STOCKHOLDERS' DEFICIT | 4. STOCKHOLDERS’ DEFICIT Sales of Securities – 2022 During the year ended December 31, 2022, the Company entered into certain Securities Purchase Agreements (the “Agreement”) with certain accredited investors (the “Investors”), including Richard Blumberg, Michael James and John Imhoff, each a member of the Company’s Board of Directors, pursuant to which the Company issued 6,711,540 shares of its common stock, four year warrants to purchase an aggregate of 6,711,540 shares of Common Stock at $0.50 per share and 6,711,540 shares of Common Stock at $0.65 per share (the “Warrants”) for an aggregate purchase price of $3,355,270 (the “Transaction”). After payment of all fees and expenses relating to the transaction, the Company received net proceeds of approximately $3.2 million. The primary use of proceeds was to fund the completion and filing of clinical study data needed for FDA approval of the Company’s LuViva Advanced Cervical Scan. The proceeds were also used to support international distribution partners to grow sales and for general and administrative expenses. Common Stock The Company has authorized 500,000,000 shares of common stock with $0.001 par value. As of December 31, 2023 and 2022, 54,105,101 and 48,595,715 common shares were issued and outstanding, respectively. During the years ended December 31, 2023 and 2022 the Company issued 5,509,386 and 34,922,132 shares of common stock, respectively, as summarized in the following tables: Number of Shares Issuances of common stock to investors 6,711,540 Issuances of common stock for warrants exercised 5,127,923 Issuances of common stock to Auctus for Exchange Agreement 3,900,000 Issuances of common stock for payment of Series D Preferred dividends 81,973 Issuances of common stock for payment of Series E Preferred dividends 179,858 Issuances of common stock for payment of Series F Preferred dividends 163,214 Issuances of common stock for payment of Series F-2 Preferred dividends 114,304 Issuances of common stock for payment of interest 241,914 Issuances of common stock for Series F one-time 15% dividend 255,401 Issuances of common stock for Series F-2 one-time 15% dividend 368,505 Conversion of Series C-2 Preferred stock to common stock 1,124,500 Conversion of Series D Preferred stock to common stock 975,000 Conversion of Series E Preferred stock to common stock 3,390,000 Conversion of Series F Preferred stock to common stock 1,480,000 Conversion of Series F-2 Preferred stock to common stock 10,808,000 Total common stock issued during the year ended December 31, 2022 34,922,132 Common stock warrants exercised 3,128,274 Issuance of common stock for payment of Series D preferred dividends 151,347 Issuance of common stock for payment of Series E preferred dividends 378,294 Issuance of common stock for payment of Series F preferred dividends 233,308 Issuance of common stock for payment of Series F-2 preferred dividends 120,284 Issuance of common stock for payment of interest 417,879 Issuance of common stock to consultants 800,000 Conversion of Series E preferred stock to common stock 20,000 Conversion of Series F preferred stock to common stock 200,000 Conversion of Series F-2 preferred stock to common stock 60,000 Total common stock issued during the year ended December 31, 2023 5,509,386 Summary table of common stock transactions: Shares outstanding at December 31, 2021 13,673,583 Common shares issued during the year ended December 31, 2022 34,922,132 Shares outstanding at December 31, 2022 48,595,715 Common shares issued during the year ended December 31, 2023 5,509,386 Shares outstanding at December 31, 2023 54,105,101 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 December 31, 2023 and December 31, 2022, there were 286 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 572,000 shares, 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 December 31, 2023 and 2022. Upon conversion of the Series C Preferred Stock prior to the Dividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the number of unpaid dividends through the Dividend End Date on the converted shares. At December 31, 2023 and 2022, the “make-whole payment” for a converted share of Series C Preferred Stock would convert to 200 shares of the Company’s common stock. The Series C Preferred Stock generally has no voting rights except as required by Delaware law. Upon the Company’s liquidation or sale to or merger with another corporation, each share will be entitled to a liquidation preference of $1,000, plus any accrued but unpaid dividends. Series C1 Convertible Preferred Stock The board designated 20,250 shares of preferred stock as Series C1 Preferred Stock, of which 1,049.25 shares were issued and outstanding at December 31, 2023 and 2022. At December 31, 2023 and 2022, there were 1,049.25 shares outstanding with a conversion price of $0.50 per share, such that each share of Series C1 Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 2,098,500 common shares. The Series C1 Preferred Stock has terms that are substantially the same as the Series C Preferred Stock, except that the Series C1 Preferred Stock does not pay dividends (unless and to the extent declared