10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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 March 31, 2021

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. [X] 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). [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,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	[  ]	Accelerated filer	[  ]
Non-accelerated filer	[X]	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 May 11, 2021, was 403,582,037.

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	14
Item 3. Quantitative and Qualitative Disclosures About Market Risk	19
Item 4. Controls and Procedures	19
PART II - OTHER INFORMATION
Item 1. Legal Proceedings	20
Item 1A. Risk Factors	20
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	20
Item 3. Defaults Upon Senior Securities	21
Item 4. Mine Safety Disclosures	21
Item 5. Other Information	21
Item 6. Exhibits	21
SIGNATURES	22

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, 2020), and Item 1A of Part II of this Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and:

● Our potential receipt of sales from investigational 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 halogenated xanthene-based investigational drug products and/or drug substances,

● Our ability to raise additional capital, including but not limited to our ability to close on additional tranches of the 2020 Financing pursuant to the 2020 Term Sheet that our Board approved effective as of December 31, 2019, and

● 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.

1

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

	March 31, 2021			December 31, 2020
	(unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	349,771		$	97,231
Short-term receivables - legal fees, settlement and other, net		4,388			3,930
Prepaid expenses		274,962			322,518
Total Current Assets		629,121			423,679
Equipment and furnishings, less accumulated depreciation as of March 31, 2021 and December 31, 2020: $81,529 and $78,313, respectively		41,485			44,701
Operating lease right-of-use asset		100,815			120,821
Total Assets	$	771,421		$	589,201
Liabilities and Stockholders’ Deficiency
Current Liabilities:
Accounts payable - trade	$	945,670		$	956,860
Accrued interest		3,127,531			2,774,968
Accrued interest – related parties		1,901,893			1,766,493
Current portion of notes payable		199,208			236,228
Convertible notes payable		17,847,000			16,622,000
Convertible notes payable – related parties		6,745,000			6,770,000
Other accrued expenses		1,512,920			1,500,782
Current portion of operating lease liability		85,678			84,383
Total Current Liabilities		32,364,900			30,711,714
Non-current portion of notes payable		-			39,061
Non-current portion of operating lease liability		22,391			44,783
Total Liabilities		32,387,291			30,795,558
Commitments and contingencies (Note 10)
Stockholders’ Deficiency:
Preferred stock; par value $0.001 per share; 25,000,000 shares authorized; Series B Convertible Preferred Stock; 240,000 shares designated; 100 shares issued and outstanding at March 31, 2021 and December 31, 2020; aggregate liquidation preference of $3,500 at March 31, 2021 and December 31, 2020		-			-
Common stock; par value $0.001 per share; 1,000,000,000 shares authorized; 403,557,037 and 398,807,037 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively		403,558			398,808
Additional paid-in capital		210,178,197			209,923,347
Accumulated other comprehensive loss		(33,260	)		(34,097	)
Accumulated deficit		(242,164,365	)		(240,494,415	)
Total Stockholders’ Deficiency		(31,615,870	)		(30,206,357	)
Total Liabilities and Stockholders’ Deficiency	$	771,421		$	589,201

See accompanying notes to condensed consolidated financial statements.

2

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	For the Three Months Ended
	March 31,
	2021			2020
Operating Expenses:
Research and development	$	655,144		$	909,446
General and administrative		525,532			538,794
Total Operating Expenses		1,180,676			1,448,240
Total Operating Loss		(1,180,676	)		(1,448,240	)
Other Income/(Expense):
Research and development tax credit		-			26,251
Investment and interest income		1			79
Interest expense		(489,275	)		(405,151	)
Total Other Expense		(489,274	)		(378,821	)
Net Loss	$	(1,669,950	)	$	(1,827,061	)
Basic and Diluted Loss Per Common Share	$	(0.00	)	$	(0.00	)
Weighted Average Number of Common Shares Outstanding - Basic and Diluted		402,184,815			390,557,607

See accompanying notes to condensed consolidated financial statements.

3

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

	For the Three Months Ended
	March 31,
	2021			2020
Net Loss	$	(1,669,950	)	$	(1,827,061	)
Other Comprehensive Loss:
Foreign currency translation adjustments		837			(9,027	)
Total Comprehensive Loss	$	(1,669,113	)	$	(1,836,088	)

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, 2021
	Preferred Stock								Additional		Accumulated Other
	Series B				Common Stock				Paid-In		Comprehensive			Accumulated
	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	)

	FOR THE THREE MONTHS ENDED MARCH 31, 2020
	Preferred Stock								Additional		Accumulated Other
	Series B				Common Stock				Paid-In		Comprehensive			Accumulated
	Shares		Amount		Shares		Amount		Capital		Loss			Deficit			Total
Balance at January 1, 2020		100	$	-		389,889,475	$	389,889	$	209,378,835	$	(24,008	)	$	(233,816,828	)	$	(24,072,112	)
Common stock issued upon exercise of warrants		-		-		800,000		800		41,840		-			-			42,640
Comprehensive loss:								-
Net loss		-		-		-		-		-		-			(1,827,061	)		(1,827,061	)
Other comprehensive loss		-		-		-		-		-		(9,027	)		-			(9,027	)
Balance at March 31, 2020		100	$	-		390,689,475	$	390,689	$	209,420,675	$	(33,035	)	$	(235,643,889	)	$	(25,865,560	)

See accompanying notes to condensed consolidated financial statements.

5

PROVECTUS BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	For the Three Months Ended March 31,
	2021			2020
Cash Flows From Operating Activities:
Net loss	$	(1,669,950	)	$	(1,827,061	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		19,750			-
Noncash lease expense		20,006			17,961
Depreciation		3,216			3,523
Amortization of patents		-			167,780
Changes in operating assets and liabilities
Short term receivables		(515	)		(27,728	)
Prepaid expenses		45,822			109,888
Accounts payable - trade		(10,927	)		456,437
Other accrued expenses		12,252			(2,795	)
Operating lease liability		(21,096	)		(19,478	)
Accrued interest expense		487,962			405,151
Net Cash Used In Operating Activities		(1,113,480	)		(716,322	)
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable		1,200,000			200,000
Proceeds from issuance of convertible notes payable - related parties		-			100,000
Repayment of short-term note payable		(74,417	)		-
Proceeds from exercise of warrants		239,850			42,640
Net Cash Provided By Financing Activities		1,365,433			342,640
Effect of Exchange Rate Changes on Cash		587			(3,285	)
Net Increase (Decrease) In Cash and Cash Equivalents		252,540			(376,967	)
Cash and Cash Equivalents, Beginning of Period		97,231			590,706
Cash and Cash Equivalents, End of Period	$	349,771		$	213,739

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, with the aim of maximizing the curative impact of these medicines and achieving immunity from treated disease. These investigational drugs are based on an entire, wholly owned, family of small molecules called halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal disodium (“RBD”).

● Oncology: PV-10^®, an investigational cancer immunotherapy administered by intralesional (“IL”) injection and an injectable formulation of cGMP RBD, 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 RBD 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.

