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GUIDED THERAPEUTICS INC

For the period ended Jun 30, 2024. Filed Aug 14, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 14, 2024

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Notes to Unaudited Condensed Consolidated Financial Statements

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

**1.**ORGANIZATION, BACKGROUND, AND BASIS OF PRESENTATION

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

Basis of Presentation

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

All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company as of June 30, 2024 and December 31, 2023, and the consolidated results of operations and cash flows for the three and six-month periods ended June 30, 2024 and 2023 have been included.

The Company’s prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced net losses since its inception and, as of June 30, 2024, it had an accumulated deficit of approximately $152.1 million. To date, the Company has engaged primarily in research and development efforts and the early stages of marketing its products. The Company may not be successful in growing sales for its products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. The Company’s products may not ever gain market acceptance and the Company may not ever generate significant revenues or achieve profitability. The development and commercialization of the Company’s products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. The Company expects operating losses to continue for the foreseeable future as it continues to expend substantial resources to complete development of its products, obtain regulatory clearances or approvals, build its marketing, sales, manufacturing and finance capabilities, and conduct further research and development.

The Company is not organized by multiple operating segments for the purpose of making operating decisions or assessing performance. Accordingly, the Company operates in one reportable operating segment. The Company’s principal decision maker is the Chief Executive Officer and acting Chief Financial Officer. Management believes that its business operates as one reportable segment because: a) the Company measures profit and loss as a whole; b) the principal decision makers do not review information based on any operating segment; c) the Company does not maintain discrete financial information on any specific segment; d) the Company has not chosen to organize its business around different products and services, and e) the Company has not chosen to organize its business around geographic areas.

Going Concern

The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

At June 30, 2024, the Company had a negative working capital of approximately $4.7 million, accumulated deficit of $152.3 million, and incurred a net loss including preferred dividends of $1.2 million for the six months then ended. Stockholders’ deficit totaled approximately $4.7 million at June 30, 2024, primarily due to recurring net losses from operations.

During the year ended December 31, 2023, the Company received $0.4 million of proceeds from warrant exercises. During the six months ended June 30, 2024, the Company received $0.2 million of proceeds from the issuance of promissory notes payable. 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 or stockholders’ equity.

2. SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the allowance for doubtful accounts, inventory valuation, valuation of share-based compensation and the valuation of the convertible note payable derivative liability. Management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to the Company’s financial statements.

Accounting Standard Updates

A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any that the implementation of such proposed standards would have on the Company’s consolidated financial statements.

Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be a cash equivalent.

Concentrations of Credit Risk

The Company maintains a cash balance in a financial institution that is insured by the Federal Deposit Insurance Corporation up to certain federal limitations. At times, the Company’s cash balance exceeds these federal limitations. The amount in excess of insured limitations was nil and $156,112 as of June 30, 2024 and December 31, 2023, respectively.

Trade Receivables

Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of June 30, 2024 and December 31, 2023.

Inventory Valuation

All inventories are stated at the lower of cost or net realizable value, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when incurred. Inventories consisted of the following as of June 30, 2024 and December 31, 2023:

(in thousands)
June 30,December 31,
20242023
Raw materials$1,360$1,360
Work-in-progress4646
Finished goods4444
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. Depreciation and amortization expense are included in general and administrative expense on the statements of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment consisted of the following as of June 30, 2024 and December 31, 2023:

(in thousands)
June 30,December 31,
20242023
Equipment$951$951
Software634634
Furniture and fixtures1717
Leasehold improvements1212
Subtotal1,6141,614
Less accumulated depreciation(1,586)(1,582)
Property, equipment and leasehold improvements, net
$28$32

Depreciation expense related to property and equipment for the three and six months ended June 30, 2024 and 2023 was not material.

Debt Issuance Costs

Debt issuance costs are capitalized and amortized over the term of the associated debt. Debt issuance costs are presented in the balance sheet as a direct deduction from the carrying amount of the debt liability consistent with the debt discount.

Patent Costs (Principally Legal Fees)

Costs incurred in filing, prosecuting, and maintaining patents are recurring, and expensed as incurred. Maintaining patents are expensed as incurred as the Company has not yet received U.S. FDA approval and recovery of these costs is uncertain. Such costs were not material for the three and six months ended June 30, 2024 and 2023.

Leases

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

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

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

Accrued Liabilities

Accrued liabilities as of June 30, 2024 and December 31, 2023 are summarized as follows:

(in thousands)
June 30, 2024December 31, 2023
Compensation$356$401
Professional fees95216
Interest143188
Vacation2927
Preferred dividends210228
Other accrued expenses78
Total$840$1,068

Stock Subscription Payable

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

Revenue Recognition

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

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

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 June 30, 2024, December 31, 2023 and December 31, 2022, respectively.

