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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2022

 

or

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to

 

Commission file number 001-36457

 

PROVECTUS BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   90-0031917

(State or other jurisdiction

of incorporation or organization)

  

(I.R.S. Employer

Identification No.)
     

10025 Investment Drive, Suite 250

Knoxville, Tennessee

   37932
(Address of principal executive offices)   (Zip Code)

 

866-594-5999

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
None   N/A   N/A

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐
       
Non-accelerated filer ☒ Smaller reporting company ☒
       
    Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

 

The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of May 11, 2022, was 419,447,119.

 

 

 

 
 

 

TABLE OF CONTENTS

 

  Page
PART I - FINANCIAL INFORMATION  
   
Cautionary Note Regarding Forward-Looking Statements 1
Item 1. Financial Statements (unaudited) 2
Condensed Consolidated Balance Sheets 2
Condensed Consolidated Statements of Operations 3
Condensed Consolidated Statements of Comprehensive Loss 4
Condensed Consolidated Statements of Changes in Stockholders’ Deficiency 5
Condensed Consolidated Statements of Cash Flows 6
Notes to Condensed Consolidated Financial Statements 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 12
Item 3. Quantitative and Qualitative Disclosures About Market Risk 17
Item 4. Controls and Procedures 17
   
PART II - OTHER INFORMATION  
   
Item 1. Legal Proceedings 17
Item 1A. Risk Factors 17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 17
Item 3. Defaults Upon Senior Securities 18
Item 4. Mine Safety Disclosures 18
Item 5. Other Information 18
Item 6. Exhibits 18
   
SIGNATURES 19

 

 
 

 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “predict,” “project,” “should,” “strategy,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements after this date, unless otherwise required by law.

 

Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”) (including those described in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2021), and Item 1A of Part II of this Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and:

 

  ● Our potential receipt of sales from investigational rose bengal sodium-based drug products PV-10® and PH-10®, and/or any other halogenated xanthene-based drug products (if and when approved); and licensing, milestone, royalty, and/or other payments related to these investigational drug products and/or the Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual property relating to rose bengal sodium-based and other halogenated xanthene-based investigational drug products and/or drug substances,
     
  ● Our ability to raise additional capital through the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, and/or public offerings of debt or equity securities,
     
  ● The widespread outbreak of an illness or communicable/infectious disease, such as severe acute respiratory syndrome coronavirus 2, or a public health crisis, could disrupt our business and adversely affect our operations and financial condition, and
     
  ● Recently, many companies across a variety of sectors have reported disruptions, shortages, and other supply chain-related issues. In the biopharmaceutical sector, delays and interruptions in the supply chain have been particularly pronounced. During the first quarter of 2022, we were able to effectively manage our supply of prescription drug candidates in a manner that avoided any significant interruptions to our clinical programs.

 

1
 

 

PART I - FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS.

 

PROVECTUS BIOPHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    March 31,     December 31,  
    2022     2021  
      (Unaudited)          
Assets                
                 
Current Assets:                
Cash and cash equivalents   $ 173,614     $ 682,984  
Restricted cash     2,307,395       2,423,958  
Short-term receivables     3,050       5,107  
Prepaid expenses and other current assets     227,908       329,908  
                 
Total Current Assets     2,711,967       3,441,957  
                 
Equipment and furnishings, less accumulated depreciation of $94,396 and $91,178, respectively     28,618       31,836  
Operating lease right-of-use asset     15,177       39,563  
                 
Total Assets   $ 2,755,762     $ 3,513,356  
                 
Liabilities and Stockholders’ Deficiency                
                 
Current Liabilities:                
Accounts payable   $ 1,597,496     $ 1,287,459  
Deposit for purchase of Series D-1 Preferred Stock     -       150,000  
Unearned grant revenue     2,312,395       2,500,000  
Other accrued expenses     2,185,761       2,002,486  
Accrued interest     35,856       10,578  
Accrued interest - related parties     10,044       6,044  
Notes payable     154,925       238,452  
Convertible notes payable     1,310,000       1,260,000  
Convertible notes payable - related parties     200,000       200,000  
Operating lease liability     18,203       45,617  
                 
