UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
file number 001-36457
PROVECTUS
BIOPHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
90-0031917
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
10025
Investment Drive , Suite 250
Knoxville ,
Tennessee
37932
(Address
of principal executive offices)
(Zip
Code)
866 - 594-5999
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
None
N/A
N/A
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The
number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of May 11, 2022, was 419,447,119 .
TABLE
OF CONTENTS
Page
PART
I - FINANCIAL INFORMATION
Cautionary
Note Regarding Forward-Looking Statements
1
Item
1. Financial Statements (unaudited)
2
Condensed
Consolidated Balance Sheets
2
Condensed
Consolidated Statements of Operations
3
Condensed
Consolidated Statements of Comprehensive Loss
4
Condensed
Consolidated Statements of Changes in Stockholders’ Deficiency
5
Condensed
Consolidated Statements of Cash Flows
6
Notes
to Condensed Consolidated Financial Statements
7
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
12
Item
3. Quantitative and Qualitative Disclosures About Market Risk
17
Item
4. Controls and Procedures
17
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
17
Item
1A. Risk Factors
17
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
17
Item
3. Defaults Upon Senior Securities
18
Item
4. Mine Safety Disclosures
18
Item
5. Other Information
18
Item
6. Exhibits
18
SIGNATURES
19
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under U.S. federal securities laws. These
statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express
management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,”
“plan,” “predict,” “project,” “should,” “strategy,” “will,” and
other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results
to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such
statements after this date, unless otherwise required by law.
Risks
and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include
those discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”) (including those described in
Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2021), and Item 1A of Part II of this Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022, and:
●
Our
potential receipt of sales from investigational rose bengal sodium-based drug products PV-10 ® and PH-10 ® ,
and/or any other halogenated xanthene-based drug products (if and when approved); and licensing, milestone, royalty, and/or other
payments related to these investigational drug products and/or the Company’s liquidation, dissolution, or winding up, or any
sale, lease, conveyance, or other disposition of any intellectual property relating to rose bengal sodium-based and other halogenated
xanthene-based investigational drug products and/or drug substances,
●
Our
ability to raise additional capital through the proceeds of private placement transactions, the exercise of existing warrants and
outstanding stock options, and/or public offerings of debt or equity securities,
●
The
widespread outbreak of an illness or communicable/infectious disease, such as severe acute respiratory syndrome coronavirus 2, or
a public health crisis, could disrupt our business and adversely affect our operations and financial condition, and
●
Recently,
many companies across a variety of sectors have reported disruptions, shortages, and other supply chain-related issues. In the biopharmaceutical
sector, delays and interruptions in the supply chain have been particularly pronounced. During the first quarter of 2022, we were
able to effectively manage our supply of prescription drug candidates in a manner that avoided any significant interruptions to our
clinical programs.
1
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS.
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
March
31,
December
31,
2022
2021
(Unaudited)
Assets
Current
Assets:
Cash
and cash equivalents
$ 173,614
$ 682,984
Restricted
cash
2,307,395
2,423,958
Short-term
receivables
3,050
5,107
Prepaid
expenses and other current assets
227,908
329,908
Total
Current Assets
2,711,967
3,441,957
Equipment
and furnishings, less accumulated depreciation of
$ 94,396 and $ 91,178 , respectively
28,618
31,836
Operating
lease right-of-use asset
15,177
39,563
Total
Assets
$ 2,755,762
$ 3,513,356
Liabilities
and Stockholders’ Deficiency
Current
Liabilities:
Accounts
payable
$ 1,597,496
$ 1,287,459
Deposit
for purchase of Series D-1 Preferred Stock
-
150,000
Unearned
grant revenue
2,312,395
2,500,000
Other
accrued expenses
2,185,761
2,002,486
Accrued
interest
35,856
10,578
Accrued
interest - related parties
10,044
6,044
Notes
payable
154,925
238,452
Convertible
notes payable
1,310,000
1,260,000
Convertible
notes payable - related parties
200,000
200,000
Operating
lease liability
18,203
45,617
Total
Current Liabilities
7,824,680
7,700,636
Commitments,
contingencies, and litigations (Note 11)
-
Stockholders’
Deficiency:
Series
D Convertible Preferred Stock; 12,374,000 shares designated; 12,373,247
shares issued and outstanding at March 31, 2022 and December 31, 2021; aggregate liquidation preference of $ 14,164,889 at March 31,
2022 and December 31, 2021
12,373
12,373
Series
D-1 Convertible Preferred Stock; 11,241,000
shares designated; 9,270,860
and 9,218,449
shares issued and outstanding at March 31, 2022 and December
31, 2021, respectively; aggregate liquidation preference of
$ 106,132,320
and $ 105,532,804
at March 31, 2022 and December 31, 2021, respectively
9,271
9,219
Preferred
stock value
Common
stock; par value $ 0.001 per share; 1,000,000,000 shares authorized;
419,447,119 shares issued and outstanding at March 31, 2022 and December 31, 2021
419,447
419,447
Additional
paid-in capital
241,590,054
241,440,106
Accumulated
other comprehensive loss
( 35,183 )
( 34,467 )
Accumulated
deficit
( 247,064,880 )
( 246,033,958 )
Total
Stockholders’ Deficiency
( 5,068,918 )
( 4,187,280 )
Total
Liabilities and Stockholders’ Deficiency
$ 2,755,762
$ 3,513,356
See
accompanying notes to condensed consolidated financial statements.
