The following discussion should be read in conjunction with our financial statements and related notes in Part II, Item 8. The following discussion contains forward-looking statements that involve risks, uncertainties and assumptions that could cause actual results to differ materially from management's expectations. You should review the "Risk Factors" and "Cautionary Note Concerning Forward-Looking Statements" sections of this Annual Report for a discussion of the important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. Because such statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made. 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 aDelaware corporation, originally incorporated in 1992 under the name "SpectRx, Inc. " and, onFebruary 22, 2008 , changed our name toGuided 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 ofDecember 31, 2021 we have an accumulated deficit of approximately$142.4 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. 26 Table of Contents Our product revenues to date have been limited. In 2021, 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 2022 will be derived from revenue from the sale of LuViva devices and disposables. Current Demand for LuViva
Based on discussions with our distributors, we currently hold and expect to generate additional purchase orders for approximately$1.5 million in LuViva devices and disposables and expect to recognize revenue for from these sales during 2022. 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 amount of sales. Accordingly, we have not identified any particular trends with regard to sales of our products. In order to increase demand for LuViva, the Company is focused on three primary markets:the United States ,China andEurope . Inthe United States , the Company is actively pursuing FDA approval by initiating a clinical trial protocol involving approximately 400 study participants. The protocol was drafted with input from FDA and two prestigious clinical centers that will participate in enrolling the 400 women at multiple sites within their hospital systems. Clinical trial agreements have been drafted and agreed upon, the budget at one institution has been agreed upon and is under negotiation at the other institution. The LuViva devices have been prepared and have passed bench testing in order to begin the study. All requested materials have been submitted for review by the respective hospital institutional review boards (IRBs). Once the IRB's have approved the study, enrollment may begin, which is expected prior to the end of 2022 and last approximately eight to nine months; however, there can be no assurance that the study will be completed by the end of 2022. InChina , the study protocol and budgets have been agreed upon at two clinical centers and the study has begun at one center, with two more to be added this year. This study will enroll approximately 320 women and is expected to be completed in the first half of 2022, although there can be no assurance that the study will be completed within this time frame. InEurope , the Company attended a meeting inBucharest, Romania onNovember 3-4, 2021 , hosted by our central Eastern and Russian distribution partner. The LuViva system was demonstrated for doctors at a local clinic and the head Ob-Gyn physician intends to keep the LuViva device and order additional Cervical Guides to test patients as part of her practice. RESULTS OF OPERATIONS COMPARISON OF 2021 and 2020 Sales Revenue, Cost of Goods Sold and Gross Profit from Devices and Disposables: Revenues from the sale of LuViva devices for the year endedDecember 31, 2021 were$81,000 , compared to$102,000 for the year endedDecember 31, 2020 , a decrease of$21,000 or 21%. Cost of goods sold was$61,000 during the year endedDecember 31, 2021 , compared to cost of goods recovered of$41,000 during the year endedDecember 31, 2020 . Cost of goods recovered in 2020 was the result of the buy-back of parts from one customer that were then sold, resulting in a revaluation of the inventory reserve. Cost of goods sold increased during the year endedDecember 31, 2021 due to inventory write-offs of slow-moving inventory. This resulted in gross profit of$20,000 on the sales of devices and disposals for the year endedDecember 31, 2021 , compared to gross profit of$143,000 for the same period in 2020. Research and Development Expenses: Research and development expenses for the year endedDecember 31, 2021 decreased to$69,000 from$143,000 during the same period in 2020. The decrease of$74,000 or 52% was primarily due to a reduction in research and development clinical costs and payroll expenses.