● Pediatric Oncology: IL PV-10 is also 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 RBD are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including leukemias).

● Virology: Systemically-administered formulations of cGMP RBD are undergoing preclinical study for the novel strain of coronavirus (“CoV”): severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”).

● Microbiology: Different formulations of cGMP RBD are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”) bacteria, such as gram-positive and gram-negative.

● Ophthalmology: Topical formulations of cGMP RBD are undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis.

● Dermatology: PH-10^®, an investigational immuno-dermatology agent administered as a topical gel and formulation of cGMP RBD, is undergoing monotherapy clinical study and preclinical study of combination therapy with approved drugs for inflammatory dermatoses (including psoriasis and atopic dermatitis).

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, 2020 filed with the SEC on March 2, 2021. 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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.

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, 2021.

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 and cash equivalents were $349,771 at March 31, 2021. 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 2020 Financing (as defined in Note 4), 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 through the 2020 Financing or otherwise, it will not be able to pay its obligations as they become due.

8

During the three months ended March 31, 2021, warrant holders exercised warrants to purchase an aggregate of 4,500,000 shares of common stock at a price of $0.0533 per share. In connection with these exercises, the Company received aggregate cash proceeds of $239,850.

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 2021 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, including the 2020 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 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. Critical Accounting Policies

Since the date, the Company’s December 31, 2020 consolidated financial statements were issued in its 2020 Annual Report, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.

Recently Adopted Accounting Standards

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The amendments in ASU 2019-12 simplify the accounting for income taxes by removing certain exceptions to the general principles in Accounting Standards Codification (“ASC”) Topic 740, Income Taxes. The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 will be effective for the Company’s fiscal year beginning after December 15, 2020, with early adoption permitted. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s financial statements or disclosures.

9

4. Convertible Notes Payable

2020 Financing

On December 31, 2019, the Board approved a Definitive Financing Term Sheet (the “2020 Term Sheet”), which sets forth the terms under which the Company will use its best efforts to arrange for financing of a maximum of $20,000,000 (the “2020 Financing”). The 2020 Financing will be in the form of secured convertible loans from investors that will be evidenced by convertible promissory notes (the “2020 Notes”). The 2020 Term Sheet is similar to the 2017 Term Sheet. Subject to the terms and conditions of the 2020 Term Sheet, the Company will use its best efforts to arrange for the 2020 Financing, which amounts will be obtained in several tranches. The proceeds from the 2020 Financing will be used to fund the Company’s clinical development program, as currently constituted and envisioned, and to fund the Company’s general and administrative expenses.

Pursuant to the 2020 Term Sheet, the 2020 Notes (defined below) will convert into shares of the Company’s Series D Preferred Stock on or before June 20, 2021, subject to certain exceptions. As of December 31, 2019, and through the date of filing, the Series D Preferred Stock had not been designated by the Board.

The 2020 Financing will be in the form of a secured convertible loan (the “2^nd Loan”) from the Investors (the “2^nd Loan Investors”) that will be evidenced by convertible promissory notes (individually, a “2020 Note” and collectively, the “2020 Notes”) subordinate to the 2017 Notes in right of payment and to the security interests granted to holders of the 2017 Notes. In addition to customary provisions, the 2020 Notes contains the following provisions:

(i) It will be secured by a second priority security interest on the Company’s IP subordinate to the first priority security interest of the 2017 Notes;

(ii) The 2^nd Loan will bear interest at the rate of eight percent (8%) per annum on the outstanding principal amount of the 2^nd Loan that has been funded to the Company;

(iii) In the event there is a change of control of the Company’s Board, the term of the 2020 Notes will be accelerated and all amounts due under the 2020 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 2^nd Loan that has been funded to the Company;

(iv) The outstanding principal amount and interest payable under the 2^nd Loan will become convertible at the sole discretion of the 2^nd Loan Investors into shares of the Company’s Series D Preferred Stock, a series of preferred stock to be designated by the Board, at a price per share equal to $2.8620; and

(v) Notwithstanding (iv) above, the principal amount of the 2020 Notes and the interest payable under the 2^nd Loan will automatically convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $2.8620 effective on June 20, 2021 subject to certain exceptions.

Upon conversion of the 2^nd Loan, the 2^nd Loan Investors will release their second lien on the IP. 2^nd Loan Investors in the 2020 Financing will hold Series D Preferred Stock pari passu with the Series D Preferred Stock of 1^st Loan Investors in the 2017 Financing.

Since financing was launched and through March 31, 2021, the Company had received aggregate loans of $4,525,000 in connection with the 2020 Financing.

The Series D Preferred Stock

As of March 31, 2021, and through the date of filing, the Series D Preferred Stock had not been designated by the Board. Per the terms of the notes issued in connection with the 2017 and 2020 Financings, if the Company has not designated the Series D Preferred Stock or if an insufficient number of Series D Preferred shares exist upon a conversion by a note holder, then the outstanding loans will continue to accrue interest at a rate of 8% per annum until which time the Company has designated a sufficient number of Series D Preferred shares. As a result, the Company did not analyze the notes for a potential beneficial conversion feature as the definition of a firm commitment has not been met since the notes were not convertible as of their respective dates of issuance or as of March 31, 2021.

Convertible Notes Payable – Related Parties

During the three months ended March 31, 2021, the Company did not enter into any additional related party 2020 Notes. As of March 31, 2021 and December 31, 2020, the Company had borrowed $100,000 under these notes.

Convertible Notes Payable – Non-Related Parties

During the three months ended March 31, 2021, the Company entered into additional non-related party 2020 Notes in the aggregate principal amount of $1,200,000. As of March 31, 2021 and December 31, 2020, the Company had borrowed $4,425,000 and $3,225,000, respectively, under these notes.

5. Notes Payable

The Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of March 31, 2021 and December 31, 2020, the balance of the note payable was $136,708 and $212,790, respectively.

10

6. Related Party Transactions

During the three months ended March 31, 2021 and March 31, 2020, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $84,800 and $52,400, respectively, for services rendered. Accrued director fees for Mr. Horowitz as of March 31, 2021 and December 31, 2020 were $18,750 and $75,000, respectively. Mr. Horowitz serves as both COO and a Director.

See Note 4 and Note 7 for details of other related party transactions.

Director fees during the three months ended March 31, 2021 and March 31, 2020 were $96,250 and $96,250, respectively. Accrued directors’ fees as of March 31, 2021 and December 31, 2020 were $1,271,839 and $1,175,589, respectively.

7. Short-term Receivables

The following table summarizes the receivables at March 31, 2021 and December 31, 2020:

	March 31, 2021
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	4,388	$	-		$	-		$	4,388
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	4,388	$	-		$	-		$	4,388

	December 31, 2020
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	3,930	$	-		$	-		$	3,930
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	3,930	$	-		$	-		$	3,930

8. Stockholders’ Deficiency

Common Stock

During the three months ended March 31, 2021, the Company issued an aggregate of 250,000 shares of immediately vested restricted common stock with a grant date value of $19,750 for services. See also Note 11 – Subsequent Events.

