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, 2023

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 9, 2023, the registrant had 52,096,121 shares of Common Stock, $0.001 par value per share, outstanding.

PART I — FINANCIAL INFORMATION
		Page
Item 1.	Financial Statements	3
	Unaudited Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022	3
	Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2023 and 2022	5
	Unaudited Condensed Consolidated Statements of Stockholders' Deficit for the Three and Nine Months Ended September 30, 2023 and 2022	6
	Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022	15
	Notes to Unaudited Condensed Consolidated Financial Statements	16
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	39
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	46
Item 4.	Controls and Procedures	46
PART II — OTHER INFORMATION
Item 1.	Legal Proceedings	47
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	47
Item 6.	Exhibits	48
Signatures		49

2

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited in thousands)

	September 30,		December 31,
	2023		2022
ASSETS
Current Assets:
Cash and cash equivalents	$	731	$	2,313
Accounts receivable, net of allowance for doubtful accounts of $2 and $48 at September 30, 2023 and December 31, 2022, respectively		7		6
Inventory, net of reserves of $818 at September 30, 2023 and December 31, 2022		648		548
Other current assets		192		137
Total current assets		1,578		3,004
Non-Current Assets:
Property and equipment, net		35		42
Operating lease right-of-use assets, net of amortization		247		303
Other assets		17		17
Total non-current assets		299		362
TOTAL ASSETS	$	1,877	$	3,366
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities:
Accounts payable	$	2,153	$	2,186
Accounts payable, related parties		31		39
Accrued liabilities		807		1,247
Deferred revenue		451		509
Current portion of lease liability		88		79
Current portion of long-term debt		-		17
Current portion of long-term debt, related parties		39		504
Short-term notes payable		94		57
Short-term notes payable, related parties		-		1
Short-term convertible debt		1,171		230
Total current liabilities		4,834		4,869
Long-Term Liabilities
Long-term lease liability		179		246
Derivative liability		-		5
Long-term convertible debt		-		1,046
Long-term debt, related parties		514		83
Total long-term liabilities		693		1,380
Total liabilities		5,527		6,249
COMMITMENTS AND CONTINGENCIES (Note 7)

3

Series C convertible preferred stock, $0.001 par value; 9.0 shares authorized, 0.3 shares issued and outstanding as of September 30, 2023 and December 31, 2022. Liquidation preference of $286 at September 30, 2023 and December 31, 2022.		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, 2023 and December 31, 2022. Liquidation preference of $1,049 at September 30, 2023 and December 31, 2022.		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, 2023 and December 31, 2022. Liquidation preference of $2,700 at September 30, 2023 and December 31, 2022.		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, 2023 and December 31, 2022. Liquidation preference of $438 at September 30, 2023 and December 31, 2022.		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, 2023 and December 31, 2022. Liquidation preference of $883 and $888 at September 30, 2023 and December 31, 2022, respectively.		834			839
Series F convertible preferred stock, $0.001 par value; 1.5 shares authorized, 1.0 and 1.1 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively. Liquidation preference of $1,006 and $1,056 at September 30, 2023 and December 31, 2022, respectively.		838			880
Series F-2 convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.5 shares issued and outstanding as of September 30, 2023 and December 31, 2022. Liquidation preference of $520 and $535 at September 30, 2023 and December 31, 2022, respectively.		475			489
Common stock, $0.001 par value; 500,000 shares authorized, 52,042 and 48,596 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively.		3,439			3,437	)
Additional paid-in capital		140,672			138,090	)
Treasury stock at cost		(132	)		(132	)
Accumulated deficit		(150,649	)		(147,359	)
Total stockholders’ deficit		(3,650	)		(2,883	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	1,877		$	3,366

The accompanying notes are an integral part of these condensed consolidated statements.

4

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,
	2023			2022			2023			2022
Sales - devices and disposables	$	-		$	3		$	66		$	13
Cost of goods sold		4			-			46			2
Gross profit		(4	)		3			20			11
Operating expenses:
Research and development		69			8			142			38
Sales and marketing		69			52			203			129
General and administrative		481			1,167			2,647			2,229
Total operating expenses		619			1,227			2,992			2,396
Loss from operations		(623	)		(1,224	)		(2,972	)		(2,385	)
Other income (expenses):
Interest expense		(71	)		(155	)		(206	)		(512	)
Change in fair value of derivative liability		-			5			5			13
Gain from extinguishment of debt		17			270			69			345
Other income (expenses)		-			2			1			5
Total other income (expense)		(54	)		122			(131	)		(149	)
Loss before income taxes		(677	)		(1,102	)		(3,103	)		(2,534	)
Provision for income taxes		-			-			-			-
Net loss		(677	)		(1,102	)		(3,103	)		(2,534	)
Deemed dividend for warrant exchanges		-			-			(65	)		-
Preferred stock dividends		(40	)		48			(122	)		(581	)
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS	$	(717	)	$	(1,054	)	$	(3,290	)	$	(3,115	)
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
Basic	$	(0.01	)	$	(0.03	)	$	(0.07	)	$	(0.11	)
Diluted	$	(0.01	)	$	(0.03	)	$	(0.07	)	$	(0.11	)
Weighted average shares outstanding
Basic		51,473			34,829			50,588			27,335
Diluted		51,473			34,829			50,588			27,335

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

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.

6

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

7

					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.

8

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2022

(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, 2022		-	$	105		1	$	170		3	$	531		1	$	159
Issuance of common stock to investors				-		-		-		-		-		-		-
Issuance of warrants to investors		-		-		-		-		-		-		-		-
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		-		-		-		-		-		-		-		-
Conversion of Series F-2 preferred stock to common stock		-		-		-		-		-		-		-		-
Stock-based compensation		-		-		-		-		-		-		-		-
Issuance of warrants to consultants		-		-		-		-		-		-		-		-
Accrued Preferred Dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-
Balance at September 30, 2022		-	$	105		1	$	170		3	$	531		1	$	159

	Preferred Stock				Preferred Stock				Preferred Stock
	Series E				Series F				Series F2
	Shares		Amount		Shares		Amount		Shares			Amount
Balance at June 30, 2022		1	$	839		1	$	892		3		$	2,536
Issuances of common stock to investors		-		-		-		-		-			-
Issuance of warrants to investors		-		-		-		-		-			-
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		-		-		-		-		-			-
Conversion of Series F-2 preferred stock to common stock		-		-		-		-		(3	)		(2,047	)
Stock-based compensation		-		-		-		-		-			-
Issuance of warrants to consultants		-		-		-		-		-			-
Accrued Preferred Dividends		-		-		-		-		-			-
Net loss		-		-		-		-		-			-
Balance at September 30, 2022		1	$	839		1	$	892		-		$	489

9

					Additional
	Common Stock				Paid-In		Treasury			Accumulated
	Shares		Amount		Capital		Stock			Deficit			Total
Balance at June 30, 2022		27,583	$	3,416	$	130,166	$	(132	)	$	(144,448	)	$	(5,766	)
Issuance of common stock to investors		6,637		7		1,389		-			-			1,396
Issuance of warrants to investors		-		-		1,796		-			-			1,796
Issuance of common stock for payment of Series D preferred dividends		17		-		10		-			-			10
Issuance of common stock for payment of Series E preferred dividends		117		-		67		-			-			67
Issuance of common stock for payment of interest		121		-		70		-			-			70
Conversion of Series F-2 preferred stock to common stock		8,944		9		2,038		-			-			-
Stock-based compensation		-		-		44		-			-			44
Issuances of warrants to consultants		-		-		786		-			-			786
Accrued Preferred Dividends		-		-		-		-			48			48
Net loss		-		-		-		-			(1,102	)		(1,102	)
Balance at September 30, 2022		43,419	$	3,432	$	136,366	$	(132	)	$	(145,502	)	$	(2,651	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