Total Current Liabilities     7,824,680       7,700,636  
                 
Commitments, contingencies, and litigations (Note 11)     -           
                 
Stockholders’ Deficiency:                
Series D Convertible Preferred Stock; 12,374,000 shares designated; 12,373,247 shares issued and outstanding at March 31, 2022 and December 31, 2021; aggregate liquidation preference of $14,164,889 at March 31, 2022 and December 31, 2021                 12,373                       12,373      
Series D-1 Convertible Preferred Stock; 11,241,000 shares designated; 9,270,860 and 9,218,449 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively; aggregate liquidation preference of
$106,132,320 and $105,532,804 at March 31, 2022 and December 31, 2021, respectively		  
     		               9,271                               9,219        
Common stock; par value $0.001 per share; 1,000,000,000 shares authorized; 419,447,119 shares issued and outstanding at March 31, 2022 and December 31, 2021                 419,447                       419,447      
Additional paid-in capital     241,590,054       241,440,106  
Accumulated other comprehensive loss     (35,183 )     (34,467 )
Accumulated deficit     (247,064,880 )     (246,033,958 )
                 
Total Stockholders’ Deficiency     (5,068,918 )     (4,187,280 )
                 
Total Liabilities and Stockholders’ Deficiency   $ 2,755,762     $ 3,513,356  

 

See accompanying notes to condensed consolidated financial statements.

 

2
 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

    2022     2021  
    For the Three Months Ended  
    March 31,  
    2022     2021  
             
Grant Revenue   $ 187,605     $ -  
                 
Operating Expenses:                
Research and development     671,116       655,144  
General and administrative     516,547       525,532  
Total Operating Expenses     1,187,663       1,180,676  
                 
Total Operating Loss     (1,000,058 )     (1,180,676 )
                 
Other Income/(Expense):                
Interest income and interest expense     (30,864 )     (489,274 )
                 
Total Other Expense, Net     (30,864 )     (489,274 )
                 
Net Loss   $ (1,030,922 )   $ (1,669,950 )
                 
Basic and Diluted Loss Per Common Share   $ (0.00 )   $ (0.00 )
                 
Weighted Average Number of Common Shares Outstanding - Basic and Diluted     419,447,119       402,184,815  

 

See accompanying notes to condensed consolidated financial statements.

 

3
 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

 

    2022     2021  
    For the Three Months Ended  
    March 31,  
    2022     2021  
             
Net Loss   $ (1,030,922 )   $ (1,669,950 )
Other Comprehensive Loss:                
Foreign currency translation adjustments     (716 )     837  
Total Comprehensive Loss   $ (1,031,638 )   $ (1,669,113 )

 

See accompanying notes to condensed consolidated financial statements.

 

4
 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY

(Unaudited)

 

FOR THE THREE MONTHS ENDED MARCH 31, 2022

 

    Preferred Stock   Preferred Stock   Preferred Stock           Additional   Accumulated Other        
    Series B   Series D   Series D-1   Common Stock   Paid-In   Comprehensive   Accumulated    
    Shares   Amount   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 )

 

FOR THE THREE MONTHS ENDED MARCH 31, 2021

 

    Preferred Stock   Preferred Stock   Preferred Stock           Additional   Accumulated Other        
    Series B   Series D   Series D-1   Common Stock   Paid-In   Comprehensive   Accumulated    
    Shares   Amount   Shares   Amount   Shares   Amount   Shares   Amount   Capital   Loss   Deficit   Total
                                                 
Balance at January 1, 2021     100     $ -        -      -      -      -     398,807,037     $ 398,808     $ 209,923,347     $ (34,097 )   $ (240,494,415 )   $ (30,206,357 )
                                                                                                 
Common stock issued upon exercise of warrants     -       -        -      -      -      -     4,500,000       4,500       235,350       -       -       239,850  
Stock-based compensation:                                                                                                
Common Stock     -       -                               250,000       250       19,500       -       -       19,750  
Comprehensive loss:                                                     -                                  
Net loss     -       -          -        -        -        -     -       -       -       -       (1,669,950 )     (1,669,950 )
Other comprehensive loss     -       -                                       -       -       -       837       -       837  
                                                                                                 
Balance at March 31, 2021     100     $ -        -      -      -      -     403,557,037     $ 403,558     $ 210,178,197     $ (33,260 )   $ (242,164,365 )   $ (31,615,870 )

 

See accompanying notes to condensed consolidated financial statements.

