UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2026
or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
file number 001-36457
PROVECTUS
BIOPHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
90-0031917
(State
or other jurisdiction
of
incorporation or organization)
(I.R.S.
Employer
Identification
No.)
800
S. Gay Street , Suite 1610
Knoxville ,
Tennessee
37929
(Address
of principal executive offices)
(Zip
Code)
866 - 594-5999
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address, and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
None
N/A
N/A
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The
number of shares outstanding of the registrant’s common stock, par value $ 0.001 per share, as of August 11, 2026 was 420,279,879 .
TABLE
OF CONTENTS
Page
PART
I - FINANCIAL INFORMATION
Cautionary Note Regarding Forward-Looking Statements
1
Item 1. Financial Statements (unaudited)
2
Condensed Consolidated Balance Sheets
2
Condensed Consolidated Statements of Operations
3
Condensed Consolidated Statements of Comprehensive Loss
4
Condensed Consolidated Statements of Changes in Stockholders’ Deficit
5
Condensed Consolidated Statements of Cash Flows
7
Notes to Condensed Consolidated Financial Statements
8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
17
Item 3. Quantitative and Qualitative Disclosures About Market Risk
26
Item 4. Controls and Procedures
26
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
27
Item 1A. Risk Factors
27
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
27
Item 3. Defaults Upon Senior Securities
27
Item 4. Mine Safety Disclosures
27
Item 5. Other Information
27
Item 6. Exhibits
28
SIGNATURES
29
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under U.S. federal securities laws. These
statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express
management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,”
“plan,” “predict,” “project,” “should,” “strategy,” “will,” and
other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results
to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such
statements after this date, unless otherwise required by law.
Risks
and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include
those discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”) (including those described in
Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025), and:
●
The
uncertainty of generating (i) sales from rose bengal sodium (“RBS”)-based drug product candidates PV-10 ® ,
PH-10, PV-305, and/or any RBS-based or other halogenated xanthene (“HX”)-based drug product candidates (if and when approved),
(ii) licensing, milestone, royalty, and/or other payments related to these drug product candidates, and/or (iii) payments from the
Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual
property relating to these drug product candidates and/or RBS- and other HX-based drug substances;
●
The
uncertainty of raising additional capital through the proceeds of private placement transactions of debt and/or equity securities,
and outstanding stock options, and/or public offerings of debt and/or equity securities; and
●
The
disruptions from a public health crisis, such as severe acute respiratory syndrome coronavirus 2, or an economic predicament, such
as tariffs, or another macro upheaval to our business that could adversely affect our operations and financial condition.
1
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS.
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30,
December 31,
2026
2025
(Unaudited)
Assets
Current Assets:
Cash
$ 1,156,915
$ 251,291
Prepaid expenses and other current assets
211,969
316,583
Total Current Assets
1,368,884
567,874
Equipment and furnishings, less accumulated depreciation of $ 120,945 and $ 120,013 , respectively
2,068
3,000
Operating lease right-of-use asset
102,549
126,628
Total Assets
$ 1,473,501
$ 697,502
Liabilities and Stockholders’ Deficit
Current Liabilities:
Accounts payable
$ 931,972
$ 716,220
Accrued interest
49,469
23,540
Accrued interest - related parties
114,154
120,384
Accrued interest
114,154
120,384
Other accrued expenses
3,159,127
3,161,379
Notes payable
92,443
217,772
Convertible notes payable
2,075,000
870,000
Convertible notes payable - related parties
1,235,000
1,740,000
Convertible notes payable
1,235,000
1,740,000
Operating lease liability, current portion
49,980
48,083
Total Current Liabilities
7,707,145
6,897,378
Notes payable, non-current portion
-
23,621
Operating lease liability, non-current portion
53,920
79,221
Total Liabilities
7,761,065
7,000,220
Commitments and contingencies (Note 13)
-
-
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 June 30, 2026 and December 31, 2025; 956,985
shares issued and outstanding at June 30, 2026 and December
31, 2025; aggregate liquidation preference of $ 1,643,333
at June 30, 2026 and December 31, 2025
957
957
Series D-1 Convertible Preferred Stock; 23,042,900 shares designated at June 30,
2026 and December 31, 2025; 14,748,463 and 14,183,315 shares issued and outstanding at June 30, 2026 and December 31, 2025,
respectively; aggregate liquidation preference of $ 237,111,197 and $ 227,778,438 at June 30, 2026 and December 31, 2025,
respectively
14,748
14,183
Preferred Stock Value
14,748
14,183
Common stock; par value $ 0.001 per share; 1,000,000,000 shares authorized; 420,279,879 shares issued and outstanding at June 30, 2026 and December 31, 2025
420,280
420,280
Additional paid-in capital
258,475,479
256,179,846
Accumulated other comprehensive loss
( 59,803 )
( 60,191 )
Accumulated deficit
( 265,126,832 )
( 262,853,812 )
Total Provectus Biopharmaceuticals, Inc., Stockholders’ Deficit
( 6,275,171 )
( 6,298,737 )
Non-controlling interest in subsidiary
( 12,393 )
( 3,981 )
Total Stockholders’ Deficit
( 6,287,564 )
( 6,302,718 )
Total Liabilities and Stockholders’ Deficit
$ 1,473,501
$ 697,502
See
accompanying notes to condensed consolidated financial statements.
2
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2026
2025
2026
2025
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2026
2025
2026
2025
Grant Revenue
$ -
$ 57,480
$ -
$ 336,108
Operating Expenses:
Research and development
131,130
880,835
464,464
1,282,987
General and administrative
807,548
977,373
1,722,117
1,951,790
Total Operating Expenses
938,678
1,858,208
2,186,581
3,234,777
Total Operating Loss
( 938,678 )
( 1,800,728 )
( 2,186,581 )
( 2,898,669 )
Other Income (Expense):
Research and development credit
281
-
281
-
Interest expense
( 50,319 )
( 51,353 )
( 103,365 )
( 115,014 )
Total Other Expense, Net
( 50,038 )
( 51,353 )
( 103,084 )
( 115,014 )
Net Loss
( 988,716 )
( 1,852,081 )
( 2,289,665 )
( 3,013,683 )
Net Loss attributable to noncontrolling interest
( 6,150 )
( 37,661 )
( 16,645 )
( 59,155 )
Net Loss attributable to common stockholders
$ ( 982,566 )
$ ( 1,814,420 )
$ ( 2,273,020 )
$ ( 2,954,528 )
Basic and Diluted Loss Per Common Share
$
( 0.00 )
$
( 0.00 )
$
( 0.01 )
$ ( 0.01 )
Weighted Average Number of Common Shares Outstanding - Basic
and Diluted
420,279,879
420,279,879
420,279,879
420,279,879
See
accompanying notes to condensed consolidated financial statements.
3
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
2026
2025
2026
2025
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2026
2025
2026
2025
Net Loss
$ ( 988,716 )
$ ( 1,852,081 )
$ ( 2,289,665 )
$ ( 3,013,683 )
Other Comprehensive Loss:
Foreign currency translation adjustments
103
328
388
380
Comprehensive Loss, net
( 988,613 )
( 1,851,753 )
( 2,289,277 )
( 3,013,303 )
Comprehensive Loss attributed to non-controlling interest
( 6,150 )
( 37,661 )
( 16,645 )
( 59,155 )
Comprehensive Loss attributed to controlling interest
$ ( 982,463 )
$ ( 1,814,092 )
$ ( 2,272,632 )
$ ( 2,954,148 )
See
accompanying notes to condensed consolidated financial statements.
4
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2026
(Unaudited)
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Loss
Deficit
Interest
Total
Preferred
Stock
Preferred Stock
Additional
Accumulated 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, 2026
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 )
Issuance of common stock of
majority-owned subsidiary
-
-
-
-
-
-
66,767
-
-
8,233
75,000
Conversion of 2025 Notes to Series D-1 Preferred Stock
-
-
171,735
172
-
-
491,329
-
-
-
491,501
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
306,051
-
-
-
306,051
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 1,290,454 )
( 10,495 )
( 1,300,949 )
Other comprehensive income
-
-
-
-
-
-
-
285
-
-
285
Balance at March 31, 2026
956,985
957
14,355,050
14,355
420,279,879
420,280
257,043,993
( 59,906 )
( 264,144,266 )
( 6,243 )
( 6,730,830 )
Conversion of 2025 Notes to Series D-1 Preferred Stock
-
-
203,859
204
-
-
583,230
-
-
-
583,434
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
305,944
-
-
-
305,944
Conversion of accrued directors’ fees to Series D-1 Preferred Stock
-
-
189,554
189
-
-
542,312
-
-
-
542,501
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 982,566 )
( 6,150 )
( 988,716 )
Other comprehensive income
-
-
-
-
-
-
-
103
-
-
103
Balance at June 30, 2026
956,985
$ 957
14,748,463
$ 14,748
420,279,879
$ 420,280
$ 258,475,479
$ ( 59,803 )
$ ( 265,126,832 )
$ ( 12,393 )
$ ( 6,287,564 )
See
accompanying notes to condensed consolidated financial statements.
