Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS.
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30,
December 31,
2024
2023
(Unaudited)
Assets
Current Assets:
Cash
$ 29,581
$ 76,576
Restricted cash
559,702
950,223
Short-term receivables
767
476
Prepaid expenses and other current assets
210,194
337,522
Total Current Assets
800,244
1,364,797
Equipment and furnishings, less accumulated depreciation of $ 115,455 and $ 110,994 , respectively
7,559
12,020
Operating lease right-of-use asset
48,624
72,026
Total Assets
$ 856,427
$ 1,448,843
Liabilities and Stockholders’ Deficit
Current Liabilities:
Accounts payable
$ 1,321,947
$ 1,675,891
Unearned grant revenue
460,185
953,248
Other accrued expenses
3,388,425
3,240,436
Accrued interest
62,076
22,600
Accrued interest - related parties
89,030
123,828
Accrued interest
89,030
123,828
Notes payable
109,862
277,815
Convertible notes payable
1,153,000
800,000
Convertible notes payable - related parties
1,735,000
1,875,000
Convertible notes payable
1,735,000
1,875,000
Operating lease liability, current portion
49,975
48,077
Total Current Liabilities
8,369,500
9,016,895
Operating lease liability, non-current portion
-
25,299
Total Liabilities
8,369,500
9,042,194
Commitments, contingencies, and litigations (Note 12)
-
-
Stockholders’ Deficit:
Preferred stock; par value $ 0.001 per share; 25,000,000 shares authorized;
Series D Convertible Preferred Stock; 957,100 and 12,374,000 shares designated at June 30, 2024 and December 31, 2023, respectively; 956,985 and 12,373,247 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $ 1,095,556 and $ 14,164,889 at June 30, 2024 and December 31, 2023, respectively
957
12,373
Series D-1 Convertible Preferred Stock; 23,042,900 and 11,241,000 shares designated
at June 30, 2024 and December 31, 2023, respectively; 12,002,888 and 10,361,097 shares issued and outstanding at June 30, 2024 and
December 31, 2023, respectively; aggregate liquidation preference of $ 137,408,291 and $ 118,613,136 at June 30, 2024 and December 31,
2023, respectively
12,003
10,361
Preferred stock, value
12,003
10,361
Common stock; par value $ 0.001 per share; 1,000,000,000 shares authorized; 419,522,119 shares issued
and outstanding at June 30, 2024 and December 31, 2023
419,522
419,522
Additional paid-in capital
246,156,198
244,714,967
Accumulated other comprehensive loss
( 60,454 )
( 60,165 )
Accumulated deficit
( 254,041,299 )
( 252,690,409 )
Total Stockholders’ Deficit
( 7,513,073 )
( 7,593,351 )
Total Liabilities and Stockholders’ Deficit
$ 856,427
$ 1,448,843
See
accompanying notes to condensed consolidated financial statements.
2
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2024
2023
2024
2023
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Grant Revenue
$ 254,991
$ 161,842
$ 493,063
$ 366,867
Operating Expenses:
Research and development
472,927
434,214
1,028,462
982,607
General and administrative
576,918
527,831
706,720
966,676
Total Operating Expenses
1,049,845
962,045
1,735,182
1,949,283
Total Operating Loss
( 794,854 )
( 800,203 )
( 1,242,119 )
( 1,582,416 )
Other Income/(Expense):
Research and development tax credit
9,301
15,965
9,301
15,965
Interest expense
( 61,295 )
( 50,824 )
( 118,072 )
( 96,065 )
Total Other Expense, Net
( 51,994 )
( 34,859 )
( 108,771 )
( 80,100 )
Net Loss
$ ( 846,848 )
$ ( 835,062 )
$ ( 1,350,890 )
$ ( 1,662,516 )
Basic and Diluted Loss Per Common Share
$ ( 0.00 )
$ ( 0.00 )
$ ( 0.00 )
$ ( 0.00 )
Weighted Average Number of Common Shares Outstanding - Basic and Diluted
419,522,119
419,497,119
419,522,119
419,497,119
See
accompanying notes to condensed consolidated financial statements.
