UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

FORM 10-Q

(Mark One)

[X]☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 20172023

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)

Delaware90-0031917

(State or other jurisdiction of

of incorporation or organization)

(I.R.S. Employer

Identification No.)

10025 Investment Drive, 800 S. Gay Street, Suite 2501610

Knoxville, Tennessee

3793237929
(Address of principal executive offices)(Zip Code)

866-594-5999866-594-5999

(Registrant’s telephone number, including area code)

7327 Oak Ridge Highway, Suite ANot Applicable

Knoxville, Tennessee 37931

(Former Name, Former Addressname, former address, and Former Fiscal Year,former fiscal year, if Changed Since Last Report)changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
NoneN/AN/A

Indicate by check mark whether the registrant: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. [X] ☒ Yes [  ] ☐ No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). [X] ☒ 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”company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer[  ]☐Accelerated filer[X]☐
Non-accelerated filer[  ] (Do not check if a smaller reporting company)☒Smaller reporting company[X]☒
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 [X] ☒ No

The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of November 7, 2017,13, 2023, was 370,737,143.419,522,119.

 

 
 

TABLE OF CONTENTS

Page
PART I - FINANCIAL INFORMATION
Cautionary Note Regarding Forward-Looking Statements1
Item 1. Financial Statements (unaudited)2
Condensed Consolidated Balance Sheets2
Condensed Consolidated Statements of Operations3
Condensed Consolidated Statements of Comprehensive Loss4
Condensed Consolidated Statements of Changes in Stockholders’ Deficit5
Condensed Consolidated Statements of Cash Flows46
Notes to Condensed Consolidated Financial Statements57
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations1217
Item 3. Quantitative and Qualitative Disclosures About Market Risk1627
Item 4. Controls and Procedures1627
PART II - OTHER INFORMATION
Item 1. Legal Proceedings28
Item 1A. Risk Factors1728
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds1728
Item 3. Defaults Upon Senior Securities1828
Item 4. Mine Safety Disclosures1828
Item 5. Other Information1828
Item 6. Exhibits1829
SIGNATURES1930

 
 

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 andexpectations. 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, 2016)2022), and the following:and:

●The uncertainty of generating (i) sales from rose bengal sodium-based drug product candidates, PV-10® and PH-10®, and/or any other halogenated xanthene-based drug product candidates (if and when approved), (ii) licensing, milestone, royalty, and/or other payments related to these drug product 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 product candidates and/or rose bengal sodium- and other halogenated xanthene-based drug substances;
●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;
●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; and
●The disruptions, shortages, and other supply chain-related issues that many companies across different industry sectors have reported and continue to report. In the biopharmaceutical sector, delays and interruptions in the supply chain have been particularly pronounced. During the first nine months of 2023, we were able to effectively manage our supply of drug product candidates and drug substance in a manner that avoided any significant interruptions to our clinical development and drug discovery programs.

●     our potential receipt of sales from investigational drug products PV-10 and PH-10, transaction fees, licensing and royalty payments, and/or payments in connection with the Company’s liquidation, dissolution or winding up, or any sale, lease, conveyance or other disposition of any intellectual property relating to our investigational drug products, and/or drug substance Rose Bengal;

●     our ability to raise additional capital; and

●     our ability to close on additional tranches of the financing from a group of the Company’s stockholders (the “PRH Group”) pursuant to the Definitive Financing Commitment Term Sheet we entered into with the PRH Group effective as of March 19, 2017.

1
 1

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTSSTATEMENTS.

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

  September 30, 2017  December 31, 2016 
  (Unaudited)    
Assets        
         
Current Assets:        
Cash and cash equivalents $208,281  $1,165,738 
Short-term receivable - settlement  -   300,000 
Prepaid expenses  325,423   360,562 
         
Total Current Assets  533,704   1,826,300 
        
Equipment and furnishings, less accumulated depreciation of $33,081 and $464,140, respectively  85,172   72,033 
Patents, net of accumulated amortization of $9,977,317 and $9,473,978, respectively  1,738,127   2,241,467 
Long-term receivable – reimbursable legal fees, net of reserve for uncollectibility of $455,500  455,500   455,500 
Long-term receivable – settlement, net of discount and reserve for uncollectibility of $1,549,043  1,039,769   1,015,710 
Total Assets $3,852,272  $5,611,010 
         
Liabilities and Stockholders’ (Deficiency) Equity        
         
Current Liabilities:        
Accounts payable - trade��$3,551,979  $1,919,870 
Other accrued expenses  509,086   221,956 
         
Total Current Liabilities $4,061,065  $2,141,826 
         
Convertible notes payable  3,100,000   - 
Convertible notes payable - related parties  4,000,000   - 
         
Total Liabilities  11,161,065   2,141,826 
Commitments and contingencies        
Stockholders' (Deficiency) Equity:        
Preferred stock; par value $0.001 per share; 25,000,000 shares authorized; Series B Convertible Preferred Stock; 240,000 shares designated; 100 and 8,600 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively; aggregate liquidation preference of $3,500 and $301,000 at September 30, 2017 and December 31, 2016, respectively  -   9 
Common stock; par value $0.001 per share; 1,000,000,000 shares authorized; 370,737,143 and 364,773,297 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively  370,737   364,773 
Additional paid-in capital  208,339,700   208,327,822 
Accumulated deficit  (216,019,230)  (205,223,420)
Total Stockholder's (Deficiency) Equity  (7,308,793)  3,469,184 
Total Liabilities and Stockholders' (Deficiency) Equity $3,852,272  $5,611,010 
  September 30,  December 31, 
  2023  2022 
  (Unaudited)    
Assets        
         
Current Assets:        
Cash $367,250  $21,605 
Restricted cash  1,042,957   1,410,102 
Short-term receivables  947   394 
Prepaid expenses and other current assets  181,180   467,081 
         
Total Current Assets  1,592,334   1,899,182 
         
Equipment and furnishings, less accumulated depreciation of $108,764 and $102,073, respectively  14,250   20,941 
Operating lease right-of-use asset  83,509   117,123 
         
Total Assets $1,690,093  $2,037,246 
         
Liabilities and Stockholders’ Deficit        
         
Current Liabilities:        
Accounts payable $1,785,322  $2,094,258 
Unearned grant revenue  1,074,358   1,510,958 
Other accrued expenses  3,057,678   2,404,012 
Accrued interest  13,867   30,844 
Accrued interest - related parties  122,646   40,992 
Notes payable  78,066   239,394 
Convertible notes payable  775,000   625,000 
Convertible notes payable - related parties  2,217,500   1,202,500 
Operating lease liability, current portion  47,146   44,422 
         
Total Current Liabilities  9,171,583   8,192,380 
         
Operating lease liability, non-current portion  37,714   73,376 
         
Total Liabilities  9,209,297   8,265,756 
         
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; 12,374,000 shares designated; 12,373,247 shares issued and outstanding at September 30, 2023 and December 31, 2022; aggregate liquidation preference of $14,164,889 at September 30, 2023 and December 31, 2022  12,373   12,373 
Series D-1 Convertible Preferred Stock; 11,241,000 shares designated; 10,146,818 and 9,746,626 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively; aggregate liquidation preference of $116,160,245 and $111,578,880 at September 30, 2023 and December 31, 2022, respectively  10,146   9,747 
Preferred stock, value  -   - 
Common stock; par value $0.001 per share; 1,000,000,000 shares authorized; 419,522,119 and 419,497,119 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively  419,522   419,497 
Additional paid-in capital  244,101,958   242,954,193 
Accumulated other comprehensive loss  (36,207)  (35,679)
Accumulated deficit  (252,026,996)  (249,588,641)
         
Total Stockholders’ Deficit  (7,519,204)  (6,228,510)
         
Total Liabilities and Stockholders’ Deficit $1,690,093  $2,037,246 

See accompanying notes to condensed consolidated financial statements.

2
 2

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  2017  2016  2017  2016 
             
Operating Expenses:                
Research and development $2,390,061  $2,461,407  $6,622,382  $6,874,353 
General and administrative  728,943   3,315,555   4,197,689   12,454,661 
                 
Total Operating Loss  (3,119,004)  (5,776,962)  (10,820,071)  (19,329,014)
                 
Investment income  7,511   318   24,261   1,985 
Public offering issuance expense  -   (436,248)  -   (436,248)
Gain on change in fair value of warrant liability  -   336,649   -   336,649 
                 
Net Loss  (3,111,493)  (5,876,243)  (10,795,810)  (19,426,628)
                 
Dividend paid-in kind to preferred shareholders  (50)  (2,257,432)  (14,107)  (2,257,432)
Deemed dividend  -   (726,989)  -   (726,989)
                 
Net Loss Applicable to Common Shareholders $(3,111,543) $(8,860,664) $(10,809,917) $(22,411,049)
                 
Basic and Diluted Loss Per Common Share $(0.01) $(0.04) $(0.03) $(0.10)
                

Weighted Average Number of Common

Shares Outstanding - Basic and Diluted

  370,546,735   222,959,570   368,722,485   213,722,977 
  2023  2022  2023  2022 
  For the Three Months Ended  For the Nine Months Ended 
  September 30,  September 30, 
  2023  2022  2023  2022 
             
Grant Revenue $69,733  $314,890  $436,600  $824,205 
                 
Operating Expenses:                
Research and development  350,792   580,390   1,333,399   2,068,154 
General and administrative  433,089   400,689   1,399,765   1,500,278 
Total Operating Expenses  783,881   981,079   2,733,164   3,568,432 
                 
Total Operating Loss  (714,148)  (666,189)  (2,296,564)  (2,744,227)
                 
Other Income/(Expense):                
Research and development tax credit  (167)  (638)  15,798   37,621 
Interest expense, net  (61,524)  (46,440)  (157,589)  (115,424)
                 
Total Other Income (Expense), Net  (61,691)  (47,078)  (141,791)  (77,803)
                 
Net Loss $(775,839) $(713,267) $(2,438,355) $(2,822,030)
                 
Basic and Diluted Loss Per Common Share $(0.00) $(0.00) $(0.01) $(0.01)
                 
Weighted Average Number of Common Shares Outstanding - Basic and Diluted  419,515,869   419,489,239   419,503,438   419,461,313 

See accompanying notes to condensed consolidated financial statements.

