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 March 31, 2024

Commission File No. 000-22179

GUIDED THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware	58-2029543
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

5835 Peachtree Corners East, Suite B

Peachtree Corners, Georgia 30092

(Address of principal executive offices) (Zip Code) 

(770) 242-8723

(Registrant’s telephone number, including area code)     

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes ☒      No☐

Indicate by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes ☒      No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):

Large Accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act. Yes ☐      No ☒ 

As of May 10, 2024, the registrant had 55,685,464 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 March 31, 2024 and December 31, 2023	3
	Unaudited Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2024 and 2023	4
	Unaudited Condensed Consolidated Statements of Stockholders' Deficit for the Three Months Ended March 31, 2024 and 2023	5
	Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2024 and 2023	6
	Notes to Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33
PART II — OTHER INFORMATION
Item 1.	Legal Proceedings	34
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34
Item 3.	Defaults Upon Senior Securities	34
Item 4.	Mine Safety Disclosures	34
Item 5.	Other Information	34
Item 6.	Exhibits	35
Signatures		36

2

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
	March 31,			December 31,
	2024			2023
ASSETS
Current Assets:
Cash and cash equivalents	$	445		$	591
Accounts receivable, net of allowance for credit losses of $2 at March 31, 2024 and December 31, 2023		7			7
Inventory, net of reserves of $818 at March 31, 2024 and December 31, 2023		632			632
Other current assets		156			163
Total current assets		1,240			1,393
Non-Current Assets:
Property and equipment, net		30			32
Operating lease right-of-use asset, net of amortization		207			227
Other assets		17			17
Total non-current assets		254			276
TOTAL ASSETS	$	1,494		$	1,669
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities:
Accounts payable	$	1,924		$	1,991
Accounts payable, related parties		30			32
Accrued liabilities		780			970
Deferred revenue		748			424
Current portion of lease liability		95			91
Current portion of long-term debt, related parties		512			39
Short-term notes payable		24			59
Short-term convertible notes payable		1,229			1,203
Total current liabilities		5,342			4,809
Long-Term Liabilities
Long-term lease liability		130			155
Long-term debt, related parties		34			511
Total long-term liabilities		164			666
Total liabilities		5,506			5,475
COMMITMENTS AND CONTINGENCIES (Note 6)
STOCKHOLDERS’ DEFICIT:
Series C convertible preferred stock, $0.001 par value; 9.0 shares authorized, 0.3 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $286 at March 31, 2024 and December 31, 2023.		105			105
Series C1 convertible preferred stock, $0.001 par value; 20.3 shares authorized, 1.0 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $1,049 at March 31, 2024 and December 31, 2023.		170			170
Series C2 convertible preferred stock, $0.001 par value; 5,000 shares authorized, 2.7 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $2,700 at March 31, 2024 and December 31, 2023.		439			439
Series D convertible preferred stock, $0.001 par value; 6.0 shares authorized, 0.4 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $438 at March 31, 2024 and December 31, 2023.		159			159
Series E convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.9 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $883 at March 31, 2024 and December 31, 2023.		834			834
Series F convertible preferred stock, $0.001 par value; 1.5 shares authorized, Series F convertible preferred stock, $0.001 par value; 1.5 shares authorized, 1.1 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $1,006 at March 31, 2024 and December 31, 2023.		838			838
Series F-2 convertible preferred stock, $0.001 par value; 5.0 shares authorized, 0.5 shares issued and outstanding as of March 31, 2024 and December 31, 2023. Liquidation preference of $520 at March 31, 2024 and December 31, 2023.		475			475
Common stock, $0.001 par value; 500,000 shares authorized, 55,614 and 54,105 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively.		3,441			3,441
Additional paid-in capital		141,218			140,983
Treasury stock at cost		(132	)		(132	)
Accumulated deficit		(151,559	)		(151,118	)
Total stockholders’ deficit		(4,012	)		(3,806	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	1,494		$	1,669

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

3

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share data)
	Three Months Ended
	March 31,
	2024			2023
Sales - devices and disposables	$	6		$	22
Cost of goods sold		2			9
Gross profit		4			13
Operating expenses:
Research and development		54			7
Sales and marketing		73			73
General and administrative		236			776
Total operating expenses		363			856
Loss from operations		(359	)		(843	)
Other income (expenses):
Interest expense		(64	)		(66	)
Interest income		3			-
Change in fair value of derivative liability		-			5
Gain from extinguishment of debt		17			35
Other income		1			-
Total other income (expense)		(43	)		(26	)
Loss before income taxes		(402	)		(869	)
Provision for income taxes		-			-
Net loss		(402	)		(869	)
Deemed dividend for warrant exchanges		-			(65	)
Preferred stock dividends		(39	)		(35	)
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS	$	(441	)	$	(969	)
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
Basic	$	(0.01	)	$	(0.02	)
Diluted	$	(0.01	)	$	(0.02	)
Weighted average shares outstanding
Basic		54,750			49,297
Diluted		54,750			49,297

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

4

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE THREE MONTHS ENDED MARCH 31, 2024
(unaudited, in thousands)
	Preferred Stock				Preferred Stock				Preferred Stock				Preferred Stock
	Series C				Series C1				Series C2				Series D
	Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount
Balance at December 31, 2023		-	$	105		1	$	170		2	$	439		1	$	159
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-		-		-		-
Issuance of common stock for payment of interest		-		-		-		-		-		-		-		-
Settlement of previously accrued professional fees through common stock issuance
Stock-based compensation		-		-		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-
Balance at March 31, 2024		-	$	105		1	$	170		2	$	439		1	$	159

	Preferred Stock				Preferred Stock				Preferred Stock
	Series E				Series F				Series F2
	Shares		Amount		Shares		Amount		Shares		Amount
Balance at December 31, 2023		1	$	834		1	$	838		-	$	475
Issuance of common stock for payment of Series D preferred dividends		-		-		-		-		-		-
Issuance of common stock for payment of Series E preferred dividends		-		-		-		-		-		-
Issuance of common stock for payment of Series F preferred dividends		-		-		-		-		-		-
Issuance of common stock for payment of Series F-2 preferred dividends		-		-		-		-		-		-
Issuance of common stock for payment of interest		-		-		-		-		-		-
Settlement of previously accrued professional fees through common stock issuance
Stock-based compensation		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-
Net loss		-		-		-		-		-		-
Balance at March 31, 2024		1	$	834		1	$	838		-	$	475