Significant Customers

As of June 30, 2024, trade receivables of $2,047 (net of the allowance for credit losses of $450) were attributed to one customer. As of December 31, 2023, accounts receivable of $7,442 (net of the allowance for credit losses of $1,500) were attributed to two customers.

Research and Development

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

Income Taxes

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

The Company has filed for an extension for its 2023 federal and state corporate tax returns. Although the Company has been experiencing recurring losses, it is obligated to file tax returns for compliance with IRS regulations and that of applicable state jurisdictions. At June 30, 2024, the Company had approximately $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.

The Black-Scholes option pricing model requires the input of certain assumptions that require the Company’s judgment, including the expected term and the expected stock price volatility of the underlying stock. The assumptions used in calculating the fair value of stock-based compensation represent management’s best estimates, but these estimates involve inherent uncertainties and the application of judgment. As a result, if factors change resulting in the use of different assumptions, stock-based compensation expense could be materially different in the future.

During the six months ended June 30, 2024, the Company recognized $29,673 of expense related to stock options and $30,932 of expense for warrants issued to a director. During the six months ended June 30, 2023, the Company recognized $206,306 of expense related to stock options, $116,000 of expense for stock issued to a director and $1,361,143 of expense for warrants issued to consultants and executives.

Derivatives

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

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

Fair Value Measurements

ASC 820, “Fair Value Measurements and Disclosures,” clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is a market-based measurement that should be determined based upon assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

·Level 1: Quoted prices for identical assets or liabilities in active markets that the Company can access at the measurement date.
·Level 2: Significant other observable inputs other than level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data.
·Level 3: Significant unobservable inputs that reflect the Company’s judgment about the assumptions that market participants would use in pricing an asset or liability.

An asset or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs.

Assets and liabilities measured at fair value are based on one or more of the following three valuation techniques noted in ASC 820:

·Market approach: Prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities.
·Cost approach: Amount that would be required to replace the service capacity of an asset (replacement cost).
·Income approach: Techniques to convert future amounts to a single present value amount

The Company believes its valuation methods are appropriate and consistent with other market participants, however the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different fair value measurement at the reporting date.

3. STOCKHOLDERS’ DEFICIT

Common Stock

The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of June 30, 2024 and December 31, 2023,56,266,661 and 54,105,101 shares of common stock were issued and outstanding, respectively.

During the six months ended June 30, 2024, the Company issued 2,161,560 shares of common stock, as summarized below:

Number ofShares
Issuance of common stock for payment of Series D preferred dividends125,505
Issuance of common stock for payment of Series E preferred dividends52,332
Issuance of common stock for payment of Series F preferred dividends444,621
Issuance of common stock for payment of Series F-2 preferred dividends235,544
Issuance of common stock for payment of interest903,558
Issuance of common stock to consultants400,000
Total common stock issued during the six months ended June 30, 20242,161,560
Summary table of common stock transactions:
Shares outstanding at December 31, 202354,105,101
Common shares issued during the six months ended June 30, 20242,161,560
Shares outstanding at June 30, 202456,266,661

Preferred Stock

The Company has authorized 5,000,000 shares of preferred stock with a $0.001 par value. The board of directors has the authority to issue these shares and to set dividends, voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions.

Series C Convertible Preferred Stock

The board designated 9,000 shares of preferred stock as Series C Convertible Preferred Stock, (the “Series C Preferred Stock”). Pursuant to the Series C certificate of designations, shares of Series C Preferred Stock are convertible into common stock by their holder at any time and may be mandatorily convertible upon the achievement of specified average trading prices for the Company’s common stock. At June 30, 2024 and December 31, 2023, there were 286 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 572,000 shares, subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt.

Holders of the Series C Preferred Stock are entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in cash or, subject to certain conditions, the Company’s common stock. Unpaid accrued dividends were $120,120 as of June 30, 2024 and December 31, 2023. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At June 30, 2024 and December 31, 2023, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock.

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

Series C1 Convertible Preferred Stock

The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at June 30, 2024 and December 31, 2023. The C1 Convertible Preferred Stock has a conversion price of $0.50 per share, such that each share would convert into approximately 2,000 shares of the Company’s common stock, for a total of 2,098,500 shares of common stock.

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

Series C2 Convertible Preferred Stock

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

At June 30, 2024 and December 31, 2023, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C2 preferred stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares.

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

Series D Convertible Preferred Stock

The board designated 6,000 shares of preferred stock as Series D Preferred Stock, 438 of which remained outstanding as of June 30, 2024 and December 31, 2023. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer (now the Chief Executive Officer) and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock,1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. Each Series D Preferred Stock is convertible into 3,000 shares of common stock. The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750.

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

During the six months ended June 30, 2024, the Company issued 125,505 shares of common stock for the payment of accrued Series D Preferred Stock dividends. As of June 30, 2024, and December 31, 2023, the Company had accrued dividends for the Series D Preferred Stock of $8,360.

