The note may be prepaid within 120 days of issuance for a discount of 2.0 -3.0 % of the principal and accrued interest due. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest. In the event of default, the unpaid portion of the Notes and accrued interest is convertible into shares of common stock at a conversion rate equal to the variable conversion price. The variable conversion price is equal to the lowest closing price of our common stock during the ten days prior to the conversion date multiplied by 65.0%. The Company assessed the embedded conversion features and determined that they are not considered clearly and closely related to the host notes, and therefore meet the definition of derivatives. Therefore, these embedded conversion features are required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the derivative liabilities on the issuance dates of the Notes and recorded them as discounts that net against the convertible notes. The Company is required to remeasure the derivative liabilities to their then fair values at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement). At September 30, 2024, the balance due on the Notes was $162,150 and total accrued interest was $9,438. The associated debt discounts and unamortized debt issuance costs as of September 30, 2024 and December 31, 2023 are included in “Short-term convertible debt” on the condensed consolidated balance sheets and are presented below (in thousands): | | September 30, 2024 | | | December 31, 2023 | | Short-term convertible promissory notes | | $ | 162 | | | $ | - | | Unamortized debt issuance costs | | | (5 | ) | | | - | | Debt discount | | | (23 | ) | | | - | | 1800 Diagonal Lending Convertible Note | | $ | 134 | | | $ | - | |
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 $2.4 million. The note may not have been prepaid in whole or in part except as otherwise explicitly allowed. Any amount of principal or interest on the note which was not paid when due shall bore interest at the rate of the lessor of 24% or the maximum permitted by law (the “default interest”). The variable conversion prices equaled the lesser of: (i) the lowest trading price on the issue date, and (ii) the variable conversion price. The variable conversion price was 95% multiplied by the market price (the market price means the average of the five lowest trading prices during the period beginning on the issue date and ending on the maturity date), minus $0.04 per share, provided however that in no event could the variable conversion price be less than $0.15. If an event of default under this note occurred and/or the note was not extinguished in its entirety prior to December 17, 2020, the $0.15 price floor no longer applied. 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 $1,228,183 of debt, including an early prepayment penalty of $350,000, default premiums of $281,256, and $91,555 in interest payable. Auctus agreed to reduce the amount owed to $710,911 and to revert the May 27, 2020 note to its original term. Additionally, Auctus agreed to exchange 8,775,000 warrants that were priced between $0.15 and $0.20 and the $350,000 prepayment penalty for 3,900,000 shares of common stock, warrants to purchase 3,900,000 shares of common stock at $0.50 per share and warrants to purchase 3,900,000 shares of common stock at $0.65 per share (the “Exchange”). As a result of the Exchange Agreement, Auctus forgave a default penalty of $225,444. Following the Exchange and Repayment, the Company will make payments to Auctus in four installments, over an 18-month period. During 2024, Auctus agreed to apply the payments to the principal portion of the debt before applying the funds to the accrued interest. As a result, management has reclassified a portion of the current and prior period outstanding debt to the accrued interest. The total outstanding balance of the convertible note was $15,000 and $25,000 as of September 30, 2024 and December 31, 2023, respectively. The balances are included within “Short-term convertible debt” on the condensed consolidated balance sheets. Total accrued interest on the Auctus convertible note was $116,029 and $121,995 as of September 30, 2024 and December 31, 2023, respectively.
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v3.24.3
RELATED PARTY DEBT
|
9 Months Ended |
Sep. 30, 2024 |
RELATED PARTY DEBT |
|
RELATED PARTY DEBT |
9. RELATED PARTY DEBT Short-Term Notes Payable Due to Related Parties During the nine months ended September 30, 2024, the Company issued promissory notes totaling $75,000 to members of the Board of Directors. The promissory notes mature in the third quarter of 2025, at which time the principal and accrued interest payments are due in full. The promissory notes accrue interest at a rate of 9.0%. The holders of the promissory notes also received 75,000 common stock purchase warrants, which have exercise prices of $0.25 and will expire four years after issuance. The warrants, which had an estimated fair value of $8,800, were recorded as a discount on the notes payable. The Company estimated the fair value of the warrants using the Black-Scholes option pricing model with the following weighted-average assumptions: Expected term (years) | | | 4.0 | | Volatility | | | 397.1 | % | Risk-free interest rate | | | 3.9 | % | Dividend yield | | | 0.0 | % |
The outstanding principal and associated debt discounts as of September 30, 2024 and December 31, 2023 are presented below (in thousands): | | Short-Term Notes Payable Due to Related Parties | | | | September 30, 2024 | | | December 31, 2023 | | Short-term promissory notes | | $ | 75 | | | $ | - | | Debt discount | | | (7 | ) | | | - | | Short-term notes payable due to related parties | | $ | 68 | | | $ | - | |
Current Portion of Long-Term Debt, Related Parties 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 $660,895 for a $207,111 promissory note dated September 4, 2018. On July 20, 2018, the Company entered into an exchange agreement with Dr. Cartwright, whereby Dr. Cartwright agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $1,621,499 for a $319,000 promissory note dated September 4, 2018 that incurs interest at a rate of 6.0% per annum. 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 $267,085, the maturity date was February 18, 2023, and the interest rate was 6.0%. For Dr. Faupel the principal amount on the new note was $153,178, the maturity date was February 18, 2023, and the interest rate was 6.0%. Additionally, the Company exchanged $100,000 and $85,000 of the balances owed to Dr. Cartwright and Dr. Faupel for 100 and 85 shares of Series F-2 Preferred Stock, respectively. 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 debt owed to Dr. Faupel and Dr. Cartwright (in thousands): For Dr. Faupel: Salary | | $ | 134 | | Bonus | | | 20 | | Vacation | | | 95 | | Interest on compensation | | | 67 | | Loans to Company | | | 196 | | Interest on loans | | | 149 | | Total outstanding prior to exchange | | | 661 | | | | | | | Amount forgiven in prior years | | | (454 | ) | Amount exchanged for Series F-2 Preferred Stock | | | (85 | ) | Total interest accrued through December 31, 2023 | | | 57 | | Balance outstanding at December 31, 2023 | | $ | 179 | | | | | | | Interest accrued through September 30, 2024 | | | 7 | | Balance outstanding at September 30, 2024 | | $ | 186 | |
For Dr. Cartwright Salary | | $ | 337 | | Bonus | | | 675 | | Loans to Company | | | 528 | | Interest on loans | | | 81 | | Total outstanding prior to exchange | | | 1,621 | | | | | | | Amount forgiven in prior years | | | (1,302 | ) | Amount exchanged for Series F-2 Preferred Stock | | | (100 | ) | Total interest accrued through December 31, 2023 | | | 93 | | Payments on outstanding debt | | | (25 | ) | Balance outstanding at December 31, 2023 | | $ | 287 | | | | | | | Interest accrued through September 30, 2024 | | | 11 | | Balance outstanding at September 30, 2024 | | $ | 298 | |
On March 22, 2021, the Company entered into an exchange agreement with Richard Fowler. As of December 31, 2020, the Company owed Mr. Fowler $546,214 ($412,624 in deferred salary and $133,590 in accrued interest). The Company exchanged $50,000 of the amount owed of $546,214 for 50 shares of Series F-2 Preferred Stock (convertible into 200,000 shares of common stock), and a $150,000 unsecured note. The note accrues interest at the rate of 6.0% (18.0% in the event of default) beginning on March 22, 2022 and is payable in monthly installments of $3,600 for four years, with the first payment due on March 15, 2022. The effective interest rate of the note is 6.18%. During the three and nine months ended September 30, 2024, Mr. Fowler forgave $16,145 and $49,205 of the outstanding balance of deferred compensation, respectively. During the three and nine months ended September 30, 2023, Mr. Fowler forgave $17,183 and $52,354 of the outstanding balance of deferred compensation, respectively. As of September 30, 2024, Mr. Fowler may forgive up to $80,131 of the remaining deferred compensation if the Company complies with the repayment plan described above. The reductions in the outstanding balance met the criteria for troubled debt. The basic criteria are that the borrower is troubled, i.e., they are having financial difficulties, and a concession is granted by the creditor. As of September 30, 2024, the outstanding principal amount owed on the note was $53,886, of which $40,875 is included in “Current portion of long-term debt, related parties” and $13,011 is included in “Long-term debt, related parties.” As of December 31, 2023, the outstanding principal amount owed on the note was $82,945, of which $39,090 is included in “Current portion of long-term debt, related parties” and $43,855 is included in “Long-term debt, related parties.” Future debt obligations at September 30, 2024 for debt owed to related parties is as follows: Year | | Amount (in thousands) | | 2024 (remaining) | | | 10 | | 2025 | | | 600 | | 2026 | | | 3 | | Total | | $ | 613 | |
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v3.24.3
INCOME (LOSS) PER SHARE OF COMMON STOCK