Warrants

During the three months ended March 31, 2021, warrant holders exercised warrants to purchase an aggregate of 4,500,000 shares of common stock at a price of $0.0533 per share. In connection with these exercises, the Company received aggregate cash proceeds of $239,850. See also Note 11 – Subsequent Events.

11

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 $7,900 per month.

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. Total operating lease expense for the three months ended March 31, 2020 was $21,302, of which, $14,201 was included within research and development and $7,101 was included within general and administrative expenses on the condensed consolidated statement of operations.

As of March 31, 2021, the Company had no leases that were classified as a financing lease. As of March 31, 2021, the Company did not have additional operating and financing leases that have not yet commenced. 

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

	For The Three Months Ended
	March 31,
	2021			2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases	$	23,831		$	22,441
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	-		$	-
Weighted Average Remaining Lease Term
Operating leases		1.25 Years			2.25 Years
Weighted Average Discount Rate
Operating leases		8.0	%		8.0	%

12

Future minimum payments under the Company’s non-cancellable lease obligations as of March 31, 2021 were as follows:

Years	Amount
2021		69,579
2022		46,687
Total future minimum lease payments		116,266
Less: amount representing imputed interest		(8,196	)
Total	$	108,070

10. 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.

11. Subsequent Events

Common Stock

Subsequent to March 31, 2021, the Company issued an aggregate of 25,000 shares of immediately vested restricted common stock to a strategic advisory board member.

Warrants

Subsequent to March 31, 2021, the Company issued three-year immediately vested warrants to purchase an aggregate of 25,000 shares of common stock with an exercise price of $0.2862 per share to a strategic advisory board member.

13

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, 2020 filed with the SEC on March 2, 2021 (“2020 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 based on an entire, wholly owned, family of small molecules called HXs. The Company’s lead HX molecule is proprietary cGMP RBD. IL PV-10, a cancer immunotherapy and injectable formulation of cGMP RBD, can induce immunogenic cell death (“ICD”), and is undergoing clinical study for adult solid tumor cancers, such as melanoma and GI tumors (e.g., HCC, mCRC, mNET, mUM), and preclinical study for pediatric solid tumor cancers (e.g., neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, osteosarcoma). Topically-administered PH-10, an immune-modulatory agent and formulation of cGMP RBD, is undergoing clinical study for inflammatory dermatoses (e.g., psoriasis, atopic dermatitis). New formulations of and routes of administration for cGMP RBD are being investigated for hematology (e.g., acute myeloid leukemia, acute monocytic leukemia), virology (e.g., SARS-CoV-2), oncology (e.g., high-risk and refractory adult solid tumor cancers), microbiology (e.g., MDR bacteria), and ophthalmology (e.g., infectious keratitis).

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. 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 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, 2021.

Our Science and Technology

Oncology. IL PV-10 drug product is Provectus’ cGMP injectable formulation of the Company’s pharmaceutical-grade (cGMP) RBD (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt) drug substance. RBD selectively accumulates in the lysosomes of cancer cells. Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning (Piao et al., Ann N Y Acad Sci 2016). Cancer progression and metastasis are associated with lysosomal compartment changes (Nishimura et al., Pathol Oncol Res 1998; Gocheva et al., Genes Dev 2006), which are closely correlated with, among other things, invasive growth, angiogenesis, and drug resistance (Fahrenbacher et al., Cancer Res 2005).

Lysosomes are the central organelles for intracellular degradation of biological macromolecules and organelles. Discovered by Christian de Duve, M.D. in 1955, lysosomes have been linked with a number of biological processes like cell death, inflammasome activation, and immune response. In 1959, Dr. de Duve described lysosomes as “suicide bags,” because their rupture led to cell death and tissue autolysis. Lysosomes have been shown to play a role in each of the primary pathways of cell death, which are apoptosis, autophagy, and necrosis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes.

14

Provectus showed that RBD selectively accumulates in the lysosomes of cancer cells and disrupts them, causing the cancer cells to die. RBD has also been shown by Provectus and independent researchers to trigger each major, distinct form of lysosomal cell death; that is, apoptosis, autophagy, and necrosis.

RBD’s lysosomal targeting comprises:

● Transiting the plasmalemma (i.e., the cell membrane) of cancer cells. RBD penetrates the cell membrane of cancerous cells which normally protects the cancer cell from its surrounding environment. RBD, however, is excluded from normal cells;

● Accumulating in the lysosomes of cancer cells. As noted above, the physicochemical properties of lysosomes trap RBD;

● Triggering the release of lysosomal contents. Acute autolysis can occur within 60 minutes. Early preclinical work by Provectus on RBD’s lysosomal targeting showed identical responses in different disease models, such as Hepa1-6 murine hepatocellular carcinoma, HTB-133 human breast carcinoma, and H96Ar human multi-drug resistant small cell lung carcinoma;

● Inducing the rapid cell death of cancer cells. Early trypan blue exclusion work by Provectus confirmed cell death within hours; and,

● Intracellular pH consistency with the release of acidic lysosomal contents. Early seminaphthorhodafluor-1 (“SNARF-1”) staining work by Provectus confirmed lower intracellular pH upon exposure to RBD.

Hematology. In primary cells and cell lines derived from pediatric leukemia patients, RBD may lead to stimulator of interferon genes (“STING”) dimerization and the release of interferon gamma, indicating a potential immune activation mechanism of RBD. Heat shock proteins, which chaperone misfolded or abnormally-folded proteins, associated with STING dimerization in RBD-treated cells, indicating a mechanism that may lead to enhanced STING activation following RBD-specific treatment.

Virology. The Company’s work in this disease area to identify drug activity and elucidate mechanism(s) of action is ongoing.

Microbiology. The Company’s work in this disease area to identify drug activity and elucidate mechanism(s) of action is ongoing.

Ophthalmology. The Company’s work in this disease area to identify drug activity is ongoing.

Dermatology. For psoriasis, pathways significantly improved by monotherapy PH-10 drug product treatment include published psoriasis transcriptomes and cellular responses mediated by IL-17, IL-22, and interferons. Clinical work has shown that more than 500 disease-related genes were down-regulated after four weeks of application and a wide-range of central psoriasis-related genes, including IL-23, IL-17, IL-22, S100A7, IL-19, IL-36, and CXCL1, were normalized (i.e., treated lesional skin had values in the same range as baseline non-lesional skin).

15

Our Drug Development Strategy

Oncology. The Company’s strategy is to (i) demonstrate the independent action of single-agent IL PV-10; that is, safety and activity in T cell and non-T cell inflamed tumor types, in high and low tumor mutation burden tumor types, and in other tumor type categories, such as gene mutations, (ii) demonstrate the coordinated induction of multiple immune signaling pathways (i.e., functional ICD), (Snyder et al., Sci Immunol 2019) by IL PV-10 treatment, (iii) demonstrate the functional T cell response generated by IL PV-10 treatment, and (iv) contrast and compare IL PV-10 treatment (i.e., safety, activity, and induced immune response) with that of immune checkpoint blockade (“CB”) and other drug classes in single-agent and IL PV-10-based combination therapy settings.