5
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2025
(Unaudited)
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, 2025
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
-
-
-
-
-
-
634,782
-
-
65,218
700,000
Conversion of 2022 Notes to
Series D-1 Preferred Stock
-
-
365,400
365
-
-
1,046,329
-
-
-
1,046,694
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
315,100
-
-
-
315,100
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 1,140,108 )
( 21,494 )
( 1,161,602 )
Other comprehensive income
-
-
-
-
-
-
-
52
-
-
52
Balance at March 31, 2025
956,985
957
13,471,623
13,471
420,279,879
420,280
253,086,238
( 60,689 )
( 258,563,069 )
33,831
( 5,068,981 )
Balance
956,985
957
13,471,623
13,471
420,279,879
420,280
253,086,238
( 60,689 )
( 258,563,069 )
33,831
( 5,068,981 )
Conversion of 2022 Notes to Series D-1
Preferred Stock
-
-
252,940
253
-
-
723,656
-
-
-
723,909
Stock-based compensation:
Amortization of stock options
-
-
-
-
-
-
322,070
-
-
-
322,070
Comprehensive loss:
Net loss
-
-
-
-
-
-
-
-
( 1,814,420 )
( 37,661 )
( 1,852,081 )
Other comprehensive income
-
-
-
-
-
-
-
328
-
-
328
Balance at June 30, 2025
956,985
$ 957
13,724,563
$ 13,724
420,279,879
$ 420,280
$ 254,131,964
$ ( 60,361 )
$ ( 260,377,489 )
$ ( 3,830 )
$ ( 5,874,755 )
Balance
956,985
957
13,724,563
13,724
420,279,879
420,280
254,131,964
( 60,361 )
( 260,377,489 )
( 3,830 )
( 5,874,755 )
See
accompanying notes to condensed consolidated financial statements.
6
PROVECTUS
BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2026
2025
For the Six Months Ended
June 30,
2026
2025
Cash Flows From Operating Activities:
Net loss
$ ( 2,289,665 )
$ ( 3,013,683 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
611,995
637,170
Non-cash operating lease expense
24,079
24,623
Depreciation
932
932
Changes in operating assets and liabilities
Prepaid expenses and other current assets
104,614
335,198
Accounts payable
215,752
204,488
Unearned grant revenue
-
( 336,108 )
Accrued interest
99,635
108,128
Other accrued expenses
540,248
447,980
Operating lease liability
( 23,404 )
( 25,299 )
Net Cash Used In Operating Activities
( 715,814 )
( 1,616,571 )
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable
1,355,000
150,000
Proceeds from issuance of convertible notes payable - related parties
340,000
845,000
Proceeds from issuance of common stock of majority-owned subsidiary
75,000
700,000
Repayment of short-term note payable
( 148,950 )
( 152,126 )
Net Cash Provided By Financing Activities
1,621,050
1,542,874
Effect of exchange rates on cash and restricted cash
388
442
Net Increase (Decrease) In Cash and Restricted Cash
905,624
( 73,255 )
Cash and Restricted Cash, Beginning of Period
251,291
489,726
Cash and Restricted Cash, End of Period
$ 1,156,915
$ 416,471
Cash and restricted cash consisted of the following:
Cash
$ 1,156,915
$ 385,929
Restricted cash
-
30,542
Cash and Restricted Cash,
End of Period
$ 1,156,915
$ 416,471
Supplemental Disclosures of Cash Flow Information:
Cash paid during the period for:
Interest
$
2,972
$ 4,305
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
Conversion of 2025 Notes and related accrued interest to Series D-1 Preferred Stock
$ 1,074,935
$ -
Conversion of accrued directors’ fees to Series D-1 Preferred Stock
$ 542,501
$ -
Right-of-use
asset obtained in exchange for operating lease liability
$ -
$ 150,133
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. Our drug product candidates are
based on synthetic, small molecule rose bengal sodium (“RBS”), which is a member of a class of molecules called halogenated
xanthenes (“HXs”).
The
Company’s proprietary patented and trade-secreted, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”)
in all our clinical development and non-clinical research programs. The Company is the first entity to advance RBS into clinical trials
for the treatment of disease. The Company is also the first entity, and currently the only one, to date to make pharmaceutical-grade
RBS API consistently at a purity of nearly 100%.
RBS
can be delivered by different routes of administration. RBS may concurrently display stimulatory and inhibitory effects and may target
disease in a bifunctional multi-modal manner. Direct contact by RBS with disease may lead to cell death or repair by one or more targeting
mechanisms, depending on the disease being treated and the concentration of RBS being utilized in the formulation. Multivariate innate
and adaptive immune activation, signaling, and response may follow.
The
Company’s RBS drug platform and pipeline comprise drug product candidates and non-clinical formulations that use different amounts
of RBS and are delivered by different routes of administration specific to each disease area, including:
●
Clinical:
Drug 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),
●
In
vitro: Early discovery programs in infectious diseases and tissue regeneration and repair, and
●
In
silico: Computer modeling of amyotrophic lateral sclerosis and other proprietary disease targets.
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.
Changes
in U.S. Trade Policies and Other Geopolitical Events Could Adversely Affect Our Operations
Ongoing
uncertainty around U.S. trade policies, tariffs, and international agreements may impact the cost and availability of materials, supplies,
and equipment used in the Company’s operations or those of the Company’s partners. Any disruptions or increased costs resulting from these changes could
negatively affect the Company’s business, financial condition, results of operations, and the market price of the Company’s common stock.
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, 2025 filed with the SEC on March 25, 2026. 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, 2026 are
not necessarily indicative of the results that may be expected for the year ending December 31, 2026.
8
2.
Liquidity and Going Concern
To
date, the Company has not generated any revenues from product sales or from commercial operations.
The
Company’s cash was $ 1,156,915 and $ 251,291 at June 30, 2026 and December 31, 2025, respectively. The Company’s working capital
deficit was $ 6,338,261 and $ 6,329,504 as of June 30, 2026 and December 31, 2025, respectively, net loss for the six months ended June
30, 2026 and 2025 was $ 2,289,665 and $ 3,013,683 , respectively, and cash used in operations was $ 715,814 and $ 1,616,571 for the six months
ended June 30, 2026 and 2025, 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 HX-based drug products, and to raise additional capital.
The
Company plans to access capital resources through possible public or private equity offerings, including the 2025 Financing (see
Note 5), exchange offers, debt financings, corporate collaborations, other debt or other means. In addition, the Company continues
to explore opportunities to strategically monetize its clinical-stage drug candidates, PV-10, PH-10, and PV-305 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 and debt 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, we cannot assure
you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing
our prescription drug candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan
to seek additional funds to meet our current and long-term requirements in 2026 and beyond. We anticipate that these funds will otherwise
come from the proceeds of private placement transactions, including the 2025 Financing, exercise of outstanding stock options, or public
offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to
raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition, any
such financing may result in significant dilution to stockholders.
As
of June 30, 2026, cash requirements for our current liabilities include approximately $ 4,141,079 for accounts payable and other accrued
expenses (including lease liabilities) and $ 92,443 for notes payable related to our financing of our commercial insurance policies and
software license. Principal and interest in the aggregate amount of $ 163,444 owed in connection with the 2021 Convertible Notes Payable
will be paid back in August 2026. Principal and interest in the aggregate amount of $ 3,310,179 owed in connection with 2025 Convertible
Notes Payable automatically convert to preferred stock at maturity and are only subject to repayment in the event of a change of control
or event of default. The Company intends to meet its cash requirements from its current cash balance and from future financings.
