Item 8. Financial Statements and Supplementary Data
ITEM
8.
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA.
INDEX
TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (CBIZ CPAs P.C., PCAOB ID No. 199 )
F-1
Report of Independent Registered Public
Accounting Firm (Marcum LLP, PCAOB ID No. 688 )
F-2
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2025 and 2024
F-4
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2025 and 2024
F-5
Consolidated Statements of Changes In Stockholders’ Deficit for the Years Ended December 31, 2025 and 2024
F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2025 and 2024
F-7
Notes to Consolidated Financial Statements
F-8
– F-28
27
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors of
Provectus
Biopharmaceuticals, Inc.
Opinion
on the Financial Statements
We have audited the accompanying consolidated balance sheet of Provectus Biopharmaceuticals,
Inc. (the “Company”) as of December 31, 2025, the related consolidated statements of operations, comprehensive loss, changes
in stockholders’ deficit and cash flows for the year then ended, and the related notes (collectively referred to as the “financial
statements”). In our opinion, based on our audit, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year then ended December
31, 2025, in conformity with accounting principles generally accepted in the United States of America.
As
discussed in Notes 2 and 11 to the financial statements, the Company adopted ASU 2023-09, Income Taxes (Topic 740): Improvements to
Income Tax Disclosures (“ASU 2023-09”). We have also audited the adjustments to the 2024 financial statements retrospectively adjust the disclosures for the adoption of ASU 2023-09 in 2025. In our opinion, such retrospective adjustments are appropriate and
have been properly applied. We were not engaged to audit, review, or apply any procedures to the 2024 financial statements of the Company
other than with respect to these retrospective adjustments, and accordingly, we do not express an opinion or any other form of assurance
on the 2024 financial statements taken as a whole.
Explanatory
Paragraph – Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As
more fully described in Note 2, the Company has a significant working capital deficit, has incurred significant losses and needs to
raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in
Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
CBIZ CPAS P.C.
CBIZ
CPAs P.C.
We
have served as the Company’s auditor since 2016 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective
November 1, 2024).
Los
Angeles, CA
March 25, 2026
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors of
Provectus
Biopharmaceuticals, Inc.
Opinion
on the Financial Statements
We have audited, before the effects of the retrospective
adjustments to the disclosures for the adoption of ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures
(“ASU 2023-09”) as discussed in Notes 2 and 11 to the consolidated financial statements, the accompanying consolidated balance
sheet of Provectus Biopharmaceuticals, Inc. (the “Company”) as of December 31, 2024, the related consolidated statements
of operations, comprehensive loss, changes in stockholders’ deficit and cash flows for the year then ended, and the related notes
(collectively referred to as the “financial statements”). In our opinion the financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows
for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
We were not engaged to audit, review, or apply any procedures to the retrospective adjustments to the disclosures for the adoption of
ASU 2023-09 as discussed in Notes 2 and 11 to the financial statements, and accordingly, we do not express an opinion or any other form
of assurance about whether such adjustments are appropriate and have been properly applied. Those retrospective adjustments were audited
by CBIZ CPAs P.C.
Explanatory
Paragraph – Going Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described
in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds
to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue
as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
Marcum LLP
Marcum
LLP
We
have served as the Company’s auditor from 2016 through 2025.
Los
Angeles, CA
March 27, 2025
F- 2
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONSOLIDATED
BALANCE SHEETS
December 31,
December 31,
2025
2024
Assets
Current Assets:
Cash
$ 251,291
$ 307,442
Restricted cash
-
182,284
Prepaid expenses and other current assets
316,583
487,046
Total Current Assets
567,874
976,772
Equipment and furnishings, less accumulated depreciation of $ 120,013 and $ 118,151 , respectively
3,000
4,863
Operating lease right-of-use asset
126,628
24,624
Total Assets
$ 697,502
$ 1,006,259
Liabilities and Stockholders’ Deficit
Current Liabilities:
Accounts payable
$ 716,220
$ 1,106,551
Unearned grant revenue
-
336,108
Accrued interest
23,540
27,774
Accrued interest - related parties
120,384
144,913
Accrued interest
120,384
144,913
Other accrued expenses
3,161,379
2,175,376
Notes payable
217,772
206,463
Convertible notes payable
870,000
853,000
Convertible notes payable - related parties
1,740,000
2,100,000
Convertible notes payable
1,740,000
2,100,000
Operating lease liability, current portion
48,083
25,299
Total Current Liabilities
6,897,378
6,975,484
Notes payable, non-current portion
23,621
-
Operating lease liability, non-current portion
79,221
-
Total Liabilities
7,000,220
6,975,484
Commitments, contingencies, and litigation (Note 16)
-
-
Stockholders’ Deficit:
Preferred stock; par value $ 0.001 per share; 25,000,000 shares authorized;
Series D Convertible Preferred Stock; 957,100 shares designated at December 31, 2025 and 2024; 956,985 shares issued and
outstanding at December 31, 2025 and 2024; aggregate liquidation preference of $ 1,643,333 and $ 1,095,556 at December 31, 2025 and
December 31, 2024, respectively
957
957
Series D-1 Convertible Preferred Stock; 23,042,900 shares designated at December 31, 2025 and December 31, 2024; 14,183,315 and
13,106,223 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively; aggregate liquidation preference
of $ 227,778,438 and $ 150,040,045 at December 31, 2025 and December 31, 2024, respectively
14,183
13,106
Preferred Stock, value
14,183
13,106
Common stock; par value $ 0.001 per share; 1,000,000,000 shares authorized; 420,279,879 shares issued and outstanding at December
31, 2025 and 2024
420,280
420,280
Additional paid-in capital
256,179,846
251,090,027
Accumulated other comprehensive loss
( 60,191 )
( 60,741 )
Accumulated deficit
( 262,853,812 )
( 257,422,961 )
Total Provectus Biopharmaceuticals, Inc., Stockholders’ Deficit
( 6,298,737 )
( 5,959,332 )
Non-controlling interest in subsidiary
( 3,981 )
( 9,893 )
Total Stockholders’ Deficit
( 6,302,718 )
( 5,969,225 )
Total Liabilities and Stockholders’ Deficit
$ 697,502
$ 1,006,259
See
accompanying notes to consolidated financial statements.
F- 3
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
For the Years Ended
December 31,
2025
2024
Grant Revenue
$ 336,108
$ 617,140
Operating Expenses:
Research and development
1,897,276
2,050,663
General and administrative
3,733,597
3,098,861
Total Operating Expenses
5,630,873
5,149,524
Total Operating Loss
( 5,294,765 )
( 4,532,384 )
Other Income (Expense):
Research and development credit
-
9,320
Interest expense
( 210,359 )
( 239,073 )
Total Other Income (Expense), Net
( 210,359 )
( 229,753 )
Net Loss
( 5,505,124 )
( 4,762,137 )
Net Loss attributable to noncontrolling interest
( 74,273 )
( 29,585 )
Net Loss attributable to common stockholders
$ ( 5,430,851 )
$ ( 4,732,552 )
Basic and Diluted Loss Per Common Share
$ ( 0.01 )
$ ( 0.01 )
Weighted Average Number of Common Shares Outstanding - Basic and Diluted
420,279,879
419,810,059
See
accompanying notes to consolidated financial statements.
F- 4
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
For the Years Ended
December 31,
2025
2024
Net Loss
$ ( 5,505,124 )
$ ( 4,762,137 )
Other Comprehensive Loss (Gain):
Foreign currency translation adjustments
550
( 576 )
Comprehensive Loss, net
( 5,504,574 )
( 4,762,713 )
Comprehensive Loss attributed to non-controlling interest
( 74,273 )
( 29,585 )
Comprehensive Loss attributed to controlling interest
$ ( 5,430,301 )
$ ( 4,733,128 )
See
accompanying notes to consolidated financial statements.