 

5
 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    2022     2021  
    For the Three Months Ended  
    March 31,  
    2022     2021  
Cash Flows From Operating Activities:                
Net loss   $ (1,030,922 )   $ (1,669,950 )
Adjustments to reconcile net loss to net cash used in operating activities:          
 		  
 		  
 		  
 		  
 		  
 
Stock-based compensation     -       19,750  
Non-cash lease expense     24,386       20,006  
Depreciation     3,218       3,216  
Changes in operating assets and liabilities                
Short term receivables     2,143       (515 )
Prepaid expenses     101,964       45,822  
Accounts payable     309,732       (10,927 )
Unearned grant revenue     (187,605 )     -  
Other accrued expenses     183,001       12,252  
Operating lease liability     (27,414 )     (21,096 )
Accrued interest expense     29,278       487,962  
                 
Net Cash Used In Operating Activities     (592,219 )     (1,113,480 )
                 
Cash Flows From Financing Activities:                
Proceeds from issuance of convertible notes payable  
 		  
 		  
50,000		  
 		  
 		  
 		  
1,200,000		  
 
Repayment of short-term note payable     (83,527 )     (74,417 )
Proceeds from exercise of warrants     -       239,850  
Net Cash (Used In) Provided By Financing Activities     (33,527 )     1,365,433  
                 
Effect of exchange rates on cash, cash equivalents, and restricted cash     (187 )     587  
                 
Net (Decrease) Increase In Cash, Cash Equivalents, and Restricted Cash     (625,933 )     252,540  
                 
Cash, Cash Equivalents, and Restricted Cash, Beginning of Period     3,106,942       97,231  
                 
Cash, Cash Equivalents, and Restricted Cash, End of Period   $ 2,481,009     $ 349,771  
                 
Cash, cash equivalents and restricted cash consisted of the following:                
Cash and cash equivalents   $ 173,614     $ 349,771  
Restricted cash     2,307,395       -  
    $ 2,481,009     $ 349,771  
                 
Supplemental Disclosures of Cash Flow Information:                
Cash paid during the period for:                
Interest   $ -     $ -  
Income taxes   $ -     $ -  

 

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 with its subsidiaries, “Provectus” or the “Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, based on a class of small molecules called halogenated xanthenes (“HXs”) that is entirely owned by the Company. Our lead HX molecule is named rose bengal sodium (“RBS”). A second synthesized HX molecule is 4,5,6,7-tetrabromo-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenz- ofuran-1,9′-xanthen]-3-one.

 

  ●

Oncology: PV-10®, an investigational cancer immunotherapy administered by intralesional (“IL”) injection and an injectable formulation of cGMP RBS, is undergoing clinical study for adult solid tumor cancers, such as melanoma and gastrointestinal (“GI”) tumors, including hepatocellular carcinoma (“HCC”), colorectal cancer metastatic to the liver (“mCRC”), neuroendocrine tumors (“NET”) metastatic to the liver (“mNET”), and uveal melanoma metastatic to the liver (“mUM”), among others. Orphan drug designation (“ODD”) status was granted to PV-10 by the U.S. Food and Drug Administration (the “FDA”) for metastatic melanoma in 2006, HCC in 2011, and ocular melanoma (including uveal melanoma) in 2019.

 

Oral formulations of cGMP RBS are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, such as head and neck, breast, colorectal, and testicular cancers. In vivo data of a colorectal tumor murine model that continuously promotes abnormal cell proliferation and transformation into cancer indicate increased survival in both prophylactic and therapeutic settings.
     
  ● Pediatric Oncology: IL PV-10 is undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma). ODD status was granted to PV-10 by the FDA for neuroblastoma in 2018.
     
  ● Hematology: Oral formulations of cGMP RBS are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including leukemias). In vivo data of an acute lymphoblastic leukemia murine model indicated increased survival.
     