|
9 Months Ended |
Sep. 30, 2024 |
INCOME (LOSS) PER SHARE OF COMMON STOCK |
|
INCOME (LOSS) PER SHARE OF COMMON STOCK |
10. INCOME (LOSS) PER SHARE OF COMMON STOCK Basic net income (loss) per share attributable to common stockholders, amounts are computed by dividing the net income (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the year. Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the year, plus Series C, Series C-1, Series C-2, Series 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 nine months ended September 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 September 30, 2024 and 2023, these instruments were convertible into 57,954,585 and 54,457,934 common shares, respectively. The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders (in thousands, except for per-share data): | | September 30, | | | | 2024 | | | 2023 | | | | | | | | | Net loss | | $ | (1,891 | ) | | $ | (3,290 | ) | Basic weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | | Net loss per share (basic) | | $ | (0.03 | ) | | $ | (0.07 | ) | Diluted weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | | Net loss per share (diluted) | | $ | (0.03 | ) | | $ | (0.07 | ) |
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.3
FAIR VALUE MEASUREMENTS
|
9 Months Ended |
Sep. 30, 2024 |
FAIR VALUE MEASUREMENTS |
|
FAIR VALUE MEASUREMENTS |
11. FAIR VALUE MEASUREMENTS The convertible notes payable derivative liabilities are considered Level 3 measurements, due to the significant unobservable inputs in the valuation, which are based on a forecast of the Company’s future stock performance and, as the note payable is contingently convertible upon an event of default, management’s estimate of the likelihood and timing of conversion. Based on the terms and provisions of the Diagonal Lending notes 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 notes 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. |
The following tables present the fair value of the bifurcated conversion options: | | Fair Value at September 30, 2024 (in thousands) | | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | | | | | | | | | | | | | | | Derivative liability/bifurcated conversion options in connection with Diagonal Lending promissory notes | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | | | | | | | | | | | | | | | | | | | Total short-term liabilities at fair value | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | |
Derivative financial instruments and changes thereto recorded in the three and nine months ended September 30, 2024 and 2023 include the following: | | Three Months Ended September 30, | | | | 2024 | | | 2023 | | | | | | | | | Fair value, beginning of period | | $ | 13 | | | $ | - | | Inception of derivative liability | | | 6 | | | | - | | Change in fair value of beneficial conversion features | | | 1 | | | | - | | | | | | | | | | | Fair value, end of period | | $ | 20 | | | $ | - | |
| | Nine Months Ended September 30, | | | | 2024 | | | 2023 | | | | | | | | | Fair value, beginning of period | | $ | - | | | $ | (5 | ) | Inception of derivative liability | | | 12 | | | | - | | Change in fair value of beneficial conversion features | | | 8 | | | | 5 | | | | | | | | | | | Fair value, end of period | | $ | 20 | | | $ | - | |
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- DefinitionThe entire disclosure of the fair value measurement of assets and liabilities, which includes financial instruments measured at fair value that are classified in shareholders' equity, which may be measured on a recurring or nonrecurring basis.
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v3.24.3
SUBSEQUENT EVENTS
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9 Months Ended |
Sep. 30, 2024 |
SUBSEQUENT EVENTS |
|
SUBSEQUENT EVENTS |
12. SUBSEQUENT EVENTS Promissory Note On October 10, 2024, the Company issued a promissory note totaling $200,000 to an unaffiliated third party (the “Holder”). The promissory note matures on October 10, 2025 and will accrue interest at a rate of 12.0% per annum. Monthly payments of $20,000 are due on the note, beginning November 30, 2024 until August 31, 2025, while the interest payment is due on or before October 10, 2025. If not repaid by the maturity date, the unpaid balance of the note will accrue interest at a rate of 16.0% per annum. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. The Holder also received 667,667 common stock purchase warrants, which have an exercise price of $0.25 and will expire on October 9, 2028. Agreement with SMI On October 21, 2024, the Company executed an agreement with SMI (the “Agreement”), which supersedes all previous agreements, other than existing purchase orders (except those as modified and summarized below). Pursuant to the Agreement, the Company plans to execute a purchase agreement with a distributor of SMI for 35 base units, connected, aligned, calibrated and tested (“Completed Instrumentation Packages”). SMI, to obtain the license for global manufacturing rights and exclusive distribution of LuViva within certain jurisdictions, agreed to: | 1. | Meet an established schedule for minimum sales of the product in China. | | 2. | Establish a manufacturing capability for the manufacture of LuViva and its accessories including the single use disposable Cervical Guide “Disposables” or “Accessories”). | | 3. | Apply for NMPA approval for LuViva no later than October 30, 2024. Said application was filed by SMI with NMPA on October 16, 2024. |
Under the terms of the agreement, the Handheld Unit and Base Unit constitute an Instrumentation Package or “IP”. An IP and mobile cart with a monitor constitute a fully functional LuViva device ready for sale. SMI will be responsible for the manufacture of the mobile carts that house the IPs and the display monitor. All active purchase orders will be revised to include 100 IPs to be provided by GTI to SMI and/or its distribution partners to meet expected demand for the end of 2024 and 2025, as summarized below: | 1. | Forty-seven (47) of the 100 IPs will be provided by GTI to SMI, at an approximate price of $1,351,250; The number of IPs may be reduced if the full payment is delayed beyond the end of 2024. | | 2. | Thirty-five (35) of the 100 IPs will be provided by GTI to SMI or to one of SMI’s distributors, at a total price of $700,000. | | 3. | Eighteen (18) of the 100 IPs will be provided to SMI at no additional charge, beyond what has already been paid by SMI. |
To meet demand for the remainder of 2024 and for the first half of 2025, SMI agreed to purchase a minimum of 500,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. To meet demand for the second half of 2025, SMI agreed to purchase an additional 100 IPs and 1,000,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip. SMI agreed to pay a minimum of $400,000 to the Company prior to December 31, 2024, to cover additional components, devices and costs incurred by the Company. Beginning in 2026 and extending into 2030, to preserve its licensing rights, SMI shall be committed to the minimum LuViva Cervical Guide Radio Frequency Identification Chips and Royalty Sales (“RFID Chips”) of the single-use Cervical Guide Chip, at a sale price to SMI at $1.00, as specified in the table below: Year | | Cumulative Number of Devices Placed or Sold | | | Cumulative Resulting Minimum Tests | | | Cumulative Minimum Cervical Guide Royalty Payments to GTI | | 2026 | | | 300 | | | | 1,440,000 | | | $ | 1,440,000 | | 2027 | | | 400 | | | | 5,040,000 | | | $ | 4,480,000 | | 2028 | | 1500 | | | | 15,840,000 | | | $ | 15,840,000 | | 2029 | | 3000 | | | | 37,440,000 | | | $ | 37,440,000 | | 2030 | | 4000 | | | | 66,240,000 | | | $ | 66,240,000 | |
If by April 30, 2025, SMI fails to achieve commercialization of LuViva in China, SMI shall no longer have any rights to manufacture, distribute or sell LuViva. Issuances of Common Stock Subsequent to September 30, 2024, we issued 400,000 common shares to Mr. Blumberg, pursuant to his consulting agreement. Additionally, we issued 52,795 common shares for Series D preferred stock dividends, 5,558 common shares for Series F preferred stock dividends, and 100,000 common shares for the conversion of 25 shares of Series F preferred stock.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.3
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
SIGNIFICANT ACCOUNTING POLICIES |
|
Use of Estimates |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the inventory valuation, valuation of share-based compensation and the valuation of the convertible note payable derivative liability. Management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to the Company’s financial statements.
|
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 |
The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was nil and $156,112 as of September 30, 2024 and December 31, 2023, respectively.
|
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 September 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 September 30, 2024 and December 31, 2023: | | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Raw materials | | $ | 1,364 | | | $ | 1,360 | | Work-in-progress | | | 46 | | | | 46 | | Finished goods | | | 44 | | | | 44 | | Inventory reserve | | | (818 | ) | | | (818 | ) | | | | | | | | | | Total inventory | | $ | 636 | | | $ | 632 | |
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 September 30, 2024 and December 31, 2023: | | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Equipment | | $ | 951 | | | $ | 951 | | Software | | | 634 | | | | 634 | | Furniture and fixtures | | | 17 | | | | 17 | | Leasehold improvements | | | 12 | | | | 12 | | | | | | | | | | | Subtotal | | | 1,614 | | | | 1,614 | | Less accumulated depreciation | | | (1,589 | ) | | | (1,582 | ) | Property, equipment and leasehold improvements, net | | $ | 25 | | | $ | 32 | |
Depreciation expense related to property and equipment for the three and nine months ended September 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 nine months ended September 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.”