F- 5
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR
THE YEARS ENDED DECEMBER 31, 2025 AND 2024
Accumulated
Preferred Stock
Preferred Stock
Additional
Other
Non-
Series D
Series D-1
Common Stock
Paid-In
Comprehensive
Accumulated
controlling
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Interest
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 )
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 )
-
-
-
-
Issuance of common stock of majority-owned subsidiary
-
-
-
-
-
-
280,308
-
-
19,692
300,000
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
1,280,776
-
-
-
1,280,776
Conversion of accrued directors’ fees to Series D-1 Preferred Stock
-
-
744,878
745
-
-
2,131,094
-
-
2,131,839
Conversion of 2022 Notes to Series D-1 Preferred Stock
-
-
934,398
934
-
-
2,673,290
-
-
-
2,674,224
Conversion of Series D-1 Preferred Stock to Common Stock
-
-
( 75,776 )
( 75 )
757,760
758
( 683 )
-
-
-
-
Comprehensive loss:
Net Loss
-
-
-
-
-
-
-
-
( 4,732,552 )
( 29,585 )
( 4,762,137 )
Other Comprehensive Loss
-
-
-
-
-
-
-
( 576 )
-
-
( 576 )
Balance at December 31, 2024
956,985
$ 957
13,106,223
$ 13,106
420,279,879
$ 420,280
$ 251,090,027
$ ( 60,741 )
$ ( 257,422,961 )
$ ( 9,893 )
$ ( 5,969,225 )
Issuance of common stock of majority-owned subsidiary
-
-
-
-
-
-
769,815
-
-
80,185
850,000
Conversion of 2022 Notes to Series D-1 Preferred Stock
-
-
618,340
618
-
-
1,769,985
-
-
-
1,770,603
Conversion of 2024 Notes to Series D-1 Preferred Stock
-
-
458,752
459
-
-
1,312,473
-
-
-
1,312,932
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
1,237,546
-
-
-
1,237,546
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 5,430,851 )
( 74,273 )
( 5,505,124 )
Other comprehensive income
-
-
-
-
-
-
-
550
-
-
550
Balance at December 31, 2025
956,985
$ 957
14,183,315
$ 14,183
420,279,879
$ 420,280
$ 256,179,846
$ ( 60,191 )
$ ( 262,853,812 )
$ ( 3,981 )
$ ( 6,302,718 )
See
accompanying notes to consolidated financial statements.
F- 6
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
For the Year Ended
December 31,
2025
2024
Cash Flows From Operating Activities:
Net loss
$ ( 5,505,124 )
$ ( 4,762,137 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,237,546
1,280,776
Non-cash operating lease expense
48,128
47,402
Depreciation
1,863
7,157
Changes in operating assets and liabilities
Short term receivables
-
476
Prepaid expenses and other current assets
478,387
84,247
Accounts payable
( 390,331 )
( 569,157 )
Unearned grant revenue
( 336,108 )
( 617,140 )
Accrued interest
201,772
225,481
Other accrued expenses
986,003
1,066,881
Operating lease liability
( 48,127 )
( 48,077 )
Net
Cash Used In Operating Activities
( 3,325,991 )
( 3,284,091 )
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable
870,000
853,000
Proceeds from issuance of convertible notes payable - related parties
1,640,000
2,000,000
Proceeds from issuance of common stock of majority-owned subsidiary
850,000
300,000
Repayment of short-term note payable
( 272,994 )
( 305,135 )
Repayment of 2021 convertible note payable - related party
-
( 100,000 )
Net
Cash Provided By Financing Activities
3,087,006
2,747,865
Effect of exchange rates on cash and restricted cash
550
( 847 )
Net Decrease In Cash and
Restricted Cash
( 238,435 )
( 537,073 )
Cash
and Restricted Cash, Beginning of Period
489,726
1,026,799
Cash
and Restricted Cash, End of Period
$ 251,291
$ 489,726
Cash and restricted cash consisted of the following:
Cash
$ 251,291
$ 307,442
Restricted cash
-
182,284
Cash
and Restricted Cash, End of Period
$ 251,291
$ 489,726
Supplemental Disclosures of Cash Flow Information:
Cash paid during the period for:
Interest
$ 4,305
$ 5,439
Income taxes
$ -
$ -
Non-cash investing and
financing activities:
Conversion of 2022 Notes and related accrued interest to
Series D-1 Preferred Stock
$ 1,770,603
$ 2,674,224
Conversion of 2024 Notes and related accrued interest to
Series D-1 Preferred Stock
$ 1,312,932
$ -
ROU asset in exchange for lease liability
$ 149,642
$ -
Purchase of insurance policies financed by short-term note payable
$ ( 203,638 )
$ ( 233,783 )
Purchase of software financed by short-term note payable
$ 104,286
$ -
Conversion of accrued directors’ fees to Series D-1 Preferred Stock
$ -
$ 2,131,389
Conversion of Series D-1 Preferred Stock to common stock
$ -
$ 683
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
Issuance of common stock of majority-owned subsidiary
$ -
$ 95,000
See
accompanying notes to consolidated financial statements.
F- 7
PROVECTUS
BIOPHARMACEUTICALS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
1.
Business Organization and Nature of Operations
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 bioactive 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 formulations of our current non-clinical in vivo proof-of-concept
and in vitro 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 with disease may lead to cell death
or repair, depending on the disease being treated and the concentration of RBS being utilized in the therapeutic 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 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),
●
In
vivo: Proof-of-concept programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral),
and
●
In
vitro: Early discovery programs 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.
2.
Liquidity and Going Concern
To
date, the Company has not generated any revenues or profits from planned principal operations.
The
Company’s cash balance was $ 251,291 at December 31, 2025. There was no restricted cash associated with the grant received from
the State of Tennessee at December 31, 2025 due to the completion of the grant award program during 2025. The Company’s working
capital deficit was $ 6,329,503 and $ 5,998,712 as of December 31, 2025 and 2024, respectively. Net loss for the years ended December
31, 2025 and 2024 were $ 5,505,124 and $ 4,762,137 , respectively, and cash used in operations was $ 3,325,991 and $ 3,284,091 for the years
ended December 31, 2025 and 2024, respectively. Since the Company’s inception, there has been a history of recurring net losses
from operations, recurring use of cash in operating activities and working capital deficits.
F- 8
Future
cash requirements for our current liabilities include approximately $ 3.9 million
for accounts payable and accrued expenses, approximately $ 0.2 million
for notes payable and approximately $ 48,000 for
future payments under operating leases. Also, a related party convertible note payable in the amount of $ 100,000
plus approximately $ 59,444
of related interest is past due, and additional convertible debt in the amount of $ 2,510,000
plus $ 107,824
of accrued interest will mature 1 one
year from the date of the notes if not converted prior to maturity,
The Company continues to incur significant
operating losses. Further, 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 consolidated financial statements are issued.
The
Company plans to access capital resources through possible public or private equity offerings, including additional convertible debt
issuance pursuant to the 2025 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 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.
These
factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans to mitigate
the factors which raise substantial doubt include (1) raising funds from the proceeds of private placement transactions, the exercise
of outstanding stock options, or public offerings of debt or equity securities, and (2) monetizing the Company’s lead drug candidates.
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 such financing will be available when needed or on acceptable terms, or 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.
Under
ASC Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility
to evaluate whether conditions and/or events raise substantial doubt about its ability to meet future financial obligations as they become
due within one year after the date that these consolidated financial statements are issued. The accompanying consolidated financial statements
have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction
of liabilities in the normal course of business. The consolidated financial statements do not include any adjustment that might become
necessary should the Company be unable to continue as a going concern.
3.
Significant Accounting Policies
Basis
of Presentation
The
consolidated financial statements include the consolidated results of Provectus, its wholly owned subsidiaries, and its majority-owned subsidiary, VisiRose (see Note 15). The interests of
non-controlling shareholders in VisiRose are presented as net loss attributable to noncontrolling interest in the Consolidated Statements
of Operations and as noncontrolling interest in subsidiary in the Consolidated Balance Sheets. 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, stock-based compensation, accrued liabilities, and the valuation allowance related to the Company’s deferred tax assets.