on the common stock) or at-the-market “make-whole payments” and, while it has the same anti-dilution protections afforded the Series C preferred stock, it does not automatically reset in connection with a reverse stock split or conversion of our outstanding convertible debt. Series C2 Convertible Preferred Stock On August 31, 2018, the Company entered into agreements with certain holders of the Company’s Series C1 Convertible Preferred Stock, including the chairman of the Company’s board of directors, the former Chief Operating Officer (now the Chief Executive Officer) and a director of the Company pursuant to which those holders separately agreed to exchange each share of the Series C1 Preferred Stock held for one (1) share of the Company’s newly created Series C2 Convertible Preferred Stock. In total, for 3,262.25 shares of Series C1 Convertible Preferred Stock to be surrendered, the Company issued 3,262.25 shares of Series C2 Convertible Preferred Stock. At December 31, 2023 and 2022, there were 2,700 shares outstanding, each with a conversion price of $0.50 per share, such that each share of Series C preferred stock would convert into approximately 2,000 shares of the Company’s common stock; for a total of 5,400,000 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. During the year ended December 31, 2022, the Company issued 1,124,500 common stock shares for the conversion of 562.25 shares of Series C2 Preferred stock. As of December 31, 2023 and 2022, 2,700 shares of Series C2 Convertible Preferred stock remained outstanding with a conversion price of $0.50 per share, such that each share of Series C2 Convertible Preferred Stock would convert into approximately 2,000 shares of the Company’s common stock, for a total of 5,400,000 common shares. 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 December 31, 2023 and 2022. On January 8, 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors (“the Series D Investors”) pursuant to all obligations under the Series D Certificate of Designation. The Series D Investors included the Chief Executive Officer, Chief Operating Officer and a director of the Company. In total, for $763,000 the Company issued 763 shares of Series D Preferred Stock, 1,526,000 shares of common stock, 1,526,000 common stock warrants exercisable at $0.25, and 1,526,000 common stock warrants, exercisable at $0.75. Each Series D Preferred Stock is convertible into 3,000 shares of common stock. The Series D Preferred Stock have cumulative dividends at the rate per share of 10% per annum. Each share of Series D Preferred Stock has a par value of $0.001 per share and a stated value equal to $750. Each share of Series D Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series D Certificate of Designation (the “Series D Conversion Price”). The conversion of Series D Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series D Preferred. If the average of the VWAPs (as defined in the Series D Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series D Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series D Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends. During the year ended December 31, 2023, the Company issued 151,347 shares of common stock for payment of Series D Preferred Stock dividends. During the year ended December 31, 2022, the Company entered into various agreements with Series D Preferred shareholders, pursuant to which each holder separately agreed to exchange their Series D Preferred shares into the Company’s common shares (in accordance with their existing Series D Preferred Share Agreements). In addition, the holders agreed to exchange 650,000 common stock warrants with a strike price of $0.25 for 650,000 warrants with a strike price of $0.20, which were required to be immediately exercised. The Company received $130,000 from the holders for exercises of the aforementioned warrants. During the year ended December 31, 2022, the Company issued (1) 975,000 common stock shares for the conversion of 325 shares of Series D Preferred Stock, and (2) 81,973 shares of common stock for the payment of accrued Series D Preferred Stock dividends. As of December 31, 2023 and 2022, the Company had accrued dividends for Series D preferred shares of $8,360 and $8,213, respectively. Series E Convertible Preferred Stock The board designated 5,000 shares of preferred stock as Series E Preferred Stock, 883 and 888 of which remained outstanding as of December 31, 2023 and 2022, respectively. Each share of Series E Preferred is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series E Certificate of Designation (the “Series E Conversion Price”). The conversion of Series E Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder of the Series E Preferred. If the average of the VWAPs (as defined in the Series E Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series E Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series E Preferred, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. Each share of Series E Preferred Stock has a par value of $0.001 per share and a stated value equal to $1,000, subject to the increase set forth in its Certificate of Designation. Each holder of