|
Accrued Liabilities |
Accrued liabilities as of September 30, 2024 and December 31, 2023 are summarized as follows: | | (in thousands) | | | | September 30, 2024 | | | December 31, 2023 | | | | | | | | | Compensation | | $ | 383 | | | $ | 401 | | Professional fees | | | 126 | | | | 216 | | Interest | | | 188 | | | | 188 | | Vacation | | | 31 | | | | 27 | | Preferred dividends | | | 188 | | | | 228 | | Other accrued expenses | | | 7 | | | | 8 | | | | | | | | | | | Total | | $ | 923 | | | $ | 1,068 | |
|
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 must be 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. |
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 $747,780, $424,225, and $509,101 as of September 30, 2024, December 31, 2023 and December 31, 2022, respectively.
|
Significant Customers |
As of September 30, 2024, trade receivables of $2,047 (net of the allowance for credit losses of $450) were attributed to one customer. As of December 31, 2023, accounts receivable of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers.
|
Research and Development |
Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred.
|
Income Taxes |
The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company has filed its 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 September 30, 2024, the Company had approximately $66.4 million of net operating losses carryforward available, $3.8 million of which will expire on December 31, 2024. The remaining net operating loss will be eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related to the deferred tax assets generated from the net operating losses. 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 50.0% likely of being ultimately realized upon settlement. The tax position is derecognized when it is no longer more likely than not of being sustained. The Company classifies income tax related interest and penalties as interest expense and selling, general and administrative expense, respectively, on the consolidated statements of operations.
|
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 nine months ended September 30, 2024, the Company recognized $60,860 of expense for stock options and $41,242 of expense for warrants issued to a director. Additionally, during the nine months ended September 30, 2024, the Company accrued $30,889 of expense for common stock owed to a director, pursuant to his consulting agreement. During the nine months ended September 30, 2023, the Company recognized $221,143 of expense related to stock options, $9,333 of expense for stock issued to consultants and executives and $1,546,089 of expense for warrants issued to consultants and executives. Additionally, during the nine months ended September 30, 2023, the Company accrued $83,301 of expense for common stock owed to a director, pursuant to his consulting agreement.
|
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, which is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument. Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense.
|
Fair Value Measurements |
ASC 820, “Fair Value Measurements and Disclosures,” clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that should be determined based upon assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: | · | Level 1: Quoted prices for identical assets or liabilities in active markets that the Company can access at the measurement date. | | | | | · | Level 2: Significant other observable inputs other than level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data. | | | | | · | Level 3: Significant unobservable inputs that reflect the Company’s judgment about the assumptions that market participants would use in pricing an asset or liability. |
An asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. Assets and liabilities measured at fair value are based on one or more of the following three valuation techniques noted in ASC 820: | · | Market approach: Prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. | | | | | · | Cost approach: Amount that would be required to replace the service capacity of an asset (replacement cost). | | | | | · | Income approach: Techniques to convert future amounts to a single present value amount |
The Company believes its valuation methods are appropriate and consistent with other market participants, however the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.
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- DefinitionDisclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value.
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v3.24.3
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
SIGNIFICANT ACCOUNTING POLICIES |
|
Schedule of Inventory valuation |
| | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Raw materials | | $ | 1,364 | | | $ | 1,360 | | Work-in-progress | | | 46 | | | | 46 | | Finished goods | | | 44 | | | | 44 | | Inventory reserve | | | (818 | ) | | | (818 | ) | | | | | | | | | | Total inventory | | $ | 636 | | | $ | 632 | |
|
Schedule of Property and equipment |
| | (in thousands) | | | | September 30, | | | December 31, | | | | 2024 | | | 2023 | | | | | | | | | Equipment | | $ | 951 | | | $ | 951 | | Software | | | 634 | | | | 634 | | Furniture and fixtures | | | 17 | | | | 17 | | Leasehold improvements | | | 12 | | | | 12 | | | | | | | | | | | Subtotal | | | 1,614 | | | | 1,614 | | Less accumulated depreciation | | | (1,589 | ) | | | (1,582 | ) | Property, equipment and leasehold improvements, net | | $ | 25 | | | $ | 32 | |
|
Schedule of Accrued liabilities |
| | (in thousands) | | | | September 30, 2024 | | | December 31, 2023 | | | | | | | | | Compensation | | $ | 383 | | | $ | 401 | | Professional fees | | | 126 | | | | 216 | | Interest | | | 188 | | | | 188 | | Vacation | | | 31 | | | | 27 | | Preferred dividends | | | 188 | | | | 228 | | Other accrued expenses | | | 7 | | | | 8 | | | | | | | | | | | Total | | $ | 923 | | | $ | 1,068 | |
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v3.24.3
STOCKHOLDERS DEFICIT (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
STOCKHOLDERS' DEFICIT: |
|
Schedule of Common stock issued |
| | Number of Shares | | Issuance of common stock in private placement offering | | | 3,333,335 | | Issuance of common stock for payment of Series D preferred dividends | | | 196,063 | | Issuance of common stock for payment of Series E preferred dividends | | | 625,511 | | Issuance of common stock for payment of Series F preferred dividends | | | 444,621 | | Issuance of common stock for payment of Series F-2 preferred dividends | | | 235,544 | | Issuance of common stock for payment of interest | | | 1,116,709 | | Issuance of common stock to consultants | | | 400,000 | | Total common stock issued during the nine months ended September 30, 2024 | | | 6,351,783 | | | | | | | Summary table of common stock transactions: | | | | | Shares outstanding at December 31, 2023 | | | 54,105,101 | | Common shares issued during the nine months ended September 30, 2024 | | | 6,351,783 | | Shares outstanding at September 30, 2024 | | | 60,456,884 | |
|
Schedule of Company's outstanding warrants to purchase common stock |
| | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | | | | | | | Outstanding, December 31, 2023 | | | 28,584,580 | | | $ | 0.50 | | Warrants issued | | | 5,368,335 | | | | 0.19 | | Warrants expired | | | (1,561,500 | ) | | | 0.44 | | Outstanding, September 30, 2024 | | | 32,391,415 | | | $ | 0.46 | |
| | Warrants (Underlying Shares) | | | Weighted-Average Exercise Price Per Share | | | | | | | Outstanding, December 31, 2022 | | | 35,586,980 | | | $ | 0.46 | | Warrants issued | | | 6,773,750 | | | | 0.26 | | Warrants exchanged | | | (1,025,000 | ) | | | 0.25 | | Warrants expired | | | (9,545,200 | ) | | | 0.30 | | Warrants exercised | | | (973,750 | ) | | | 0.20 | | Outstanding, September 30, 2023 | | | 30,816,780 | | | $ | 0.49 | |