The
aforementioned factors indicate that management’s plans do not alleviate the substantial doubt about the Company’s ability
to continue as a going concern for a period of one year from the issuance of these financial statements.
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 condensed 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, 2025 consolidated financial statements were issued in its 2025 Annual Report on March 25, 2026,
there have been no material changes to the Company’s significant accounting policies.
Basis
of Presentation
The
condensed consolidated financial statements include the consolidated results of Provectus, its wholly owned subsidiaries, and its majority-owned
subsidiary, VisiRose (see Note 12). The interests of non-controlling shareholders in VisiRose are presented as net loss attributable
to noncontrolling interest in the condensed consolidated statements of operations and as noncontrolling interest in the condensed 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.
Cash
Concentrations
Cash
is maintained at financial institutions and, at times, balances may exceed federally insured limits of $ 250,000 , although the Company
seeks to minimize this through treasury management. The Company has never experienced any losses related to these balances although no
assurance can be provided that it will not experience any losses in the future. As of June 30, 2026 and December 31, 2025, the Company
had cash balances in excess of FDIC insurance limits of $ 906,915 and $ 1,291 , respectively.
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.
Basic
and Diluted Loss Per Common Share
Basic
loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of
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
2026
2025
June 30,
2026
2025
Options
50,803,344
53,873,102
Convertible preferred stock
148,441,615
138,202,615
2021 unsecured convertible notes and accrued interest
571,085
543,133
2022 unsecured convertible notes and accrued interest
-
-
2024 unsecured convertible notes and accrued interest
-
4,503,941
2025 unsecured convertible notes and accrued interest
11,565,965
3,542,069
Total potentially dilutive shares
211,382,009
200,664,860
10
Segment
The
Company has one operating and reporting segment (namely, clinical stage biotechnology), for 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 a 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 condensed consolidated statements of operations and comprehensive loss.
The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.
Reclassifications
A
portion of the prior period stock-based compensation expense ($ 13,490 and $ 26,832 for the three and six months ended June 30, 2025, respectively), 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
Adopted Accounting Pronouncements
In
November 2024, the FASB issued ASU 2024-04, Debt-Debt with Conversions and Other Options . ASU 2024-04 is intended to clarify requirements
for determining whether certain settlements of convertible debt instruments, including convertible debt instruments with cash conversion
features or convertible debt instruments that are not currently convertible, should be accounted for as an induced conversion. This ASU
is effective for all entities for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those
annual reporting periods, with early adoption permitted. The Company adopted this standard on January 1, 2026. The adoption of ASU 2024-04
did not have a material impact on its condensed consolidated financial statements and related disclosures.
4.
Other Accrued Expenses
The
following table summarizes the other accrued expenses at June 30, 2026 and December 31, 2025:
Schedule
of Other Accrued Expenses
June 30,
December 31,
2026
2025
Accrued payroll and taxes
$ 2,820,522
$ 2,349,284
Accrued vacation
48,009
189,153
Accrued directors’ fees
-
387,500
Accrued other expenses
290,596
235,442
Total Other Accrued Expenses
$ 3,159,127
$ 3,161,379
11
5.
Convertible Notes Payable
The
following summarizes convertible notes payable activity during the six months ended June 30, 2026 and 2025:
Schedule of Convertible Notes Payable
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
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, 2025
$ -
$ 100,000
$ 353,000
$ 1,285,000
$ 500,000
$ 715,000
$ -
$ -
$ 853,000
$ 2,100,000
Notes issued
-
-
-
-
-
-
-
455,000
-
455,000
Principal converted
-
-
( 153,000 )
( 815,000 )
-
-
-
-
( 153,000 )
( 815,000 )
Balance as of March 31, 2025
-
100,000
200,000
470,000
500,000
715,000
-
455,000
700,000
1,740,000
Notes issued
-
-
-
-
-
-
150,000
390,000
150,000
390,000
Principal converted
-
-
( 200,000 )
( 470,000 )
-
-
-
-
( 200,000 )
( 470,000 )
Balance as of June 30, 2025
$ -
$ 100,000
$ -
$ -
$ 500,000
$ 715,000
$ 150,000
$ 845,000
$ 650,000
$ 1,660,000
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, 2026
$ -
$ 100,000
$ -
$ -
$ -
$ -
$ 870,000
$ 1,640,000
$ 870,000
$ 1,740,000
Notes issued
-
-
-
-
-
-
110,000
225,000
110,000
225,000
Principal converted
-
-
-
-
-
-
-
( 455,000 )
-
( 455,000 )
Balance as of March 31, 2026
-
100,000
-
-
-
-
980,000
1,410,000
980,000
1,510,000
Balance
-
100,000
-
-
-
-
980,000
1,410,000
980,000
1,510,000
Notes issued
-
-
-
-
-
-
1,245,000
115,000
1,245,000
115,000
Principal converted
-
-
-
-
-
-
( 150,000 )
( 390,000 )
( 150,000 )
( 390,000 )
Balance as of June 30, 2026
$ -
$ 100,000
$ -
$ -
$ -
$ -
$ 2,075,000
$ 1,135,000
$ 2,075,000
$ 1,235,000
Balance
$ -
$ 100,000
$ -
$ -
$ -
$ -
$ 2,075,000
$ 1,135,000
$ 2,075,000
$ 1,235,000
The
2021 Notes and 2025 Notes are, together, the “Convertible Notes”. The embedded conversion options associated with the Convertible
Notes do not require bifurcation and treatment as a derivative liability.
Related
party investors in the Company’s convertible notes consist of an officer, an officer/director of the Company and a beneficial owner
of more than 10% of the Company’s outstanding equity securities.
2025
Financing Note
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.
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 mature twelve (12) months after the issue date of a 2025 Note
and automatically convert into shares of the Company’s Series D-1 Preferred Stock at maturity at a price per share equal to $ 2.862 . Each share of Series D-1
Preferred Stock is convertible into ten ( 10 )
shares of the Company’s Common Stock.
During
the three months ended June 30, 2026, the Company received 2025 Notes proceeds in the aggregate amount of $ 1,360,000 , of which $ 1,245,000
was from non-related parties, $ 100,000 was from a shareholder considered a related party due to beneficial ownership exceeding 10% of
the Company’s outstanding securities, and $ 15,000 was from an officer and director of the Company. During the three months ended June 30, 2025, the Company received 2025 Notes proceeds in the aggregate amount of
$540,000, of which $150,000 was from non-related parties and $390,000 was from an officer and director of the Company.
During
the six months ended June 30, 2026, the Company received 2025 Notes proceeds in the aggregate amount of $ 1,695,000 ,
of which $ 1,355,000
was from non-related parties, $ 100,000
was from a shareholder considered a related party due to beneficial ownership exceeding 10% of the Company’s outstanding securities, and $ 240,000
was from an officer and director of the Company. During the six months ended June 30, 2025, the Company received 2025 Notes proceeds in the aggregate amount of $995,000,
of which $150,000 was from non-related parties and $845,000 was from an officer and director of the Company.
As
of June 30, 2026, principal and interest in the amount of $ 3,210,000 and $ 100,179 , respectively, remains outstanding on the 2025 Notes.
See Note 15 for details on conversions of 2025 Notes subsequent to June
30, 2026.
12
2021
Financing
On
September 20, 2022, the Board approved the closure of the 2021 Financing.
As
of June 30, 2026, principal and interest in the amount of $ 100,000
and $ 63,444 ,
respectively, remain outstanding on the 2021 Note. The Company expects to repay the outstanding principal and accrued interest in August
2026.
For
the three months ended June 30, 2026 and 2025, the Company recorded interest expense of $ 2,000 in each period related to the 2021
Notes. For the six months ended June 30, 2026 and 2025, the Company recorded interest expense of $ 4,000 in each period related to
the 2021 Notes.
Interest
Expense on Convertible Notes Payable
During
the three months and six months ended June 30, 2026, the Company incurred an aggregate of $ 49,212
and $ 99,635 , respectively, in interest expense on outstanding 2021 and 2025 Notes.
During
the three months and six months ended June 30, 2025, the Company incurred an aggregate of $ 49,976
and $ 108,128 , respectively, in interest expense on outstanding 2021, 2022, 2024, and 2025 Notes.
As
of June 30, 2026 and December 31, 2025, aggregate interest accrued on the Convertible Notes was $ 163,623 and $ 143,924 , respectively.
6.
