PVCT 10-K & 10-Q changes, risk factors and insider trading

The Company’s cash balance was $489,726$251,291 at December 31, 2024,2025. whichCash includes $182,284 of restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficiency was $5,998,712 and $7,652,098balances as of December 31, 2024 included $182,284 of restricted cash associated with a grant received from the State of Tennessee. There was no restricted cash associated with the grant received from the State of Tennessee as of December 31, 2025 due to the completion of the grant award program during 2025. The Company’s working capital deficit was $6,329,503 and 2023,$5,998,712 as of December 31, 2025 and 2024, respectively. The Company continues to incur significant operating losses and management expects that significant on-going operating expenditures will be necessary to successfully implement our business plan and develop and market our products. These circumstances raise substantial doubt about our ability to continue as a going concern for a period of one year from the date that the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued. Implementation of our plans and our ability to continue as a going concern will depend upon our ability to develop our prescription drug candidates and prescription drug formulation candidates, and to raise additional capital.

Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexitycomplexity, and novelty of the product candidatecandidate, and requires substantial resources for research, development, and testing. We cannot predict whether our research and clinical approaches will result in drugs that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the drug approval process and may require us to conduct additional nonclinical and clinical testing or to perform post-marketing studies. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may delay commercialization of, and our ability to derive revenues from our prescription drug candidates, impose costly procedures on us, and diminish any competitive advantages that we may otherwise enjoy.

Because we expect sales or licensure of our prescription drug candidates, if approved,candidates to generate substantially all of our revenues if they are approved, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional financing.

The Company is selectively continuing ongoing and planning to initiate new monotherapy and/or combination therapy ITU PV-10 clinical trials inof melanomasolid and livertumor 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.

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 representinclude costs incurred toin conductconnection with research activities and undertakethe clinical clinicaldevelopment trials to developof our drug product candidates. These expenses consist primarily of:

General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits, and stock-based compensationcompensation, expensefor employees engaged in executive and otherfinance relatedfunctions. costs for personnel in executive, finance, accounting, business development, legal, information technologyGeneral and corporateadministrative communicationexpenses functions.also Other costs include facility facility-related costs not otherwise included in research and development expenses, insurance,director fees, insurance costs, and professional fees for legal, patentpatent, accounting, information technology, corporate communications, and accountingother services.consulting services provided by third-party firms.

For the years ended December 31, 20242025 and 2023,2024, there was $617,140$336,108 and $557,710$617,140 respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development on the consolidated statements of operations. The decrease of $281,032 or 45.5% was primarily attributable to the completion and full recognition of grant revenue under the awarded program in 2025.

Research and development tax credits in Australia were $9,320 for the year ended December 31, 2024, a decrease of $6,376 or 40.6%, compared to $15,696$0 for the year ended December 31, 2023.2025, compared to $9,320 for the year ended December 31, 2024. The decrease was mainly dueattributable to nothe absence of active clinical trials currently in Australia.Australia during the current period.

Interest expense increaseddecreased by $22,859$28,714, fromor $216,21412.0%, to $210,359 for the year ended December 31, 20232025, tofrom $239,073 for the year ended December 31, 2024. The increase decrease was dueprimarily attributable to the issuance of new 2022 and 2024 Notes, partially offset by the impact of the conversion of the 20212022 and 20222024 Notes into shares of Series D-1 Preferred Stock.Stock resulting in lower debt balances during the 2025 period.

OurThe cash, and restricted cash were $489,726 at December 31, 2024, which includes the $182,284 of restricted cash associated with the grant received from the State of Tennessee. The consolidated financial statements and notes thereto included in this Annual Report on Form 10-K 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. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $257,422,961$262,853,811 as of December 31, 2024.2025. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date that the consolidated financial statements included elsewhere in this Annual Report on Form 10-K are issued. Our consolidated 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.

As of December 31, 2024,2025, cash requirements for our current liabilities include approximately $3,307,226$3,925,681 for accounts payable and other accrued expenses (including lease liabilities) and a $206,463$217,772 note payable related to our short-term financing of our commercial insurance insurancepolicies policies.and purchased software. Also, ifa notrelated convertedparty priorconvertible tonote maturity,payable in the amount of $100,000 plus approximately $59,444 of related interest is past due. Additional related and non-related convertible debt in the amount of $2,953,000$2,510,000 plus $172,687$107,824 of accrued accrued interest will mature one year from the date of the notes.notes Theif 2024not Notesconverted are only subjectprior 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.maturity.

We experienced negative cash flows from operating activities for the years ended December 31, 20242025 and 20232024 in the amounts of $3,325,991 $3,284,091 and $2,571,978,$3,284,091, respectively. The net cash used in operating activities for the year ended December 31, 20242025 was primarily due to cash used to fund a net loss of $4,762,137,$5,505,123, adjusted for non-cash items in the aggregate amount of $1,335,335,$1,287,537 mainly driven by stock-based compensation, plus $156,942$891,595 of cash generated from changes in the levels of operating assets and liabilities. The net cash used in operating activities for the year ended December 31, 20232024 was primarily due to cash used to fund a net loss of $3,101,768,$4,762,137, adjusted for non-cash expenses in the aggregate amount of $56,868, $1,335,335 mainly driven by stock-based compensation, plus $472,922$142,711 of cash generated from changes in the levels of operating assets and liabilities.