2
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2022
2021
For
the Three Months Ended
March
31,
2022
2021
Grant
Revenue
$ 187,605
$ -
Operating
Expenses:
Research
and development
671,116
655,144
General
and administrative
516,547
525,532
Total
Operating Expenses
1,187,663
1,180,676
Total
Operating Loss
( 1,000,058 )
( 1,180,676 )
Other
Income/(Expense):
Interest
income and interest expense
( 30,864 )
( 489,274 )
Total
Other Expense, Net
( 30,864 )
( 489,274 )
Net
Loss
$ ( 1,030,922 )
$ ( 1,669,950 )
Basic
and Diluted Loss Per Common Share
$ ( 0.00 )
$ ( 0.00 )
Weighted
Average Number of Common Shares
Outstanding - Basic and Diluted
419,447,119
402,184,815
See
accompanying notes to condensed consolidated financial statements.
3
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
2022
2021
For
the Three Months Ended
March
31,
2022
2021
Net
Loss
$ ( 1,030,922 )
$ ( 1,669,950 )
Other
Comprehensive Loss:
Foreign
currency translation adjustments
( 716 )
837
Total
Comprehensive Loss
$ ( 1,031,638 )
$ ( 1,669,113 )
See
accompanying notes to condensed consolidated financial statements.
4
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY
(Unaudited)
FOR
THE THREE MONTHS ENDED MARCH 31, 2022
Preferred
Stock
Preferred
Stock
Preferred
Stock
Additional
Accumulated
Other
Series
B
Series
D
Series
D-1
Common
Stock
Paid-In
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Balance
at January 1, 2022
-
-
12,373,247
$ 12,373
9,218,449
$ 9,219
419,447,119
$ 419,447
$ 241,440,106
$ (34,467 )
$ (246,033,958 )
$ (4,187,280 )
Series
D-1 Preferred Stock issued for cash
-
-
-
-
52,411
52
-
-
149,948
-
-
150,000
Common stock issued upon exercise of warrants
-
-
-
-
-
Common stock issued upon exercise of warrants, shares
Common stock
Common stock, shares
Comprehensive
loss:
-
-
-
-
Net
loss
-
-
-
-
-
-
-
-
(1,030,922 )
(1,030,922 )
Other
comprehensive loss
-
-
-
-
-
-
-
(716 )
-
(716 )
Balance
at March 31, 2022
-
-
12,373,247
$ 12,373
9,270,860
$ 9,271
419,447,119
$ 419,447
$ 241,590,054
$ (35,183 )
$ (247,064,880 )
$ (5,068,918 )
FOR
THE THREE MONTHS ENDED MARCH 31, 2021
Preferred
Stock
Preferred
Stock
Preferred
Stock
Additional
Accumulated
Other
Series
B
Series
D
Series
D-1
Common
Stock
Paid-In
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Balance
at January 1, 2021
100
$ -
-
-
-
-
398,807,037
$ 398,808
$ 209,923,347
$ (34,097 )
$ (240,494,415 )
$ (30,206,357 )
Common
stock issued upon exercise of warrants
-
-
-
-
-
-
4,500,000
4,500
235,350
-
-
239,850
Stock-based
compensation:
Common
Stock
-
-
250,000
250
19,500
-
-
19,750
Comprehensive
loss:
-
Net
loss
-
-
-
-
-
-
-
-
-
-
(1,669,950 )
(1,669,950 )
Other
comprehensive loss
-
-
-
-
-
837
-
837
Balance
at March 31, 2021
100
$ -
-
-
-
-
403,557,037
$ 403,558
$ 210,178,197
$ (33,260 )
$ (242,164,365 )
$ (31,615,870 )
See
accompanying notes to condensed consolidated financial statements.