Notes Payable
The
Company obtained financing for its commercial insurance policies and software license. As of June 30, 2026 and December 31, 2025, the
balance of the notes payable was $ 92,443 and $ 217,772 , respectively.
7.
Related Party Transactions
Directors’
fees incurred during the three months ended June 30, 2026 and 2025, were $ 77,500
and $ 77,500 ,
respectively. Directors’ fees incurred during the six months ended June 30, 2026 and 2025, were $ 155,000
and $ 155,000 ,
respectively. Accrued directors’ fees as of June 30, 2026 and December 31, 2025 were $ 0
and $ 387,500 , respectively. See Note 9 for details of the conversion of accrued directors’ fees into Series D-1 Convertible Preferred Stock.
See Note 5 for details of other related party transactions.
8.
Prepaid Expenses and Other Current Assets
The
following table summarizes the prepaid expenses and other current assets at June 30, 2026 and December 31, 2025:
Schedule
of Prepaid Expenses and Other Current Assets
June 30,
December 31,
2026
2025
Deferred tax asset
$ 1,596
$ 1,596
Prepaid insurance
131,527
186,111
Prepaid rent
8,106
8,106
Prepaid subscriptions
11,813
28,848
Prepaid other
23,228
20,524
Prepaid software
35,699
71,398
Total Prepaid Expenses and Other Current Assets
$ 211,969
$ 316,583
9.
Stockholders’ Deficit
Preferred
Stock
During
the three months ended June 30, 2026, the Company issued 203,859 shares of Series D-1 Convertible Preferred Stock upon the conversion
of $ 540,000 of principal and $ 43,434 of accrued interest outstanding on the 2025 Notes.
During
the six months ended June 30, 2026, the Company issued 375,594 shares of Series D-1 Convertible Preferred Stock upon the conversion of
$ 995,000 of principal and $ 79,935 of accrued interest outstanding on the 2025 Notes.
During
the three months ended June 30, 2026, the Company issued 189,554 shares of Series D-1 Convertible Preferred Stock for accrued directors’
fees of $ 542,501 at a stock price of $ 2.862 .
Preferred
Shares
On
January 30, 2026, 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.
See
Note 15 for details on issuances of Series D-1 Preferred Stock subsequent to June 30, 2026.
13
Stock
Options
On
April 1, 2025, the Company granted 5 -year
options for purchase of 120,000
options per quarter, and issued on the first day of the quarter, totaling to 480,000
throughout the term, at an exercise price of $ 0.30
per share to a consultant (the “Consultant Options”). These options are fully vested on the date of grant.
The
grant date value of the stock options was calculated using the Black Scholes valuation model with the following assumptions:
Schedule
of Grant Date Value of Stock Options Valuation Assumptions
Risk free interest rate
3.86 %
Expected term (years)
2.5
Expected volatility
90 %
Expected dividends
0.00 %
No
stock options were exercised during the three and six months ended June 30, 2026 or the three and six months ended June 30, 2025.
The
following table summarizes stock option activities during the six months ended June 30, 2026:
Schedule
of Option Activity
Shares
Weighted Average Exercise
Price
Weighted Average Remaining
Life
in Years
Options outstanding at January 1, 2026
50,683,344
$ 0.2863
8.8
Granted
120,000
$ 0.3000
4.5
Options outstanding at June 30, 2026
50,803,344
$ 0.2863
8.3
Options exercisable at June 30, 2026
34,547,368
$ 0.2864
8.3
The
following table summarizes information about outstanding and exercisable options at June 30, 2026:
Schedule
of Stock Options Outstanding and Exercisable
Options Outstanding
Options Exercisable
Outstanding
Weighted Average
Exercisable
Number of
Remaining Life
Number of
Exercise Price
Options
In Years
Options
$ 0.2862
814,681
3.7
543,124
$ 0.2862
49,503,421
8.7
33,519,002
$ 0.2862
5,242
4.5
5,242
$ 0.3000
480,000
4.0
480,000
50,803,344
8.3
34,547,368
During
the three months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense of $ 305,944 and $ 322,070 , respectively,
in connection with the amortization of stock options, of which $ 13,490 and $ 13,490 , respectively, is included in research and development
expense and $ 292,454 and $ 308,580 , respectively, is included in general and administrative expense.
During
the six months ended June 30, 2026 and 2025, the Company recognized stock-based compensation expense of $ 611,995
and $ 637,170 ,
respectively, in connection with the amortization of stock options, of which $ 26,832
is included in research and development expense for both years and $ 585,163
and $ 610,338 ,
respectively, is included in general and administrative expense.
As
of June 30, 2026, there was $ 618,613 of unrecognized stock-based compensation related to the above stock options, which will be recognized
over the weighted average remaining vesting period of 5.1 months.
14
10.
Leases
Total
operating lease expense for the three months ended June 30, 2026 was $ 14,678 , of which $ 9,297 was included within research and development
and $ 5,381 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, 2025 was $ 12,783 , of which $ 8,450 was included within research and development and $ 4,333
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, 2026 was $ 27,020 ,
of which $ 18,361
was included within research and development and $ 8,659
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, 2025 was $ 24,994 ,
of which $ 16,596
was included within research and development and $ 8,398
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,
2026
2025
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating leases
$ 23,404
$ 25,299
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ 150,133
Weighted Average Remaining Lease Term
Operating leases
2 years
3 years
Weighted Average Discount Rate
Operating leases
7.0 %
5.0 %
Future
minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2026 were as follows:
Schedule
of Future Minimum Payments Under Non-cancellable Lease
Years
Amount
Remainder of 2026
$ 27,020
2027
54,716
2028
27,695
Total lease payments
109,431
Less: amount representing imputed interest
( 5,531 )
Present value of lease liability
103,900
Less: current portion
( 49,980 )
Lease liability, non-current portion
$ 53,920
11.
Grants
The
Company recorded grant revenue of $ 0 during the three and six months ended June 30, 2026, and $ 57,480 and $ 336,108 during the three and
six months ended June 30, 2025, respectively, in connection with a $ 2,500,000 grant from the State of Tennessee (the “Tennessee
Grant”). The Tennessee Grant was provided as reimbursement of research and development expenses related to the development of animal
health drug products. All grant revenue related to the Tennessee Grant was recognized as of June 30, 2025. No additional revenue will be
recognized for expenses incurred in connection with the Tennessee Grant. As of June 30, 2026 and December 31, 2025, the Company did not
have any unearned grant revenue liability on the accompanying condensed consolidated balance sheet.
12.
License Transactions
VisiRose
During
the three months ended June 30, 2026 and 2025, the Company’s majority-owned subsidiary, VisiRose, received investments totaling
$ 0 and $ 0 , respectively.
During
the six months ended June 30, 2026 and 2025, the Company’s majority-owned subsidiary, VisiRose, received investments totaling $ 75,000
and $ 700,000 , respectively, in exchange for the issuance of 396 and 3,694 shares of VisiRose common stock, respectively. In accordance
with the licensing agreement between the Company and the University of Miami, VisiRose also issued an additional 40 and 188 shares of
common stock, respectively, during the six months ended June 30, 2026 and 2025 to the University of Miami to maintain the University’s 5.0 % ownership interest.
As
of June 30, 2026, Provectus holds a majority ownership interest in its subsidiary, VisiRose, with an 88.9 % stake, while the University
of Miami retains a 5.0 % ownership interest, and two additional investors together hold approximately 6.1 %. In accordance with U.S. Generally
Accepted Accounting Principles (GAAP), the Company consolidates VisiRose’s financial results within its condensed consolidated
financial statements.
15
During
the three months ended June 30, 2026 and 2025, the Company recorded a net loss attributable to VisiRose noncontrolling interest of $ 6,150
and $ 37,661 , respectively, reflecting the noncontrolling interests’ proportionate share of the VisiRose losses.
During
the six months ended June 30, 2026 and 2025, the Company recorded a net loss attributable to VisiRose noncontrolling interest of $ 16,645
and $ 59,155 , respectively, reflecting the noncontrolling interests’ proportionate share of the VisiRose losses.
13.
Commitments and Contingencies
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.
14.
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.