Series E Convertible Preferred Stock

The Board designated 5,000 shares of preferred stock as Series E Preferred Stock,883 of which remained outstanding as of June 30, 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 six months ended June 30, 2024, the Company issued 52,332 shares of common stock for payment of accrued Series E Preferred Stock dividends. As of June 30, 2024 and December 31, 2023, the Company had accrued dividends of $57,592 and $30,272 for the Series E Preferred Stock, respectively.

Series F Convertible Preferred Stock

The Board designated 1,500 shares of preferred stock as Series F Preferred Stock,1,006 of which remained outstanding as of June 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series F Investors”). In total, for $1,436,000 the Company issued 1,436 shares of Series F Preferred Stock. Each Series F Preferred Stock is convertible into 4,000 shares of common stock. The Series F Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Preferred Stock is $1,000.

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

During the six months ended June 30, 2024, the Company issued 444,621 shares of common stock for the payment of annual Series F Preferred Stock dividends. As of June 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F preferred shares of $15,761 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 June 30, 2024 and December 31, 2023. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. Each Series F-2 Preferred share is convertible into 4,000 shares of common stock. The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000.

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

During the six months ended June 30, 2024, the Company issued 235,544 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. As of June 30, 2024 and December 31, 2023, the Company had accrued dividends for Series F-2 preferred shares of $7,918 and $23,579, respectively.

Warrants

The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the six months ended June 30, 2024 and 2023:

Warrants(UnderlyingShares)Weighted-Average Exercise Price Per Share
Outstanding, December 31, 202328,584,580$0.50
Warrants issued1,000,0000.30
Warrants expired(761,500)0.37
Outstanding, June 30, 202428,823,080$0.50
Warrants(Underlying Shares)Weighted-Average Exercise Price Per Share
Outstanding, December 31, 202235,586,980$0.46
Warrants issued5,873,7500.25
Warrants exchanged(1,025,000)0.25
Warrants expired(9,478,200)0.30
Warrants exercised(973,750)0.20
Outstanding, June 30, 202329,983,780$0.49

During the six months ended June 30, 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 six months ended June 30, 2024, the Company issued 100,000 warrants in conjunction with the issuance of a $100,000 note payable to an unaffiliated third party. See Note 7,*“Notes Payable”*for additional details on the note payable. Management estimated the fair value of the warrants issued utilizing the Black-Scholes Option Pricing model with the following assumptions:

Expected term (years)4.0
Volatility389.2%
Risk-free interest rate4.4%
Dividend yield0.0%

On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, are fully vested and will expire on May 13, 2028. During the six months ended June 30, 2023, the Company recorded approximately $679,959 of stock-based compensation expense attributed to the warrants.

On May 14, 2023, the Compensation Committee of the Company’s Board of Directors also approved the issuance of 4,000,000 common stock warrants to Mark Faupel,2,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter from the U.S. Food and Drug Administration for the LuViva Advanced Cervical Scan and 1,500,000 of which will be vested upon receipt by the Corporation of an Approval Letter or equivalent from the Chinese National Medical Products Administration for the LuViva Advanced Cervical Scan. The warrants, which have a strike price of $0.40, will expire five years after they are exercisable with a maximum term of 10 years from issuance. As of June 30, 2023, the Company has concluded it is not probable that the performance conditions related to the warrants will be achieved, and as a result no compensation expense related to the warrants has been recorded.

During the six months ended June 30, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants, pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. The Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296.

During the six months ended June 30, 2023, management estimated the fair value of the warrants issued utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions:

Expected term (years)3.9
Volatility290.6%
Risk-free interest rate3.7%
Dividend yield0.0%

4. STOCK OPTIONS

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

During the six months ended June 30, 2024 and 2023, the Company recognized expense for stock options of $29,673 and $206,306, respectively. There was no stock option activity during the six months ended June 30, 2024.

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

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

The following tables summarize the Company’s stock option activity and related information for the six months ended June 30, 2024 and 2023:

Number ofShares · 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, 20232,338,636$0.416.5 years$-
Options outstanding as of June 30, 20242,338,636$0.416.1 years$-
Options exercisable as of June 30, 20241,980,114$0.435.6 years$-
Number ofShares · 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, 20221,500,000$0.497.5 years$-
Options granted1,025,000$0.26
Options forfeited(186,364)$0.31
Options outstanding as of June 30, 20232,338,636$0.417.1 years$-
Options exercisable as of June 30, 20231,755,114$0.456.2 years$-

The aggregate intrinsic value is calculated as the difference between the Company’s closing stock price as of June 30, 2024 and the exercise price, multiplied by the number of options. As of June 30, 2024, there was $94,578 of unrecognized stock-based compensation expense. Such costs are expected to be recognized over a weighted average period of approximately 1.75 years. The weighted-average fair value of awards granted was nil and $0.26 during the six months ended June 30, 2024 and 2023, respectively.

