UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 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. ☒ Yes
☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes
☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The
number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of August 12, 2021, was 404,007,037 .
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
20
Item
4. Controls and Procedures
20
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
21
Item
1A. Risk Factors
21
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
21
Item
3. Defaults Upon Senior Securities
22
Item
4. Mine Safety Disclosures
22
Item
5. Other Information
22
Item
6. Exhibits
22
SIGNATURES
23
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 June 30, 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 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, 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
June
30,
December
31,
2021
2020
(Unaudited)
Assets
Current Assets:
Cash and cash
equivalents
$ 47,407
$ 97,231
Short-term receivables
- legal fees, settlement and other, net
5,408
3,930
Prepaid
expenses
294,406
322,518
Total Current Assets
347,221
423,679
Equipment and furnishings, less accumulated depreciation
of $ 84,745
and $ 78,313 ,
respectively
38,269
44,701
Operating lease right-of-use
asset
80,809
120,821
Total
Assets
$ 466,299
$ 589,201
Liabilities and Stockholders’
Deficiency
Current Liabilities:
Accounts payable - trade
$ 1,209,108
$ 956,860
Other accrued expenses
1,653,506
1,500,782
Current portion of accrued
interest
-
2,774,968
Current portion of accrued
interest - related parties
-
1,766,493
Current portion of note
payable
127,393
236,228
Current portion of convertible
notes payable
-
16,622,000
Current portion of convertible
notes payable - related parties
-
6,770,000
Current
portion of operating lease liability
86,974
84,383
Total Current Liabilities
3,076,981
30,711,714
Note payable, non-current
portion
-
39,061
Operating
lease liability, non-current portion
-
44,783
Total
Liabilities
3,076,981
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 June 30, 2021 and December
31, 2020; aggregate liquidation preference of $ 3,500
at June 30, 2021 and December 31, 2020
-
-
Series D Convertible
Preferred Stock; 12,374,000 shares
designated; 12,373,247 and 0 shares
issued and outstanding at June 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference of $ 14,164,889 and
$ 0 at
June 30, 2021 and December 31, 2020, respectively (See Note 4. Convertible Notes Payable – Liquidation Preference )
12,373
-
Series D-1 Convertible
Preferred Stock; 9,441,000 shares
designated; 9,440,594 and 0 shares
issued and outstanding at June 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference of $ 108,075,431 and
$ 0 at
June 30, 2021 and December 31, 2020, respectively (See Note 4. Convertible Notes Payable – Liquidation Preference )
9,441
-
Preferred stock, value
9,441
-
Common stock; par value $ 0.001
per share; 1,000,000,000
shares authorized; 403,782,037
and 398,807,037
shares issued and outstanding at June 30, 2021 and December
31, 2020, respectively
403,783
398,808
Additional paid-in capital
240,742,061
209,923,347
Accumulated other comprehensive
loss
( 34,381 )
( 34,097 )
Accumulated
deficit
( 243,743,959 )
( 240,494,415 )
Total
Stockholders’ Deficiency
( 2,610,682 )
( 30,206,357 )
Total
Liabilities and Stockholders’ Deficiency
$ 466,299
$ 589,201
See
accompanying notes to condensed consolidated financial statements.
2
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2021
2020
2021
2020
For the Three
Months Ended
For the Six
Months Ended
June
30,
June
30,
2021
2020
2021
2020
Operating Expenses:
Research and
development
$ 602,979
$ 696,454
$ 1,258,123
$ 1,605,900
General
and administrative
619,038
514,394
1,144,570
1,053,188
Total
Operating Expenses
1,222,017
1,210,848
2,402,693
2,659,088
Total
Operating Loss
( 1,222,017 )
( 1,210,848 )
( 2,402,693 )
( 2,659,088 )
Other Income/(Expense):
EIDL grant
-
3,000
-
3,000
Research and development
tax credit
32,144
113
32,144
26,364
Investment and interest
income
-
3,334
1
3,413
Gain from extinguishment
63,094
-
63,094
-
Interest
expense
( 452,812 )
( 410,404 )
( 942,087 )
( 815,555 )
Total
Other Expense, Net
( 357,574 )
( 403,957 )
( 846,848 )
( 782,778 )
Net
Loss
$ ( 1,579,591 )
$ ( 1,614,805 )
$ ( 3,249,541 )
$ ( 3,441,866 )
Basic
and Diluted Loss Per Common Share
$ ( 0.00 )
$ ( 0.00 )
$ ( 0.01 )
$ ( 0.01 )
Weighted Average Number
of Common Shares Outstanding - Basic and Diluted
403,628,466
390,714,200
402,910,628
390,635,608
See
accompanying notes to condensed consolidated financial statements.
