PROVECTUS BIOPHARMACEUTICALS, INC. 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36457 PROVECTUS BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 90-0031917 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 800 S. Gay Street , Suite 1610 Knoxville , Tennessee 37929 (Address of principal executive offices) (Zip Code) 866 - 594-5999 (Registrant’s telephone number, including area code) Not Applicable (Former name, former address, and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered None N/A N/A Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No The number of shares outstanding of the registrant’s common stock, par value $ 0.001 per share, as of August 12, 2024, was 419,906,859 . TABLE OF CONTENTS Page PART I - FINANCIAL INFORMATION Cautionary Note Regarding Forward-Looking Statements 1 Item 1. Financial Statements (unaudited) 2 Condensed Consolidated Balance Sheets 2 Condensed Consolidated Statements of Operations 3 Condensed Consolidated Statements of Comprehensive Loss 4 Condensed Consolidated Statements of Changes in Stockholders’ Deficit 5 Condensed Consolidated Statements of Cash Flows 7 Notes to Condensed Consolidated Financial Statements 8 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 17 Item 3. Quantitative and Qualitative Disclosures About Market Risk 27 Item 4. Controls and Procedures 27 PART II - OTHER INFORMATION Item 1. Legal Proceedings 28 Item 1A. Risk Factors 28 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 28 Item 3. Defaults Upon Senior Securities 28 Item 4. Mine Safety Disclosures 28 Item 5. Other Information 28 Item 6. Exhibits 29 SIGNATURES 30 Cautionary Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “predict,” “project,” “should,” “strategy,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements after this date, unless otherwise required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”) (including those described in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2023), and: ● The uncertainty of generating (i) sales from rose bengal sodium-based drug candidates (if and when approved), such as PV-10 ® and PH-10 ® , and/or any other halogenated xanthene-based drug candidates (if and when approved), (ii) licensing, milestone, royalty, and/or other payments related to these drug candidates, and/or (iii) payments from the Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual property relating to these drug candidates and/or rose bengal sodium- and other halogenated xanthene-based active pharmaceutical ingredients; ● The uncertainty of raising additional capital through the proceeds of private placement transactions of debt and/or equity securities, the exercise of existing warrants and outstanding stock options, and/or public offerings of debt and/or equity securities; and ● The disruptions from the widespread outbreak of an illness or communicable/infectious disease, such as severe acute respiratory syndrome coronavirus 2, or another public health crisis to our business that could adversely affect our operations and financial condition. 1 PART I - FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS. PROVECTUS BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS June 30, December 31, 2024 2023 (Unaudited) Assets Current Assets: Cash $ 29,581 $ 76,576 Restricted cash 559,702 950,223 Short-term receivables 767 476 Prepaid expenses and other current assets 210,194 337,522 Total Current Assets 800,244 1,364,797 Equipment and furnishings, less accumulated depreciation of $ 115,455 and $ 110,994 , respectively 7,559 12,020 Operating lease right-of-use asset 48,624 72,026 Total Assets $ 856,427 $ 1,448,843 Liabilities and Stockholders’ Deficit Current Liabilities: Accounts payable $ 1,321,947 $ 1,675,891 Unearned grant revenue 460,185 953,248 Other accrued expenses 3,388,425 3,240,436 Accrued interest 62,076 22,600 Accrued interest - related parties 89,030 123,828 Accrued interest 89,030 123,828 Notes payable 109,862 277,815 Convertible notes payable 1,153,000 800,000 Convertible notes payable - related parties 1,735,000 1,875,000 Convertible notes payable 1,735,000 1,875,000 Operating lease liability, current portion 49,975 48,077 Total Current Liabilities 8,369,500 9,016,895 Operating lease liability, non-current portion - 25,299 Total Liabilities 8,369,500 9,042,194 Commitments, contingencies, and litigations (Note 12) - - Stockholders’ Deficit: Preferred stock; par value $ 0.001 per share; 25,000,000 shares authorized; Series D Convertible Preferred Stock; 957,100 and 12,374,000 shares designated at June 30, 2024 and December 31, 2023, respectively; 956,985 and 12,373,247 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $ 1,095,556 and $ 14,164,889 at June 30, 2024 and December 31, 2023, respectively 957 12,373 Series D-1 Convertible Preferred Stock; 23,042,900 and 11,241,000 shares designated at June 30, 2024 and December 31, 2023, respectively; 12,002,888 and 10,361,097 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $ 137,408,291 and $ 118,613,136 at June 30, 2024 and December 31, 2023, respectively 12,003 10,361 Preferred stock, value 12,003 10,361 Common stock; par value $ 0.001 per share; 1,000,000,000 shares authorized; 419,522,119 shares issued and outstanding at June 30, 2024 and December 31, 2023 419,522 419,522 Additional paid-in capital 246,156,198 244,714,967 Accumulated other comprehensive loss ( 60,454 ) ( 60,165 ) Accumulated deficit ( 254,041,299 ) ( 252,690,409 ) Total Stockholders’ Deficit ( 7,513,073 ) ( 7,593,351 ) Total Liabilities and Stockholders’ Deficit $ 856,427 $ 1,448,843 See accompanying notes to condensed consolidated financial statements. 2 PROVECTUS BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) 2024 2023 2024 2023 For the Three Months Ended For the Six Months Ended June 30, June 30, 2024 2023 2024 2023 Grant Revenue $ 254,991 $ 161,842 $ 493,063 $ 366,867 Operating Expenses: Research and development 472,927 434,214 1,028,462 982,607 General and administrative 576,918 527,831 706,720 966,676 Total Operating Expenses 1,049,845 962,045 1,735,182 1,949,283 Total Operating Loss ( 794,854 ) ( 800,203 ) ( 1,242,119 ) ( 1,582,416 ) Other Income/(Expense): Research and development tax credit 9,301 15,965 9,301 15,965 Interest expense ( 61,295 ) ( 50,824 ) ( 118,072 ) ( 96,065 ) Total Other Expense, Net ( 51,994 ) ( 34,859 ) ( 108,771 ) ( 80,100 ) Net Loss $ ( 846,848 ) $ ( 835,062 ) $ ( 1,350,890 ) $ ( 1,662,516 ) Basic and Diluted Loss Per Common Share $ ( 0.00 ) $ ( 0.00 ) $ ( 0.00 ) $ ( 0.00 ) Weighted Average Number of Common Shares Outstanding - Basic and Diluted 419,522,119 419,497,119 419,522,119 419,497,119 See accompanying notes to condensed consolidated financial statements. 3 PROVECTUS BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) 2024 2023 2024 2023 For the Three Months Ended For the Six Months Ended June 30, June 30, 2024 2023 2024 2023 Net Loss $ ( 846,848 ) $ ( 835,062 ) $ ( 1,350,890 ) $ ( 1,662,516 ) Other Comprehensive Loss: Foreign currency translation adjustments 126 ( 278 ) ( 289 ) ( 87 ) Total Comprehensive Loss $ ( 846,722 ) $ ( 835,340 ) $ ( 1,351,179 ) $ ( 1,662,603 ) See accompanying notes to condensed consolidated financial statements. 4 PROVECTUS BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT (Unaudited) FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 Shares Amount Shares Amount Shares Amount Capital Loss Deficit Total Accumulated Preferred Stock Preferred Stock Additional Other Series D Series D-1 Common Stock Paid-In Comprehensive Accumulated Shares Amount Shares Amount Shares Amount Capital Loss Deficit Total Balance at January 1, 2024 12,373,247 $ 12,373 10,361,097 $ 10,361 419,522,119 $ 419,522 $ 244,714,967 $ ( 60,165 ) $ ( 252,690,409 ) $ ( 7,593,351 ) Conversion of 2021 Note to Series D1 Preferred Stock - - 226,474 226 - - 647,935 - - 648,161 Comprehensive loss: Net loss - - - - - - - - ( 504,042 ) ( 504,042 ) Other comprehensive loss - - - - - - - ( 415 ) - ( 415 ) Balance at March 31, 2024 12,373,247 $ 12,373 10,587,571 $ 10,587 419,522,119 $ 419,522 $ 245,362,902 $ ( 60,580 ) $ ( 253,194,451 ) $ ( 7,449,647 ) Forfeited shares of Series D Preferred Stock ( 11,416,262 ) ( 11,416 ) - - - - 11,416 - - - Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock - - 1,141,626 1,141 - - ( 1,141 ) - - - Conversion of 2021 Note to Series D1 Preferred Stock - - 273,691 274 - - 783,021 - - 783,296 Comprehensive loss: Net loss - - - - - - - - ( 846,848 ) ( 846,848 ) Other comprehensive income - - - - - - - 126 - 126 Balance at June 30, 2024 956,985 $ 957 12,002,888 $ 12,003 419,522,119 $ 419,522 $ 246,156,198 $ ( 60,454 ) $ ( 254,041,299 ) $ ( 7,513,073 ) 5 FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 Shares Amount Shares Amount Shares Amount Capital Loss Deficit Total Accumulated Preferred Stock Preferred Stock Additional Other Series D Series D-1 Common Stock Paid-In Comprehensive Accumulated Shares Amount Shares Amount Shares Amount Capital Loss Deficit Total Balance at January 1, 2023 12,373,247 $ 12,373 9,746,626 $ 9,747 419,497,119 $ 419,497 $ 242,954,193 $ ( 35,679 ) $ ( 249,588,641 ) $ ( 6,228,510 ) Conversion of 2021 Note to Series D-1 Preferred Stock - - 18,872 18 - - 53,992 - - 54,010 Comprehensive loss: Net loss - - - - - - - - ( 827,454 ) ( 827,454 ) Other comprehensive income - - - - - - - 191 - 191 Balance at March 31, 2023 12,373,247 $ 12,373 9,765,498 $ 9,765 419,497,119 $ 419,497 $ 243,008,185 $ ( 35,488 ) $ ( 250,416,095 ) $ ( 7,001,763 ) Balance 12,373,247 $ 12,373 9,765,498 $ 9,765 419,497,119 $ 419,497 $ 243,008,185 $ ( 35,488 ) $ ( 250,416,095 ) $ ( 7,001,763 ) Conversion of 2021 Note to Series D-1 Preferred Stock - - 188,757 189 - - 540,033 - - 540,222 Comprehensive loss: Net loss - - - - - - - - ( 835,062 ) ( 835,062 ) Other comprehensive loss - - - - - - - ( 278 ) - ( 278 ) Balance at June 30, 2023 12,373,247 $ 12,373 9,954,255 $ 9,954 419,497,119 $ 419,497 $ 243,548,218 $ ( 35,766 ) $ ( 251,251,157 ) $ ( 7,296,881 ) Balance 12,373,247 12,373 9,954,255 9,954 419,497,119 419,497 243,548,218 ( 35,766 ) ( 251,251,157 ) ( 7,296,881 ) See accompanying notes to condensed consolidated financial statements. 6 PROVECTUS BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) 2024 2023 For the Six Months Ended June 30, 2024 2023 Cash Flows From Operating Activities: Net loss $ ( 1,350,890 ) $ ( 1,662,516 ) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash lease expense 23,402 22,272 Depreciation 4,461 4,461 Changes in operating assets and liabilities Short term receivables ( 299 ) ( 1,366 ) Prepaid expenses and other current assets 127,328 314,165 Accounts payable ( 353,763 ) ( 104,704 ) Unearned grant revenue ( 493,063 ) ( 366,866 ) Other accrued expenses 148,011 483,019 Operating lease liability ( 23,401 ) ( 21,597 ) Accrued interest 111,134 91,239 Net Cash Used In Operating Activities ( 1,807,080 ) ( 1,241,893 ) Cash Flows From Financing Activities: Proceeds from issuance of convertible notes payable 353,000 - Proceeds from issuance of convertible notes payable - related parties 1,285,000 1,325,000 Repayment of short-term note payable ( 167,953 ) ( 152,856 ) Repayment of 2021 convertible note payable - related party ( 100,000 ) - Proceeds from exercise of warrants - - Net Cash Provided By Financing Activities 1,370,047 1,172,144 Effect of exchange rates on cash and restricted cash ( 483 ) ( 2,799 ) Net Decrease In Cash and Restricted Cash ( 437,516 ) ( 72,548 ) Cash and Restricted Cash, Beginning of Period 1,026,799 1,431,707 Cash and Restricted Cash, End of Period $ 589,283 $ 1,359,159 Cash and restricted cash consisted of the following: Cash $ 29,581 $ 176,010 Restricted cash 559,702 1,183,149 Cash and Restricted Cash, End of Period $ 589,283 $ 1,359,159 Supplemental Disclosures of Cash Flow Information: Cash paid during the period for: Interest $ - $ - Income taxes $ - $ - Non-cash investing and financing activities: Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock $ - $ 594,232 Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock $ 1,431,457 $ - Forfeited shares of Series D Preferred Stock $ ( 11,416 ) $ - Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock $ 1,141 $ - Purchase of insurance policies financed by short-term note payable $ - $ ( 61,735 ) See accompanying notes to condensed consolidated financial statements. 7 PROVECTUS BIOPHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 1. Business Organization, Nature of Operations and Basis of Presentation Provectus Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases based on a class of synthetic small molecule halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal sodium (“RBS”). The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug candidates of our current clinical development programs and the non-clinical formulations of our current non-clinical proof-of-concept in vivo and early discovery programs. Importantly, our pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The Company believes that RBS targets disease in a bifunctional multi-modal manner. Direct contact by RBS may lead to cell death or repair, depending on the disease being treated and the concentration of RBS utilized in the treatment formulation, by one or more targeting mechanisms. Multivariate innate and adaptive immune activation, signaling, and response may follow that may manifest as stimulatory, inhibitory, or both. The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such as those trials reported on the clinical trials registry at ClinicalTrials.gov. The Company believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%. The Company’s small molecule medical science platform comprises several different drug candidates and non-clinical targets using different concentrations delivered by different routes of administration specific to each disease area and/or disease indication, including: ● Clinical development programs in oncology (intratumoral administration), dermatology (topical), and ophthalmology (topical), ● Proof-of-concept in vivo programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral), and ● Early discovery programs ( in vitro ) in infectious diseases and tissue regeneration and repair. Risks and Uncertainties The Company’s activities are subject to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription drug candidates. 8 Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be reviewed in conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10-K for the year ended December 31, 2023 filed with the SEC on March 28, 2024. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. 2. Liquidity and Going Concern To date, the Company has not generated any revenues or profits from planned principal operations. The Company’s cash and restricted cash were $ 589,283 at June 30, 2024 which includes $ 559,702 of restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficit was $ 7,569,256 and $ 7,652,098 as of June 30, 2024 and December 31, 2023, respectively, net loss for the six months ended June 30, 2024 and 2023 was $ 1,350,890 and $ 1,662,516 , respectively, and cash used in operations was $ 1,807,080 and $ 1,241,893 for the six months ended June 30, 2024 and 2023, respectively. The Company continues to incur significant operating losses. Management expects that significant on-going operating expenditures will be necessary to successfully implement the Company’s business plan and develop and market its products. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to develop PV-10, PH-10, and/or any other halogenated xanthene-based drug products, and to raise additional capital. The Company plans to access capital resources through possible public or private equity offerings, including the 2024 financing (see Note 13), exchange offers, debt financings, corporate collaborations, or other means. In addition, the Company continues to explore opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions, although there can be no assurance that the Company will be successful with such plans. The Company has historically been able to raise capital through equity offerings, although there can be no assurance that it will continue to be successful in the future. If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due. The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, there can be no assurance that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other halogenated xanthene-based drug candidate developed by the Company or entering into any financial transaction. Moreover, even if the Company is successful in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements in 2024 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While the Company believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, there can be no assurance that it will be able to obtain funds on commercially acceptable terms, or complete additional financing in a timely manner. Any such financing may result in significant dilution to stockholders. These factors raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that may be necessary should we be unable to continue as a going concern. Our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate our continuation as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent realizable or settlement values. 