3
 3

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSCOMPREHENSIVE LOSS

(Unaudited)

  Nine Months Ended September 30, 
  2017  2016 
       
Cash Flows From Operating Activities        
Net loss $(10,795,810) $(19,426,628)

Adjustments to reconcile net loss to net cash

used in operating activities:

        
Depreciation  12,500   9,926 
Amortization of patents  503,340   503,340 
Warrant incentive expense  -   2,718,407 
Issuance of stock for services  -   20,163 
Public offering issuance expense  -   436,248 
Gain on change in fair value of warrant liability  -   (336,649)
Changes in operating assets and liabilities        
Settlement receivable  275,941   386,226 
Other current assets  35,139   (146,030)
Accounts payable - trade  1,799,409   (400,931)
Accrued settlement expense  -   (1,850,000)
Other accrued expenses  287,130   161,532 
         
Net Cash Used In Operating Activities  (7,882,351)  (17,924,396)
         
Cash Flows From Investing Activities        
Purchase of fixed assets  (25,639)  - 
Net Cash Used In Operating Activities  (25,639)  - 
         
Cash Flows From Financing Activities        
Gross proceeds from sales of convertible preferred stock and warrants  -   6,000,000 
Payment of offering costs in connection with August 2016 financing  -   (711,470)
Net proceeds from the issuance of common stock and warrants pursuant to warrant exchange offer  -   3,635,040 
Proceeds from issuance of convertible notes payable  2,950,000   - 
Proceeds from issuance of convertible notes payable - related party  4,000,000   - 
Proceeds from exercise of warrants  533   - 
Net Cash Provided By Financing Activities  6,950,533   8,923,570 
         
Net Change In Cash and Cash Equivalents  (957,457)  (9,000,826)
         
Cash and Cash Equivalents, Beginning of Period  1,165,738   14,178,902 
         
Cash and Cash Equivalents, End of Period $208,281  $5,178,076 
         
Supplemental Disclosures of Cash Flow Information:        
Cash paid during the period for:        
Interest $-  $- 
Taxes $-  $- 
         
Non-cash investing and financing activities:        
Conversion of preferred stock into common stock $3,987  $31,066 
Dividend paid-in kind to preferred shareholders $1,595  $- 
Contractual dividends on preferred stock $-  $729,989 
Issuance in-kind of preferred stock dividends $14,107  $2,257,432 
Common stock issued in satisfaction of trade debt $17,300  $- 
Notes payable issued in satisfaction of trade debt $150,000  $- 
  2023  2022  2023  2022 
  For the Three Months Ended  For the Nine Months Ended 
  September 30,  September 30, 
  2023  2022  2023  2022 
             
Net Loss $(775,839) $(713,267) $(2,438,355) $(2,822,030)
Other Comprehensive Loss:                
Foreign currency translation adjustments  -   (1,241)  (441)  (2,285)
Total Comprehensive Loss $(775,839) $(714,508) $(2,438,796) $(2,824,315)

See accompanying notes to condensed consolidated financial statements.

4
 

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(Unaudited)

FOR THE NINE MONTHS ENDED SEPTEMBER 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 D1 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)
                                         
Conversion of 2021 Note to Series D1 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)
                                         
Common stock issued for services  -   -   -   -   25,000   25   2,825   -   -   2,850 
Conversion of 2021 Note to Series D1 Preferred Stock  -   -   122,725   122   -   -   351,110           351,232 
Conversion of 2022 Note to Series D1 Preferred Stock  -   -   69,838   70   -   -   199,805           199,875 
Comprehensive loss:                                      - 
Net loss  -   -   -   -   -   -   -   -   (775,839)  (775,839)
Other comprehensive loss  -   -   -   -   -   -   -   (441)  -   (441)
                                         
Balance at September 30, 2023  12,373,247  $12,373   10,146,818  $10,146   419,522,119  $419,522  $244,101,958  $(36,207) $(252,026,996) $(7,519,204)

 FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2022

                 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, 2022  12,373,247  $12,373   9,218,449  $9,219   419,447,119  $419,447  $241,440,106  $(34,467) $(246,033,958) $(4,187,280)
                                         
Series D-1 Preferred Stock issued for cash  -   -   52,411   52   -   -   149,948   -   -   150,000 
Comprehensive loss:                                        
Net loss  -   -   -   -   -   -   -   -   (1,030,922)  (1,030,922)
Other comprehensive loss  -   -   -   -   -   -   -   (716)  -   (716)
                                         
Balance at March 31, 2022  12,373,247   12,373   9,270,860   9,271   419,447,119   419,447   241,590,054   (35,183)  (247,064,880)  (5,068,918)
                                         
Comprehensive loss:                                        
Net loss  -   -   -   -   -   -   -   -   (1,077,841)  (1,077,841)
Other comprehensive loss  -   -   -   -   -   -   -   (328)  -   (328)
                                         
Balance at June 30, 2022  12,373,247   12,373   9,270,860   9,271   419,447,119   419,447   241,590,054   (35,511)  (248,142,721)  (6,147,087)
Balance  12,373,247   12,373   9,270,860   9,271   419,447,119   419,447   241,590,054   (35,511)  (248,142,721)  (6,147,087)
                                         
Stock-based compensation:                                        
Common Stock  -   -   -   -   50,000   50   2,975   -   -   3,025 
Comprehensive loss:                                        
Net loss  -   -   -   -   -   -   -   -   (713,267)  (713,267)
Other comprehensive income  -   -   -   -   -   -   -   (1,241)  -   (1,241)
                                         
Balance at September 30, 2022  12,373,247  $12,373   9,270,860  $9,271   419,497,119  $419,497  $241,593,029  $(36,752) $(248,855,988) $(6,858,570)
Balance  12,373,247  $12,373   9,270,860  $9,271   419,497,119  $419,497  $241,593,029  $(36,752) $(248,855,988) $(6,858,570)

See accompanying notes to condensed consolidated financial statements.

45
 

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  2023  2022 
  For the Nine Months Ended 
  September 30, 
  2023  2022 
    
Cash Flows From Operating Activities:        
Net loss $(2,438,355) $(2,822,030)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock-based compensation  2,850   3,025 
Non-cash lease expense  33,613   41,947 
Depreciation  6,691   8,857 
Changes in operating assets and liabilities        
Short term receivables  (553)  4,351 
Prepaid expenses and other current assets  359,572   142,129 
Accounts payable  (308,728)  654,017 
Unearned grant revenue  (436,600)  (824,205)
Other accrued expenses  653,664   442,355 
Operating lease liability  (32,938)  (47,664)
Accrued interest  150,017   110,536 
         
Net Cash Used In Operating Activities  (2,010,767)  (2,286,682)
         
Cash Flows From Financing Activities:        
Proceeds from issuance of convertible notes payable  700,000   550,000 
Proceeds from issuance of convertible notes payable - related parties  1,525,000   510,000 
Repayment of short-term note payable  (234,997)  (166,317)
Net Cash Provided By Financing Activities  1,990,003   893,683 
         
Effect of exchange rates on cash and restricted cash  (736)  (2,592)
         
Net Decrease In Cash and Restricted Cash  (21,500)  (1,395,591)
         
Cash and Restricted Cash, Beginning of Period  1,431,707   3,106,942 
         
Cash and Restricted Cash, End of Period $1,410,207  $1,711,351 
         
Cash and restricted cash consisted of the following:        
Cash and cash equivalents $367,250  $67,030 
Restricted cash  1,042,957   1,644,321 
Cash and Restricted Cash, End of Period $1,410,207  $1,711,351 
         
Non-cash investing and financing activities:        
For purchase of Series D-1 Preferred Stock $-  $(150,000)
Right-of-use assets obtained in exchange for operating lease liabilities $-  $130,422 
Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock $804,533  $- 
Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock $170,126     
Purchase of insurance policies financed by short-term note payable $(73,669) $(57,146)

See accompanying notes to condensed consolidated financial statements.

6

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(together with its subsidiaries, (“Provectus”“Provectus” or the “Company”“the Company”), is a clinical-stage biotechnology company developing pharmaceutical drug productsimmunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes such(“HXs”). Our lead HX molecule is named rose bengal sodium (“RBS”).

The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient in the drug product candidates of our current clinical development programs and the preclinical formulations of our current drug 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 manner. First, direct contact may lead to cell death or repair, depending on the disease being treated and the concentration of the RBS utilized in the treatment. Second, multivariate immune signaling, activation, and response may follow that may manifest as Rose Bengal,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 solid tumor cancersa 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 HX medical science platform comprises several different drug product candidates and preclinical pharmaceutical-grade RBS formulations using different concentrations delivered by different routes of administration specific to each disease area and/or indication. The Company’s HX medical science platform includes clinical development programs in adults as well as pediatric cancers,oncology, dermatology, and inflammatory dermatoses for dermatology ophthalmology; in both adultsvivo proof-of-concept programs in oncology, hematology, wound healing, and children. To date, the Company has not generated any revenues from planned principal operations. animal health; and in vitro drug discovery programs 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 and/or commercialize the Company’s investigationalprescription drug products.candidates.

7

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, 20162022 filed with the U.S. Securities and Exchange Commission (the “SEC”)SEC on March 31, 2017.30, 2023. 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 three and nine months ended September 30, 20172023 are not necessarily indicative of the results that may be expected for the twelve monthsyear ending December 31, 2017.2023.

2. Liquidity and Financial ConditionGoing Concern

To date, the Company has not generated any revenues or profits from planned principal operations.

The Company’s cash and restricted cash equivalents were $208,281$1,410,207 at September 30, 2017, compared with $1,165,738 at2023 which includes $1,042,957 of restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficit was $7,579,249 and $6,293,198 as of September 30, 2023 and December 31, 2016.2022, respectively, net loss for the nine months ended September 30, 2023 and 2022 was $2,438,355 and $2,822,030, respectively, and cash used in operations was $2,010,767 and $2,286,682 for the nine months ended September 30, 2023 and September 30, 2022, 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 of developing, licensing and/or commercializingand develop and market its investigational drug products. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that thethese 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 licensePV-10, PH-10, and/or commercialize its investigationalany other halogenated xanthene-based drug products, and/orand to raise additional capital.

The 2017 Financing

On March 23, 2017, the Company entered into an exclusive Definitive Financing Commitment Term Sheet with a group of the Company’s stockholders (the “PRH Group”), which was amended and restated effective as of March 19, 2017 (the “Term Sheet”) that set forth the terms on which the PRH Group would use their best efforts to arrange for a financing of a minimum of $10,000,000 and maximum of $20,000,000 (the “2017 Financing”).

As of September 30, 2017, the Company had received aggregate Loans (as defined below) of $7,100,000 in connection with the 2017 Financing. See Note 4 – Convertible Notes Payable. Subsequent to September 30, 2017, the Company received aggregate Loans of $2,150,000 in connection with the 2017 Financing. See Note 7 – Subsequent Events.

The 2017 Financing is in the form of a secured convertible loan (the “Loan”) from the PRH Group or other investors in the 2017 Financing (the “Investors”). The Loan is evidenced by secured convertible promissory notes (individually a “PRH Note” and collectively, the “PRH Notes”) from the Company to the PRH Group or the Investors. In addition to the customary provisions, the PRH Note contains the following provisions:

(i)It is secured by a first priority security interest on the Company’s intellectual property (the “IP”);
(ii)The Loan bears 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;
(iii)The Loan proceeds are held in one or more accounts (the “Escrow”) pending the funding of the tranches of the 2017 Financing pursuant to borrowing requests made by the Company;

5

(iv)

The PRH Notes, including interest and principal, are due and payable in full on the earlier of: (i) on such date upon which the Company defaults under the PRH Notes, (ii) upon a change of control of the Company, or (iii) dates ranging from April 2, 2019 to the twenty-four (24) month anniversary of the funding of the Final Tranche, depending on the specific PRH Note. In the event there is a change of control of the Company’s board of directors (the “Board”) as proposed by any person or group other than the Investors, the term of the PRH Notes will be accelerated and all amounts due under the PRH Notes will be immediately due and payable, plus interest at the rate of eight percent (8%) per annum, plus a penalty in the amount equal to ten times (10x) the outstanding principal amount of the Loan that has been funded to the Company;

(v)The outstanding principal amount and interest payable under the Loan will be convertible at the sole discretion of the Investors into shares of the Company’s Series D Preferred Stock, a new series of preferred stock to be designated by the Board, at a price per share equal to $0.2862; and
(vi)Notwithstanding (v) above, the principal amounts of the PRH Notes and the interest payable under the Loan will automatically convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $0.2862 effective on the 24-month anniversary of the funding of the Final Tranche of the 2017 Financing subject to certain exceptions.