F- 9
Restricted
Cash
Restricted
cash of $ 182,284 as of December 31, 2024 consists of a grant award received from the State of Tennessee. There was no restricted cash
available as of December 31, 2025 due to the completion of the grant award program during 2025. See Note 14, 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 no assurance can be provided that it will not experience any losses in the future. As of December 31, 2025 and 2024,
the Company had cash and restricted cash balances in excess of FDIC insurance limits of $ 1,291 and $ 239,726 , respectively.
Equipment
and Furnishings, net
Equipment
and furnishings are stated at cost less accumulated depreciation. Depreciation of equipment and furnishings is provided for using
the straight-line method over the estimated useful lives of the assets. Computers and office equipment are being depreciated over five
years ; furniture and fixtures are being depreciated over ten
years . Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease
term. Maintenance and repairs are charged to operations as incurred. The Company capitalizes costs attributable to the betterment of
property and equipment when such betterment extends the useful life of the assets.
Long-Lived
Assets
The
Company reviews the carrying values of its long-lived assets for possible impairment whenever an event or change in circumstances indicates
that the carrying amount of the assets may not be recoverable. Any long-lived assets held for disposal are reported at the lower of their
carrying amounts or fair value less cost to sell. Management has determined there to be no impairment of its long-lived assets during
the years ended December 31, 2025 and 2024.
Grant
Revenue
Grant
revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been
met. Cash received from grants in advance of incurring qualifying costs is recorded as restricted cash and unearned grant revenue. Grant revenue is recognized
when qualifying costs are incurred.
Research
and Development
Research and development costs are expensed as incurred.
Certain shared operating costs, including insurance and facility-related expenses such as rent and utilities, are allocated to research
and development based on management’s estimate of the portion of those costs attributable to research and development activities,
which is currently approximately two-thirds of such costs.
Research and development expenses consist primarily
of payroll and related costs, including stock-based compensation, consulting and contract labor, laboratory supplies and pharmaceutical
preparations, insurance, rent and utilities, and depreciation and amortization.
F- 10
Patent
Costs
The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the accompanying
consolidated statements of operations.
Leases
The
Company leases properties under operating leases. The Company recognizes a liability to make lease payments, the “lease liability,”
and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset” upon the
commencement of a lease. The lease liability is measured at the present value of the remaining lease payments, discounted at the Company’s
incremental borrowing rate. The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance
of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term,
any unamortized initial direct costs, and any impairment of the right-of-use-asset. Operating lease expense consists of a single lease
cost calculated so that the remaining cost of the lease is allocated over the remaining lease term on a straight-line basis, variable
lease payments not included in the lease liability, and any impairment of the right-of-use asset.
Income
Taxes
The
Company accounts for income taxes under the liability method in accordance with Accounting Standards Codification (“ASC”)
740 “ Income Taxes ”. Under this method, deferred income tax assets and liabilities are determined based on differences
between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be
in effect when the differences are expected to reverse. A valuation allowance is established if it is more likely than not that all,
or some portion, of deferred income tax assets will not be realized. The Company has recorded a full valuation allowance to reduce its
net deferred income tax assets to zero. In the event the Company were to determine that it would be able to realize some or all its deferred
income tax assets in the future, an adjustment to the deferred income tax asset would increase income in the period such determination
was made.
The
Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination.
Any recognized income tax positions would be measured at the largest amount that is greater than 50% likely of being realized. Changes
in recognition or measurement would be reflected in the period in which the change in judgment occurs. The Company would recognize any
corresponding interest and penalties associated with its income tax positions in income tax expense. There were no income taxes, interest
or penalties incurred in 2025 or 2024.
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 qualifying 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 classified as derivative liabilities and any related equity classified freestanding instruments are recorded
as a discount to the host 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 equity.
F- 11
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
December 31,
2025
2024
Options
50,683,344
20,881,145
Convertible preferred stock
142,790,135
132,019,215
2021 unsecured convertible notes and accrued interest
557,109
529,156
2022 unsecured convertible notes and accrued interest
-
6,058,054
2024 unsecured convertible notes and accrued interest
-
4,334,130
2025 unsecured convertible notes and accrued interest
9,065,270
-
Total potentially dilutive shares
203,095,858
163,821,700
Fair
Value of Financial Instruments
The
Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “ Fair Value Measurements
and Disclosures ” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands
disclosures about fair value measurements. The Company determines the estimated fair value of amounts presented in these consolidated
financial statements using available market information and appropriate methodologies. However, considerable judgment is required in
interpreting market data to develop the estimates of fair value. The estimates presented in the consolidated financial statements are
not necessarily indicative of the amounts that could be realized in a current exchange between buyer and seller. The use of different
market assumptions and/or estimation methodologies may have a material effect on the estimated fair value amounts. These fair value estimates
were based upon pertinent information available as of December 31, 2025 and 2024. The carrying amounts of the Company’s financial
assets and liabilities, such as cash, restricted cash, other current assets, accounts payable, unearned grant income, and
accrued expenses approximate fair value due to the short-term nature of these instruments.
The
carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include contractual
interest rates, are comparable to rates of returns for instruments of similar credit risk.
ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level
1
Inputs
use quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
Level
2
Inputs
use directly or indirectly observable inputs. These inputs include quoted prices for similar assets and liabilities in active markets
as well as other inputs such as interest rates and yield curves that are observable at commonly quoted intervals.
Level
3
Inputs
are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity for the
related asset or liability.
In
instances where inputs used to measure fair value fall into different levels in the above fair value hierarchy, fair value measurements
in their entirety are categorized based on the lowest level input that is significant to the valuation. The Company’s assessment
of the significance of particular inputs to these fair value measurements requires judgment and considers factors specific to each asset
or liability.
F- 12
Both
observable and unobservable inputs may be used to determine the fair value of positions that are classified within the Level 3 category.
As a result, the unrealized gains and losses for assets within the Level 3 category may include changes in fair value that were attributable
to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in historical company data) inputs. Financial
assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar
techniques and at least one significant model assumption or input is unobservable.
Foreign
Currency Translation
The
Company’s reporting currency is the United States Dollar. The functional currencies of the Company’s operating subsidiaries
are their local currencies (United States Dollar and Australian Dollar). Australian Dollar denominated assets and liabilities of $ 11,787
and $ 1,650 at December 31, 2025 and $ 7,295 and $ 1,020 at December 31, 2024, respectively are translated into the United States Dollar
at the balance sheet date, and net expense accounts of ($ 11 ) and ($ 1,745 ) for the years ended December 31, 2025 and 2024, respectively
are translated at a weighted average exchange rate for the years then ended. Equity is translated at historical rates and the resulting
foreign currency translation adjustments are included as a component of accumulated other comprehensive loss (“AOCL”), which
is a separate component of stockholders’ deficit. Therefore, the U.S. dollar value of the non-equity translated items in the Company’s
consolidated financial statements will fluctuate from period to period as the result of the changing value of the U.S. dollar versus the Australian Dollar.
The
Company engages in foreign currency denominated transactions with its Australian subsidiary. At the date that the transaction is recognized,
each asset, liability, revenue, expense, gain, or loss arising from the transaction is measured and recorded in the functional currency
of the recording entity using the exchange rate in effect at that date. At each balance sheet date, recorded monetary balances denominated
in a currency other than the functional currency are adjusted using the exchange rate at the balance sheet date, with gains or losses
recorded in other income or other expense.
Stock-Based
Compensation
The
Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The
fair value of the award is measured on the grant date and then is recognized over the period during which services are required to be
provided in exchange for the award, usually the vesting period. The Company computes the fair value of equity-classified options granted
using the Black-Scholes option pricing model. Option valuation models require the input of highly subjective assumptions including the
expected volatility factor of the market price of the Company’s common stock which is determined by reviewing its historical public
market closing prices.