9 3. Significant Accounting Policies Since the date the Company’s December 31, 2023 consolidated financial statements were issued in its 2023 Annual Report on March 28, 2024, there have been no material changes to the Company’s significant accounting policies. Principles of Consolidation Intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates, judgments 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. The Company’s significant estimates and assumptions include the recoverability and useful lives of long-lived assets, accrued liabilities, and the valuation allowance related to the Company’s deferred tax assets. Restricted Cash Restricted cash consists of a grant award received from the State of Tennessee. Restricted cash available as of June 30, 2024 is $ 559,702 . See Note 10, Grants. Cash Concentrations Cash and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits of $ 250,000 , although the Company seeks to minimize this through treasury management. The Company has never experienced any losses related to these balances although there can be no assurance that it will not experience any losses in the future. As of June 30, 2024 and December 31, 2023, the Company had cash and restricted cash balances in excess of FDIC insurance limits of $ 339,283 and $ 776,799 , respectively. 10 Basic and Diluted Loss Per Common Share Basic loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the period. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive: Schedule of Securities Excluded from Calculation of Weighted Average Dilutive Common Shares June 30, 2024 2023 Warrants - 475,000 Options 3,225,000 3,425,000 Convertible preferred stock 120,985,865 111,915,797 2021 unsecured convertible notes 505,746 2,022,750 2022 unsecured convertible notes 10,113,074 7,485,783 Total potentially dilutive shares 134,829,685 125,324,330 Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07 “ Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures .” These amendments require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reporting segment are required to provide both the new disclosures and all of the existing disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09. 4. Other Accrued Expenses The following table summarizes the other accrued expenses at June 30, 2024 and December 31, 2023: Schedule of Other Accrued Expenses June 30, December 31, 2024 2023 Accrued payroll and taxes $ 1,037,118 $ 719,460 Accrued vacation 109,706 92,985 Accrued directors’ fees 2,054,339 2,330,589 Accrued other expenses 187,262 97,402 Total other accrued expenses $ 3,388,425 $ 3,240,436 11 5. Convertible Notes Payable The following summarizes convertible notes payable activity during the six months ended June 30, 2024: 2021 Financing Schedule of Convertible Notes Payable Non-Related Party Related Party Face Amount Face Amount Total Balance as of January 1, 2024 $ - $ 200,000 $ 200,000 Repayment - ( 100,000 ) ( 100,000 ) Balance as of June 30, 2024 $ - $ 100,000 $ 100,000 2022 Financing Non-Related Party Related Party Face Amount Face Amount Total Balance as of January 1, 2024 $ 800,000 $ 1,675,000 $ 2,475,000 Issued 353,000 1,285,000 1,638,000 Conversion - ( 1,325,000 ) ( 1,325,000 ) Balance as of June 30, 2024 $ 1,153,000 $ 1,635,000 $ 2,788,000 Balance $ 1,153,000 $ 1,635,000 $ 2,788,000 On July 11, 2024, the Board approved the closure of the 2022 Financing. Through June 30, 2024, the Company received 2022 Notes proceeds in the aggregate amount of $ 4,865,500 , of which $ 3,637,500 is from a related party investor (a Company officer/director). For further details on the terms of the 2021 and 2022 Notes, refer to our Form 10-K as filed with the SEC on March 28, 2024. 12 2024 Repayment of 2021 Notes During the six months ended June 30, 2024, the Company repaid $ 100,000 principal owed on the 2021 Note. As of June 30, 2024, principal and interest in the amount of $ 100,000 and $ 44,744 , respectively, remains outstanding on the 2021 Note. 2024 Conversions of 2022 Notes into Preferred Stock During the three months ended June 30, 2024, principal and interest in the aggregate amount of $ 783,296 , owed in connection with the 2022 Notes were converted into 273,691 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock. During the six months ended June 30, 2024, principal and interest in the aggregate amount of $ 1,431,457 , owed in connection with the 2022 Notes were converted into 500,165 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock. 6. Notes Payable The Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of June 30, 2024 and December 31, 2023, the balance of the note payable was $ 109,862 and $ 277,815 , respectively. 7. Related Party Transactions During the three months ended June 30, 2024 and 2023, the Company had consulting fees of $ 0 and $ 63,600 , respectively, to Mr. Bruce Horowitz (Capital Strategists) for services rendered. During the six months ended June 30, 2024 and 2023, the Company had consulting fees of $ 63,600 and $ 127,200 , respectively. As of March 25, 2024, Mr. Horowitz resigned as COO and member of the Board. On March 26, 2024, the Company paid Mr. Horowitz $ 250,000 and on June 27, 2024, the Company paid $ 258,000 for outstanding consulting fees. Mr. Horowitz waived the amount of $ 469,000 due to him in directors’ fees. See Note 5 for details of other related party transactions. Directors’ fees incurred during the three months ended June 30, 2024 and 2023, were $ 77,500 and $ 96,250 , respectively. Directors’ fees incurred during the six months ended June 30, 2024 and 2023, were $ 173,750 and $ 192,500 , respectively. Accrued directors’ fees as of June 30, 2024 and December 31, 2023 were $ 2,054,339 and $ 2,330,589 , respectively. 8. Stockholders’ Deficit Preferred Stock During the three months ended June 30, 2024, the Company issued 273,691 shares of Series D-1 Convertible Preferred Stock upon the conversion of $ 725,000 of principal and $ 58,294 accrued interest outstanding on the 2022 Notes. During the six months ended June 30, 2024, the Company issued 500,165 shares of Series D-1 Convertible Preferred Stock upon the conversion of $ 1,325,000 of principal and $ 106,457 accrued interest outstanding on the 2022 Notes. On June 21, 2024, the Board of Directors approved the conversion of 11,416,242 Series D Preferred Shares held by Dominic Rodrigues (a Company officer and director) into 1,141,626 shares of Series D-1 Preferred shares. Number of Preferred Shares On June 24, 2024, the Company filed an amended Series D Certificate of Designation to decrease the authorized shares from 12,374,000 to 957,100 shares of Series D Convertible Preferred Stock. The Series D-1 Certificate of Designation was also amended to increase the authorized shares from 9,441,000 to 23,042,900 shares of Series D-1 Convertible Preferred Stock. 2024 Equity Compensation Plan At the shareholder meeting held on June 20, 2024, the proposal for the new 2024 Equity Compensation Plan was approved. The approval gives the Company authority to grant Options and award Restricted Stock under the 2024 Equity Compensation Plan for up to 100,000,000 shares of our common stock, which are approximately fifteen percent ( 15 %) of the issued and outstanding shares of Common Stock on an as converted basis as of the effective date of the 2024 Equity Compensation Plan. Options During the three and six months ended June 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of options. The following table summarizes option activities during the six months ended June 30, 2024: Schedule of Option Activity Weighted Average Weighted Average Remaining Aggregate Intrinsic Shares Exercise Price Life in Years Value Outstanding and exercisable at January 1, 2024 3,225,000 $ 0.27 $ - Expired - - Outstanding and exercisable at June 30, 2024 3,225,000 $ 0.27 1.40 $ - 13 The following table summarizes information about options outstanding and exercisable at June 30, 2024: Summary of Stock Options Outstanding Exercise Price Outstanding and Exercisable Weighted Average Remaining Contractual Life Intrinsic Value $ 0.12 2,425,000 1.40 $ 14,550 $ 0.29 100,000 1.40 $ - $ 0.75 550,000 1.50 $ - $ 0.88 150,000 0.10 $ - 3,225,000 1.40 $ 14,550 Warrants During the three and six months ended June 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of warrants. The following table summarizes warrant activities during the six months ended June 30, 2024: Schedule of Warrant Activity Number of Weighted Average Weighted Average Remaining Aggregate Intrinsic Warrants Exercise Price Life in Years Value Outstanding and exercisable at January 1, 2024 412,500 $ 1.07 Expired ( 412,500 ) 1.07 Outstanding and exercisable at June 30, 2024 - $ - - $ - 14 Annual Stockholder Meeting Proposals The Company held its annual meeting of stockholders on June 20, 2024. Stockholders authorized the Company’s board of directors (the “Board”) to amend the Company’s Certificate of Incorporation, as amended by the Certificate of Designation of Series D Convertible Preferred Stock and Certificate of Designation of Series D-1 Convertible Preferred Stock (the “Certificates of Designation”), to effect a reverse stock split of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible Preferred Stock at a ratio of between 1-for-10 and 1-for-50 , where the ratio would be determined by the Board at its discretion, and to make corresponding amendments to the Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse stock split, consistent with the Board’s recommendation. The Company’s stockholders also authorized the Board to amend the Company’s Certificate of Incorporation, as amended by the Certificates of Designation, to decrease the number of authorized shares of the Company’s common stock and preferred stock by the same reverse stock split ratio determined by the Board, consistent with the Board’s recommendation. The Board has not acted on these stockholder authorizations as of the filing date. 9. Leases On June 18, 2022, the Company leased 2,700 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of three years ending on June 30, 2025. The monthly base rent ranges from $ 4,053 to $ 4,278 over the term of the lease. Total operating lease expense for the three months ended June 30, 2024 was $ 13,002 , of which $ 8,668 was included within research and development and $ 4,334 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the three months ended June 30, 2023 was $ 12,672 of which $ 8,448 was included within research and development and $ 4,224 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the six months ended June 30, 2024 was $ 25,844 , of which $ 17,229 was included within research and development and $ 8,615 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the six months ended June 30, 2023 was $ 26,179 of which $ 17,453 was included within research and development and $ 8,726 was included within general and administrative expenses on the condensed consolidated statements of operations. A summary of the Company’s right-of-use assets and liabilities is as follows: Schedule of Right-of-use Assets and Liabilities For the Six Months Ended June 30, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating leases $ 23,402 $ 21,597 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ - $ - Weighted Average Remaining Lease Term Operating leases 1 year 2 years Weighted Average Discount Rate Operating leases 5.0 % 5.0 % Future minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2024 were as follows: Future Minimum Payments Schedule of Future Minimum Payments Under Non-cancellable Lease Years Amount 2024 $ 25,669 2025 25,669 Total lease payments 51,338 Less: amount representing imputed interest ( 1,363 ) Present value of lease liability 49,975 Less: current portion ( 49,975 ) Lease liability, non-current portion $ - 10. Grants On October 25, 2021, the Company received a grant award of $ 2,500,000 from the State of Tennessee for the study of animal cancers and dermatological disorders for the period October 15, 2021 to June 30, 2022 (the “Tennessee Grant” or “Grant”). The Tennessee Grant was pre-funded; therefore, the funds do not need to be used in full by June 30, 2022. The Tennessee Grant was provided as reimbursement of research and development expenses related to the development of animal health drug products. The Company has elected gross presentation of the Tennessee Grant income whereby grant revenue is recognized as qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been met. Qualifying costs are presented as research and development expenses included in the Company’s statement of operations, in the period that such costs are incurred. As of June 30, 2024 and December 31, 2023, $ 460,185 and $ 953,248 , respectively, have been recorded as unearned grant revenue liability on the accompanying condensed consolidated balance sheets, respectively. The Company recorded grant revenue of $ 254,991 and $ 493,063 during the three and six months ended June 30, 2024, respectively, and $ 161,842 and $ 366,867 during the three and six months ended June 30, 2023, respectively. 15 11. License Transactions In the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS. On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”) for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”) of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade RBS for the treatment of bacterial, fungal, and viral infections of the eye. The Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company paid $5,000 for the option that expires on May 31, 2023; agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option and up to $25,000 of past UM patent expenses for this IP; and entered into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and TOP PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis. On March 21, 2024, the Company entered into an exclusive worldwide license for the IP. Details of the license agreement are reported in the Company’s Current Report on Form 8-K filed with the SEC on March 27, 2024. 12. Commitments, Contingencies and Litigation The Company may, from time to time, be involved in litigation arising from the ordinary course of business. The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material adverse effect on the Company’s condensed consolidated financial position, results of operations or cash flows. 13. Subsequent Events The Company has evaluated events that have occurred after the balance sheet and through the date the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed below. 2024 Financing On July 11, 2024, the Board approved a Financing Term Sheet (the “2024 Term Sheet”), which set forth the terms under which the Company will use its best efforts to arrange for financing of a maximum of $ 10,000,000 (the “2024 Financing”), which amounts will be obtained in several tranches. Pursuant to the 2024 Term Sheet, the 2024 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve months after the issue date of a 2024 Note, subject to certain exceptions. The 2024 Financing will be in the form of an unsecured convertible loan (the “2024 Loan”) from the investors (the “2024 Loan Investors”) and evidenced by convertible promissory notes (individually, a “2024 Note” and collectively, the “2024 Notes”). In addition to customary provisions, the 2024 Notes will contain the following provisions: (i) The 2024 Loan will bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has been funded to the Company; (ii) In the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the 2024 Notes may be immediately due and payable at the 2024 Loan Investors’ option; (iii) The outstanding principal amount and interest payable under the 2024 Loan may be convertible at the 2024 Loan Investors’ option into shares of Series D-1 Convertible Preferred Stock at a price per share equal to $ 2.8620 . The Series D-1 Convertible Preferred Stock is convertible into ten ( 10 ) shares of common stock; and (iv) The outstanding principal amount and interest payable under the 2024 Loan will be automatically convertible into shares of the Company’s Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note at a price per share equal to $ 2.8620 . For further details on the terms of the 2024 Financing and the details of the 2024 Notes, refer to our Form 8-K as filed with the SEC on July 17, 2024. Convertible Notes Payable Subsequent to June 30, 2024, the Company entered into 2024 Notes with a related party investor (Executive Officer) in the aggregate principal amount of $ 215,000 . Series D-1 Preferred Stock Subsequent to June 30, 2024, principal and interest in the aggregate amount of $ 972,600 , owed in connection with 2022 Notes was converted into 339,833 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. Subsequent to June 30, 2024, a holder of 38,474 shares of Series D-1 Preferred Stock voluntarily converted the Preferred Stock into 384,740 shares of Common Stock. 