Sales and Marketing Expenses: Sales and marketing expenses for the year ended
27 Table of Contents
General and Administrative Expense: General and administrative expenses for the year endedDecember 31, 2021 increased to approximately$2,172,000 compared to$913,000 during the same period in 2020. The increase of approximately$1,259,000 , or 138%, was primarily due to a charge of$556,000 for warrants issued toMr. Blumberg for consulting services and consulting expenses of$228,000 for warrants issued to finders in the capital raises. Additionally, during the year endedDecember 31, 2020 , the Company reversed$292,000 of a reserve taken for a deposit made for inventory parts for its devices, which lowered general and administrative expenses in the prior period. The remaining increase in current period general and administrative expenses was due to minimal increases in rent expense, payroll-related expenses, and miscellaneous other expenses. Interest Expense: Interest expense for the year endedDecember 31, 2021 increased to approximately$1,150,000 , compared to$1,056,000 during the same period in 2020. The increase of approximately$94,000 , or 9%, was primarily due to a$350,000 prepayment penalty incurred on short-term convertible notes payable, offset by lower interest incurred for outstanding notes payable and convertible debt during the year endedDecember 31, 2021 . Fair Value of Derivative Liability: Loss from the change in the fair value of the derivative liability was$91,000 during the year endedDecember 31, 2021 , compared to$25,000 during the same period in 2020. The increase in the loss of$66,000 , or 264%, was due to changes in the fair value of the associated derivative liability and extinguishment due to a$700,000 payoff of the associated loan. Gain (Loss) from Extinguishment of Debt: During the year endedDecember 31, 2021 , the Company recognized a gain on extinguishment of debt of$578,000 , compared to a loss on extinguishment of debt of$296,000 during the same period in 2020. The gain from debt extinguished in 2021 was primarily due to forgiveness of debt principal and accrued interest totaling$578,000 during 2021. The loss of$296,000 recognized in the prior period was related to debt eliminated from debt exchange agreements. Change in Fair Value of Warrants: The gain recorded due to change in fair value of warrants was$448,000 during the year endedDecember 31, 2021 , compared to$1,879,000 during the same period in 2020. The decrease of$1,431,000 , or 76%, was primarily due to an exchange agreement signed withGPB Debt Holdings II LLC ("GPB"), which resulted changes to the terms of the warrants and reclassification of the warrants from liabilities to equity. Other Income: Other income during the year endedDecember 31, 2021 was$507,000 , compared to$271,000 during the same period in 2020. The increase of$236,000 , or 87%, was primarily due to the write-off of a$350,000 subscription receivable liability during 2021. The increase was offset by additional income recorded for recovery of employment expenses and aged payables with had exceeded their statute of limitations on collectability during 2020. Net Loss: Net loss attributable to common stockholders was$2,431,000 during the year endedDecember 31, 2021 , compared to$401,000 during the same period in the prior year. The increase in net loss of$2,030,000 or 506% was due to the reasons described above.
There was no income tax benefit recorded for 2021 or 2020, due to recurring net operating losses.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception, we have raised capital through the public and private sale of debt and equity, funding from collaborative arrangements, and grants. As ofDecember 31, 2021 , we had cash of approximately$643,000 and negative working capital of$4,057,000 .
Our major cash flows for the years
28 Table of Contents Capital resources for 2021 During 2021, the Company received$1,130,000 of cash from the sale of 10% debenture unit investments and incurred transactional fees of$86,400 . The Company issued the finders 413,600 warrants for the Company's common stock shares. The investors received a total of 1,130,000 warrants for common stock shares. The debentures are convertible into 2,260,000 of the Company's common stock shares. During 2021, the Company received$2,114,000 of cash from the sale of equity securities and incurred transactional fees of$139,000 . The Company also issued the finders 98,000 of the Company's common stock shares and 643,700 warrants for the Company's common stock shares. The investors received a total of 1,436 and 3,237 shares of Series F and Series F-2 preferred stock, respectively. Each share of Series F or Series F-2 preferred stock is convertible into 4,000 shares of the Company's common stock, at the election of the investor. During 2021, the Company finalized an investment byPower Up Lending Group Ltd ("Power Up"). Power Up invested$132,000 , (of which the Company received$125,000 net of costs) for 153,000 shares of Series G preferred stock. As ofDecember 31, 2021 , all Series G preferred shares were redeemed. During 2021, the Company entered into