Segment
The
Company has one operating and reporting segment (clinical stage biotechnology), namely, the development of immunotherapy medicines. The
accounting policies of the segment are the same as those described in the summary of significant accounting policies. The chief operating
decision maker (“CODM”), who is the Company’s chief executive officer, utilizes the Company’s financial information
on an aggregate, consolidated basis for purposes of making operating decisions, allocating resources, and assessing financial performance,
as well as for making strategic operations decisions and managing the organization. The CODM is not regularly provided with disaggregated
expense information, other than the expense information included in the consolidated statements of operations and comprehensive loss.
The measure of segment assets is reported on the balance sheet as total assets.
Reclassifications
A portion of the prior period stock-based compensation expense, which was
previously reported in general and administrative expenses, has been reclassified to research and development expense in order to conform
to the current period presentation. This reclassification has no effect on previously reported results of operations or loss per share.
Recently
Issued Accounting Pronouncements
In
November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures .
ASU 2024-03 is intended to improve disclosures about a public business entity’s expenses and provide more detailed information
to investors about the types of expenses in commonly presented expense captions. The amendments in this ASU will be applied retrospectively
and are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December
15, 2027, with early adoption permitted. The Company is currently evaluating the impact of implementing this guidance.
In
December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832) – Accounting for Government Grants Received by Business
Entities . This ASU establishes authoritative guidance on the accounting for government grants received by business entities, which
previously did not exist. In the absence of specific guidance, many business entities analogized to the guidance in International Accounting
Standard (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance, or Subtopic 958-605, Not-for-Profit Entities—Revenue
Recognition. The ASU defines two types of government grants: (1) a grant related to an asset (for which there are two approaches to record
the grant proceeds) and (2) a grant related to income. A grant related to an asset is conditioned on the purchase, construction, or acquisition
of an asset (for example, a long-lived asset or inventory). A grant related to income is other than a grant related to an asset (for
example, a grant that reimburses a business entity for operating expenses). The ASU defines the criteria that need to be met in order
to recognize government grant proceeds and prescribes that a business entity present a grant related to income and a grant related to
an asset for which the deferred income approach is elected as part of earnings either (1) separately under a general heading such as
other income or (2) deducted from the related expense. The ASU is effective for fiscal years beginning after December 15, 2028, and interim
periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of implementing this
guidance.
F- 13
Recently
Adopted Accounting Pronouncements
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 adopted the amendments of ASU 2023-09
effective January 1, 2025, and has included the required disclosures in this Annual Report on Form 10-K for the year ended December
31, 2025. The adoption of ASU 2023-09 enhances the transparency of income tax disclosures primarily related to the rate
reconciliation and income taxes paid information. The retrospective adoption of ASU 2023-09 did not have a material impact on the
Company’s consolidated financial condition, results of operations or cash flows since the guidance pertains to disclosure
only.
4.
Other Accrued Expenses
The
following table summarizes the other accrued expenses at December 31, 2025 and 2024:
Schedule
of Other Accrued Expenses
For the Years Ended
December 31,
2025
2024
Accrued payroll and taxes
$ 2,349,284
$ 1,501,449
Accrued vacation
189,153
131,099
Accrued directors’ fees
387,500
77,500
Accrued other expenses
235,442
465,328
Total other accrued expenses
$ 3,161,379
$ 2,175,376
F- 14
5.
Convertible Notes Payable
The
following summarizes convertible note activity during the years ended December 31, 2025 and 2024:
Schedule of Convertible Notes Payable
2021 Financing
2022 Financing
2024 Financing
2025 Financing
Total
Non-Related Party
Related Party
Non-Related Party
Related Party
Non-Related Party
Related Party
Non-Related Party
Related Party
Non-Related Party
Related Party
Balance as of January 1, 2024
$ -
$ 200,000
$ 800,000
$ 1,675,000
$ -
$ -
$ -
$ -
$ 800,000
$ 1,875,000
Notes issued
-
-
353,000
1,285,000
500,000
715,000
-
-
853,000
2,000,000
Principal converted
-
( 100,000 )
( 800,000 )
( 1,675,000 )
-
-
-
-
( 800,000 )
( 1,775,000 )
Balance as of January 1, 2025
-
100,000
353,000
1,285,000
500,000
715,000
-
-
853,000
2,100,000
Balance
-
100,000
353,000
1,285,000
500,000
715,000
-
-
853,000
2,100,000
Notes issued
-
-
-
-
-
-
870,000
1,640,000
870,000
1,640,000
Principal converted
-
-
( 353,000 )
( 1,285,000 )
( 500,000 )
( 715,000 )
-
-
( 853,000 )
( 2,000,000 )
Balance as of December 31, 2025
$ -
$ 100,000
$ -
$ -
$ -
$ -
$ 870,000
$ 1,640,000
$ 870,000
$ 1,740,000
Balance
$ -
$ 100,000
$ -
$ -
$ -
$ -
$ 870,000
$ 1,640,000
$ 870,000
$ 1,740,000
As
of December 31, 2025 and December 31, 2024, accrued interest on the convertible notes was $ 143,924
and $ 172,687 ,
respectively.
Related
party investors in the Company’s convertible notes consist of an officer and an officer/director of the Company.
2021
Financing
The
2021 Financing is in the form of unsecured convertible notes (individually, a “2021 Note” and collectively, the “2021
Notes”). Pursuant to the 2021 Term Sheet, the 2021 Notes will either be paid back, convert into shares of the Company’s Series
D-1 Preferred Stock, or convert into Company equity securities and/or debt instruments of certain future financings on or before twelve
months after the issue date of a 2021 Note, subject to certain exceptions.
In
addition to customary provisions, the 2021 Notes contain the following provisions:
(i)
The
2021 Notes 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 2021 Notes will be accelerated and all amounts due under the
2021 Notes may be immediately due and payable at the investors’ option;
(iii)
The
outstanding principal amount and interest payment under the 2021 Notes may be paid back at maturity at the investors’ option;
(iv)
The
outstanding principal amount and interest payable under the 2021 Notes are convertible at the holders’ option into shares of
Series D-1 Preferred Stock at a price per share equal to $ 2.862 . The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares
of common stock; and
(v)
In
the event the Company conducts a qualified equity or debt financing and the Company receives gross proceeds in the aggregate amount
of $ 20 million, the 2021 Notes may be converted into the equity securities and/or debt instruments of such financing at the same
terms as those investors.
The
embedded conversion options associated with the 2021 Notes do not require bifurcation and treatment as a derivative liability.
On
September 20, 2022, the Board approved the closure of the 2021 Financing.
As
of December 31, 2025, principal and interest in the amount of $ 100,000 and $ 59,444 , respectively, remains outstanding on the 2021 Note.
During the year ended December 31, 2024, the Company repaid $ 100,000 of principal owed on the 2021 Note.
For
the years ended December 31, 2025 and 2024, the Company recorded interest expense of $ 8,000 and $ 13,400 , respectively, related
to the 2021 Notes.
F- 15
2022
Financing
Pursuant
to the 2022 Term Sheet, the 2022 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve
months after the issue date of a 2022 Note, subject to certain exceptions.
The
2022 Financing is in the form of unsecured convertible promissory notes (individually, a “2022 Note” and collectively, the
“2022 Notes”). In addition to customary provisions, the 2022 Notes will contain the following provisions:
(i)
The
2022 Notes 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 2022 Notes will be accelerated and all amounts due under the
2022 Notes may be immediately due and payable at the 2022 Note Investors’ option;
(iii)
The
outstanding principal amount and interest payable under the 2022 Notes is convertible at the holders’ option into shares of
Series D-1 Preferred Stock at a price per share equal to $ 2.862 . The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares
of common stock; and
(iv)
The
outstanding principal amount and interest payable under the 2022 Notes will be automatically convertible into shares of the Company’s
Series D-1 Preferred Stock twelve (12) months after the issue date of a 2022 Note.