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

Expected term (years)10.0
Volatility366.4%
Risk-free interest rate3.8%
Dividend yield0.00

On March 3, 2023, Dr. Gene Cartwright retired from his position as President and Chief Executive Officer of the Company and as a member of the Board. Upon his departure, Mr. Cartwright forfeited 186,364 unvested stock options. On May 2, 2023, the Company’s Board of Directors approved an extension of the expiration date of Mr. Cartwright’s vested options to June 1, 2025. Management measured the modified stock option award using the Black-Scholes option pricing model and recorded expense of $59,216 during the six months ended June 30, 2023, representing the excess fair value of the modified award over the original award. Management estimated the fair value of the modified award using the Black-Scholes option pricing model and the following assumptions:

Expected term (years)2.0
Volatility182.8%
Risk-free interest rate4.0%
Dividend yield0.0%

5. LITIGATION AND CLAIMS

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular year.

As of June 30, 2024, and December 31, 2023, there was no accrual recorded for any potential losses related to pending litigation.

6. COMMITMENTS AND CONTINGENCIES

Operating Leases

Our corporate offices, which also comprise our administrative, research and development, marketing and production facilities, are located on a 12,835 square foot leased property. Total operating lease cost recognized for this lease was unchanged from the prior period and was $27,351 and $54,702 for the three and six months ended June 30, 2024, respectively. The below table presents total operating lease right-of-use assets and lease liabilities as of June 30, 2024 and December 31, 2023:

(in thousands)
June 30,December 31
20242023
Operating lease right-of-use assets$185$227
Operating lease liabilities$203$246

The table below presents the maturities of operating lease liabilities as of June 30, 2024:

(in thousands)
Operating
Lease Payments
2024 (remaining)58
2025118
202650
Total future lease payments226
Less: discount(23)
Total lease liabilities$203

The table below presents the weighted-average remaining lease term and discount rate used in the calculation of operating lease right-of-use assets and lease liabilities as of June 30, 2024 and December 31, 2023

(in thousands)
June 30, 2024December 31, 2023
Weighted average remaining lease term (years)1.92.4
Weighted average discount rate11.4%11.4%

Related Party Contracts

On June 5, 2016, the Company entered into a license agreement with Shenghuo Medical, LLC pursuant to which the Company granted Shenghuo an exclusive license to manufacture, sell and distribute LuViva in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Shenghuo was already the Company’s exclusive distributor in China, Macau and Hong Kong, and the license extended to manufacturing in those countries as well. Under the terms of the license agreement, once Shenghuo was capable of manufacturing LuViva in accordance with ISO 13485 for medical devices, Shenghuo would pay the Company a royalty equal to $2.00 or 20% of the distributor price (subject to a discount under certain circumstances), whichever is higher, per disposable distributed within Shenghuo’s exclusive territories. In connection with the license grant, Shenghuo was to underwrite the cost of securing approval of LuViva with Chinese Food and Drug Administration. At its option, Shenghuo also would provide up to $1.0 million in furtherance of the Company’s efforts to secure regulatory approval for LuViva from the U.S. Food and Drug Administration, in exchange for the right to receive payments equal to 2% of the Company’s future sales in the United States, up to an aggregate of $4.0 million. Pursuant to the license agreement, Shenghuo had the option to have a designee appointed to the Company’s board of directors (current director Richard Blumberg is the designee).

On September 6, 2016, the Company entered into a royalty agreement with one of its directors, John Imhoff, and another stockholder, Dolores Maloof, pursuant to which the Company sold to them a royalty of future sales of single-use cervical guides for LuViva. Under the terms of the royalty agreement, and for consideration of $50,000, the Company will pay them an aggregate perpetual royalty initially equal to $0.10, and from and after October 2, 2016, equal to $0.20, for each 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 June 30, 2024, unrecognized consulting expense associated with the agreement was nil and 2,500,000 of the warrants had been issued, of which 1,750,000 were issued to Mr. Blumberg and 750,000 were issued to non-related parties.

During the six months ended June 30, 2023, the Company entered into an agreement with Mr. Blumberg to exchange 875,000 of the outstanding warrants for 831,250 warrants with a strike price of $0.20, which were exercised during the first quarter of 2023.

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
Volatility108.7%
Risk-free interest rate4.3%
Dividend yield0.0%

During the six months ended June 30, 2024 and 2023, the Company issued 900,000 warrants to Mr. Blumberg, pursuant to the agreement, and recognized expense of nil and $590,840, respectively. Total unrecognized expense for the warrants was nil as of June 30, 2024. During the six months ended June 30, 2024 and 2023, the Company recognized $7,425 and $111,833 of expense for the shares of common stock due to Mr. Blumberg, respectively. As 400,000 shares had not been issued as of June 30, 2024, the Company estimated the total amount of expense for the future issuances using the closing price of the Company’s stock as of June 30, 2024.