	Common Stock				Additional Paid-In		Treasury			Accumulated
	Shares		Amount		Capital		Stock			Deficit			Total
Balance at December 31, 2023		54,106	$	3,441	$	140,983	$	(132	)	$	(151,118	)	$	(3,806	)
Issuance of common stock for payment of Series D preferred dividends		54		-		9		-			-			9
Issuance of common stock for payment of Series E preferred dividends		52		-		8		-			-			8
Issuance of common stock for payment of Series F preferred dividends		445		-		54		-			-			54
Issuance of common stock for payment of Series F-2 preferred dividends		164		-		20		-			-			20
Issuance of common stock for payment of interest		393		-		57		-			-			57
Settlement of previously accrued professional fees through common stock issuance		400		-		57		-			-			57
Stock-based compensation		-		-		30		-			-			30
Accrued preferred dividends		-		-		-		-			(39	)		(39	)
Net loss		-		-		-		-			(402	)		(402	)
Balance at March 31, 2024		55,614	$	3,441	$	141,218	$	(132	)	$	(151,559	)	$	(4,012	)

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

5

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
FOR THE THREE MONTHS ENDED MARCH 31, 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		-		-		-		-		-		-		-		-
Issuance of common stock to consultants		-		-		-		-		-		-		-		-
Stock-based compensation		-		-		-		-		-		-		-		-
Impact of warrant exchanges		-		-		-		-		-		-		-		-
Accrued preferred dividends		-		-		-		-		-		-		-		-
Net loss		-		-		-		-		-		-		-		-
Balance at March 31, 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		-		-			-		(22	)		-		-
Conversion of Series F-2 preferred stock to common stock		-		-			-		-			-		(14	)
Issuance of common stock for payment of interest		-		-			-		-			-		-
Issuance of common stock to consultants		-		-			-		-			-		-
Stock-based compensation		-		-			-		-			-		-
Impact of warrant exchanges		-		-			-		-			-		-
Accrued preferred dividends		-		-			-		-			-		-
Net loss		-		-			-		-			-		-
Balance at March 31, 2023		1	$	834			1	$	858			3	$	475

	Common Stock				Additional 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		1,072		1		221		-			-			222
Issuance of common stock for payment of Series D preferred dividends		26		-		6		-			-			6
Issuance of common stock for payment of Series E preferred dividends		26		-		8		-			-			8
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		85		-		20		-			-			20
Conversion of Series E preferred stock to common stock		20		-		5		-			-			-
Conversion of Series F preferred stock to common stock		120		-		22		-			-			-
Conversion of Series F-2 preferred stock to common stock		60		-		14		-			-			-
Issuance of common stock for payment of interest		178		-		59		-			-			59
Issuance of common stock to consultants		400		-		116		-			-			116
Stock-based compensation		-		-		448		-			-			448
Impact of warrant exchanges		-		-		65		-			(65	)		-
Accrued preferred dividends		-		-		-		-			(35	)		(35	)
Net loss		-		-		-		-			(869	)		(869	)
Balance at March 31, 2023		50,814	$	3,438	$	139,127	$	(132	)	$	(148,328	)	$	(2,855	)

	Three Months Ended
	March 31,
	2024			2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(402	)	$	(869	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		2			2
Amortization of debt issuance costs and discounts		32			32
Stock based compensation		30			564
Change in fair value of derivatives		-			(5	)
Amortization of lease right-of-use-asset		21			18
Gain from forgiveness of debt		(17	)		(35	)
Other non-cash expenses (income)		-			6
Change in operating assets and liabilities:
Accounts receivable		1			(1	)
Inventory		-			(36	)
Other current assets		8			16
Accounts payable and accrued liabilities		(78	)		(152	)
Lease liabilities		(21	)		(18	)
Deferred revenue		324			(21	)
NET CASH USED IN OPERATING ACTIVITIES		(100	)		(499	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from warrant exercises		-			195
Payments made on notes payable		(46	)		(172	)
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES		(46	)		23
NET CHANGE IN CASH AND CASH EQUIVALENTS		(146	)		(476	)
Cash at beginning of period		591			2,313
CASH AT END OF PERIOD	$	445		$	1,837
SUPPLEMENTAL DISCLOSURE FOR OPERATING ACTIVITIES:
Cash paid for interest	$	12		$	47
SUPPLEMENTAL DISCLOSURE FOR NON-CASH INVESTING AND FINANCING ACTIVITIES:
Dividends on preferred stock	$	39		$	35
Deemed dividends for warrant exchanges	$	-		$	65
Common stock issued for payment of interest	$	57		$	59
Common stock issued for payment of accrued dividends	$	91		$	88
Settlement of previously accrued professional fees through common stock issuance	$	57		$	-
Conversion of Series E Preferred Shares into Common Stock	$	-		$	5
Conversion of Series F Preferred Shares into Common Stock	$	-		$	22
Conversion of Series F-2 Preferred Shares into Common Stock	$	-		$	14

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

6

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

1. ORGANIZATION, BACKGROUND, AND BASIS OF PRESENTATION

Guided Therapeutics, Inc. (formerly SpectRx, Inc.), together with its wholly owned subsidiary, InterScan, Inc. (formerly Guided Therapeutics, Inc.), collectively referred to herein as the “Company”, is a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. The Company’s primary focus is the continued commercialization of its LuViva non-invasive cervical cancer detection device and extension of its cancer detection technology into other cancers, including esophageal. The Company’s technology, including products in research and development, primarily relates to biophotonics technology for the non-invasive detection of cancers.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) pursuant to Section 13 or 15(d) under the Securities Exchange Act of 1934. The December 31, 2023 balances reported herein are derived from the audited consolidated financial statements for the year ended December 31, 2023. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.

All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company as of March 31, 2024 and December 31, 2023, and the consolidated results of operations and cash flows for the three-month periods ended March 31, 2024 and 2023 have been included.

The Company’s prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced net losses since its inception and, as of March 31, 2024, it had an accumulated deficit of approximately $151.6 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 by multiple operating segments for the purpose of making operating decisions or assessing performance. Accordingly, the Company operates in one reportable operating segment. The Company’s principal decision maker is the Chief Executive Officer and acting Chief Financial Officer. Management believes that its business operates as one reportable segment because: a) the Company measures profit and loss as a whole; b) the principal decision makers do not review information based on any operating segment; c) the Company does not maintain discrete financial information on any specific segment; d) the Company has not chosen to organize its business around different products and services, and e) the Company has not chosen to organize its business around geographic areas.

7

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 March 31, 2024, the Company had a negative working capital of approximately $4.1 million, accumulated deficit of $151.6 million, and incurred a net loss including preferred dividends of $0.4 million for the three months then ended. Stockholders’ deficit totaled approximately $4.0 million at March 31, 2024, primarily due to recurring net losses from operations.

During the year ended December 31, 2023, the Company received $436 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/NMPA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

Reclassifications

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications did not affect net loss, revenues and stockholders’ equity.

2. SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

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

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 distributors’ financial conditions and generally does not require collateral. The Company reviews all outstanding accounts receivable for collectability on a quarterly basis. An allowance for credit losses is recorded for any amounts deemed uncollectable. Uncollectibility is determined based on the determination that a distributor 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.