Series E Preferred Stock is entitled to receive cumulative dividends of 8% per annum, payable annually in cash or, at the option of the Company, shares of common stock. During the year ended December 31, 2023, the Company issued (1) 20,000 shares of common stock for the conversion of 5 shares of Series E Convertible Preferred Stock, and (2) 378,294 shares of common stock for payment of Series E Preferred Stock dividends. During the year ended December 31, 2022, the Company issued (1) 3,390,000 common stock shares for the conversion of 847.5 shares of Series E Convertible Preferred Stock, and (2) 179,858 common stock shares for the payment of Series E Preferred Stock dividends. As of December 31, 2023 and 2022, the Company had accrued dividends of $30,272 and $30,414 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 and 1,056 of which were issued and outstanding as of December 31, 2023 and 2022, respectively. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $1,436,000 the Company issued 1,436 shares of Series F Convertible Preferred Stock. Each Series F Preferred share is convertible into 4,000 shares of common stock. The Series F Convertible Preferred Stock is entitled to cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F Convertible Preferred Stock is $1,000. Each share of Series F Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F Certificate of Designation (the “Series F Conversion Price”). The conversion of Series F Preferred Stock is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F Preferred, for cash in an amount equal to aggregate stated value then outstanding plus accrued but unpaid dividends. During the year ended December 31, 2023, the Company issued 200,000 shares of common stock for the conversion of 50 shares of Series F Convertible Preferred Stock and 233,308 shares of common stock for payment of annual Series F Convertible Preferred Stock dividends. During the year ended December 31, 2022, the Company issued 1,480,000 shares of common stock for the conversion of 370 shares of Series F Preferred stock and 163,214 shares of common stock for the payment of annual Series F Preferred Stock dividends. During the year ended December 31, 2022, the Company also issued 255,401 shares of common stock for the payment of a one-time, non-recurring 15% dividend to the Series F Preferred shareholders (as required by the Series F Certificate of Designation, in the event the Company did not uplist to the NASDAQ stock exchange or file its clinical data intended for FDA approval of LuViva by December 31, 2021). As of December 31, 2023 and 2022, the Company had accrued dividends of $46,108 and $48,400 for the Series F Convertible Preferred Stock, respectively. Series F-2 Convertible Preferred Stock The Company was oversubscribed for its Series F Preferred Stock, resulting in the requirement to file an additional Certificate of Designation for Series F-2 Preferred Stock with substantially the same terms as the Series F Preferred Stock. The Board designated 3,500 shares of preferred stock as Series F-2 Preferred Stock, 520 and 535 of which were issued and outstanding as of December 31, 2023 and 2022, respectively. During 2021, the Company entered into a Stock Purchase Agreement with certain accredited investors. In total, for $678,000 the Company issued 678 shares of Series F-2 Preferred Stock. In addition, the Company exchanged outstanding debt of $2,559,000 for 2,559 shares of Series F-2 Preferred Stock. Each Series F-2 Preferred share is convertible into 4,000 shares of common stock. The Series F-2 Preferred Stock will have cumulative dividends at the rate per share of 6% per annum. The stated value on the Series F-2 Preferred Stock is $1,000. Each share of Series F-2 Preferred Stock is convertible, at any time for a period of 5 years after issuance, into that number of shares of Common Stock, determined by dividing the Stated Value by $0.25, subject to certain adjustments set forth in the Series F-2 Certificate of Designation (the “Series F-2 Conversion Price”). The conversion of Series F-2 Preferred is subject to a 4.99% beneficial ownership limitation, which may be increased to 9.99% at the election of the holder. If the average of the VWAPs (as defined in the Series F-2 Certificate of Designation) for any consecutive 5 trading day period (“Measurement Period”) exceeds 200% of the then Series F-2 Conversion Price and the average daily trading volume of the Common Stock on the primary trading market exceeds 1,000 shares per trading day during the Measurement Period (subject to adjustments), the Company may redeem the then outstanding Series F-2 Preferred Stock, for cash in an amount equal to aggregate Stated Value then outstanding plus accrued but unpaid dividends. During the year ended December 31, 2023, the Company issued 60,000 shares of common stock for the conversion of 15 shares of Series F-2 Preferred Stock and 120,284 shares of common stock for payment of annual Series F-2 Preferred Stock dividends. During the year ended December 31, 2022, the Company issued 10,808,000 shares of common stock for the conversion of 2,702 shares of Series F-2 Preferred stock and 114,304 shares of common stock for