The
embedded conversion options associated with the 2022 Notes do not require bifurcation and treatment as a derivative liability.
On
July 11, 2024, the Board approved the closure of the 2022 Financing.
During
the year ended December 31, 2025, principal and interest in the aggregate amount $ 1,770,603 , owed in connection with the 2022 Notes were
converted into 618,340 shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 per share. During the year ended December
31, 2024, principal and interest in the aggregate amount of $ 2,674,224 , owed in connection with the 2022 Notes were converted into 934,398
shares of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 per share. Any fractional shares issuable pursuant to the formula
were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 9, Stockholders’ Deficit for additional information
on the Series D-1 Preferred Stock.
As
of December 31, 2025, all outstanding 2022 Notes have been converted to Series D-1 Preferred Stock. For the years ended December 31,
2025 and 2024, the Company recorded interest expense of $ 36,788 and $ 186,654 , respectively, related to the 2022 Notes.
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.
F- 16
The
2024 Financing is in the form of unsecured convertible promissory notes (individually, a “2024 Note” and collectively, the
“2024 Notes”). In addition to customary provisions, the 2024 Notes contain the following provisions:
(i)
The
2024 Notes 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 option of the holder;
(iii)
The
outstanding principal amount and interest payable under the 2024 Notes is convertible at the holder’s option into shares of
Series D-1 Preferred Stock at a price per share equal to $ 2.862 . The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares
of common stock; and
(iv)
The
outstanding principal amount and interest payable under the 2024 Notes 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.
The
embedded conversion options associated with the 2024 Notes do not require bifurcation and treatment as a derivative liability.
During the year ended December 31, 2025,
principal and interest in the aggregate amount $ 1,312,932 , owed in connection with the 2024 Notes were converted into 458,752 shares
of Series D-1 Preferred Stock at the Conversion Price of $ 2.862 per share. Any fractional shares issuable pursuant to the formula
were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 9, Stockholders’ Deficit for additional
information on the Series D-1 Preferred Stock. As of
December 31, 2025, all outstanding 2024 Notes have been converted to Series D-1 Preferred Stock.
For the years ended December 31,
2025 and 2024, the Company recorded interest expense of $ 72,504 and
$ 25,428 ,
respectively, related to the 2024 Notes.
On
January 15, 2025, the Board approved the closure of the 2024 Financing.
2025
Financing
On
January 15, 2025, the Board approved a Financing Term Sheet (the “2025 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 “2025 Financing”), which
amounts will be obtained in several tranches.
Pursuant
to the 2025 Term Sheet, the 2025 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve
months after the issue date of a 2025 Note.
The
2025 Financing will be in the form of unsecured convertible loans from the investors (the “2025 Note Investors”) and evidenced
by convertible promissory notes (individually, a “2025 Note” and collectively, the “2025 Notes”). In addition
to customary provisions, the 2025 Notes will contain the following provisions:
(i)
The
2025 Notes bear interest at the rate of eight percent ( 8 %) per annum.
(ii)
In
the event there is a change of control of the Board, the term of the 2025 Notes will be accelerated and all amounts due under the
2025 Notes may be immediately due and payable at the 2025 Note Investors’ option;
(iii)
The
outstanding principal amount and interest payable under the 2025 Notes may be converted early at the 2025 Note Investors’ option
into shares of Series D-1 Preferred Stock at a price per share equal to $ 2.862 . Each share of Series D-1 Preferred Stock is convertible
into ten ( 10 ) shares of common stock; and
(iv)
The
outstanding principal amount and interest payable under the 2025 Notes will automatically convert into shares of the Company’s
Series D-1 Preferred Stock twelve (12) months after the issue date of a 2025 Note. Each share of Series D-1 Preferred Stock is convertible
into ten (10) shares of the Company’s Common Stock.
As
of December 31, 2025, principal and interest in the amount of $ 2,510,000 and $ 84,480 , respectively, remains outstanding on the 2025 Notes.
For the year ended December 31, 2025, the Company recorded interest expense of $ 84,480 , related to the 2025 Notes.
F- 17
6.
Notes Payable
The
Company obtained short-term financing from First Insurance Funding in 2025 for our commercial insurance policies and Wells Fargo for
our new NetSuite Software. As of December 31, 2025, the balance of the notes payable was $ 241,393 , of which $217,772 was classified as a current liability and $23,621 was
classified as a non-current liability. As of December 31, 2024, the balance
of the note payable was $ 206,463 . For the years ended December 31, 2025 and 2024, the Company recorded interest expense of $ 5,338 and
$ 13,591 , respectively, related to the notes payable.
7.
Related Party Transactions
During
the year ended December 31, 2024, the Company incurred consulting fees of $ 63,600 for services rendered by Bruce Horowitz (Capital Strategists)
a former member of the Board and former Chief Operating Officer (“COO”). 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.
Director
fees for Mr. Horowitz for the years ended December 31, 2025 and 2024 were $ 0
and $ 18,750 , respectively. Mr. Horowitz waived the amount of $ 450,000
due to him in director fees upon his resignation.
On
March 25, 2024, the Board retained Dominic Rodrigues as the Company’s interim chief operations consultant pursuant to an Independent
Contractor Agreement entered into with Mr. Rodrigues. In this role, Mr. Rodrigues will serve as the Company’s principal executive
officer and will be paid $ 20,000 per calendar month for his services as principal executive officer. During the year ended December 31,
2024, the Company incurred fees of $ 13,800 for interim consulting services rendered by Mr. Rodrigues. In April 2024, Mr. Rodrigues was
hired as an employee to serve in the role of president and principal executive officer.
See
Note 5 for details of other related party transactions.
Directors’
fees incurred during the year ended December 31, 2025 and 2024, were $ 310,000
and $ 328,750 ,
respectively. In the first quarter of 2024, the Company recognized a net gain of $ 121,250 ,
primarily attributable to the $ 450,000
in fees waived by Mr. Horowitz.
8.
Prepaid Expenses and Other Current Assets
The
following table summarizes the prepaid expenses and other current assets at December 31, 2025 and 2024:
Schedule
of Prepaid Expenses And Other Current Assets
For the Years Ended
December 31,
2025
2024
Deferred tax asset
$ 1,596
$ 1,596
Prepaid insurance
186,111
209,320
Prepaid rent
8,106
8,106
Prepaid subscriptions
28,848
27,418
Prepaid other
20,524
4,223
Other current assets
71,398
236,383
Total Prepaid Expenses and Other Current Assets
$ 316,583
$ 487,046
Other
current assets at December 31, 2025 primarily consisted of prepaid software costs related to the implementation of NetSuite. At December
31, 2024, other current assets primarily consisted of a refund receivable from the University of Tennessee College of Veterinary Medicine
following the termination of a contract.
In addition, as of December 31, 2025
and 2024, the Company has a short-term receivable in the amount of $2,100,000 that is owed from Peter Culpepper, the former Interim Chief
Executive Officer of the Company. The Company has established a reserve of $2,100,000 as of December 31, 2025 and 2024, such that the
carrying value of the receivable is $0 as of December 31, 2025 and 2024.
F- 18
9.
Stockholders’ Deficit
Authorized
Capital
As
of December 31, 2025, the Company was authorized to issue 1,000,000,000 shares of common stock, $ 0.001 par value, and 25,000,000 shares
of preferred stock, $ 0.001 par value. The holders of the Company’s common stock are entitled to one vote per share. The preferred
stock is designated as follows: 957,100 shares to Series D Convertible Preferred Stock (the “Series D Preferred Stock”),
and 23,042,900 shares of Series D-1 Convertible Preferred Stock (the “Series D-1 Preferred Stock”) and 1,000,000 shares undesignated.