3
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
2021
2020
2021
2020
For the Three
Months Ended
For the Six
Months Ended
June
30,
June
30,
2021
2020
2021
2020
Net Loss
$ ( 1,579,591 )
$ ( 1,614,805 )
$ ( 3,249,541 )
$ ( 3,441,866 )
Other Comprehensive Income
(Loss):
Foreign
currency translation adjustments
( 1,121 )
2,233
( 34,381 )
( 30,802 )
Total Comprehensive
Loss
$ ( 1,580,712 )
$ ( 1,612,572 )
$ ( 3,283,922 )
$ ( 3,472,668 )
See
accompanying notes to condensed consolidated financial statements.
4
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY
(Unaudited)
FOR
THE SIX MONTHS ENDED JUNE 30, 2021
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Accumulated
Preferred
Stock
Preferred
Stock
Preferred
Stock
Additional
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
Common stock issued for
service
Common stock issued for
services, shares
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 )
Common
stock issued for services
-
-
-
-
-
-
25,000
25
1,650
-
-
1,675
Common
stock issued upon exercise of warrants
-
-
-
-
-
-
200,000
200
10,460
-
-
10,660
Stock-based
compensation:
Warrants
-
-
-
-
-
-
-
-
488
-
-
488
Conversion
of PRH Notes to Series D Preferred Stock
-
-
12,373,247
12,373
-
-
-
-
3,528,849
-
-
3,541,222
Conversion
of PRH Notes to Series D-1 Preferred Stock
-
-
-
-
9,440,594
9,441
-
-
27,022,417
-
-
27,031,858
Comprehensive
loss:
Net loss
-
-
-
-
-
-
-
-
-
-
( 1,579,591 )
( 1,579,591 )
Other
comprehensive income
-
-
-
-
-
-
-
-
-
( 1,121 )
-
( 1,121 )
Other
comprehensive income (loss)
-
-
-
-
-
-
-
-
-
( 1,121 )
-
( 1,121 )
Balance at June 30, 2021
100
$ -
12,373,247
$ 12,373
9,440,594
$ 9,441
403,782,037
$ 403,783
$ 240,742,061
$ ( 34,381 )
$ ( 243,743,959 )
$ ( 2,610,682 )
FOR
THE SIX MONTHS ENDED JUNE 30, 2020
Accumulated
Preferred
Stock
Preferred
Stock
Preferred
Stock
Additional
Other
Series
B
Series
D
Series
D1
Common
Stock
Paid-In
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
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 )
Beginning Balance
100
$ -
-
-
390,689,475
$ 390,689
$ 209,420,675
$ ( 33,035 )
$ ( 235,643,889 )
$ ( 25,865,560 )
Common stock issued for
services
-
-
25,000
25
1,125
-
-
1,150
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 1,614,805 )
( 1,614,805 )
Other
comprehensive income
-
-
-
-
-
-
-
2,233
-
2,233
Other
comprehensive income (loss)
-
-
-
-
-
-
-
2,233
-
2,233
Balance at June 30, 2020
100
$ -
-
-
390,714,475
$ 390,714
$ 209,421,800
$ ( 30,802 )
$ ( 237,258,694 )
$ ( 27,476,982 )
Ending Balance
100
$ -
-
-
390,714,475
$ 390,714
$ 209,421,800
$ ( 30,802 )
$ ( 237,258,694 )
$ ( 27,476,982 )
See
accompanying notes to condensed consolidated financial statements.
5
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2021
2020
For the Six
Months Ended
June
30,
2021
2020
Cash Flows From Operating
Activities:
Net loss
$ ( 3,249,541 )
$ ( 3,441,866 )
Adjustments to reconcile
net loss to net cash used in operating activities:
Stock-based compensation
21,913
1,150
Noncash lease expense
40,012
36,801
Depreciation
6,432
7,046
Amortization of patents
-
228,107
Forgiveness
of PPP Loan
( 62,500 )
-
Changes in operating assets
and liabilities
Short term receivables
( 1,632 )
47,653
Prepaid expenses
123,230
207,590
Accounts payable - trade
252,254
332,134
Loan payable
( 85,398 )
-
Other accrued expenses
152,786
120,817
Operating lease liability
( 42,191 )
( 38,958 )
Accrued
interest expense
939,618
815,430
Net
Cash Used In Operating Activities
( 1,905,017 )
( 1,684,096 )
Cash Flows From Financing
Activities:
Proceeds from issuance of
convertible notes payable
1,700,000
2,375,000
Proceeds from issuance of
convertible notes payable - related parties
-
100,000
Repayment of short-term
note payable
( 95,387 )
-
Proceeds from note payable
-
62,500
Proceeds from exercise
of warrants
250,510
42,640
Net
Cash Provided By Financing Activities
1,855,123
2,580,140
Effect
of Exchange Rate Changes on Cash
70
( 3,536 )
Net
(Decrease)/Increase In Cash and Cash Equivalents
( 49,824 )
892,508
Cash
and Cash Equivalents, Beginning of Period
97,231
590,706
Cash
and Cash Equivalents, End of Period
$ 47,407
$ 1,483,214
Supplemental Disclosures
of Cash Flow Information:
Cash paid during the period
for:
Interest
$ -
$ -
Income
taxes
$ -
$ -
Non-cash investing and
financing activities:
Conversion of 2017 Notes and 2020 Notes to Convertible Preferred Stock Series
D and D-1
30,560,080
-
Purchase of insurance policies
financed by short-term note payable
( 309,710 )
-
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).