3
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
2024
2023
2024
2023
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Net Loss
$ ( 846,848 )
$ ( 835,062 )
$ ( 1,350,890 )
$ ( 1,662,516 )
Other Comprehensive Loss:
Foreign currency translation adjustments
126
( 278 )
( 289 )
( 87 )
Total Comprehensive Loss
$ ( 846,722 )
$ ( 835,340 )
$ ( 1,351,179 )
$ ( 1,662,603 )
See
accompanying notes to condensed consolidated financial statements.
4
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
(Unaudited)
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Accumulated
Preferred Stock
Preferred Stock
Additional
Other
Series D
Series D-1
Common Stock
Paid-In
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Balance at January 1, 2024
12,373,247
$ 12,373
10,361,097
$ 10,361
419,522,119
$ 419,522
$ 244,714,967
$ ( 60,165 )
$ ( 252,690,409 )
$ ( 7,593,351 )
Conversion of 2021 Note to Series D1 Preferred Stock
-
-
226,474
226
-
-
647,935
-
-
648,161
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 504,042 )
( 504,042 )
Other comprehensive loss
-
-
-
-
-
-
-
( 415 )
-
( 415 )
Balance at March 31, 2024
12,373,247
$ 12,373
10,587,571
$ 10,587
419,522,119
$ 419,522
$ 245,362,902
$ ( 60,580 )
$ ( 253,194,451 )
$ ( 7,449,647 )
Forfeited shares of Series D Preferred Stock
( 11,416,262 )
( 11,416 )
-
-
-
-
11,416
-
-
-
Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock
-
-
1,141,626
1,141
-
-
( 1,141 )
-
-
-
Conversion of 2021 Note to Series D1 Preferred Stock
-
-
273,691
274
-
-
783,021
-
-
783,296
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 846,848 )
( 846,848 )
Other comprehensive income
-
-
-
-
-
-
-
126
-
126
Balance at June 30, 2024
956,985
$ 957
12,002,888
$ 12,003
419,522,119
$ 419,522
$ 246,156,198
$ ( 60,454 )
$ ( 254,041,299 )
$ ( 7,513,073 )
5
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2023
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Accumulated
Preferred Stock
Preferred Stock
Additional
Other
Series D
Series D-1
Common Stock
Paid-In
Comprehensive
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Total
Balance at January 1, 2023
12,373,247
$ 12,373
9,746,626
$ 9,747
419,497,119
$ 419,497
$ 242,954,193
$ ( 35,679 )
$ ( 249,588,641 )
$ ( 6,228,510 )
Conversion of 2021 Note to Series D-1 Preferred Stock
-
-
18,872
18
-
-
53,992
-
-
54,010
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 827,454 )
( 827,454 )
Other comprehensive income
-
-
-
-
-
-
-
191
-
191
Balance at March 31, 2023
12,373,247
$ 12,373
9,765,498
$ 9,765
419,497,119
$ 419,497
$ 243,008,185
$ ( 35,488 )
$ ( 250,416,095 )
$ ( 7,001,763 )
Balance
12,373,247
$ 12,373
9,765,498
$ 9,765
419,497,119
$ 419,497
$ 243,008,185
$ ( 35,488 )
$ ( 250,416,095 )
$ ( 7,001,763 )
Conversion of 2021 Note to Series D-1 Preferred Stock
-
-
188,757
189
-
-
540,033
-
-
540,222
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 835,062 )
( 835,062 )
Other comprehensive loss
-
-
-
-
-
-
-
( 278 )
-
( 278 )
Balance at June 30, 2023
12,373,247
$ 12,373
9,954,255
$ 9,954
419,497,119
$ 419,497
$ 243,548,218
$ ( 35,766 )
$ ( 251,251,157 )
$ ( 7,296,881 )
Balance
12,373,247
12,373
9,954,255
9,954
419,497,119
419,497
243,548,218
( 35,766 )
( 251,251,157 )
( 7,296,881 )
See
accompanying notes to condensed consolidated financial statements.