The
following table presents disaggregated financial information with respect to the Company’s Clinical Stage Biotechnology segment
for the three and six months ended June 30, 2026 and 2025, respectively:
Schedule
of Segment Reporting Information
2026
2025
2026
2025
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2026
2025
2026
2025
Grant Revenue
$ -
$ 57,480
$ -
$ 336,108
Operating Expenses:
Research and development
Conference and conventions
1,413
-
1,413
-
Clinical trial and research expenses
81,204
733,295
270,341
983,791
Insurance
40,304
51,827
79,967
99,816
Payroll and taxes
( 14,841 )
73,773
63,177
155,952
Stock-based compensation
13,490
13,490
26,832
26,832
Rent and utilities
9,297
8,450
18,361
16,596
Travel and entertainment
263
-
4,373
-
Total research and development
131,130
880,835
464,464
1,282,987
General and administrative
Depreciation
465
465
932
931
Directors’ fees
77,500
77,500
155,000
155,000
Donations
-
-
-
50,000
Insurance
33,173
26,194
68,477
52,954
Legal fees
79,446
125,133
222,797
246,155
Other general and administrative expenses
36,966
32,509
64,597
49,381
Payroll and taxes
137,144
224,404
358,817
441,117
Professional fees
139,323
178,303
249,278
336,930
Rent and utilities
5,381
4,333
10,675
8,984
Stock-based compensation
292,454
308,580
585,163
610,338
Travel and entertainment
5,696
-
6,381
-
Foreign currency transaction gains
-
( 48 )
-
-
Total general and administrative
807,548
977,373
1,722,117
1,951,790
Total Operating Loss
( 938,678 )
( 1,800,728 )
( 2,186,581 )
( 2,898,669 )
Other Income (Expense):
Research and development credit
281
-
281
-
Interest expense
( 50,319 )
( 51,353 )
( 103,365 )
( 115,014 )
Net Loss
$ ( 988,716 )
$ ( 1,852,081 )
$ ( 2,289,665 )
$ ( 3,013,683 )
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.
15.
Subsequent Events
The
Company has evaluated events that have occurred after the balance sheet date and through the date the condensed 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 financial statements, except as disclosed
below:
Series
D-1 Preferred Stock
Subsequent
to June 30, 2026, principal and interest in the aggregate amount of $ 270,144 , owed in connection with 2025 Notes was converted into 94,392
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.
16
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The
following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results
of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in
conjunction with the accompanying unaudited condensed consolidated financial statements and our Annual Report on Form 10-K for the year
ended December 31, 2025 filed with the SEC on March 25, 2026 (“2025 Form 10-K”), which includes additional information about
our critical accounting policies and practices and risk factors. Historical results and percentage relationships set forth in the condensed
consolidated statement of operations, including trends which might appear, are not necessarily indicative of future operations.
Clinical
Development and Drug Discovery
The
Company’s small molecule platform, which comprises different drug candidates and non-clinical formulations made from pharmaceutical-grade
RBS using different concentrations and delivered by different routes of administration specific to each disease and/or disease indication,
includes:
Clinical
Development Programs
●
Oncology:
Intratumoral PV-10 has undergone and is undergoing multiple, monotherapy and combination therapy, early-to-late-stage clinical
trials, expanded access programs (“EAPs”) for groups of and individual patients, and/or quality of life (“QOL”)
study at multiple clinical sites in Australia, Europe, and the U.S. for the treatments of Stage III and IV melanoma, different types
of liver cancers, and breast cancer.
PV-10
has undergone clinical monotherapy and combination therapy study of mechanisms of action and immune response for melanoma, metastatic
uveal melanoma, and metastatic neuroendocrine tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen
Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas.
The
Company is planning to conduct a single-site clinical trial of pre-operative penile squamous cell carcinoma (“penile SCC”),
where patients would receive monotherapy PV-10.
PV-10
is undergoing non-clinical monotherapy study for hepatocellular carcinoma at the Center for Interventional Oncology at the National
Institutes of Health Clinical Center in Bethesda, Maryland. PV-10 is also undergoing non-clinical monotherapy study for alveolar
rhabdomyosarcoma at a pediatric research hospital.
●
Dermatology:
Topical PH-10, a formulation of PV-10, has undergone multiple mid-stage, monotherapy clinical trials for the treatments of psoriasis
and atopic dermatitis at different clinical sites in the U.S.
PH-10
has undergone clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University
in New York, New York (“TRU”).
Different
PV-10 formulations have undergone non-clinical combination therapy study for psoriasis and are undergoing non-clinical monotherapy
study for skin inflammation and skin aging at TRU.
●
Ophthalmology:
The Company believes that clinical proof-of-concept (“POC”) of topical administration of non-pharmaceutical grade
rose bengal in combination with a light source medical device for the treatment of infectious keratitis has been shown by clinicians
and researchers at the University of Miami’s (“UM’s”) Bascom Palmer Eye Institute (“BPEI”) in
Miami, Florida, who are now collaborating with the Company to evaluate the potential use of our pharmaceutical-grade RBS.
Topical
formulation PV-305, a formulation of PV-10, has undergone non-clinical combination therapy study (i.e., drug and device) for diseases
and disorders of the eye, such as infectious keratitis, at BPEI.
The
Company launched a clinical-stage start-up biotechnology company named VisiRose, Inc. (“VisiRose”), a collaboration between
the Company and UM to commercialize BPEI’s ocular research using PV-305.
17
Proof-of-Concept
Programs
●
Oncology:
Intratumoral PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of relapsed and refractory
pediatric solid tumor cancers at the University of Calgary’s Cumming School of Medicine in Calgary, Alberta, Canada (“UCal”).
The Company believes that the UCal researchers have achieved monotherapy in vivo POC of intratumoral administration for pediatric
solid tumor cancers.
●
Oral
(“PO”) formulations of PV-10 have undergone non-clinical monotherapy study for high-risk and refractory adult solid tumor
cancers at UCal. The Company believes that the UCal researchers and the Company have both achieved monotherapy in vivo POC
of PO administration, that the Company has achieved monotherapy in vivo POC of PO administration in both prophylactic and
therapeutic settings, and that the Company has achieved monotherapy in vivo POC of PO administration for adult solid tumors.
●
Hematology:
PO formulations of PV-10 have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric
and other blood cancers, including leukemias, at UCal. The Company believes that the UCal researchers have achieved in vivo
POC of PO administration for blood cancers.
●
Wound
Healing: The Company believes that monotherapy in vivo POC of topical administration of non-pharmaceutical grade rose
bengal for the treatment of this indication has been shown by researchers at the University of Texas Medical Branch (“UTMB”)
in Galveston, Texas, who are now collaborating with the Company to use our pharmaceutical-grade RBS.
Topical
formulations of PV-10 have undergone non-clinical monotherapy study for the healing of full-thickness cutaneous wounds at UTMB.
●
Animal
Health: PV-10 formulations have undergone non-clinical monotherapy study for the treatment of cutaneous canine cancers at the
University of Tennessee’s College of Veterinary Medicine in Knoxville, Tennessee. The Company believes that it has achieved
monotherapy POC of intratumoral administration for canine cancers.
Early
Drug Discovery Programs
●
Immune
vaccine adjuvant: Different formulations of PV-10 have undergone non-clinical study as a vaccine adjuvant to enhance T cell responses
for anti-viral and anti-cancer vaccines.
●
Infectious
Diseases: PO and intranasal (“IN”) formulations of PV-10 have undergone non-clinical monotherapy study for the treatment
of SARS-CoV-2 at UCal, another Canadian academic research center, the University of Tennessee Health Science Center (“UTHSC”)
in Memphis, Tennessee, and a U.S. contract research organization. Different formulations of PV-10 have undergone non-clinical monotherapy
and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug-resistant
strains) and have undergone non-clinical monotherapy study for the treatment of oral bacterial infections at UTHSC. Different formulations
of PV-10 have undergone non-clinical monotherapy study for the treatment of fungal infections at UTHSC.
●
Tissue
Regeneration and Repair : Different formulations of PV-10 have undergone non-clinical monotherapy study for vertebrate development,
wound healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada.
●
Proprietary:
Different formulations of PV-10 are undergoing non-clinical study for proprietary diseases at an academic medical center.
Computer
Modeling Programs
●
Computer-based
molecular docking of RBS has been done and is being done for amyotrophic lateral sclerosis and other disease targets.