the payment of annual Series F-2 Preferred Stock dividends. During the year ended December 31, 2022, the Company also issued 368,505 shares of common stock for the payment of a one-time, non-recurring 15% dividend to the Series F-2 Preferred shareholders (as required by the Series F-2 Certificate of Designation, in the event the Company did not uplist to the NASDAQ stock exchange or file its clinical data intended for FDA approval of LuViva by December 31, 2021). As of December 31, 2023 and 2022, the Company had accrued dividends of $23,579 and $24,267 for the Series F-2 Convertible Preferred Stock, respectively. Series G Convertible Preferred Stock During January 2021, the board designated 1,000 shares of preferred stock as Series G Convertible Preferred Stock, none of which remained outstanding as of December 31, 2023 and 2022. The Series G Convertible Preferred Stock had a mandatory redemption feature and was fully redeemed prior to January 1, 2022. Warrants The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the years ended December 31, 2023 and 2022: Warrants (Underlying Shares) Weighted-Average Exercise Price Per Share Outstanding, December 31, 2021 27,669,634 $ 0.29 Warrants issued 24,223,080 $ 0.54 Warrants cancelled/expired (4,450,866 ) $ 0.54 Warrants exchanged (8,775,000 ) $ 0.19 Warrants exercised (3,079,868 ) $ 0.17 Outstanding, December 31, 2022 35,586,980 $ 0.46 Warrants issued 8,782,730 $ 0.22 Warrants cancelled/expired (9,545,200 ) $ 0.30 Warrants exchanged (3,257,200 ) $ 0.25 Warrants exercised (2,982,730 ) $ 0.15 Outstanding, December 31, 2023 28,584,580 $ 0.50 Warrant Transactions – 2023 On May 14, 2023, the Compensation Committee of the Company’s Board of Directors approved the issuance of 4,000,000 common stock warrants to Mark Faupel, upon his appointment to the Company’s Board as President and Chief Executive Officer on March 10, 2023. The warrants, which have a strike price of $0.25, are fully vested and will expire on May 13, 2028. During the year ended December 31, 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 December 31, 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 year ended December 31, 2023, the Company issued 1,800,000 warrants to Richard Blumberg, a related party, pursuant to a consulting agreement. See Note 7, “Commitments and Contingencies” During the year ended December 31, 2023, the Company entered into various agreements with holders of the Company’s $0.25 strike price warrants (including Richard Blumberg, a related party), pursuant to which each holder separately agreed to exchange 1,025,000 common stock warrants with a strike price of $0.25 for 973,750 common stock warrants with a strike price of $0.20. During the year ended December 31, 2023, the Company received approximately $194,750 from the holders for the exercise of the 973,750 warrants. The Company measured the effect of the exchange as the excess of fair value of the exchanged instruments over the fair value of the original instruments and recorded a deemed dividend of approximately $65,296. During the year ended December 31, 2023, the Company entered into agreements with Richard Blumberg (a Director of the Company) and Lee Bowles who were holders of 2,232,200 common stock warrants with a strike price of $0.25. The parties agreed to exchange their warrants for 2,008,980 common stock warrants with a strike price of $0.12 and a contractual term of 5 days. During November 2023, the Company received approximately $241,078 from the holders and issued 2,008,980 common shares upon exercise of the 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 $33,676. Management estimated the fair value of the warrants issued during the year ended December 31, 2023 utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions: Expected term 2.9 Years Volatility 241.2 % Risk-free interest rate 3.3 % Dividend yield 0.0 % Warrant Transactions – 2022 During the year ended December 31, 2022, the Company issued 13,423,080 warrants to investors (see “ Sales of Securities - 2022” During the year ended December 31, 2022, the Company exchanged 8,775,000 warrants for 7,800,000 newly issued warrants in accordance with an exchange agreement with Auctus. See Note 9, “ Auctus Convertible Debt” During the year ended December 31, 2022, the Company issued 3,000,000 warrants to consultants as consideration for performing services. The expense for such warrants will be recognized on a pro-rata basis over the term of their respective agreements. Management estimated the fair value of the warrants issued during the year ended December 31, 2022 utilizing the Black-Scholes Option Pricing model with the following weighted-average assumptions: Expected term 3.8 Years Volatility 148.4 % Risk-free interest rate 3.6 % Dividend yield 0.0 % During the year ended December 31, 2022, the Company issued 5,127,923 common shares for warrants exercised, 2,193,599 of which were for warrants exercised prior to December 31, 2021. As of December 31, 2022, the Company had received approximately $36,386 of proceeds for the exercise of 145,544 warrants, which was included in Accrued Liabilities as of December 31, 2022 pending issuance of the common shares. |