●
Animal
Health: Different formulations of cGMP RBD 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, 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 and six months ended
June 30, 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 June 30, 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.
Basic and Diluted Loss Per Common Share
Basic loss per common share is computed by dividing
net loss by the weighted average number of vested common shares outstanding during the period. Diluted earnings per share reflects the
potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common
stock. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion
would have been anti-dilutive:
Schedule of Securities Excluded from Calculation of Weighted Average Dilutive Common Shares
June 30,
June 30,
2021
2020
Warrants
82,589,164
95,767,428
Options
4,800,000
2,800,000
Convertible preferred stock
21,813,941
65,663
Total potentially dilutive shares
109,203,105
98,633,091
2.
Liquidity and Going Concern
The
Company’s cash and cash equivalents were $ 47,407
at June 30, 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, 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
During
the six months ended June 30, 2021, warrant holders exercised warrants to purchase an aggregate of 4,700,000
shares of common stock at a price of $ 0.0533
per share. In connection with these exercises,
the Company received aggregate cash proceeds of $ 250,510 .
On June 20, 2021, the outstanding non-amended
2017 Notes converted into 12,373,247
shares of Series D Convertible Preferred Stock at the Original Conversion Price of $0 .2862 ,
and all the outstanding Amended 2017 Notes and outstanding 2020 Notes converted into 9,440,594
shares of Series D-1 Convertible Preferred Stock at the New Conversion Price of $ 2.862 .
The outstanding non-amended 2017 Notes, Amended 2017 Notes and 2020 Notes had totaled $ 30,560,080
in principal and interest.
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, 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 Financial Accounting Standards Board (“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.
Convertible Instruments
The Company evaluates its convertible instruments
to determine if those contracts or embedded components of those contracts qualify as derivative financial instruments to be separately
accounted for in accordance with ASC Topic 815: Derivatives and Hedging . The accounting treatment of derivative financial instruments
requires that the Company record embedded conversion options and any related freestanding instruments at their fair values as of the
inception date of the agreement and at fair value as of each subsequent balance sheet date. Any change in fair value is recorded as non-operating,
non-cash income or expense for each reporting period at each balance sheet date. The Company reassesses the classification of its derivative
instruments at each balance sheet date. If the classification changes as a result of events during the period, the contract is reclassified
as of the date of the event that caused the reclassification. Embedded conversion options and any related freestanding instruments are
recorded as a discount to the host instrument.
If the instrument is determined to not be
a derivative liability, the Company then evaluates for the existence of a beneficial conversion feature by comparing the commitment date
fair value to the effective conversion price of the instrument.
Preferred Stock
The Company applies the accounting standards
for distinguishing liabilities from equity when determining the classification and measurement of its preferred stock. Preferred shares
subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred
shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption
upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other
times, preferred shares are classified as stockholders’ deficiency.
9
4.
Convertible Notes Payable
2017
Financing
On
March 23, 2017, the Company entered into a 2017 Term Sheet with the PRH Group that set forth the terms on which the PRH Group would use
their best efforts to arrange for a financing of a minimum of $ 10,000,000
and maximum of $ 20,000,000
(the “2017 Financing”). The 2017
Financing was in the form of a secured convertible loan from the PRH Group and other investors in the 2017 Financing, which were evidenced
by secured convertible promissory notes (individually a “2017 Note” and collectively, the “2017 Notes”) from
the Company to the PRH Group and other investors. As of June 30, 2021 and December 31, 2020, the Company had received aggregate proceeds
of $ 20,067,000
from the issuance of the 2017 Notes, respectively,
of which $ 6,770,000
was received from related parties.
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 was in the form of secured convertible loans from investors that were evidenced by secured convertible promissory notes (the
“2020 Notes”). The 2020 Term Sheet was similar to the 2017 Term Sheet. Subject to the terms and conditions of the 2020 Term
Sheet, the Company used its best efforts to arrange for the 2020 Financing, which amounts were obtained in several tranches. As of June
30, 2021 and December 31, 2020, the Company had received proceeds of $ 5,025,000
and $ 3,325,000 ,
respectively, in connection with the 2020 Financing,
of which $ 100,000
was received from related parties.