Series
D and Series D-1 Preferred Stock
The
rights, preferences and privileges of the Series D Preferred Stock and Series D-1 Preferred Stock (collectively, the “D-Series
Preferred Stock”) are set forth in their respective Certificates of Designation.
Rank
The
Series D Preferred Stock and the Series D-1 Preferred Stock rank pari passu with each other. The D-Series 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 D-Series Preferred as to dividends and distributions upon a change
of control transaction, or the liquidation, winding-up and dissolution of the Company.
Dividends
The
D-Series Preferred Stock does 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 D-Series 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 D-Series 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
D-Series Preferred Stock. If a Company Event occurs within two years of June 20, 2021 (the “Date of Issuance”), the holders
of D-Series Preferred Stock will receive, for each share of D-Series Preferred Stock, an amount in cash equal to the Original Issue Price
(as defined in the respective Certificates of Designation) multiplied by four. If a Company Event occurs from and after the second anniversary
of the Date of Issuance, the holders of D-Series Preferred Stock will receive, for each share of D-Series Preferred Stock, an amount
in cash equal to the Original Issue Price multiplied by six. The Original Issue Price for the Series D Preferred Stock is $ 0.2862 , and
the Original Issue Price for the Series D-1 Preferred Stock is $ 2.862 .
Voting
Rights
Holders
of shares of D-Series Preferred Stock will vote together with the holders of common stock as a single class. Each share of Series D Preferred
Stock carries the right to one vote per share. Each share of Series D-1 Preferred Stock carries the right to ten 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 D-Series Preferred Stock without the affirmative vote of a majority of
the votes entitled to be cast by holders of outstanding shares of D-Series Preferred Stock, voting together as a single class with each
share of D-Series 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 D-Series Preferred Stock.
F- 19
Conversion
The
Series D 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 Preferred Stock is convertible at the option of the holders thereof into shares of common stock based on a one-for-ten
conversion ratio. The conversion ratio of the D-Series Preferred Stock is subject to adjustment for stock splits and combinations, recapitalizations,
reclassifications, reorganizations, mergers, and consolidations. The D-Series Preferred Stock will automatically convert into shares
of common stock upon the fifth anniversary of the date of issuance. See Note 18 – Subsequent Events for information related to the extension of the automatic conversion date.
Preferred
Stock Issuances
During
the year ended December 31, 2025, convertible notes with principal and accrued interest in the aggregate amount of $ 3,083,535
were converted into 1,077,092
shares of Series D-1 Preferred Stock.
During
the year ended December 31, 2024, the Company issued 744,878 shares of Series D-1 Preferred Stock in satisfaction of accrued directors’
fees in the amount of $ 2,131,839 .
During
the year ended December 31, 2024, the Company issued 1,141,262 shares of Series D-1 Preferred Stock in exchange of 11,416,626 shares
of Series D Preferred Stock.
During
the year ended December 31, 2024, convertible notes with principal and accrued interest in the aggregate amount of $ 2,674,224
were converted into 934,398
shares of Series D-1 Preferred Stock.
Common
Stock Issuances
During
the year ended December 31, 2025, the Company did not issue any shares of common stock. During the year ended December 31, 2024, the
Company issued 757,760 shares of common stock upon the conversion of 75,776 shares of Series D-1 Preferred Stock.
10.
Stock Incentive Plan and Warrants
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 the 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. As of December 31, 2025, there were 49,196,656 shares available for issuance under the 2024 Equity Compensation
Plan.
The
following table summarizes option activity during the years ended December 31, 2025 and 2024:
Stock
Options
Schedule
of Option Activity
Shares
Weighted Average
Exercise Price
Weighted Average Remaining
Life in
Years
Aggregate Intrinsic
Value
Outstanding at January 1, 2025
53,393,102
$ 0.29
9.3
$ -
Granted
365,242
0.30
Forfeited
( 3,075,000 )
0.24
Options outstanding at December 31, 2025
50,683,344
0.29
8.8
-
Options exercisable at December 31, 2025
34,427,368
$ 0.28
8.8
$ -
F- 20
On
December 2, 2024, the Company granted five and ten-year options for the purchase of 50,318,102 shares of the Company’s common stock
exercisable at $ 0.2862 per share, as follows:
●
Ten-year
options for the purchase of 1,550,164 shares of the Company’s common stock, with an aggregate grant date value of $ 112,070
were granted to certain directors of the Company. The options were fully vested upon grant.
●
Ten-year
options for the purchase of 47,953,253 shares of the Company’s common stock, with an aggregate grant date value of $ 3,466,802
were granted to certain Company executives. One-third of the options were fully vested upon grant; the remaining two-thirds vested
on each of the next two anniversaries of the date of grant.
●
Five-year
options for the purchase of 814,685 shares of the Company’s common stock, with an aggregate grant date value of $ 39,317 were
granted to an employee of the Company. One-third of the options were fully vested upon grant; the remaining two-thirds vested on
each of the next two anniversaries of the date of grant.
The
grant date value of the stock options was calculated using the Black Sholes valuation model with the following assumptions:
Schedule
of Grant Date Value of Stock Option using Black Sholes Valuation Model
Options granted during the
year ended December 31,
2025
2024
Risk free interest rate
3.84 %
3.86 %
4.08 %
-
4.19 %
Expected term (years)
2.5
-
2.5
3.0
-
5.5
Expected volatility
90 %
-
91 %
94 %
-
100 %
Expected dividends
0.00 %
0.00 %
Option
forfeitures are accounted for at the time of occurrence. The expected term used is the estimated period of time that options granted
are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term
of employee option grants. The Company utilizes an expected volatility figure based on the historical volatility of its common stock
over a period of time equivalent to the expected term of the instrument being valued. The risk-free interest rate was determined from
the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being
valued. Forfeitures during the period primarily relate to the options previously held by a former executive officer.
During
the year ended December 31, 2025, the Company recognized stock-based compensation expense of $ 1,237,546 .
During the year ended December 31, 2024, the Company recognized stock-based compensation expense of $ 1,280,776 .
As of December 31, 2025, there was $ 1,230,608
of unrecognized stock-based compensation related to the above
stock options, which will be recognized over the weighted average remaining vesting period of less than one year.
As
of December 31, 2025 and 2024, the intrinsic value of outstanding and exercisable options was $ 0 .
The
following table summarizes information about stock options outstanding at December 31, 2025:
Schedule of Stock Options Outstanding
Options Outstanding
Options Exercisable
Exercise Price
Outstanding
Number of
Options
Weighted Average Remaining Life
In Years
Exercisable
Number of
Options
$ 0.29
50,323,344
8.8
34,067,368
$ 0.30
360,000
4.5
360,000
50,683,344
8.8
34,427,368
F- 21
Warrants
The
following table summarizes warrant activity during the year ended December 31, 2024:
Schedule
of Warrant Activity
Number of Warrants
Weighted Average Exercise Price
Weighted Average Remaining Life in Years
Outstanding and exercisable at January 1, 2024
412,000
$ 0.97
Forfeited
( 412,500 )
0.97
Outstanding and exercisable at December 31, 2024
-
$ -
-
There
was no warrant activity during the year ended December 31, 2025.
11.
