PROVECTUS BIOPHARMACEUTICALS, INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
PVCT$0.07+3.6%Stored close · as of Jun 30, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001641172-25-023864
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022229
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 88 previous paragraphs and 88 current paragraphs.
69 unchanged; 13 reworded; 6 added; 6 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Grant revenue recognized during the three months ended September 30, 2025 was $0, compared to $109,745 for the same period in 2024, representing a decrease of $109,745, or 100.0%. The decrease was primarily attributable to the completion and full recognition of grant revenue under the awarded program*.*
Current report
General and administrative expenses were $929,746 for the three months ended September 30, 2025, an increase of $278,260, or 42.7%, compared to $651,486 for the same period in 2024. The increase was primarily attributable to stock-based compensation expense recognized during the current period from stock options granted in December 2024, as well as higher payroll and related taxes, and increases in other general and administrative costs, which were largely related to late fees on invoices. These increases were partially offset by lower legal fees related to patents, professional fees, and insurance costs compared to the prior-year period.
Current report
Interest expense was $48,022 for the three months ended September 30, 2025, compared to $58,679 for the same period in 2024, representing a decrease of $10,657, or 18.2%. The decrease was primarily attributable to lower outstanding balances of convertible debt and notes payable during the 2025 period.
Current report
Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024
Current report
Research and development expenses were $1,628,848 for the nine months ended September 30, 2025, an increase of $186,399, or 12.9%, compared to $1,442,449 for the same period in 2024. The increase was primarily driven by higher clinical trial and research expenses related to ongoing manufacturing and development activities for a new drug candidate, as well as a rise in payroll and taxes and stock-based compensation reflecting higher personnel costs. These increases were partially offset by a decrease in insurance expense and the absence of depreciation and amortization expense recognized in the prior-year period, as the result of assets being fully depreciated.
Current report
**Interest expense was $163,036 for the nine months ended September 30, 2025, compared to $176,751 for the same period in 2024, representing a decrease of $13,715, or 7.8%. The decrease was primarily attributable to lower outstanding balances of convertible debt and notes payable during the 2025 period.
Removed paragraphs (6)
Previous report
Grant revenue recognized during the three months ended June 30, 2025, was $57,480, compared to $254,991 for the same period in 2024, representing a decrease of $197,511, or 77.5%. The decrease was primarily due to lower qualifying research and development expenses eligible for reimbursement under the grant.
Previous report
General and administrative expenses were $990,863 for the three months ended June 30, 2025, compared to $576,918 for the three months ended June 30, 2024, reflecting an increase of $413,945 or 71.8%. The increase was primarily due to (i) higher payroll expenses and associated taxes resulting primarily from the addition of two officers hired in April 2024, (ii) increased professional fees related to the annual shareholders meeting, and (iii) higher stock-based compensation from stock options granted in December 2024.
Previous report
Interest expense decreased by $9,942 or 16.2% from $61,295 for the three months ended June 30, 2024 to $51,353 for the three months ended June 30, 2025, primarily as the result of lower convertible debt and notes payable balances outstanding during the period.
Previous report
Comparison of the Six Months Ended June 30, 2025 and June 30, 2024
Previous report
Research and development expenses were $1,256,155 for the six months ended June 30, 2025, representing an increase of $227,693, or 22.1%, compared to $1,028,462 for the same period in 2024. The increase was primarily driven by higher clinical trial and research costs related to the manufacturing of a new drug.
Previous report
Interest expense decreased by $3,058 or 2.6% from $118,072 for the six months ended June 30, 2024 to $115,014 for the six months ended June 30, 2025, primarily as the result of lower convertible debt and notes payable balances outstanding during the period.
Reworded paragraphs (13)
Previous wording
The Company is selectively continuing ongoing and planning to initiate new monotherapy and combination therapy ITU 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 ITU 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 ITU PV-10 based on these indications and data.
Current wording
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.
Previous wording
The Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and ITU 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 ITU 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).
Current wording
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).
Previous wording
The Company’s net loss increased by $1,005,233 for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, primarily as the result of a decrease in grant revenue and an increase in operating expenses, described below.
Current wording
The Company’s net loss increased by $309,278 for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024, primarily as the result of a decrease in grant revenue and an increase in operating expenses, described below.
Previous wording
Research and development expenses were $867,345 for the three months ended June 30, 2025, an increase of $394,418, or 83.4%, compared to $472,927 for the same period in 2024. The increase was primarily driven by higher clinical trial and research expenses related to the manufacturing of a new drug.
Current wording
Research and development expenses were $345,861 for the three months ended September 30, 2025, representing a decrease of $68,126, or 16.5%, compared to $413,987 for the same period in 2024. The decrease was primarily driven by lower clinical trial and research expenses, reflecting reduced costs related to the manufacturing of a new drug, as well as a decline in insurance expense.
Previous wording
Research and development tax credit in Australia decreased by $9,301 or 100.0% from $9,301 for the three months ended June 30, 2024 to $0 for the three months ended June 30, 2025. The decrease was due to the absence of active clinical trials in Australia during the 2025 period.