Firm Commitment
Previously, the Company
had not designated the Series D Preferred Stock into which the 2017 Notes and the 2020 Notes (collectively the “Notes”) were
convertible into. As a result, the Company did not analyze the Notes for a potential beneficial conversion feature as the definition
of a firm commitment had not been met since the Notes were not yet convertible. On June 17, 2021, the required Certificates
of Designation were filed with the Delaware Secretary of State. Accordingly, a firm commitment was achieved. The Company
analyzed the Notes for a beneficial conversion feature and determined that there was none because the Notes have an effective conversion
price of $ 0.2862 and $ 2.862 per share of underlying common stock, which exceeds the $ 0.07 per share commitment date closing market price
of the common stock.
The
Series D and D-1 Convertible Preferred Stock
The
2017 Notes originally provided that they were convertible into a new class of the Company’s preferred stock, $ 0.001
par value per share (“Preferred Stock”),
at a price per share equal to $ 0.2862
(the “Original Conversion Price”),
which would be convertible into one share (the “Original Conversion Ratio”) of the Company’s common stock, $0.001 par
value per share (“Common Stock”).
In
order to ensure that the Company had sufficient authorized shares of Preferred Stock into which the 2017 Notes would convert, yet keep
the economic terms of the 2017 Notes substantially equivalent, the Company entered into amendments (the “Amendments”) to
the 2017 Notes (as amended, the “Amended 2017 Notes”) with a large majority of the holders of 2017 Notes to increase the
conversion price by 10 times from $ 0.2862 to $ 2.862
(the “New Conversion Price”) and
to change the conversion ratio by providing that one share of Preferred Stock would be convertible into 10 shares of Common Stock
(the “New Conversion Ratio”). The impact of the Amendments was to reduce by 10 times the number of shares of Preferred
Stock into which the 2017 Notes would convert, while keeping the economic terms the same by increasing the conversion ratio into Common
Stock by 10 times. The 2020 Notes had substantially similar terms to the Amended 2017 Notes, including being convertible into Preferred
Stock at the New Conversion Price, with the Preferred Stock being convertible into Common Stock at the New Conversion Ratio.
In
order to (i) address the fact that a small minority of the holders of 2017 Notes did not execute the Amendments and (ii) ensure economic
fairness for all of the holders of the 2017 Notes and 2020 Notes, the Company designated two separate classes of Preferred Stock into
which the 2017 Notes and 2020 Notes would convert: (i) the Company’s Series D Convertible Preferred Stock, par value $ 0.001
per share (the “Series D Convertible Preferred
Stock”), was designated for the holders of 2017 Notes who did not execute the Amendments and (ii) the Company’s Series D-1
Convertible Preferred Stock, par value $ 0.001
per share (the “Series D-1 Convertible
Preferred Stock”), was designated for the holders of Amended 2017 Notes (i.e., who did execute the Amendments) and the holders
of the 2020 Notes.
On
June 20, 2021, the outstanding non-amended 2017 Notes converted into 12,373,247
shares of Series D Convertible Preferred Stock
at the Original Conversion Price of $ 0.2862 , and all the outstanding Amended 2017 Notes and outstanding 2020 Notes converted
into 9,440,594
shares of Series D-1 Convertible Preferred Stock at
the New Conversion Price of $ 2.862 .
As
a result of the conversion of the 2017 Notes and 2020 Notes into convertible preferred stock, all the security interests of these
notes in the Company’s intellectual property were released.
The
rights, preferences and privileges of the Series D Convertible Preferred Stock are set forth in a Certificate of Designation of Preferences,
Rights and Limitations of Series D Convertible Preferred Stock (the “Series D Certificate of Designation”). The rights, preferences
and privileges of the Series D-1 Convertible Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and
Limitations of Series D-1 Convertible Preferred Stock (the “Series D-1 Certificate of Designation”). The Board of Directors
of the Company approved each of the Series D Certificate of Designation and Series D-1 Certificate of Designation on June 16, 2021, and
each of the Series D Certificate of Designation and Series D-1 Certificate of Designation were filed with the Delaware Secretary of State
on June 17, 2021. The Series D Certificate of Designation and Series D-1 Certificate of Designation are the same, other than certain
key differences to account solely for the different conversion ratios for the holders of 2017 Notes who did not execute Amendments compared
to the holders of Amended 2017 Notes and the holders of 2020 Notes.
Number
of Shares
The
Series D Certificate of Designation established and designated 12,374,000 shares of Series D Convertible Preferred Stock. The Series
D-1 Certificate of Designation established and designated 9,441,000 shares of Series D-1 Convertible Preferred Stock.
Rank
The
Series D Convertible Preferred Stock and the Series D-1 Convertible Preferred Stock rank pari passu with each other.
The Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock rank senior to the Common Stock and any other class
or series of the Company’s capital stock, the terms of which do not provide that shares of such class rank senior to, or pari
passu with, the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock as to dividends and distributions
upon a change of control transaction, or the liquidation, winding-up and dissolution of the Company.