6
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2024
2023
For the Six Months Ended
June 30,
2024
2023
Cash Flows From Operating Activities:
Net loss
$ ( 1,350,890 )
$ ( 1,662,516 )
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash lease expense
23,402
22,272
Depreciation
4,461
4,461
Changes in operating assets and liabilities
Short term receivables
( 299 )
( 1,366 )
Prepaid expenses and other current assets
127,328
314,165
Accounts payable
( 353,763 )
( 104,704 )
Unearned grant revenue
( 493,063 )
( 366,866 )
Other accrued expenses
148,011
483,019
Operating lease liability
( 23,401 )
( 21,597 )
Accrued interest
111,134
91,239
Net Cash Used In Operating Activities
( 1,807,080 )
( 1,241,893 )
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable
353,000
-
Proceeds from issuance of convertible notes payable - related parties
1,285,000
1,325,000
Repayment of short-term note payable
( 167,953 )
( 152,856 )
Repayment of 2021 convertible note payable - related party
( 100,000 )
-
Proceeds from exercise of warrants
-
-
Net Cash Provided By Financing Activities
1,370,047
1,172,144
Effect of exchange rates on cash and restricted cash
( 483 )
( 2,799 )
Net Decrease In Cash and Restricted Cash
( 437,516 )
( 72,548 )
Cash and Restricted Cash, Beginning of Period
1,026,799
1,431,707
Cash and Restricted Cash, End of Period
$ 589,283
$ 1,359,159
Cash and restricted cash consisted of the following:
Cash
$ 29,581
$ 176,010
Restricted
cash
559,702
1,183,149
Cash and Restricted Cash,
End of Period
$ 589,283
$ 1,359,159
Supplemental Disclosures of Cash Flow Information:
Cash paid during the period for:
Interest
$ -
$ -
Income taxes
$ -
$ -
Non-cash investing and financing activities:
Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock
$ -
$ 594,232
Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock
$ 1,431,457
$ -
Forfeited shares of Series D Preferred Stock
$ ( 11,416 )
$ -
Issuance of Series D-1 Preferred Stock for forfeited shares
of Series D Preferred Stock
$ 1,141
$ -
Purchase of insurance policies financed by short-term note payable
$ -
$ ( 61,735 )
See
accompanying notes to condensed consolidated financial statements.
7
PROVECTUS
BIOPHARMACEUTICALS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
Business Organization, Nature of Operations and Basis of Presentation
Provectus
Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”),
is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases based on a class of synthetic small
molecule halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal sodium (“RBS”).
The
Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug
candidates of our current clinical development programs and the non-clinical formulations of our current non-clinical proof-of-concept
in vivo and early discovery programs. Importantly, our pharmaceutical-grade RBS displays different therapeutic effects at different
concentrations and can be formulated for delivery by different routes of administration.
The
Company believes that RBS targets disease in a bifunctional multi-modal manner. Direct contact by RBS may lead to cell death or repair,
depending on the disease being treated and the concentration of RBS utilized in the treatment formulation, by one or more targeting mechanisms.
Multivariate innate and adaptive immune activation, signaling, and response may follow that may manifest as stimulatory, inhibitory,
or both.
The
Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such
as those trials reported on the clinical trials registry at ClinicalTrials.gov.
The
Company believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently
at a purity of nearly 100%.
The
Company’s small molecule medical science platform comprises several different drug candidates and non-clinical targets using different
concentrations delivered by different routes of administration specific to each disease area and/or disease indication, including:
● Clinical
development programs in oncology (intratumoral administration), dermatology (topical), and
ophthalmology (topical),
● Proof-of-concept
in vivo programs in oncology (oral), hematology (oral), wound healing (topical), and
canine cancers (intratumoral), and
● Early
discovery programs ( in vitro ) in infectious diseases and tissue regeneration and repair.