This strategy may quicken the advancement of single-agent IL PV-10 along a pathway-to-approval in solid tumor cancer indications where there is high unmet need, limited activity from other therapies, and the opportunity to display the immune response from IL PV-10 treatment, such as mNET (NCT02693067). This strategy may also permit the Company to develop and advance a cancer combination therapy involving one or more CB and/or other drug classes along a pathway-to-approval in a disease indication where there is high unmet need, limited activity from standard of care (“SOC”) treatment, and the opportunity to display how IL PV-10 augments clinical response to existing or emerging SOCs, such as mUM (i.e., combination therapy with an anti-CTLA-4 agent and an anti-PD-1 agent) (NCT00986661).

Hematology. The Company and research collaborators are undertaking preclinical work on a potential, systemically-administered, cGMP RBD leukemia treatment and/or cancer vaccine for pediatric patients.

Virology. The Company and research collaborators are undertaking preclinical work on a potential, systemically-administered, cGMP RBD therapy for SARS-CoV-2 and other classes of enveloped and non-enveloped viruses.

Microbiology. The Company and research collaborators are undertaking preclinical work on cGMP RBD therapy for MDR bacteria.

Ophthalmology. The Company and clinical and research collaborators are undertaking preclinical work on potential, topically-administered, cGMP RBD therapy for the treatment of infectious keratitis.

Dermatology. The Company’s strategy is to (i) demonstrate 12-week single-agent administration proof-of-concept (“POC”) for topical PH-10 that includes (a) a preclinical safety study of extended 12-week administration (compared to, previously, four weeks), (b) a clinical mechanism of action study in atopic dermatitis, which would be a “book-end” trial to the already completed clinical mechanism study in psoriasis, (c) Phase 2 randomized controlled trials of topical PH-10 for the treatment of psoriasis and atopic dermatitis that may potentially utilize SOC comparators, and (d) end-of-Phase 2 meetings with the FDA upon the completion of the abovementioned Phase 2 trials, and (ii) expand POC topical PH-10 treatment to include dermatology combination therapy. Our goal for this POC work is to achieve Phase 3 trial-ready status for topical PH-10 in both psoriasis and atopic dermatitis.

Components of Operating Results

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.

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.

16

Results of Operations

Comparison of the Three Months Ended March 31, 2021 and March 31, 2020

Overview

Total operating expenses were $1,180,676 for the three months ended March 31, 2021, a decrease of $267,564 or 18.5% compared to the three months ended March 31, 2020. The decrease was driven primarily by our continued transformation and process improvement efforts within the Company along with slower recruitment and treatment in clinical trials due to the effects of SARS-CoV-2. Net loss for the three months ended March 31, 2021 was $1,669,950, a decrease of $157,111 or 8.6% which was primarily attributable to lower costs incurred in connection with our preclinical and clinical trial programs and general and administrative costs.

	For the Three Months Ended
	March 31,						Increase/
	2021			2020			(Decrease)			% Change
Operating Expenses:
Research and development	$	655,144		$	909,446		$	(254,302	)		-28.0	%
General and administrative		525,532			538,794			(13,262	)		-2.5	%
Total Operating Expenses		1,180,676			1,448,240			(267,564	)		-18.5	%
Total Operating Loss		(1,180,676	)		(1,448,240	)		(267,564	)		18.5	%
Other Income/(Expense):
Research and development tax credit		-			26,251			(26,251	)		-100.0	%
Investment and interest income		1			79			(78	)		-98.7	%
Interest expense		(489,275	)		(405,151	)		(84,124	)		20.8	%
Total Other Expense, Net		(489,274	)		(378,821	)		(110,453	)		29.2	%
Net Loss	$	(1,669,950	)	$	(1,827,061	)	$	(157,111	)		8.6	%

Research and Development Expenses

Research and development expenses were $655,144 for the three months ended March 31, 2021, a decrease of $254,302 or 28.0% compared to $909,466 for the three months ended March 31, 2020. The decrease was primarily due to (i) reduced cost on clinical trials due to slower recruitment and treatment in clinical trials due to the effects of SARS-CoV-2, (ii) lower amortization due to patents being fully amortized, and (iii) a decrease in insurance expense.

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2021 and March 31, 2020:

	For the Three Months Ended
	March 31,				Increase/
	2021		2020		(Decrease)			% Change
Operating Expenses:
Research and development:
Clinical trial and research expenses	$	511,580	$	584,057	$	(72,477	)		-12.4	%
Depreciation/amortization		2,162		169,942		(167,780	)		-98.7	%
Insurance		51,388		73,592		(22,204	)		-30.2	%
Payroll and taxes		72,334		66,479		5,855			8.8	%
Rent and utilities		17,680		15,376		2,304			15.0	%
Total research and development	$	655,144	$	909,446	$	(254,302	)		-28.0	%

17

General and Administrative Expenses

General and administrative expenses were $525,532 for the three months ended March 31, 2021, a decrease of $13,262 or 2.5% compared to $538,794 for the three months ended March 31, 2020. The decrease was primarily due to (i) lower professional fees, offset by (ii) higher legal fees, (iii) an increase in payroll and related taxes due to addition of employee, and (vi) higher other general and administrative cost.

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2021 and March 31, 2020:

	For the Three Months Ended
	March 31,				Increase/
	2021		2020		(Decrease)			% Change
Operating Expenses:
General and administrative:
Depreciation	$	1,054	$	1,361	$	(307	)		-22.6	%
Directors fees		96,250		96,250		-			0.0	%
Insurance		43,566		41,866		1,700			4.1	%
Legal and litigation		132,015		88,062		43,953			49.9	%
Other general and administrative cost		31,005		17,007		13,998			82.3	%
Payroll and taxes		46,060		35,486		10,574			29.8	%
Professional fees		165,716		250,011		(84,295	)		-33.7	%
Rent and utilities		8,726		7,660		1,066			13.9	%
Foreign currency translation		1,140		1,091		49			4.5	%
Total general and administrative	$	525,532	$	538,794	$	(13,262	)		-2.5	%

Other Income/(Expense)

Interest expense increased by $84,124 from $405,151 for the three months ended March 31, 2020 to $489,275 for the three months ended March 31, 2021. The increase was due to the increased number of convertible notes payable outstanding relating to the PRH Notes.

Liquidity and Capital Resources

Our cash and cash equivalents were $349,771 at March 31, 2021, compared to $97,231 at December 31, 2020. 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 $242,164,365 as of March 31, 2021. 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.

During the three months ended March 31, 2021, the Company entered into additional non-related party 2020 Notes in the aggregate principal amount of $1,200,000.

During the three months ended March 31, 2021, warrant holders exercised warrants to purchase an aggregate of 4,500,000 shares of common stock at an exercise price of $0.0533 per share. In connection with these exercises, the Company received aggregate cash proceeds of $239,850.

Management’s plans include selling our equity securities and obtaining other financing to fund our capital requirement and on-going operations, including the 2020 Financing; 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 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, 2021.