Dividends
The
Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock do not have any dividend preference but are entitled
to receive, on a pari passu basis, dividends, if any, that are declared and paid on the Common Stock and any other class
of the Company’s capital stock that ranks junior or on par to the Series D Convertible Preferred Stock and Series D-1 Convertible
Preferred Stock.
Liquidation
Preference
Upon
the occurrence of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales of
the Company’s assets (each, a “Company Event”), holders of Series D Convertible Preferred Stock and Series D-1 Convertible
Preferred Stock will be entitled to receive a liquidation preference before any distributions are made to holders of any other class
or series of the Company’s capital stock junior to the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred
Stock. If a Company Event occurs within two years of June 20, 2021 (the “Date of Issuance”), the holders of Series D Convertible
Preferred Stock and Series D-1 Convertible Preferred Stock will receive for each share of Series D Convertible Preferred Stock and Series
D-1 Convertible Preferred Stock, respectively, an amount in cash equal to the Original Issue Price (as defined in the Series D Certificate
of Designation and Series D-1 Certificate of Designation, respectively) multiplied by four. If a Company Event occurs from and after
the second anniversary of the Date of Issuance, the holders of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred
Stock will receive for each share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock, respectively, an
amount in cash equal to the Original Issue Price multiplied by six. The Original Issue Price for the Series D Convertible Preferred Stock
is $ 0.2862 , and the Original Issue Price for the Series D-1 Convertible Preferred Stock is $ 2.862 .
Voting
Rights
Holders
of shares of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will vote together with the holders of Common
Stock as a single class. Each share of Series D Convertible Preferred Stock carries the right to one vote per share. Each share of Series
D-1 Convertible Preferred Stock carries the right to 10 votes per share.
The
Company is not permitted to amend, alter or repeal its Certificate of Incorporation or Bylaws in a manner adverse to the relative rights,
preferences, qualifications, limitations or restrictions of the Series D Convertible Preferred Stock and Series D-1 Convertible Preferred
Stock without the affirmative vote of a majority of the votes entitled to be cast by holders of outstanding shares of Series D Convertible
Preferred Stock and Series D-1 Convertible Preferred Stock, voting together as a single class with each share of Series D Convertible
Preferred Stock and Series D-1 Convertible Preferred Stock having a number of votes equal to the number of shares of Common Stock then
issuable upon conversion of such share of Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock.
Conversion
The
Series D Convertible Preferred Stock is convertible at the option of the holders thereof into shares of Common Stock based on a one-for-one
conversion ratio. The Series D-1 Convertible Preferred Stock is convertible at the option of the holders thereof into shares of Common
Stock based on a one-for-10 conversion ratio. The conversion ratio of the Series D Convertible Preferred Stock and Series D-1 Convertible
Preferred Stock is subject to adjustment for stock splits and combinations, recapitalizations, reclassifications, reorganizations, mergers
and consolidations. The Series D Convertible Preferred Stock and Series D-1 Convertible Preferred Stock will automatically convert into
shares of Common Stock upon the fifth anniversary of the Date of Issuance.
5.
Notes Payable
On
April 20, 2020, the Company received a $ 62,500
loan under the CARES Act PPP (the “PPP
Loan”). The
PPP provides for loans to qualifying businesses for amounts of up to 2.5 times certain of the borrower’s average monthly payroll
expenses. On May 20, 2021, the Company applied
for forgiveness of the PPP Loan. On June 2, 2021, the Company was awarded full forgiveness of the PPP Loan. The Company recognized a
gain on forgiveness of note payable in the period in which it obtained forgiveness, and is included in gain from extinguishment on
the accompanying condensed consolidated statements of operations.
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of June 30, 2021
and December 31, 2020, the balance of the note payable was $ 127,393
and $ 212,790 ,
respectively.
10
6.
Related Party Transactions
During
the three months ended June 30, 2021 and June 30, 2020, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees
of $ 42,400
and $ 11,200 ,
respectively, for services rendered.
During the
six months ended June 30, 2021 and June 30, 2020, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $ 127,200
and $ 63,600 ,
respectively, for services rendered.
Accrued
director fees for Mr. Horowitz as of June 30, 2021 and December 31, 2020 were $ 37,500
and $ 75,000 ,
respectively. Mr. Horowitz serves as both COO and a Director.
See
Note 4 for details of other related party transactions.
Director
fees during the three months ended June 30, 2021 and June 30, 2020 were $ 96,250
and $ 96,250 ,
respectively.
Director
fees during the six months ended June 30, 2021 and June 30, 2020 were $ 192,500
and $ 192,500 ,
respectively.
Accrued directors’ fees as of June 30, 2021 and
December 31, 2020 were $ 1,368,089
and $ 1,175,589 ,
respectively, and are included in other accrued expenses on the accompanying condensed consolidated balance sheet.
7.