16 ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in conjunction with the accompanying unaudited condensed financial statements and our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 28, 2024 (“2023 Form 10-K”), which includes additional information about our critical accounting policies and practices and risk factors. Historical results and percentage relationships set forth in the consolidated statement of operations, including trends which might appear, are not necessarily indicative of future operations. Clinical Development and Drug Discovery The Company’s small molecule HX medical science platform, which comprises different drug candidates and non-clinical formulations made from pharmaceutical-grade RBS using different concentrations and delivered by different routes of administration specific to each disease and/or disease indication, includes: Clinical Development Programs ● Oncology: Intratumoral (“ITU”) formulation PV-10 ® (“ITU PV-10”) has undergone and is undergoing multiple, monotherapy and combination therapy, early- to late-stage clinical trials, expanded access programs (“EAPs”) for groups of and individual patients, and/or quality of life (“QOL”) study at multiple clinical sites in Australia, Europe, and the U.S. for the treatments of Stage III and IV melanoma and different types of liver cancers. ITU PV-10 has undergone clinical monotherapy and combination therapy mechanism of action and mechanism of immune response study for melanoma, metastatic uveal melanoma, and metastatic neuroendocrine tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas. ● Dermatology: Topical (“TOP”) formulation PH-10 ® (“TOP PH-10”) has undergone multiple mid-stage, monotherapy clinical trials for the treatments of psoriasis and atopic dermatitis at different clinical sites in the U.S. TOP PH-10 has undergone clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University in New York, New York (“TRU”). Different formulations have undergone non-clinical combination therapy study for psoriasis and are undergoing non-clinical monotherapy study for skin inflammation at TRU. ● Ophthalmology: The Company believes that clinical monotherapy proof-of-concept (“POC”) of TOP administration of non-pharmaceutical grade rose bengal for the treatment of infectious keratitis has been shown by clinicians and researchers at the University of Miami’s Bascom Palmer Eye Institute (“BPEI”) in Miami, Florida, who are now collaborating with the Company to evaluate the potential use of our pharmaceutical-grade RBS. TOP PV-305 has undergone non-clinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis, at BPEI. 17 Non-clinical Proof-of-Concept In Vivo Programs ● Oncology: ITU PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of pancreatic cancer and human papillomavirus-positive and negative head and neck squamous cell carcinoma at Moffitt. ITU PV-10 has undergone non-clinical monotherapy study for the treatment of penile squamous cell carcinoma at an academic medical center. ITU PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of relapsed and refractory pediatric solid tumor cancers at the University of Calgary’s Cumming School of Medicine in Calgary, Canada (“UCal”). The Company believes that the UCal researchers have achieved in vivo monotherapy POC of ITU administration. Oral (“PO”) formulations are undergoing non-clinical monotherapy study for high-risk and refractory adult solid tumor cancers at UCal. The Company believes that the UCal researchers and the Company have both achieved in vivo monotherapy POC of PO administration, that the Company has achieved in vivo monotherapy POC of PO administration in both prophylactic and therapeutic settings, and that the Company has achieved in vivo monotherapy POC of intravenous (“IV”) administration. ● Hematology: PO formulations have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric and other blood cancers, including leukemias, at UCal. The Company believes that the UCal researchers have achieved in vivo monotherapy POC of PO administration. ● Wound Healing: Different formulations are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds. The Company believes that in vivo monotherapy POC of TOP administration of non-pharmaceutical grade rose bengal for the treatment of this indication has been shown by researchers at the University of Texas Medical Branch in Galveston, Texas, who are now collaborating with the Company to use our pharmaceutical-grade RBS. ● Animal Health: Different formulations are undergoing non-clinical monotherapy study for the treatment of canine soft tissue sarcomas at the University of Tennessee’s College of Veterinary Medicine in Knoxville, Tennessee. The Company believes that it has achieved monotherapy POC of ITU administration in canines. Non-clinical Early Drug Discovery (In Vitro) Programs ● Immune vaccine adjuvant: Different formulations have undergone and are undergoing non-clinical study as a vaccine adjuvant to enhance T cell responses for anti-viral and anti-cancer vaccines. ● Infectious Diseases: PO and intranasal (“IN”) formulations have undergone and are undergoing non-clinical monotherapy study for the treatment of SARS-CoV-2 at UCal, another Canadian academic research center, the University of Tennessee Health Science Center (“UTHSC”) in Memphis, Tennessee, and a U.S. contract research organization. Different formulations have undergone non-clinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug resistant strains) and have undergone non-clinical monotherapy study for the treatment of oral bacterial infections at UTHSC. Different formulations have undergone non-clinical monotherapy study for the treatment of fungal infections at UTHSC. ● Tissue Regeneration and Repair : Different formulations have undergone non-clinical monotherapy study for vertebrate development, wound healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada. ● Proprietary: Different formulations are undergoing non-clinical study for a proprietary disease at an academic medical center. 18 Business Strategy The Company is selectively continuing ongoing and planning to initiate new monotherapy and combination therapy ITU PV-10 clinical trials in melanoma and liver cancer indications to generate more and/or new clinical data and appropriately utilizing clinical data from historical ITU PV-10 trials, EAPs, and/or QOL study of these oncology indications. Our goals are to pursue drug approval pathways and/or co-development relationships with commercial pharmaceutical companies for ITU PV-10 based on these indications and data. The Company is developing a systemically administered formulation of pharmaceutical-grade RBS for the treatment of cancer. Our goals, when this work is complete, are to file an investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”), take an initial systemic drug candidate into an early-stage clinic trial for an initial oncology or hematology indication, and/or pursue a co-development collaboration or out-license arrangement for this route of administration and disease area. The Company is developing different formulations of pharmaceutical-grade RBS using different concentrations and different routes of administration (e.g., PO, IV, IN) for other disease areas by endeavoring to show non-clinical activity and lack of toxicity. Our goals, when each task of this work is completed, are to file an IND with the FDA, take an initial drug candidate into an early-stage clinic trial for an initial indication, and/or pursue a co-development collaboration or out-license arrangement for the respective disease area and route of administration. The Company is endeavoring to fully elucidate the traits and characteristics of the RBS molecule using different academic medical centers under sponsored research and testing agreements. Our goal is to gain and communicate additional knowledge of the RBS molecule’s targeting, mechanism, signaling, immune response, and other features that are common to and/or different from each disease area and indication under research. The Company is doing rigorous, chemical analytical comparisons of non-pharmaceutical grades of rose bengal from specialty chemical suppliers against the Company’s pharmaceutical-grade RBS. Our goal is to demonstrate the proprietary nature of the Company’s pharmaceutical-grade RBS and that our pharmaceutical-grade RBS meets the necessary uniformity and purity requirements for commercial pharmaceutical use. 19 RBS API and Drug Candidate Manufacturing Our pharmaceutical-grade RBS resulted from the Company’s innovation of a proprietary, patented, commercial-scale process to synthesize