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”), a class entirely owned by the Company.
Our
lead HX molecule is named rose bengal sodium (“RBS”). The Company has established a multi-step approach using
quality-by-design principles for synthesizing and manufacturing pharmaceutical-grade RBS by current good manufacturing practice
(“cGMP”) and under the guidelines of The International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use. A second HX molecule has been synthesized,
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.
Oral
formulations of cGMP RBS are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory
adult solid tumor cancers. |
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● |
Pediatric
Oncology: IL PV-10 is undergoing preclinical study for pediatric solid tumor cancers. |
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Hematology:
Oral formulations of cGMP RBS are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including
leukemias). |
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● |
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”). |
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● |
Microbiology:
Different formulations of cGMP RBS are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”)
bacteria. |
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● |
Ophthalmology:
Topical formulations of cGMP RBS are undergoing preclinical study as potential treatments for diseases and disorders of the eye. |
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Dermatology:
PH-10®, an investigational immune-dermatology agent administered as a topical formulation of cGMP RBS, is undergoing
monotherapy clinical study as well as preclinical study as a monotherapy and in combination therapy with approved drugs for inflammatory
dermatoses. |
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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.
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 and six months ended June
30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.
SARS-CoV-2
was 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, 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 $2,032,609 at June 30, 2022 which includes $1,948,335 of restricted cash resulting from
a grant received from the State of Tennessee. The Company’s working capital deficiency was $6,215,548 and $4,258,679 as of June
30, 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.
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
June 30, 2022 and December 31, 2021, the Company’s cash equivalents consist of Treasury bills of $0 and $42,594, respectively.
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 $551,665. 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 June 30, 2022 and
December 31, 2021, the Company had cash, cash equivalents, and restricted cash balances in excess of FDIC insurance limits of $1,782,609
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
| |
| | | |
| | |
| |
June 30, | | |
June 30, | |
| |
2022 | | |
2021 | |
Warrants | |
| 512,500 | | |
| 82,589,164 | |
Options | |
| 3,425,000 | | |
| 4,800,000 | |
Convertible preferred stock | |
| 105,081,847 | | |
| 106,778,757 | |
2021 unsecured convertible notes | |
| 7,311,088 | | |
| - | |
| |
| | | |
| | |
Total potentially dilutive shares | |
| 116,330,435 | | |
| 194,167,921 | |
4.
Other Accrued Expenses
The
following table summarizes the other accrued expenses at June 30, 2022 and December 31, 2021:
Schedule of Other Accrued Expenses
| |
| | | |
| | |
| |
June 30,
2022 | | |
December 31,
2021 | |
Accrued payroll and taxes | |
$ | 259,008 | | |
$ | 174,533 | |
Accrued vacation | |
| 56,356 | | |
| 42,871 | |
Accrued directors’ fees | |
| 1,753,089 | | |
| 1,560,589 | |
Accrued other expenses | |
| 263,168 | | |
| 224,493 | |
Total Other Accrued Expenses | |
$ | 2,331,621 | | |
$ | 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 | |
| |
| | | |
| | | |
| | |
Beginning Balance | |
$ | 1,310,000 | | |
$ | 200,000 | | |
$ | 1,510,000 | |
Issued | |
| 500,000 | | |
| - | | |
| 500,000 | |
| |
| | | |
| | | |
| | |
Balance as of June 30, 2022 | |
$ | 1,810,000 | | |
$ | 200,000 | | |
$ | 2,010,000 | |
Ending Balance | |
$ | 1,810,000 | | |
$ | 200,000 | | |
$ | 2,010,000 | |
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 June 30, 2022, the Company had received 2021 Notes proceeds of $2,010,000, of which $200,000 is from a related party investor (a Company officer).
Subsequent
to June 30, 2022, the Company received 2021 Notes proceeds of $225,000 from a related party investor (a Company director). See Note
12. Subsequent Events.
6.
Notes Payable
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of June 30, 2022
and December 31, 2021, the balance of the note payable was $142,693 and $238,452, respectively.
7.
Related Party Transactions
During
the three months ended June 30, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $42,400 and
$42,400, respectively, for services rendered. Director fees for Mr. Horowitz for the three months ended June 30, 2022 and 2021 were $18,750
and $18,750, respectively.
During
the six months ended June 30, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $84,800 and
$127,200, respectively, for services rendered. Director fees for Mr. Horowitz for the six months ended June 30, 2022 and 2021 were $37,500
and $37,500, respectively.