  ● Virology: Systemic administration of formulations of cGMP RBS are undergoing preclinical study for the novel strain of coronavirus (“CoV”): severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”). In silico data indicate docking-based binding affinity to SARS-CoV-2’s main protease, spike protein, and different variants of the spike protein. In vitro data indicate activity against SARS-CoV-2 in African green monkey kidney cell (Vero) and human lung epithelial cell (Calu-3) models, and synergistic activity with remdesivir in a Vero cell model.
     
  ● Microbiology: Different formulations of cGMP RBS are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”) bacteria, such as gram-positive and gram-negative. In vitro data indicate activity against a battery of gram-positive bacteria, including MDR strains, under fluorescent, LED, and natural light, and against gram-positive bacterial biofilms.
     
  ● Ophthalmology: Topical formulations of cGMP RBS are undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis.
     
  ● Dermatology: PH-10®, an investigational immune-dermatology agent administered as a topical formulation of cGMP RBS, is undergoing monotherapy clinical study and preclinical study as a monotherapy and in combination therapy with approved drugs for inflammatory dermatoses (including psoriasis and atopic dermatitis).
     
  ● Animal Health: Different formulations of cGMP RBS are undergoing development as potential treatments for animal cancers and dermatological disorders.

 

To date, the Company has not generated any revenues or profits from planned principal operations. The Company’s activities are subject to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription drug candidates.

 

7
 

 

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, 2021 filed with the SEC on March 29, 2022. 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 months ended March 31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.

 

SARS-CoV-2 was reportedly first identified in late-2019 and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets they serve. The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees and contractors and to minimize business disruption. The Company considered the impact of SARS-CoV-2 pandemic on its business and operational assumptions and estimates, and determined there were no material adverse impacts on the Company’s results of operations and financial position at March 31, 2022.

 

The full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is uncertain. The Company has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate and/or complete current and/or future preclinical studies and/or clinical trials, disrupt the Company’s regulatory activities, and/or have other adverse effects on the Company’s clinical development.

 

2. Liquidity and Going Concern

 

The Company’s cash, cash equivalents, and restricted cash were $2,481,009 at March 31, 2022 which includes the $2,307,395 of restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficiency was $5,112,713and $4,258,679as of March 31, 2022 and December 31, 2021, respectively. The Company continues to incur significant operating losses. Management expects that significant on-going operating expenditures will be necessary to successfully implement the Company’s business plan and develop and market its products. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to develop PV-10, PH-10, and/or any other halogenated xanthene-based drug products, and to raise additional capital.

 

The Company plans to access capital resources through possible public or private equity offerings, including the 2021 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 assurance can be provided that it will continue to be successful in the future. If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due.

 

8
 

 

The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, the Company cannot assure that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other halogenated xanthene-based drug candidate developed by the Company or entering into any financial transaction. Moreover, even if the Company is successful in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements in 2022 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While the Company believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide assurance that it will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.

 

3. Significant Accounting Policies

 

Since the date the Company’s December 31, 2021 consolidated financial statements were issued in its 2021 Annual Report, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.

 

Recently Adopted Accounting Standards

 

In October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-10 “Codification Improvements”, which improves consistency by amending the Codification to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions in the Codification by amending and adding new headings, cross referencing to other guidance, and refining or correcting terminology. The guidance is effective for the Company beginning in the first quarter of fiscal year 2022 with early adoption permitted. The Company adopted this standard on January 1, 2022 and it did not have a material effect on its condensed consolidated financial statements.

 

On May 3, 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company adopted this standard on January 1, 2022 and it did not have a material effect on its condensed consolidated financial statements.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of March 31, 2022 and December 31, 2021, the Company’s cash equivalents consist of Treasury bills of $42,594.

 

Restricted Cash

 

Restricted cash consists of a grant award of $2,500,000 received in cash from the State of Tennessee less expenses and deposits to vendors in the amount of $192,605. See Note 10. Grants.

 

Cash Concentrations

 

Cash, cash equivalents, 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 no assurance can be provided that it will not experience any losses in the future. As of March 31, 2022 and December 31, 2021, the Company had cash, cash equivalent, and restricted cash balances in excess of FDIC insurance limits of $2,231,009 and $2,856,942, respectively.

 

Reclassifications

 

Certain prior year balances have been reclassified in order to conform to current year presentation. These reclassifications had no effect on previously reported results of operations or loss per share.