8

Concentrations of Credit Risk

The Company maintains cash balances that are 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 $173,104 and $156,112 as of March 31, 2024 and December 31, 2023, respectively.

Inventory Valuation

All inventories are stated at lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred. The following table summarizes our inventory as of March 31, 2024 and December 31, 2023:

	(in thousands)
	March 31,			December 31,
	2024			2023
Raw materials	$	1,360		$	1,360
Work-in-progress		46			46
Finished goods		44			44
Inventory reserve		(818	)		(818	)
Total inventory	$	632		$	632

The company periodically reviews the value of items in inventory and provides write-downs or write-offs of inventory based on its assessment of market conditions. Write-downs and write-offs are charged to cost of goods sold.

Property and Equipment

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over estimated useful lives of three to seven years. Leasehold improvements are amortized at the shorter of the useful life of the asset or the remaining lease term. 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 are summarized as follows at March 31, 2024 and December 31, 2023:

	(in thousands)
	March 31,			December 31,
	2024			2023
Equipment	$	951		$	951
Software		634			634
Furniture and fixtures		17			17
Leasehold improvements		12			12
Subtotal		1,614			1,614
Less accumulated depreciation		(1,584	)		(1,582	)
Property, equipment and leasehold improvements, net	$	30		$	32

Depreciation expense related to property and equipment for the three months ended March 31, 2024 and 2023 was not material.

9

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 months ended March 31, 2024 and 2023.

Leases

A lease provides the lessee the right to control the use of an identified asset for a period of time in exchange for consideration. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The Company determines if an arrangement is a lease at inception. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.

Where an operating lease contains extension options that the Company is reasonably certain to exercise, the extension period is included in the calculation of the right-of-use assets and lease liabilities.

The discount rate used to determine the commencement date present value of lease payments is the interest rate implicit in the lease, or when that is not readily determinable, the Company utilizes its secured borrowing rate. Right-of-use assets include any lease payments required to be made prior to commencement and exclude lease incentives. Both right-of-use assets and lease liabilities exclude variable payments not based on an index or rate, which are treated as period costs. The Company’s lease agreements do not contain significant residual value guarantees, restrictions or covenants. See Note 6, “Commitments and Contingencies.”

Accrued Liabilities

Accrued liabilities as of March 31, 2024 and December 31, 2023 are summarized as follows:

	(in thousands)
	March 31, 2024		December 31, 2023
Compensation	$	423	$	401
Professional fees		85		216
Interest		53		90
Vacation		33		27
Preferred dividends		178		228
Other accrued expenses		8		8
Total	$	780	$	970

10

Stock Subscription Payable

Cash received from investors for shares of common stock that have not yet been issued is recorded as a liability, which is presented within Accrued Liabilities on the consolidated balance sheet.

Revenue Recognition

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

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

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

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

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

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

The Company’s revenues do not require significant estimates or judgments and are recognized when control of the promised goods or services is transferred to the Company’s customers, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. Revenue is measured as the amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The Company does not offer returns, discounts, loyalty programs or other sales incentive programs that are material to revenue recognition. The Company is not party to contracts that include multiple performance obligations or material variable consideration.

11

Contract Balances

The Company defers payments received as revenue until earned based on the related contracts and applying ASC 606 as required. Deferred revenue totaled $747,780, $424,225, and $509,101 as of March 31, 2024, December 31, 2023 and December 31, 2022, respectively.

Significant Customers

As of March 31, 2024, a receivable of $6,882 (net of the allowance for credit losses of $1,500) was attributed to one customer. As of December 31, 2023, accounts receivable of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers.

Research and Development

Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs associated with internal and contracted clinical trials. All research and development costs are expensed as incurred.

Income Taxes

The provision for income taxes is determined in accordance with ASC 740, “Income Taxes”. The Company provides for income taxes based on enacted tax law and statutory tax rates at which items of income and expense are expected to be settled in our income tax return. Certain items of revenue and expense are reported for Federal income tax purposes in different periods than for financial reporting purposes, thereby resulting in deferred income taxes. Deferred taxes are also recognized for operating losses that are available to offset future taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

The Company has filed for an extension for its 2023 federal and state corporate tax returns. Although the Company has been experiencing recurring losses, it is obligated to file tax returns for compliance with IRS regulations and that of applicable state jurisdictions. At March 31, 2024, the Company had approximately $66.4 million of net operating losses carryforward available, $3.8 million of which will expire on December 31, 2024. The remaining net operating loss will be eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related the deferred tax assets generated from the net operating losses.

The Company recognizes uncertain tax positions based on a benefit recognition model. Provided that the tax position is deemed more likely than not of being sustained, the Company recognizes the largest amount of tax benefit that is greater than 50.0% likely of being ultimately realized upon settlement. The tax position is derecognized when it is no longer more likely than not of being sustained. The Company classifies income tax related interest and penalties as interest expense and selling, general and administrative expense, respectively, on the consolidated statements of operations.

Warrants

The Company has issued warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including warrants based on the fair value at the date of issue. The fair value of warrants classified as equity instruments at the date of issuance is estimated using the Black-Scholes or binomial option pricing models.

Stock Based Compensation

The Company accounts for its stock-based awards in accordance with ASC Subtopic 718, “Compensation – Stock Compensation”, which requires fair value measurement on the grant date and recognition of compensation expense for all stock-based payment awards made to employees and directors. The Company determines the fair value of stock options using the Black-Scholes model. The fair value of restricted stock awards is based upon the quoted market price of the shares of common stock on the date of grant. The fair value of stock-based awards is expensed over the requisite service periods of the awards. The Company accounts for forfeitures of stock-based awards as they occur.

12

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.

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. STOCKHOLDERS’ DEFICIT

Common Stock

The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of March 31, 2024 and December 31, 2023, 55,613,449 and 54,105,101 shares of common stock were issued and outstanding, respectively.

During the three months ended March 31, 2024, the Company issued 1,508,348 shares of common stock, as summarized below:

	Number of Shares
Issuance of common stock for payment of Series D preferred dividends		54,494
Issuance of common stock for payment of Series E preferred dividends		52,332
Issuance of common stock for payment of Series F preferred dividends		444,621
Issuance of common stock for payment of Series F-2 preferred dividends		163,529
Issuance of common stock for payment of interest		393,372
Issuance of common stock to consultants		400,000
Total common stock issued during the year ended December 31, 2023		1,508,348
Summary table of common stock transactions:
Shares outstanding at December 31, 2023		54,105,101
Common shares issued during the three months ended March 31, 2024		1,508,348
Shares outstanding at March 31, 2024		55,613,449

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.

13

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 March 31, 2024 and December 31, 2023, there were 286 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 572,000 shares, subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt.

Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in cash or, subject to certain conditions, the Company’s common stock. Unpaid accrued dividends were $120,120 as of March 31, 2024 and December 31, 2023. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At March 31, 2024 and December 31, 2023, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock.