Risks
and Uncertainties
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.
8
Basis
of Presentation
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, 2023 filed with the SEC on March 28, 2024. 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 six months ended June 30, 2024 are
not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
2.
Liquidity and Going Concern
To
date, the Company has not generated any revenues or profits from planned principal operations.
The
Company’s cash and restricted cash were $ 589,283 at June 30, 2024 which includes $ 559,702 of restricted cash resulting from a grant
received from the State of Tennessee. The Company’s working capital deficit was $ 7,569,256 and $ 7,652,098 as of June 30, 2024 and
December 31, 2023, respectively, net loss for the six months ended June 30, 2024 and 2023 was $ 1,350,890 and $ 1,662,516 , respectively,
and cash used in operations was $ 1,807,080 and $ 1,241,893 for the six months ended June 30, 2024 and 2023, 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 2024 financing (see Note
13), 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 there can be no assurance 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, there can be
no assurance 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 2024 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, there can be no assurance
that it will be able to obtain funds on commercially acceptable terms, or complete additional financing in a timely manner. Any such
financing may result in significant dilution to stockholders.
These factors raise substantial doubt about our ability to continue as
a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification
of liabilities that may be necessary should we be unable to continue as a going concern.
Our
condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q have been prepared in conformity
with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate our
continuation as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The
carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to
represent realizable or settlement values.
9
3.
Significant Accounting Policies
Since
the date the Company’s December 31, 2023 consolidated financial statements were issued in its 2023 Annual Report on March 28, 2024,
there have been no material changes to the Company’s significant accounting policies.
Principles
of Consolidation
Intercompany
balances and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”)
requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. The Company’s significant estimates and assumptions include the recoverability and useful lives of long-lived
assets, accrued liabilities, and the valuation allowance related to the Company’s deferred tax assets.
Restricted
Cash
Restricted
cash consists of a grant award received from the State of Tennessee. Restricted cash available as of June 30, 2024 is $ 559,702 . See Note
10, Grants.
Cash
Concentrations
Cash
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 there can be no assurance that it will not experience any losses in the future. As of June 30, 2024 and December 31,
2023, the Company had cash and restricted cash balances in excess of FDIC insurance limits of $ 339,283 and $ 776,799 , respectively.
10
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,
2024
2023
Warrants
-
475,000
Options
3,225,000
3,425,000
Convertible preferred stock
120,985,865
111,915,797
2021 unsecured convertible notes
505,746
2,022,750
2022 unsecured convertible notes
10,113,074
7,485,783
Total potentially dilutive shares
134,829,685
125,324,330
Recently Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07 “ Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures .”
These amendments require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis
and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required
annually. Public entities with a single reporting segment are required to provide both the new disclosures and all of the existing disclosures
required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal
years beginning after December 15, 2024, with early adoption permitted. The
Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The amendments in
this update address investor requests for more transparency about income tax information through improvements to income tax disclosures
primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to
improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for the Company for annual periods beginning
after December 15, 2024, with early adoption permitted. The Company is currently evaluating
any new disclosures that may be required upon adoption of ASU 2023-09.
4.
Other Accrued Expenses
The
following table summarizes the other accrued expenses at June 30, 2024 and December 31, 2023:
Schedule of Other Accrued Expenses
June 30,
December 31,
2024
2023
Accrued payroll and taxes
$ 1,037,118
$ 719,460
Accrued vacation
109,706
92,985
Accrued directors’ fees
2,054,339
2,330,589
Accrued other expenses
187,262
97,402
Total other accrued expenses
$ 3,388,425
$ 3,240,436
11
5.