10

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2022

(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, 2021		-	$	105		1	$	170		3	$	531		1	$	276
Common stock warrants exercised		-		-		-		-		-		-		-		-
Issuance of common stock to investors		-		-		-		-		-		-		-		-
Issuance of warrants to investors		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of interest		-		-		-		-		-		-		-		-
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		-		-		-		-		-		-		-		-
Conversion of Series D preferred stock to common stock		-		-		-		-		-		-		-		(117	)
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		-		-		-		-		-		-		-		-
Stock-based compensation		-		-		-		-		-		-		-		-
Issuance of warrants to consultants		-		-		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-
Balance at September 30, 2022		-	$	105		1	$	170		3	$	531		1	$	159

11

	Preferred Stock						Preferred Stock					Preferred Stock
	Series E						Series F					Series F2
	Shares			Amount			Shares		Amount			Shares			Amount
Balance at December 31, 2021		2		$	1,639			1	$	1,187			3		$	2,963
Common stock warrants exercised		-			-			-		-			-			-
Issuance of common stock to investors		-			-			-		-			-			-
Issuance of warrants to investors		-			-			-		-			-			-
Issuance of common stock for payment of Series D preferred dividends		-			-			-		-			-			-
Issuance of common stock for payment of Series E preferred dividends		-			-			-		-			-			-
Issuance of common stock for payment of Series F preferred dividends		-			-			-		-			-			-
Issuance of common stock for payment of Series F-2 preferred dividends		-			-			-		-			-			-
Issuance of common stock for payment of interest		-			-			-		-			-			-
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		-			-			-		-			-			-
Conversion of Series D preferred stock to common stock		-			-			-		-			-			-
Conversion of Series E preferred stock to common stock		(1	)		(800	)		-		-			-			-
Conversion of Series F preferred stock to common stock		-			-			-		(295	)		-			-
Conversion of Series F-2 preferred stock to common stock		-			-			-		-			(3	)		(2,474	)
Stock-based compensation		-			-			-		-			-			-
Issuance of warrants to consultants		-			-			-		-			-			-
Accrued preferred dividends		-			-			-		-			-			-
Net loss		-			-			-		-			-			-
Balance at September 30, 2022		1		$	839			1	$	892			-		$	489

12

					Additional
	Common Stock				Paid-In		Treasury			Accumulated
	Shares		Amount		Capital		Stock			Deficit			Total
Balance at December 31, 2021		13,674	$	3,403	$	126,800	$	(132	)	$	(142,387	)	$	(5,445	)
Common stock warrants exercised		5,128		5		841		-			-			846
Issuance of common stock to investors		6,637		7		1,389		-			-			1,396
Issuance of warrants to investors		-		-		1,796		-			-			1,796
Issuance of common stock for payment of Series D preferred dividends		65		-		39		-			-			39
Issuance of common stock for payment of Series E preferred dividends		181		-		102		-			-			102
Issuance of common stock for payment of Series F preferred dividends		161		-		107		-			-			107
Issuance of common stock for payment of Series F-2 preferred dividends		114		-		75		-			-			75
Issuance of common stock for payment of interest		242		-		150		-			-			150
Issuance of common stock for Series F and Series F-2 one-time 15% dividends		624		1		399		-			-			400
Conversion of Series D preferred stock to common stock		975		1		117		-			-			1
Conversion of Series E preferred stock to common stock		3,390		3		797		-			-			-
Conversion of Series F preferred stock to common stock		1,420		1		294		-			-			-
Conversion of Series F-2 preferred stock to common stock		10,808		11		2,463		-			-			-
Stock-based compensation		-		-		132		-			-			132
Issuance of warrants to consultants		-		-		865		-			-			865
Accrued preferred dividends		-		-		-		-			(581	)		(581	)
Net loss		-		-		-		-			(2,534	)		(2,534	)
Balance at September 30, 2022		43,419	$	3,432	$	136,366	$	(132	)	$	(145,502	)	$	(2,651	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

13

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited, in thousands)

	Nine Months Ended
	September 30,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(3,103	)	$	(2,534	)
Adjustments to reconcile net loss to net cash used in operating activities:
Bad debt expense		2			-
Depreciation		7			1
Amortization of debt issuance costs and discounts		97			111
Stock-based compensation		1,860			997
Change in fair value of derivative liability		(5	)		(13	)
Amortization of lease right-of-use-asset		56			50
Gain from forgiveness of debt		(69	)		(345	)
Other non-cash expenses		20			156
Change in operating assets and liabilities:
Accounts receivable		(3	)		16
Inventory		(99	)		(25	)
Other current assets		74			332
Accounts payable and accrued liabilities		(130	)		(7	)
Lease liabilities		(58	)		(51	)
Deferred revenue		(59	)		172
NET CASH USED IN OPERATING ACTIVITIES		(1,410	)		(1,140	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		-			(28	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from warrant exercises		195			495
Payments made on notes payable		(367	)		(465	)
Proceeds from issuance of common stock, net of costs		-			1,396
Proceeds from issuances of warrants, net of costs		-			1,796
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES		(172	)		3,222
NET CHANGE IN CASH		(1,582	)		2,054
Cash at beginning of period		2,313			643
CASH AT END OF PERIOD	$	731		$	2,697
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES:
Cash paid for interest	$	97		$	89
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES:
Dividends on preferred stock	$	122		$	581
Deemed dividends for warrant exchanges	$	65		$	-
Settlement of interest through common stock issuance	$	119		$	151
Settlement of dividends through common stock issuance	$	166		$	722
Settlement of previously accrued professional fees through common stock issuance	$	167		$	-
Conversion of Series D preferred shares into common stock	$	-		$	118
Conversion of Series E preferred shares into common stock	$	5		$	800
Conversion of Series F preferred shares into common stock	$	42		$	296
Conversion of Series F-2 preferred shares into common stock	$	14		$	2,473
Directors and Officers insurance obtained with financing	$	119		$	124

The accompanying notes are an integral part of these condensed consolidated financial statements.

15

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 condensed 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, 2022 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, 2022 balances reported herein are derived from the audited consolidated financial statements for the year ended December 31, 2022. 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, 2023 and December 31, 2022, and the consolidated results of operations and cash flows for the three and nine-month periods ended September 30, 2023 and 2022 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, 2023, it had an accumulated deficit of approximately $150.6 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 into multiple operating segments for the purpose of making operating decisions or assessing performance. Accordingly, the Company operates in one reportable operating segment. The Company’s principal decision maker is the Chief Executive Officer and acting Chief Financial Officer. Management believes that its business operates as one reportable segment because: a) the Company measures profit and loss as a whole; b) the principal decision maker does not review information based on any operating segment; c) the Company does not maintain discrete financial information on any specific segment; d) the Company has not chosen to organize its business around different products and services, and e) the Company has not chosen to organize its business around geographic areas.