5
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2022
2021
For
the Three Months Ended
March
31,
2022
2021
Cash
Flows From Operating Activities:
Net
loss
$ ( 1,030,922 )
$ ( 1,669,950 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Stock-based
compensation
-
19,750
Non-cash
lease expense
24,386
20,006
Depreciation
3,218
3,216
Changes
in operating assets and liabilities
Short
term receivables
2,143
( 515 )
Prepaid
expenses
101,964
45,822
Accounts
payable
309,732
( 10,927 )
Unearned
grant revenue
( 187,605 )
-
Other
accrued expenses
183,001
12,252
Operating
lease liability
( 27,414 )
( 21,096 )
Accrued
interest expense
29,278
487,962
Net
Cash Used In Operating Activities
( 592,219 )
( 1,113,480 )
Cash
Flows From Financing Activities:
Proceeds
from issuance of convertible notes payable
50,000
1,200,000
Repayment
of short-term note payable
( 83,527 )
( 74,417 )
Proceeds
from exercise of warrants
-
239,850
Net
Cash (Used In) Provided By Financing Activities
( 33,527 )
1,365,433
Effect
of exchange rates on cash, cash equivalents, and restricted cash
( 187 )
587
Net
(Decrease) Increase In Cash, Cash Equivalents, and Restricted Cash
( 625,933 )
252,540
Cash,
Cash Equivalents, and Restricted Cash, Beginning of Period
3,106,942
97,231
Cash,
Cash Equivalents, and Restricted Cash, End of Period
$ 2,481,009
$ 349,771
Cash,
cash equivalents and restricted cash consisted of the following:
Cash
and cash equivalents
$ 173,614
$ 349,771
Restricted
cash
2,307,395
-
$ 2,481,009
$ 349,771
Supplemental
Disclosures of Cash Flow Information:
Cash
paid during the period for:
Interest
$ -
$ -
Income
taxes
$ -
$ -
See
accompanying notes to condensed consolidated financial statements.
6
PROVECTUS
BIOPHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
Business
Organization, Nature of Operations and Basis of Presentation
Provectus
Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or the “Company”),
is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, based on a class of small molecules
called halogenated xanthenes (“HXs”) that is entirely owned by the Company. Our lead HX molecule is named rose bengal sodium
(“RBS”). A second synthesized HX molecule is 4,5,6,7-tetrabromo-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenz-
ofuran-1,9′-xanthen]-3-one.
●
Oncology:
PV-10 ® , an investigational cancer immunotherapy administered by intralesional
(“IL”) injection and an injectable formulation of cGMP RBS, is undergoing clinical
study for adult solid tumor cancers, such as melanoma and gastrointestinal (“GI”)
tumors, including hepatocellular carcinoma (“HCC”), colorectal cancer metastatic
to the liver (“mCRC”), neuroendocrine tumors (“NET”) metastatic to
the liver (“mNET”), and uveal melanoma metastatic to the liver (“mUM”),
among others. Orphan drug designation (“ODD”) status was granted to PV-10 by
the U.S. Food and Drug Administration (the “FDA”) for metastatic melanoma in
2006, HCC in 2011, and ocular melanoma (including uveal melanoma) in 2019.
Oral
formulations of cGMP RBS are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory
adult solid tumor cancers, such as head and neck, breast, colorectal, and testicular cancers. In vivo data of a colorectal
tumor murine model that continuously promotes abnormal cell proliferation and transformation into cancer indicate increased survival
in both prophylactic and therapeutic settings.
●
Pediatric
Oncology: IL PV-10 is undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma,
rhabdomyosarcoma, and osteosarcoma). ODD status was granted to PV-10 by the FDA for neuroblastoma in 2018.
●
Hematology:
Oral formulations of cGMP RBS are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including
leukemias). In vivo data of an acute lymphoblastic leukemia murine model indicated increased survival.
●
Virology:
Systemic administration of formulations of cGMP RBS are undergoing preclinical study for the novel strain of coronavirus (“CoV”):
severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”). In silico data indicate docking-based
binding affinity to SARS-CoV-2’s main protease, spike protein, and different variants of the spike protein. In vitro
data indicate activity against SARS-CoV-2 in African green monkey kidney cell (Vero) and human lung epithelial cell (Calu-3) models,
and synergistic activity with remdesivir in a Vero cell model.
●
Microbiology:
Different formulations of cGMP RBS are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”)
bacteria, such as gram-positive and gram-negative. In vitro data indicate activity against a battery of gram-positive bacteria,
including MDR strains, under fluorescent, LED, and natural light, and against gram-positive bacterial biofilms.
●
Ophthalmology:
Topical formulations of cGMP RBS are undergoing preclinical study as potential treatments for diseases of the eye, such as infectious
keratitis.
●
Dermatology:
PH-10 ® , an investigational immune-dermatology agent administered as a topical formulation of cGMP RBS,
is undergoing monotherapy clinical study and preclinical study as a monotherapy and in combination therapy with approved drugs for
inflammatory dermatoses (including psoriasis and atopic dermatitis).
●
Animal
Health: Different formulations of cGMP RBS are undergoing development as potential treatments for animal cancers and dermatological
disorders.