Convertible Notes Payable
The
following summarizes convertible notes payable activity during the six months ended June 30, 2024:
2021
Financing
Schedule of Convertible Notes Payable
Non-Related Party
Related Party
Face Amount
Face Amount
Total
Balance as of January 1, 2024
$ -
$ 200,000
$ 200,000
Repayment
-
( 100,000 )
( 100,000 )
Balance as of June 30, 2024
$ -
$ 100,000
$ 100,000
2022
Financing
Non-Related Party
Related Party
Face Amount
Face Amount
Total
Balance as of January 1, 2024
$ 800,000
$ 1,675,000
$ 2,475,000
Issued
353,000
1,285,000
1,638,000
Conversion
-
( 1,325,000 )
( 1,325,000 )
Balance as of June 30, 2024
$ 1,153,000
$ 1,635,000
$ 2,788,000
Balance
$ 1,153,000
$ 1,635,000
$ 2,788,000
On
July 11, 2024, the Board approved the closure of the 2022 Financing. Through June 30, 2024, the Company received 2022 Notes proceeds
in the aggregate amount of $ 4,865,500 , of which $ 3,637,500 is from a related party investor (a Company officer/director).
For
further details on the terms of the 2021 and 2022 Notes, refer to our Form 10-K as filed with the SEC on March 28, 2024.
12
2024
Repayment of 2021 Notes
During
the six months ended June 30, 2024, the Company repaid $ 100,000 principal owed on the 2021 Note. As of June 30, 2024, principal and interest
in the amount of $ 100,000 and $ 44,744 , respectively, remains outstanding on the 2021 Note.
2024
Conversions of 2022 Notes into Preferred Stock
During
the three months ended June 30, 2024, principal and interest in the aggregate amount of $ 783,296 , owed in connection with the 2022 Notes
were converted into 273,691 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares issuable pursuant
to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional
information on the Series D-1 Preferred Stock.
During
the six months ended June 30, 2024, principal and interest in the aggregate amount of $ 1,431,457 , owed in connection with the 2022
Notes were converted into 500,165 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares
issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8,
Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.
6.
Notes Payable
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of June 30, 2024
and December 31, 2023, the balance of the note payable was $ 109,862 and $ 277,815 , respectively.
7.
Related Party Transactions
During
the three months ended June 30, 2024 and 2023, the Company had consulting fees of $ 0 and
$ 63,600 , respectively, to Mr. Bruce Horowitz
(Capital Strategists) for services rendered. During the six months ended June 30, 2024 and 2023, the Company had consulting
fees of $ 63,600
and $ 127,200 ,
respectively. As of March 25, 2024, Mr. Horowitz resigned as COO and member of the Board. On March 26, 2024, the Company paid Mr.
Horowitz $ 250,000
and on June 27, 2024, the Company paid $ 258,000
for outstanding consulting fees. Mr. Horowitz
waived the amount of $ 469,000 due
to him in directors’ fees.
See
Note 5 for details of other related party transactions.
Directors’
fees incurred during the three months ended June 30, 2024 and 2023, were $ 77,500
and $ 96,250 ,
respectively. Directors’ fees incurred during the six months ended June 30, 2024 and 2023, were $ 173,750
and $ 192,500 ,
respectively. Accrued directors’ fees as of June 30, 2024 and December 31, 2023 were $ 2,054,339
and $ 2,330,589 ,
respectively.
8.
Stockholders’ Deficit
Preferred
Stock
During the three months ended June 30, 2024, the Company issued 273,691
shares of Series D-1 Convertible Preferred Stock upon the conversion of $ 725,000 of principal and $ 58,294 accrued interest outstanding
on the 2022 Notes.
During
the six months ended June 30, 2024, the Company issued 500,165 shares of Series D-1 Convertible Preferred Stock upon the conversion of
$ 1,325,000 of principal and $ 106,457 accrued interest outstanding on the 2022 Notes.
On
June 21, 2024, the Board of Directors approved the conversion of 11,416,242
Series D Preferred Shares held by Dominic Rodrigues (a Company officer and director) into 1,141,626 shares
of Series D-1 Preferred shares.