|
Schedule of fair value warrants issued under Black-Scholes Option Pricing model |
Expected term (years) | | | 4.0 | | Volatility | | | 397.3 | % | Risk-free interest rate | | | 3.5 | % | Dividend yield | | | 0.0 | % |
Expected term (years) | 3.8 | Volatility | | 266.4% | Risk-free interest rate | 3.8% | Dividend yield | 0.0% |
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v3.24.3
STOCK OPTIONS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
STOCK OPTIONS |
|
Schedule of Stock options vested, unvested and granted |
| | 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 | | | 2,338,636 | | | $ | 0.41 | | | 6.5 years | | $ | - | | Options granted | | | 545,000 | | | $ | 0.12 | | | | | | | | Options outstanding as of September 30, 2024 | | | 2,883,636 | | | $ | 0.35 | | | 6.6 years | | $ | 29,975 | | Options exercisable as of September 30, 2024 | | | 2,172,614 | | | $ | 0.41 | | | 5.7 years | | $ | 7,494 | |
| | 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 | | | 1,500,000 | | | $ | 0.49 | | | 7.5 years | | $ | - | | Options granted | | | 1,025,000 | | | $ | 0.26 | | | | | | | | Options forfeited | | | (186,364 | ) | | $ | 0.31 | | | | | | | | Options outstanding as of September 30, 2023 | | | 2,338,636 | | | $ | 0.41 | | | 6.8 years | | $ | - | | Options exercisable as of September 30, 2023 | | | 1,811,364 | | | $ | 0.45 | | | 6.0 years | | $ | - | |
|
Schedule of Stock option activity |
Expected term (years) | | | 6.1 | | Volatility | | | 797.4 | % | Risk-free interest rate | | | 4.2 | % | Dividend yield | | | - | |
Expected term (years) | | | 10.0 | | Volatility | | | 366.4 | % | Risk-free interest rate | | | 3.8 | % | Dividend yield | | | 0.00 | |
Expected term (years) | | | 2.0 | | Volatility | | | 182.8 | % | Risk-free interest rate | | | 4.0 | % | Dividend yield | | | 0.0 | % |
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v3.24.3
CONVERTIBLE DEBT (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
CONVERTIBLE DEBT |
|
Scheduled of unamortized debt issuance costs |
| | Senior Secured Convertible Debenture | | | | September 30, 2024 | | | December 31, 2023 | | 10% Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,130 | | Unamortized debt issuance costs | | | - | | | | (12 | ) | Debt discount | | | - | | | | (38 | ) | Senior Unsecured Convertible Debentures | | $ | 1,130 | | | $ | 1,080 | |
|
Scheduled of note payable discount, unamortized debt issuance costs and unamortized debt discount |
| | September 30, 2024 | | | December 31, 2023 | | Short-term convertible promissory notes | | $ | 162 | | | $ | - | | Unamortized debt issuance costs | | | (5 | ) | | | - | | Debt discount | | | (23 | ) | | | - | | 1800 Diagonal Lending Convertible Note | | $ | 134 | | | $ | - | |
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v3.24.3
RELATED PARTY DEBT (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
RELATED PARTY DEBT |
|
Fair value of the warrants using the Black-Scholes option pricing model of short term debt |
Expected term (years) | | | 4.0 | | Volatility | | | 397.1 | % | Risk-free interest rate | | | 3.9 | % | Dividend yield | | | 0.0 | % |
|
Schedule of Short-term debt, related parties |
| | Short-Term Notes Payable Due to Related Parties | | | | September 30, 2024 | | | December 31, 2023 | | Short-term promissory notes | | $ | 75 | | | $ | - | | Debt discount | | | (7 | ) | | | - | | Short-term notes payable due to related parties | | $ | 68 | | | $ | - | |
|
Schedule of Long-term debt, related parties |
Salary | | $ | 134 | | Bonus | | | 20 | | Vacation | | | 95 | | Interest on compensation | | | 67 | | Loans to Company | | | 196 | | Interest on loans | | | 149 | | Total outstanding prior to exchange | | | 661 | | | | | | | Amount forgiven in prior years | | | (454 | ) | Amount exchanged for Series F-2 Preferred Stock | | | (85 | ) | Total interest accrued through December 31, 2023 | | | 57 | | Balance outstanding at December 31, 2023 | | $ | 179 | | | | | | | Interest accrued through September 30, 2024 | | | 7 | | Balance outstanding at September 30, 2024 | | $ | 186 | |
Salary | | $ | 337 | | Bonus | | | 675 | | Loans to Company | | | 528 | | Interest on loans | | | 81 | | Total outstanding prior to exchange | | | 1,621 | | | | | | | Amount forgiven in prior years | | | (1,302 | ) | Amount exchanged for Series F-2 Preferred Stock | | | (100 | ) | Total interest accrued through December 31, 2023 | | | 93 | | Payments on outstanding debt | | | (25 | ) | Balance outstanding at December 31, 2023 | | $ | 287 | | | | | | | Interest accrued through September 30, 2024 | | | 11 | | Balance outstanding at September 30, 2024 | | $ | 298 | |
|
Schedule of Long-term debt, related parties debt obligations |
Year | | Amount (in thousands) | | 2024 (remaining) | | | 10 | | 2025 | | | 600 | | 2026 | | | 3 | | Total | | $ | 613 | |
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v3.24.3
INCOME (LOSS) PER SHARE OF COMMON STOCK (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Black-Scholes Option [Member] |
|
Schedule of Earnings per share |
| | September 30, | | | | 2024 | | | 2023 | | | | | | | | | Net loss | | $ | (1,891 | ) | | $ | (3,290 | ) | Basic weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | | Net loss per share (basic) | | $ | (0.03 | ) | | $ | (0.07 | ) | Diluted weighted average number of shares outstanding | | | 55,929 | | | | 50,588 | | Net loss per share (diluted) | | $ | (0.03 | ) | | $ | (0.07 | ) |
|
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- DefinitionTabular disclosure of an entity's basic and diluted earnings per share calculations, including a reconciliation of numerators and denominators of the basic and diluted per-share computations for income from continuing operations.
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v3.24.3
FAIR VALUE MEASUREMENTS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
FAIR VALUE MEASUREMENTS |
|
Schedule of fair value for liabilities measured on a recurring basis |
| | Fair Value at September 30, 2024 (in thousands) | | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | | | | | | | | | | | | | | | Derivative liability/bifurcated conversion options in connection with Diagonal Lending promissory notes | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | | | | | | | | | | | | | | | | | | | Total short-term liabilities at fair value | | $ | - | | | $ | - | | | $ | 20 | | | $ | 20 | |
|
Schedule of change in fair value instruments |
| | Three Months Ended September 30, | | | | 2024 | | | 2023 | | | | | | | | | Fair value, beginning of period | | $ | 13 | | | $ | - | | Inception of derivative liability | | | 6 | | | | - | | Change in fair value of beneficial conversion features | | | 1 | | | | - | | | | | | | | | | | Fair value, end of period | | $ | 20 | | | $ | - | |
| | Nine Months Ended September 30, | | | | 2024 | | | 2023 | | | | | | | | | Fair value, beginning of period | | $ | - | | | $ | (5 | ) | Inception of derivative liability | | | 12 | | | | - | | Change in fair value of beneficial conversion features | | | 8 | | | | 5 | | | | | | | | | | | Fair value, end of period | | $ | 20 | | | $ | - | |
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v3.24.3
SUBSEQUENT EVENTS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
SUBSEQUENT EVENTS |
|
Schedule of preserve its licensing rights in future |