To
date, the Company has not generated any revenues or profits from planned principal operations. The Company’s activities are subject
to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription
drug candidates.
7
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”) for interim financial information pursuant to Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial statements and should be reviewed in
conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10-K for the year
ended December 31, 2021 filed with the SEC on March 29, 2022. In the opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March
31, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.
SARS-CoV-2
was reportedly first identified in late-2019 and subsequently declared a global pandemic by the World Health Organization on March 11,
2020. As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets they serve.
The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees and contractors
and to minimize business disruption. The Company considered the impact of SARS-CoV-2 pandemic on its business and operational assumptions
and estimates, and determined there were no material adverse impacts on the Company’s results of operations and financial position
at March 31, 2022.
The
full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is uncertain. The Company has
experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse
impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate
and/or complete current and/or future preclinical studies and/or clinical trials, disrupt the Company’s regulatory activities,
and/or have other adverse effects on the Company’s clinical development.
2.
Liquidity and Going Concern
The
Company’s cash, cash equivalents, and restricted cash were $ 2,481,009 at
March 31, 2022 which includes the $ 2,307,395 of
restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficiency was $ 5,112,713
and $ 4,258,679
as of March 31, 2022 and December 31, 2021, respectively. The Company continues to incur significant operating losses. Management
expects that significant on-going operating expenditures will be necessary to successfully implement the Company’s business
plan and develop and market its products. These circumstances raise substantial doubt about the Company’s ability to continue
as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued.
Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s
ability to develop PV-10, PH-10, and/or any other halogenated xanthene-based drug products, and to raise additional
capital.
The
Company plans to access capital resources through possible public or private equity offerings, including the 2021 financing (see
Note 5), exchange offers, debt financings, corporate collaborations, or other means. In addition, the Company continues
to explore opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing
transactions, although there can be no assurance that the Company will be successful with such plans. The Company has historically been
able to raise capital through equity offerings, although no assurance can be provided that it will continue to be successful in the future.
If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due.
8
The
primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, the Company
cannot assure that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other halogenated
xanthene-based drug candidate developed by the Company or entering into any financial transaction. Moreover, even if the Company is successful
in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements
in 2022 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions,
the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While the Company
believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide
assurance that it will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant
dilution to stockholders.
3.
Significant Accounting
Policies
Since
the date the Company’s December 31, 2021 consolidated financial statements were issued in its 2021 Annual Report, there have been
no material changes to the Company’s significant accounting policies, except as disclosed below.
Recently
Adopted Accounting Standards
In
October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
2020-10 “Codification Improvements” , which improves consistency by amending the Codification to include all disclosure
guidance in the appropriate disclosure sections and clarifies application of various provisions in the Codification by amending and adding
new headings, cross referencing to other guidance, and refining or correcting terminology. The guidance is effective for the Company
beginning in the first quarter of fiscal year 2022 with early adoption permitted. The Company adopted this standard on January 1, 2022
and it did not have a material effect on its condensed consolidated financial statements.
On
May 3, 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50),
Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic
815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding
equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard
is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should
apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption
is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the
guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company adopted this standard
on January 1, 2022 and it did not have a material effect on its condensed consolidated financial statements.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of
March 31, 2022 and December 31, 2021, the Company’s cash equivalents consist of Treasury bills of $ 42,594 .
Restricted
Cash
Restricted
cash consists of a grant award of $ 2,500,000 received in cash from the State of Tennessee less expenses and deposits to vendors in the
amount of $ 192,605 . See Note 10. Grants.
Cash
Concentrations
Cash,
cash equivalents, and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits
of $ 250,000 , although the Company seeks to minimize this through treasury management. The Company has never experienced any losses related
to these balances although no assurance can be provided that it will not experience any losses in the future. As of March 31, 2022 and
December 31, 2021, the Company had cash, cash equivalent, and restricted cash balances in excess of FDIC insurance limits of $ 2,231,009
and $ 2,856,942 , respectively.
Reclassifications
Certain
prior year balances have been reclassified in order to conform to current year presentation. These reclassifications had no effect on
previously reported results of operations or loss per share.
Basic
and Diluted Loss Per Common Share
Basic
loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the
period. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common
stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average dilutive
common shares because their inclusion would have been anti-dilutive:
Schedule of Securities Excluded from Calculation of Weighted Average Dilutive Common Shares
March
31,
March
31,
2022
2021
Warrants
512,500
82,764,164
Options
3,625,000
4,800,000
Convertible
preferred stock
105,081,847
65,666
2021
unsecured convertible notes
5,436,408
-
Total
potentially dilutive shares
114,655,755
87,629,830
9
4.