16

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, 2023, the Company had a negative working capital of approximately $3.3 million, accumulated deficit of $150.6 million, and incurred a net loss including preferred and deemed dividends of $3.3 million for the nine months then ended. Stockholders’ deficit totaled approximately $3.7 million at September 30, 2023, primarily due to recurring net losses from operations.

During the nine months ended September 30, 2023, the Company raised $195 thousand from warrant exercises. During the year ended December 31, 2022, the Company raised $3.2 million from the sale of common stock and warrants (net of expenses), and $532 thousand from warrant exercises. The Company will need to continue to raise capital in order to provide funding for its operations and FDA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

2. SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the allowance for doubtful accounts, inventory valuation and input variables for Black-Scholes and binomial option pricing models. The Company uses the binomial option pricing model for the calculation of the fair value of freestanding warrants with market conditions.

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.

Accounts Receivable

The Company performs periodic credit evaluations of its customers’ financial conditions and generally does not require collateral. The Company reviews all outstanding accounts receivable for collectability on a quarterly basis. An allowance for doubtful accounts is recorded for any amounts deemed uncollectable. Uncollectibility is determined based on the determination that a customer will not be able to make payment and the time frame has exceeded one year. The Company does not accrue interest receivables on past due accounts receivable.

17

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 approximately $482,776 and $2,064,772 as of September 30, 2023 and December 31, 2022, respectively.

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, 2023 and December 31, 2022:

	(in thousands)
	September 30,			December 31,
	2023			2022
Raw materials	$	1,364		$	1,260
Work-in-progress		58			68
Finished goods		44			38
Inventory reserve		(818	)		(818	)
Total inventory	$	648		$	548

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 statement of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment consisted of the following as of September 30, 2023 and December 31, 2022:

	(in thousands)
	September 30,			December 31,
	2023			2022
Equipment	$	1,083		$	1,083
Software		656			656
Furniture and fixtures		41			41
Leasehold improvements		12			12
Subtotal		1,792			1,792
Less accumulated depreciation		(1,757	)		(1,750	)
Property, equipment and leasehold improvements, net	$	35		$	42

Depreciation expense related to property and equipment for the three and nine months ended September 30, 2023 was $2,316 and $6,947, respectively. Depreciation expense for the three and nine months ended September 30, 2022 was not material.

18

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, 2023 and 2022.

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 7 – “Commitments and Contingencies.”

Accrued Liabilities

Accrued liabilities as of September 30, 2023 and December 31, 2022 are summarized as follows:

	(in thousands)
	September 30, 2023		December 31, 2022
Compensation	$	374	$	444
Professional fees		141		285
Stock subscription payable		-		36
Interest		70		189
Vacation		27		41
Preferred dividends		188		231
Other accrued expenses		7		21
Total	$	807	$	1,247

19

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 condensed consolidated balance sheet.

Revenue Recognition

ASC 606, Revenue from Contracts with Customers, establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue will now be recognized by a vendor when control over the goods or services is transferred to the customer. The application of the core principle in ASC 606 is carried out in five steps:

· Step 1 – Identify the contract with a customer: a contract is defined as an agreement (including oral and implied), between two or more parties, that creates enforceable rights and obligations and sets out the criteria for each of those rights and obligations. The contract needs to have commercial substance and it is probable that the entity will collect the consideration to which it will be entitled.

· Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.

· Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.

· Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach in limited circumstances. Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and reallocation of changes in standalone selling prices after inception is not permitted.

· Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.

The Company did not recognize material revenues during the nine-month periods ended September 30, 2023 or 2022. The Company’s revenues do not require significant estimates or judgments. 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. As of September 30, 2023 and December 31, 2022, deferred revenue was approximately $450,516 and $509,101, respectively.

20

Significant Customers

As of September 30, 2023, accounts receivable outstanding was approximately $8,942, the outstanding amount was netted against a $1,500 allowance, leaving a balance of $7,442 which was from two customers. As of December 31, 2022, accounts receivable outstanding was $54,484; the outstanding amount was netted against a $48,172 allowance, leaving a balance of $6,312, which was from one customer.

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.

At September 30, 2023, the Company had approximately $65.6 million of net operating losses carryforward available. This 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 for 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% 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.

21

During the nine months ended September 30, 2023, the Company recognized $221,143 of expense related to stock options, $92,699 of expense for stock issued to consultants and executives and $1,546,089 of expense for warrants issued to consultants and executives. As of September 30, 2023 and December 31, 2022, accrued expense for the shares of common stock due but unissued to Richard Blumberg, a related party, totaled $83,366 and $166,667, respectively. See Note 7 to our financial statements for additional information.

Derivatives

The Company reviews the terms of convertible debt issued to determine whether there are embedded derivative instruments, including embedded conversion options, which are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrument contains more than one embedded derivative instrument, including the conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.

Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life of the instrument through periodic charges to interest expense.

3.   FAIR VALUE OF FINANCIAL INSTRUMENTS

The guidance for fair value measurements, ASC 820, Fair Value Measurements and Disclosures, establishes the authoritative definition of fair value, sets out a framework for measuring fair value, and outlines the required disclosures regarding fair value measurements. Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The Company uses a three-tier fair value hierarchy based upon observable and non-observable inputs as follow:

· Level 1–Quoted market prices in active markets for identical assets and liabilities;

· Level 2–Inputs, other than level 1 inputs, either directly or indirectly observable; and

· Level 3–Unobservable inputs developed using internal estimates and assumptions (there is little or no market date) which reflect those that market participants would use.

The Company records its derivative activities at fair value. There was no movement of instruments between fair value hierarchy tiers during the nine months ended September 30, 2023 or 2022. Derivative liabilities measured on a recurring basis were not material as of September 30, 2023. The following tables present the fair value of derivative liabilities measured on a recurring basis as of December 31, 2022:

	Fair Value at December 31, 2022 (in thousands)
	Level 1		Level 2		Level 3			Total
Derivative liability/bifurcated conversion option in connection with Auctus $326,016 loan on December 17, 2019		-		-		(5	)		(5	)
Total long-term liabilities at fair value	$	-	$	-	$	(5	)	$	(5	)

22

The following is a summary of changes to Level 3 instruments during the nine months ended September 30, 2023:

	(in thousands)
	Derivative
Balance at December 31, 2022	$	(5	)
Change in fair value during the period		5
Balance at September 30, 2023	$	-

4.  STOCKHOLDERS’ DEFICIT

Common Stock

The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of September 30, 2023 and December 31, 2022, 52,041,502 and 48,595,715 shares of common stock were issued and outstanding, respectively.

During the nine months ended September 30, 2023, the Company issued 3,445,787 shares of common stock, as summarized below:

	Number of Shares
Common stock warrants exercised		1,119,294
Issuance of common stock for payment of Series D preferred dividends		96,728
Issuance of common stock for payment of Series E preferred dividends		378,294
Issuance of common stock for payment of Series F preferred dividends		233,308
Issuance of common stock for payment of Series F-2 preferred dividends		120,284
Issuance of common stock for payment of interest		417,879
Issuance of common stock to consultants		800,000
Conversion of Series E preferred stock to common stock		20,000
Conversion of Series F preferred stock to common stock		200,000
Conversion of Series F-2 preferred stock to common stock		60,000
Total common stock issued during the nine months ended September 30, 2023		3,445,787
Summary table of common stock share transactions:
Shares outstanding at December 31, 2022		48,595,715
Common shares issued during the nine months ended September 30, 2023		3,445,787
Common shares outstanding at September 30, 2023		52,041,502

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.