Number
of Preferred Shares
On
June 24, 2024, the Company filed an amended Series D Certificate of Designation to decrease the authorized shares from 12,374,000
to 957,100
shares of Series D Convertible Preferred Stock. The Series D-1 Certificate of Designation was also amended to increase the
authorized shares from 9,441,000
to 23,042,900
shares of Series D-1 Convertible Preferred Stock.
2024 Equity Compensation Plan
At the shareholder meeting held on June
20, 2024, the proposal for the new 2024 Equity Compensation Plan was approved. The approval gives the Company authority to grant Options
and award Restricted Stock under the 2024 Equity Compensation Plan for up to 100,000,000
shares of our common stock, which are approximately fifteen percent ( 15 %)
of the issued and outstanding shares of Common Stock on an as converted basis as of the effective date of the 2024 Equity Compensation
Plan.
Options
During
the three and six months ended June 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of options.
The
following table summarizes option activities during the six months ended June 30, 2024:
Schedule
of Option Activity
Weighted Average
Weighted Average Remaining
Aggregate Intrinsic
Shares
Exercise Price
Life in Years
Value
Outstanding and exercisable at January 1, 2024
3,225,000
$ 0.27
$ -
Expired
-
-
Outstanding and exercisable at June 30, 2024
3,225,000
$ 0.27
1.40
$ -
13
The
following table summarizes information about options outstanding and exercisable at June 30, 2024:
Summary
of Stock Options Outstanding
Exercise Price
Outstanding and Exercisable
Weighted Average Remaining Contractual Life
Intrinsic Value
$ 0.12
2,425,000
1.40
$ 14,550
$ 0.29
100,000
1.40
$ -
$ 0.75
550,000
1.50
$ -
$ 0.88
150,000
0.10
$ -
3,225,000
1.40
$ 14,550
Warrants
During
the three and six months ended June 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of warrants.
The
following table summarizes warrant activities during the six months ended June 30, 2024:
Schedule
of Warrant Activity
Number of
Weighted Average
Weighted Average Remaining
Aggregate Intrinsic
Warrants
Exercise Price
Life in Years
Value
Outstanding and exercisable at January 1, 2024
412,500
$ 1.07
Expired
( 412,500 )
1.07
Outstanding and exercisable at June 30, 2024
-
$ -
-
$ -
14
Annual
Stockholder Meeting Proposals
The
Company held its annual meeting of stockholders on June 20, 2024. 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. The Company’s stockholders also authorized the Board 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
On
June 18, 2022, the Company leased 2,700 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement
for a term of three years ending on June 30, 2025. The monthly base rent ranges from $ 4,053 to $ 4,278 over the term of the lease.
Total
operating lease expense for the three months ended June 30, 2024 was $ 13,002 , of which $ 8,668 was included within research and development
and $ 4,334 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating
lease expense for the three months ended June 30, 2023 was $ 12,672 of which $ 8,448 was included within research and development and $ 4,224
was included within general and administrative expenses on the condensed consolidated statements of operations.
Total
operating lease expense for the six months ended June 30, 2024 was $ 25,844 , of which $ 17,229 was included within research and development
and $ 8,615 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating
lease expense for the six months ended June 30, 2023 was $ 26,179 of which $ 17,453 was included within research and development and $ 8,726
was included within general and administrative expenses on the condensed consolidated statements 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,
2024
2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases
$ 23,402
$ 21,597
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ -
Weighted Average Remaining Lease Term
Operating leases
1 year
2 years
Weighted Average Discount Rate
Operating leases
5.0 %
5.0 %
Future
minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2024 were as follows:
Future
Minimum Payments
Schedule of Future Minimum Payments Under Non-cancellable Lease
Years
Amount
2024
$ 25,669
2025
25,669
Total lease payments
51,338
Less: amount representing imputed interest
( 1,363 )
Present value of lease liability
49,975
Less: current portion
( 49,975 )
Lease liability, non-current portion
$ -
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 (the “Tennessee Grant” or “Grant”). The Tennessee
Grant was pre-funded; therefore, the funds do not need to be used in full by June 30, 2022. The Tennessee Grant was provided as reimbursement
of research and development expenses related to the development of animal health drug products. The Company has elected gross presentation
of the Tennessee Grant income whereby grant revenue is recognized as qualifying costs are incurred and there is reasonable assurance
that the conditions of the grant have been met. Qualifying costs are presented as research and development expenses included in the Company’s
statement of operations, in the period that such costs are incurred.