The Series C Preferred Stock generally has no voting rights except as required by Delaware law. Upon the Company’s liquidation or sale to or merger with another corporation, each share will be entitled to a liquidation preference of $1,000, plus any accrued but unpaid dividends.

Series C1 Convertible Preferred Stock

The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at March 31, 2024 and December 31, 2023.

At March 31, 2024 and December 31, 2023, 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 common shares.

The Series C1 Preferred Stock has terms that are substantially the same as the Series C Preferred Stock, except that the Series C1 Preferred Stock does not pay dividends (unless and to the extent declared on the common stock) or at-the-market “make-whole payments” and, while it has the same anti-dilution protections afforded the Series C preferred stock, it does not automatically reset in connection with a reverse stock split or conversion of our outstanding convertible debt.

Series C2 Convertible Preferred Stock

On August 31, 2018, the Company entered into agreements with certain holders of the Company’s Series C1 Convertible Preferred Stock, including the chairman of the Company’s board of directors, the former Chief Operating Officer (now the Chief Executive Officer) and a director of the Company pursuant to which those holders separately agreed to exchange each share of the Series C1 Preferred Stock held for one (1) share of the Company’s newly created Series C2 Convertible Preferred Stock. In total, for 3,262.25 shares of Series C1 Convertible Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Convertible Preferred Stock.

At March 31, 2024 and December 31, 2023, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C2 preferred stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares.

14

The terms of the Series C2 Convertible Preferred Stock are substantially the same as the Series C1 shares, except that (i) shares of Series C1 Convertible Preferred Stock were not convertible into the Company’s common stock by their holder for a period of 180 days following the date of the filing of the Certificate of Designation (the “Lock-Up Period”); (ii) the Series C2 Convertible Preferred Stock has the right to vote as a single class with the Company’s common stock on an as-converted basis, notwithstanding the Lock-Up Period; and (iii) the Series C2 Convertible Preferred Stock will automatically convert into that number of securities sold in the next Qualified Financing (as defined in the Exchange Agreement) determined by dividing the stated value ($1,000 per share) of such share of Series C2 Preferred Stock by the purchase price of the securities sold in the Qualified Financing.

Series D Convertible Preferred Stock

The board designated 6,000 shares of preferred stock as Series D Preferred Stock, 438 of which remained outstanding as of March 31, 2024 and December 31, 2023. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer (now the Chief Executive Officer) and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock, 1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. Each Series D Preferred Stock is convertible into 3,000 shares of common stock. The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750.

Each share of Series D Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series D Certificate of Designation (the “Series D Conversion Price”). The conversion of Series D Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series D Preferred. If the average of the VWAPs (as defined in the Series D Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series D Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series D Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends.

During the three months ended March 31, 2024, the Company issued 54,494 shares of common stock for the payment of accrued Series D Preferred Stock dividends. As of March 31, 2024, and December 31, 2023, the Company had accrued dividends for the Series D Preferred Stock of $8,360.

Series E Convertible Preferred Stock

The Board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 of which remained outstanding as of March 31, 2024 and December 31, 2023. 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 three months ended March 31, 2024, the Company issued 52,332 shares of common stock for payment of accrued Series E Preferred Stock dividends. As of March 31, 2024 and December 31, 2023, the Company had accrued dividends of $39,932 and $30,272 for the Series E Preferred Stock, respectively.

15

Series F Convertible Preferred Stock

The Board designated 1,500 shares of preferred stock as Series F Preferred Stock, 1,006 of which remained outstanding as of March 31, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series F Investors”). In total, for $1,436,000 the Company issued 1,436 shares of Series F Preferred Stock. Each Series F Preferred Stock is convertible into 4,000 shares of common stock. The Series F Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Preferred Stock is $1,000.

Each share of Series F Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F Certificate of Designation (the “Series F Conversion Price”). The conversion of Series F Preferred Stock is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends.

During the three months ended March 31, 2024, the Company issued 444,621 shares of common stock for the payment of annual Series F Preferred Stock dividends. As of March 31, 2024 and December 31, 2023, the Company had accrued dividends for Series F preferred shares of $671 and $46,108, respectively.

Series F-2 Convertible Preferred Stock

The Company was oversubscribed for its Series F Preferred Stock, resulting in the requirement to file an additional Certificate of Designation for Series F-2 Preferred Stock with substantially the same terms as the Series F Preferred Stock. The Board designated 3,500 shares of preferred stock as Series F-2 Preferred Stock, 520 of which were issued and outstanding as of March 31, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. Each Series F-2 Preferred share is convertible into 4,000 shares of common stock. The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000.

Each share of Series F-2 Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F-2 Certificate of Designation (the “Series F-2 Conversion Price”). The conversion of Series F-2 Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F-2 Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F-2 Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F-2 Preferred Stock, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends.

During the three months ended March 31, 2024, the Company issued 163,529 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. As of March 31, 2024 and December 31, 2023, the Company had accrued dividends for Series F-2 preferred shares of $9,118 and $23,579, respectively.

16

Warrants

The following tables summarize transactions involving the Company’s outstanding warrants to purchase common stock for the three months ended March 31, 2024 and 2023:

	Warrants (Underlying Shares)			Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2023		28,584,580		$	0.50
Warrants issued		900,000			0.30
Warrants expired		(196,000	)		0.25
Outstanding, March 31, 2024		29,288,580		$	0.50

	Warrants (Underlying Shares)			Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2022		35,586,980		$	0.46
Warrants issued		1,873,750			0.25
Warrants exchanged		(1,025,000	)		0.25
Warrants expired		(7,410,000	)		0.20
Warrants exercised		(973,750	)		0.20
Outstanding, March 31, 2023		28,051,980		$	0.54

During the three months ended March 31, 2024 and 2023, the Company issued 900,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 6, “Commitments and Contingencies” for additional information.

During the three months ended March 31, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants, pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. The Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296.

4. STOCK OPTIONS

The Company’s Stock Plan (the “Plan”) allows for the issuance of incentive stock options, nonqualified stock options, and stock purchase rights. The exercise price of options was determined by the Company’s board of directors, but incentive stock options were granted at an exercise price equal to the fair market value of the Company’s common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The aggregate number of common shares that may be issued or reserved pursuant to stock option or other awards under the plan may not exceed 2,500,000 common shares.

17

During the three months ended March 31, 2024 and 2023, the Company recognized expense for stock options of $14,837 and $107,068, respectively. The following tables summarize the Company’s stock option activity and related information for the three months ended March 31, 2024 and 2023:

	Number of Shares		Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Life	Aggregate Intrinsic Value of In-the-Money Options  (in thousands)
Options outstanding as of December 31, 2023		2,338,636	$	0.41	6.5 years	$	-
Options outstanding as of March 31, 2024		2,338,636	$	0.41	6.3 years	$	-
Options exercisable as of March 31, 2024		1,923,864	$	0.44	5.7 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 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 March 31, 2023		2,338,636		$	0.41	6.9 years	$	-
Options exercisable as of March 31, 2023		1,656,205		$	0.45	5.8 years	$	-

On February 10, 2023, the Company granted 925,000 stock options to employees, executives and directors of the Company. The stock options, which have exercise prices of $0.2629, will expire on February 9, 2033. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on May 10, 2023.