23

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, 2023 and December 31, 2022, 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 of common stock, 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, 2023 and December 31, 2022. 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, 2023 and December 31, 2022, 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, 2023 and December 31, 2022. In addition, some 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 Preferred Stock. In total, for 3,262.25 shares of Series C1 Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Preferred 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.

At September 30, 2023 and December 31, 2022, there were 1,049.25 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C1 Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 2,098,500 shares of common stock.

Series C2 Convertible Preferred Stock

On August 31, 2018, the Company entered into agreements with certain holders of the Company’s Series C1 Preferred Stock, including the chairman of the Company’s board of directors, and the Chief Operating 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 Preferred Stock. In total, for 3,262.25 shares of Series C1 Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Preferred Stock.

The terms of the Series C2 Preferred Stock are substantially the same as the Series C1 Preferred Stock, except that (i) shares of Series C1 Preferred Stock may not be 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 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 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.

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At September 30, 2023 and December 31, 2022, there were 2,700 shares outstanding, each 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 5,400,000 shares of common stock.

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, 2023 and December 31, 2022. 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 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, 2023, the Company issued 96,728 shares of common stock for payment of Series D Preferred Stock dividends. As of September 30, 2023 and December 31, 2022, the Company had accrued dividends of $8,360 and $8,213, for the Series D Preferred Stock, respectively.

Series E Convertible Preferred Stock

The Board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 and 888 of which remained outstanding as of September 30, 2023 and December 31, 2022, respectively. 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, 2023, the Company issued 20,000 shares of common stock for the conversion of 5 shares of Series E Convertible Preferred Stock and 378,294 shares of common stock for payment of Series E Preferred Stock dividends. As of September 30, 2023 and December 31, 2022, the Company had accrued dividends of $12,612 and $30,414 for the Series E Preferred Stock, respectively.

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Series F Convertible Preferred Stock

The Board designated 1,500 shares of preferred stock as Series F Preferred Stock, 1,006 and 1,056 of which were issued and outstanding as of September 30, 2023 and December 31, 2022, respectively. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $1,436,000 the Company issued 1,436 shares of Series F Convertible Preferred Stock. Each Series F Preferred share is convertible into 4,000 shares of common stock. The Series F Convertible Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Convertible 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, 2023, the Company issued 200,000 shares of common stock for the conversion of 50 shares of Series F Convertible Preferred Stock and 233,308 shares of common stock for payment of annual Series F Convertible Preferred Stock dividends. As of September 30, 2023 and December 31, 2022, the Company had accrued dividends of $31,108 and $48,400 for the Series F Convertible Preferred Stock, 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 and 535 of which were issued and outstanding as of September 30, 2023 and December 31, 2022, respectively. 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, 2023, the Company issued 60,000 shares of common stock for the conversion of 15 shares of Series F-2 Preferred Stock and 120,284 shares of common stock for payment of annual Series F-2 Preferred Stock dividends. As of September 30, 2023 and December 31, 2022, the Company had accrued dividends of $15,779 and $24,267 for the Series F-2 Convertible Preferred Stock, respectively.

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Warrants

The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the nine months ended September 30, 2023:

	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

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, are fully vested 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, 2023, 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 7, “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. During the nine months ended September 30, 2023, 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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5.   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 plan provides for stock options to be granted up to 10% of the outstanding shares of common stock.

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 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	%

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.

During the nine months ended September 30, 2023 and 2022, the Company recognized stock-based compensation expense for stock options of $221,143 and $131,735, respectively. There was no stock option activity during the nine months ended September 30, 2022. The following table summarizes the Company’s stock option activity and related information for the nine months ended September 30, 2023 and 2022:

	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	$	-

	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 September 30, 2022		1,500,000	$	0.49	7.8 Years	$	-
Options exercisable as of September 30, 2022		1,227,136	$	0.49	7.8 Years	$	-

The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of September 30, 2023 and the exercise price, multiplied by the number of options. As of September 30, 2023, there was $139,088 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately 2.5 years. The weighted-average fair value of awards granted was $0.26 and nil during the nine months ended September 30, 2023 and 2022, respectively.

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The Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period. The Black-Scholes option pricing model and the following weighted-average assumptions were used to estimate the fair value of awards granted during the nine months ended September 30, 2023:

Expected term (years)	10.0
Volatility	366.4	%
Risk-free interest rate	3.8	%
Dividend yield	0.00

6. 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 the 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, 2023, and December 31, 2022, there was no accrual recorded for any potential losses related to pending litigation.

7. COMMITMENTS AND CONTINGENCIES

Operating Leases

The below table presents total operating lease right-of-use assets and lease liabilities as of September 30, 2023 and December 31, 2022:

	(in thousands)
	September 30,		December 31
	2023		2022
Operating lease right-of-use assets	$	247	$	303
Operating lease liabilities	$	267	$	325

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The table below presents the maturities of operating lease liabilities as of September 30, 2023:

	(in thousands)
	Operating
	Lease Payments
2023 (remaining)		28
2024		115
2025		118
2026		50
Total future lease payments		311
Less: discount		(44	)
Total lease liabilities	$	267

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, 2023 and December 31, 2022

	(in thousands)
	September 30, 2023			December 31, 2022
Weighted average remaining lease term (years)		2.7			3.4
Weighted average discount rate		11.4	%		11.4	%

Related Party Contracts

On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Shenghuo was already the Company’s exclusive distributor in China, Macau and Hong Kong, and the license extended to manufacturing in those countries as well. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or 20% of the distributor price (subject to a discount under certain circumstances), whichever is higher, per disposable distributed within Shenghuo’s exclusive territories. In connection with the license grant, Shenghuo was to underwrite the cost of securing approval of LuViva with Chinese Food and Drug Administration. At its option, Shenghuo also would provide up to $1.0 million in furtherance of the Company’s efforts to secure regulatory approval for LuViva from the U.S. Food and Drug Administration, in exchange for the right to receive payments equal to 2% of the Company’s future sales in the United States, up to an aggregate of $4.0 million. 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 disposable 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 was 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 are 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 a result of this agreement, the Company recognized nil and $79,444 of consulting expense during the nine months ended September 30, 2023 and 2022, respectively. Unrecognized consulting expense to be recognized under this agreement was nil as of September 30, 2023. As of September 30, 2023, 2,500,000 of the warrants had been issued, of which 600,000 had been transferred to Ironstone Capital Corp and 150,000 were transferred to other third parties. During the nine months ended September 30, 2023, the Company entered into an agreement with Mr. Blumberg to exchange 875,000 of the outstanding warrants for 831,250 warrants with a strike price of $0.20, which were exercised during the first quarter of 2023. As of September 30, 2023, 750,000 of the strike price $0.25 warrants held by Mr. Blumberg remained outstanding.