As of September 30, 2017, and through the date of filing, the Series D Preferred Stock had not been designated by the Board. As a result, the PRH Notes were not convertible as of their respective dates of issuance or as of September 30, 2017.

The Series D Preferred Stock shall have a first priority right to receive proceeds from the sale, liquidation or dissolution of the Company or any of the Company’s assets (each, a “Company Event”). If a Company Event occurs within two (2) years of the date of issuance of the Series D Preferred Stock (the “Date of Issuance”), the holders of Series D Preferred Stock shall receive a preference of four times (4x) their respective investment amount. If a Company Event occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D Preferred Stock shall receive a preference of six times (6x) their respective investment amount.

The Series D Preferred Stock shall be convertible at the option of the holders thereof into shares of the Company’s common stock based on a formula to achieve a one-for-one conversion ratio such that one share of Series D Preferred Stock would convert into one share of common stock. The Series D Preferred Stock shall automatically convert into shares of Common Stock upon the fifth anniversary of the Date of Issuance. On an as-converted basis, the Series D Preferred Stock shall carry the right to one (1) vote per share. The Series D Preferred Stock shall not have any dividend preference but shall be entitled to receive, on apari passu basis, dividends, if any, that are declared and paid on any other class of the Company’s capital stock. The holders of Series D Preferred Stock shall not have anti-dilution protection.

The Company plans to access capital resources through possible public or private equity offerings, including the 2017 Financing,2022 financing (see Note 5), 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 no assurancethere can be providedno assurance that it will continue to be successful in the future. If the Company is unable to raise sufficient capital, through the 2017 Financing or otherwise, it will not be able to pay its obligations as they become due.

The primary business objective of Managementmanagement is to build the Company into a fully integrated globalcommercial-stage biotechnology company. However, the Company cannot assure youcompany; however, there can be no assurance that theyit will be successful in co-developing, licensing, and/or licensingcommercializing PV-10, PH-10, and/or any other halogenated xanthene-based drug candidate developed by the Company or entering into any equityfinancial 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 20172023 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, including the 2017 Financing, 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, the Company cannot providethere can be no assurance that it will be able to complete additional financing in a timely manner. In addition, anyAny such financing may result in significant dilution to stockholders.

NYSE Delisting

On October 13, 2016, the Company received notice from NYSE MKT that NYSE MKT commenced delisting procedures and immediately suspended trading in the Company’s common stock and class of warrants that was listed on NYSE MKT (“Listed Warrants”) and on October 17, 2016, the Company’s common stock began trading on the OTCQB Marketplace. On October 20, 2016, the Company submitted a request for a review of such delisting determination and on November 10, 2016, the Company submitted to the Listing Qualifications Panel its written submission in connection with its appeal. In addition, on November 23, 2016, the Company received notice from NYSE MKT stating that the Company was not in compliance with Section 1003(a)(iii) of the NYSE MKT Company Guide (requiring stockholders’ equity of $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years). As of December 31, 2016, the Company had stockholders’ equity of approximately $3.5 million.

8
 6

The hearing before3. Significant Accounting Policies

Since the Listing Qualifications Panel occurred on January 25, 2017. On January 31, 2017, the Company received notice from the Listing Qualifications Panel that it affirmed NYSE MKT’s original determination to delistdate the Company’s common stock and Listed Warrants. On February 14, 2017, the Company submitted a request for the Committee for Review to reconsider the Listing Qualification Panel’s decision. The Committee for Review considered the Company’s request for reviewDecember 31, 2022 consolidated financial statements were issued in its 2022 Annual Report on March 30, 2017. On April 21, 2017, the NYSE MKT filed a Form 25 with the SEC, notifying the SEC of the NYSE MKT’s intention to remove the Company’s shares of common stock and Listed Warrants from listing and registration on the NYSE MKT effective May 1, 2017, pursuant to the provisions of Rule 12d2-2(b) of the Securities Exchange Act of 1934, as amended. The Company’s common stock and Listed Warrants continue to trade on the OTCQB following the delisting from the NYSE MKT under the trading symbols “PVCT” and “PVCTWS,” respectively. However, the Company can provide no assurance that its common stock and Listed Warrants will continue to trade on the OTCQB in the future.

3. Significant Accounting Policies

The Company’s significant accounting policies are disclosed in Note 3 – Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Since the date of the Annual Report,2023, there have been no material changes to the Company’s significant accounting policies, exceptpolicies.

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, stock-based compensation, 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 disclosed below.of September 30, 2023 is $1,042,957. See Note 10, Grants.

RecentCash 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 September 30, 2023 and December 31, 2022, the Company had cash and restricted cash balances in excess of FDIC insurance limits of $1,160,207 and $1,181,707, respectively.

9

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

  2023  2022 
  September 30, 
  2023  2022 
Warrants  437,500   487,500 
Options  3,225,000   3,425,000 
Convertible preferred stock  113,841,427   105,081,847 
2021 unsecured convertible notes  817,766   8,602,376 
2022 unsecured convertible notes  10,115,192   646,952 
         
Total potentially dilutive shares  128,636,885   118,243,675 

Recently Adopted Accounting Pronouncements

In October 2016,August 2020, the FASB issued ASU No. 2016-17, “Consolidation (Topic 810)2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Interests Held through Related Parties That Are under Common Control” (“Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity. The amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital. In addition, this ASU 2016-17”). ASU 2016-17 requires, when assessing which party is the primary beneficiary in a variable interest entity (VIE), that the decision maker considers interests held by entities under common control on a proportionate basis instead of treating those interests as if they were that of the decision maker itself, as current GAAP requires.improves disclosure requirements for convertible instruments and earnings-per-share guidance. The ASU isalso revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events. The amendments in this update are effective for annual periods, and interim periods therein,our fiscal years beginning after December 15, 2016. Early application is permitted in any interim or annual period. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements.

In May 2017, the FASB issued ASU No. 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting” (“ASU 2017-09”). ASU 2017-09 provides clarity on the accounting for modifications of stock-based awards. ASU 2017-09 requires adoption on a prospective basis in the annual and interim periods beginning after December 15, 2017 for share-based payment awards modified on or after the adoption date. The Company is currently evaluating the effect that adopting this new accounting guidance will have on its condensed consolidated financial statements and related disclosures.

In July 2017, the FASB issued ASU No. 2017-11, “Earnings Per Share (Topic 260) and Derivatives and Hedging (Topic 815) - Accounting for Certain Financial Instruments with Down Round Features” (“ASU 2017-11”). Equity-linked instruments, such as warrants and convertible instruments may contain down round features that result in the strike price being reduced on the basis of the pricing of future equity offerings. Under ASU 2017-11, a down round feature will no longer require a freestanding equity-linked instrument (or embedded conversion option) to be classified as a liability that is re-measured at fair value through the income statement (i.e. marked-to-market). However, other features of the equity-linked instrument (or embedded conversion option) must still be evaluated to determine whether liability or equity classification is appropriate. Equity classified instruments are not marked-to-market. For earnings per share ("EPS") reporting, the ASU requires companies to recognize the effect of the down round feature only when it is triggered by treating it as a dividend and as a reduction of income available to common shareholders in basic EPS. The amendments in this ASU are effective for all entities for fiscal years,2023, and interim periods within those fiscal years. Early adoption will be permitted, but no earlier than for fiscal years beginning after December 15, 2018. Early adoption is permitted, including adoption in any interim period.2020. The Company is currently evaluatingearly adopted ASU 2017-112020-06 effective January 1, 2023 which eliminated the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments.

4. Other Accrued Expenses

The following table summarizes the other accrued expenses at September 30, 2023 and its impact on its condensed consolidated financial statements.December 31, 2022:

4.

Schedule of Other Accrued Expenses

  September 30,  December 31, 
  2023  2022 
Accrued payroll and taxes $611,646  $314,160 
Accrued vacation  88,691   69,077 
Accrued directors’ fees  2,234,339   1,945,589 
Accrued other expenses  123,002   75,186 
Total Other Accrued Expenses $3,057,678  $2,404,012 

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5. Convertible Notes Payable

2021 Financing

Schedule of Convertible Notes Payable – Related Parties

  Non-Related Party  Related Party    
  Face Amount  Face Amount  Total 
Balance as of January 1, 2023 $550,000  $525,000  $1,075,000 
             
Conversion  (50,000)  -   (50,000)
Balance as of March 31, 2023  500,000   525,000   1,025,000 
Conversion  (500,000)  -   (500,000)
Balance as of June 30, 2023  -   525,000   525,000 
Balance  -   525,000   525,000 
Conversion  -   (325,000)  (325,000)
Issued            
Balance as of September 30, 2023 $-  $200,000  $200,000 

On February 21, 2017,Through September 30, 2023, the Company issued 2021 Notes with aggregate proceeds of $1,075,000 of which $525,000 was from related party investors (an officer and a promissory note in favordirector of Eric A. Wachter, Ph.D., the Company’s Chief Technology Officer (“Wachter”), evidencing an unsecured loan from Wachter toCompany).

2022 Financing

  Non-Related Party  Related Party    
  Face Amount  Face Amount  Total 
Balance as of January 1, 2023 $75,000  $677,500  $752,500 
Balance $75,000  $677,500  $752,500 
             
Issued  -   600,000   600,000 
             
Balance as of March 31, 2023  75,000   1,277,500   1,352,500 
Balance  75,000   1,277,500   1,352,500 
Issued  -   725,000   725,000 
             
Balance as of June 30, 2023  75,000   2,002,500   2,077,500 
Balance  75,000   2,002,500   2,077,500 
Issued  700,000   200,000   900,000 
Conversion  -   (185,000)  (185,000)
Balance as of September 30, 2023 $775,000  $2,017,500  $2,792,500 
Balance $775,000  $2,017,500  $2,792,500 

Through September 30, 2023, the Company in the original principal amountissued 2022 Notes with aggregate proceeds of up to $2,500,000 (the “Wachter Note”). Interest accrues on the outstanding balance$2,977,500 of which $2,202,500 is from a related party investor (a director of the Wachter Note at six percent (6%) per annum calculatedCompany) in connection with the 2022 Financing.

For further details on a 360-day basis. As of March 31, 2017, the Company had borrowed the entire $2,500,000 principal amount under the Wachter Note. The Company evaluated the terms of the Wachter Note2021 and determined that since2022 Notes, refer to our Form 10-K as filed with the conversion price is not yet fixed and will be based upon the price per New Security (as defined in the Wachter Note) issued upon the completion of a future Qualified Equity Financing (as defined in the Wachter Note), that the measurement of a beneficial conversion feature cannot be completed. On April 3, 2017, the Wachter Note was amended and restated in order to modify its terms to mirror the PRH Notes and to convert the Wachter Note into the 2017 Financing. The Company accounted for the amendment as a debt modification. There was no material impact as a result of applying debt modification accounting.SEC on March 30, 2023.