Other Accrued Expenses
The
following table summarizes the other accrued expenses at March 31, 2022 and December 31, 2021:
Schedule of Other Accrued Expenses
March
31, 2022
December
31, 2021
Accrued
payroll and taxes
$ 244,349
$ 174,533
Accrued
vacation
50,859
42,871
Accrued
directors’ fees
1,656,839
1,560,589
Accrued
other expenses
233,714
224,493
Total
Other Accrued Expenses
$ 2,185,761
$ 2,002,486
5.
Convertible Notes Payable
2021
Financing
Schedule of Convertible Notes Payable
Non-Related Party
Related Party
Face Amount
Face Amount
Total
Balance as of January 1, 2022
$ 1,260,000
$ 200,000
$ 1,460,000
Issued
50,000
-
50,000
Balance as of March 31, 2022
$ 1,310,000
$ 200,000
$ 1,510,000
For further details on
the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.
As
of March 31, 2022, the Company had received 2021 Notes proceeds of $ 1,510,000 , of which $ 200,000 is from a related party investor (an
officer of the Company).
6.
Notes Payable
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of March 31, 2022
and December 31, 2021, the balance of the note payable was $ 154,925 and $ 238,452 , respectively.
7.
Related Party Transactions
During
the three months ended March 31, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $ 42,400
and $ 84,800 ,
respectively, for services rendered. Director fees for Mr. Horowitz for the three months ended March 31, 2022 and 2021 were $ 18,750
and $ 18,750 ,
respectively. Accrued director fees for Mr. Horowitz as of March 31, 2022 and December 31, 2021 were $ 300,000
and $ 281,250 ,
respectively. Total amount owed to Capital Strategists
as of March 31, 2022 and December 31, 2021 were $ 127,200 .
Mr. Horowitz serves as both COO and a Director,
of the Company.
See
Note 5 for details of other related party transactions.
Director
fees during the three months ended March 31, 2022 and 2021 were $ 96,250
and $ 96,250 ,
respectively. Accrued directors’ fees as of March 31, 2022 and December 31, 2021 were $ 1,656,839
and $ 1,560,589 ,
respectively.
8.
Stockholders’ Deficiency
Preferred
Stock
During
the three months ended March 31, 2022, the Company issued 52,411
shares of restricted Series D-1 Convertible Preferred
Stock in exchange for an investment of $ 150,000
from a non-related party investor.
10
9.
Leases
The
Company currently leases 4,500
square feet of corporate office space in Knoxville,
Tennessee through an operating lease agreement for a term of five
years ending on June
30, 2022 . Payments are approximately $ 6,100
per month.
On
February 23, 2022, the Company negotiated a continued reduced rent from January 1, 2022 through June 30, 2022 in the amount of $ 6,100
per month.
Total
operating lease expense for the three months ended March 31, 2022 was $ 14,959 ,
of which, $ 9,973
was included within research and development
and $ 4,986
was included within general and administrative
expenses on the condensed consolidated statement of operations. Total operating lease expense for the three months ended March 31, 2021
was $ 24,762 ,
of which, $ 16,508
was included within research and development
and $ 8,254
was included within general and administrative
expenses on the condensed consolidated statement of operations.
A
summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right-of-use Assets and Liabilities
For
The Three Months Ended
March
31,
2022
2021
Cash
paid for amounts included in the measurement of lease liabilities:
Operating
cash flows used in operating leases
$ 18,447
$ 23,831
Right-of-use
assets obtained in exchange for lease obligations:
Operating
leases
$ -
$ -
Weighted
Average Remaining Lease Term
Operating
leases
3
months
1
year 3 months
Weighted
Average Discount Rate
Operating
leases
8.0 %
8.0 %
Future
minimum payments under the Company’s non-cancellable lease obligations as of March 31, 2022 were as follows:
Schedule of Future Minimum Payments Under Non-cancellable Lease
Years
Amount
2022
$ 18,447
Total
future minimum lease payments
18,447
Less:
amount representing imputed interest
( 234 )
Total
$ 18,203
10.
Grants
On
October 25, 2021, the Company received a grant award of $ 2,500,000 from the State of Tennessee for the study of animal cancers and dermatological
disorders for the period October 15, 2021 to June 30, 2022. As of March 31, 2022, the grant award of $ 2,312,395 is recorded as unearned
grant revenue liability on the accompanying condensed consolidated balance sheets. The Company recorded $ 187,605 of grant revenue during
the three months ended March 31, 2022.
11.
Commitments, Contingencies and Litigation
The
Company may, from time to time, be involved in litigation arising in the ordinary course of business or which may be expected to be covered
by insurance. The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material
adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
12.
Subsequent Events
The
Company has evaluated events that have occurred after the balance sheet and through the date the financial statements were issued. Based
upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment
or disclosure in the financial statements, except as disclosed below.