an exchange agreement withRichard Fowler . As ofDecember 31, 2020 , the Company owedMr. Fowler $546,214 ($412,624 in deferred salary and$133,590 in accrued interest).Mr. Fowler exchanged$50,000 of the amount owed of$546,214 for 50 shares of Series F-2 Preferred Shares (convertible into 200,000 shares of common stock) and a$150,000 unsecured note. The note accrues interest at the rate of 6.0% (18.0% in the event of default) beginning onMarch 1, 2022 and is payable in monthly installments of$3,600 for four years, with the first payment being due onMarch 15, 2022 . The effective interest rate of the note is 6.18%.Mr. Fowler forgave$86,554 and may forgive up to$259,661 of debt if the Company complies with the repayment plan described above. Capital resources for 2020 During 2020, we received equity investments in the amount of$1,735,500 . These investors received a total of 1,735.50 Series E preferred stock (if the Investor elects to convert their Series E preferred stock, each Series E preferred stock shares converts into 4,000 shares of our common stock shares). During January andApril 2020 , we received equity investments in the amount of$128,000 . These investors received a total of 256,000 common stock shares, 256,000 warrants issued to purchase common stock shares at a strike price of$0.25 , 256,000 warrants to purchase common stock shares at a strike price of$0.75 and 128 Series D preferred stock (if the Investor elects to convert their Series D preferred stock, each Series D preferred stock shares converts into 3,000 shares of our common stock shares). Of the amount invested$38,000 was from related parties. OnJanuary 6, 2020 , we entered into an exchange agreement withJones Day . Upon making a payment of$175,000 , which had not yet occurred, we will exchange$1,744,768 of debt outstanding for:$175,000 , an unsecured promissory note in the amount of$550,000 ; due 13 months form the date of issuance, that may be called at any time prior to maturity upon a payment of$150,000 ; and an unsecured promissory note in the principal amount of$444,768 , bearing an annualized interest rate of 6.0% and due in four equal annual installments beginning on the second anniversary of the date of issuance. OnJanuary 8, 2020 , we exchanged$2,064,366 in debt for several equity instruments (noted below) that were determined to have a total fair value of$2,065,548 , resulting in a loss on extinguishment of debt of$1,183 which is recorded in other income (expense) on the accompanying consolidated statements of operations. We also issued 6,957,013 warrants to purchase common stock shares; with exercise prices of$0.25 ,$0.75 and$0.20 . OnJune 3, 2020 , we exchanged$328,422 in debt fromAuctus , (summarized in footnote 10: Convertible Notes), for 500,000 common stock shares and 700,000 warrants to purchase common stock shares. The fair value of the common stock shares was$250,000 (based on a$0.50 fair value for our stock) and of the warrants to purchase common stock shares was$196,818 (based on a$0.281 Black-Scholes option pricing model). This resulted in a net loss on extinguishment of debt of$118,396 ($446,818 fair value less the$328,422 of exchanged debt).
OnJune 30, 2020 , we exchanged$125,000 in debt (duringJune 2020 ,$125,000 in payables had been converted into short-term debt) from Mr.James Clavijo , for 500,000 common stock shares and 250,000 warrants to purchase common stock shares. The fair value of the common stock shares was$250,000 (based on a$0.50 fair value for our stock) and of the warrants to purchase common stock shares was$99,963 (based on a$0.40 Black-Scholes fair valuation). This resulted in a net loss on extinguishment of debt of$224,963 ($349,963 fair value less the$125,000 of exchanged debt). After the exchange transaction, the balance due toMr. Clavijo of$10,213 was paid. 29 Table of Contents
OnJuly 9, 2020 , we entered into an exchange agreement with Mr.Bill Wells (a former employee). In lieu of agreeing to dismiss approximately half of what is owed or$220,000 ,Mr. Wells will receive the following: (i) cash payments of$20,000 within 60 days of the signing of the agreement; cash payments over time in the amount of$90,000 in the form of an unsecured note to be executed within 30 days of a new financing(s) totaling at least$3.0 million . The note shall bear interest of 6.0% and mature over 18 months; (iii) 66,000 common share stock options that vest at a rate of 3,667 per month and have a$0.49 exercise price (if two consecutive payments in (ii) are not made the stock options will be canceled and a cash payment will be required; and (iv) the total amount of forgiveness by creditor of approximately$110,000 shall be prorated according to amount paid.
The following table summarizes the debt exchanges:
Total Debt and Total Warrants Warrants Warrants Warrants Warrants Accrued Accrued Common Stock (Exercise (Exercise (Exercise (Exercise (Exercise Interest Total Debt Interest Shares
$0.15 )$0.20 )$0.25 )$0.50 )$0.75 ) Aquarius$ 145,544 $ 107,500 $ 38,044 291,088 - - 145,544 - 145,544 K2 Medical (Shenghuo)3 803,653 771,927 31,726 1,905,270 - 496,602 704,334 - 704,334
Mr.