Year | | Cumulative Number of Devices Placed or Sold | | | Cumulative Resulting Minimum Tests | | | Cumulative Minimum Cervical Guide Royalty Payments to GTI | | 2026 | | | 300 | | | | 1,440,000 | | | $ | 1,440,000 | | 2027 | | | 400 | | | | 5,040,000 | | | $ | 4,480,000 | | 2028 | | 1500 | | | | 15,840,000 | | | $ | 15,840,000 | | 2029 | | 3000 | | | | 37,440,000 | | | $ | 37,440,000 | | 2030 | | 4000 | | | | 66,240,000 | | | $ | 66,240,000 | |
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v3.24.3
SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Property and equipment, gross |
$ 1,614
|
$ 1,614
|
Less accumulated depreciation |
(1,589)
|
(1,582)
|
Property, equipment and leasehold improvements, net |
25
|
32
|
Equipment [Member] |
|
|
Property and equipment, gross |
951
|
951
|
Furniture and Fixtures [Member] |
|
|
Property and equipment, gross |
17
|
17
|
Software [Member] |
|
|
Property and equipment, gross |
634
|
634
|
Leasehold Improvement [Member] |
|
|
Property and equipment, gross |
$ 12
|
$ 12
|
X |
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v3.24.3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
9 Months Ended |
|
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Accounts receivable |
$ 2,047
|
|
$ 7,442
|
|
Accounts receivable, net of allowance |
450
|
|
1,500
|
|
Deferred revenue |
747,780
|
|
424,225
|
$ 509,101
|
Remaining net operating loss |
3,800,000
|
|
|
|
Net operating loss carry forward |
$ 66,400,000
|
|
|
|
Percentage amount of tax benefit |
50.00%
|
|
|
|
Excess of insured limitations |
$ 156,112
|
|
$ 156,112
|
|
Consultants and Executives [Member] |
|
|
|
|
Expenses related to warrants issued |
|
$ 1,546,089
|
|
|
Director [Member] |
|
|
|
|
Expense related to stock options |
60,860
|
221,143
|
|
|
Common stock owed accrued expense amount |
30,889
|
83,301
|
|
|
Expenses related to warrants issued |
$ 41,242
|
$ 9,333
|
|
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v3.24.3
STOCKHOLDERS DEFICIT (Details)
|
9 Months Ended |
Sep. 30, 2024
shares
|
Issuances of common stock |
6,351,783
|
Share outstanding, beginning |
54,105,101
|
Common shares issued during the year ended |
6,351,783
|
Share outstanding, ending |
60,456,884
|
Issuances of Common Stock for Payment of Series D Preferred Dividends [Member] |
|
Issuances of common stock |
196,063
|
Issuances of Common Stock for Payment of Series E Preferred Dividends [Member] |
|
Issuances of common stock |
625,511
|
Issuances of Common Stock for Payment of Series F Preferred Dividends [Member] |
|
Issuances of common stock |
444,621
|
Issuances of Common Stock for Payment of Series F-2 Preferred Dividends [Member] |
|
Issuances of common stock |
235,544
|
Issuances of Common Stock for Payment of Interest [Member] |
|
Issuances of common stock |
1,116,709
|
Issuance of Common Stock to Consultants [Member] |
|
Issuances of common stock |
400,000
|
Issuance of common stock in private placement offering [Member] |
|
Issuances of common stock |
3,333,335
|
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v3.24.3
STOCKHOLDERS DEFICIT (Details 1) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
STOCKHOLDERS' DEFICIT: |
|
|
Warrants outstanding, beginning balance |
28,584,580
|
35,586,980
|
Warrants issued |
5,368,335
|
6,773,750
|
Warrants cancelled/expired |
(1,561,500)
|
(9,545,200)
|
Warrants exchanged |
|
$ 1,025,000
|
Warrants exercised |
|
(973,750)
|
Warrants outstanding, ending balance |
32,391,415
|
30,816,780
|
Weighted Average Exercise Price Per Share, beginning balance |
$ 0.50
|
$ 0.46
|
Weighted Average Exercise Price Per Share, Warrants issued |
0.19
|
0.26
|
Weighted Average Exercise Price Per Share, Warrants cancelled/expired |
0.44
|
0.30
|
Weighted Average Exercise Price Per Share, Warrants exchanged |
|
0.25
|
Weighted Average Exercise Price Per Share, Warrants exercised |
|
0.20
|
Weighted Average Exercise Price Per Share, ending balance |
$ 0.46
|
$ 0.49
|
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v3.24.3
STOCKHOLDERS DEFICIT (Details Narrative) - USD ($)
|
|
9 Months Ended |
12 Months Ended |
|
May 14, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2021 |
Dec. 31, 2023 |
Issuances of common stock |
|
6,351,783
|
|
|
|
Common stock, par value |
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock shares converts into common stock |
|
100,000
|
|
|
|
Shares outstanding |
|
60,456,884
|
|
|
54,105,101
|
Outstanding shares exchanged to Preferred stock |
|
57,954,585
|
54,457,934
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
Gross proceeds |
|
$ 300,000
|
|
|
|
Issuances of common stock |
|
3,333,335
|
|
|
|
Exercised price |
|
$ 0.12
|
|
|
|
Chinese National Medical Products Administration [Member] |
|
|
|
|
|
Issuance of common stock warrants |
4,000,000
|
|
|
|
|
Strike price of warrants |
$ 0.40
|
|
|
|
|
Warrant vested shares |
1,500,000
|
|
|
|
|
Exercisable term |
10 years
|
|
|
|
|
Food And Drug Administration [Member] |
|
|
|
|
|
Warrant vested shares |
2,500,000
|
|
|
|
|
Warrant [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
Issuances of common stock |
|
3,333,335
|
|
|
|
Purchase price per unit |
|
$ 0.09
|
|
|
|
Warrant [Member] | Mark Faupel [Member] |
|
|
|
|
|
Issuance of common stock warrants |
4,000,000
|
|
|
|
|
Stock-based compensation expense |
|
|
$ 679,959
|
|
|
Strike price of warrants |
$ 0.25
|
|
|
|
|
Board Members [Member] |
|
|
|
|
|
Issuance of common stock warrants |
|
1,666,677
|
|
|
|
Issuance of Warrants |
|
75,000
|
|
|
|
Note payable to an unaffiliated third party |
|
$ 75,000
|
|
|
|
Issuances of common stock |
|
3,333,335
|
|
|
|
Warrants Exchanges - 2021 [Member] |
|
|
|
|
|
Common stock warrants |
|
973,750
|
|
|
|
Strike price of warrants |
|
$ 0.25
|
$ 0.25
|
|
|
Unpaid accrued dividends |
|
|
$ 65,296
|
|
|
Exchange common stock warrants |
|
|
1,025,000
|
|
|
Common stock warrants strike price per share |
|
|
$ 0.20
|
|
|
Exercise of warrants, value |
|
|
$ 194,750
|
|
|
Exercise of warrants, shares |
|
|
973,750
|
|
|
Warrants Exchanges - 2021 [Member] | Richard Blumberg [Member] |
|
|
|
|
|
Number of warrant issued |
|
1,800,000
|
900,000
|
|
|
Series C Convertible Preferred Shares [Member] |
|
|
|
|
|
Issuance of Warrants |
|
160,000
|
|
|
|
Note payable to an unaffiliated third party |
|
$ 150,000
|
|
|
|
Common stock, shares authorized |
|
500,000,000
|
|
|
500,000,000
|
Common stock shares issued |
|
60,456,884
|
|
|
54,105,101
|
Common stock shares outstanding |
|
60,456,884
|
|
|
54,105,101
|
Conversion price per share |
|
$ 0.50
|
|
|
|
Common stock, par value |
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock shares converts into common stock |
|
2,000
|
|
|
|
Preferred stock shares converts into common stock |
|
572,000
|
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock shares designated |
|
9,000
|
|
|
9,000
|
Liquidation preference |
|
$ 1,000
|
|
|
$ 1,000
|
Make-whole payment shares |
|
200
|
|
|
200
|
Shares outstanding |
|
286
|
|
|
286
|
Unpaid accrued dividends |
|
$ 120,120
|
|
|
$ 120,120
|
Preferred stock shares issued |
|
300
|
|
|
300.0
|
Preferred stock shares outstanding |
|
300.0
|
|
|
300.0
|
Cumulative dividend rate |
|
12.00%
|
|
|
|
Preferred stock shares authorized |
|
9,000.0
|
|
|
9,000.0
|
Series C1 Convertible Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.50
|
|
|
|
Preferred stock shares converts into common stock |
|
2,000
|
|
|
|
Preferred stock shares converts into common stock |
|
2,098,500
|
|
|
|
Preferred stock shares designated |
|
20,250
|
|
|
|
Preferred stock shares issued |
|
1,049
|
|
|
1,049
|
Preferred stock shares outstanding |
|
1,049
|
|
|
1,049
|
Series C2 Convertible Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.50
|
|
|
|
Preferred stock shares converts into common stock |
|
2,000
|
|
|
|
Preferred stock shares converts into common stock |