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 7

On April 3, 2017,2023 Conversions of 2021 Notes into Preferred Stock

The following summarizes the Company entered into a PRH Note with Cal Enterprises LLC, a Nevada limited liability company, an affiliate of Dominic Rodrigues, a director ofconversion activity during the Company, in the principal amount of up to $2,500,000. As ofnine months ended September 30, 2017, the Company had borrowed $1,500,000 under this note.2023:

Convertible

Schedule of Conversion of Notes Payable – Non-Related Partiesinto Preferred Stock

  Series D-1 
  

Preferred

Stock

 
Principal converted $875,000 
Accrued interest converted  70,466 
Total converted $945,466 
Conversion price $2.862 
Total shares  330,354 

During the three months ended September 30, 2017, the Company entered into additional PRH Notes with accredited investors2023, principal and interest in the aggregate principal amount of $550,000,$351,239, owed in connection with the 2021 Notes were converted into 122,725 shares of which, $150,000 was issued in satisfaction of trade debt. As of September 30, 2017, the Company had borrowed $3,100,000 under these notes.

See Note 2 – Liquidity and Financial Condition for the terms of the PRH Notes. As of September 30, 2017, and through the date of filing, the Series DD-1 Preferred Stock had not been designated byat the Board. As a result, the PRH Notes were not convertible asConversion Price of their respective dates of issuance or as of September 30, 2017.$2.862.

5. Stockholders’ Deficiency

Conversion of Series B Preferred Stock

During the nine months ended September 30, 2017, holders2023, principal and interest in the aggregate amount of $945,466, owed in connection with the 2021 Notes were converted 8,500into 330,354 shares of Series BD-1 Preferred Stock into 3,986,676at the Conversion Price of $2.862. Any fractional shares of common stock such that they were entitled to dividends, including a make-whole payment, that the Company elected to pay in shares of common stock. As a result, the Company issued 1,594,670 shares of common stock relatedissuable pursuant to the formula were rounded up to the next whole share of Series BD-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.

2023 Conversions of 2022 Notes into Preferred Stock dividends

The following summarizes the conversion activity during the nine months ended September 30, 2017. 2023:

  Series D-1 
  

Preferred

Stock

 
Principal converted $185,000 
Accrued interest converted  14,875 
Total converted $199,875 
Conversion price $2.862 
Total shares  69,838 

During the three and nine months ended September 30, 2023, principal and interest in the aggregate amount of $199,875, owed in connection with the 2022 Notes were converted into 69,838 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.

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6. Notes Payable

The Company recorded aggregate dividends paid in kindobtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of $14,107September 30, 2023 and December 31, 2022, the balance of the note payable was $78,066 and $239,394, respectively.

7. Related Party Transactions

During the three months ended September 30, 2023 and 2022, the Company had consulting fees of $63,600 each to Mr. Bruce Horowitz (Capital Strategists) for services rendered. Director fees for Mr. Horowitz for the three months ended September 30, 2023 and 2022 were $18,750 each.

During the nine months ended September 30, 2023 and 2022, the Company had consulting fees of $190,800 each to Mr. Bruce Horowitz (Capital Strategists) for services rendered. Director fees for Mr. Horowitz for the nine months ended September 30, 2023 and 2022 were $56,250 each.

Accrued director fees for Mr. Bruce Horowitz as of September 30, 2023 and December 31, 2022 were $412,500 and $356,250, respectively. Total amounts owed to Capital Strategists for consulting fees as of September 30, 2023 and December 31, 2022 were $381,600 and $212,000, respectively. Mr. Horowitz serves as both Chief Operating Officer (“COO”) and a Company director.

See Note 5 for details of other related party transactions.

Director fees during the three and nine months ended September 30, 2023 and 2022 were $96,250 and $288,750, respectively. Accrued directors’ fees as of September 30, 2023 and December 31, 2022 were $2,234,339 and $1,945,589, respectively.

8. Stockholders’ Deficit

Preferred Stock

During the nine months ended September 30, 2023, the Company issued 330,354 shares of Series D-1 Convertible Preferred Stock upon the conversion of $875,000 of principal and $70,466 accrued interest outstanding on the 2021 Notes.

During the nine months ended September 30, 2023, the Company issued 69,838 shares of Series D-1 Convertible Preferred Stock upon the conversion of $185,000 of principal and $14,875 accrued interest outstanding on the 2022 Notes.

Options

During the three and nine months ended September 30, 2023 and 2022, the Company did not have any issuances, grants, or exercises of options.

The following table summarizes option activities during the nine months ended September 30, 2017.2023:

Schedule of Option Activity

     Weighted Average  Weighted Average Remaining  Aggregate Intrinsic 
  Shares  Exercise Price  Life in Years  Value 
             
Outstanding and exercisable at January 1, 2023  3,425,000  $0.29         $     - 
Forfeited  (200,000)  0.67         
Outstanding and exercisable at September 30, 2023  3,225,000   0.27   2.11  $- 

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The following table summarizes information about options outstanding and exercisable at September 30, 2023:

Summary of Stock Options Outstanding

Exercise Price  Outstanding and Exercisable  Weighted Average Remaining Contractual Life  Intrinsic Value 
           
$0.12   2,425,000   2.10  $    - 
$0.29   100,000   2.10  $- 
$0.75   550,000   2.20  $- 
$0.88   150,000   0.80  $- 
               
     3,225,000   2.11  $- 

Exercise

Warrants

During the three and nine months ended September 30, 2023 and 2022, the Company did not have any issuances, grants, or exercises of warrants.

The following table summarizes warrant activities during the nine months ended September 30, 2023:

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, 2023  475,000  $0.97         
Forfeited  (37,500)  0.29         
Outstanding and exercisable at September 30, 2023  437,500  $1.03   0.60  $- 

The following table summarizes information about warrants outstanding and exercisable at September 30, 2023:

Summary of Warrants Outstanding

Exercise Price  Outstanding and Exercisable  Weighted Average
Remaining Contractual Life		  Intrinsic Value 
           
$0.29   50,000   0.29  $      - 
$1.00   18,000   0.64  $- 
$1.12   366,000   0.64  $- 
$2.00   3,500   0.64  $- 
               
     437,500   0.60  $- 

Holders of the outstanding warrants are not entitled to vote and the exercise prices of such warrants are subject to customary anti-dilution provisions.

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DuringAnnual Stockholder Meeting Proposals

The Company held its annual meeting of stockholders on June 21, 2023. 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

The Company leased 4,500 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of five years ending on June 30, 2022. Payments were approximately $6,100 per month due to the Company negotiating a continued reduced rent from January 1, 2022 through June 30, 2022.

On June 30, 2022, the lease expired and was not renewed. 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 September 30, 2017, a warrant holder exercised a warrant to purchase 10,000 shares2023 was $12,560, of common stock at a pricewhich, $8,373 was included within research and development and $4,187 was included within general and administrative expenses on the condensed consolidated statements of $0.053 per share. In connection with the exercise, the Company received $533.

Issuance of Common Stock

Duringoperations. Total operating lease expense for the three months ended September 30, 2017,2022 was $12,497 of which, $8,331 was included within research and development and $4,166 was included within general and administrative expenses on the condensed consolidated statements of operations.

Total operating lease expense for the nine months ended September 30, 2023 was $38,739, of which, $25,826 was included within research and development and $12,913 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the nine months ended September 30, 2022 was $50,548, of which, $33,698 was included within research and development and $16,850 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 Nine Months Ended 
  September 30, 
  2023  2022 
       
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows used in operating leases $32,938  $50,784 
         
Right-of-use assets obtained in exchange for lease obligations:        
Operating leases $-  $130,422 
         
Weighted Average Remaining Lease Term        
Operating leases  1 year 9 months   2 years 9 months 
         
Weighted Average Discount Rate        
Operating leases  5.0%  5.0% - 8.0%

Future minimum payments under the Company’s non-cancellable lease obligations as of September 30, 2023 were as follows:

Future Minimum Payments

Schedule of Future Minimum Payments Under Non-cancellable Lease

Years Amount 
2023 $12,497 
2024  50,663 
2025  25,668 
Total lease payments  88,828 
Less: amount representing imputed interest  (3,968)
Present value of lease liability  84,860 
Less: current portion  (47,146)
Lease liability, non-current portion $37,714 

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10. Grants

On October 25, 2021, the Company issued an aggregatereceived a grant award of 372,500 shares of restricted unregistered common stock at an average price of $0.046 per share in satisfaction of accounts payable of $17,300.

6. Litigation

Kleba Shareholder Derivative Lawsuit

On June 6, 2014, the Company, in its capacity as a nominal defendant, entered into a Stipulated Settlement Agreement and Mutual Release (the “Derivative Lawsuit Settlement”) in the shareholder derivative lawsuit filed by Glenn Kleba, derivatively on behalf of the Company, and later amended to include Don B. Dale as a plaintiff, in the Circuit Court for$2,500,000 from the State of Tennessee Knox Countyfor the study of animal cancers and dermatological disorders for the period October 15, 2021 to June 30, 2022 (the “Court”“Tennessee Grant” or “Grant”), against H. Craig Dees, Ph.D., Timothy C. Scott, Ph.D., Eric A. Wachter, Ph.D.,. 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 Peter R. Culpepper (collectively,development expenses related to the “Executives”), Stuart Fuchs, Kelly M. McMasters, and Alfred E. Smith, IV (collectively, together with the Executives, the “Individual Defendants”), and against thedevelopment of animal health drug products. The Company as a nominal defendant (the “Shareholder Derivative Lawsuit”), which alleged (i) breach of fiduciary duties; (ii) waste of corporate assets; and (iii) unjust enrichment. Under the termshas elected gross presentation of the Derivative Lawsuit Settlement, among other things,Tennessee Grant income whereby grant revenue is recognized as qualifying costs are incurred and there is reasonable assurance that the Executives each agreed (A) to re-pay to the Company $2.24 millionconditions of the cash bonuses they each received in 2010grant have been met. Qualifying costs are presented as research and 2011, which amount equals 70% of such bonuses or an estimate of the after-tax net proceeds to each Executive; provided, however, that subject to certain terms and conditions set forthdevelopment expenses included in the Derivative Lawsuit Settlement, the Executives are entitled to a 2:1 credit such that total actual repayment may be $1.12 million each; (B) to reimburse the Company for 25%Company’s statement of the actual costs, net of recovery from any other source, incurred by the Company as a result of the Shareholder Derivative Lawsuit; and (C) to grant to the Company a first priority security interest in 1,000,000 shares of the Company’s common stock owned by each such Executive to serve as collateral for the amounts due to the Company under the Derivative Lawsuit Settlement. Under the Derivative Lawsuit Settlement, Messrs. Fuchs and Smith and Dr. McMasters have each agreed to pay the Company $25,000 in cash, subject to reduction by such amount that the Company’s insurance carrier pays to the Company on behalf of such defendant pursuant to such defendant’s directors and officers liability insurance policy.

8

On July 24, 2014, the Court approved the terms of the Derivative Lawsuit Settlement and awarded $911,000 to plaintiffs’ counsel for attorneys’ fees and reimbursement of expenses in connection with their roleoperations, in the Shareholder Derivative Lawsuit. The payment to plaintiff’s counsel was made by the Company during October 2014 and was recorded as other current assets at December 31, 2014, as the Company is seeking reimbursement of the full amount from its insurance carrier. If the full amount is not received from insurance, the amount remaining will be reimbursed to the Company from the Individual Defendants. period that such costs are incurred.