On March 7, 2023, the Company granted 100,000 stock options, which have exercise prices of $0.27 and will expire on March 6, 2033, to Alan Grujic, upon appointing him to the Board of Directors. One fourth of the stock options vested immediately, while the remaining options will vest over a period of 33 months, beginning on June 7, 2023.

As of March 31, 2024, there was $109,415 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately two years. The weighted-average fair value of awards granted was $0.26 during the three months ended March 31, 2023.

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 three months ended March 31, 2023:

	March 31,
	2023
Expected term (years)		10.0
Volatility		366.4	%
Risk-free interest rate		3.8	%
Dividend yield		0.0	%

5. LITIGATION AND CLAIMS

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in 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 March 31, 2024, and December 31, 2023, there was no accrual recorded for any potential losses related to pending litigation.

18

6. COMMITMENTS AND CONTINGENCIES

Operating Leases

Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located on a 12,835 square foot leased property. Total operating lease cost recognized for this lease was $27,351 for the three months ended March 31, 2024 and 2023. The below table presents total operating lease right-of-use assets and lease liabilities as of March 31, 2024 and December 31, 2023:

	(in thousands)
	March 31, 2024		December 31, 2023
Operating lease right-of-use assets	$	207	$	227
Operating lease liabilities	$	225	$	246

The table below presents the maturities of operating lease liabilities as of March 31, 2024:

	(in thousands)
	Operating
	Leases
2024 (remaining)	$	87
2025		118
2026		50
Total future lease payments		255
Less: discount		(30	)
Total lease liabilities	$	225

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 March 31, 2024 and December 31, 2023:

	March 31, 2024			December 31, 2023
Weighted average remaining lease term (years)		2.2			2.4
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).

19

On September 6, 2016, the Company entered into a royalty agreement with one of its directors, John Imhoff, and another stockholder, Dolores Maloof, pursuant to which the Company sold to them a royalty of future sales of single-use cervical guides for LuViva. Under the terms of the royalty agreement, and for consideration of $50,000, the Company will pay them an aggregate perpetual royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20, for each cervical guide that the Company sells (or that is sold by a third party pursuant to a licensing arrangement with the Company).

On January 22, 2020, the Company entered into a promotional agreement with a related party, which is partially owned by Mr. Blumberg, to provide investor and public relations services for a period of two years. As compensation for these services, the Company agreed to issue a total of 5,000,000 warrants, broken into four tranches of 1,250,000. The warrants have a strike price of $0.25 and 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 of March 31, 2024, unrecognized consulting expense associated with the agreement was nil and 2,500,000 of the warrants had been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties.

During the three months ended March 31, 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.

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 to the Company in exchange for the following: (1) 3,600,000 3-year warrants with exercise prices ranging from $0.30 - $0.60, and (2) 1,600,000 common stock shares. On September 30, 2021, the Company and Mr. Blumberg entered into an amended agreement, pursuant to which issuance of the warrants and common shares became predicated on the Company obtaining financing or a series of financings resulting in minimum receipts of at least $1.0 million. Upon receipt of the funds, the Company agreed to issue the common shares and warrants owed to Mr. Blumberg in four equal tranches, to be issued every six months, beginning six months after the financing transaction. On November 11, 2022, the Company and Mr. Blumberg entered into an amended agreement, upon which the exercise prices of the warrants were changed to $0.30. The Company estimated the fair value of the modified warrants using the Black-Scholes option pricing model and the following assumptions:

Expected term (years)	3.0
Volatility	108.7	%
Risk-free interest rate	4.3	%
Dividend yield	0.0	%

During the three months ended March 31, 2024 and 2023, the Company issued 900,000 warrants to Mr. Blumberg, pursuant to the agreement, and recognized expense of nil and $295,420 respectively. Total unrecognized expense for the warrants was nil as of March 31, 2024. During the three months ended March 31, 2024 and 2023, the Company recognized nil and $65,611 of expense for the shares of common stock due to Mr. Blumberg, respectively. As 400,000 shares had not been issued as of March 31, 2024, the Company estimated the total amount of expense for the future issuances using the closing price of the Company’s stock as of March 31, 2024.

On August 24, 2022, the Company entered into an agreement with Ironstone Capital Corp. and Alan Grujic (the “Advisory Group”) whereby the Advisory Group agreed to perform marketing and investor relations services over a term of twelve months, commencing on the closing of a financing of at least $2.5 million. In consideration for these services, the Company issued 800,000 warrants (“first tranche of warrants”) with an exercise price of $0.50 to Mr. Grujic, which were due within 10 business days of closing the financing transaction (the “Transaction”) that took place in September 2022. In the event the Company’s 20 trading day variable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing, the Company would have issued 600,000 warrants (“second tranche of warrants”) with an exercise price of $0.75 to Mr. Grujic. In the event the Company’s 20 trading day VWAP exceeds $1.50 within two years of the closing of the financing, the Company will issue an additional 600,000 warrants (“third tranche of warrants”) to Mr. Grujic. Once issued, the warrants vest immediately and will expire two years from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with the U.S. FDA or if the Chinese NMPA (formerly Chinese FDA) approval is not granted by each due date for reaching each respective pricing milestone, then the due date for reaching each milestone shall be extended by six months. As of March 31, 2024, the deadline to achieve the stock price of $1.50 has passed and the second tranche warrants will therefore not be issued.

20

Pursuant to the agreement, the Company also agreed to pay the Advisory Group $2,000 per month for 12 months, starting the month after the closing of the Transaction. Subsequently, the agreement was amended to extend the term of the agreement to September of 2024.

The Company estimated the fair value of the first tranche warrants issued in September 2022 using the Black-Scholes option pricing model with the following assumptions:

Expected term (years)	2.0
Volatility	173.0	%
Risk-free interest rate	3.4	%
Dividend yield	0.0	%

Expense related to the first tranche of warrants was recognized in prior years. Unrecognized expense related to the first tranche warrants was nil as of March 31, 2024.

The Company estimated the fair value of the second tranche warrants using the Binomial Lattice model with the following assumptions:   

Expected term (years)	1.0
Volatility	144.4	%
Risk-free interest rate	3.6	%
Dividend yield	0.0	%

The Company 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 tranche of warrants of nil and $29,706 during the three months ended March 31, 2024 and 2023, respectively. Unrecognized expense for the second tranche of warrants was nil as of March 31, 2024. The Company recognized expense for the third tranche of warrants of $15,466 for the three months ended March 31, 2024 and 2023. Unrecognized expense for the third tranche of warrants was $25,776 as of March 31, 2024.