Current wording
The research and development tax credit in Australia decreased to $0 for the three months ended September 30, 2025, compared to $56 for the same period in 2024, a decrease of $56, or 100.0%. The decrease was due to the absence of active clinical trial activities in Australia during the 2025 period.
Previous wording
The Company’s net loss increased by $1,662,793 or 123.1% for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024, primarily due to a decline in grant revenue and higher operating expenses, as described below.
Current wording
The Company’s net loss increased by $1,972,071 or 83.4% for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024, primarily due to a decline in grant revenue and higher operating expenses, as described below.
Previous wording
Grant revenue was $336,108 for the six months ended June 30, 2025, compared to $493,063 for the six months ended June 30, 2024, representing a decrease of $156,955 or 31.8%. The decrease was primarily due to lower qualifying research and development expenses eligible for reimbursement under the grant.
Current wording
Grant revenue was $336,108 for the nine months ended September 30, 2025, compared to $602,808 for the same period in 2024, representing a decrease of $266,700, or 44.2%. The decrease was primarily attributable to the completion and full recognition of grant revenue under the awarded program through June 30, 2025.
Previous wording
The following table summarizes research and development expenses for the six months ended June 30, 2025 and 2024.
Current wording
The following table summarizes research and development expenses for the nine months ended September 30, 2025 and 2024.
Previous wording
General and administrative expenses were $1,978,622 for the six months ended June 30, 2025, compared to $706,720 for the six months ended June 30, 2024, representing an increase of $1,271,902, or 180.0%. The increase was primarily attributable to (i) higher directors’ fees in 2025, driven by the reversal of $469,000 previously accrued director fees for Mr. Bruce Horowitz, our former COO, following his resignation on March 25, 2024, (ii) increased professional fees related to audit and accounting fees, (iii) higher payroll and payroll taxes resulting from the addition of two new officers in April 2024, (iv) increased donations due to a contribution made to the University of Miami by the Company’s majority-owned subsidiary, VisiRose, and (v) higher stock-based compensation from stock options granted in December 2024. These increases were partially offset by (vi) lower insurance costs following a change in insurance carrier and (vii) reduced legal costs associated with patents.
Current wording
General and administrative expenses were $2,881,536 for the nine months ended September 30, 2025, an increase of $1,523,330, or 112.2%, compared to $1,358,206 for the same period in 2024. The increase was primarily attributable to stock-based compensation expense recognized during the current period from stock options granted in December 2024, as well as higher directors’ fees driven by the reversal of $450,000 previously accrued director fees for Mr. Bruce Horowitz, our former COO, following his resignation on March 25, 2024, higher payroll and payroll taxes resulting from the addition of two new officers in April 2024, and other general and administrative costs, which were largely related to late fees on invoices. Additional increases included donations that were not incurred in the prior year. These increases were partially offset by lower legal fees related to patents and insurance expenses compared to the same period in 2024.
Previous wording
The following table summarizes general and administrative expenses for the six months ended June 30, 2025 and 2024.
Current wording
The following table summarizes general and administrative expenses for the nine months ended September 30, 2025 and 2024.
Previous wording
Research and development tax credit in Australia decreased by $9,301 or 100.0% from $9,301 for the six months ended June 30, 2024 to $0 for the six months ended June 30, 2025. The decrease was due to the absence of active clinical trials in Australia during the 2025 period.
Current wording
The research and development tax credit in Australia decreased to $0 for the nine months ended September 30, 2025, compared to $9,357 for the same period in 2024, a decrease of $9,357, or 100.0%. The decrease was due to the absence of active clinical trial activities in Australia during the 2025 period.
Previous wording
The Company’s cash and restricted cash were $416,471 at June 30, 2025, which includes $30,542 of restricted cash resulting from a grant received from the State of Tennessee, compared to $489,726 at December 31, 2024, which included $182,284 of restricted cash. The Company’s working capital deficit was $5,924,919 and $5,998,712 as of June 30, 2025 and December 31, 2024, respectively. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $260,377,489 as of June 30, 2025. 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.
Current wording
The Company’s cash and restricted cash were $72,479 at September 30, 2025, compared to $489,726 at December 31, 2024, which included $182,284 of restricted cash. The Company’s working capital deficit was $6,193,668 and $5,998,712 as of September 30, 2025 and December 31, 2024, respectively. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $261,688,770 as of September 30, 2025. 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.
Previous wording
As of June 30, 2025, cash requirements for our current liabilities include approximately $3,980,690 for accounts payable and other accrued expenses (including lease liabilities) and $54,337 for a note payable related to our short-term financing of our commercial insurance policies. Also, if not converted prior to maturity, convertible debt in the amount of $2,310,000 plus $148,212 of accrued interest will mature one year from the date of the notes. The 2021, 2024, and 2025 Notes are only subject to repayment in the event of a change of control or event of default. The Company intends to meet these cash requirements from its current cash balance and from future financing.
Current wording
As of September 30, 2025, cash requirements for our current liabilities include approximately $4,049,213 for accounts payable and other accrued expenses (including lease liabilities) and $105,860 for a note payable related to our financing of our commercial insurance policies and purchased software. Principal and interest in the aggregate amount of $2,316,583 owed in connection with 2021, 2024, and 2025 Notes convert automatically 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 financing.