|
5,400,000
|
|
|
|
Preferred stock shares surrendered |
|
3,262
|
|
|
|
Dividing the stated value |
|
1,000
|
|
|
|
Preferred stock shares issued |
|
3,262
|
|
|
|
Preferred stock shares outstanding |
|
2,700
|
|
|
2,700
|
Series F-2 Convertible Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.25
|
|
|
|
Preferred stock shares converts into common stock |
|
4,000
|
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock shares designated |
|
3,500
|
|
|
|
Conversion beneficial ownership limitation |
|
4.99%
|
|
|
|
Maturity period |
|
5 years
|
|
|
|
Stated value of preference share |
|
$ 1,000
|
|
|
|
Outstanding shares exchanged to Preferred stock |
|
2,559
|
|
|
|
Preferred stock shares issued |
|
500
|
|
|
500.0
|
Increased beneficial ownership percentage |
|
9.99%
|
|
|
|
Common Stock primary trading shares exceed |
|
1,000
|
|
|
|
Exceeds percentage |
|
200.00%
|
|
|
|
Preferred stock shares outstanding |
|
520
|
|
|
520
|
Preferred stock shares received |
|
678,000
|
|
|
|
Accrued dividends of preferred shares |
|
$ 15,718
|
|
|
$ 23,579
|
Outstanding debt |
|
$ 2,559,000
|
|
|
|
Issuance of common stock for conversion of Series F-2 Convertible Preferred Stock |
|
235,544
|
|
|
|
Preferred stock shares outstanding |
|
500.0
|
|
|
500.0
|
Preferred stock shares authorized |
|
5,000.0
|
|
|
5,000.0
|
Preferred stock stated value |
|
$ 1,000
|
|
|
|
Cumulative dividends, per annum |
|
6.00%
|
|
|
|
Series D Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.25
|
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
|
Preferred stock shares designated |
|
6,000
|
|
|
|
Conversion beneficial ownership limitation |
|
4.99%
|
|
|
|
Maturity period |
|
5 years
|
|
|
|
Stated value of preference share |
|
$ 750
|
|
|
|
Preferred stock shares issued |
|
763
|
|
|
|
Increased beneficial ownership percentage |
|
9.99%
|
|
|
|
Common Stock primary trading shares exceed |
|
1,000
|
|
|
|
Exceeds percentage |
|
200.00%
|
|
|
|
Preferred stock converted share |
|
3,000
|
|
|
|
Shares issued common stock amount |
|
$ 763,000
|
|
|
|
Common stock, issued public shares |
|
1,526,000
|
|
|
|
Shares issued for payment of accured stock dividend |
|
$ 196,063
|
|
|
|
Warrant exercise price per share |
|
$ 0.25
|
|
|
|
Common stock warrants exercise price 1 |
|
$ 0.75
|
|
|
|
Preferred stock dividends accrued |
|
$ 8,360
|
|
|
|
Series E Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.25
|
|
|
|
Preferred stock shares converts into common stock |
|
4,000
|
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
|
Preferred stock shares designated |
|
5,000
|
|
|
|
Conversion beneficial ownership limitation |
|
4.99%
|
|
|
|
Maturity period |
|
5 years
|
|
|
|
Liquidation preference |
|
$ 1,736
|
|
|
|
Preferred stock shares issued |
|
1,736
|
|
|
|
Common Stock primary trading shares exceed |
|
1,000
|
|
|
|
Exceeds percentage |
|
200.00%
|
|
|
|
Issuance of common stock for conversion of Series E Convertible Preferred Stock |
|
625,511
|
|
|
|
Increased election holder |
|
9.99%
|
|
|
|
Preferred stock stated value |
|
$ 1,000
|
|
|
|
Accrued dividends |
|
$ 12,612
|
|
|
$ 30,272
|
Cumulative dividends, per annum |
|
8.00%
|
|
|
|
Series F Preferred Shares [Member] |
|
|
|
|
|
Conversion price per share |
|
$ 0.25
|
|
|
|
Preferred stock shares converts into common stock |
|
|
|
4,000
|
|
Preferred stock shares designated |
|
1,500
|
|
|
|
Conversion beneficial ownership limitation |
|
4.99%
|
|
|
|
Maturity period |
|
5 years
|
|
|
|
Stated value of preference share |
|
|
|
$ 1,000
|
|
Preferred stock shares issued |
|
1,006
|
|
|
1,006
|
Common Stock primary trading shares exceed |
|
1,000
|
|
|
|
Exceeds percentage |
|
200.00%
|
|
|
|
Shares issued common stock amount |
|
|
|
$ 1,436,000
|
|
Issuance of common stock for conversion of Series F Convertible Preferred Stock |
|
444,621
|
|
|
|
Increased election holder |
|
9.99%
|
|
|
|
Preferred stock shares outstanding |
|
|
|
1,436
|
|
Cumulative dividend rate |
|
|
|
6.00%
|
|
Accrued dividends |
|
$ 30,851
|
|
|
$ 46,108
|
Preferred stock stated value |
|
$ 1,000
|
|
|
|
Preferred Stock Shares [Member] |
|
|
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock shares authorized |
|
5,000,000
|
|
|
500,000,000
|
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v3.24.3
STOCK OPTIONS (Details) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
STOCK OPTIONS |
|
|
Outstanding at beginning of year |
2,338,636
|
1,500,000
|
Options granted |
545,000
|
1,025,000
|
Options forfeited |
|
(186,364)
|
Outstanding at ending of year |
2,883,636
|
2,338,636
|
Number of shares exercisable |
2,172,614
|
1,811,364
|
Options outstanding weighted average exercise price, beginning |
$ 0.41
|
$ 0.49
|
Options granted weighted average exercise price |
0.12
|
0.26
|
Options forfeited weighted average exercise price |
|
0.31
|
Options outstanding weighted average exercise price, Ending |
0.35
|
0.41
|
Weighted average exercise price per share exercisable |
$ 0.41
|
$ 0.45
|
Weighted average remaining contractual life, Beginning |
6 years 6 months
|
7 years 6 months
|
Weighted average remaining contractual life, Ending |
6 years 7 months 6 days
|
6 years 9 months 18 days
|
Weighted average remaining contractual life exercisable |
5 years 8 months 12 days
|
6 years
|
Agrregate intrensic value, Beginning |
$ 0
|
$ 0
|
Agrregate intrensic value, Ending |
29,975
|
0
|
Agrregate intrensic value exercisable |
$ 7,494
|
$ 0
|
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v3.24.3
STOCK OPTION (Details Narrative) - USD ($)
|
|
|
9 Months Ended |
Mar. 07, 2023 |
Feb. 10, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Unrecognized stock-based compensation expense |
|
|
$ 128,792
|
|
Weighted average period |
|
|
2 years
|
|
Aggregate number of common shares |
|
|
2,500,000
|
|
Options granted weighted average exercise price |
|
|
$ 0.12
|
$ 0.26
|
Expiration date |
|
|
Jul. 08, 2034
|
|
Vesting period, description |
One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on June 7, 2023
|
One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on May 10, 2023
|
|
while the remaining options will vest over a period of 33 months, beginning on October 9, 2024
|
Director [Member] |
|
|
|
|
Stock option expense |
|
|
$ 60,860
|
$ 221,143
|
Exercise price |
|
$ 0.26
|
|
|
Options granted |
|
925,000
|
|
|
Maturity date |
|
Feb. 09, 2033
|
|
|
Dr. Cartwright [Member] |
|
|
|
|
Aggregate number of common shares |
|
|
500,000
|
|
Options granted weighted average exercise price |
|
|
$ 0.12
|
|
Stock option expense |
|
|
|
$ 59,216
|
Options granted |
|
|
45,000
|
|
Alan Gurjic [Member] |
|
|
|
|
Exercise price |
$ 0.27
|
|
|
|
Options granted |
100,000
|
|
|
|
Maturity date |
Mar. 06, 2033
|
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|
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v3.24.3
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
|
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
Sep. 02, 2022 |
Mar. 10, 2021 |
Sep. 06, 2016 |
Jun. 05, 2016 |
Jul. 31, 2024 |
May 31, 2024 |
Apr. 26, 2024 |
Feb. 17, 2024 |
Aug. 24, 2022 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jun. 28, 2024 |
Jan. 22, 2020 |
Operating lease cost |
|
|
|
|
|
|
|
|
|
$ 82,053
|
|
$ 27,351
|
|
|
|
Royalty percent |
|
|
|
20.00%
|
|
|
|
|
|
|
|
|
|
|
|
Payment to advisory group per months |
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
Weighted average price |
$ 0.20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants broken into four tranches |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,250,000
|
Strike price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.25
|