As of September 30, 20172023 and December 31, 2016,2022, $1,074,358 and $1,510,958 has been recorded as unearned Grant revenue liability on the net amount of the receivable of $455,500 is reported as non-current assets on theaccompanying condensed consolidated balance sheets.sheets, respectively. The Company recorded grant revenue of $69,733 and $436,600 during the three and nine months ended September 30, 2023, respectively, and $314,890 and $824,205 during the three and nine months ended September 30, 2022, respectively.

11. License Transactions

On October 3, 2014,February 16, 2022, and later amended on May 11, 2022, the Derivative Lawsuit Settlement was effective andCompany entered into an aggregateoption agreement with the University of 2,800,000 stock optionsMiami (“UM”) for Dr. Dees, Dr. Scott and Mr. Culpepper were rescinded. A totalan exclusive worldwide license of $1,816,667 had been repaidintellectual property (“IP”) developed by the Executives asOphthalmic Biophysics Center (“OBC”) of September 30, 2017. Bascom Palmer Eye Institute (“BPEI”) that included the use of OBC’s ophthalmic photodynamic antimicrobial therapy (“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 remaining cash settlement amounts will continue to be repaid toCompany completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company with(i) paid $5,000 for the final paymentoption to be received by October 3, 2019. The remaining balanceobtain an exclusive worldwide, royalty-bearing license that had an option expiration date of May 31, 2023, (ii) agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the Executives’ repayment dueoption, (iii) agreed to pay up to $25,000 of past UM patent expenses for this IP, and (iv) entered into a sponsored research agreement with UM on September 16, 2022 to study the Company ascombination of September 30, 2017 is $1,039,770, includingOBC’s PDAT and TOP PV-305, a reserve for uncollectibilityformulation of $1,549,043 in connection with the resignation of Dr. Dees, the Company’s former Chairman and Chief Executive Officer, and termination of Mr. Culpepper, the Company’s former Chief Financial Officer and Chief Operating Officer, and former interim Chief Executive Officer following Dr. Dees’ resignation, with a present value discount remaining of $57,623. As a result of his resignation, Dr. Dees is no longer entitled to the 2:1 credit, such that his total repayment obligation of $2,040,000 (the total $2.24 million owed by Dr. Dees pursuant to the Derivative Lawsuit Settlement less the $200,000 that he repaid), plus Dr. Dees’ proportionate share of the litigation costs, is immediately due and payable. The Company sent Dr. Dees a notice of default in March 2016pharmaceutical-grade RBS, for the total amount he owes the Company. On July 25, 2017, the United States District Court for the Eastern Districttreatment of Tennessee at Knoxville issued a Memorandum Opinion finding, among other findings, that the Company is entitled to receive total damages in the amount of $6,027,652, including $2,494,525 for Dr. Dees’ breach of the Derivative Lawsuit Settlement. See Dees Collection Lawsuit below. As a result of his termination “for cause,” Mr. Culpepper is no longer entitled to the 2:1 credit, such that his total repayment obligation of $2,051,083 (the total $2.24 million owed by Mr. Culpepper pursuant to the Derivative Lawsuit Settlement plus Mr. Culpepper’s proportionate share of the litigation cost of $227,750 less the $416,667 that he repaid) is immediately due and payable. The Company sent Mr. Culpepper a notice of default in January 2017 for the total amount he owes the Company. Mr. Culpepper disputes that he was terminated “for cause” and thus disputes that he owes the full $2,051,083 repayment amount under the Derivative Lawsuit Settlement. See Culpepper Travel Expenses and Related Collection Efforts below.

Dees Collection Lawsuit

On May 5, 2016, the Company filed a lawsuit in the United States District Court for the Eastern District of Tennessee at Knoxville (the “Court”) against Dr. Dees and his wife, Virginia Godfrey (together with Dr. Dees, the “Defendants”)infectious keratitis. The Company allegedexercised the option to negotiate a license agreement with a negotiating period that between 2013ended on November 2, 2023, when negotiating exclusivity and 2015, Dr. Dees received approximately $2.4 million in advanced or reimbursed travel and entertainment expenses from the Company and that Dr. Dees did not use these funds for legitimate travel and entertainment expenses as he requestedright of first refusal no longer apply. UM’s Office of Technology Transfer and the Company intended. Instead, the Company alleged that Dr. Dees created false receipts and documentation for the expenses and applied the fundsare currently in negotiations to personal use. The Company and Dr. Dees are parties to the Derivative Lawsuit Settlement that was negotiated to resolve certain claims asserted against Dr. Dees derivatively. Pursuant to the terms of the Derivative Lawsuit Settlement, Dr. Dees agreed to repay the Company compensation that was paid to him along with legal fees and other expenses incurred by the Company. As of the date of his resignation, Dr. Dees still owed the Company $2,267,750 under the Derivative Lawsuit Settlement. Dr. Dees has failed to make such payment,potentially finalize a full license agreement. If UM and the Company has notified him that he is in defaultare unable to reach an agreement, UM may offer its patent rights to any third party.

12. Commitments, Contingencies and demanded payment in full. Litigation

The Company established a reservemay, from time to time, be involved in litigation arising from the ordinary course of $2,267,750 asbusiness. The Company is not aware of September 30, 2017 and December 31, 2016, which amount represents the amountany pending or threatened litigation that, if resolved against the Company, believed Dr. Dees owed to the Company as of those dates. Therefore, the Company alleged counts of conversion, fraud, breach of fiduciary duty, breach of contract, breach of the Derivative Lawsuit Settlement, unjust enrichment and punitive damages in this lawsuit. The Company sought an order that the Defendants be prohibited from disposing of any property that maywould have been paid for with the misappropriated funds, the Defendants be disgorged of any funds shown to be fraudulently misappropriated and that the Company be awarded compensatory damages in an amount not less than $5 million. Furthermore, the Company sought for the damages to be joint and several as to the Defendants and that punitive damages be awarded against Dr. Dees ina material adverse effect on the Company’s favor. The Company also sought foreclosure of the Company’s first-priority security interest in the 1,000,000 shares of common stock granted by Dr. Dees to the Company as collateral pursuant to that certain Stock Pledge Agreement dated October 3, 2014, between Dr. Dees and the Company in order to secure Dr. Dees’ obligations under the Derivative Lawsuit Settlement. The Court entered a default judgment against the Defendants on July 20, 2016. On March 15, 2017, the Court granted Ms. Godfrey’s motion to set aside the default judgment against her and set a deadline of March 30, 2017 for Ms. Godfrey to file an answer to the Company’s complaint. Ms. Godfrey filed her answer on March 28, 2017 demanding that the complaint against her be dismissed. The Court held a hearing on April 26, 2017 to determine damages with respect to the motion for default judgment against Dr. Dees. On July 25, 2017, the Court issued a Memorandum Opinion finding that the Company is entitled to receive total damages in the amount of $6,027,652, comprising compensatory damages for misappropriation of travel and expense funds, compensatory damages for Dr. Dees’ breach of the Derivative Lawsuit Settlement, and punitive damages, plus costs. There can be no assurance, however, that the Company will be able to recover any or all of the damages awarded to the Company. The Court also entered a permanent injunction enjoining Dr. Dees from selling or dissipating assets until the judgment against him is satisfied. On September 1, 2017, the Company filed a motion with the Court to appoint a receiver to sell 1,000,000 shares of the Company’s common stock held by Dr. Dees and pledged as security pursuant to the Derivative Lawsuit Settlement, and to remit the proceeds of this sale to the Company.

9

Culpepper Travel Expenses and Related Collection Efforts

On December 27, 2016, the Company’s Board of Directors unanimously voted to terminate Mr. Culpepper, effective immediately, from all positions he held with the Company and each of its subsidiaries, including interim Chief Executive Officer and Chief Operating Officer of the Company, “for cause”, in accordance with the terms of the Amended and Restated Executive Employment Agreement entered into by Mr. Culpepper and the Company on April 28, 2014 (the “Culpepper Employment Agreement”) based on thecondensed consolidated financial position, results of the investigation conducted by a Special Committee of the Board of Directors regarding improper travel expense advancements and reimbursements to Mr. Culpepper.operations or cash flows.

The Special Committee retained independent counsel and an advisory firm with forensic accounting expertise to assist the Special Committee in conducting the investigation. The Special Committee found that Mr. Culpepper received $294,255 in travel expense reimbursements and advances that were unsubstantiated. The Company seeks to recover from Mr. Culpepper the entire $294,255 in unsubstantiated travel expense reimbursements and advances, as well as all attorney’s fees and auditors’/experts’ fees incurred by the Company in connection with the examination of his travel expense reimbursements.13. Subsequent Events

Under the terms of the Culpepper Employment Agreement, Mr. Culpepper is owed no severance payments as a result of his termination “for cause” as that term is defined in the Culpepper Employment Agreement. Furthermore, Mr. Culpepper is no longer entitled to the 2:1 credit under the Derivative Lawsuit Settlement such that the total $2,240,000 owed by Mr. Culpepper pursuant to the Derivative Lawsuit Settlement plus Mr. Culpepper’s proportionate share of the litigation cost in the amount of $227,750 less the amount that he repaid as of December 31, 2016 is immediately due and payable. The Company sent Mr. Culpepper a notice of default in January 2017 for the total amount he owes the Company and is in the process of resolving these claims pursuant to the alternative dispute resolution provision of the Culpepper Employment Agreement. The Company has established a reserve of $2,051,083 as of September 30, 2017evaluated events that have occurred after the balance sheet and December 31, 2016, which amount representsthrough the amountdate the financial statements were issued. Based upon the evaluation, the Company currently believes Mr. Culpepper owes to the Company, while the Company pursues collection of this amount.

Mr. Culpepper disputesdid not identify any recognized or non-recognized subsequent events that he was terminated “for cause” under the Culpepper Employment Agreement. Pursuant to the alternative dispute resolution provisions of that agreement, the Company and Mr. Culpepper participated in a mediation of their dispute on June 28, 2017. Having reached no resolution during the mediation, the parties are proceeding to arbitration, under the commercial rules of the American Arbitration Association, which will include, among other claims, both Mr. Culpepper’s claim for severance against Provectus and Provectus’ claims against Mr. Culpepper for improper expense reimbursements and amounts Culpepper owes Provectus under the Derivative Lawsuit Settlement.

The Bible Harris Smith Lawsuit

On November 17, 2016, the Company filed a lawsuitwould have required adjustment or disclosure in the Circuit Court for Knox County, Tennessee against Bible Harris Smith PC (“BHS”) for professional negligence, common law negligence and breach of fiduciary duty arising from accounting services provided by BHS to the Company. The Company alleges that between 2013 and 2015, Dr. Dees received approximately $2.4 million in advanced or reimbursed travel and entertainment expenses from the Company and that Dr. Dees did not submit back-up documentation in support of substantially all of the advances he received purportedly for future travel and entertainment expenses. The Company further alleges that had BHS provided competent accounting and tax preparation services, it would have discovered Dr. Dees’ failure to submit back-up documentation supporting the advanced travel funds at the inception of Dr. Dees’ conduct, and prevented the misuse of these and future funds. The Company has made a claim for damages against BHS in an amount in excess of $3 million. The complaint against BHS has been filed and served, an answer has been received, and the parties are in the midst of discovery.financial statements, except as disclosed below.