Short-term Receivables
The
following table summarizes the receivables at June 30, 2021 and December 31, 2020:
Summary
of Short-term Receivables
June
30, 2021
Tax
Credit
Legal
Fees
Settlement
Total
Provectus Australia Tax Credit
$ 5,408
$ -
$ -
$ 5,408
Gross receivable
-
455,500
1,649,043
2,104,543
Reserve for uncollectibility
-
( 455,500 )
( 1,649,043 )
( 2,104,543 )
Net receivable
$ 5,408
$ -
$ -
$ 5,408
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 six months ended June 30, 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.
During
the six months ended June 30, 2021, the Company issued an aggregate of 25,000
shares of immediately vested restricted common
stock to an advisory board member with a grant date value of $ 1,675
for services. See also Note 11 – Subsequent
Events.
Preferred
Stock
On
June 20, 2021, the Company issued 12,373,247
and 9,440,594
shares of Series D and D-1 Convertible Preferred
Stock, respectively. See Note 4 convertible notes payable.
Warrants
During
the six months ended June 30, 2021, warrant holders exercised warrants to purchase an aggregate of 4,700,000
shares of common stock at a price of $ 0.0533
per share. In connection with these exercises,
the Company received aggregate cash proceeds of $ 250,510 .
See Note 11 – Subsequent Events.
During
the six months ended June 30, 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 an advisory board member. The warrants
had an issuance date fair value of an aggregate of $ 488 ,
which was recognized immediately and is included in general and administrative expenses on the condensed consolidated statements of operations.
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 June 30, 2021 was $ 23,044 ,
of which, $ 15,363
was included within research and development
and $ 7,681
was included within general and administrative
expenses on the condensed consolidated statement of operations. Total operating lease expense for the three months ended June 30, 2020
was $ 22,332 ,
of which, $ 14,888
was
included within research and development and $ 7,444
was
included within general and administrative expenses on the condensed consolidated statement of operations.
Total
operating lease expense for the six months ended June 30, 2021 was $ 47,806 ,
of which, $ 31,871
was included within research and development
and $ 15,935
was included within general and administrative
expenses on the condensed consolidated statement of operations. Total operating lease expense for the six months ended June 30, 2020
was $ 43,634 ,
of which, $ 29,090
was included within research and development
and $ 14,544
was included within general and administrative
expenses on the condensed consolidated statement of operations.
As
of June 30, 2021, the Company had no leases that were classified as a financing lease. As of June 30, 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:
Schedule
of Right-of-Use Assets and Liabilities
For The Six
Months Ended
June
30,
2021
2020
Cash paid for amounts included in the measurement
of lease liabilities:
Operating cash
flows used in operating leases
$ 45,784
$ 44,882
Right-of-use assets obtained in exchange for
lease obligations:
Operating leases
$ -
$ -
Weighted Average Remaining Lease Term
Operating leases
1.00
Year
2.00
Years
Weighted Average Discount Rate
Operating leases
8.0 %
8.0 %
Future
minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2021 were as follows:
Schedule
of Future Minimum Payment for Lease
Years
Amount
2021
46,687
2022
$ 46,687
Total
future minimum lease payments
93,374
Less:
amount representing imputed interest
( 6,400 )
Total
$ 86,974
12
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
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.
Series
D-1 Convertible Preferred Stock
Subsequent
to June 30, 2021, the Company received total investments of $ 150,000
from non-related party investors in
exchange for an aggregate of 52,411
shares of restricted Series D-1 Convertible
Preferred Stock that have not yet been issued.
Common
Stock
Subsequent
to June 30, 2021, the Company issued an aggregate of 25,000
shares of immediately vested restricted common
stock to a consultant for services.
Warrants
Subsequent
to June 30, 2021, warrant holders exercised warrants to purchase an aggregate of 200,000
shares of common stock at a price of $ 0.0533
per share.
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 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 June 30, 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).
Animal
Health. The Company’s work in this disease area to develop a drug candidate or candidates is ongoing.
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.
Animal
health. The Company and research collaborators are undertaking work on cGMP RBD therapies for animal cancers and dermatological disorders.
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 June 30, 2021 and June 30, 2020
Overview
Total
operating expenses were $1,222,017 for the three months ended June 30, 2021, an increase of $11,169 or 0.9% compared
to the three months ended June 30, 2020. The increase was driven primarily by higher legal cost relating to our patents. Net loss for
the three months ended June 30, 2021 was $1,579,591, a decrease of $35,214 or 2.2% which was primarily attributable
to lower costs incurred in connection with our preclinical and clinical trial programs.