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On March 10, 2021, the Company entered into a consulting agreement with Richard Blumberg. As a result of the consulting agreement Mr. Blumberg provided $350,000, which was recorded to subscription receivable, to the Company in exchange for the following: (1) on September 26, 2021, 900,000 3-year warrants with an exercise price of $0.30 and 400,000 common stock shares; (2) on March 26, 2022, 900,000 3-year warrants with an exercise price of $0.40 and 400,000 common stock shares; (3) on September 26, 2022, 900,000 3-year warrants with an exercise price of $0.50 and 400,000 common stock shares; and (4) on March 26, 2023, 900,000 3-year warrants with an exercise price of $0.60 and 400,000 common stock shares. 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 three and nine months ended September 30, 2023, the Company recognized $149,677 and $740,517 of expense for the warrants issued to Mr. Blumberg, respectively. During the three and nine months ended September 30, 2022, the company recognized $98,476 of expense for the warrants issued to Mr. Blumberg. Total unrecognized expense for the warrants was nil as of September 30, 2023. During the nine months ended September 30, 2023 and 2022, the Company recognized $92,699 and $34,000 of expense for the shares of common stock issued and due to Mr. Blumberg, respectively. As not all of the shares had been issued as of September 30, 2023, the Company estimated the total amount of expense using the closing price of the Company’s stock as of September 30, 2023.

During the year ended December 31, 2021, the consulting agreement was amended to clarify that $350,000 is not intended to be debt and will not be required to be repaid in cash. The Company confirmed an obligation to provide Mr. Blumberg with 950,000 fully transferrable warrants, which will expire on January 1, 2024 and have an exercise price of $0.25. Issuance of the warrants owed to Mr. Blumberg for his services was predicated on the Company receiving funding receipts of $1,000,000, whether from a financing, series of financing, or gross sales. The amended agreement clarified that the warrants issued to Mr. Blumberg are compensation for services which involve investor relations, marketing services and assisting the Company with obtaining financing. During the year ended December 31, 2022, the Company obtained the requisite funding receipts and estimated the fair value of the warrants using the Black-Scholes option pricing model with the following assumptions:

Expected term (years)	1.3
Volatility	164.6	%
Risk-free interest rate	4.1	%
Dividend yield	0.0	%

During the nine months ended September 30, 2023 and 2022, expense recorded for the warrants was nil and $307,457, respectively. Unrecognized expense to be recognized for the warrants was nil as of September 30, 2023.

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 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 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 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. 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.

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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	%

The Company recognized expense of $364,800 for the first tranche warrants during the three and nine months ended September 30, 2022. Unrecognized expense related to the first tranche warrants was nil as of September 30, 2022.

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 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 second and third tranches of warrants of $35,270 and $125,613 during the three and nine months ended September 30, 2023, respectively. The Company recognized expense for the second and third tranches of warrants of $15,057 during the three and nine months ended September 30, 2022. Unrecognized expense for the second and third tranche warrants was $56,708 as of September 30, 2023.

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 best efforts to sell devices after CFDA 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.

Contingencies

Coronavirus SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, could result in additional repercussions to the Company’s operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites.

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The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain the coronavirus.

The Russia-Ukraine conflict and the sanctions imposed in response to this crisis could result in repercussions to 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.

8.   NOTES PAYABLE

Short Term Notes Payable

On July 4, 2022, the Company entered into a premium finance agreement to finance its insurance policies totaling $123,889. Monthly payments of $11,409 are due on the note, including interest incurred at a rate of 5.0%. The note, which matured on May 4, 2023, had an outstanding balance of nil and $56,569 as of September 30, 2023 and December 31, 2022, 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 matures on May 4, 2024, had an outstanding balance of $94,152 as of September 30, 2023.

During 2019, the Company issued promissory notes to Mr. Cartwright totaling $45,829. The notes were initially issued with 0% interest, however interest increased to 6.0% interest 90 days after the Company received $1,000,000 in financing proceeds. As of September 30, 2023, the notes have been repaid in full.

The following table summarizes short-term notes payable, including notes held by related parties:

	Short-term notes payable, including related parties
	September 30,    2023		December 31, 2022
Dr. Cartwright	$	-	$	1
Premium Finance (insurance)		94		57
Short-term notes payable	$	94	$	58

As of September 30, 2023 and December 31, 2022, the short-term note payable due to a related party was nil and $619, respectively.

9.  CONVERTIBLE DEBT

Auctus Convertible Note

On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with 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.

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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.

The total outstanding balance of the convertible note was $123,038 and $326,016 as of September 30, 2023 and December 31, 2022, respectively. As of September 30, 2023, the balance is included within “Short-term convertible debt” on the unaudited condensed consolidated balance sheet. As of December 31, 2022, $230,482 is included within “Short-term convertible debt” and $95,534 is included within “Long-term convertible debt” on the condensed consolidated balance sheet.

10% Senior Unsecured Convertible Debenture

On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which mature 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.

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At September 30, 2023 and December 31, 2022, the balance due on the 10% Senior Secured Convertible Debenture was $1,130,000 and total accrued interest was $28,878 and $58,494, respectively. The bond payable discount and unamortized debt issuance costs as of September 30, 2023 and December 31, 2022 are presented below (in thousands):

	September 30, 2023			December 31, 2022
10% Senior Unsecured Convertible Debentures	$	1,130		$	1,130
Unamortized debt issuance costs		(18	)		(40	)
Debt Discount		(64	)		(140	)
Senior Secured Convertible Debenture	$	1,048		$	950

As of September 30, 2023, the balance of the Senior Secured Convertible Debenture is included in “Short-term convertible debt” within the unaudited condensed consolidated balance sheet. As of December 31, 2022, the balance of the Senior Secured Convertible Debenture is included in “Long-term convertible debt” within the condensed consolidated balance sheet.

10.  LONG-TERM DEBT

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% 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, matures on February 18, 2023, and will accrue interest at a rate of 6.0%. For Dr. Faupel the principal amount on the new note was $153,178, matures on February 18, 2023, and will accrue interest at a rate of 6.0%. The modifications extended the maturity date on both of the notes. Additionally, the Company exchanged $100,000 and $85,000 of the balance 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.

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The table below summarizes the outstanding balance of long-term debt owed to Dr. Faupel and Dr. Cartwright:

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, 2022		48
Balance outstanding at December 31, 2022	$	170
Interest accrued through September 30, 2023		7
Balance outstanding at September 30, 2023	$	177

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, 2022		78
Balance outstanding at December 31, 2022	$	297
Payments on outstanding debt		(25	)
Interest accrued through September 30, 2023		12
Balance outstanding at September 30, 2023	$	284

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% (18% in the event of default) beginning on March 22, 2022 and is payable in monthly installments of $3,580 for four years, with the first payment due on March 15, 2022. The effective interest rate of the note is 6.18%.

During the nine months ended September 30, 2023, Mr. Fowler forgave $52,354 of the outstanding balance of deferred compensation and, as of September 30, 2023, may forgive up to $146,255 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, 2023, the outstanding principal amount owed on the note was $92,399, of which $38,512 is included in “Current portion of long-term debt, related parties” and the remainder is included in “Long-term debt, related parties” within the unaudited condensed consolidated balance sheets. As of December 31, 2022, the outstanding principal amount owed on the note was $119,814, of which $36,830 is included in “Current portion of long-term debt, related parties” and the remainder is included in “Long-term debt, related parties” within the condensed consolidated balance sheets.