18

Access to Capital

Management plans to access capital resources through possible public or private equity offerings, including the 2020 Financing, exchange offers, debt financings, corporate collaborations or other means. If we are unable to raise sufficient capital through the 2020 Financing or otherwise, 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 2021 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, including the 2020 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 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 Policies

For a description of our critical accounting policies, see Note 3 – Critical Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

Recently Issued Accounting Standards

Recently issued accounting standards are included in Note 3 – Critical 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”).

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.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during the fiscal quarter covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

19

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 10.

ITEM 1A. RISK FACTORS.

There have been no material changes to the risk factors that were disclosed in the 2020 Form 10-K, other than set forth below.

Our business, financial condition and results of operations may be adversely affected by the severe acute respiratory syndrome (SARS)-associated CoV-2 (SARS-CoV-2) pandemic or other similar outbreaks of contagious diseases.

Outbreaks of contagious diseases and other adverse public health developments, affecting us and/or the third parties on which we rely, could have a material and adverse effect on our business, financial condition and results of operations. The severe acute respiratory syndrome (SARS)-associated CoV-2 (SARS-CoV-2) pandemic, which was reported to have begun in late-2019 and has spread worldwide, may affect our ability to initiate and/or complete current and/or or future preclinical studies and/or clinical trials; disrupt our regulatory activities; and/or have other adverse effects on our clinical development. In addition, stay-at-home orders, business closures, travel restrictions, supply chain disruptions and employee or independent contractor illness or quarantines could result in disruptions to our operations, which could adversely impact our results from operations and financial condition. The SARS-CoV-2 pandemic has also caused substantial disruption in capital and financial markets and adversely impacted economies worldwide, any and/or all of which may disrupt our business, negatively impact our ability to raise additional funds, and adversely affect our results of operations and financial condition. Moreover, many risk factors set forth in the 2020 Form 10-K should be interpreted as heightened risks as a result of the impact of the SARS-CoV-2 pandemic. The extent to which the SARS-CoV-2 pandemic may impact our business, financial condition and results of operations will depend on the manner in which this pandemic continues to evolve and future developments in response thereto, which are highly uncertain and cannot be predicted with confidence as of the date of this Form 10-Q.

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

2020 Financing

During the three months ended March 31, 2021, the Company did not enter into any additional 2020 Notes with related party investors. As of March 31, 2021, the Company had drawn down the entire $100,000 under these notes.

During the three months ended March 31, 2021, the Company entered into additional 2020 Notes with non-related party accredited investors in the aggregate principal amount of $1,200,000. As of March 31, 2021, the Company had drawn down the entire $4,425,000 under these notes.

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

For further details on the terms of the 2017 and 2020 Notes, refer to our Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the SEC on March 2, 2021.

20

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
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**	Interactive Data Files.

** Filed herewith.

*** Furnished herewith.

21

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 11, 2021	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)

22

EX-31.1

Exhibit 31.1

CERTIFICATION

I, Bruce Horowitz, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Provectus Biopharmaceuticals, Inc.;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
	(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 11, 2021	By:	/s/ Bruce Horowitz
		Bruce Horowitz
		Chief Operating Officer (Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

I, Heather Raines, CPA, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Provectus Biopharmaceuticals, Inc.;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
	(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 11, 2021	By:	/s/ Heather Raines
		Heather Raines, CPA
		Chief Financial Officer (Principal Financial Officer)

EX-32

Exhibit 32

CERTIFICATION PURSUANT TO RULE 13a-14(b) UNDER

THE SECURITIES EXCHANGE ACT OF 1934 AND

SECTION 1350 OF CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE

Each of the undersigned, Bruce Horowitz, the Chief Operating Officer (principal executive officer) of Provectus Biopharmaceuticals, Inc. (the “Company”), and Heather Raines, CPA, the Chief Financial Officer (principal financial officer) of the Company, certifies, pursuant to Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1) this Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act, and (2) the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of the Company.

This Certification is signed on May 11, 2021.

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)

XML

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2021	May 11, 2021
Cover [Abstract]
Entity Registrant Name	PROVECTUS BIOPHARMACEUTICALS, INC.
Entity Central Index Key	0000315545
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Reporting Status Current	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business Flag	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		403,582,037
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2021

XML

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and cash equivalents	$ 349,771	$ 97,231
Short-term receivables - legal fees, settlement and other, net	4,388	3,930
Prepaid expenses	274,962	322,518
Total Current Assets	629,121	423,679
Equipment and furnishings, less accumulated depreciation as of March 31, 2021 and December 31, 2020: $81,529 and $78,313, respectively	41,485	44,701
Operating lease right-of-use asset	100,815	120,821
Total Assets	771,421	589,201
Current Liabilities:
Accounts payable - trade	945,670	956,860
Accrued interest	3,127,531	2,774,968
Accrued interest - related parties	1,901,893	1,766,493
Current portion of notes payable	199,208	236,228
Convertible notes payable	17,847,000	16,622,000
Convertible notes payable - related parties	6,745,000	6,770,000
Other accrued expenses	1,512,920	1,500,782
Current portion of operating lease liability	85,678	84,383
Total Current Liabilities	32,364,900	30,711,714
Non-current portion of notes payable		39,061
Non-current portion of operating lease liability	22,391	44,783
Total Liabilities	32,387,291	30,795,558
Commitments and contingencies (Note 10)
Stockholders' Deficiency:
Preferred stock; par value $0.001 per share; 25,000,000 shares authorized; Series B Convertible Preferred Stock; 240,000 shares designated; 100 shares issued and outstanding at March 31, 2021 and December 31, 2020; aggregate liquidation preference of $3,500 at March 31, 2021 and December 31, 2020
Common stock; par value $0.001 per share; 1,000,000,000 shares authorized; 403,557,037 and 398,807,037 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively	403,558	398,808
Additional paid-in capital	210,178,197	209,923,347
Accumulated other comprehensive loss	(33,260)	(34,097)
Accumulated deficit	(242,164,365)	(240,494,415)
Total Stockholders' Deficiency	(31,615,870)	(30,206,357)
Total Liabilities and Stockholders' Deficiency	$ 771,421	$ 589,201

XML

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Accumulated depreciation on equipment and furnishings	$ 81,529	$ 78,313
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	25,000,000	25,000,000
Aggregate liquidation preference	$ 3,500	$ 3,500
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	1,000,000,000	1,000,000,000
Common stock, shares issued	403,557,037	398,807,037
Common stock, shares outstanding	403,557,037	398,807,037
Series B Convertible Preferred Stock [Member]
Preferred stock, shares authorized	240,000	240,000
Preferred stock, shares issued	100	100
Preferred stock, shares outstanding	100	100

XML

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating Expenses:
Research and development	$ 655,144	$ 909,446
General and administrative	525,532	538,794
Total Operating Expenses	1,180,676	1,448,240
Total Operating Loss	(1,180,676)	(1,448,240)
Other Income/(Expense):
Research and development tax credit		26,251
Investment and interest income	1	79
Interest expense	(489,275)	(405,151)
Total Other Expense	(489,274)	(378,821)
Net Loss	$ (1,669,950)	$ (1,827,061)
Basic and Diluted Loss Per Common Share	$ (0.00)	$ (0.00)
Weighted Average Number of Common Shares Outstanding - Basic and Diluted	402,184,815	390,557,607