 

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:

 

    March 31,     March 31,  
    2022     2021  
Warrants     512,500       82,764,164  
Options     3,625,000       4,800,000  
Convertible preferred stock     105,081,847       65,666  
2021 unsecured convertible notes     5,436,408       -  
                 
Total potentially dilutive shares     114,655,755       87,629,830  

 

9
 

 

4. Other Accrued Expenses

 

The following table summarizes the other accrued expenses at March 31, 2022 and December 31, 2021:

 

    March 31, 2022     December 31, 2021  
Accrued payroll and taxes   $ 244,349     $ 174,533  
Accrued vacation     50,859       42,871  
Accrued directors’ fees     1,656,839       1,560,589  
Accrued other expenses     233,714       224,493  
Total Other Accrued Expenses   $ 2,185,761     $ 2,002,486  

 

5. Convertible Notes Payable

 

2021 Financing

    Non-Related Party     Related Party        
    Face Amount     Face Amount     Total  
Balance as of January 1, 2022   $ 1,260,000     $ 200,000     $ 1,460,000  
                         
Issued     50,000       -        50,000  
                         
Balance as of March 31, 2022   $ 1,310,000     $ 200,000     $ 1,510,000  

 

For further details on the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.

 

As of March 31, 2022, the Company had received 2021 Notes proceeds of $1,510,000, of which $200,000 is from a related party investor (an officer of the Company).

 

6. Notes Payable

 

The Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of March 31, 2022 and December 31, 2021, the balance of the note payable was $154,925 and $238,452, respectively.

 

7. Related Party Transactions

 

During the three months ended March 31, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $42,400 and $84,800, respectively, for services rendered. Director fees for Mr. Horowitz for the three months ended March 31, 2022 and 2021 were $18,750 and $18,750, respectively. Accrued director fees for Mr. Horowitz as of March 31, 2022 and December 31, 2021 were $300,000 and $281,250, respectively. Total amount owed to Capital Strategists as of March 31, 2022 and December 31, 2021 were $127,200. Mr. Horowitz serves as both COO and a Director, of the Company.

 

See Note 5 for details of other related party transactions.

 

Director fees during the three months ended March 31, 2022 and 2021 were $96,250 and $96,250, respectively. Accrued directors’ fees as of March 31, 2022 and December 31, 2021 were $1,656,839 and $1,560,589, respectively.

 

8. Stockholders’ Deficiency

 

Preferred Stock

 

During the three months ended March 31, 2022, the Company issued 52,411 shares of restricted Series D-1 Convertible Preferred Stock in exchange for an investment of $150,000 from a non-related party investor.

 

10
 

 

9. Leases

 

The Company currently leases 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 are approximately $6,100 per month.

 

On February 23, 2022, the Company negotiated a continued reduced rent from January 1, 2022 through June 30, 2022 in the amount of $6,100 per month.

 

Total operating lease expense for the three months ended March 31, 2022 was $14,959, of which, $9,973 was included within research and development and $4,986 was included within general and administrative expenses on the condensed consolidated statement of operations. Total operating lease expense for the three months ended March 31, 2021 was $24,762, of which, $16,508 was included within research and development and $8,254 was included within general and administrative expenses on the condensed consolidated statement of operations.

 

A summary of the Company’s right-of-use assets and liabilities is as follows:

 

    For The Three Months Ended  
    March 31,  
    2022     2021  
Cash paid for amounts included in the measurement of lease liabilities:                
Operating cash flows used in operating leases   $ 18,447     $ 23,831  
                 
Right-of-use assets obtained in exchange for lease obligations:                
Operating leases   $ -     $ -  
                 
Weighted Average Remaining Lease Term                
Operating leases     3 months       1 year 3 months  
                 
Weighted Average Discount Rate                
Operating leases     8.0 %     8.0 %

 

Future minimum payments under the Company’s non-cancellable lease obligations as of March 31, 2022 were as follows:

 

Years   Amount  
2022   $ 18,447  
Total future minimum lease payments     18,447  
Less: amount representing imputed interest     (234 )
Total   $ 18,203  

 

10. Grants

 

On October 25, 2021, the Company received a grant award of $2,500,000 from the State of Tennessee for the study of animal cancers and dermatological disorders for the period October 15, 2021 to June 30, 2022. As of March 31, 2022, the grant award of $2,312,395 is recorded as unearned grant revenue liability on the accompanying condensed consolidated balance sheets. The Company recorded $187,605 of grant revenue during the three months ended March 31, 2022.