Income Taxes
The
domestic and foreign components of loss before income taxes from operations for the years ended December 31, 2025 and 2024 are as follows:
Schedule of Domestic and Foreign Loss Before Income Taxes
2025
2024
Year ended December 31
2025
2024
Components of Pre-Tax Income (Loss):
Domestic
$ ( 5,505,122 )
$ ( 4,763,882 )
Foreign
( 40 )
( 1,745
)
Net Pre-Tax Loss
$ ( 5,505,162 )
$ ( 4,765,627 )
The
income tax provision (benefit) consists of the following:
Schedule of Income Tax Provision (Benefit)
Year ended December 31
2025
2024
Federal:
Current
$
-
$
-
Deferred
410,747
151,885
State and local:
Current
-
-
Deferred
33,005
166,260
Foreign
Current
-
-
Deferred
( 1,068 )
12,995
( 442,684 )
331,140
Change in valuation allowance
442,684
( 331,140 )
Income tax provision (benefit)
$ -
$ -
F- 22
The
reconciliations between the statutory federal income tax rate and the Company’s effective tax rate are as follows:
Schedule of Statutory Federal Income Tax Rate and Effective Tax Rate
2025
2024
Year Ended December 31
2025
2024
Amount
Percentage
Amount
Percentage
Tax benefit at federal statutory rate
$
( 1,156,076
)
( 21.0 )%
$
( 1,000,049
)
( 21.0 )%
State income taxes, net of federal benefit *
( 282,688
)
( 5.1 )%
( 244,536
)
( 5.1 )%
Permanent differences
( 63,220
)
( 1.3 )%
482,802
10.1 %
Change in valuation allowance
442,684
8.0 %
( 331,140
)
( 7.0 )%
Prior year true-up:
Timing differences
( 137,933
)
( 2.5 )%
43,519
0.9 %
Federal NOL carryforward difference
( 366,375
)
( 6.7 )%
276
0.0 %
State of TN NOL carryforward difference
( 87,224
)
( 1.6 )%
( 51,737
)
( 1.1 )%
Foreign NOL carryforward difference
( 1,337
)
0.0 %
12,558
0.3 %
Expiration of federal & state net operating loss carryforwards
Federal
1,161,471
21.1 %
749,958
15.7 %
State of TN
497,108
9.0 %
364,915
7.7 %
Miscellaneous
( 6,411
)
( 0.1 )%
( 26,566
)
( 0.6 )%
Effective income tax rate
$
-
0.0 %
$
-
0.0 %
* 100%
State of Tennessee
The
components of the Company’s deferred income taxes are summarized below:
Schedule of Components of Deferred Income Taxes
2025
2024
December 31
2025
2024
Deferred Tax Assets:
Net operating loss carryforwards
$ 42,142,967
$ 41,456,195
Research and development credit carryovers
3,554,718
3,456,321
Stock-based compensation
658,163
428,117
Intangible assets
623,987
539,373
Capitalized R&D expenditures
-
884,683
Contribution carryovers
13,068
-
Accrued liabilities
545,523
311,400
Gross deferred tax assets
47,538,426
47,076,089
Deferred Tax Liabilities:
Intangible assets
( 784 )
( 1,271 )
Prepaid expenses
( 82,321 )
( 62,182 )
Other
-
-
Gross deferred tax liabilities
( 83,105 )
( 63,453 )
Valuation allowance
( 47,455,321 )
( 47,012,636 )
Deferred tax asset, net of valuation allowance
$ -
$ -
Change in valuation allowance
$ ( 442,684 )
$ 331,140
A
valuation allowance against deferred tax assets is required if, based on the weight of available evidence, it is more likely than not
that some or all of the deferred tax assets may not be realized. The Company is in the early stages of development and realization of
the deferred tax assets is not considered more likely than not. As a result, the Company has recorded a full valuation allowance for
the net deferred tax asset. A portion of the valuation allowance relates to Research and Development credit carryovers. There has been
no formal Research and Development studies performed related to the amounts calculated for these credits. While management believes the
amounts taken as credits are accurate, it is possible a future adjustment would be necessary to reduce the value of the of these credit
carryovers.
F- 23
Since
inception of the Company on January 17, 2002, the Company has generated federal, state, and Australian tax net operating losses of approximately
$ 166 million, $ 140 million, and $ 109 thousand, respectively. Under the Tax Cuts and Jobs Act, federal net operating losses incurred after
December 31, 2017 may be carried forward indefinitely. The tax loss carryforwards of the Company may be subject to limitation by Section
382 of the Internal Revenue Code with respect to the amount utilizable each year. This limitation could reduce the Company’s ability
to utilize net operating loss carryforwards. Federal net operating losses (“NOLs”) totaling $ 135.0 million expire in various
amounts between 2026 and 2037. Federal NOLS totaling $ 31.4 million do not expire.
Schedule of Net Operating Loss
Year
Year of
Generated
Expiration
Amount
2006
2026
$ 7,192,407
2007
2027
10,218,952
2008
2028
7,017,372
2009
2029
9,573,948
2010
2030
10,344,298
2011
2031
11,225,047
2012
2032
11,193,882
2013
2033
10,273,181
2014
2034
9,075,738
2015
2035
17,455,417
2016
2036
19,710,699
2017
2037
11,703,175
2018
N/A
6,255,067
2019
N/A
4,085,063
2020
N/A
4,167,397
2021
N/A
3,167,687
2022
N/A
1,336,826
2023
N/A
1,114,861
2024
N/A
4,106,962
2025
N/A
7,208,598
Total NOLS
$ 166,426,577
State
NOLS totaling $ 140.0 million expire in various years between 2026 and 2041.
Year
Year of
Generated
Expiration
Amount
2010
2026
$ 10,440,651
2011
2027
11,362,120
2012
2028
11,311,394
2013
2029
10,381,763
2014
2030
9,278,510
2015
2031
18,547,287
2016
2032
20,166,661
2017
2033
12,131,850
2018
2034
6,455,113
2019
2035
4,211,210
2020
2036
4,234,755
2021
2037
3,232,081
2022
2038
3,758,942
2023
2039
2,122,720
2024
2040
4,577,022
2025
2041
7,341,058
Total NOLS
$ 139,553,137
F- 24
Australia
NOLS totaling $ 109,374 do not expire.
Year Generated
Year of Expiration
Amount
2017
N/A
$ 628
2018
N/A
51,041
2019
N/A
12,943
2020
N/A
13,754
2021
N/A
11,270
2022
N/A
11,920
2023
N/A
5,293
2024
N/A
3,603
2025
N/A
( 1,610 )
Total NOLS
$ 109,374
The
Company has determined that there are no uncertain tax positions as of December 31, 2025 or 2024.
We
file income tax returns in the U.S., Tennessee, and Australia. As of December 31, 2025, the U.S. federal and Tennessee tax years open
to examination are 2022 through 2025. The Australia income tax return remains open to examination for 2023 through 2025.
To
date, the Company’s operations conducted by its Australian subsidiary consist primarily of research and development activities.
As of December 31, 2025, there were no accumulated earnings and profits in the Company’s foreign subsidiary. At current tax rates,
no additional federal income taxes (net of available tax attributes) would be payable if such earnings were to be repatriated.
12.
Leases
Leases
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 ranged from $ 4,053 to $ 4,278 over the term on the
lease.
On
April 24, 2025, the Company entered into the first amendment to its operating lease agreement, extending the lease term by an additional
three years through June 30, 2028. Pursuant to the amendment, monthly base rent will range from $ 4,391 to $ 4,616 over the extended term.
Total
expense for operating leases for the year ended December 31, 2025 was $ 47,523 , of which $ 31,457 was included within research and development
and $ 16,066 was included within general and administrative expenses on the consolidated statements of operations. Total expense for operating
leases for the year ended December 31, 2024 was $ 51,446 , of which, $ 34,297 was included within research and development and $ 17,149 was
included within general and administrative expenses on the 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 Years Ended
December 31,
2025
2024
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases
$ 47,637
$ 48,077
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 150,133
$ -
Weighted Average Remaining Lease Term
Operating leases
2 years, 6 months
6 months
Weighted Average Discount Rate
Operating leases
7.0 %
5.0 %
F- 25
Future
minimum payments under the non-cancellable lease as of December 31, 2025 were as follows:
Schedule of Future Minimum Payments Under Non-cancellable Lease
Years
Amount
2026
$ 53,364
2027
54,716
2028
27,696
Total lease payments
135,776
Less: amount representing imputed interest
( 8,472 )
Present value of lease liability
127,304
Less: current portion
( 48,083 )
Lease liability, non-current portion
$ 79,221
13.