Warrants exercise prices |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.25
|
|
Commitments Other [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consideration amount company received |
|
|
|
|
|
|
|
|
|
|
|
$ 885,144
|
|
|
|
Tranche Second and Third [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price |
|
|
|
|
|
|
|
|
|
$ 1.50
|
|
$ 1.50
|
|
|
|
Tranche Second [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized expense |
|
|
|
|
|
|
|
|
|
$ 0
|
$ 29,706
|
$ 79,216
|
$ 79,216
|
|
|
Unrecognized expense |
|
|
|
|
|
|
|
|
|
|
|
41,242
|
46,397
|
|
|
Tranche Third [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized expense |
|
|
|
|
|
|
|
|
|
$ 10,311
|
$ 15,466
|
|
|
|
|
Unrecognized expense |
|
|
|
|
|
|
|
|
|
|
|
10,311
|
|
|
|
Royalty Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty consideration |
|
|
$ 50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Agreement Smi Fund [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description related to standstill agreement |
|
|
|
|
|
|
contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can place a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545
|
|
|
|
|
|
|
|
|
Amendment payment from SMI |
|
|
|
|
|
|
|
$ 531,100
|
|
|
|
|
|
|
|
Description related to SMI fund agreement |
|
|
|
|
|
|
|
SMI, through SMI’s authorized distribution partner, initiated a wire payment of $330,000 in partial satisfaction of $531,100 owed to the Company
|
|
|
|
|
|
|
|
Additional Commitment payment |
|
|
|
|
$ 500,000
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
Additional payments |
|
|
|
|
|
|
|
|
|
|
|
4,000,000.0
|
|
|
|
Consideration for inventory payment |
|
|
|
|
|
|
|
|
|
|
|
$ 4,400,000
|
|
|
|
Alan Gurjic [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excercise price |
|
|
|
|
|
|
|
|
$ 0.75
|
|
|
|
|
|
|
Weighted average price |
|
|
|
|
|
|
|
|
$ 1.50
|
|
|
|
|
|
|
Advisory Group | Consulting Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants |
|
|
|
|
|
|
|
|
|
831,250
|
|
831,250
|
|
|
5,000,000
|
Number of warrants issued |
|
|
|
|
|
|
|
|
|
2,500,000
|
|
2,500,000
|
|
|
|
Strike price |
|
|
|
|
|
|
|
|
|
$ 0.20
|
|
$ 0.20
|
|
|
|
Ironstone capital corp and Alan Gurjic [Member] | Consulting Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued warrants |
|
|
|
|
|
|
|
|
800,000
|
|
|
|
|
|
|
Excercise price |
|
|
|
|
|
|
|
|
$ 0.50
|
|
|
|
|
|
|
Weighted average price |
|
|
|
|
|
|
|
|
$ 1.00
|
|
|
|
|
|
|
Mr. Blumberg [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued warrants |
|
|
|
|
|
|
|
|
600,000
|
|
|
1,800,000
|
|
|
|
Shares issued |
|
400,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Blumberg [Member] | Consulting Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Terms of amendment to agreement |
|
,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on Mr. Blumberg’s assistance in helping the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million
|
royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized expenses for Warrants issued |
|
|
|
|
|
|
|
|
|
|
|
$ 740,517
|
|
|
|
Recognized expenses for common stock |
|
|
|
|
|
|
|
|
|
|
|
$ 31,889
|
$ 151,933
|
|
|
Number of outstanding warrants for exchange |
|
|
|
|
|
|
|
|
|
|
|
|
875,000
|
|
|
Subscription receivable |
|
$ 350,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise prices |
|
$ 0.30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. Blumberg [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants issued |
|
|
|
|
|
|
|
|
|
1,750,000
|
|
1,750,000
|
|
|
|
Non-related parties [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants issued |
|
|
|
|
|
|
|
|
|
750,000
|
|
750,000
|
|
|
|
Third Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued warrants |
|
|
|
|
|
|
|
|
600,000
|
|
|
|
|
|
|
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v3.24.3
SHORT TERM NOTES PAYABLE (Details) - Black-Scholes Option [Member]
|
1 Months Ended |
9 Months Ended |
Jul. 23, 2024 |
Jun. 28, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Expected term (years) |
4 years
|
4 years
|
6 years 1 month 6 days
|
10 years
|
Volatility |
397.30%
|
389.20%
|
797.40%
|
366.40%
|
Risk-free interest rate |
3.90%
|
4.40%
|
4.20%
|
3.80%
|
Dividend yield |
0.00%
|
0.00%
|
0.00%
|
0.00%
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v3.24.3
SHORT TERM NOTES PAYABLE (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
|
|
Jul. 04, 2024 |
Jul. 04, 2023 |
Jul. 23, 2024 |
Jun. 28, 2024 |
Apr. 15, 2024 |
Sep. 30, 2024 |
Dec. 31, 2023 |
Monthly payment |
$ 12,025
|
$ 12,041
|
$ 10,000
|
$ 20,000
|
$ 2,000
|
|
|
Deferred compensation |
|
|
|
|
81,768
|
|
|
Outstanding principal balance |
|
|
|
|
|
$ 59,422
|
$ 59,422
|
Promissory note |
|
|
50,000
|
100,000
|
$ 87,162
|
|
|
Short term note payable |
|
|
|
|
|
75,000
|
0
|
Long term note payable |
|
|
|
|
|
53,000
|
0
|
Accrued interest |
|
|
$ 5,000
|
$ 10,000
|
|
|
|
Common stock purchase warrants |
|
|
|
100,000
|
|
|
|
Exercise price |
|
|
|
$ 0.25
|
|
|
|
Line of credit facility, maximum borrowing capacity |
$ 129,556
|
$ 129,073
|
|
|
|
|
|
Promissory note maturity date |
May 04, 2025
|
May 04, 2024
|
Jan. 01, 2025
|
|
May 05, 2028
|
|
|
Accrued interest rate |
8.80%
|
7.90%
|
|
|
6.00%
|
|
|
Note payable [Member] |
|
|
|
|
|
|
|
Outstanding principal balance |
|
|
$ 6,329
|
$ 11,998
|
|
93,784
|
$ 93,784
|
Short term note payable |
|
|
|
|
|
24,000
|
|
Long term note payable |
|
|
|
|
|
$ 53,162
|
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v3.24.3
CONVERTIBLE DEBT (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
9 Months Ended |
|
|
|
|
|
|
Jun. 11, 2024 |
Sep. 02, 2022 |
Jul. 22, 2024 |
May 17, 2021 |
Sep. 30, 2024 |
Jul. 23, 2024 |
Jun. 28, 2024 |
Apr. 15, 2024 |
Dec. 31, 2023 |
Sep. 01, 2022 |
Dec. 17, 2019 |
Convertible promissory note |
|
|
|
|
|
|
|
|
|
|
$ 2,400,000
|
Convertible debt conversion price description |
|
|
|
|
The variable conversion price was 95% multiplied by the market price (the market price means the average of the five lowest trading prices during the period beginning on the issue date and ending on the maturity date)
|
|
|
|
|
|
|
Trading price |
|
|
|
|
|
|
|
|
|
|
$ 0.04
|
Variable conversion price |
|
|
|
|
|
|
|
|
|
|
$ 0.15
|
Early prepayment penalty |
|
$ 350,000
|
|
|
|
|
|
|
|
|
|
Default premiums |
|
281,256
|
|
|
|
|
|
|
|
|
|
Interest payable |
|
91,555
|
|
|
|
|
|
|
|
|
|
Reduced amount owed to Auctus after the Exchange |
|
$ 710,911
|
|
|
|
|
|
|
|
|
|
Warrants exchanged by Auctus |
|
8,775,000
|
|
|
|
|
|
|
|
|
|
Warrant exchange price , decrease |
|
$ 0.15
|
|
|
|
|
|
|
|
|
|
Warrant exchange price , increase |
|
$ 0.20
|
|
|
|
|
|
|
|
|
|
Default penalty forgiven by Auctus |
|
$ 225,444
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
24.00%
|
|
|
|
|
|
|
Notes payable |
|
|
|
|
|
$ 50,000
|
$ 100,000
|
$ 87,162
|
|
|
|
Auctus [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
|
|
|
|
$ 116,029
|
|
|
|
$ 121,995
|
|
|
Share Issue |
|
3,900,000
|
|
|
|
|
|
|
|
|
|
Prepayment penalty |
|
|
|
|
|
|
|
|
|
$ 350,000
|
|
Total balance of the convertible debt outstanding |
|
|
|
|
15,000
|
|
|
|
25,000
|
$ 1,228,183
|
|
Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
|
Warrant exchange price , increase |
|
$ 0.50
|
|
|
|
|
|
|
|
|
|
Warrant to purchase |
|
|
|
|
|
|
|
|
|
3,900,000
|
|
Warrant Two [Member] |
|
|
|
|
|
|
|
|
|
|
|
Warrant exchange price , increase |
|
$ 0.65
|
|
|
|
|
|
|
|
|
|
Warrant to purchase |
|
|
|
|
|
|
|
|
|
3,900,000
|
|
10% Senior Unsecured Convertible Debenture [Member] |
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note |
|
|
|
$ 1,000
|
1,130,000
|
|
|
|
|
|
|
Accrued interest |
|
|
|
|
$ 51,980
|
|
|
|
$ 58,494
|
|
|