Other Commitments

On July 24, 2019, the Company agreed to grant Shandong Yaohua Medical Instrument Corporation (“SMI”) (1) exclusive manufacturing rights, excepting the disposable cervical guides for the Republic of Turkey, and the final assembly rights for Hungary, and (2) exclusive distribution and sales for LuViva in jurisdictions, subject to the terms and conditions described below.

21

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.

On February 17, 2024, the Company entered into a fourth amendment to the agreement with SMI. Under the terms of the amended agreement, SMI agreed to pay the Company $531,100 on or prior to March 15, 2024. On March 18, 2024, SMI, through SMI’s authorized distribution partner, initiated a wire payment of $330,000 in partial satisfaction of $531,100 owed to the Company. The payment was received by the Company on March 20, 2024. As the full payment was not received by March 15, 2024, the Company had the right to terminate the agreement with two weeks’ notice to SMI, however the Company did not exercise this option. 

The amended agreement also provides for a timeline for the Company to deliver inventory during 2024, including LuViva devices and components, as well as approximately 1,640,000 RFID chips. In consideration, SMI agreed to pay a total of $4.4 million during 2024, including the payment due on March 15, 2024.

On March 27, 2024, the parties entered into a Standstill Agreement (the “Standstill Agreement”). The parties agreed that SMI will make a nonrefundable payment of $100,000 to the Company prior to March 31, 2024. In exchange, the Company will not initiate any legal proceedings, including but not limited to filing a lawsuit, obtaining a judgement, or enforcing any security interest, as related to the March shortfall in payments of $201,100, until April 30, 2024. Upon paying $100,000, SMI will have the option to extend the Standstill Agreement until June 15, 2024 by making a nonrefundable payment to the Company of $150,000. One additional payment of $150,000 may be made to extend the standstill rights until July 30, 2024, if mutually agreed upon. If SMI is unable to make the payments pursuant to the Standstill Agreement, the Company agreed to seek loans on behalf of SMI to cover the payments. SMI agreed to reimburse the Company for these loans along with all expenses associated with them within three months of the loans being issued as long as the loans are used solely for (1) parts for LuViva devices to be used by SMI for marketing and promotional activities, or (2) labor or consulting fees connected to providing parts, assemblies of devices or disposables to SMI. Additionally, SMI confirmed its commitment to make payments to GTI of at least $4.0 million during 2024 and as part of this commitment will make payments of $200,000 and $500,000 by the end of May 2024 and July 2024, respectively, to ensure that the program commercialization proceeds according to schedule.  

On April 26, 2024, the parties extended and amended the Standstill Agreement (the “Standstill Extension”) until July 30, 2024, see Note 11 “Subsequent Events” for details.

Contingencies

The conflict in Ukraine, which has already had an impact on financial markets, could result in additional repercussions in our operating business, including delays in obtaining regulatory approval to market our products in Russia. The future impact of the conflict is highly uncertain and cannot be predicted, and we cannot provide any assurance that the conflict will not have a material adverse impact on our operations or future results or filings with regulatory health authorities. 

22

7. NOTES PAYABLE

Short Term Notes Payable

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 $24,003 and $59,422 as of March 31, 2024 and December 31, 2023, respectively.

8. 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.

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 $116,142 and $123,039 as of March 31, 2024 and December 31, 2023, respectively. The balances are included within “Short-term convertible notes payable” on the condensed consolidated balance sheets. Total accrued interest on the Auctus convertible note was $23,956 as of March 31, 2024 and December 31, 2023.

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.

23

At March 31, 2024 and December 31, 2023, the balance due on the 10% Senior Unsecured Convertible Debenture was $1,130,000 and total accrued interest was $28,564 and $58,494, respectively. The bond payable discount and unamortized debt issuance costs as of March 31, 2024 and December 31, 2023 are presented below (in thousands):

	March 31, 2024			December 31, 2023
10% Senior Unsecured Convertible Debentures	$	1,130		$	1,130
Unamortized debt issuance costs		(4	)		(12	)
Debt Discount		(13	)		(38	)
Senior Unsecured Convertible Debenture	$	1,113		$	1,080

As of March 31, 2024 and December 31, 2023, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible notes payable” within the condensed consolidated balance sheets.

9. RELATED PARTY DEBT

On July 14, 2018, the Company entered into an exchange agreement with Dr. Faupel, whereby Dr. Faupel agreed to exchange outstanding amounts due to him for loans, interest, bonus, salary and vacation pay in the amount of $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, the maturity date was February 18, 2023, and the interest rate was 6.0%. For Dr. Faupel the principal amount on the new note was $153,178, the maturity date was February 18, 2023, and the interest rate was 6.0%. Additionally, the Company exchanged $100,000 and $85,000 of the balances owed to Dr. Cartwright and Dr. Faupel for 100 and 85 shares of Series F-2 Preferred Stock, respectively.

On February 18, 2023, the Company amended the terms of the promissory notes held by Mark Faupel and Gene Cartwright. Under the terms of the new agreements, the promissory notes will mature on February 18, 2025.

24

The tables below summarize the outstanding balance of long-term debt owed to Dr. Faupel and Dr. Cartwright (in thousands):

For Dr. Faupel:
Salary	$	134
Bonus		20
Vacation		95
Interest on compensation		67
Loans to Company		196
Interest on loans		149
Total outstanding prior to exchange		661
Amount forgiven in prior years		(454	)
Amount exchanged for Series F-2 Preferred Stock		(85	)
Total interest accrued through December 31, 2023		57
Balance outstanding at December 31, 2023	$	179
Interest accrued through March 31, 2024		2
Balance outstanding at March 31, 2024	$	181
For Dr. Cartwright
Salary	$	337
Bonus		675
Loans to Company		528
Interest on loans		81
Total outstanding prior to exchange		1,621
Amount forgiven in prior years		(1,302	)
Amount exchanged for Series F-2 Preferred Stock		(100	)
Total interest accrued through December 31, 2023		93
Payments on outstanding debt		(25	)
Balance outstanding at December 31, 2023	$	287
Interest accrued through March 31, 2024		4
Balance outstanding at March 31, 2024	$	291

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 $3,600 for four years, with the first payment due on March 15, 2022. The effective interest rate of the note is 6.18%.

During the three months ended March 31, 2024 and 2023, Mr. Fowler forgave $16,659 and $17,721 of the outstanding balance of deferred compensation and, as of March 31, 2024, may forgive up to $112,677 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 March 31, 2024 and December 31, 2023, the outstanding principal amount owed on the note was $73,429 and $82,945, respectively.