Subsequent
to March 31, 2022, the Company entered into a 2021 Note with a non-related party investor in the aggregate principal amount of $ 500,000
in connection with a 2021 Loan received by the Company for the same amount.
Subsequent
to March 31, 2022, the Company announced it has added Aru Narendran, MD, PhD at the University of Calgary to the Scientific Advisory
Board.
11
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The
following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results
of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in
conjunction with the accompanying unaudited condensed financial statements and our Annual Report on Form 10-K for the year ended December
31, 2021 filed with the SEC on March 29, 2022 (“2021 Form 10-K”), which includes additional information about our critical
accounting policies and practices and risk factors. Historical results and percentage relationships set forth in the consolidated statement
of operations, including trends which might appear, are not necessarily indicative of future operations.
Overview
Provectus
is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, based on a class of small molecules
called HXs that is entirely owned by the Company. The Company’s lead HX molecule is cGMP RBS.
Components
of Operating Results
Grant
Revenue
Grant
income is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met.
Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as other income
when qualifying costs are incurred.
Research
and Development Expenses
A
large component of our total operating expenses is the Company’s investment in research and development activities, including the
clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake
clinical trials to develop our drug product candidates. These expenses consist primarily of:
●
Costs
of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among
others;
●
Salaries
and related expenses for personnel, including stock-based compensation expense;
●
Other
outside service costs including cost of contract manufacturing;
●
The
costs of supplies and reagents; and,
●
Occupancy
and depreciation charges.
We expense research and
development costs as incurred.
Research
and development activities are central to our business model. We expect our research and development expenses to increase in the future
as we advance our existing product candidates through clinical trials and pursue their regulatory approval. Undertaking clinical development
and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are
unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent we
will generate revenue from any subsequent commercialization and sale of our drug product candidates.
General
and Administrative Expenses
General
and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for personnel in
executive, finance, accounting, business development, legal, information technology and corporate communication functions. Other costs
include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, patent
and accounting services.
12
Results
of Operations
Comparison
of the Three Months Ended March 31, 2022 and March 31, 2021
Overview
Total
operating expenses were $1,187,663 for the three months ended March 31, 2022, an increase of $6,987 or 0.6% compared to the three months
ended March 31, 2021. The increase was driven primarily by (i) increased clinical trial cost, (ii) higher insurance costs and (iii)
higher payroll and taxes, partially offset by (iv) lower legal and litigation fees and (v) lower rent and utilities cost. Net loss for
the three months ended March 31, 2022 was $1,030,922, a decrease of $639,028 or 38.3% which was primarily attributable to lower interest
expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021 and the recognition
of grant revenue in the amount of $187,605.
For
the Three Months Ended
March
31,
2022
2021
Increase/(Decrease)
%
Change
Grant
Revenue
$ 187,605
$ -
$ 187,605
0.0 %
Operating
Expenses:
Research
and development
671,116
655,144
15,972
2.4 %
General
and administrative
516,547
525,532
(8,985 )
-1.7 %
Total
Operating Expenses
1,187,663
1,180,676
6,987
0.6 %
Total
Operating Loss
(1,000,058 )
(1,180,676 )
180,618
-15.3 %
Other
Income/(Expense):
Interest
income and interest expense
(30,864 )
(489,274 )
458,410
-93.7 %
Total
Other Expense, Net
(30,864 )
(489,274 )
458,410
-93.7 %
Net
Loss
$ (1,030,922 )
$ (1,669,950 )
$ 639,028
-38.3 %
Grant
Revenue
For the 3 months
ended March 31, 2022 and 2021, there was $187,605 and $0, respectively, of grant revenue recognized related to qualifying expenses that
were incurred and included within research and development on the condensed consolidated statements of operations.
Research
and Development Expenses
Research
and development expenses were $671,116 for the three months ended March 31, 2022, an increase of $15,972 or 2.4% compared to $655,144
for the three months ended March 31, 2021. The increase was primarily due to (i) increased cost on clinical trials due to increased recruitment
and treatment in clinical trials, and (ii) higher insurance cost, partially offset by (iii) lower payroll and payroll taxes, and (iv)
a decrease in rent expense.
For
the Three Months Ended
March
31,
2022
2021
Increase/(Decrease)
%
Change
Research
and development:
Clinical
trial and research expenses
531,691
511,580
$ 20,111
3.9 %
Depreciation/amortization
2,164
2,162
2
0.1 %
Insurance
58,523
51,388
7,135
13.9 %
Payroll
and taxes
67,115
72,334
(5,219 )
-7.2 %
Rent
and utilities
11,623
17,680
(6,057 )
-34.3 %
Total
research and development
$ 671,116
$ 655,144
$ 15,972
2.4 %
13
General
and Administrative Expenses
General
and administrative expenses were $516,547 for the three months ended March 31, 2022, a decrease of $8,985 or 1.7% compared to $525,532
for the three months ended March 31, 2021. The decrease was primarily due to (i) lower legal fees relating to patents, (ii) reduced rent
and utilities cost, and (iii) lower other general and administrative cost, partially offset by (iv) increased payroll and taxes
and (v) higher insurance cost.