On August 24, 2022, the Company entered into an agreement with Ironstone Capital Corp. and Alan Grujic (the “Advisory Group”) whereby the Advisory Group agreed to perform marketing and investor relations services over a term of twelve months, commencing on the closing of a financing of at least $2.5 million. In consideration for these services, the Company issued 800,000 warrants (“first tranche of warrants”) with an exercise price of $0.50 to Mr. Grujic, which were due within 10 business days of closing the financing transaction (the “Transaction”) that took place in September 2022. In the event the Company’s 20 trading day variable weighted average price (“VWAP”) exceeds $1.00 within one year of the closing of the financing, the Company would have issued 600,000 warrants (“second tranche of warrants”) with an exercise price of $0.75 to Mr. Grujic. In the event the Company’s 20 trading day VWAP exceeds $1.50 within two years of the closing of the financing, the Company will issue an additional 600,000 warrants (“third tranche of warrants”) to Mr. Grujic. Once issued, the warrants vest immediately and will expire two years from the date of issuance. If the Company’s U.S. clinical study is not completed and filed with the U.S. FDA or if the Chinese NMPA (formerly Chinese FDA) approval is not granted by each due date for reaching each respective pricing milestone, then the due date for reaching each milestone shall be extended by six months. As of June 30, 2024, the deadline to achieve the stock price of $1.50 has passed and the second tranche warrants will therefore not be issued.

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

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

Expected term (years)2.0
Volatility173.0%
Risk-free interest rate3.4%
Dividend yield0.0%

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 June 30, 2024.

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

Expected term (years)1.0
Volatility144.4%
Risk-free interest rate3.6%
Dividend yield0.0%

The Company recognized expense for the second tranche of warrants of nil and $29,706 during the three months ended June 30, 2024 and 2023, respectively. The Company recognized expense for the second tranche of warrants of nil and $59,412 during the six months ended June 30, 2024 and 2023, respectively. Unrecognized expense for the third tranche of warrants was nil as of June 30, 2024.

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

Expected term (years)2.0
Volatility172.1%
Risk-free interest rate3.6%
Dividend yield0.0%

The Company recognized expense for the third tranche of warrants of $15,466 during the three months ended June 30, 2024 and 2023. The Company recognized expense for the third tranche of warrants of $30,932 during the six months ended June 30, 2024 and 2023. Unrecognized expense for the third tranche of warrants was $10,311 as of June 30, 2024.

Other Commitments

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

First, SMI shall complete the payment for parts, per the purchase order, for five additional LuViva devices. Second, in consideration for the $885,144 that the Company received, SMI will receive 12,147 shares of common stock. Third, SMI shall honor all existing purchase orders it has executed to date with the Company, in order to maintain jurisdiction sales and distribution rights. If SMI needs to purchase cervical guides, then it will do so at a cost including labor, plus ten percent markup. The Company will provide 200 cervical guides at no cost for the clinical trials. Fourth, the Company and SMI will make 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 the Standstill Agreement (“Standstill Extension”) until July 30, 2024, contingent on payments from SMI totaling $770,000 on or before July 30, 2024. In addition, because SMI did not make its scheduled payment of $100,000 on or before March 31, 2024, the Company can place a 25% surcharge on the cost of goods and services already paid for by SMI. Additionally, the Standstill Extension reduced the number of RFID chips the Company committed to shipping by 240,000 and reduced the total amount due from SMI in 2024 by $247,545. The other terms from the Amendment and Standstill Agreement remained intact.

The Company and SMI executed an extension to the Standstill Agreement (the “Second Standstill Extension”) subsequent to June 30, 2024. Please see Note 12,“Subsequent Events” for details.

Contingencies

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

7. NOTES PAYABLE

On June 28, 2024, the Company issued a promissory note totaling $100,000 to an unaffiliated third party. The promissory note matures on January 1, 2025 and will accrue total interest of $10,000. Monthly payments of $20,000 are due on the note, beginning August 1, 2024 until December 1, 2024, while the interest payment is due on or before January 1, 2025. The promissory note may be prepaid in full or in part without penalty or premium. The holder of the promissory note also received 100,000 common stock purchase warrants, which will have an exercise price of $0.25 and will expire on July 1, 2028. The warrants, which had an estimated fair value of $11,998, were recorded as a discount on the note payable.