XML

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Income Statement [Abstract]
Net Loss	$ (1,669,950)	$ (1,827,061)
Other Comprehensive Loss:
Foreign currency translation adjustments	837	(9,027)
Total Comprehensive Loss	$ (1,669,113)	$ (1,836,088)

XML

Condensed Consolidated Statements of Changes in Stockholders' Deficiency (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Preferred Stock Series B [Member]
Beginning Balance
Beginning Balance, shares	100	100
Common stock issued upon exercise of warrants
Common stock issued upon exercise of warrants, shares
Stock-based compensation: Common stock
Stock-based compensation: Common stock, shares
Net loss
Other comprehensive loss
Ending Balance
Ending Balance, shares	100	100
Common Stock [Member]
Beginning Balance	$ 398,808	$ 389,889
Beginning Balance, shares	398,807,037	389,889,475
Common stock issued upon exercise of warrants	$ 4,500	$ 800
Common stock issued upon exercise of warrants, shares	4,500,000	800,000
Stock-based compensation: Common stock	$ 250
Stock-based compensation: Common stock, shares	250,000
Net loss
Other comprehensive loss
Ending Balance	$ 403,558	$ 390,689
Ending Balance, shares	403,557,037	390,689,475
Additional Paid-in Capital [Member]
Beginning Balance	$ 209,923,347	$ 209,378,835
Common stock issued upon exercise of warrants	235,350	41,840
Stock-based compensation: Common stock	19,500
Net loss
Other comprehensive loss
Ending Balance	210,178,197	209,420,675
Accumulated Other Comprehensive Loss [Member]
Beginning Balance	(34,097)	(24,008)
Common stock issued upon exercise of warrants
Stock-based compensation: Common stock
Net loss
Other comprehensive loss	837	(9,027)
Ending Balance	(33,260)	(33,035)
Accumulated Deficit [Member]
Beginning Balance	(240,494,415)	(233,816,828)
Common stock issued upon exercise of warrants
Stock-based compensation: Common stock
Net loss	(1,669,950)	(1,827,061)
Other comprehensive loss
Ending Balance	(242,164,365)	(235,643,889)
Beginning Balance	(30,206,357)	(24,072,112)
Common stock issued upon exercise of warrants	239,850	42,640
Stock-based compensation: Common stock	19,750
Net loss	(1,669,950)	(1,827,061)
Other comprehensive loss	837	(9,027)
Ending Balance	$ (31,615,870)	$ (25,865,560)

XML

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash Flows From Operating Activities:
Net loss	$ (1,669,950)	$ (1,827,061)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	19,750
Noncash lease expense	20,006	17,961
Depreciation	3,216	3,523
Amortization of patents		167,780
Changes in operating assets and liabilities
Short term receivables	(515)	(27,728)
Prepaid expenses	45,822	109,888
Accounts payable - trade	(10,927)	456,437
Other accrued expenses	12,252	(2,795)
Operating lease liability	(21,096)	(19,478)
Accrued interest expense	487,962	405,151
Net Cash Used In Operating Activities	(1,113,480)	(716,322)
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable	1,200,000	200,000
Proceeds from issuance of convertible notes payable - related parties		100,000
Repayment of short-term note payable	(74,417)
Proceeds from exercise of warrants	239,850	42,640
Net Cash Provided By Financing Activities	1,365,433	342,640
Effect of Exchange Rate Changes on Cash	587	(3,285)
Net Increase (Decrease) In Cash and Cash Equivalents	252,540	(376,967)
Cash and Cash Equivalents, Beginning of Period	97,231	590,706
Cash and Cash Equivalents, End of Period	$ 349,771	$ 213,739

XML

Business Organization, Nature of Operations and Basis of Presentation

3 Months Ended

Mar. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Business Organization, Nature of Operations and Basis of Presentation

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, with the aim of maximizing the curative impact of these medicines and achieving immunity from treated disease. These investigational drugs are based on an entire, wholly owned, family of small molecules called halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal disodium (“RBD”).

● Oncology: PV-10^®, an investigational cancer immunotherapy administered by intralesional (“IL”) injection and an injectable formulation of cGMP RBD, 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 RBD 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.

● Pediatric Oncology: IL PV-10 is also 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 RBD are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including leukemias).

● Virology: Systemically-administered formulations of cGMP RBD are undergoing preclinical study for the novel strain of coronavirus (“CoV”): severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”).

● Microbiology: Different formulations of cGMP RBD are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”) bacteria, such as gram-positive and gram-negative.

● Ophthalmology: Topical formulations of cGMP RBD are undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis.

● Dermatology: PH-10^®, an investigational immuno-dermatology agent administered as a topical gel and formulation of cGMP RBD, is undergoing monotherapy clinical study and preclinical study of combination therapy with approved drugs for inflammatory dermatoses (including psoriasis and atopic dermatitis).

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.

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, 2020 filed with the SEC on March 2, 2021. 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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.

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, 2021.

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.

XML

Liquidity and Going Concern

3 Months Ended

Mar. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Liquidity and Going Concern

2. Liquidity and Going Concern

The Company’s cash and cash equivalents were $349,771 at March 31, 2021. 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 2020 Financing (as defined in Note 4), 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 through the 2020 Financing or otherwise, it will not be able to pay its obligations as they become due.

During the three months ended March 31, 2021, warrant holders exercised warrants to purchase an aggregate of 4,500,000 shares of common stock at a price of $0.0533 per share. In connection with these exercises, the Company received aggregate cash proceeds of $239,850.

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 2021 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, including the 2020 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 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.

XML

Critical Accounting Policies

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Critical Accounting Policies

3. Critical Accounting Policies

Since the date the Company’s December 31, 2020 consolidated financial statements were issued in its 2020 Annual Report, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.

Recently Adopted Accounting Standards

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The amendments in ASU 2019-12 simplify the accounting for income taxes by removing certain exceptions to the general principles in Accounting Standards Codification (“ASC”) Topic 740, Income Taxes. The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 will be effective for the Company’s fiscal year beginning after December 15, 2020, with early adoption permitted. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s financial statements or disclosures.

XML

Convertible Notes Payable

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Convertible Notes Payable

4. Convertible Notes Payable

2020 Financing

On December 31, 2019, the Board approved a Definitive Financing Term Sheet (the “2020 Term Sheet”), which sets forth the terms under which the Company will use its best efforts to arrange for financing of a maximum of $20,000,000 (the “2020 Financing”). The 2020 Financing will be in the form of secured convertible loans from investors that will be evidenced by convertible promissory notes (the “2020 Notes”). The 2020 Term Sheet is similar to the 2017 Term Sheet. Subject to the terms and conditions of the 2020 Term Sheet, the Company will use its best efforts to arrange for the 2020 Financing, which amounts will be obtained in several tranches. The proceeds from the 2020 Financing will be used to fund the Company’s clinical development program, as currently constituted and envisioned, and to fund the Company’s general and administrative expenses.