18
Business
Strategy
The
Company is selectively continuing ongoing and planning to initiate new monotherapy and combination therapy intratumoral PV-10 clinical
trials in melanoma and liver cancer indications to generate more and/or new clinical data and appropriately utilizing clinical data from
historical intratumoral PV-10 trials, EAPs, and/or QOL study of these oncology indications. Our goals are to pursue drug approval pathways
and/or co-development relationships with commercial pharmaceutical companies for intratumoral PV-10 based on these indications and data.
The
Company is developing a systemically administered formulation of pharmaceutical-grade RBS for the treatment of cancer. Our goals, when
this work is complete, are to file an investigational new drug application (“IND”) with the U.S. Food and Drug Administration
(“FDA”), take an initial systemic drug candidate into an early-stage clinical trial for an initial oncology or hematology indication,
and/or pursue a co-development collaboration or out-license arrangement for this route of administration and disease area.
The
Company is developing different formulations of pharmaceutical-grade RBS using different concentrations and different routes of administration
for other disease areas by endeavoring to show non-clinical activity and lack of toxicity. Our goals, when each task of this work is
completed, are to file an IND with the FDA, take an initial drug candidate into an early-stage clinical trial for an initial indication,
and/or pursue a co-development collaboration or out-license arrangement for the respective disease area and route of administration.
The
Company is endeavoring to fully elucidate the traits and characteristics of the RBS molecule using different academic medical centers
under sponsored research and testing agreements. Our goal is to gain and communicate additional knowledge of the RBS molecule’s
targeting, mechanism, signaling, immune response, and other features that are common to and/or different from each disease area and indication
under research.
The
Company is doing rigorous chemical analytical comparisons of non-pharmaceutical grades of rose bengal from specialty chemical suppliers
against the Company’s pharmaceutical-grade RBS. Our goal is to demonstrate the proprietary nature of the Company’s pharmaceutical-grade
RBS and that our pharmaceutical-grade RBS meets the necessary uniformity and purity requirements for commercial pharmaceutical use.
RBS
API and Drug Candidate Manufacturing
Our
pharmaceutical-grade RBS resulted from the Company’s innovation of a proprietary, patented, commercial-scale process to synthesize
and utilize the RBS molecule into a viable active pharmaceutical ingredient (“API”) for commercial pharmaceutical use; the
development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing
processes; the production and multi-year stability testing of multiple API and drug candidate lots; the comprehensive documentation of
lot composition and reproducibility; and the review and acceptance of CMC data from these lots by seven different national drug regulatory
agencies for use in a prior, multi-country, multi-center Phase 3 randomized control trial of the Company.
The
Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing
practice (“cGMP”) regulations, and the guidelines of The International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use (ICH). These processes utilize controls that eliminate the formation of historical
impurities and avoid the introduction of potentially hazardous impurities that the Company believes may have been and could be
present in uncontrolled and unreported amounts in non-pharmaceutical grades of rose bengal.
The
Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and intratumoral PV-10
drug candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of API and drug candidate
have been reviewed by multiple national drug regulatory agencies prior to granting clinical trial authorizations for the Company to commence
a historical Phase 3 study of intratumoral PV-10 for the treatment of the Company’s former lead indication of locally advanced
cutaneous melanoma, including the U.S. FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s
Therapeutic Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité
du Médicament et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión
Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica (ANMAT).
19
RBS
Non-Proprietary Name
The
RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (“WHO”)
Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for a non-proprietary
name in the third quarter of 2020 and reached the status of recommended International Non-proprietary Names (“INN”). INN
Recommended List 88, which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in the fourth
quarter of 2022.
Non-Pharmaceutical
Grades of Rose Bengal
Commercial
Grade
Commercial
grade rose bengal can be purchased from specialty chemical suppliers in the U.S. and in other parts of the world that manufacture it
under non-cGMP conditions. Commercial grade rose bengal appears to have reported purities that may vary between 80% and 95% and may contain
substantial amounts of unreported impurities and/or gross contaminants. Commercial grade rose bengal is typically used by researchers
unaffiliated with the Company for non-clinical study of the rose bengal molecule for potential biomedical therapeutic applications.
We
believe that commercial grade rose bengal is still manufactured using the original historical process, or a variant thereof, developed
by the molecule’s original Swiss creator Rudolph Gnehm in 1881. Some chemical manufacturers may, however, apply purification techniques
that the Company believes still result in commercial grade rose bengal possessing questionable purity and contaminants and substantial
lot-to-lot manufacturing variability.
Diagnostic
Grade
Diagnostic
grade rose bengal describes non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions, strips,
and devices, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic
diagnostic tests such as the rose bengal test for human brucellosis.
We
presume, but have not yet confirmed, that diagnostic grade rose bengal is derived from commercial grade rose bengal that may have undergone
a form of purification under cGMP regulations and/or may have been compounded by a pharmacist, academic medical researcher, or commercial
entity under cGMP regulations. Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy
of diagnostic grade rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.
Chemical
Analytical Comparison
In
the first quarter of 2022, the Company began work with a U.S. contract development and manufacturing organization to assess rigorously
and methodically three lots of commercial grade rose bengal, one each from three different specialty chemical suppliers, and compare
these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS. This chemical analytical work was substantially
completed by the end of the third quarter of 2022. The Company believes that the preliminary results of these analyses indicate that
all three lots of commercial grade rose bengal had rose bengal purity that was drastically different from what was represented on their
respective certificates of analysis (“CofAs”), and that one of the three lots contained gross contaminants that were not
represented on its CofA.
Potential
Barriers to Entry
The
Company believes that the Company’s proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over
non-pharmaceutical-grade rose bengal (i.e., commercial and diagnostic grades) that researchers, clinicians, and academic, business, and/or
governmental competitors have used, are using, and/or may attempt to use for potential biomedical applications. The Company believes
that non-pharmaceutical-grade rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants,
substantial lot-to-lot manufacturing variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible,
consistent, and fulsome CMC specifications and documentation. The Company believes that historical and potentially hazardous impurities
and other manufacturing and handling issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological,
and economic challenges to overcome and validate for compliance with modern drug regulatory standards.
20
Components
of Operating Results
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 unearned grant revenue and recognized as grant
revenue when qualifying costs are incurred.
Research
and Development Expenses
A
large component of our total operating expenses is the Company’s investment in research and development activities, including the
clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake
clinical trials to develop our drug candidates. These expenses consist primarily of:
●
Costs
of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations, and consultants, among
others;
●
Salaries
and related expenses for personnel, including stock-based compensation expense;
●
Other
outside service costs including cost of contract manufacturing;
●
The
costs of supplies and reagents; and,
●
Occupancy, insurance
and depreciation charges.
We
expense research and development costs as incurred.
Research
and development activities are central to our business model. We expect our research and development expenses to increase in the future
as we advance our existing product candidates through clinical trials and pursue their regulatory approval. Undertaking clinical development
and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are
unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent, we
will generate revenue from any subsequent commercialization and sale of our drug candidates.
General
and Administrative Expenses
General
and administrative expenses consist primarily of personnel-related costs, including salaries, benefits, and stock-based compensation,
for employees engaged in executive and finance functions. General and administrative expenses also include facility-related costs not
otherwise included in research and development expenses, director fees, insurance costs, and professional fees for legal, patent, accounting,
information technology, corporate communications, and other consulting services provided by third-party firms.
21
Results
of Operations
Comparison
of the Three Months Ended June 30, 2026 and June 30, 2025
For the Three Months Ended
June 30,
Increase/
2026
2025
(Decrease)
% Change
Grant Revenue
$
-
$ 57,480
$ (57,480 )
-100.0 %
Operating Expenses:
Research and development
131,130
880,835
(749,705 )
-85.1 %
General and administrative
807,548
977,373
(169,825 )
-17.4 %
Total Operating Expenses
938,678
1,858,208
(919,530 )
-49.5 %
Total Operating Loss
(938,678 )
(1,800,728 )
862,050
-47.9 %
Other Income (Expense):
Research and development credit
281
-
281
100.0 %
Interest expense
(50,319 )
(51,353 )
(1,034 )
-2.0 %
Total Other Expense, Net
(50,038 )
(51,353 )
(1,315 )
-2.6 %
Net Loss
(988,716 )
(1,852,081 )
(863,365 )
-46.6 %
Net Loss attributable to noncontrolling interest
(6,150 )
(37,661 )
(31,511 )
-83.7 %
Net Loss attributable to common stockholders
$ (982,566 )
$ (1,814,420 )
$ (831,854 )
-45.8 %
Overview
The
Company’s net loss decreased by $863,365 or 46.6% for the three months ended June 30, 2026 as compared to the three months ended
June 30, 2025, primarily as the result of a decrease in operating expenses, described below.