For the Three Months Ended
March
31,
2022
2021
Increase/(Decrease)
%
Change
General
and administrative:
Depreciation
$ 1,054
$ 1,054
$ -
0.0 %
Directors
fees
96,250
96,250
-
0.0 %
Insurance
48,218
43,566
4,652
10.7 %
Legal
and litigation
112,534
132,015
(19,481 )
-14.8 %
Other
general and administrative cost
22,859
31,005
(8,146 )
-26.3 %
Payroll
and taxes
64,299
46,060
18,239
39.6 %
Professional
fees
166,355
165,716
639
0.4 %
Rent
and utilities
5,599
8,726
(3,127 )
-35.8 %
Foreign
currency translation
(621 )
1,140
(1,761 )
-154.5 %
Total
general and administrative
$ 516,547
$ 525,532
$ (8,985 )
-1.7 %
Other
Income/(Expense)
Interest
expense decreased by $458,410 from $489,274 for the three months ended March 31, 2021 to $30,864 for the three months ended March 31,
2022. The decrease was due to the lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to
preferred stock on June 20, 2021.
For
the Three Months Ended
March
31,
2022
2021
Increase/(Decrease)
%
Change
Other
Income/(Expense):
Interest
income and interest expense
$ (30,864 )
$ (489,274 )
$ 458,410
-93.7 %
Total
Other Expenses, Net
$ (30,864 )
$ (489,274 )
$ 458,410
-93.7 %
14
Liquidity
and Capital Resources
The
Company’s cash, cash equivalents, and restricted cash were $2,481,009 at March 31, 2022 which includes the $2,307,395 of restricted
cash resulting from a grant received from the State of Tennessee, compared to $3,106,942 at December 31, 2021, which included $2,423,958
of restricted cash. The Company’s working capital deficiency was $5,112,713 and $4,258,679 as of March 31, 2022 and December
31, 2021, respectively. The condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q
have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the
normal course of business. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated
deficit of $247,064,880 as of March 31, 2022. These conditions raise substantial doubt about our ability to continue as a going concern
for a period within one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are
issued. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may
be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to
obtain additional financing as may be required to fund current operations.
As
of March 31, 2022, cash required for our current liabilities included approximately $3,801,460 for accounts payable and accrued
expenses (including lease liabilities) and a $154,925 note payable related to our short-term financing of our commercial insurance policies.
Also, if not converted prior to maturity, convertible debt in the amount of $1,510,000 plus accrued interest will mature one year from
the date of the notes. There are no cash requirements for long-term liabilities at March 31, 2022. The Company intends to meet these
cash requirements from its current cash balance and from future financing.
Management’s
plans include selling our equity securities and obtaining other financing, including the 2021 financing, to fund our capital requirements
and on-going operations; however, there can be no assurance we will be successful in these efforts. The condensed consolidated financial
statements do not include any adjustment that might be necessary if we are unable to continue as a going concern. Significant funds will
be needed to continue and complete our ongoing and planned clinical trials.
The
SARS-CoV-2 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions,
which could impact our ability to raise additional funds and may also impact the volatility of our stock price and trading in our stock.
Moreover, the pandemic has also significantly impacted economies worldwide, which could result in adverse effects on our business and
operations. We cannot be certain what the overall impact of the SARS-CoV-2 pandemic will be on our business. It has the potential to
adversely affect our business, financial condition, results of operations, and prospects. The Company has experienced slower than normal
enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse impact on the Company’s
business and financial results, including the timing and ability of the Company to raise capital, initiate and/or complete current and/or
future preclinical studies and/or clinical trials; disrupt the Company’s regulatory activities; and/or have other adverse effects
on the Company’s clinical development. We have taken several temporary precautionary measures intended to help ensure the well-being
of our employees and contractors and to minimize disruption to our business. We considered the impact of the SARS-CoV-2 pandemic on our
business and operational assumptions and estimates, and determined there were no material adverse impacts on our results of operations
and financial position at March 31, 2022.
15
Access
to Capital
Management
plans to access capital resources through possible public or private equity offerings, including the 2021 financing, equity financings,
debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital, we will not be able to pay our
obligations as they become due.
The
primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure
you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing
our prescription drug product candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless
plan to seek additional funds to meet our current and long-term requirements in 2022 and beyond. We anticipate that these funds will
otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options,
or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be
able to raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition,
any such financing may result in significant dilution to stockholders.