For the Three
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
Research and
development
$ 602,979
$ 696,454
$ (93,475 )
-13.4 %
General
and administrative
619,038
514,394
104,644
20.3 %
Total
Operating Expenses
1,222,017
1,210,848
11,169
0.9 %
Total
Operating Loss
(1,222,017 )
(1,210,848 )
(11,169 )
0 .9 %
Other Income/(Expense):
EIDL grant
-
3,000
(3,000 )
0.0 %
Research and development
tax credit
32,144
113
32,031
28346 %
Investment and interest
income
-
3,334
(3,334 )
0.0 %
Gain from extinguishment
63,094
-
63,094
100.0
%
Interest
expense
(452,812 )
(410,404 )
(42,408 )
10.3 %
Total
Other Expense, Net
(357,574 )
(403,957 )
46,383
-11.5 %
Net
Loss
$ (1,579,591 )
$ (1,614,805 )
$ 35,214
-2.2 %
Research
and Development Expenses
Research
and development expenses were $602,979 for the three months ended June 30, 2021, a decrease of $93,475 or 13.4% compared to $696,454
for the three months ended June 30, 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 June 30, 2021 and June 30, 2020:
For the Three
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
Research and development:
Clinical trial
and research expenses
$ 465,627
$ 477,384
$ (11,757 )
-2.5 %
Depreciation/amortization
2,162
62,489
(60,327 )
-96.5 %
Insurance
51,393
72,685
(21,292 )
-29.3 %
Payroll and taxes
67,706
68,282
(576 )
-0.8 %
Rent
and utilities
16,091
15,614
477
3.1 %
Total
research and development
$ 602,979
$ 696,454
$ (93,475 )
-13.4 %
17
General
and Administrative Expenses
General
and administrative expenses were $619,038 for the three months ended June 30, 2021, an increase of $104,644 or 20.3%
compared to $514,394 for the three months ended June 30, 2020. The increase was primarily due to (i) higher professional fees, (ii)
higher legal fees relating to patents, (iii) an increase in payroll and related taxes due to addition of employee, partially offset by
(iv) lower insurance cost.
The
following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2021 and June 30,
2020:
For the Three
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
General and administrative:
Depreciation
$ 1,055
$ 1,362
$ (307 )
-22.5 %
Directors fees
96,250
96,250
-
0.0 %
Insurance
42,262
53,610
(11,348 )
-21.2 %
Legal and litigation
216,723
129,563
87,160
67.3 %
Other general and administrative
cost
15,583
18,766
(3,183 )
-17.0 %
Payroll and taxes
62,540
48,436
14,104
29.1 %
Professional fees
172,759
158,318
14,441
9.1 %
Rent and utilities
8,219
8,078
141
1.7 %
Foreign
currency translation
3,647
11
3,636
0.0 %
Total
general and administrative
$ 619,038
$ 514,394
$ 104,644
20.3 %
Other
Income/(Expense)
Other income increased
by $88,791 from $6,447 for the three months ended June 30, 2020 to $95,238 for the three months ended June 30, 2021.
The increase was mainly due to the PPP loan forgiveness and the research and development tax credit in Australia.
Interest
expense increased by $42,408 from $410,404 for the three months ended June 30, 2020 to $452,812 for the three months ended
June 30, 2021. The increase was due to the increased principal balance of convertible notes payable outstanding during the period
relating to the 2020 Notes.
Comparison
of the Six Months Ended June 30, 2021 and June 30, 2020
Overview
Total
operating expenses were $2,402,693 for the six months ended June 30, 2021, a decrease of $256,395 or 9.6% compared to the six months
ended June 30, 2020. The decrease was driven primarily by our continued transformation and process improvement efforts within the Company
along with lower amortization due to patents being fully amortized and slower recruitment and treatment in clinical trials due to the
effects of SARS-CoV-2. Net loss for the six months ended June 30, 2021 was $3,249,541, a decrease of $192,325 or 5.6% which
was primarily attributable to lower costs incurred in connection with our preclinical and clinical trial programs.
For the Six
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
Research and
development
$ 1,258,123
$ 1,605,900
$ (347,777 )
-21.7 %
General
and administrative
1,144,570
1,053,188
91,382
8.7 %
Total
Operating Expenses
2,402,693
2,659,088
(256,395 )
-9.6 %
Total
Operating Loss
(2,402,693 )
(2,659,088 )
(256,395 )
9.6 %
Other Income/(Expense):
EIDL grant
-
3,000
(3,000 )
-0.0 %
Research and development
tax credit
32,144
26,364
5,780
21.9 %
Investment and interest
income
1
3,413
(3,412 )
0.00 %
Gain from extinguishment
63,094
-
63,094
100.0
%
Interest
expense
(942,087 )
(815,555 )
(126,532 )
15.5 %
Total
Other Expense, Net
(846,848 )
(782,778 )
(64,070 )
8.2 %
Net
Loss
$ (3,249,541 )
$ (3,441,866 )
$ (192,325 )
5.6 %
Research
and Development Expenses
Research
and development expenses were $1,258,123 for the six months ended June 30, 2021, a decrease of $347,777 or 21.7% compared to $1,605,900
for the six months ended June 30, 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 six months ended June 30, 2021 and June 30, 2020:
For the Six
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
Research and development:
Clinical trial
and research expenses
$ 977,207
$ 1,061,441
$ (84,234 )
-7.9 %
Depreciation/amortization
4,324
232,431
(228,107 )
-98.1 %
Insurance
102,781
146,277
(43,496 )
-29.7 %
Payroll and taxes
140,040
134,761
5,279
3.9 %
Rent
and utilities
33,771
30,990
2,781
9.0 %
Total
research and development
$ 1,258,123
$ 1,605,900
$ (347,777 )
-21.7 %
18
General
and Administrative Expenses
General
and administrative expenses were $1,144,570 for the six months ended June 30, 2021, an increase of $91,382 or 8.7% compared to $1,053,188
for the six months ended June 30, 2020. The increase was primarily due to (i) higher legal fees relating to patents, (ii) an increase
in payroll and related taxes due to addition of employee, partially offset by (iii) a decrease in professional fees.