Grant
Revenue
Grant
revenue recognized during the three months ended June 30, 2026 was $0, compared to $57,480 for the same period in 2025, representing
a decrease of $57,480, or 100.0%. The decrease was attributable to the completion and full recognition of grant revenue in 2025 under
the awarded program .
Operating
Expenses
Research
and Development Expenses
The
following table summarizes research and development expenses for the three months ended June 30, 2026 and 2025.
For
the Three Months Ended
June
30,
Increase/
2026
2025
(Decrease)
%
Change
Research
and development
Conference and conventions
$ 1,413
$ -
$ 1,413
100.0 %
Clinical trial and research expenses
81,204
733,295
(652,091 )
-88.9 %
Insurance
40,304
51,827
(11,523 )
-22.2 %
Payroll and taxes
(14,841 )
73,773
(88,614 )
-120.1 %
Stock-based compensation
13,490
13,490
-
0.0 %
Rent and utilities
9,297
8,450
847
10.0 %
Travel and entertainment
263
-
263
100.0 %
Total research and development
$ 131,130
$ 880,835
$ (749,705 )
-85.1 %
Research
and development expenses were $131,130 for the three months ended June 30, 2026, a decrease of $749,705, or 85.1%, compared to
$880,835 for the same period in 2025. The decrease was primarily driven by lower clinical trial and research-related costs due to
reduced activity levels during the period, including manufacturing and development activities associated with the new drug
candidate. The decrease was also attributable to lower payroll-related expenses resulting from the reversal of accrued vacation
expense to align with a newly implemented vacation policy, and insurance costs.
22
General
and Administrative Expenses
The
following table summarizes general and administrative expenses for the three months ended June 30, 2026 and 2025.
For
the Three Months Ended
June
30,
Increase/
2026
2025
(Decrease)
%
Change
General and administrative
Depreciation
$ 465
$ 465
$ -
0.0 %
Directors’ fees
77,500
77,500
-
0.0 %
Insurance
33,173
26,194
6,979
26.6 %
Legal fees
79,446
125,133
(45,687 )
-36.5 %
Other general and administrative expenses
36,966
32,509
4,458
13.7 %
Payroll and taxes
137,144
224,404
(87,260 )
-38.9 %
Professional fees
139,323
178,303
(38,980 )
-21.9 %
Rent and utilities
5,381
4,333
1,048
24.2 %
Stock-based compensation
292,454
308,580
(16,126 )
-5.2 %
Travel and entertainment
5,696
-
5,696
100.0 %
Foreign currency translation gains
-
(48 )
48
100.0 %
Total general and administrative
$ 807,548
$ 977,373
$ (169,825 )
-17.4 %
General
and administrative expenses were $807,548 for the three months ended June 30, 2026, a decrease of $169,825, or 17.4%, compared to $977,373
for the same period in 2025. The decrease was primarily attributable to lower professional fees related to timing of accounting services,
decreased payroll and taxes due to the reversal of accrued vacation expense, reduced legal fees, and lower stock-based compensation
amortization expense recognized during the current period. These
decreases were partially offset by higher insurance expenses, higher other general and administrative expenses due to renewal of software
licenses and higher travel and entertainment expenses compared to the same period in 2025.
Other
Income/(Expense)
Other
income was $281 for the three months ended June 30, 2026, compared to $0 for the same period in 2025, representing an increase of $281,
or 100.0%. The increase was due to a research and development tax credit refund received in Australia.
Interest
expense was $50,319 for the three months ended June 30, 2026, compared to $51,353 for the same period in 2025, representing a decrease
of $1,034, or 2.0%. The decrease was primarily attributable to lower outstanding balances of convertible debt and notes payable during
the 2026 period.
Comparison
of the Six Months Ended June 30, 2026 and June 30, 2025
For
the Six Months Ended
June
30,
Increase/
2026
2025
(Decrease)
%
Change
Grant
Revenue
$ -
$ 336,108
$ (336,108 )
-100.0 %
Operating
Expenses:
Research
and development
464,464
1,282,987
(818,523 )
-63.8 %
General
and administrative
1,722,117
1,951,790
(229,673 )
-11.8 %
Total
Operating Expenses
2,186,581
3,234,777
(1,048,196 )
-32.4 %
Total
Operating Loss
(2,186,581 )
(2,898,669 )
712,088
-24.6 %
Other
Income (Expense):
Research
and development credit
281
-
281
100.0 %
Interest
expense
(103,365 )
(115,014 )
( 11,649 )
-10.1 %
Total
Other Expense, Net
(103,084 )
(115,014 )
( 11,930 )
-10.4 %
Net
Loss
(2,289,665 )
(3,013,683 )
( 724,018 )
-24.0 %
Net
Loss attributable to noncontrolling interest
(16,645 )
(59,155 )
(42,510 )
- 71.9 %
Net
Loss attributable to common stockholders
$ (2,273,020 )
$ (2,954,528 )
$ (681,508 )
-23.1 %
Overview
The
Company’s net loss decreased by $724,018 or 24.0% for the six months ended June 30, 2026 as compared to the six months ended June
30, 2025, primarily as the result of a decrease in operating expenses, described below.
Grant
Revenue
Grant
revenue recognized during the six months ended June 30, 2026 was $0, compared to $336,108 for the same period in 2025, representing a
decrease of $336,108, or 100.0%. The decrease was attributable to the completion and full recognition of grant revenue in 2025 under
the awarded program .
23
Operating
Expenses
Research
and Development Expenses
The
following table summarizes research and development expenses for the six months ended June 30, 2026 and 2025.
For the Six Months Ended
June 30,
Increase/
2026
2025
(Decrease)
% Change
Research and development
Conference and conventions
$ 1,413
$ -
$ 1,413
100.0 %
Clinical trial and research expenses
270,341
983,791
(713,450 )
-72.5 %
Insurance
79,967
99,816
(19,849 )
-19.9 %
Payroll and taxes
63,177
155,952
(92,775 )
-59.5 %
Stock-based compensation
26,832
26,832
-
0.0 %
Rent and utilities
18,361
16,596
1,765
10.6 %
Travel and entertainment
4,373
-
4,373
100.0 %
Total research and development
$ 464,464
$ 1,282,987
$ (818,523 )
-63.8 %
Research
and development expenses were $464,464 for the six months ended June 30, 2026, a decrease of $818,523, or 63.8%, compared to
$1,282,987 for the same period in 2025. The decrease was primarily driven by lower clinical trial and research-related costs due to
reduced activity levels during the period, including manufacturing and development activities associated with the new drug
candidate. The decrease was also attributable to lower payroll-related expenses and insurance costs.
General
and Administrative Expenses
The
following table summarizes general and administrative expenses for the six months ended June 30, 2026 and 2025.
For the Six Months Ended
June 30,
Increase/
2026
2025
(Decrease)
% Change
General and administrative
Depreciation
$ 932
$ 931
$ 1
0.1 %
Directors’ fees
155,000
155,000
-
0.0 %
Donations
-
50,000
(50,000 )
-100.0 %
Insurance
68,477
52,954
15,523
29.3 %
Legal fees
222,797
246,155
(23,358 )
-9.5 %
Other general and administrative expenses
64,597
49,381
15,217
30.8 %
Payroll and taxes
358,817
441,117
(82,300 )
-18.7 %
Professional fees
249,278
336,930
(87,652 )
-26.0 %
Rent and utilities
10,675
8,984
1,691
18.8 %
Stock-based compensation
585,163
610,338
(25,175 )
-4.1 %
Travel and entertainment
6,381
-
6,381
100.0 %
Total general and administrative
$ 1,722,117
$ 1,951,790
$ (229,673 )
-11.8 %
General
and administrative expenses were $1,722,117 for the six months ended June 30, 2026, a decrease of $229,673, or 11.8%, compared to
$1,951,790 for the same period in 2025. The decrease was primarily attributable to lower professional fees related to timing of
accounting services, decreased payroll and taxes due to the reversal of accrued vacation expense, reduced legal fees, and lower
stock-based compensation amortization expense recognized during the current period, as
well as a one-time donation in 2025. These decreases were partially offset by higher insurance expenses, higher other general and
administrative expenses due to renewal of software licenses and increase in travel and entertainment expenses compared to the same
period in 2025.