and utilize the RBS molecule into a viable active pharmaceutical ingredient (“API”) for commercial pharmaceutical use; the development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing processes; the production and multi-year stability testing of multiple API and drug candidate lots; the comprehensive documentation of lot composition and reproducibility; and the review and acceptance of CMC data from these lots by seven different national drug regulatory agencies for use in a prior, multi-country, multi-center Phase 3 randomized control trial of the Company. The Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice (“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use. These processes utilize controls that eliminate the formation of historical impurities and avoid the introduction of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported amounts in non-pharmaceutical grades of rose bengal. The Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and ITU PV-10 drug candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of API and drug candidate have been reviewed by multiple national drug regulatory agencies prior to granting clinical trial authorizations for the Company to commence a historical Phase 3 study of ITU PV-10 for the treatment of locally advanced cutaneous melanoma, including the U.S. FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s Therapeutic Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). RBS Non-proprietary Name The RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (“WHO”) Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for the non-proprietary name in the third quarter of 2020 and reached the status of recommended International Non-proprietary Names (“INN”). INN Recommended List 88, which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in the fourth quarter of 2022. 20 Non-Pharmaceutical Grades of Rose Bengal Commercial-Grade This material may be purchased from specialty chemical suppliers in the U.S. and from other parts of the world; however, the Company believes that the material itself is almost exclusively made in China and India under non-cGMP conditions. Commercial grade rose bengal appears to have reported purity that may vary between approximately 80% and 95%, and that may contain substantial amounts of unreported impurities and/or gross contaminants. Commercial grade rose bengal is typically used by researchers unaffiliated with the Company for non-clinical study of the rose bengal molecule for potential biomedical therapeutic applications. We believe that commercial grade rose bengal is still manufactured using the historical process (or a variant thereof) that was developed by the synthetic molecule’s original Swiss creator Rudolph Gnehm in 1881. Some manufacturers may, however, apply purification techniques that the Company believes still result in materials that may possess questionable purity and contaminants and may also be subject to substantial lot-to-lot manufacturing variability. Diagnostic-Grade The Company coined this phrase to describe non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions and strips, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic diagnostic tests such as the rose bengal test in human brucellosis. We presume, but have not yet confirmed, that diagnostic-grade rose bengal is derived from commercial-grade rose bengal that may have undergone a form of purification and/or may have been compounded under cGMP regulations by a pharmacist, academic medical researcher, or commercial entity. Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy of rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability. Chemical Analytical Comparison In the first quarter of 2022, the Company began work with a U.S. contract development and manufacturing organization to assess rigorously and methodically three lots of commercial-grade rose bengal, one each from three different specialty chemical suppliers, and compare these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS. This chemical analytical work was substantially completed by the end of the third quarter of 2022. The Company believes that the preliminary results of these analyses indicate that all three lots of commercial grade rose bengal had rose bengal purity that was drastically different from what was represented on their respective certificates of analysis (“CofAs”), and that one of the three lots contained gross contaminants that were not represented on its CofA. Potential Barriers to Entry The Company believes that the Company’s proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over non-pharmaceutical-grades of rose bengal that researchers, clinicians, and academic, business, and/or governmental competitors have used, are using, and/or may attempt to use for potential biomedical applications. The Company believes that non-pharmaceutical-grades of rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants, substantial lot-to-lot manufacturing variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible, consistent, and fulsome CMC specifications and documentation. The Company believes that historical and potentially hazardous impurities and other manufacturing and handling issues facing non-pharmaceutical grades of rose bengal may pose significant scientific, technological, and economic challenges to overcome and validate for compliance with modern drug regulatory standards. 21 Components of Operating Results Grant Revenue Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as grant revenue when qualifying costs are incurred. Research and Development Expenses A large component of our total operating expenses is the Company’s investment in research and development activities, including the clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake clinical trials to develop our drug candidates. These expenses consist primarily of: ● Costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others; ● Salaries and related expenses for personnel, including stock-based compensation expense; ● Other outside service costs including cost of contract manufacturing; ● The costs of supplies and reagents; and, ● Occupancy and depreciation charges. We expense research and development costs as incurred. Research and development activities are central to our business model. We expect our research and development expenses to increase in the future as we advance our existing product candidates through clinical trials and pursue their regulatory approval. Undertaking clinical development and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent we will generate revenue from any subsequent commercialization and sale of our drug candidates. General and Administrative Expenses General and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for personnel in executive, finance, accounting, business development, legal, information technology and corporate communication functions. Other costs include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, patent and accounting services. 22 Results of Operations Comparison of the Three Months Ended June 30, 2024 and June 30, 2023 Overview Grant revenue was $254,991 for the three months ended June 30, 2024, an increase of $93,149 or 57.6% compared to the three months ended June 30, 2023. Total operating expenses were $1,049,845 for the three months ended June 30, 2024, an increase of $87,800 or 9.1% compared to the three months ended June 30, 2023. The increase was driven primarily by (i) increased payroll and taxes for the addition of two officers, (ii) higher clinical trial costs related to study closure, partially offset by (iii) lower directors’ fees and professional fees due to the resignation of Bruce Horowitz, our former Chief Operating Officer, (iv) lower legal costs related to patents, and (v) lower insurance costs. Net loss for the three months ended June 30, 2024 was $846,848, an increase of $11,786 or 1.4% compared to the three months ended June 30, 2023. For the Three Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Grant Revenue $ 254,991 $ 161,842 $ 93,149 57.6 % Operating Expenses: Research and development 472,927 434,214 38,713 8.9 % General and administrative 576,918 527,831 49,087 9.3 % Total Operating Expenses 1,049,845 962,045 87,800 9.1 % Total Operating Loss (794,854 ) (800,203 ) 5,349 0.7 % Other Income/(Expense): Research and development tax credit 9,301 15,965 (6,664 ) 41.7 % Interest expense (61,295 ) (50,824 ) (10,471 ) -20.6 % Total Other Expense, Net (51,994 ) (34,859 ) (17,135 ) -49.2 % Net Loss $ (846,848 ) $ (835,062 ) $ (11,786 ) -1.4 % Grant Revenue For the three months ended June 30, 2024 and June 30, 2023, there was $254,991 and $161,842, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements of operations. Research and Development Expenses Research and development expenses were $472,927 for the three months ended June 30, 2024, an increase of $38,713 or 8.9% compared to $434,214 for the three months ended June 30, 2023. The increase was primarily due to (i) higher clinical trial costs associated with study closure, and (ii) increased insurance costs. The following table summarizes research and development expenses for the three months ended June 30, 2024 and 2023. For the Three Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Operating Expenses: Research and development: Clinical trial and research expenses $ 339,441 $ 309,284 $ 30,157 9.8 % Depreciation/amortization 1,765 2,043 (278 ) -13.6 % Insurance 57,540 49,356 8,184 16.6 % Payroll and taxes 65,513 65,083 430 0.7 % Rent and utilities 8,668 8,448 220 2.6 % Total research and development $ 472,927 $ 434,214 $ 38,713 8.9 % 23 General and Administrative Expenses General and administrative expenses were $576,918 for the three months ended June 30, 2024, an increase of $49,087 or 9.3% compared to $527,831 for the three months ended June 30, 2023. The increase was primarily due to (i) increased payroll and taxes for the addition of two new officers, and (ii) increased other general and administrative costs, partially offset by (iii) lower directors’ fees and professional fees due to the resignation of Bruce Horowitz, our prior Chief Operating Officer, (iv) lower insurance costs, and (v) lower legal costs related to patents. The following table summarizes general and administrative expenses for the three months ended June 30, 2024 and 2023. For the Three Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Operating Expenses: General and administrative: Depreciation $ 465 $ 188 $ 277 147.3 % Directors’ fees 77,500 96,250 (18,750 ) -19.5 % Insurance 41,684 52,465 (10,781 ) -20.5 % Legal and litigation 136,660 147,525 (10,865 ) -7.4 % Other general and administrative cost 26,636 23,990 2,646 11.0 % Payroll and taxes 170,772 63,594 107,178 168.5 % Professional fees 117,992 138,975 (20,983 ) -15.1 % Rent and utilities 4,846 4,844 2 0.0 % Foreign currency transactions 363 - 363 100.0 % Total general and administrative $ 576,918 $ 527,831 $ 49,087 9.3 % Other Expense, Net Interest expense increased by $10,471 or 20.6% from $50,824 for the three months ended June 30, 2023 to $61,295 for the three months ended June 30, 2024. The increase was mainly due to the interest expense costs incurred in connection with the higher notes payable and convertible debt balances. Research and development tax credit in Australia decreased by $6,664 or 41.7% from $15,965 for the three months ended June 30, 2023 to $9,301 for the three months ended June 30, 2024. The decrease was mainly due to no active clinical trials currently in Australia. Comparison of the Six Months Ended June 30, 2024 and June 30, 2023 Overview Grant revenue was $493,063 for the six months ended June 30, 2024, an increase of $126,196 or 34.4% compared to the six months ended June 30, 2023. Total operating expenses were $1,735,182 for the six months ended June 30, 2024, a decrease of $214,101 or 11.0% compared to the six months ended June 30, 2023. The decrease was driven primarily by (i) reduced directors’ fees and professional fees due to the resignation of Bruce Horowitz, our former Chief Operating Officer, partially offset by (ii) higher clinical trial costs related to study closure, (iii) increased payroll and taxes due to the addition of two new officers, (iv) higher legal costs related to patents and general corporate counsel, and (v) higher other general and administrative cost. Net loss for the six months ended June 30, 2024 was $1,350,890, a decrease of $311,626 or 18.7% compared to the six months ended June 30, 2023. For the Six Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Grant Revenue $ 493,063 $ 366,867 $ 126,196 34.4 % Operating Expenses: Research and development 1,028,462 982,607 45,855 4.7 % General and administrative 706,720 966,676 (259,956 ) -26.9 % Total Operating Expenses 1,735,182 1,949,283 (214,101 ) -11.0 % Total Operating Loss (1,242,119 ) (1,582,416 ) (340,297 ) -21.5 % Other Income/(Expense): Research and development tax credit 9,301 15,965 (6,664 ) -41.7 % Interest expense (118,072 ) (96,065 ) (22,007 ) -22.9 % Total Other Expense, Net (108,771 ) (80,100 ) (28,671 ) -35.8 % Net Loss $ (1,350,890 ) $ (1,662,516 ) $ 311,626 -18.7 % Grant Revenue For the six months ended June 30, 2024 and June 30, 2023, there was $493,063 and $366,867, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements of operations. Research and Development Expenses Research and development expenses were $1,028,462 for the six months ended June 30, 2024, an increase of $45,855 or 4.7% compared to $982,607 for the six months ended June 30, 2023. The increase was primarily due to (i) higher clinical trial costs associated with study closure, and (ii) higher payroll and taxes. The following table summarizes research and development expenses for the six months ended June 30, 2024 and 2023. For the Six Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Operating Expenses: Research and development: Clinical trial and research expenses 758,821 715,879 $ 42,942 6.0 % Depreciation/amortization 3,530 3,530 - 0.0 % Insurance 115,087 114,656 431 0.4 % Payroll and taxes 133,795 131,089 2,706 2.1 % Rent and utilities 17,229 17,453 (224 ) -1.3 % Total research and development $ 1,028,462 $ 982,607 $ 45,855 4.7 % 24 General and Administrative Expenses General and administrative expenses were $706,720 for the six months ended June 30, 2024, a decrease of $259,956 or 26.9% compared to $966,676 for the six months ended June 30, 2023. The decrease was primarily due to (i) lower directors’ fees and professional fees due to the resignation of Bruce Horowitz, our prior Chief Operating Officer partially offset by (ii) higher legal fees related to patents and corporate matters pertaining to the 2024 proxy statement and officer’s resignation, (iii) higher payroll and taxes due to addition of two new officers, and (iv) higher other general and administrative costs due to a refund received in 2023 for employee retention. The following table summarizes general and administrative expenses for the six months ended June 30, 2024 and 2023. For the Six Months Ended June 30, 2024 2023 Increase/(Decrease) % Change Operating Expenses: General and administrative: Depreciation $ 931 $ 931 $ - 0.0 % Directors’ fees (276,250 ) 192,500 (468,750 ) -243.5 % Insurance 87,263 89,088 (1,825 ) -2.0 % Legal and litigation 313,480 207,597 105,883 51.0 % Other general and administrative cost 41,347 12,910 28,437 220.3 % Payroll and taxes 235,621 128,433 107,188 83.5 % Professional fees 294,122 325,502 (31,380 ) -9.6 % Rent and utilities 9,697 9,715 (18 ) -0.2 % Foreign currency transactions 509 - 509 100.0 % Total general and administrative $ 706,720 $ 966,676 $ (259,956 ) -26.9 % Other Expense, Net Interest expense increased by $22,007 or 22.9% from $96,065 for the six months ended June 30, 2023 to $118,072 for the six months ended June 30, 2024. The increase was mainly due to the interest expense costs incurred in connection with the higher notes payable and convertible debt balances. Research and development tax credit in Australia decreased by $6,664 or 41.7% from $15,965 for the six months ended June 30, 2023 to $9,301 for the six months ended June 30, 2024. The decrease was mainly due to no active clinical trials currently in Australia. Liquidity and Capital Resources The Company’s cash and restricted cash were $589,283 at June 30, 2024 which includes $559,702 of restricted cash resulting from a grant received from the State of Tennessee, compared to $1,026,799 at December 31, 2023, which included $950,223 of restricted cash. The Company’s working capital deficit was $7,569,256 and $7,652,098 as of June 30, 2024 and December 31, 2023, respectively. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $254,041,299 as of June 30, 2024. These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. The condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations. As of June 30, 2024, cash required for our current liabilities included approximately $4,760,347 for accounts payable and other accrued expenses (including operating lease liabilities) and a $109,862 note payable related to our short-term financing of our commercial insurance policies. Also, if not converted prior to maturity, convertible debt in the amount of $2,888,000 plus accrued interest will mature one year from the date of the notes. The Company intends to meet these cash requirements from its current cash balance and from future financing. Management’s plans include selling our equity securities and obtaining other financing, including the issuance of 2024 unsecured convertible notes (the “2024 Financing”), to fund our capital requirements and on-going operations; however, there can be no assurance that the Company will be successful in these efforts. Significant funds will be needed to continue and complete our ongoing and planned clinical trials. 25 Access to Capital Management plans to access capital resources through possible public or private equity offerings, including the 2024 Financing, equity financings, debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital, we will not be able to pay our obligations as they become due. The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, there can be no assurance that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing our prescription drug candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan to seek additional funds to meet our current and long-term requirements in 2024 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, the exercise of outstanding stock options, or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to raise additional funds, there can be no assurance that we will be able to obtain funds on commercially acceptable terms, or complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders. Critical Accounting Estimates We prepare our condensed consolidated financial statements in accordance with U.S. GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis. We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above. Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as special purpose entities (“SPEs”). Available Information Our website is located at www.provectusbio.com. We make available free of charge through this website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Reference to our website does not constitute incorporation by reference of the information contained on the site and should not be considered part of this document. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC as we do. The website is http://www.sec.gov. The Company also intends to use press releases, the Company’s website and certain social media accounts as a means of disclosing information and observations about the Company and its business, and for complying with the Company’s disclosure obligations under Regulation FD: the Provectus Substack account (provectus.substack.com), the @ProvectusBio X account (twitter.com/provectusbio), and the Company’s LinkedIn account (linkedin.com/company/provectus-biopharmaceuticals). The information and observations that the Company posts through these social media channels may be deemed material. Accordingly, investors should monitor these social media channels in addition to following the Company’s press releases, SEC filings, and website. The social media channels that the Company intends to use as a means of disclosing the information described above may be updated from time to time. The contents of the websites provided above are not intended to be incorporated by reference into this Quarterly Report on Form 10-Q or our Annual Report on Form 10-K or in any other report or document we file with the SEC. Further, our references to the URLs for these websites are intended to be inactive textual references only. 26 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. Not applicable. ITEM 4. CONTROLS AND PROCEDURES. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Inherent Limitations on Effectiveness of Controls Even assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that our control system’s objective will be met, and our principal executive officer and principal financial officer has concluded that our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Changes in Internal Control Over Financial Reporting There has been no change in our internal control over financial reporting that occurred during the fiscal quarter covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. 27 PART II - OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS. The information required by this item is incorporated by reference from Part I, Item 1. Financial Statements, Notes to Condensed Consolidated Financial Statements, Note 12. ITEM 1A. RISK FACTORS. There have been no material changes to the risk factors that were disclosed in the 2023 Form 10-K. ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. 2022 Financing During the three and six months ended June 30, 2024, the Company received aggregate proceeds of $670,000 and $1,638,000, respectively pursuant to certain unsecured convertible notes (the “2022 Notes”). Through June 30, 2024, the Company had drawn down $4,865,500 under the 2022 Notes. For further details on the terms of the 2022 Notes, refer to our Form 10-K as filed with the SEC on March 28, 2024. Preferred Convertible Stock During the three and six months ended June 30, 2024, the Company issued 273,691 and 500,165 shares, respectively, of restricted Series D-1 Convertible Preferred Stock upon the conversion of $725,000 and $1,325,000 of principal and $58,296 and $106,457 accrued interest, respectively, outstanding on the 2022 Notes. The Company believes that such transactions were exempt from the registration requirements of the Securities Act of 1933, as amended, (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act (or Rule 506(b) of Regulation D promulgated thereunder) as transactions by an issuer not involving a public offering. ITEM 3. DEFAULTS UPON SENIOR SECURITIES. None. ITEM 4. Mine Safety Disclosures. Not applicable. ITEM 5. OTHER INFORMATION. None. 28 ITEM 6. EXHIBITS. Exhibit No. Description 3.1 Certificate of Amendment to the Certificate of Designation of Preferences, Rights, and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s current report on Form 8-K filed with the SEC on June 25, 2024). 3.2 Certificate of Amendment to the Certificate of Designation of Preferences, Rights, and Limitations of Series D-1 Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 of the Company’s current report on Form 8-K filed with the SEC on June 25, 2024). 4.1 Form of Unsecured Convertible Promissory Note (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 8-K filed with the SEC on July 17, 2024). 10.1 Pershing Employment Agreement, dated April 16, 2024, between the Company and Ed Pershing (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed with the SEC on April 16, 2024). 10.2 Rodrigues Employment Agreement, dated April 16, 2024, between the Company and Dominic Rodrigues (incorporated by reference to Exhibit 10.2 of the Company’s current report on Form 8-K filed with the SEC on April 16, 2024). 10.3 Provectus Biopharmaceuticals, Inc. 2024 Equity Compensation Program (incorporated by reference to Appendix C of the Company’s definitive proxy statement on Schedule 14A filed with the SEC on May 6, 2024). 10.4 Conversion Agreement, dated June 21, 2024, by and between the Company and Dominic Rodrigues (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed with the SEC on June 25, 2024). 10.5 2024 Financing Term Sheet (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed with the SEC on July 17, 2024). 31.1** Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification). 31.2** Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification). 32*** Certification of Principal Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification). 101.INS** Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. 101.SCH** Inline XBRL Taxonomy Extension Schema Document. 101.CAL** Inline XBRL Taxonomy Extension Calculation Linkbase Document. 101.LAB** Inline XBRL Taxonomy Extension Label Linkbase Document. 101 PRE** Inline XBRL Taxonomy Extension Presentation Linkbase Document. 101.DEF** Inline XBRL Taxonomy Extension Definition Linkbase Document. 104** Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) ** Filed herewith. *** Furnished herewith. 29 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. PROVECTUS BIOPHARMACEUTICALS, INC. August 13, 2024 By: /s/ Dominic Rodrigues Dominic Rodrigues President (Principal Executive Officer) By: /s/ Heather Raines Heather Raines, CPA Chief Financial Officer (Principal Financial Officer) 30