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Future debt obligations at September 30, 2023 for debt owed to related parties is as follows:

Year	Amount (thousands)
2023 (remaining)		9
2024		39
2025		502
2026		3
Total	$	553

6% Unsecured Promissory Note

On July 9, 2020, we entered into an exchange agreement with Mr. Bill Wells, a former employee. In lieu of agreeing to dismiss approximately half of what was owed to him, or $220,000, Mr. Wells received the following: (i) cash payment totaling $20,000; (ii) an unsecured promissory note in the amount of $90,000, to be executed within 30 days of completing new financing(s) totaling at least $3.0 million and (iii) 66,000 common stock options that vest at a rate of 3,667 per month and have a $0.49 exercise price (if two consecutive payments in (ii) are not made the stock options will be canceled and a cash payment will be required). Pursuant to the agreement, Mr. Wells agreed that the total amount forgiven of $110,000 shall be prorated according to the amount paid to him.

During the year ended December 31, 2021, the Company closed a financing round that exceeded the $3.0 million threshold and issued an unsecured promissory note in the amount of $97,052 to Mr. Wells. The note, for which monthly installment payments of $5,000 are due, matures 18 months after the issuance date and incurs interest at a rate of 6.0% per annum. During the nine months ended September 30, 2023 and 2022, the Company made principal payments of $17,052 and $50,000 to Mr. Wells, respectively. As a result of these payments, Mr. Wells forgave equivalent amounts of the remaining amount of compensation. 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, 2023 and December 31, 2022, the outstanding principal balance on the note was nil and $17,052, respectively. As of December 31, 2022, the balance is included in “Current portion of long-term debt” within the condensed consolidated balance sheet. As of September 30, 2023 and December 31, 2022, accrued interest on the note was nil and $5,139, respectively.

11.  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 (1) Series C, Series C1, Series C2, Series D, Series E, Series F and Series F-2 convertible preferred stock, convertible debt, (2) stock options and (3) warrants convertible into shares of common stock.

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The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except for per-share data):

	September 30,
	2023			2022
Net loss	$	(3,290	)	$	(3,115	)
Basic weighted average number of shares outstanding		50,588			27,335
Net loss per share (basic)		(0.07	)		(0.11	)
Diluted weighted average number of shares outstanding		50,588			27,335
Net loss per share (diluted)		(0.07	)		(0.11	)
Dilutive equity instruments (number of equivalent units):
Stock options		-			982
Preferred stock		-			6,932
Convertible debt		-			1,092
Warrants		-			14,086
Total Dilutive instruments		-			23,092

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 are anti-dilutive.

12.  SUBSEQUENT EVENTS

On October 16, 2023, the Company issued 54,619 common shares for Series D Preferred dividends.

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ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

FORWARD-LOOKING STATEMENTS

In addition to historical information, this Quarterly Report on Form 10-Q may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act), which provides a “safe harbor” for forward-looking statements made by us. All statements, other than statements of historical facts, including statements concerning our plans, objectives, goals, beliefs, business strategies, future events, business conditions, results of operations, financial position, business outlook, business trends, and other information, may be forward-looking statements. Words such as “might,” “will,” “may,” “should,” “estimates,” “expects,” “continues,” “contemplates,” “anticipates,” “projects,” “plans,” “potential,” “predicts,” “intends,” “believes,” “forecasts,” “future,” and variations of such words or similar expressions are intended to identify forward-looking statements. The forward-looking statements are not historical facts, and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by their nature, are inherently uncertain and beyond our control. Our expectations, beliefs, estimates, and projections are expressed in good faith and we believe there is a reasonable basis for them. However, there can be no assurance that management’s expectations, beliefs, estimates, and projections will occur or can be achieved, and actual results may vary materially from what is expressed in or indicated by the forward-looking statements.

These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results, including those that may be set forth under “Risk Factors” below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 2022 and this quarterly report on Form 10-Q. Examples of these uncertainties and risks include, but are not limited to:

· access to sufficient debt or equity capital to meet our operating and financial needs;

· the extent of dilution of the holdings of our existing stockholders upon the issuance, conversion or exercise of securities issued as part of our capital raising efforts;

· the extent to which certain debt holders may call the notes to be paid;

· the effectiveness and ultimate market acceptance of our products and our ability to generate sufficient sales revenues to sustain our growth and strategy plans;

· whether our products in development will prove safe, feasible and effective;

· whether and when we or any potential strategic partners will obtain required regulatory approvals in the markets in which we plan to operate;

· our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products;

· the lack of immediate alternate sources of supply for some critical components of our products;

· our ability to establish and protect the proprietary information on which we base our products, including our patent and intellectual property position;

· the current outbreak of the Coronavirus SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, could result in additional repercussions in our operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites;

· 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 drawn that we will make additional updates with respect thereto or with respect to other forward-looking statements.

The following discussion should be read in conjunction with our financial statements and notes thereto included elsewhere in this report.

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OVERVIEW

We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the sales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. The underlying technology of LuViva primarily relates to the use of biophotonics for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.

LuViva provides a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva improves patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.

We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”

Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants.

Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception and, as of September 30, 2023 we have an accumulated deficit of approximately $150.7 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. During the nine months ended September 30, 2023 and 2022, the majority of our revenues were from the sale of components of our LuViva devices and disposables. We expect that the majority of our revenue in the near future will be derived from sales of LuViva devices and disposables.

Current Demand for LuViva

Based on written agreements and ongoing discussions with our distributors, we currently hold and expect to generate additional purchase orders for approximately $3.0 million in LuViva devices and disposables and expect those purchase orders to result in actual sales of $1.5 to $2.5 million throughout 2023 and 2024, 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, the Company, in 2023 and 2024, is focused on three primary markets: the United States, China and Europe.

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In the United States, the Company is actively pursuing FDA approval by initiating a clinical trial protocol involving approximately 400 study participants. The protocol was drafted with input from FDA and at least two prestigious clinical centers that are participating in the study. Four clinical centers have agreed to participate in the study and have granted institutional review board approval to start the study.  Budgets have been agreed to and clinical research agreements have been executed with all four institutions. The LuViva devices have been prepared and have passed bench testing in order to begin the study.  In addition to individual institutional review board approvals, on July 20, 2022 we announced that the study had also been approved by the designated central Institutional Review Board (“IRB”). Below is a summary of progress made toward starting the study after delays due primarily to Covid-19, the resulting staffing shortages at medical institutions and the back log of clinical studies that were put on the back burner in deference to Covid-19 related studies.

1)	Winship Cancer Center at Emory University (“Emory”) - On November 9, 2022, we received a letter from Emory’s IRB that we were conditionally approved to start the study, pending responses to three questions, which we provided to that IRB on November 10, 2022. All questions were addressed resulting in full institutional board approval for the study. A budget revision was initiated and approved by Emory on October 25, 2023. Both the budget and a revised clinical trial agreement were executed on October 26, 2023. An updated budget and an associated amendment to the previously signed clinical trial agreement were executed on November 7, 2023. Patients are expected to be enrolled in November 2023.
2)	University of Alabama at Birmingham (“UAB”) – In November of 2022 we were granted full scientific committee approval and local IRB approval. We signed the clinical research agreement with UAB on December 15, 2022 and began on site orientation and training in March of 2023. Recruiting of test subjects began in April 2023 and the first subjects were enrolled and tested on May 5, 2023. UAB is actively enrolling and testing patients for the study.
3)	In April 2023, the Company signed a Clinical Trial Agreement and budget with a third site, Great Lakes Bay Health Centers (“GLB”), which has granted the Company approval to start the study. GLB is actively enrolling and testing patients for the study.
4)	A fourth site, Tidewater Clinical Research in Virginia Beach, VA has approved the study. Physician training on the use of LuViva and the clinical trial protocol occurred in July 2023 and TCR is actively enrolling and testing patients for the study.
5)	The U.S. FDA has required, as a part of the quality control for the study, that the pathology diagnoses for patients enrolled in the study be performed at an institution different than the one enrolling patients. To that end, we have signed a research contract with the University of Florida Pathology Department to provide those services.