Pursuant to the 2020 Term Sheet, the 2020 Notes (defined below) will convert into shares of the Company’s Series D Preferred Stock on or before June 20, 2021, subject to certain exceptions. As of December 31, 2019, and through the date of filing, the Series D Preferred Stock had not been designated by the Board.

The 2020 Financing will be in the form of a secured convertible loan (the “2^nd Loan”) from the Investors (the “2^nd Loan Investors”) that will be evidenced by convertible promissory notes (individually, a “2020 Note” and collectively, the “2020 Notes”) subordinate to the 2017 Notes in right of payment and to the security interests granted to holders of the 2017 Notes. In addition to customary provisions, the 2020 Notes contains the following provisions:

(i) It will be secured by a second priority security interest on the Company’s IP subordinate to the first priority security interest of the 2017 Notes;

(ii) The 2^nd Loan will bear interest at the rate of eight percent (8%) per annum on the outstanding principal amount of the 2^nd Loan that has been funded to the Company;

(iii) In the event there is a change of control of the Company’s Board, the term of the 2020 Notes will be accelerated and all amounts due under the 2020 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 2^nd Loan that has been funded to the Company;

(iv) The outstanding principal amount and interest payable under the 2^nd Loan will become convertible at the sole discretion of the 2^nd Loan Investors into shares of the Company’s Series D Preferred Stock, a series of preferred stock to be designated by the Board, at a price per share equal to $2.8620; and

(v) Notwithstanding (iv) above, the principal amount of the 2020 Notes and the interest payable under the 2^nd Loan will automatically convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $2.8620 effective on June 20, 2021 subject to certain exceptions.

Upon conversion of the 2^nd Loan, the 2^nd Loan Investors will release their second lien on the IP. 2^nd Loan Investors in the 2020 Financing will hold Series D Preferred Stock pari passu with the Series D Preferred Stock of 1^st Loan Investors in the 2017 Financing.

Since financing was launched and through March 31, 2021, the Company had received aggregate loans of $4,525,000 in connection with the 2020 Financing.

The Series D Preferred Stock

As of March 31, 2021, and through the date of filing, the Series D Preferred Stock had not been designated by the Board. Per the terms of the notes issued in connection with the 2017 and 2020 Financings, if the Company has not designated the Series D Preferred Stock or if an insufficient number of Series D Preferred shares exist upon a conversion by a note holder, then the outstanding loans will continue to accrue interest at a rate of 8% per annum until which time the Company has designated a sufficient number of Series D Preferred shares. As a result, the Company did not analyze the notes for a potential beneficial conversion feature as the definition of a firm commitment has not been met since the notes were not convertible as of their respective dates of issuance or as of March 31, 2021.

Convertible Notes Payable – Related Parties

During the three months ended March 31, 2021, the Company did not enter into any additional related party 2020 Notes. As of March 31, 2021 and December 31, 2020, the Company had borrowed $100,000 under these notes.

Convertible Notes Payable – Non-Related Parties

During the three months ended March 31, 2021, the Company entered into additional non-related party 2020 Notes in the aggregate principal amount of $1,200,000. As of March 31, 2021 and December 31, 2020, the Company had borrowed $4,425,000 and $3,225,000, respectively, under these notes.

XML

Notes Payable

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Notes Payable

5. Notes Payable

The Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of March 31, 2021 and December 31, 2020, the balance of the note payable was $136,708 and $212,790, respectively.

XML

Related Party Transactions

3 Months Ended

Mar. 31, 2021

Related Party Transactions [Abstract]

Related Party Transactions

6. Related Party Transactions

During the three months ended March 31, 2021 and March 31, 2020, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $84,800 and $52,400, respectively, for services rendered. Accrued director fees for Mr. Horowitz as of March 31, 2021 and December 31, 2020 were $18,750 and $75,000, respectively. Mr. Horowitz serves as both COO and a Director.

See Note 4 and Note 7 for details of other related party transactions.

Director fees during the three months ended March 31, 2021 and March 31, 2020 were $96,250 and $96,250, respectively. Accrued directors’ fees as of March 31, 2021 and December 31, 2020 were $1,271,839 and $1,175,589, respectively.

XML

Short-term Receivables

3 Months Ended

Mar. 31, 2021

Receivables [Abstract]

Short-term Receivables

7. Short-term Receivables

The following table summarizes the receivables at March 31, 2021 and December 31, 2020:

	March 31, 2021
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	4,388	$	-		$	-		$	4,388
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	4,388	$	-		$	-		$	4,388

	December 31, 2020
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	3,930	$	-		$	-		$	3,930
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	3,930	$	-		$	-		$	3,930

XML

Stockholders' Deficiency

3 Months Ended

Mar. 31, 2021

Equity [Abstract]

Stockholders' Deficiency

8. Stockholders’ Deficiency

Common Stock

During the three months ended March 31, 2021, the Company issued an aggregate of 250,000 shares of immediately vested restricted common stock with a grant date value of $19,750 for services. See also Note 11 – Subsequent Events.

Warrants

During the three months ended March 31, 2021, warrant holders exercised warrants to purchase an aggregate of 4,500,000 shares of common stock at a price of $0.0533 per share. In connection with these exercises, the Company received aggregate cash proceeds of $239,850. See also Note 11 – Subsequent Events.

XML

Leases

3 Months Ended

Mar. 31, 2021

Leases [Abstract]

Leases

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 $7,900 per month.

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. Total operating lease expense for the three months ended March 31, 2020 was $21,302, of which, $14,201 was included within research and development and $7,101 was included within general and administrative expenses on the condensed consolidated statement of operations.

As of March 31, 2021, the Company had no leases that were classified as a financing lease. As of March 31, 2021, the Company did not have additional operating and financing leases that have not yet commenced. 

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

	For The Three Months Ended
	March 31,
	2021			2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases	$	23,831		$	22,441
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	-		$	-
Weighted Average Remaining Lease Term
Operating leases		1.25 Years			2.25 Years
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, 2021 were as follows:

Years	Amount
2021		69,579
2022		46,687
Total future minimum lease payments		116,266
Less: amount representing imputed interest		(8,196	)
Total	$	108,070

XML

Commitments, Contingencies and Litigation

3 Months Ended

Mar. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments, Contingencies and Litigation

10. Commitments, Contingencies and Litigation

None

XML

Subsequent Events

3 Months Ended

Mar. 31, 2021

Subsequent Events [Abstract]

Subsequent Events

11. Subsequent Events

Common Stock

Subsequent to March 31, 2021, the Company issued an aggregate of 25,000 shares of immediately vested restricted common stock to a strategic advisory board member.

Warrants

Subsequent to March 31, 2021, the Company issued three-year immediately vested warrants to purchase an aggregate of 25,000 shares of common stock with an exercise price of $0.2862 per share to a strategic advisory board member.