Accrued
director fees for Mr. Horowitz as of June 30, 2022 and December 31, 2021 were $318,750 and $281,250, respectively. Total amount owed
to Capital Strategists for consulting fees as of June 30, 2022 and December 31, 2021 were $169,600 and $127,200, respectively. Mr. Horowitz
serves as both Chief Operating Officer (“COO”) and a Company director.
See
Note 5 for details of other related party transactions.
Director
fees during the three months ended June 30, 2022 and 2021 were $96,250 and $96,250, respectively. Director fees during the six months
ended June 30, 2022 and 2021 were $192,500 and $192,500, respectively. Accrued directors’ fees as of June 30, 2022 and December
31, 2021 were $1,753,089 and $1,560,589, respectively.
8.
Stockholders’ Deficiency
Preferred
Stock
During
the six months ended June 30, 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.
Annual
Stockholder Meeting Proposals
The
Company held its annual meeting of stockholders on June 22, 2022. As proposal number 4, stockholders authorized the Company’s
board of directors (the “Board”) to amend the Company’s Certificate of Incorporation, as amended by the
Certificate of Designation of Series D Convertible Preferred Stock and Certificate of Designation of Series D-1 Convertible
Preferred Stock (the “Certificates of Designation”), to
effect a reverse stock split of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible
Preferred Stock at a ratio of between 1-for-10 and 1-for-50, where the ratio would be determined by the Board at its
discretion, and to make corresponding amendments to the Certificates of Designation to provide for the proportional adjustment of
certain terms upon a reverse stock split, consistent with the Board’s recommendation. As proposal number 5, the
Company’s stockholders also authorized the Board, given the stockholders’ approval of proposal number 4, to amend the
Company’s Certificate of Incorporation, as amended by the Certificates of Designation, to decrease the number of authorized
shares of the Company’s common stock and preferred stock by the same reverse stock split ratio determined by the Board,
consistent with the Board’s recommendation. The Board has not acted on these stockholder authorizations as of the filing date.
9.
Leases
The
Company leased 4,500 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of
five years ending on June 30, 2022. Payments were approximately $6,100 per month due to the Company negotiating a continued reduced rent
from January 1, 2022 through June 30, 2022.
On
June 30, 2022, the lease expired and was not renewed. On June 18, 2022, the Company moved into 2,700
square feet of leased corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of three
years ending June 30, 2025. The monthly base rent ranges from $4,053
to $4,278
over the term on the lease.
Total
operating lease expense for the three months ended June 30, 2022 was $23,092, of which, $15,395 was included within research and development
and $7,697 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, 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 six months ended June 30, 2022 was $38,051, of which, $25,367 was included within research and development
and $12,684 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.
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, | |
| |
2022 | | |
2021 | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | |
| |
Operating cash flows used in operating leases | |
$ | 38,625 | | |
$ | 45,784 | |
| |
| | | |
| | |
Right-of-use assets obtained in exchange for lease obligations: | |
| | | |
| | |
Operating leases | |
$ | 151,693 | | |
$ | - | |
| |
| | | |
| | |
Weighted Average Remaining Lease Term | |
| | | |
| | |
Operating leases | |
| 3 years | | |
| 1 year | |
| |
| | | |
| | |
Weighted Average Discount Rate | |
| | | |
| | |
Operating leases | |
| 5% - 8.0 | % | |
| 8.0 | % |
Future
minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2022 were as follows:
Schedule of Future Minimum Payments Under Non-cancellable Lease
| |
| | |
Years | |
Amount | |
2022 | |
$ | 24,318 | |
2023 | |
| 49,311 | |
2024 | |
| 50,663 | |
2025 | |
| 25,669 | |
Total future minimum lease payments | |
| 149,961 | |
Less: amount representing imputed interest | |
| 11,098 | |
Total | |
$ | 138,863 | |
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 June 30, 2022, $1,990,685 has been recorded as unearned
grant revenue liability on the accompanying condensed consolidated balance sheets. The Company recorded $509,315 of grant revenue during
the six months ended June 30, 2022. The grant was pre-funded; therefore, the funds do not need to be used in full by June 30, 2022.
11.
Commitments, Contingencies and Litigation
The
Company may, from time to time, be involved in litigation arising from the ordinary course of business and/or that 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.
Convertible
Notes Payable
Subsequent
to June 30, 2022, the Company received 2021 Notes proceeds of $225,000 from a related party investor (a Company director).
Common
Stock
Subsequent
to June 30, 2022, the Company issued an aggregate of 25,000 shares of immediately vested restricted common stock to a consultant with
a grant date value of $1,500 for services.
Subsequent
to June 30, 2022, the Company issued an aggregate of 25,000 shares of immediately vested restricted common stock to an employee with
a grant date value of $1,500 as an award.