25

Future debt obligations at March 31, 2024 for debt owed to related parties is as follows:

Year	Amount (in thousands)
2024 (remaining)		30
2025		513
2026		3
Total	$	546

10. INCOME (LOSS) PER SHARE OF COMMON STOCK

Basic net income (loss) per share attributable to common stockholders, amounts are computed by dividing the net income (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the year.

Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the year, plus Series C, Series C-1, Series C-2, Series D, Series E, Series F and Series F-2 convertible preferred stock, convertible debt, convertible preferred dividends, warrants and stock options convertible into common stock shares.

During a period of net loss, basic and diluted earnings per share are the same as the assumed exercise of warrants and the conversion of convertible debt and preferred stock are anti-dilutive. For the three months ended March 31, 2024 and 2023, all stock options, convertible preferred stock, convertible debt and warrants were anti-dilutive and were therefore excluded from the computation of diluted loss per share. At March 31, 2024 and 2023, these instruments were convertible into 53,011,448 and 51,948,265 common shares, respectively.

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

	March 31,
	2024			2023
Net loss		(441	)		(969	)
Basic weighted average number of shares outstanding		54,750			49,297
Net loss per share (basic)		(0.01	)		(0.02	)
Diluted weighted average number of shares outstanding		54,750			49,297
Net loss per share (diluted)		(0.01	)		(0.02	)

11. SUBSEQUENT EVENTS

Issuances of Common Stock

Subsequent to March 31, 2024, we issued 143,026 shares of common stock for Preferred Series D and Series F-2 dividends.

Employee Note Payable

On April 15, 2024, the Company issued an $87,162 promissory note to a former employee, for compensation and vacation pay due. The promissory note, which incurs interest at a rate of 6% per annum, matures on May 5, 2028. Monthly payments of $2,000 are due on the promissory note until maturity.

SMI Standstill Agreement Extension

On April 26, 2024, the parties extended the Standstill Agreement (“Standstill Extension”) until July 30, 2024, contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can recoup that by placing a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545. The other terms from the Amendment and Standstill Agreement remain intact.

26

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

FORWARD-LOOKING STATEMENTS

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

These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results, including those that may be set forth under "Risk Factors" below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 2023 and this quarterly report on Form 10-Q. Examples of these uncertainties and risks include, but are not limited to:

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

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

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

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

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

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

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

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

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

· The impact of the conflict between Russia and Ukraine on economic conditions in general and on our business operations;

· the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines;

· the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and

· other risks and uncertainties described from time to time in our reports filed with the SEC.

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.

27

Forward-looking statements speak only as of the date the statements are made. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect thereto or with respect to other forward-looking statements.

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

OVERVIEW

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

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

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

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

Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception and, as of March 31, 2024, we have an accumulated deficit of approximately $151.6 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 three months ended March 31, 2024 and 2023, 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.

28

Current Demand for LuViva

Based on written agreements and ongoing discussions with our distributors, including an amended agreement executed on February 17, 2024, we currently hold and expect to generate additional purchase orders for approximately $4.2 million in LuViva devices and disposables and expect those purchase orders to result in actual sales of $1.5 to $2.5 million throughout in 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, we are focused on three primary markets: the United States, China and Europe.

In the United States, the Company is actively pursuing FDA approval by initiating a clinical trial protocol involving approximately 400 study participants, with the exact number depending in part on the numbers of women in the study both with and without cervical disease. The protocol was drafted with input from FDA and at least two prestigious clinical centers that are participating in the study. In 2023, FDA completed its review of the protocol and had no further recommendations or questions. Also in 2023, four clinical sites agreed to participate in the study and all four of the study sites are fully IRB approved. All four sites have received LuViva devices and have been trained on their use. One site unexpectedly needed additional approvals from the local hospital that is contributing subjects to the study, but that approval was granted on March 28, 2024. Three of the four sites have undergone one or more clinical study monitoring visits by Company clinical study monitors. Clinical study monitoring visits are required by FDA to ensure that the study is being conducted under FDA guidelines and in compliance with the study protocol. Findings from the initial clinical study monitoring visits include:

1)	There have not been any adverse events reported related to the use of LuViva.
2)	All three monitored clinical study sites are adhering to the study protocol and are completing the necessary case report forms according to FDA standards.
3)	Enrollment rates have increased during 2024.
4)	Approximately 122 patients have been enrolled and tested.

Based on current and expected enrollment rates, we expect the study to be completed in 2024, however there can be no assurance that the study will progress within the expected timeline.

Regarding international sales efforts, our focus has been on achieving regulatory approval to sell LuViva in China. Our Chinese partner, SMI, has reported to us that as of March 31, 2024, all study subjects needed for Chinese National Medical Products Administration (NMPA) approval have been enrolled and tested. There have been no reports of any adverse events from the study associated with the LuViva device. SMI believes that they can file the clinical report with NMPA during the second quarter of 2024 and that approval could occur in 2024, although there can be no assurance that NMPA filing and approval will be completed within the projected time frames.

In Europe, our distribution partners, Newmars Medical Technologies (“Newmars”), reported that sales efforts have restarted after delays caused by Covid-19. They are now actively pursuing potential customers in Poland, Hungary and Romania, where we have obtained the required approvals to sell our products though Newmars.

CRITICAL ACCOUNTING POLICIES

Our material accounting policies, which we believe are the most critical to investors understanding of our financial results and condition, are discussed below. Because we are still early in our enterprise development, the number of these policies requiring explanation is limited. When we begin to generate revenue from different sources, we expect that the number of applicable policies and complexity of the judgments required will increase.

29

Revenue Recognition: ASC 606, Revenue from Contracts with Customers establishes a single and comprehensive framework which sets out how much revenue is to be recognized, and when. The core principle is that a vendor should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the vendor expects to be entitled in exchange for those goods or services. Revenue will now be recognized by a vendor when control over the goods or services is transferred to the customer. In contrast, Revenue based revenue recognition around an analysis of the transfer of risks and rewards; this now forms one of a number of criteria that are assessed in determining whether control has been transferred. The application of the core principle in ASC 606 is carried out in five steps:

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

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

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

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

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

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

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

Allowance for Accounts Receivable: The Company reviews all outstanding accounts receivable for collectability on a quarterly basis. An allowance for credit losses is recorded for any amounts deemed uncollectable. The allowance is adjusted based on our assessment of the ability of our distributors to make required payments and our review of the financial condition of our distributors.

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.

30

RESULTS OF OPERATIONS

COMPARISON OF THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022

Sales Revenue and Cost of Goods Sold: Revenues from the sale of LuViva devices and disposables for the three months ended March 31, 2024, were $5,720, compared to $22,049 for the three months ended March 31, 2023. Cost of goods sold was $1,875 during the three months ended March 31, 2024, compared to $8,789 during the three months ended March 31, 2023. The decrease in cost of goods sold in the current year was due to lower sales. As of March 31, 2024, we have a deferred revenue balance of $747,780, which will be recognized as revenue when our products are shipped, which is expected to occur in 2024.