Overall, with three of the four clinical sites now enrolling patients, approximately 12% of the total number of patients needed for the study have been enrolled and tested. We expect the study to be completed in 2024, however there can be no assurance that the studies will progress within the timeframes described above.

Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China.  Our Chinese partner, SMI, has reported to us that as of October 31, 2023, 12 additional patients are needed to complete the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval. Based on this progress, the study could be completed during November 2023 and submitted for approval shortly thereafter, although there can be no assurance that the study and filing will be completed within the projected time frame.

In Europe, the Company attended a meeting in Bucharest, Romania on November 3-4, 2021, hosted by our central Eastern and Russian distribution partner. The LuViva system was demonstrated for doctors at a local clinic and the head Ob-Gyn physician’s hospital has accepted the LuViva device into service and is expected to order additional Cervical Guides to test patients as part of her practice.

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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 is probable that the entity will collect the consideration to which it will be entitled.

Step 2 – Identify the performance obligations in the contract: a performance obligation in a contract is a promise (including implicit) to transfer a good or service to the customer. Each performance obligation should be capable of being distinct and is separately identifiable in the contract.

Step 3 – Determine the transaction price: transaction price is the amount of consideration that the entity can be entitled to, in exchange for transferring the promised goods and services to a customer, excluding amounts collected on behalf of third parties.

Step 4 – Allocate the transaction price to the performance obligations in the contract: for a contract that has more than one performance obligation, the entity will allocate the transaction price to each performance obligation separately, in exchange for satisfying each performance obligation. The acceptable methods of allocating the transaction price include adjusted market assessment approach, expected cost plus a margin approach, and the residual approach in limited circumstances. Discounts given should be allocated proportionately to all performance obligations unless certain criteria are met and reallocation of changes in standalone selling prices after inception is not permitted.

Step 5 – Recognize revenue as and when the entity satisfies a performance obligation: the entity should recognize revenue at a point in time, except if it meets any of the three criteria, which will require recognition of revenue over time: the entity’s performance creates or enhances an asset controlled by the customer, the customer simultaneously receives and consumes the benefit of the entity’s performance as the entity performs, and the entity does not create an asset that has an alternative use to the entity and the entity has the right to be paid for performance to date.

Valuation of Deferred Taxes: We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.

Valuation of Equity Instruments Granted to Employee, Service Providers and Investors: On the date of issuance, the instruments are recorded at their fair value as determined using either the Black-Scholes valuation model or Monte Carlo Simulation model.

Allowance for Accounts Receivable: We estimate losses from the inability of our distributors to make required payments and periodically review the payment history of each of our distributors, as well as their financial condition, and revise our reserves as a result.

Inventory Valuation: All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when purchased.

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RESULTS OF OPERATIONS

COMPARISON OF THREE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

Sales Revenue, Cost of Goods Sold and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices and disposables for the three months ended September 30, 2023 were nil, compared to $3,476 for the three months ended September 30, 2022. Cost of goods sold was $3,743 during the three months ended September 30, 2023, compared to $131 for the three months ended September 30, 2022. The increase in cost of goods sold in the current year was due inventory count adjustments. While we currently hold and expect to generate purchase orders for approximately $3.0 million in LuViva devices and disposables, supply chain issues have caused delays in our ability to procure some of the electrical components that are needed for our products. As of September 30, 2023, we have a deferred revenue balance of $450,516 for sales of our products, which will be recognized as revenue when our products are shipped. We anticipate recognizing revenue for approximately half of these shipments in 2023 with the remainder in first quarter of 2024 due to increased availability of certain parts.

Research and Development Expenses: Research and development expenses for the three months ended September 30, 2023 and 2022 were $69,140 and $7,903, respectively. The increase of $61,237, or 775%, was primarily due to an increase in research and development clinical costs and payroll expenses related to clinical trials.

Sales and Marketing Expenses: Sales and marketing expenses for the three months ended September 30, 2023 and 2022 were $69,359 and $52,251, respectively. The increase of $17,108, or 33%, was primarily due to higher travel and payroll-related expenses.

General and Administrative Expense: General and administrative expenses for the three months ended September 30, 2023 and 2022 were $480,550 and $1,166,894, respectively. The decrease of $686,334, or 59%, was primarily due to $690,809 lower expense for warrants and common stock issued to Mr. Grujic and Mr. Blumberg, pursuant to their respective agreements. Additionally, there was a decrease of $64,378 in expenses for outside services, including fees for consultants and attorneys, a $29,075 decrease in stock option expense and a $5,996 decrease in other miscellaneous expenses. These decreases were offset by an increase of $78,368 in payroll and benefits costs and a $25,546 increase in property taxes.

Interest Expense: Interest expense for the three months ended September 30, 2023 and 2022 was $71,481 and $154,958, respectively. The decrease of $83,477, or 54%, was due to a decrease in outstanding debt, resulting in lower interest recognized for outstanding notes payable and convertible debt during the three months ended September 30, 2023 versus the three months ended September 30, 2022.

Change in Fair Value of Derivative Liability: The gain due to the change in fair value of the derivative liability during the three months ended September 30, 2023 and 2022 was $66 and $4,687, respectively. The change in the fair value of the derivative liability was due to changes to our stock price during the period and a reduction in the principal amount of debt owed.

Gain from Extinguishment of Debt: Gain from extinguishment of debt for the three months ended September 30, 2023 and 2022 was $17,184 and $269,799, respectively. The decrease in the current period was due to a lower amount of debt forgiven as the amount of debt owed has declined.

Preferred Stock Dividends: Expense related to preferred stock dividends for the three months ended September 30, 2023 was $40,073, compared to income of $47,869 during the three months ended September 30, 2022. Income was recorded in the prior period due to reversal of $128,943 of previously accrued preferred stock dividend expense, due to the conversion of Series F-2 Preferred Stock into common shares prior to the date annual dividends are due.

Net loss: Net loss attributable to common stockholders during the three months ended September 30, 2023 and 2022 was $716,777 and $1,054,427, respectively. The decrease in net loss of $337,660, or 32%, was due to the reasons outlined above.

There was no income tax benefit recorded for the three months ended September 30, 2023 or 2022, due to recurring net operating losses. A full valuation allowance has been recorded for the deferred tax assets generated from the net operating losses.