 

11. Commitments, Contingencies and Litigation

 

The Company may, from time to time, be involved in litigation arising in the ordinary course of business or which may be expected to be covered by insurance. The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.

 

12. Subsequent Events

 

The Company has evaluated events that have occurred after the balance sheet and through the date the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed below.

 

Subsequent to March 31, 2022, the Company entered into a 2021 Note with a non-related party investor in the aggregate principal amount of $500,000 in connection with a 2021 Loan received by the Company for the same amount.

 

Subsequent to March 31, 2022, the Company announced it has added Aru Narendran, MD, PhD at the University of Calgary to the Scientific Advisory Board.

 

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, 2021 filed with the SEC on March 29, 2022 (“2021 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.

 

Overview

 

Provectus is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, based on a class of small molecules called HXs that is entirely owned by the Company. The Company’s lead HX molecule is cGMP RBS.

 

Components of Operating Results

 

Grant Revenue

 

Grant income is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as other income when qualifying costs are incurred.

 

Research and Development Expenses

 

A large component of our total operating expenses is the Company’s investment in research and development activities, including the clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake clinical trials to develop our drug 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 regulatory approval. Undertaking clinical development and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent we will generate revenue from any subsequent commercialization and sale of our drug product candidates.

 

General and Administrative Expenses

 

General and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for personnel in executive, finance, accounting, business development, legal, information technology and corporate communication functions. Other costs include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, patent and accounting services.

 

12

 

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2022 and March 31, 2021

 

Overview

 

Total operating expenses were $1,187,663 for the three months ended March 31, 2022, an increase of $6,987 or 0.6% compared to the three months ended March 31, 2021. The increase was driven primarily by (i) increased clinical trial cost, (ii) higher insurance costs and (iii) higher payroll and taxes, partially offset by (iv) lower legal and litigation fees and (v) lower rent and utilities cost. Net loss for the three months ended March 31, 2022 was $1,030,922, a decrease of $639,028 or 38.3% which was primarily attributable to lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021 and the recognition of grant revenue in the amount of $187,605.

 

    For the Three Months Ended              
    March 31,              
    2022     2021     Increase/(Decrease)     % Change  
                         
Grant Revenue   $ 187,605     $ -     $ 187,605       0.0 %
                                 
Operating Expenses:                                
Research and development     671,116       655,144       15,972       2.4 %
General and administrative     516,547       525,532       (8,985 )     -1.7 %
Total Operating Expenses     1,187,663       1,180,676       6,987       0.6 %
                                 
Total Operating Loss     (1,000,058 )     (1,180,676 )     180,618       -15.3 %
                                 
Other Income/(Expense):                                
Interest income and interest expense     (30,864 )     (489,274 )     458,410       -93.7 %
                                 
Total Other Expense, Net     (30,864 )     (489,274 )     458,410       -93.7 %
                                 
Net Loss   $ (1,030,922 )   $ (1,669,950 )   $ 639,028       -38.3 %

 

Grant Revenue

 

For the 3 months ended March 31, 2022 and 2021, there was $187,605 and $0, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development on the condensed consolidated statements of operations.

 

Research and Development Expenses

 

Research and development expenses were $671,116 for the three months ended March 31, 2022, an increase of $15,972 or 2.4% compared to $655,144 for the three months ended March 31, 2021. The increase was primarily due to (i) increased cost on clinical trials due to increased recruitment and treatment in clinical trials, and (ii) higher insurance cost, partially offset by (iii) lower payroll and payroll taxes, and (iv) a decrease in rent expense.