On April 15, 2024, the Company entered into an exchange agreement with a former employee, whereby the former employee agreed to exchange outstanding amounts due to him for deferred compensation in the amount of $81,768 for an $87,162 promissory note dated April 15, 2024. Beginning on May 5, 2024, monthly payments of $2,000 are due on the note until its maturity date. The promissory note, which accrues interest at a rate of 6% per annum, matures on May 5, 2028. The total balance of the promissory note was $83,162 as of June 30, 2024, of which $24,000 is presented in “Short-term notes payable” on the consolidated balance sheets and $59,162 is included in “Long-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 matured on May 4, 2024, had an outstanding balance of nil and $59,422 as of June 30, 2024 and December 31, 2023, respectively.

The following table summarizes short-term notes payable (in thousands):

Short-term notes payable
June 30, 2024 · December 31, 2023
Short-term promissory note$100$-
Current portion of long-term promissory note24-
Premium Finance (insurance)-59
Debt Discount(12)-
Short-term notes payable$112$59

8. CONVERTIBLE DEBT

10% Senior Unsecured Convertible Debenture

On May 17, 2021, the Company issued 10% Senior Unsecured convertible debentures to investors, which matured on May 17, 2024 (the “Maturity Date”). The Company subscribed $1,130,000 of the $1,000 convertible debentures. The terms of the debentures are as follows: 1) the principal amount of some or all of the convertible debentures and accrued interest are convertible into shares of common stock at the holder’s option, at a price of $0.50 per common stock share (the “conversion price”), subject to adjustment in certain events, at any time prior to maturity date; 2) upon successful uplist to a U.S. National Exchange, the note will automatically convert into the uplisting financing; 3)each debenture unit included 1,000 common stock warrants with an exercise price of $0.80 and an expiration date of May 17, 2023; 4) if a Change of Control (as defined in the Convertible Debenture Certificate) occurs prior to the Maturity Date, unless the holder elects in writing to convert the Convertible Debentures into shares of common stock, the Company will repay in cash upon the closing of such Change of Control all outstanding principal and accrued interest under each Convertible Debenture plus a Change of Control premium equal to an additional 3% of the outstanding principal sum under such Convertible Debenture. Prior to the closing of an Change of Control, in lieu of repayment as set forth in the preceding sentence, the holder has the right to elect in writing to convert, effective immediately prior to the effective date of such Change of Control, all outstanding principal and accrued Interest under the Convertible Debentures into shares of common stock at the Conversion Price; 5) Subject to a holder’s option of electing conversion prior to the Redemption Date (as such term is defined below), on or after the date that is 24 months from the Closing Date if the daily volume weighted average trading price of the shares of common stock is $1.50 per share of common stock or more for each trading day over a 30 consecutive trading day period, the Company may, at any time (the “Redemption Date”), at its option, redeem all, or any portion of the Convertible Debentures for either: (i) a cash payment (in the form of a certified cheque or bank draft) that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date; or (ii) by issuing and delivering shares of common stock to the holders of Convertible Debentures at a deemed price of $0.50 per share of common stock that is equal to all outstanding principal and accrued interest under each Convertible Debenture up to the Redemption Date, or any combination of (i) or (ii), upon not less than 30 days and not more than 60 days prior written notice in the manner provided in the Debenture Certificate, to the holder of Convertible Debentures.

At June 30, 2024 and December 31, 2023, the balance due on the 10% Senior Secured Convertible Debenture was $1,130,000 and total accrued interest was $24,860 and $58,494, respectively. After the May 17, 2024 maturity date, the interest rate increased to the default rate of 18.0%. The bond payable discount and unamortized debt issuance costs as of June 30, 2024 and December 31, 2023 are presented below (in thousands):

Senior Secured Convertible Debenture
June 30, 2024December 31, 2023
10% Senior Unsecured Convertible Debentures$1,130$1,130
Unamortized debt issuance costs-(12)
Debt Discount-(38)
Senior Unsecured Convertible Debenture$1,130$1,080

As of June 30, 2024, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible notes payable in default” within the condensed consolidated balance sheets. As of December 31, 2023, the balance of the Senior Unsecured Convertible Debenture is included in “Short-term convertible notes payable” within the condensed consolidated balance sheets.

1800 Diagonal Lending Note

On June 11, 2024, the Company entered into a securities purchase agreement and contingently convertible note with 1800 Diagonal Lending LLC (“Diagonal Lending”). The convertible note issued to Diagonal Lending had a total principal balance of $100,050 and an original issue discount of $13,050. The note, which will accrue total interest of $14,007, will mature on April 15, 2025. A payment of $57,029 is due on the note on December 15, 2024. The remaining balance due, including accrued interest, will be paid in monthly payments of $14,257 from January 15, 2025 through April 15, 2025. The note may be prepaid within 120 days of issuance for a discount of 2.0 -3.0 % of the principal and accrued interest due. Any amount of principal or interest on the note which is not paid when due will bear interest at the rate of the lessor of 22% or the maximum permitted by law. The Company may not sell, lease, or otherwise dispose of any significant portion of its assets outside of the ordinary course of business without the express permission of Diagonal Lending. In the event of default, the note will become immediately due and payable in an amount equal to 150.0% times the sum of the then outstanding principal, accrued interest and default interest.