Blumberg 305,320 292,290 13,030 1,167,630 - 928,318 119,656 - 119,656 Mr. Case 179,291 150,000 29,291 896,456 - 896,456 - - - Mr. Grimm 51,110 50,000 1,110 255,548 - 255,548 - - - Mr. Gould 111,227 100,000 11,227 556,136 - 556,136 - - - Mr. Mamula 15,577 15,000 577 77,885 - 77,885 - - - Dr. Imhoff2 400,417 363,480 36,937 1,699,255 - 1,497,367 100,944 - 100,944 Ms. Rosenstock1 50,000 50,000 - 100,000 - - 50,000 - 50,000 Mr. James2 2,286 2,000 286 7,745 - 5,291 1,227 - 1,227 Auctus 328,422 249,119 79,303 500,000 700,000 - - - Mr. Clavijo 125,000 125,000 - 500,000 - - - 250,000 - Mr. Wells4 220,000 220,000 - - - - - - -$ 2,737,847 $ 2,496,316 $ 241,531 7,957,013 700,000 4,713,603 1,121,705 250,000 1,121,705 ____________
1
2
3 Our COO and director,Mark Faupel , is a shareholder of Shenghuo, and a former director,Richard Blumberg , is a managing member of Shenghuo, however he does not have voting or other control rights with respect to Shenghuo's management or its equity in our Company.
4
OnJanuary 16, 2020 , we entered into an exchange agreement with GPB. Under the terms of this exchange agreement, we will exchange$3,360,811 of debt outstanding as ofDecember 12, 2019 for the following: (1) a cash payment of$1,500,000 , (2) 7,185,000 warrants to purchase common stock, previously outstanding, would be exchanged for new warrants to purchase common stock shares at a strike price of$0.20 and (3) a certain amount of preferred stock shares for the remaining balance outstanding upon the final exchange date. During 2021, we made the final payments totaling$800,000 out of the total$1,500,000 and issued 2,236 shares of Series F-2 preferred stock in accordance with the terms of the agreement. OnMarch 31, 2020 , we entered into a securities purchase agreement withAuctus Fund, LLC for the issuance and sale toAuctus of$112,750 in aggregate principal amount of a 12% convertible promissory note. OnMarch 31, 2020 , we issued the note toAuctus and issued 250,000 five-year common stock warrants at an exercise price of$0.16 . OnApril 3, 2020 , we received net proceeds of$100,000 . The note matured onJanuary 26, 2021 and accrues interest at a rate of 12% per year. As ofDecember 31, 2021 , the note is in default and accrues default interest of 24% per year. OnMay 4, 2020 , we received a loan from theSmall Business Administration (SBA) pursuant to the Paycheck Protection Program (PPP) as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in the amount of$50,184 . The Company was notified that the application for loan forgiveness was approved in the amount of$23,742 in principal and$234 in interest. The Company is planning on appealing the amount forgiven.
On
30 Table of Contents OnMay 22, 2020 , we entered into an exchange agreement withAuctus . Based on this agreement we exchanged three outstanding notes, with a total principal amount of$249,119 outstanding, as well as any accrued interest and default penalty, for$160,000 in cash payments (payable in monthly payments of$20,000 ), converted a portion of the notes pursuant to original terms of the notes into 500,000 restricted common stock shares (shares were issued onJune 3, 2020 ); and 700,000 warrants issued to purchase common stock shares with an exercise price of$0.15 . The fair value of the common stock shares was$250,000 (based on a$0.50 fair value for our stock) and of the warrants to purchase common stock shares was$196,818 (based on a$0.281 Black-Scholes fair valuation). This resulted in a net loss on extinguishment of debt of$118,396 ($446,818 fair value less the$328,422 of exchanged debt). The notes are no longer outstanding as ofDecember 31, 2021 .
OnMay 27, 2020 , we received the second tranche in the amount of$400,000 , from theDecember 17, 2019 , securities purchase agreement and convertible note withAuctus . The net amount paid to us was$313,000 . This second tranche is part of the convertible note issued toAuctus for a total of$2.4 million of which$700,000 has already been provided byAuctus . The note matures onMay 27, 2022 and incurs interest at a rate of ten percent (10%) per annum. Contingencies Based on the current outbreak of the Coronavirus SARS-CoV-2, the pathogen responsible for COVID-19, which has already had an impact on financial markets, there could be additional repercussions in our operating business, including but not limited to, the sourcing of materials for product candidates, manufacture of supplies for preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for trials due to such things as quarantines, conduct of patient monitoring and clinical trial data retrieval at investigational study sites. The future impact of the outbreak is highly uncertain and cannot be predicted, and we cannot provide any assurance that the outbreak will not have a material adverse impact on our operations or future results or filings with regulatory health authorities. The extent of the impact, if any, we will depend on future developments, including actions taken to contain the coronavirus. The conflict inUkraine , 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 inRussia . The future impact of the conflict is highly uncertain and cannot be predicted, and we cannot provide any assurance that the conflict will not have a material adverse impact on our operations or future results or filings with regulatory health authorities.
Off-Balance Sheet Arrangements
We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.
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