Research and Development Expenses: Research and development expenses were $53,554 and $7,146 during the three months ended March 31, 2024 and 2023, respectively. The increase of $46,408, or 649.4%, was primarily due to an increase in costs related to clinical trials in the three months ended March 31, 2024 compared to the three months ended March 31, 2023.

Sales and Marketing Expenses: Sales and marketing expenses of $72,572 and $73,045 during the three months ended March 31, 2024 and 2023, respectively, were materially consistent over the two periods.

General and Administrative Expense: General and administrative expenses were $236,227 and $776,433 during the three months ended March 31, 2024 and 2023, respectively. Lower general and administrative costs of $540,206, or 69.6%, was primarily driven by a $392,273 decline in expense for warrants and common stock issued to consultants and related parties, a decrease of $92,232 in stock option expense, a decrease of $81,300 for professional fees paid to consultants, and a decrease of $8,605 in other miscellaneous operating costs. The decline in our general and administrative expenses during the three months ended March 31, 2024 was partially offset by a $23,320 increase in payroll and benefits expense and an $10,850 increase in taxes.

Interest Expense: Interest expense of $64,118 and $65,680 during the three months ended March 31, 2024 and 2023, respectively, was materially consistent over the two periods.  

Change in Fair Value of Derivative Liability: The gain for the change in fair value of the derivative liability during the three months ended March 31, 2024 and 2023 was nil and $4,818, respectively, which was due to changes to our stock price during the period.

Gain from Extinguishment of Debt: The gain from extinguishment of debt during the three months ended March 31, 2024 and 2023 was $16,659 and $34,773, respectively. The decrease of $18,114, or 52%, 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 nil and $65,296 in the period ended March 31, 2024 and 2023. The expense in the prior period was recognized as the excess fair value of warrant instruments exchanged over the fair value of the original warrants.

Preferred Stock Dividends: Expense related to preferred stock dividends was $38,907 and $34,758 for the three months ended March 31, 2024 and 2023, respectively. The increase of $4,149, or 11.9% was due to differences in the value of common shares issued to settle preferred stock dividends.

Net Loss: Net loss attributable to common stockholders was $441,372 and $969,508 during the three months ended March 31, 2024 and 2023, respectively. The reasons for the fluctuation are outlined above.

There was no income tax benefit recorded for the three months ended March 31, 2024 or 2023, due to recurring net operating losses.

LIQUIDITY AND CAPITAL RESOURCES

Going Concern Considerations

We have incurred significant losses since our inception. At March 31, 2024, the Company had a negative working capital of approximately $4.1 million, accumulated deficit of $151.6 million, and incurred a net loss including preferred dividends of $0.4 million for the three months then ended. Stockholders’ deficit totaled approximately $4.0 million at March 31, 2024, primarily due to recurring net losses from operations.

31

The Company will need to continue to raise capital in order to provide funding for its operations and FDA approval process. If sufficient capital cannot be raised, the Company will continue its plans of curtailing operations by reducing discretionary spending and staffing levels and attempting to operate by only pursuing activities for which it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent practicable, liquidate and/or file for bankruptcy protection.

Liquidity

The Company’s primary liquidity requirements are for working capital, funding clinical studies, and other costs associated with achieving regulatory approval to sell our products. Although income taxes are not currently a significant use of funds, after the benefits of our net operating loss carryforwards are fully recognized, they could become a material use of funds, depending on our future profitability and future tax rates. We anticipate we will require approximately $1.8 million to $2.2 million of funds to operate our business over the next twelve months, including approximately $0.6 million of funds to complete our ongoing clinical studies.

Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As of March 31, 2024, we had cash of approximately $0.45 million and negative working capital of $4.1 million.

Our major cash flows for the three months ended March 31, 2024 consisted of cash used for operating activities of $0.1 million and cash used for financing activities of $46 thousand, which was for payments made on outstanding debt.

Our major cash flows for the three months ended March 31, 2023 consisted of cash used by operating activities of $0.5 million and net cash provided by financing activities of $23 thousand, which was derived from $195 thousand of proceeds from warrant exercises, offset by payments made on outstanding debt.

Contingencies

The conflict in Ukraine, which has already had an impact on financial markets, could result in additional repercussions in our operating business, including delays in obtaining regulatory approval to market our products in Russia. The future impact of the conflict is highly uncertain and cannot be predicted, and we cannot provide any assurance that the conflict will not have a material adverse impact on our operations or future results or filings with regulatory health authorities.

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.

32

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 March 31, 2024, due to the existence of material weaknesses in our internal control over financial reporting. The material weaknesses identified arose from a lack of recourses to properly research and account for complex transactions and lack of oversight and approval by the Board of Directors and Audit Committee, including formally documented approval of significant transactions, including related party transactions. While management is currently in the early stages of developing a remediation plan, we have yet to fully remediate this material weakness.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

33

PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

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

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

During the three months ended March 31, 2024, the Company issued 400,000 shares of common stock and 900,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. The warrants, which will expire on March 1, 2027, have a strike price of $0.30.

ITEM 3: DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4: MINE SAFETY DISCLOSURES.

Not applicable

ITEM 5: OTHER INFORMATION.

None.

34

ITEM 6. EXHIBITS

Exhibit Number	Exhibit Description
3.1	Restated Certificate of Incorporation, as amended through November 3, 2016 (incorporated by reference to Exhibit 3.1 to the annual report on Form 10-K filed March 15, 2016)
3.2	Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed March 23, 2012)
3.3	Amended and Restated Certificate of Incorporation, (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed November 15, 2018)
3.4	Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.4 to the annual report on Form 10-K, filed April 20, 2020)
3.5	Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the annual report on Form 10-K filed April 5, 2021)
3.6	Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock (incorporated by reference to Exhibit 3.6 to the annual report on Form 10-K filed April 5, 2021)
3.7	Certificate of Designation of Preferences, Rights and Limitations of Series F-2 Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on June 10, 2021)
3.8	Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock (incorporated by reference to Exhibit 3.8 to the annual report on Form 10-K filed March 30, 2022)
3.9	Certificate of Amendment to the Certificate of Incorporation of Guided Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the current report on Form 8-K, filed on January 7, 2022)
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 March 31, 2024, formatted in Inline XBRL: (i) the Condensed Consolidated Balance Sheets (unaudited); (ii) the Condensed Consolidated Statements of Income (unaudited);  (iii) the Condensed Consolidated Statements in Stockholders' Deficit (unaudited); (iv) the Condensed Consolidated Statements of Cash Flows (unaudited); and (v) the Notes to the Condensed Consolidated Financial Statements (unaudited).
104	The cover page from Guided Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (formatted in Inline XBRL and included in Exhibit 101)

_____________   

*Filed herewith  

35

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: May 13, 2024

36