Net cash provided by financing activities during the years ended December 31, 2025 and 2024 and 2023 was $2,733,158$3,087,006 and $2,191,555,$2,747,865, respectively. During the year ended December 31, 2025, we received $2,510,000 proceeds from the issuance of convertible notes payable, $850,000 from the issuance of common stock of our majority-owned subsidiary, VisiRose, and offset by $272,994 for the repayment of the short-term note payable. During the year ended December 31, 2024, we received $2,853,000 proceeds from the issuance of convertible notes payable,payable and received $300,000 from the issuance of common stock of our majority-owned subsidiary, VisiRose, andVisiRose. These cash proceeds were offset by the $305,135 repayment of a short-term note payable, and the $100,000 repayment of a 2021 convertible note payable and $305,135 for repayment of the short-term note payable. During the year ended December 31, 2023, we received $2,475,000 proceeds from the issuance of convertible notes payable and paid $283,445 for the repayment of the short-term note payable.

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 consolidated financial statements that require estimation but are not deemed critical, as defined above.

Ongoing uncertainty around U.S. trade policies, tariffs, and international agreements may impact the cost and availability of materials, supplies, and equipment used in ourthe Company’s operations or those of ourthe Company’s partners. Any disruptions or increased costs resulting from these changes could negatively affect ourthe Company’s business, financial condition, results of operations, and the market price of ourthe Company’s common stock.

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 clinicclinical 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 clinicclinical 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’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice practice (“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use.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.

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 extentextent, we will generate revenue from any subsequent commercialization and sale of our drug candidates.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025

The Company’s net loss increaseddecreased by $139,347$863,365 or 12.0%46.6% for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025, primarily as the result of a decrease in grant revenue and a decrease in operating expenses, described below.

Grant revenue recognized during the three months ended MarchJune 31,30, 2026 was $0, compared to $278,628$57,480 for the same period in 2025, representing a decrease of $278,628,$57,480, or 100.0%. The decrease was attributable to the completion and full recognition of grant revenue in 2025 under the awarded program.

The following table summarizes research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025.

Research and development expenses were $333,334$131,130 for the three months ended March 31,June 30, 2026, a decrease of $69,370,$749,705, or 17.2%,85.1%, compared to $402,704 $880,835 for the same period in 2025. The decrease occurred despite the addition of a new drug candidate and 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. These decreases were partially offset by higher travel and entertainment expenses related to meetings with the University of Miami and Bascom Palmer.

The following table summarizes general and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025.

General and administrative expenses were $914,569$807,548 for the three months ended MarchJune 31,30, 2026, a decrease of $59,296,$169,825, or 6.1%,17.4%, compared to $973,865$977,373 for the same period in 2025. The decrease was primarily attributable to lower professional fees related to timing of accounting servicesservices, 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 from stock options granted in December 2025, as well as a one time donation in 2025.period. These decreases were partially offset by higher legalinsurance fees related to patents,expenses, higher other general and administrative expenses due to renewal of software licenses and higher insurancetravel and entertainment expenses compared to the same period in 2025.

Other Income/(Expense)

InterestOther expenseincome was $53,046$281 for the three months ended MarchJune 31,30, 2026, compared to $63,661$0 for the same period in 2025, representing aan decrease increase of $10,615, $281, or 16.7%.100.0%. The decreaseincrease was primarily attributabledue to lowera outstanding balances of convertible debtresearch and notesdevelopment payabletax during thecredit 2026refund period.received in Australia.

The Company’s cash was $223,883$1,156,915 at MarchJune 31,30, 2026, compared to $251,291 at December 31, 2025. The Company’s working capital deficit deficit was $6,781,376$6,338,261 and $6,329,504 as of MarchJune 31,30, 2026 and December 31, 2025, respectively. We have continuing net losses and negative cash cash flows from operating activities. In addition, we have an accumulated deficit of $264,144,266$265,126,832 as of MarchJune 31,30, 2026. These conditions raise 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 statements included elsewhere in this Quarterly Report on Form 10-Q are issued. The condensed consolidated financial statements and notes thereto 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.

As of MarchJune 31,30, 2026, cash requirements for our current liabilities include approximately $4,432,651$4,141,079 for accounts payable and other accrued expenses (including lease liabilities) and $161,265$92,443 for notes payable related to our financing of our commercial insurance policies and and software license. Principal and interest in the aggregate amount of $2,647,845$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 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 financings.

Management plans to access capital resources through possible public or private equity offerings and/ or debt offerings, including the 2025 Financing, 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.