Critical
Accounting Estimates
The
preparation of financial statements and related disclosures must be in conformity with U.S. GAAP. These accounting principles require
us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements
as well as the reported amounts of revenue and expense during the periods presented. We believe that the estimates and judgments upon
which it relies are reasonably based upon information available to us at the time that it makes these estimates and judgments. To the
extent that there are material differences between these estimates and actual results, our financial results will be affected. The accounting
policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding
and evaluating our reported financial results are described below.
The
following is not intended to be a comprehensive list of all of our accounting policies or estimates. Our accounting policies are more
fully described in Note 3 –Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.
Stock-Based
Compensation
We
measure the cost of services received in exchange for an award of equity instruments based on the fair value of the award on the date
of grant. The fair value amount of the shares expected to ultimately vest is then recognized over the period for which services are required
to be provided in exchange for the award, usually the vesting period. The estimation of stock-based awards that will ultimately vest
requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as
a cumulative adjustment in the period that the estimates are revised. We account for forfeitures as they occur.
Research
and Development
Research
and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits
for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing
expenses, fees paid to third parties and other outside expenses. We accrue for costs incurred as the services are being provided by monitoring
the status of the clinical trial or project and the invoices received from our external service providers. We adjust our accrual as actual
costs become known.
Recently
Adopted Accounting Standards
Recently
adopted accounting standards are included in Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly
Report on Form 10-Q.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also
known as special purpose entities (“SPEs”).
16
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the
effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our principal executive officer
and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures
were effective to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit
under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and
forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer,
as appropriate to allow timely decisions regarding required disclosure.
Inherent
Limitations on Effectiveness of Controls
Even
assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial
officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error
or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the
control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that
our control system’s objective will be met, and our principal executive officer and principal financial officer has concluded that
our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the
fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of
the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error
or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error
or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management
override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future
events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become
inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes
in Internal Control Over Financial Reporting
There
has been no change in our internal control over financial reporting that occurred during the first quarter of 2022 covered by this Quarterly
Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
The
information required by this item is incorporated by reference from Part I, Item 1. Financial Statements, Notes to Condensed Consolidated
Financial Statements, Note 11.
ITEM
1A. RISK FACTORS.
There
have been no material changes to the risk factors that were disclosed in the 2021 Form 10-K.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
2021
Financing
During
the three months ended March 31, 2022, the Company had received aggregate proceeds of $50,000 pursuant to certain unsecured convertible
notes (the “2021 Notes”). As of March 31, 2022, the Company had drawn down $1,510,000 under the 2021 Notes.
For
further details on the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.
Preferred
Convertible Stock
During
the three months ended March 31, 2022, the Company issued 52,411 shares of Series D-1 Convertible Preferred Stock in consideration of
a $150,000 investment.
The
Company believes that such transactions were exempt from the registration requirements of the Securities Act of 1933, as amended, (the
“Securities Act”), in reliance on Section 4(a)(2) of the Securities Act (or Rule 506(b) of Regulation D promulgated thereunder)
as transactions by an issuer not involving a public offering.
17
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. Mine Safety Disclosures.
Not
applicable.
ITEM
5. OTHER INFORMATION.
None.
ITEM
6. EXHIBITS.
Exhibit
No.
Description
3.1
Certificate
of Incorporation of Provectus Biopharmaceuticals, Inc., as amended (incorporated by reference to Exhibit 3.1 of the Company’s
annual report on Form 10-K filed with the SEC on March 31, 2017).
3.2
Certificate
of Elimination with respect to Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s
current report on Form 8-K filed with the SEC on April 5, 2022).
3.3
Certificate
of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock (incorporated by reference to Exhibit
3.1 of the Company’s current report on Form 8-K filed with the SEC on June 24, 2021).
3.4**
Certificate
of Designation of Preferences, Rights and Limitations of Series D-1 Convertible Preferred Stock (as amended by the Certificate of
Amendment, dated March 30, 2022).
3.5
Bylaws
of Provectus Biopharmaceuticals, Inc. (incorporated by reference to Exhibit 3.4 of the Company’s annual report on Form 10-K
filed with the SEC on March 13, 2014).
31.1**
Certification
of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
31.2**
Certification
of Chief Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
32***
Certification
of Principal Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification).
101.INS
Inline
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded
within the Inline XBRL document.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
**
Filed herewith.
***
Furnished herewith.
18
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
PROVECTUS
BIOPHARMACEUTICALS, INC.
May
12, 2022
By:
/s/
Bruce Horowitz
Bruce
Horowitz
Chief
Operating Officer (Principal Executive Officer)
By:
/s/
Heather Raines
Heather
Raines, CPA
Chief
Financial Officer (Principal Financial Officer)
19
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.