In an event of default, the unpaid portion of the note and accrued interest is convertible into shares of common stock at a conversion rate equal to the variable conversion price. The variable conversion price is equal to the lowest closing price of our common stock during the ten days prior to the conversion date multiplied by 65.0%. The Company assessed this embedded conversion feature and determined that it is not considered clearly and closely related to the host note, and therefore meets the definition of a derivative. Therefore, this embedded conversion feature is required to be bifurcated from the note and accounted for separately as a derivative liability. The Company estimated the fair value of the combined derivative liability as of June 11, 2024, which was recorded as a liability and as a discount net against the subordinated convertible notes. The Company is required to remeasure the combined derivative liability to its then fair value at each subsequent balance sheet date, through an adjustment to current earnings (see Note 11 for further details on the Company’s fair value measurement).

At June 30, 2024, the balance due on the note was $100,000 and total accrued interest was $1,166. The note payable discount, unamortized debt issuance costs and unamortized debt discount (including the beneficial conversion feature) as of June 30, 2024 and December 31, 2023 is presented below (in thousands):

June 30, 2024 · December 31, 2023
Short-term convertible promissory note$100$-
Unamortized debt issuance costs(4)-
Debt Discount(12)-
Beneficial conversion feature(5)-
1800 Diagonal Lending Convertible Note$79$-

Auctus Convertible Note

On December 17, 2019, the Company entered into a securities purchase agreement and convertible note with Auctus Fund, LLC (“Auctus’). The convertible note issued to Auctus was for a total of $2.4 million. The note may not have been prepaid in whole or in part except as otherwise explicitly allowed. Any amount of principal or interest on the note which was not paid when due shall bore interest at the rate of the lessor of 24% or the maximum permitted by law (the “default interest”). The variable conversion prices equaled the lesser of: (i) the lowest trading price on the issue date, and (ii) the variable conversion price. The variable conversion price was 95% multiplied by the market price (the market price means the average of the five lowest trading prices during the period beginning on the issue date and ending on the maturity date), minus $0.04 per share, provided however that in no event could the variable conversion price be less than $0.15. If an event of default under this note occurred and/or the note was not extinguished in its entirety prior to December 17, 2020, the $0.15 price floor no longer applied.

On September 1, 2022, the Company agreed to exchange certain debt and equity owned by Auctus pursuant to an Exchange Agreement between the Company and Auctus (the “Exchange Agreement”). Immediately prior to the Exchange Agreement, Auctus held $1,228,183 of debt, including an early prepayment penalty of $350,000, default premiums of $281,256, and $91,555 in interest payable. Auctus agreed to reduce the amount owed to $710,911 and to revert the May 27, 2020 note to its original term. Additionally, Auctus agreed to exchange 8,775,000 warrants that were priced between $0.15 and $0.20 and the $350,000 prepayment penalty for 3,900,000 shares of common stock, warrants to purchase 3,900,000 shares of common stock at $0.50 per share and warrants to purchase 3,900,000 shares of common stock at $0.65 per share (the “Exchange”). As a result of the Exchange Agreement, Auctus forgave a default penalty of $225,444. Following the Exchange and Repayment, the Company will make payments to Auctus in four installments, over an 18-month period. During 2024, Auctus agreed to apply the payments to the principal portion of the debt before applying the funds to the accrued interest. As a result, management has reclassified a portion of the current and prior period outstanding debt to the accrued interest as described below.

The total outstanding balance of the convertible note was $15,000 and $25,000 as of June 30, 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 $115,646 and $121,995 as of June 30, 2024 and December 31, 2023, respectively.

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.

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
Bonus20
Vacation95
Interest on compensation67
Loans to Company196
Interest on loans149
Total outstanding prior to exchange661
Amount forgiven in prior years(454)
Amount exchanged for Series F-2 Preferred Stock(85)
Total interest accrued through December 31, 202357
Balance outstanding at December 31, 2023$179
Interest accrued through June 30, 20245
Balance outstanding at June 30, 2024$184
For Dr.Cartwright
Salary$337
Bonus675
Loans to Company528
Interest on loans81
Total outstanding prior to exchange1,621
Amount forgiven in prior years(1,302)
Amount exchanged for Series F-2 Preferred Stock(100)
Total interest accrued through December 31, 202393
Payments on outstanding debt(25)
Balance outstanding at December 31, 2023$287
Interest accrued through June 30, 20247
Balance outstanding at June 30, 2024$294

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 and six months ended June 30, 2024, Mr. Fowler forgave $16,401 and $33,060 of the outstanding balance of deferred compensation, respectively. During the three and six months ended June 30, 2023, Mr. Fowler forgave $17,450 and $35,171 of the outstanding balance of deferred compensation, respectively. As of June 30, 2024, Mr. Fowler may forgive up to $96,276 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 June 30, 2024 and December 31, 2023, the outstanding principal amount owed on the note was $63,731 and $82,945, respectively.