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COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

Sales Revenue, Cost of Sales and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices and disposables for the nine months ended September 30, 2023 and 2022 were $66,287 and $13,459, respectively. Cost of goods sold was $45,570 during the nine months ended September 30, 2023, compared to $2,408 for the nine months ended September 30, 2022. The increase in cost of goods sold in the current year was due to higher sales. While we currently hold and expect to generate purchase orders for approximately $3.0 million in LuViva devices and disposables supply chain issues have caused delays in our ability to procure some of the electrical components that are needed for our products. As of September 30, 2023, we have a deferred revenue balance of $450,516 for sales of our products, which will be recognized as revenue when our products are shipped. We anticipate recognizing revenue for approximately half of these shipments in 2023 with the remainder in first quarter of 2024 due to increased availability of certain parts.

Research and Development Expenses: Research and development expenses were $142,450 and $38,467 during the nine months ended September 30, 2023 and 2022, respectively. The increase of $103,983, or 270%, was primarily due to an increase in research and development clinical costs and payroll-related expenses related to clinical trials.  

Sales and Marketing Expenses: Sales and marketing expenses were $203,334 and $129,194 during the nine months ended September 30, 2023 and 2022, respectively. The increase of $74,140, or 57%, was primarily due to higher travel and payroll-related expenses.

General and Administrative Expense: General and administrative expenses were $2,647,017 and $2,228,586 during the nine months ended September 30, 2023 and 2022, respectively. The increase of $418,431, or 19%, was primarily due to an increase of $787,625 in payroll and benefits (including payroll taxes), which was driven by $679,959 of additional expense recorded for warrants issued in relation to the appointment of Dr. Mark Faupel as the Company’s President and Chief Executive Officer during the period. Additionally, the Company recognized $89,408 of additional stock-based compensation expense during the period, $59,216 of which was due to the modification of a stock option award, and $22,761 of additional expense for warrants and common stock issued to Mr. Grujic and Mr. Blumberg, pursuant to their respective agreements, and a $3,007 increase in other miscellaneous expenses. These increases were offset by a decrease of $475,081 in expenses for outside services, including fees for consultants and attorneys and a $9,289 decrease in property taxes.

Interest Expense: Interest expense during the nine months ended September 30, 2023 and 2022 was $205,872 and $511,600, respectively. The decrease of $305,728, or 60%, was due to a decrease in debt, which is a result of the Company’s concerted efforts to reduce debt through payoffs and exchanges.

Change in Fair Value of Derivative Liability: The gain due to the change in fair value of the derivative liability during the nine months ended September 30, 2023 and 2022 was $5,104 and $12,751, respectively. The change in the fair value of the derivative liability was due to changes to our stock price during the period and a reduction in the principal amount of debt owed.

Gain from extinguishment of debt: The gain from extinguishment of debt during the nine months ended September 30, 2023 and 2022 was $69,407 and $344,584, respectively. The decrease in the current period was due to a lower amount of debt forgiven as the amount of debt owed has declined.

Deemed Dividend for Warrant Exchanges: Expense related to deemed dividends was $65,296 and nil for the periods ended September 30, 2023 and 2022, respectively. The expense in the current period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.

Preferred Stock Dividends: Expense related to preferred stock dividends was $122,328 and $581,499 for the nine months ended September 30, 2023 and 2022, respectively. The decrease of $459,171, or 79%, was primarily due to payment of a one-time, non-recurring 15% dividend to the Series F and Series F-2 Preferred shareholders which was paid via issuance of common stock in the first quarter of 2022. The decrease was also driven by a lower amount of outstanding preferred stock due to conversions of preferred shares into shares of common stock.

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Net Loss: Net loss attributable to common stockholders was $3,289,502 for the nine months ended September 30, 2023, compared to net loss of $3,115,209 during the nine months ended September 30, 2022. The reasons for the increase in net loss are outlined above.

There was no income tax benefit recorded for the nine months ended September 30, 2023 and 2022, due to recurring net operating losses. A full valuation allowance has been recorded for the deferred tax assets generated from the net operating losses.

LIQUIDITY AND CAPITAL RESOURCES

Going Concern Considerations

We have incurred significant losses since our inception. At September 30, 2023, the Company had a negative working capital of approximately $3.3 million, accumulated deficit of $150.6 million, and incurred a net loss including preferred dividends of $3.3 million for the nine months then ended. Stockholders’ deficit totaled approximately $3.7 million at September 30, 2023, primarily due to recurring net losses from operations.

During the nine months ended September 30, 2023, the Company raised $195 thousand from warrant exercises. During the year ended December 31, 2022, the Company raised $3.2 million from the sale of common stock and warrants (net of expenses), and $532 thousand of proceeds from warrant exercises. The Company will need to continue to raise capital in order to provide funding for its operations and FDA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

Liquidity

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, 2023, we had cash of approximately $731 thousand and negative working capital of $3.3 million. Cash on hand is sufficient to fund our operations for the next four months, upon which we will need to raise capital.

Our major cash flows for the nine months ended September 30, 2023 consisted of cash used by operating activities of $1.4 million and net cash used in financing activities of $172 thousand, which was derived from $195 thousand of proceeds from warrant exercises, offset by payments made on outstanding debt.

Our major cash flows for the nine months ended September 30, 2022 consisted of cash used by operating activities of $1.1 million, cash used for investing activities of $28 thousand and net cash provided by financing activities of $3.2 million of proceeds received from the sale of common stock and warrants (net of costs), $496 thousand of proceed from warrant exercises, offset by cash outflows for payments made on notes payable.

Contingencies

The current outbreak of the Coronavirus SARS-CoV-2, the pathogen responsible for COVID-19, has led to supply chain issues that previously caused delays in our ability to procure the circuit boards needed to ship our products. While we continue to see delays in our ability to obtain necessary parts, we believe we will be able to meet our demand for the remainder of 2023. However, the outbreak could result in additional repercussions in our operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites.

The Russia-Ukraine conflict and the sanctions imposed in response to this crisis could result in repercussions to 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.

Off-Balance Sheet Arrangements

We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, we are not required to provide the information required by this item. 

ITEM 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

We maintain a set of disclosure controls and procedures designed to ensure that information required to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized, and reported, within the time periods specified in Securities and Exchange Commission (“Commission”) rules and forms. We carried out an evaluation under the supervision and with the participation of our management, including the Chief Executive Officer/Acting Chief Financial Officer, Mark Faupel, of the effectiveness of its disclosure controls and procedures. Based on that evaluation, the Chief Executive Officer/Acting Chief Financial Officer has concluded that our disclosure controls and procedures were ineffective as of September 30, 2023, 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, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the disposition of these matters, individually or in the aggregate, is not expected to have a material adverse effect on the Company’s financial condition. See Note 6 to the financial statements for additional information.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

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. During the nine months ended September 30, 2023, 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, the Company issued 1,800,000 warrants and 800,000 shares of common stock to Richard Blumberg, a related party, pursuant to a consulting agreement. The warrants, which will expire on March 1, 2026, have an exercise price of $0.30.

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. As of September 30, 2023, 150,000 of these options have been forfeited.

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.

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. The warrants, which have a strike price of $0.25, are fully vested and will expire on May 13, 2028.

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ITEM 4. 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)
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, 2023, 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, 2023 (formatted in Inline XBRL and included in Exhibit 101)

*Filed herewith

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

GUIDED THERAPEUTICS, INC.
By:	/s/ Mark Faupel
	Mark Faupel
	President, Chief Executive Officer, Chief Operating Officer and Acting Chief Financial Officer

Date: November 13, 2023

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