401(K) Profit Sharing Plan
The
Company maintains a retirement plan under Section 401(k) of the Internal Revenue Code, which covers all eligible employees. All employees
with U.S. source income are eligible to participate in the plan immediately upon employment. There was no contribution made by the Company
in 2025 or 2024.
14.
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 did 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 elected gross presentation of the Tennessee Grant income
earned and the related research and development expenses, with Tennessee Grant income presented as grant revenue in the period in
which it was earned, and qualifying costs presented as research and development expenses included in the Company’s
consolidated statement of operations in the period that such costs are incurred. As of December 31, 2024, the Company recorded
$ 336,108 as
unearned grant revenue liability on the accompanying consolidated balance sheets. The grant award program was completed and fully
recognized during 2025; accordingly, the unearned grant revenue liability was $ 0
as of December 31, 2025.
The
Company recorded $ 336,108 and $ 617,140 grant revenue during the years ended December 31, 2025 and 2024, respectively.
15.
License Transactions
On
March 21, 2024, the Company entered into an exclusive worldwide license agreement (the License Agreement”) with the University
of Miami (“UM”) for the license and development of the UM’s intellectual property related to photodynamic antimicrobial
therapy in ophthalmology. The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell
Licensed Products and/or Licensed Processes (as defined in the License Agreement) based upon patent-related rights.
As
consideration for the rights granted in the License Agreement, the Company must pay an upfront fee of $ 10,000 , royalties equal to 10%
of net sales of Licensed Products and/or Licensed Processes, and annual payments of $ 1,000 on the first through fourth anniversaries
of the License Agreement and $ 10,000 on every anniversary thereafter. In the event of a sublicense to a third party, the Company is obligated
to pay royalties to the University equal to a percentage of sublicense income ranging from 10 % to 30 % depending on the phase of clinical
trials.
F- 26
Pursuant
to the requirements of the License Agreement, the Company created a new subsidiary “VisiRose” for the purpose of developing
and commercializing Licensed Products and Licensed Processes, assigned the License Agreement to VisiRose, and entered into an equity
agreement with respect to VisiRose’s securities. Pursuant to the equity agreement, VisiRose is required to issue to the University
5 % of the total number of issued and outstanding shares of VisiRose. The University has certain anti-dilution rights related to
additional issuances of VisiRose securities before VisiRose receives a total of $ 2,000,000 in cash.
On
December 5, 2024, the Board approved the formation of a subsidiary of the Company to be incorporated under the laws of the State of Delaware
under the name VisiRose and to pursue the development and commercialization of the Company’s pharmaceutical-grade API RBS for the
treatments of ophthalmology diseases and disorders. The certificate of incorporation of VisiRose was filed with the secretary of state
of Delaware on December 5, 2024.
Provectus
holds a majority ownership interest in its subsidiary, VisiRose, with a 89.3 %
stake, while the University of Miami retains a 5.0 %
ownership interest, and two additional investors hold ownership interests of approximately 5.7 %.
In accordance with U.S. Generally Accepted Accounting Principles (GAAP), the Company consolidates VisiRose’s financial results
within its consolidated financial statements. During the years ended December 31, 2025 and 2024, the Company recorded a net loss of
$ 74,273
and $ 29,585 ,
respectively, attributable to the noncontrolling interest in VisiRose, reflecting the noncontrolling interests’ proportionate
share of the subsidiary’s losses. During the year ended December 31, 2025 additional investments of $ 850,000 were received by VisiRose. In connection
with these investments, the University of Miami received an additional 228 shares of common stock.
The
License Agreement sets forth certain diligence milestones that include forming VisiRose, creating a Licensed Product suitable for submission
to the Food and Drug Administration (“FDA”), generating Licensed Product data suitable for required submission to the FDA,
submitting a drug-device combination application to the FDA, and receiving clearance, approval or other authorization from the FDA for
the Licensed Product portion of the drug-device combination. The License Agreement also provides for development milestone payments of
$5,000 upon the first commercial sale of approved Licensed Product and $50,000 upon net sales of Licensed Product of at least $500,000.
Pursuant
to the License Agreement, the Board approved the transfer of certain assets to VisiRose, such as the License Agreement, and the Company’s
exclusive master supply agreement for API and investigational drug product, subject to final review and contract finalization by the
Board. The Company and VisiRose entered into an agreement on December 20, 2024 whereby the Company assigned the License Agreement to
VisiRose, which the University approved.
The
term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related
to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years
from the first commercial sale of Licensed Product and/or Licensed Process. The License Agreement provides that the Company may terminate
the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement
if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after
receipt of written notice.
16.
Commitments, Contingencies and Litigation
The
Company may, from time to time, be involved in litigation arising in the ordinary course of business 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.
17.
Segment Reporting
The
Company’s only segment is Clinical Stage Biotechnology. The CODM reviews profit and loss information on a consolidated basis in
order to assess performance and make decisions about the allocation of operating and capital resources.
F- 27
The
following table presents disaggregated financial information with respect to the Company’s Clinical Stage Biotechnology segment
for the years ended December 31, 2025 and 2024, respectively:
Schedule
of Segment Reporting Information
2025
2024
For the Years Ended
December 31,
2025
2024
Grant Revenue
$ 336,108
$ 617,140
Operating Expenses:
Research and development
Clinical trial and research expenses
1,318,339
1,463,422
Depreciation/amortization
-
5,294
Insurance
179,358
225,754
Payroll and taxes
314,014
270,360
Stock based compensation
54,108
51,536
Rent and utilities
31,457
34,297
Total research and development
1,897,276
2,050,663
General and administrative
Depreciation
1,863
1,863
Directors’ fees
310,000
( 121,250 )
Donations
50,000
-
Insurance
122,089
168,644
Legal fees
450,496
576,908
Other general and administrative expenses
140,240
66,372
Payroll and taxes
870,187
644,479
Professional fees
570,600
512,500
Rent and utilities
18,455
19,314
Stock based compensation
1,183,438
1,229,240
Travel and entertainment
16,229
-
Foreign currency transaction losses
-
791
Total general and administrative
3,733,597
3,098,861
Total Operating Loss
( 5,294,765 )
( 4,532,384 )
Other Income/(Expense):
Research and development tax credit
-
9,320
Interest expense
( 210,359 )
( 239,073 )
Net Loss
$ ( 5,505,124 )
$ ( 4,762,137 )
Other
general and administrative expenses primarily include costs associated with office expenses, bank charges, computer-related expenses,
dues and subscriptions, and taxes. These expenses are incurred as part of the day-to-day operations and general administration of the
Company’s segment.
18.
Subsequent Events
The
Company has evaluated events that have occurred after the balance sheet date and through the date the consolidated 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 consolidated financial statements, except as disclosed below.
Convertible
Notes Payable
Subsequent
to December 31, 2025, the Company entered into 2025 Notes with a related party investor (a director of the Company) in the aggregate
principal amount of $ 175,000 .
Subsequent to December 31, 2025, the Company entered into 2025 Notes with a non-related party investor in the aggregate principal amount
of $ 110,000 .
Preferred
Stock
Subsequent
to December 31, 2025, principal and interest in the aggregate amount of $ 491,097 representing 2025 Notes were converted into 171,594 shares
of Series D-1 Convertible Preferred Stock upon automatic conversion of the 2025 Notes.
Subsequent to December 31, 2025, the Company filed amendments with the State of Delaware extending the automatic
conversion date of its Series D and Series D-1 Preferred Stock to December 31, 2028.
VisiRose
Subsequent
to December 31, 2025, the Company’s majority-owned subsidiary, VisiRose, received investments totaling $ 75,000 in exchange for
the issuance of 396 shares of VisiRose common stock. In accordance with the licensing agreement, VisiRose also issued an additional 40
shares of common stock to the University of Miami to maintain the University’s 5 % ownership interest.
F- 28
ITEM
9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
Not
applicable.