Future debt obligations at June 30, 2024 for debt owed to related parties is as follows:

YearAmount(in thousands)
2024 (remaining)21
2025519
20263
Total$543

10. INCOME (LOSS) PER SHARE OF COMMON STOCK

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

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

During a period of net loss, basic and diluted earnings per share are the same as the assumed exercise of warrants and the conversion of convertible debt and preferred stock are anti-dilutive. For the three and six months ended June 30, 2024 and 2023, all stock options, convertible preferred stock, convertible debt and warrants were anti-dilutive and were therefore excluded from the computation of diluted loss per share. At June 30, 2024 and 2023, these instruments were convertible into 53,674,649 and 54,482,496 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):

June 30,
20242023
Net loss(1,199)(2,573)
Basic weighted average number of shares outstanding55,36850,138
Net loss per share (basic)(0.02)(0.05)
Diluted weighted average number of shares outstanding55,36850,138
Net loss per share (diluted)(0.02)(0.05)

11. FAIR VALUE MEASUREMENTS

The convertible notes payable derivative liability is considered a Level 3 measurement, due to the significant unobservable inputs in the valuation, which are based on a forecast of the Company’s future stock performance and, as the note payable is contingently convertible upon an event of default, management’s estimate of the likelihood and timing of conversion.

Based on the terms and provisions of the Diagonal Lending note payable, management built a pricing simulation that predicts the Company’s future stock prices using historical volatility. Our model is designed to utilize the Company’s best estimates of the timing and likelihood of a conversion of the note payable to calculate the variable conversion price as of the future conversion date.

The key inputs to the valuation model that was utilized to estimate the fair value of the bifurcated conversion option included:

·The forecasted future stock prices were determined using historical stock prices and the Company’s equity volatility.
·The expected conversion price was determined using the forecast and the contractual term of the convertible note agreement.
·The probability of an event of default and timing of a future conversion are based on management’s best estimate of the future settlement of the convertible note.

The following tables present the fair value of the bifurcated conversion option:

Fair Value at June 30, 2024(in thousands)
Level 1 · Level 2 · Level 3 · Total
Derivative liability/bifurcated conversion option in connection with Diagonal Lending $100,050 promissory note--1313
Total short-term liabilities at fair value$-$-$13$13

Derivative financial instruments and changes thereto recorded in the six months ended June 30, 2024 and 2023 include the following:

Six Months EndedJune 30,
2024 · 2023
Balance, beginning of period$-$(5)
Inception of derivative liability5
Change in fair value during the period75
Balance, end of period$12$-

12. SUBSEQUENT EVENTS

Issuances of Promissory Notes and Related Warrants

On July 22, 2024, we issued a $62,100 convertible promissory note to Diagonal Lending. The convertible promissory note, which had an original issue discount of $8,100, will mature on May 30, 2025 and will accrue total interest of $8,694. A payment of $35,397 will be due on January 30, 2025. The remaining balance, including the accrued interest, will be paid in monthly installments of $8,849 beginning February 28, 2024 and ending on the maturity date. The remaining terms of the convertible promissory note are identical to the June 11, 2024 convertible promissory note disclosed within Note 8,*“Convertible Debt,”*with the exception that payments on the note may be accelerated or prepaid in full at any time with no prepayment penalty.

On July 23, 2024, we issued a $50,000 promissory note to an unaffiliated third party (the “Holder”). The promissory note, which will incur total interest of $5,000, will mature on February 1, 2025. Monthly payments of $10,000 are due beginning September 1, 2024 and ending January 1, 2025. The $5,000 interest payment is due on February 1, 2025. With the Holder’s permission, the promissory note may be prepaid in full or in part without penalty or premium. In connection with the promissory note, we issued 60,000 common stock warrants with a strike price of $025. The warrants will expire on July 31, 2028.

Subsequent to June 30, 2024, we issued three $25,000 promissory notes to our directors. The promissory notes mature in one year and accrue interest at an annual rate of 9.0%. In connection with the promissory notes, we issued 75,000 common stock warrants to our directors. The warrants, which have a strike price of $0.25, will expire four years after the issuance date.

Issuances of Common Stock

Subsequent to June 30, 2024, we issued 70,558 common shares for payment of Series D Preferred dividends and 213,151 common shares for payment of accrued interest expense.

Second Extension of Standstill Amendment with SMI

Subsequent to June 30, 2024, SMI payments due on July 31, 2024 remained unpaid. On July 31, 2024, the Company and SMI jointly agreed to extend the Standstill Agreement until August 16, 2024, upon which a longer-term agreement is expected to be executed.****

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