As
of June 30, 2024 and December 31, 2023, $ 460,185 and $ 953,248 , respectively, have been recorded as unearned grant revenue liability on the accompanying
condensed consolidated balance sheets, respectively. The Company recorded grant revenue of $ 254,991 and $ 493,063 during the three and
six months ended June 30, 2024, respectively, and $ 161,842 and $ 366,867 during the three and six months ended June 30, 2023, respectively.
15
11.
License Transactions
In
the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration
on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS.
On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”)
for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”)
of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade
RBS for the treatment of bacterial, fungal, and viral infections of the eye. The Company completed the arrangements of this collaboration
during the third quarter of 2022, whereby the Company paid $5,000 for the option that expires on May 31, 2023; agreed to pay up to $10,000
of new UM patent expenses for this IP during the period of the option and up to $25,000 of past UM patent expenses for this IP; and entered
into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and TOP PV-305, a formulation
of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis.
On
March 21, 2024, the Company entered into an exclusive worldwide license for the IP. Details of the license agreement are reported in
the Company’s Current Report on Form 8-K filed with the SEC on March 27, 2024.
12.
Commitments, Contingencies and Litigation
The
Company may, from time to time, be involved in litigation arising from the ordinary course of business. 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 condensed
consolidated financial position, results of operations or cash flows.
13.
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.
2024
Financing
On
July 11, 2024, the Board approved a Financing Term Sheet (the “2024 Term Sheet”), which set forth the terms under which the
Company will use its best efforts to arrange for financing of a maximum of $ 10,000,000 (the “2024 Financing”), which amounts
will be obtained in several tranches.
Pursuant
to the 2024 Term Sheet, the 2024 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve
months after the issue date of a 2024 Note, subject to certain exceptions.
The
2024 Financing will be in the form of an unsecured convertible loan (the “2024 Loan”) from the investors (the “2024
Loan Investors”) and evidenced by convertible promissory notes (individually, a “2024 Note” and collectively, the “2024
Notes”). In addition to customary provisions, the 2024 Notes will contain the following provisions:
(i)
The
2024 Loan will bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has
been funded to the Company;
(ii)
In
the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the
2024 Notes may be immediately due and payable at the 2024 Loan Investors’ option;
(iii)
The
outstanding principal amount and interest payable under the 2024 Loan may be convertible at the 2024 Loan Investors’ option
into shares of Series D-1 Convertible Preferred Stock at a price per share equal to $ 2.8620 . The Series D-1 Convertible Preferred
Stock is convertible into ten ( 10 ) shares of common stock; and
(iv)
The
outstanding principal amount and interest payable under the 2024 Loan will be automatically convertible into shares of the Company’s
Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note at a price per share equal to $ 2.8620 .
For
further details on the terms of the 2024 Financing and the details of the 2024 Notes, refer to our Form 8-K as filed with the SEC on
July 17, 2024.
Convertible
Notes Payable
Subsequent
to June 30, 2024, the Company entered into 2024 Notes with a related party investor (Executive Officer) in the aggregate principal amount
of $ 215,000 .
Series
D-1 Preferred Stock
Subsequent
to June 30, 2024, principal and interest in the aggregate amount of $ 972,600 , owed in connection with 2022 Notes was converted into 339,833
shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 . Any fractional shares issuable pursuant to the formula were rounded
up to the next whole share of Series D-1 Preferred Stock.
Subsequent to June 30, 2024, a holder of 38,474 shares of Series D-1 Preferred
Stock voluntarily converted the Preferred Stock into 384,740 shares of Common Stock.
16
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.