XML

Critical Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Recently Adopted Accounting Standards

Recently Adopted Accounting Standards

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The amendments in ASU 2019-12 simplify the accounting for income taxes by removing certain exceptions to the general principles in Accounting Standards Codification (“ASC”) Topic 740, Income Taxes. The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 will be effective for the Company’s fiscal year beginning after December 15, 2020, with early adoption permitted. An entity that elects to early adopt the amendments in an interim period should reflect any adjustments as of the beginning of the annual period that includes that interim period. Additionally, an entity that elects early adoption must adopt all the amendments in the same period. The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s financial statements or disclosures.

XML

Short-term Receivables (Tables)

3 Months Ended

Mar. 31, 2021

Receivables [Abstract]

Summary of Short-term Receivables

The following table summarizes the receivables at March 31, 2021 and December 31, 2020:

	March 31, 2021
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	4,388	$	-		$	-		$	4,388
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	4,388	$	-		$	-		$	4,388

	December 31, 2020
	Tax Credit		Legal Fees			Settlement			Total
Provectus Australia Tax Credit	$	3,930	$	-		$	-		$	3,930
Gross receivable		-		455,500			1,649,043			2,104,543
Reserve for uncollectibility		-		(455,500	)		(1,649,043	)		(2,104,543	)
Net receivable	$	3,930	$	-		$	-		$	3,930

XML

Leases (Tables)

3 Months Ended

Mar. 31, 2021

Leases [Abstract]

Schedule of Right-of-Use Assets and Liabilities

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

	For The Three Months Ended
	March 31,
	2021			2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases	$	23,831		$	22,441
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	-		$	-
Weighted Average Remaining Lease Term
Operating leases		1.25 Years			2.25 Years
Weighted Average Discount Rate
Operating leases		8.0	%		8.0	%

Schedule of Future Minimum Payments Under Non-Cancellable Lease

Future minimum payments under the Company’s non-cancellable lease obligations as of March 31, 2021 were as follows:

Years	Amount
2021		69,579
2022		46,687
Total future minimum lease payments		116,266
Less: amount representing imputed interest		(8,196	)
Total	$	108,070

XML

Liquidity and Going Concern (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and cash equivalents	$ 349,771	$ 97,231
Warrants to purchase	4,500,000
Warrants exercise price	$ 0.0533
Proceeds from warrants	$ 239,850

XML

Convertible Notes Payable (Details Narrative) - USD ($)		3 Months Ended
	Dec. 31, 2019	Mar. 31, 2021	Dec. 31, 2020
Related Party Transaction [Line Items]
Preferred stock, par or stated value per share		$ 0.001	$ 0.001
Borrowed outstanding convertible notes payable		$ 17,847,000	$ 16,622,000
2020 Notes [Member] | Non-Related Party [Member]
Related Party Transaction [Line Items]
Borrowed outstanding convertible notes payable		4,425,000	3,225,000
Debt principal amount		1,200,000
2020 Notes [Member] | Related Party [Member]
Related Party Transaction [Line Items]
Borrowed outstanding convertible notes payable		$ 100,000	$ 100,000
2020 Financing [Member]
Related Party Transaction [Line Items]
Interest rate		8.00%
Proceeds from loans		$ 4,525,000
2020 Financing [Member] | Series D Preferred Stock [Member]
Related Party Transaction [Line Items]
Preferred stock, par or stated value per share		$ 2.8620
2020 Financing [Member] | Maximum [Member]
Related Party Transaction [Line Items]
Financing arrangement amount	$ 20,000,000
2017 and 2020 Financings [Member] | Series D Preferred Stock [Member]
Related Party Transaction [Line Items]
Interest rate			8.00%

XML

Notes Payable (Details Narrative) - USD ($)	Mar. 31, 2021	Mar. 31, 2020
Debt Disclosure [Abstract]
Note payable	$ 136,708	$ 212,790

XML

Related Party Transactions (Details Narrative) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2021	Dec. 31, 2020
Consulting fees	$ 96,250	$ 96,250
Accrued director fees	1,271,839	1,175,589
Mr Bruce Horowitz [Member]
Consulting fees	84,800	52,400
Accrued director fees	$ 18,750	$ 75,000

XML

Short-term Receivables - Summary of Receivables (Details) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Tax Credit	$ 4,388	$ 3,930
Gross receivable	2,104,543	2,104,543
Reserve for uncollectibility	(2,104,543)	(2,104,543)
Net receivable	4,388	3,930
Legal Fees [Member]
Tax Credit
Gross receivable	455,500	455,500
Reserve for uncollectibility	(455,500)	(455,500)
Net receivable
Settlement [Member]
Tax Credit
Gross receivable	1,649,043	1,649,043
Reserve for uncollectibility	(1,649,043)	(1,649,043)
Net receivable
Provectus Australia [Member]
Tax Credit	4,388	3,930
Gross receivable
Reserve for uncollectibility
Net receivable	$ 4,388	$ 3,930

XML

Stockholders' Deficiency (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Equity [Abstract]
Number of restricted common stock issued	250,000
Number of restricted common stock issued, value	$ 19,750
Warrants to purchase common stock	4,500,000
Warrant exercise price	$ 0.0533
Proceeds from warrants exercise	$ 239,850	$ 42,640

XML

Leases (Details Narrative)	3 Months Ended
	Mar. 31, 2021 USD ($) ft²	Mar. 31, 2020 USD ($)
Leases payments, per month	$ 23,831	$ 22,441
Research and Development Expense [Member]
Lease expense	16,508	14,201
General and Administrative Expense [Member]
Lease expense	8,254	7,101
Operating Leases [Member]
Lease expense	$ 24,762	$ 21,302
Knoxville, Tennessee [Member]
Area of land | ft²	4,500
Lease term	5 years
Lease expiration date	Jun. 30, 2022
Leases payments, per month	$ 7,900

XML

Leases - Schedule of Right-of-Use Assets and Liabilities (Details) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Leases [Abstract]
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating leases	$ 23,831	$ 22,441
Right-of-use assets obtained in exchange for lease obligations: Operating leases
Weighted Average Remaining Lease Term: Operating leases	1 year 2 months 30 days	2 years 2 months 30 days
Weighted Average Discount Rate: Operating leases	8.00%	8.00%

XML

Leases - Schedule of Future Minimum Payments Under Non-cancellable Lease (Details)	Mar. 31, 2021 USD ($)
Leases [Abstract]
2021	$ 69,579
2022	46,687
Total future minimum lease payments	116,266
Less: amount representing imputed interest	(8,196)
Total	$ 108,070

XML

Subsequent Events (Details Narrative) - $ / shares	1 Months Ended	3 Months Ended
	May 11, 2021	Mar. 31, 2021
Number of restricted common stock vested		250,000
Warrants to purchase common stock		4,500,000
Warrant exercise price		$ 0.0533
Subsequent Event [Member] | Strategic Advisory Board Member [Member]
Number of restricted common stock vested	25,000
Warrants to purchase common stock	25,000
Warrant exercise price	$ 0.2862
Subsequent Event [Member] | Strategic Advisory Board Member [Member] | Warrant [Member]
Warrant term	3 years