Other
Income/(Expense)
Other
income was $281 for the six months ended June 30, 2026, compared to $0 for the same period in 2025, representing an increase of $281,
or 100.0%. The increase was due to a research and development tax credit refund received in Australia.
Interest
expense was $103,365 for the six months ended June 30, 2026, compared to $115,014 for the same period in 2025, representing a decrease
of $11,649, or 10.1%. The decrease was primarily attributable to lower outstanding balances of convertible debt and notes payable during
the 2026 period.
Liquidity
and Going Concern
The
Company’s cash was $1,156,915 at June 30, 2026, compared to $251,291 at December 31, 2025. The Company’s working capital
deficit was $6,338,261 and $6,329,504 as of June 30, 2026 and December 31, 2025, respectively. We have continuing net losses and negative
cash flows from operating activities. In addition, we have an accumulated deficit of $265,126,832 as of June 30, 2026. These conditions
raise substantial doubt about our ability to continue as a going concern for a period within one year from the date that the financial
statements included elsewhere in this Quarterly Report on Form 10-Q are issued. The condensed consolidated financial statements and notes
thereto included in this Quarterly Report on Form 10-Q have been prepared on a basis that contemplates the realization of assets and
the satisfaction of liabilities and commitments in the normal course of business. Our financial statements do not include any adjustments
to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.
Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations.
24
As
of June 30, 2026, cash requirements for our current liabilities include approximately $4,141,079 for accounts payable and other accrued
expenses (including lease liabilities) and $92,443 for notes payable related to our financing of our commercial insurance policies and
software license. Principal and interest in the aggregate amount of $163,444 owed in connection with the 2021 Convertible Notes Payable
will be paid back in August 2026. Principal and interest in the aggregate amount of $3,310,179 owed in connection with 2025 Convertible
Notes Payable automatically convert to preferred stock at maturity and are only subject to repayment in the event of a change of control
or event of default. The Company intends to meet its cash requirements from its current cash balance and from future financings.
Management’s
plans include selling our equity securities and obtaining other financing, including the issuance of 2025 unsecured convertible notes
(the “2025 Financing”), to fund our capital requirements and on-going operations; however, there can be no assurance that
the Company will be successful in these efforts. Significant funds will be needed to continue and complete our ongoing and planned clinical
trials.
Access
to Capital
Management
plans to access capital resources through possible public or private equity offerings and/or debt offerings, including the 2025 Financing,
exchange offers, debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital through the
2025 Financing or otherwise, we will not be able to pay our obligations as they become due.
The
primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure
you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing
our prescription drug candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan
to seek additional funds to meet our current and long-term requirements in 2026 and beyond. We anticipate that these funds will otherwise
come from the proceeds of private placement transactions, including the 2025 Financing, exercise of outstanding stock options, or public
offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to
raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition, any
such financing may result in significant dilution to stockholders.
Critical
Accounting Estimates
We
prepare our condensed consolidated financial statements in accordance with U.S. GAAP, which require our management to make estimates
that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates,
as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences
between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates
on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations
for the future based on available information. We evaluate these estimates on an ongoing basis.
We
consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were
highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact
on our financial condition or results of operations. There are items within our financial statements that require estimation but are
not deemed critical, as defined above.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also
known as special purpose entities (“SPEs”).
Available
Information
Our
website is located at www.provectusbio.com. We make available free of charge through this website our annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant to Section
13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.
Reference to our website does not constitute incorporation by reference of the information contained on the site and should not be considered
part of this document.
The
SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file
electronically with the SEC as we do. The website is http://www.sec.gov.
25
The
Company also intends to use press releases, the Company’s website and certain social media accounts as a means of disclosing information
and observations about the Company and its business, and for complying with the Company’s disclosure obligations under Regulation
FD: the Provectus Substack account (provectus.substack.com), the @ProvectusBio X account (twitter.com/provectusbio), and the Company’s
LinkedIn account (linkedin.com/company/provectus-biopharmaceuticals). The information and observations that the Company posts through
these social media channels may be deemed material. Accordingly, investors should monitor these social media channels in addition to
following the Company’s press releases, SEC filings, and website. The social media channels that the Company intends to use as
a means of disclosing the information described above may be updated from time to time.
The
contents of the websites provided above are not intended to be incorporated by reference into this Quarterly Report on Form 10-Q or our
Annual Report on Form 10-K or in any other report or document we file with the SEC. Further, our references to the URLs for these websites
are intended to be inactive textual references only.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
Management,
with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period
covered in this report, our disclosure controls and procedures were effective to provide reasonable assurance that the information required
to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within
the time periods specified in SEC rules and forms, and is accumulated and communicated to our management, including our principal executive
officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Inherent
Limitations on Effectiveness of Controls
Even
assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial
officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error
or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the
control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that
our control system’s objective will be met, and our principal executive officer and principal financial officer have concluded that
our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the
fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of
the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error
or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error
or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management
override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future
events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become
inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes
in Internal Control Over Financial Reporting
There
has been no change in our internal control over financial reporting that occurred during the fiscal quarter covered by this Quarterly
Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
26
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
The
information required by this item is incorporated by reference from Part I, Item 1. Financial Statements, Notes to Condensed Consolidated
Financial Statements, Note 13.
ITEM
1A. RISK FACTORS.
Except
as noted below, there have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended
December 31, 2025.
The
following risk factor is provided as an update to our previously disclosed risk factors:
Changes
in U.S. Trade Policies and Other Geopolitical Events Could Adversely Affect Our Operations
Ongoing
uncertainty around U.S. trade policies, tariffs, and international agreements may impact the cost and availability of materials, supplies,
and equipment used in the Company’s operations or those of the Company’s partners. Any disruptions or increased costs resulting from these changes could
negatively affect the Company’s business, financial condition, results of operations, and the market price of the Company’s common stock.
In
addition, ongoing international conflicts (including military conflicts between Russia and Ukraine and in the Middle East) have created
volatility in the global capital markets and may have further global economic consequences, including disruptions of the supply chain.
Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
2025
Financing
During
the three months ended June 30, 2026, the Company received 2025 Notes proceeds in the aggregate amount of $1,360,000, of which $1,245,000
was from non-related parties, $100,000 was received from a shareholder considered a related party due to beneficial ownership exceeding
10% of the Company’s outstanding voting securities, and $15,000 was from an officer and director of the Company.
During
the six months ended June 30, 2026, the Company received 2025 Notes proceeds in the aggregate amount of $1,695,000, of which $1,355,000
was from non-related parties, $100,000 was received from a shareholder considered a related party due to beneficial ownership exceeding
10% of the Company’s outstanding voting securities, and $240,000 was from an officer and director of the Company.
Preferred
Convertible Stock
During
the three months ended June 30, 2026, the Company issued 203,859 shares of restricted Series D-1 Convertible Preferred Stock upon the
conversion of $540,000 of principal and $43,434 accrued interest, outstanding on the Company’s convertible notes.
During the three and six months ended June 30,
2026, the Company issued 189,554 shares of Series D-1 Convertible Preferred Stock for accrued directors’ fees of $542,501 at a
stock price of $2.862.
The
Company believes that such transactions were exempt from the registration requirements of the Securities Act of 1933, as amended, (the
“Securities Act”), in reliance on Section 4(a)(2) of the Securities Act (or Rule 506(b) of Regulation D promulgated thereunder)
as transactions by an issuer not involving a public offering.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. Mine Safety Disclosures.
Not
applicable.
ITEM
5. OTHER INFORMATION.
None.
27
ITEM
6. EXHIBITS.
Exhibit
No.
Description
31.1*
Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
31.2*
Certification of Principal Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification).
32**
Certification of Principal Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification).
101.INS*
Inline
XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded
within the Inline XBRL document.
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
104*
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed herewith.
**
Furnished herewith.
28
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
PROVECTUS
BIOPHARMACEUTICALS, INC.
August
13, 2026
By:
/s/
Dominic Rodrigues
Dominic
Rodrigues
President
(Principal Executive Officer)
By:
/s/
Heather Raines
Heather
Raines, CPA
Chief
Financial Officer (Principal Financial Officer)
29
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.