 

    For the Three Months Ended              
    March 31,              
    2022     2021     Increase/(Decrease)     % Change  
                         
Research and development:                                
Clinical trial and research expenses     531,691       511,580     $ 20,111       3.9 %
Depreciation/amortization     2,164       2,162       2       0.1 %
Insurance     58,523       51,388       7,135       13.9 %
Payroll and taxes     67,115       72,334       (5,219 )     -7.2 %
Rent and utilities     11,623       17,680       (6,057 )     -34.3 %
Total research and development   $ 671,116     $ 655,144     $ 15,972       2.4 %

 

13

 

 

General and Administrative Expenses

 

General and administrative expenses were $516,547 for the three months ended March 31, 2022, a decrease of $8,985 or 1.7% compared to $525,532 for the three months ended March 31, 2021. The decrease was primarily due to (i) lower legal fees relating to patents, (ii) reduced rent and utilities cost, and (iii) lower other general and administrative cost, partially offset by (iv) increased payroll and taxes and (v) higher insurance cost.

  

      For the Three Months Ended              
    March 31,              
    2022     2021     Increase/(Decrease)     % Change  
                         
General and administrative:                                
Depreciation   $ 1,054     $ 1,054     $ -       0.0 %
Directors fees     96,250       96,250       -       0.0 %
Insurance     48,218       43,566       4,652       10.7 %
Legal and litigation     112,534       132,015       (19,481 )     -14.8 %
Other general and administrative cost     22,859       31,005       (8,146 )     -26.3 %
Payroll and taxes     64,299       46,060       18,239       39.6 %
Professional fees     166,355       165,716       639       0.4 %
Rent and utilities     5,599       8,726       (3,127 )     -35.8 %
Foreign currency translation     (621 )     1,140       (1,761 )     -154.5 %
Total general and administrative   $ 516,547     $ 525,532     $ (8,985 )     -1.7 %

 

Other Income/(Expense)

 

Interest expense decreased by $458,410 from $489,274 for the three months ended March 31, 2021 to $30,864 for the three months ended March 31, 2022. The decrease was due to the lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021.

 

    For the Three Months Ended              
    March 31,              
    2022     2021     Increase/(Decrease)     % Change  
                         
Other Income/(Expense):                                
Interest income and interest expense   $ (30,864 )   $  (489,274 )   $  458,410       -93.7 %
Total Other Expenses, Net   $ (30,864 )   $ (489,274 )   $ 458,410       -93.7 %

 

14

 

 

Liquidity and Capital Resources

 

The Company’s cash, cash equivalents, and restricted cash were $2,481,009 at March 31, 2022 which includes the $2,307,395 of restricted cash resulting from a grant received from the State of Tennessee, compared to $3,106,942 at December 31, 2021, which included $2,423,958 of restricted cash. The Company’s working capital deficiency was $5,112,713 and $4,258,679 as of March 31, 2022 and December 31, 2021, 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 $247,064,880 as of March 31, 2022. These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations.

 

As of March 31, 2022, cash required for our current liabilities included approximately $3,801,460 for accounts payable and accrued expenses (including lease liabilities) and a $154,925 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 $1,510,000 plus accrued interest will mature one year from the date of the notes. There are no cash requirements for long-term liabilities at March 31, 2022. The Company intends to meet these cash requirements from its current cash balance and from future financing.

 

Management’s plans include selling our equity securities and obtaining other financing, including the 2021 financing, to fund our capital requirements and on-going operations; however, there can be no assurance we will be successful in these efforts. The condensed consolidated financial statements do not include any adjustment that might be necessary if we are unable to continue as a going concern. Significant funds will be needed to continue and complete our ongoing and planned clinical trials.

 

The SARS-CoV-2 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds and may also impact the volatility of our stock price and trading in our stock. Moreover, the pandemic has also significantly impacted economies worldwide, which could result in adverse effects on our business and operations. We cannot be certain what the overall impact of the SARS-CoV-2 pandemic will be on our business. It has the potential to adversely affect our business, financial condition, results of operations, and prospects. The Company has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate and/or complete current and/or future preclinical studies and/or clinical trials; disrupt the Company’s regulatory activities; and/or have other adverse effects on the Company’s clinical development. We have taken several temporary precautionary measures intended to help ensure the well-being of our employees and contractors and to minimize disruption to our business. We considered the impact of the SARS-CoV-2 pandemic on our business and operational assumptions and estimates, and determined there were no material adverse impacts on our results of operations and financial position at March 31, 2022.