The RSM Lawsuit

On June 9, 2017, the Company filed a lawsuit in the Circuit Court of Mecklenburg County, North Carolina against RSM USA LLP (“RSM”) for professional negligence, common law negligence, gross negligence, intentional misrepresentation, negligent misrepresentation and breach of fiduciary duty arising from accounting, internal auditing and consulting services provided by RSM to the Company. The Company alleges that between 2013 and 2015, Dr. Dees received approximately $2.4 million in advanced or reimbursed travel and entertainment expenses from the Company and that Dr. Dees did not submit back-up documentation in support of substantially all of the advances he received purportedly for future travel and entertainment expenses. The Company similarly alleges that Mr. Culpepper received $294,255 in travel expense reimbursements and advances that were unsubstantiated. The Company further alleges that had RSM provided competent accounting, internal audit and consulting services, it would have discovered Dr. Dees’ and Mr. Culpepper’s conduct at its inception and prevented the misuse of these and future funds. The Company has made a claim for damages against RSM in an amount in excess of $10 million. The Complaint against RSM has been filed and RSM has moved to dismiss the Complaint. The parties are briefing this motion and expect it to be argued to the Court in the next 60 days.

10

Other Regulatory Matters

From time to time the Company receives subpoenas and/or requests for information from governmental agencies with respect to its business. The Company received a subpoena from the staff of the SEC related to the travel expense advancements and reimbursements received by Dr. Dees. The Company also received a subsequent subpoena from the staff of the SEC related to the travel expense advancements and reimbursements received by Mr. Culpepper. At this time, the staff’s investigation into these matters remains ongoing, and the Company is cooperating with the staff. The Company also has engaged in settlement negotiations with the staff but no agreement has been approved by the Commission at this time, and there can be no assurance that a settlement will be reached.

7. Subsequent Events

Convertible Notes Payable

Subsequent to September 30, 2017,2023, the Company entered into PRH Notesa 2022 Note with accredited investorsa non-related party investor in the aggregate principal amount of $1,150,000$50,000 in connection with 2022 Loans received by the Company for the same amount. See Note 2 – Liquidity

Series D-1 Preferred Stock

Subsequent to September 30, 2023, principal and Financial Condition forinterest in the termsaggregate amount of $289,101, owed in connection with 2022 Notes was converted into 101,061 shares of Series D-1 Preferred Stock at the PRH Notes.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.

In addition, the Company received the remaining $1,000,000 in funding available under the Cal Enterprises LLC note, such that $2,500,000 of principal is now outstanding under the note.

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 11

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, 20162022 filed with the SEC on March 30, 2023 (“20162022 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.

OverviewClinical Development and Drug Discovery

The Company’s small molecule HX medical science platform, which comprises several different drug product candidates and preclinical formulations made from pharmaceutical-grade RBS using different concentrations and delivered by different routes of Core Technologiesadministration specific to each disease area and/or 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 preclinical combination therapy study for psoriasis and are undergoing preclinical 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 is undergoing preclinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis, at BPEI.

17

Preclinical In Vivo Proof-of-Concept Programs

●Oncology: ITU PV-10 has undergone and is underdoing preclinical 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 preclinical monotherapy study for the treatment of penile squamous cell carcinoma at an academic medical center. ITU PV-10 has undergone preclinical 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 preclinical 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 are undergoing preclinical 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 preclinical 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 preclinical 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 in canines of ITU administration.

Preclinical In Vitro Drug Discovery Programs

●Immune vaccine adjuvant: Different formulations have undergone and are undergoing preclinical 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 preclinical 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 preclinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug resistant strains) and have undergone preclinical monotherapy study for the treatment of oral bacterial infections at UTHSC.

Different formulations have undergone preclinical monotherapy study for the treatment of fungal infections at UTHSC.

●Tissue Regeneration and Repair: Different formulations are undergoing preclinical monotherapy study for vertebrate development, wound healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada.

Business Strategy

The Company is a biopharmaceutical company developing investigationalselectively 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 productsapproval pathways and/or co-development relationships with commercial pharmaceutical companies for ITU PV-10 based on Rose Bengalthese indications and related halogenated xanthenesdata.

The Company is developing a systemically administered formulation of pharmaceutical-grade RBS for the treatment of solid tumor cancers in adults as well as pediatric cancers (i.e.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”), intralesional PV-10),take an initial systemic drug product 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 inflammatory dermatoses for dermatology in both adults and children (i.e., topical PH-10).disease area.

The Company is innovatingdeveloping 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 preclinical 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 product 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 approachacademic medical centers under sponsored research and testing agreements. Our goal is to treating cancergain 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.

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RBS Drug Substance and Drug Product 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 drug substance and drug product candidate manufacturing processes; the production and multi-year stability testing of multiple drug substance and drug product candidate lots; the comprehensive documentation of lot composition and reproducibility; and the review and acceptance of CMC data from these lots by developingseven 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 drug substance and drug product 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 drug substance and ITU PV-10 drug product candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of drug substance and drug product 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 Nonproprietary 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 Nonproprietary 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.

19

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 preclinical 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 Swiss creator Rudolph Gnehm in 1881. Some manufacturers may, however, apply purification techniques that the Company believes still result in material 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 small molecule oncolytic immunotherapy. Deliveredquarter 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 and contrast these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS. This chemical analytical work was substantially completed by intralesional injection (i.e.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”), injection into a cancerous tumor), PV-10 can act locally, causing oncolytic destructionand that one of injected tumors. the three lots contained gross contaminants that were not represented on its CofA.

Potential Barriers to Entry

The local immunogenic cell death then hasCompany 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 engageovercome and validate for compliance with modern drug regulatory standards.

20

Components of Operating Results

Grant Revenue

Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the adaptive immune system for a systemic, or global, effect. By harnessingconditions of the immune systemgrant have been met. Cash received from grants in this way, PV-10 may enable patients to achieve immunity to their cancer. PH-10, delivered topically to affected skin, shares some similar mechanistic themes.advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as grant revenue when qualifying costs are incurred.

TheResearch and Development Expenses

A large component of our total operating expenses is the Company’s approach to druginvestment in research and development is centered around designing clinical studies for success based on science and medicine, rather than supportingactivities, including the broadest possible label at the outset. We have bifurcated our overall clinical development program into two complementary and related paths based on the features of our investigational drugsproduct candidates. Research and development expenses represent costs incurred to conduct research and undertake clinical trials to develop our drug product 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 rational applicabilityregulatory approval. Undertaking clinical development and relevancypursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are unable to different patient populations. In cancer,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 product candidates.

General and Administrative Expenses

General and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for example, we believe PV-10 has important implications as a single agentpersonnel 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 earlier stages of disease (i.e., Stage III or earlier), while combination of PV-10 with other classes of therapy or therapeutic agent is more appropriate for more advanced stages (i.e., Stage IV). Our ongoing preclinicallegal, patent and clinical work in melanoma, cancers of the liver, pancreatic cancer, and pediatric cancers, follow this approach.accounting services.

21

Results of Operations

Comparison of the Three Months Ended September 30, 20172023 and September 30, 20162022

Research and DevelopmentOverview

Research and Development expenses decreased by $71,346, or approximately 3%, from $2,461,407Grant revenue was $69,733 for the three months ended September 30, 20162023, a decrease of $245,157 or 77.9% compared to $2,390,061the three months ended September 30, 2022. Total operating expenses were $783,881 for the three months ended September 30, 2017. Research2023, a decrease of $197,198 or 20.1% compared to the three months ended September 30, 2022. The decrease was driven primarily by (i) decreased clinical trial costs, partially offset by (ii) higher payroll and developmenttaxes, (iii) higher legal costs related to patents, and (iv) higher professional fees related to the start of $2,390,061year-end audit work. Net loss for the three months ended September 30, 20172023 was $775,839, an increase of $62,572 or 8.8% compared to the three months ended September 30, 2022. The increase is primarily attributable to lower grant revenue recognized in the current quarter.

  For the Three Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Grant Revenue $69,733  $314,890  $(245,157)  -77.9%
                 
Operating Expenses:                
Research and development  350,792   580,390   (229,598)  -39.6%
General and administrative  433,089   400,689   32,400   8.1%
Total Operating Expenses  783,881   981,079   (197,198)  -20.1%
                 
Total Operating Loss  (714,148)  (666,189)  (47,959)  7.2%
                 
Other Income/(Expense):                
Research and development tax credit (deficit)  (167)  (638)  471   -73.8%
Interest expense, net  (61,524)  (46,440)  (15,084)  32.5%
                 
Total Other (Expense), Net  (61,691)  (47,078)  (14,613)  31.0%
                 
Net Loss $(775,839) $(713,267) $(62,572)  8.8%

Grant Revenue

For the three months ended September 30, 2023 and September 30, 2022, there was $69,733 and $314,890, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included amortizationwithin research and development expenses on the condensed consolidated statements of patents of $167,780, payroll of $215,705, consultingoperations.

Research and contract labor of $1,790,622, legal of $129,001, insurance of $75,073, lab supplies and pharmaceutical preparations of $7,820, rent and utilities of $982, and depreciation expense of $3,078. Development Expenses

Research and development costs of $2,461,407expenses were $350,792 for the three months ended September 30, 2016 included patent amortization expense2023, a decrease of $167,780, payroll of $206,563, consulting and contract labor of $1,866,360, legal of $109,828, insurance of $65,772, lab supplies and pharmaceutical preparations of $23,975, rent and utilities of $18,195, and depreciation expense of $2,934. The overall decrease was due primarily$229,598 or 39.6% compared to lower consulting and contract labor of approximately $75,738 and an increase of other costs totaling $4,392.

General and Administrative

General and administrative expenses decreased by $2,586,611, or approximately 78%, from $3,315,555$580,390 for the three months ended September 30, 20162022. The decrease was primarily due to $728,944(i) lower costs of clinical trials, partially offset by (ii) higher payroll and taxes.

  For the Three Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Operating Expenses:                
Research and development:                
Clinical trial and research expenses $198,002  $449,638  $(251,636)  -56.0%
Depreciation/amortization  1,764   1,765   (1)  -0.1%
Insurance  57,409   57,620   (211)  -0.4%
Payroll and taxes  85,244   62,457   22,787   36.5%
Rent and utilities  8,373   8,910   (537)  -6.0%
Total research and development $350,792  $580,390  $(229,598)  39.6%

22

General and Administrative Expenses

General and administrative expenses were $433,089 for the three months ended September 30, 2017. The overall decrease was due primarily to (i) decreased legal expenses of approximately $1.2 million due to a decline in investigations and litigation as well as lower negotiated hourly rates, (ii) an approximate $828,034 decrease in professional fees due to the termination and reduction in scope of certain vendor services and contracts, (iii) an approximate $176,430 decrease in payroll expense, which was due primarily to reduced salary and other benefits associated with the departure of certain executives in 2016, (iv) an approximate $155,895 decrease in travel and conference expenses, and (v) an approximate $278,750 decrease in directors fees, and2023, an increase of other costs totaling $34,263.

12

Investment Income

Investment income is immaterial$32,400 or 8.1% compared to $400,689 for all periods presented.