Convertible debentures right description |
|
|
|
each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023
|
|
|
|
|
|
|
|
Change of Control premium percentage |
|
|
|
3.00%
|
|
|
|
|
|
|
|
Default interest rate |
|
|
|
|
18.00%
|
|
|
|
|
|
|
Senior Secured Convertible rate |
|
|
|
10.00%
|
|
|
|
|
|
|
|
Deemed price |
|
|
|
$ 0.50
|
|
|
|
|
|
|
|
Debt maturity date |
|
|
|
May 17, 2024
|
May 17, 2024
|
|
|
|
|
|
|
Proceeds from convertible debenture |
|
|
|
$ 1,130,000
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
$ 0.50
|
|
|
|
|
|
|
|
1800 Diagonal Lending Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note |
|
|
|
|
$ 162,150
|
|
|
|
|
|
|
Accrued interest |
$ 14,007
|
|
$ 8,694
|
|
$ 9,438
|
|
|
|
|
|
|
Convertible note principal balance |
100,050
|
|
62,100
|
|
|
|
|
|
|
|
|
Discount on convertible note |
13,050
|
|
8,100
|
|
|
|
|
|
|
|
|
Notes payable |
$ 57,029
|
|
35,397
|
|
|
|
|
|
|
|
|
Debt maturity date |
Apr. 15, 2025
|
|
|
|
|
|
|
|
|
|
|
Convertible note monthly payments |
$ 14,257
|
|
$ 8,849
|
|
|
|
|
|
|
|
|
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RELATED PARTY DEBT (Details 3) - Long-Term Debt - Related Parties [Member] - Mr. Fowler [Member] $ in Thousands |
Sep. 30, 2024
USD ($)
|
2024 (remaining) |
$ 10
|
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3
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v3.24.3
RELATED PARTY DEBT (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
Jul. 04, 2024 |
Jul. 04, 2023 |
Apr. 15, 2024 |
Mar. 22, 2021 |
Feb. 19, 2021 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Jul. 14, 2018 |
Deferred compensation |
|
|
|
|
|
|
|
$ 133,000
|
$ 1,860,000
|
|
|
Accrued interest rate |
8.80%
|
7.90%
|
6.00%
|
|
|
|
|
|
|
|
|
Current portion of long-term debt, related parties |
|
|
|
|
|
$ 525,000
|
|
525,000
|
|
$ 39,000
|
|
Board Members [Member] |
|
|
|
|
|
|
|
|
|
|
|
Note payable to an unaffiliated third party |
|
|
|
|
|
|
|
$ 75,000
|
|
|
|
Issuance of Warrants |
|
|
|
|
|
|
|
75,000
|
|
|
|
Warrants estimated fair value |
|
|
|
|
|
|
|
$ 8,800
|
|
|
|
Accrued interest rate |
|
|
|
|
|
|
|
9.00%
|
|
|
|
Dr. Cartwright [Member] |
|
|
|
|
|
|
|
|
|
|
|
Promissory note interest rate |
|
|
|
|
6.00%
|
|
|
|
|
|
|
Debt instrument converted amount |
|
|
|
|
$ 100,000
|
|
|
|
|
|
|
Series F-2 Preferred Stock issued upon conversion of debt |
|
|
|
|
100
|
|
|
|
|
|
|
Principal amount of promissory note |
|
|
|
|
$ 267,085
|
|
|
|
|
|
|
Issuance of promissory note in exchange of related party debt |
|
|
|
|
|
|
|
|
|
|
$ 319,000
|
Loans, interest, bonus, salary and vacation paid amount |
|
|
|
|
|
|
|
|
|
|
$ 1,621,499
|
Interest rate per annum |
|
|
|
|
|
|
|
|
|
|
6.00%
|
Dr. Faupel [Member] |
|
|
|
|
|
|
|
|
|
|
|
Due to related party |
|
|
|
|
|
|
|
|
|
|
$ 660,895
|
Promissory note interest rate |
|
|
|
|
6.00%
|
|
|
|
|
|
|
Debt instrument converted amount |
|
|
|
|
$ 85,000
|
|
|
|
|
|
|
Series F-2 Preferred Stock issued upon conversion of debt |
|
|
|
|
85
|
|
|
|
|
|
|
Principal amount of promissory note |
|
|
|
|
$ 153,178
|
|
|
|
|
|
|
Issuance of promissory note in exchange of related party debt |
|
|
|
|
|
|
|
|
|
|
$ 207,111
|
Mr. Fowler [Member] |
|
|
|
|
|
|
|
|
|
|
|
Deferred compensation |
|
|
|
|
|
16,145
|
$ 17,183
|
$ 49,205
|
$ 52,354
|
|
|
Total outstanding prior to exchange |
|
|
|
|
|
80,131
|
|
80,131
|
|
|
|
Long-term debt-related parties |
|
|
|
|
|
13,011
|
|
13,011
|
|
43,855
|
|
Current portion of long-term debt, related parties |
|
|
|
|
|
40,875
|
|
40,875
|
|
39,090
|
|
Outstanding principal amount |
|
|
|
|
|
$ 53,886
|
|
$ 53,886
|
|
$ 82,945
|
|
Due to related party |
|
|
|
$ 546,214
|
|
|
|
|
|
|
|
Series F-2 Preferred Stock issued upon conversion of debt |
|
|
|
50
|
|
|
|
|
|
|
|
Interest payable |
|
|
|
$ 133,590
|
|
|
|
|
|
|
|
Due to related party, amount |
|
|
|
$ 546,214
|
|
|
|
|
|
|
|
Promissory note default interest rate |
|
|
|
18.00%
|
|
|
|
|
|
|
|
Promissory note monthly installment |
|
|
|
$ 3,600
|
|
|
|
|
|
|
|
Preferred shares converted into common stock |
|
|
|
200,000
|
|
|
|
|
|
|
|
Effective interest rate |
|
|
|
6.18%
|
|
|
|
|
|
|
|
Deferred salary |
|
|
|
$ 412,624
|
|
|
|
|
|
|
|
Unsecured note issued upon conversion of debt |
|
|
|
$ 150,000
|
|
|
|
|
|
|
|
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v3.24.3
INCOME (LOSS) PER COMMON SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
INCOME (LOSS) PER SHARE OF COMMON STOCK |
|
|
|
|
Net loss |
$ (692)
|
$ (717)
|
$ (1,891)
|
$ (3,290)
|
Basic weighted average number of shares outstanding |
|
|
55,929
|
50,588
|
Net loss per share (basic) |
|
|
$ (0.03)
|
$ (0.07)
|
Diluted weighted average number of shares outstanding |
|
|
55,929
|
50,588
|
Net loss per share (diluted) |
|
|
$ (0.03)
|
$ (0.07)
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v3.24.3
SUBSEQUENT EVENTS (Details) - Subsequent Event [Member]
|
Oct. 10, 2024
USD ($)
integer
|
2026 [Member] |
|
Cumulative Number of Devices Placed or Sold |
300
|
Cumulative Resulting Minimum Tests |
1,440,000
|
Cumulative Minimum Cervival Guide Royalty Payments to GTI | $ |
$ 1,440,000
|
2027 [Member] |
|
Cumulative Number of Devices Placed or Sold |
400
|
Cumulative Resulting Minimum Tests |
5,040,000
|
Cumulative Minimum Cervival Guide Royalty Payments to GTI | $ |
$ 4,480,000
|
2028 [Member] |
|
Cumulative Number of Devices Placed or Sold |
1,500
|
Cumulative Resulting Minimum Tests |
15,840,000
|
Cumulative Minimum Cervival Guide Royalty Payments to GTI | $ |
$ 15,840,000
|
2029 [Member] |
|
Cumulative Number of Devices Placed or Sold |
3,000
|
Cumulative Resulting Minimum Tests |
37,440,000
|
Cumulative Minimum Cervival Guide Royalty Payments to GTI | $ |
$ 37,440,000
|
2030 [Member] |
|
Cumulative Number of Devices Placed or Sold |
4,000
|
Cumulative Resulting Minimum Tests |
66,240,000
|
Cumulative Minimum Cervival Guide Royalty Payments to GTI | $ |
$ 66,240,000
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v3.24.3
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
9 Months Ended |
|
Oct. 10, 2024 |
Sep. 02, 2022 |
Oct. 21, 2024 |
Sep. 30, 2024 |
Dec. 31, 2023 |
Common Stock, Issued |
|
|
|
60,457,000
|
54,105,000
|
Share issued for conversion |
|
|
|
100,000
|
|
Exercise price |
|
$ 0.15
|
|
|
|
Mr. Blumberg [Member] |
|
|
|
|
|
Common Stock, Issued |
|
|
|
400,000
|
|
Mr. Blumberg [Member] | Series D Preferred Stock [Member] |
|
|
|
|
|
Preferred stock dividends |
|
|
|
52,795
|
|
Mr. Blumberg [Member] | Series F Preferred Stock [Member] |
|
|
|
|
|
Preferred stock dividends |
|
|
|
5,558
|
|
Share issued for conversion |
|
|
|
25
|
|
Subsequent Event [Member] | Unaffiliated Third Party [Member] |
|
|
|
|
|
Promissory note issued totaling |
$ 200,000
|
|
|
|
|
Annual interest rate |
12.00%
|
|
|
|
|
Monthly payments |
$ 20,000
|
|
|
|
|
Debt maturity date |
Oct. 10, 2025
|
|
|
|
|
Interest rate description |
If not repaid by the maturity date, the unpaid balance of the note will accrue interest at a rate of 16.0% per annum
|
|
|
|
|
Common stock purchase warrants |
667,667
|
|
|
|
|
Exercise price |
$ 0.25
|
|
|
|
|
Subsequent Event [Member] | 47 [Member] |
|
|
|
|
|
Distribution price |
|
|
$ 1,351,250
|
|
|
Subsequent Event [Member] | 35 [Member] |
|
|
|
|
|
Distribution price |
|
|
$ 700,000
|
|
|
Subsequent Event [Member] | Shandong Yaohua Medical Instrument [Member] |
|
|
|
|
|
Minimum purchase description |
|
|
To meet demand for the remainder of 2024 and for the first half of 2025, SMI agreed to purchase a minimum of 500,000 RFID chips, at prices ranging between $1.00 and $1.40 per chip
|
|
|
Additional components payment |
|
|
$ 400,000
|
|
|
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