 

15

 

 

Access to Capital

 

Management plans to access capital resources through possible public or private equity offerings, including the 2021 financing, equity financings, debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital, we will not be able to pay our obligations as they become due.

 

The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing our prescription drug 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 2022 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to raise additional funds, we cannot assure you 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.

 

Critical Accounting Estimates

 

The preparation of financial statements and related disclosures must be in conformity with U.S. GAAP. These accounting principles require us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented. We believe that the estimates and judgments upon which it relies are reasonably based upon information available to us at the time that it makes these estimates and judgments. To the extent that there are material differences between these estimates and actual results, our financial results will be affected. The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described below.

 

The following is not intended to be a comprehensive list of all of our accounting policies or estimates. Our accounting policies are more fully described in Note 3 –Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

Stock-Based Compensation

 

We measure the cost of services received in exchange for an award of equity instruments based on the fair value of the award on the date of grant. The fair value amount of the shares expected to ultimately vest is then recognized over the period for which services are required to be provided in exchange for the award, usually the vesting period. The estimation of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period that the estimates are revised. We account for forfeitures as they occur.

 

Research and Development

 

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. We accrue for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from our external service providers. We adjust our accrual as actual costs become known.

  

Recently Adopted Accounting Standards

 

Recently adopted accounting standards are included in Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

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”).

 

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

 

Inherent Limitations on Effectiveness of Controls

 

Even assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that our control system’s objective will be met, and our principal executive officer and principal financial officer has concluded that our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.

 

Changes in Internal Control Over Financial Reporting

 

There has been no change in our internal control over financial reporting that occurred during the first quarter of 2022 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.

 

PART II - OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

The information required by this item is incorporated by reference from Part I, Item 1. Financial Statements, Notes to Condensed Consolidated Financial Statements, Note 11.

 

ITEM 1A. RISK FACTORS.

 

There have been no material changes to the risk factors that were disclosed in the 2021 Form 10-K.

 

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

 

2021 Financing

 

During the three months ended March 31, 2022, the Company had received aggregate proceeds of $50,000 pursuant to certain unsecured convertible notes (the “2021 Notes”). As of March 31, 2022, the Company had drawn down $1,510,000 under the 2021 Notes.

 

For further details on the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.

 

Preferred Convertible Stock

 

During the three months ended March 31, 2022, the Company issued 52,411 shares of Series D-1 Convertible Preferred Stock in consideration of a $150,000 investment.

 

The Company believes that such transactions were exempt from the registration requirements of the Securities Act of 1933, as amended, (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act (or Rule 506(b) of Regulation D promulgated thereunder) as transactions by an issuer not involving a public offering.

 

17

 

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4. Mine Safety Disclosures.

 

Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

None.

 

ITEM 6. EXHIBITS.

 

Exhibit No.   Description
     
3.1   Certificate of Incorporation of Provectus Biopharmaceuticals, Inc., as amended (incorporated by reference to Exhibit 3.1 of the Company’s annual report on Form 10-K filed with the SEC on March 31, 2017).
     
3.2   Certificate of Elimination with respect to Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s current report on Form 8-K filed with the SEC on April 5, 2022).
     
3.3   Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s current report on Form 8-K filed with the SEC on June 24, 2021).
     
3.4**   Certificate of Designation of Preferences, Rights and Limitations of Series D-1 Convertible Preferred Stock (as amended by the Certificate of Amendment, dated March 30, 2022).
     
3.5   Bylaws of Provectus Biopharmaceuticals, Inc. (incorporated by reference to Exhibit 3.4 of the Company’s annual report on Form 10-K filed with the SEC on March 13, 2014).
     
31.1**   Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
     
31.2**   Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
     
32***   Certification of Principal Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification).
     
101.INS   Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
     
101.SCH   Inline XBRL Taxonomy Extension Schema Document.
     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document.
     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document.
     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document.
     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document.
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

** Filed herewith.

*** Furnished herewith.

 

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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.
                                         
May 12, 2022 By: /s/ Bruce Horowitz
    Bruce Horowitz
    Chief Operating Officer (Principal Executive Officer)
     
  By: /s/ Heather Raines
    Heather Raines, CPA
    Chief Financial Officer (Principal Financial Officer)

 

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