Public Offering Issuance Expense

Public offering expense was $436,248 as a result of a public offering in the three months ended September 30, 2016, as compared to no expense in the 2017 period.

Gain on Change in Fair Value of Warrant Liability

2022. The gain on change in fair value of warrant liabilityincrease was $336,649primarily due to a change in(i) higher legal fees related to patents and (ii) higher professional fees related to the fair valuestart of warrants that were issued in connection with our August 2016 public offering inyear-end audit work.

  For the Three Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Operating Expenses:                
General and administrative:                
Depreciation $466  $1,054  $(588)  -55.8%
Directors fees  96,250   96,250   -   0.0%
Insurance  45,302   45,272   30   0.1%
Legal  71,222   65,602   5,620   8.6%
Other general and administrative cost  15,724   14,991   733   4.9%
Payroll and taxes  60,829   61,554   (725)  -1.2%
Professional fees  138,620   111,310   27,310   24.5%
Rent and utilities  4,676   4,656   20   0.4%
                 
Total general and administrative $433,089  $400,689  $32,400   8.1%

Other Income/(Expense)

Research and development tax credit decreased from $(638) for the three months ended September 30, 2016, as compared2022 to no$(167) for the three months ended September 30, 2023. The decrease was mainly due to lower clinical trial activities in Australia resulting in a lower research and development tax refund.

Net interest expense increased by $15,084 from $46,440 for the three months ended September 30, 2022 to $61,524 for the three months ended September 30, 2023. The increase was mainly due to the interest expense costs incurred in connection with the 2017 period.higher note balances.

  For the Three Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Other Income/(Expense):                
Research and development tax credit (deficit) $(167)  (638)  471   -73.8%
Interest expense, net $(61,524)  (46,440) $(15,084)  32.5%
Total Other Income (Expenses), Net $(61,691) $(47,078) $(14,613)  31.0%

23

Comparison of the Nine Months Ended September 30, 20172023 and September 30, 20162022

Research and DevelopmentOverview

Research and Development expenses decreased by $251,971, or approximately 4%, from$6,874,353Grant revenue was $436,600 for the nine months ended September 30, 20162023, a decrease of $387,605 or 47.0% compared to$6,622,382 the nine months ended September 30, 2022. Total operating expenses were $2,733,164 for the nine months ended September 30, 2017.Research2023, a decrease of $835,268 or 23.4% compared to the nine months ended September 30, 2022. The decrease was driven primarily by (i) decreased clinical trial costs, (ii) lower rent and development costsutilities cost, (iii) lower legal fees, (iv) lower insurance cost, and (v) lower general and administrative cost due to receipt of $6,622,382employee retention credit and lower professional fees. Net loss for the nine months ended September 30, 20172023 was $2,438,355, a decrease of $383,675, or 13.6% compared to the nine months ended September 30, 2022. The decrease is primarily attributable to lower operating expenses offset by lower grant revenue recognized in the current year.

  For the Nine Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Grant Revenue $436,600  $824,205  $(387,605)  -47.0%
                 
Operating Expenses:                
Research and development  1,333,399   2,068,154   (734,755)  -35.5%
General and administrative  1,399,765   1,500,278   (100,513)  -6.7%
Total Operating Expenses  2,733,164   3,568,432   (835,268)  -23.4%
                 
Total Operating Loss  (2,296,564)  (2,744,227)  (447,633)  16.3%
                 
Other Income/(Expense):                
Research and development tax credit  15,798   37,621   (21,823)  -58.0%
Interest expense, net  (157,589)  (115,424)  (42,165)  36.5%
                 
Total Other Expense, Net  (141,791)  (77,803)  (63,988)  82.2%
                 
Net Loss $(2,438,355) $(2,822,030) $(383,675)  13.6%

Grant Revenue

For the nine months ended September 30, 2023 and September 30, 2022, there was $436,600 and $824,205, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included patent amortization expensewithin research and development on the condensed consolidated statements of $503,340, payroll of $395,192, consultingoperations.

Research and contract labor of $5,032,358, legal of $354,783, insurance of $228,961, lab supplies and pharmaceutical preparations of $22,272, rent and utilities of $38,922,conference expenses of $34,054, and depreciation expense of $12,500. Development Expenses

Research and development costs of $6,874,353expenses were $1,333,399 for the nine months ended September 30, 2016 included patent amortization expense2023, a decrease of $503,340, payroll of $737,704, consulting and contract labor of $5,054,234, legal of $256,238, insurance of $177,567, lab supplies and pharmaceutical preparations of $63,718, rent and utilities of $71,626, and depreciation expense of $9,926.

The overall decrease was due primarily$734,755 or 35.5% compared to decreased payroll expense of approximately $342,512, which was due to reduced salary and other benefits associated with the departure of an executive in 2016, and $21,876 reduction in contractor labor, offset by increases in legal of $98,545 and $13,872 of other costs.

General and Administrative

General and administrative expenses decreased by $8,256,972, or approximately 66%, from $12,454,661$2,068,154 for the nine months ended September 30, 20162022. The decrease was primarily due to $4,197,689(i) lower costs of clinical trials, (ii) lower rent and utilities, and (iii) lower insurance cost, partially offset by an increase in (iv) payroll and taxes.

  For the Nine Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
             
Operating Expenses:                
Research and development:                
Clinical trial and research expenses  913,881   1,655,623  $(741,742)  -44.8%
Depreciation/amortization  5,294   5,694   (400)  -7.0%
Insurance  172,065   173,510   (1,445)  -0.8%
Payroll and taxes  216,333   196,932   19,401   9.9%
Rent and utilities  25,826   36,395   (10,569)  -29.0%
Total research and development $1,333,399  $2,068,154  $(734,755)  -35.5%

24

General and Administrative Expenses

General and administrative expenses were $1,399,765 for the nine months ended September 30, 2017.The overall decrease was due primarily to (i) an approximate $2,718,407 decrease in warrant incentive expense which was recorded in the 2016 period, (ii) an approximate $2,142,509 decrease in professional fees due to the termination and reduction in scope of certain vendor services and contracts, (iii) decreased legal expenses of approximately $1,922,763 due to a decline in investigations and litigation, as well as lower negotiated hourly rates, (iv) an approximate $684,828 decrease in payroll expense which was due primarily to reduced salary and other benefits associated with the departure of certain executives in 2016, (v) an approximate $496,979 decrease in travel and conference expenses, and (vi) an approximate $242,917 decrease in director’s fees and2023, a decrease of other costs of $48,568.

Investment Income

Investment income is immaterial$100,513 or 6.7% compared to $1,500,278 for all periods presented.

Public Offering Issuance Expense

Public offering expense was $436,248 as a result of a public offering in the nine months ended September 30, 2016, as compared to no expense in the 2017 period.

Gain on Change in Fair Value of Warrant Liability

2022. The gain on change in fair value of warrant liabilitydecrease was $336,649primarily due to a change in the fair value(i) lower legal fees relating to patents, (ii) reduced rent and utilities cost, (iii) slightly lower insurance cost, (iv) lower other general and administrative cost related to receipt of warrants that were issued in connection with our August 2016 public offering inemployee retention credit, and (v) lower professional fees.

  For the Nine Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
Operating Expenses:                
General and administrative:                
Depreciation $1,397  $3,163  $(1,766)  -55.8%
Directors fees  288,750   288,750   -   0.0%
Insurance  134,390   138,162   (3,772)  -2.7%
Legal  278,819   304,223   (25,404)  -8.4%
Other general and administrative cost  28,634   72,326   (43,692)  -60.4%
Payroll and taxes  189,262   189,428   (166)  -0.1%
Professional fees  464,122   486,343   (22,221)  -4.6%
Rent and utilities  14,391   18,522   (4,131)  -22.3%
Foreign currency translation  -   (639)  639   -100.0%
Total general and administrative $1,399,765  $1,500,278  $(100,513)  -6.7%

Other Income/(Expense)

Research and development tax credit decreased from $37,621 for the nine months ended September 30, 2016, as compared2022 to no$15,798 for the nine months ended September 30, 2023. The decrease was mainly due to lower clinical trial activities in Australia resulting in a lower research and development tax refund.

Net interest expense increased by $42,165 from $115,424 for the nine months ended September 30, 2022 to $157,589 for the nine months ended September 30, 2023. The increase was mainly due to the interest expense costs incurred in connection with the 2017 period.higher note balances.

13
  For the Nine Months Ended       
  September 30,       
  2023  2022  Increase/(Decrease)  % Change 
Other Income/(Expense):                
Research and development tax credit $15,798  $37,621  $(21,823)  -58.0%
Interest expense, net  (157,589)  (115,424)  (42,165)  36.5%
Total Other Expense, Net $(141,791) $(77,803) $(63,988)  82.2%

Liquidity and Capital Resources

The Company’s cash and restricted cash equivalents were $208,281$1,410,207 at September 30, 2017,2023 which includes $1,042,957 of restricted cash resulting from a grant received from the State of Tennessee, compared with $1,165,738to $1,431,707 at December 31, 2016.2022, which included $1,410,102 of restricted cash. The Company’s working capital deficit was $7,579,249 and $6,293,198 as of September 30, 2023 and December 31, 2022, respectively. 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. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $216,019,230$252,026,996 as of September 30, 2017.2023. These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year afterfrom the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued.

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 obtainadditional financing as may be required to fund current operations.

As of September 30, 2023, cash required for our current liabilities included approximately $4,890,146 for accounts payable and other accrued expenses (including operating lease liabilities) and a $78,066 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 $2,992,500 plus accrued interest will mature one year from the date of the notes. As of September 30, 2023, cash required for our long-term liabilities consists of $37,714 for our operating lease. The Company intends to meet these cash requirements from its current cash balance and from future financing.

Management’s plans include selling itsour equity securities negotiating with significant vendors to reduce present and future obligations and obtaining other financing, including the issuance of 2022 unsecured convertible notes (the “2022 Financing”), to fund itsour capital requirementrequirements and on-going operations, including the 2017 Financing discussed below;operations; however, there can be no assurance that the Company will be successful in these efforts. During 2017, we have successfully negotiated reductions, with respect to outstanding obligation, owed to certain of our vendors (who provide research and development services), and we expect to continue to pursue further settlements, in consideration of our cash constraints. We have also successfully negotiated substantial reductions in professional fees to be paid to other service providers. The financial statements do not include any adjustment that might be necessary if the Company is unable to continue as a going concern. Significant funds will be needed for the Company to continue to implement its business plan of developing, licensing and/or commercializing the Company’s investigational drug products.and complete our ongoing and planned clinical trials.

The 2017 Financing

On March 23, 2017, the Company entered into an exclusive Definitive Financing Commitment Term Sheet with a group of the Company’s stockholders (the “PRH Group”), which was amended and restated effective as of March 19, 2017 (the “Term Sheet”), which sets forth the terms on which the PRH Group will use their best efforts to arrange for a financing of a minimum of $10,000,000 and maximum of $20,000,000 (the “2017 Financing”).

As of September 30, 2017, the Company had received aggregate Loans (as defined below) of $7,100,000 in connection with the 2017 Financing. Subsequent to September 30, 2017, the Company received aggregate proceeds of $2,150,000 in connection with the 2017 Financing.