The
following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2021 and June 30, 2020:
For the Six
Months Ended
June
30,
2021
2020
Increase/(Decrease)
%
Change
Operating Expenses:
General and administrative:
Depreciation
$ 2,109
$ 2,723
$ (614 )
-22.5 %
Directors fees
192,500
192,500
-
0.0 %
Insurance
85,828
95,476
(9,648 )
-10.1 %
Legal and litigation
348,738
217,625
131,113
60.2 %
Other general and administrative
cost
46,588
35,773
10,815
30.2 %
Payroll and taxes
108,600
83,922
24,678
29.4 %
Professional fees
338,475
408,329
(69,854 )
-17.1 %
Rent and utilities
16,945
15,738
1,207
7.7 %
Foreign
currency translation
4,787
1,102
3,685
334.4 %
Total
general and administrative
$ 1,144,570
$ 1,053,188
$ 91,382
8.7 %
Other
Income/(Expense)
Other income
increased by $62,462 from $32,777 for the six months ended June 30, 2020 to $95,239 for the six months ended June
30, 2021. The increase was mainly due to the PPP loan forgiveness and the research and development tax credit in Australia.
Interest
expense increased by $126,532 from $815,555 for the six months ended June 30, 2020 to $942,087 for the six months ended June 30,
2021. The increase was due to the increased principal balance on convertible notes payable outstanding during the period relating to
the 2020 Notes.
Liquidity
and Capital Resources
Our
cash and cash equivalents were $47,407 at June 30, 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 $243,743,959 as of June 30, 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 six months ended June 30, 2021, the Company entered into additional non-related party 2020 Notes in the aggregate principal amount
of $1,700,000.
During
the six months ended June 30, 2021, warrant holders exercised warrants to purchase an aggregate of 4,700,000 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 $250,510.
On June 20, 2021, the outstanding
non-amended 2017 Notes converted into 12,373,247 shares of Series D Convertible Preferred Stock at the Original Conversion Price of
$0.2862, and all the outstanding Amended 2017 Notes and outstanding 2020 Notes converted into 9,440,594 shares of Series D-1
Convertible Preferred Stock at the New Conversion Price of $2.862. The outstanding non-amended 2017 Notes, Amended 2017 Notes, and
2020 Notes had totaled $30,560,080 in principal and interest.
Management’s
plans include selling our equity securities and obtaining other 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 June 30, 2021.
19
Access
to Capital
Management
plans to access capital resources through possible public or private equity offerings, including 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 2021 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 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.
20
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 six months ended June 30, 2021, the Company did not enter into any additional 2020 Notes with related party investors. As of June
30, 2021, the Company had drawn down the entire $100,000 under these notes.
During
the six months ended June 30, 2021, the Company entered into additional 2020 Notes with non-related party accredited investors in the
aggregate principal amount of $1,700,000. As of June 30, 2021, the Company had drawn down the entire $4,925,000 under these notes.
On
June 20, 2021, the outstanding non-amended 2017 Notes converted into 12,373,247 shares of Series D Convertible Preferred Stock
at the Original Conversion Price of $0.2862, and all the outstanding Amended 2017 Notes and outstanding 2020 Notes converted into
9,440,594 shares of Series D-1 Convertible Preferred Stock at the New Conversion Price of $2.862. The Series D Convertible Preferred
Stock is convertible at the option of the holders thereof into shares of Common Stock based on a one-for-one conversion ratio. The Series
D-1 Convertible Preferred Stock is convertible at the option of the holders thereof into shares of Common Stock based on a one-for-10
conversion ratio.
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.
21
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 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 on June 24, 2021).
3.2
Certificate of Designation of Preferences, Rights and Limitations of Series D-1 Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 of the Company’s current report on Form 8-K filed on June 24, 2021).
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.
22
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
PROVECTUS
BIOPHARMACEUTICALS, INC.
August
12, 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)
23
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.