The 2017 Financing is in the form of a secured convertible loan (the “Loan”) from the PRH Group or other investors in the 2017 Financing (the “Investors”). The Loan is evidenced by secured convertible promissory notes (individually a “PRH Note” and collectively, the “PRH Notes”) from the Company to the PRH Group or the Investors. In addition to the customary provisions, the PRH Note contains the following provisions:

(i)It is secured by a first priority security interest on the Company’s intellectual property (the “IP”);
(ii)The Loan bears 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;
(iii)The Loan proceeds are held in one or more accounts (the “Escrow”) pending the funding of the tranches of the 2017 Financing pursuant to borrowing requests made by the Company;
(iv)The PRH Notes, including interest and principal, shall be due and payable in full on the earlier of: (i) on such date upon which the Company defaults under the PRH Notes, (ii) upon a change of control of the Company, or (iii) dates ranging from April 2, 2019 to the twenty-four (24) month anniversary of the funding of the Final Tranche, depending on the specific PRH Note. In the event there is a change of control of the Company’s board of directors (the “Board”) as proposed by any person or group other than the Investors, the term of the PRH Notes will be accelerated and all amounts due under the PRH Notes will be immediately due and payable, plus interest at the rate of eight percent (8%) per annum, plus a penalty in the amount equal to ten times (10x) the outstanding principal amount of the Loan that has been funded to the Company;
(v)The outstanding principal amount and interest payable under the Loan will be convertible at the sole discretion of the Investors into shares of the Company’s Series D Preferred Stock, a new series of preferred stock to be designated by the Board, at a price per share equal to $0.2862; and25

 14

(vi)Notwithstanding (v) above, the principal amount of the PRH Note and the interest payable under the Loan will automatically convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $0.2862 effective on the 24-month anniversary of the funding of the final tranche of the 2017 Financing subject to certain exceptions.

As of September 30, 2017, and through the date of filing, the Series D Preferred Stock had not been designated by the Board. As a result, the PRH Notes were not convertible as of their respective dates of issuance or as of September 30, 2017.

The Series D Preferred Stock shall have a first priority right to receive proceeds from the sale, liquidation or dissolution of the Company or any of the Company’s assets (each, a “Company Event”). If a Company Event occurs within two (2) years of the date of issuance of the Series D Preferred Stock (the “Date of Issuance”), the holders of Series D Preferred Stock shall receive a preference of four times (4x) their respective investment amount. If a Company Event occurs after the second (2nd) anniversary of the Date of Issuance, the holders of the Series D Preferred Stock shall receive a preference of six times (6x) their respective investment amount.

The Series D Preferred Stock shall be convertible at the option of the holders thereof into shares of the Company’s common stock based on a formula to achieve a one-for-one conversion ratio. The Series D Preferred Stock shall automatically convert into shares of Common Stock upon the fifth anniversary of the Date of Issuance. On an as-converted basis, the Series D Preferred Stock shall carry the right to one (1) vote per share. The Series D Preferred Stock shall not have any dividend preference but shall be entitled to receive, on apari passu basis, dividends, if any, that are declared and paid on any other class of the Company’s capital stock. The holders of Series D Preferred Stock shall not have anti-dilution protection.

NYSE Delisting

 

On October 13, 2016, the Company received notice from NYSE MKT that NYSE MKT commenced delisting procedures and immediately suspended trading in the Company’s common stock and class of warrants that was listed on NYSE MKT (“Listed Warrants”) and on October 17, 2016, our common stock began trading on the OTCQB Marketplace. On October 20, 2016, the Company submitted a request for a review of such delisting determination and on November 10, 2016, the Company submitted to the Listing Qualifications Panel its written submission in connection with its appeal. In addition, on November 23, 2016, the Company received notice from NYSE MKT stating that the Company was not in compliance with Section 1003(a)(iii) of the NYSE MKT Company Guide (requiring stockholders’ equity of $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years). As of December 31, 2016, the Company had stockholders’ equity of approximately $3.5 million.

The hearing before the Listing Qualifications Panel occurred on January 25, 2017. On January 31, 2017, the Company received notice from the Listing Qualifications Panel that it affirmed NYSE MKT’s original determination to delist the Company’s common stock and Listed Warrants. On February 14, 2017, the Company submitted a request for the Committee for Review to reconsider the Listing Qualification Panel’s decision. The Committee for Review considered the Company’s request for review on March 30, 2017. On April 21, 2017, the NYSE MKT filed a Form 25 with the U.S. Securities and Exchange Commission (the “SEC”), notifying the SEC of the NYSE MKT’s intention to remove the Company’s shares of common stock and Listed Warrants from listing and registration on the NYSE MKT effective May 1, 2017, pursuant to the provisions of Rule 12d2-2(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Company’s common stock and Listed Warrants continue to trade on the OTCQB following the delisting from the NYSE MKT under the trading symbols “PVCT” and “PVCTWS,” respectively. The Company can provide no assurance that its common stock and Listed Warrants will continue to trade on the OTCQB in the future.

Access to Capital

Management plans to access capital resources through possible public or private equity offerings, including the 20172022 Financing, exchange offers,equity financings, debt financings, corporate collaborations, or other means. The Company has historically been able to raise capital through equity offerings, although no assurance can be provided that it will continue to be successful in the future. If the Company iswe are unable to raise sufficient capital, through the 2017 Financing or otherwise, itwe will not be able to pay itsour obligations as they become due.

The primary business objective of Managementmanagement is to build the Company into a fully integratedcommercial-stage biotechnology company. However, the Company cannot assure youcompany; however, there can be no assurance that itmanagement will be successful in implementing itsthe Company’s business plan of developing, licensing, and/or commercializing the Company’s investigationalour prescription drug products.product 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 20172023 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, including the 2017 Financing, the exercise of existing warrants and 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, we cannot assure youthere can be no assurance that we will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.

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Critical Accounting Estimates and Policies

Management’s discussion and analysis of financial condition and results of operations is based upon our condensedSince the date the Company’s December 31, 2022 consolidated financial statements which have been preparedwere issued in accordance with GAAP. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. Management bases its estimates on historical experience and assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe2022 Annual Report, there have been no material changes to the items that we disclosed asCompany’s significant accounting policies. Refer to our criticalAnnual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 30, 2023 and Note 3 to the condensed consolidated financial statements of this Quarterly Report on Form 10-Q, for a discussion of our significant accounting policies and use of estimates.

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 Part II, Item 7, “Management’s DiscussionRegulation FD: the Provectus Substack account (provectus.substack.com), the @ProvectusBio X account (twitter.com/provectusbio), and Analysisthe 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 Financial Condition and Resultsdisclosing the information described above may be updated from time to time.

The contents of Operations,”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 2016 Form 10-K.references to the URLs for these websites are intended to be inactive textual references only.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not applicable.

ITEM 4. CONTROLS AND PROCEDURES.

Management,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 at September 30, 2017.of 1934, as amended (the “Exchange Act”). Based on thatthis 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 not 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.

Management’s assessment of internal controls over financial reporting at December 31, 2016 identified certain material weaknesses, as detailed in our 2016 Form 10-K. As of the filing date of this Quarterly Report, we have completed our remediation of certain deficient internal controls, including:

●Our new directors and officers have reestablished an appropriate “tone at the top” that is conducive to the proper designing, and functioning of a system of internal control.
●Enhanced the design and functioning of controls over:

-

period-end financial reporting, including the implementation of a quarterly financial close checklist;

-disclosure processes, including the establishment of a Disclosure Committee that meets quarterly in advance of the filing of our Quarterly and Annual Reports;
-the information technology environment; and
-travel and entertainment expenditures.

●

Added procedures designed to improve the evidencing of (i) transaction approvals; and (ii) certain review functions.

●

Improved the segregation of duties by adding a controller to the finance function of the Company.

Sincethese remediation measures have not been in place and tested for a sufficient period of time, we are not yet in a position to conclude that our disclosure controls and procedures and our internal controls over financial reporting are now effective, but that is our near-term goal.

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, except the implementation of the controls identified above.

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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, dodoes 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.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.

Our management is responsible for establishing and maintaining adequateChanges in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) underthat occurred during the Exchange Act). Ourfiscal 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 is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes in accordance with GAAP. Our internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures by us are being made only in accordance with authorizations of our management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the consolidated financial statements.reporting.

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PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

The information required by this item is incorporated by reference from Part 1,I, Item 1. Financial Statements, Notes to Condensed Consolidated Financial Statements, Note 6 – Litigation.12.

ITEM 1A. RISK FACTORS.

There have been no material changes to the risk factors that were disclosed in our Annual Report onthe 2022 Form 10-K for the year ended December 31, 2016.10-K.

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

20172022 Financing

During the three and nine months ended September 30, 2023, the Company received aggregate proceeds of $900,000 and $2,225,000, respectively, pursuant to certain unsecured convertible notes (the “2022 Notes”). Through September 30, 2023, the Company had drawn down $2,977,500 under the 2022 Notes.

The information above under “Part 1, Item 2. Management’s Discussion

For further details on the terms of the 2022 Notes, refer to our Form 10-K as filed with the SEC on March 30, 2023.

Preferred Convertible Stock

During the three months ended September 30, 2023, the Company issued 122,725 shares of restricted Series D-1 Convertible Preferred Stock upon the conversion of $325,000 of principal and Analysis$26,232 accrued interest outstanding on the 2021 Notes.

During the nine months ended September 30, 2023, the Company issued 330,354 shares of Financial Conditionrestricted Series D-1 Convertible Preferred Stock upon the conversion of $875,000 of principal and Results$70,466 accrued interest outstanding on the 2021 Notes.

During the three and nine months ended September 30, 2023, the Company issued 69,838 shares of Operations—Liquidityrestricted Series D-1 Convertible Preferred Stock upon the conversion of $185,000 of principal and Capital Resources—The 2017 Financing” is incorporated herein by reference.$14,875 accrued interest 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 506506(b) of Regulation D promulgated thereunder) as transactions by an issuer not involving a public offering.

Exercise of Warrants

During the quarter ended September 30, 2017, a warrant holder exercised a warrant to purchase 10,000 shares of common stock at a price of $0.053 per share or $533.00.

Issuance of Common Stock in Payment of Trade Debt

Also during the quarter ended September 30, 2017, the Company issued 372,500 shares of restricted unregistered common stock at an average price of $0.046 per share or $17,300 to holders in settlement of trade debt.

17

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

NoneNone.

ITEM 4.Mine Safety Disclosures.

Not applicable.

ITEM 5. OTHER INFORMATION.

None.

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ITEM 6. EXHIBITS.

Exhibit

No.

Description
31.1**Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
31.2**Certification of Interim Chief Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
32***Certification of Principal Executive Officer and Interim Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification).
101*101.INS**Inline XBRL Instance Document – the instance document does not appear in the Interactive Data Files.File because its XBRL tags are embedded within the Inline XBRL document.
**Filed herewith.
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.

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 18

SIGNATURES

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.
November 8, 201714, 2023By:/s/ Timothy C. Scott, Ph.D.Bruce Horowitz
Timothy C. Scott, Ph.D.Bruce Horowitz
On behalf of the registrant and as PresidentChief Operating Officer (Principal Executive Officer)
By:/s/ John R. GlassHeather Raines
John R. GlassHeather Raines, CPA
Interim Chief Financial Officer (Principal Financial Officer)

1930