What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-26 compared with 2025-03-28 · 93 added, 82 removed, 212 unchanged (45% of the section changed)

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indicative of future operations.

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

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

of solid tumor 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.

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and Development Expenses

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 product candidates.

Research and development expenses include costs incurred in connection with research activities and the clinical

development of our product candidates.

These expenses consist primarily of:

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and Administrative Expenses

and administrative expenses consist primarily of salaries, stock-based compensation expense and other related costs for personnel in

executive, finance, accounting, business development, legal, information technology and corporate communication functions.

include facility costs not otherwise included in research and development expenses, insurance, and professional fees for legal, patent

and accounting services.

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.

of the Years Ended December 31, 2025 and 2024

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$ (4,732,552 )

$ (1,630,784 )

the years ended December 31, 2025 and 2024, there was $336,108 and $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.

and Development

Research and development expenses were $1,999,127 for the year ended December

31, 2024, an increase of $249,887 or 14.3% compared to $1,749,240 for the year ended December 31, 2023.

The increase was due to (i) higher

clinical trial costs associated with closing out open trials, (ii) slightly higher rent expense, partially offset by iii) lower depreciation

expense, iv) lower insurance cost, and v) lower payroll taxes and vacation expense.

and development expenses decreased by $153,387, or 7.5%, to $1,897,276 for the year ended December 31, 2025, from $2,050,663 for the

year ended December 31, 2024.

The decrease was primarily attributable to lower clinical trial and research-related costs following

the closure of certain studies.

The decrease was also driven by reduced depreciation expense as certain assets became fully

depreciated during the period.

In addition, insurance expense declined as a result of a change in insurance carriers, and

facility-related costs, including rent and utilities, were lower compared to the prior year and write-off of old accounts payable.

These decreases were partially offset by higher stock-based compensation expense and increased payroll-related costs.

following table summarizes our research and development expenses incurred during the years ended December 31, 2025 and 2024:

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Payroll and taxes

Stock-based compensation

Rent and utilities

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and Administrative

General and administrative expenses were $3,150,397 for the year ended

December 31, 2024, an increase of $1,440,677 or 84.3% compared to $1,709,720 for the year ended December 31, 2023.

The increase was due

to (i) stock-based compensation for vested options granted to company executives, employee and independent board members, (ii) higher

legal costs relating to patent application and general business fees, (iii) increased payroll expense due to hiring two executives, (iv)

increased professional fees related to investor relations, (v) higher other general and administrative costs due to a refund received

in 2023 for employee retention, and (vi) unfavorable foreign currency translation cost, partially offset by (vii) reversal of director

Horowitz as he waived these fees upon his resignation on March 25, 2024, and (viii) lower insurance costs.

and administrative expenses increased by $634,736, or 20.5%, to $3,733,597 for the year ended December 31, 2025, from $3,098,861 for

the year ended December 31, 2024.

The increase in general and administrative expenses was primarily attributable to higher directors’

fees resulting from the reversal of previously waived director fees for Mr.

Horowitz following his resignation on March 25, 2024, as

well as increased payroll-related expenses associated with the appointment of new officers in April 2024.

General and administrative

expenses also increased due to a donation made to the University of Miami, higher professional fees primarily related to audit services,

increased travel and entertainment expenses associated with investor meetings, and additional costs related to the implementation of

NetSuite during 2025.

These increases were partially offset by lower insurance costs resulting from a change in insurance carriers, reduced

legal fees related to patent matters, and lower stock-based compensation expense primarily due to equity awards granted to two independent

directors in 2024 that did not recur in 2025, with equity awards in 2025 limited to executives and employees.

following table summarizes our general and administrative expenses incurred during the years ended December 31, 2025 and 2024:

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Stock based compensation

Travel and entertainment

Foreign currency translation

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Income/(Expense)

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 for the year ended December 31, 2023.

The decrease was mainly

due to no active clinical trials currently in Australia.

expense increased by $22,859 from $216,214 for the year ended December 31, 2023 to $239,073 for the year ended December 31, 2024.

increase was due to the issuance of new 2022 and 2024 Notes, partially offset by the impact of the conversion of the 2021 and 2022 Notes

into shares of Series D-1 Preferred Stock.

and development tax credits in Australia were $0 for the year ended December 31, 2025, compared to $9,320 for the year ended December

The decrease was attributable to the absence of active clinical trials in Australia during the current period.

expense decreased by $28,714, or 12.0%, to $210,359 for the year ended December 31, 2025, from $239,073 for the year ended December 31,

The decrease was primarily attributable to the conversion of the 2022 and 2024 Notes into shares of Series D-1 Preferred Stock

resulting in lower debt balances during the 2025 period.

following table summarizes our Other Income/(Expenses) incurred during the years ended December 31, 2025 and 2024:

For the Years Ended

Increase/(Decrease)

Other Income/Expense):

Research and development tax credit

Interest expense, net

Interest expense

Total Other Income/(Expense), Net

and Going Concern

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 as of December 31, 2024.

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 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.

cash was $251,291 at December 31, 2025, compared to $489,726 at December 31, 2024.

Cash balances 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

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 $262,853,811 as of December

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.

plans include selling our equity securities and obtaining other financing to fund our capital requirements and on-going operations, including

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be needed to continue and complete our ongoing and planned clinical trials.

of December 31, 2024, cash requirements for our current liabilities include approximately $3,307,226 for accounts payable and

accrued expenses (including lease liabilities) and a $206,463 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 $2,953,000 plus $172,687 of accrued

interest will mature one year from the date of the notes.

The 2024 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

of December 31, 2025, cash requirements for our current liabilities include approximately $3,925,681 for accounts payable and other

accrued expenses (including lease liabilities) and a $217,772 note payable related to our financing of our commercial insurance

policies and purchased software.

Also, a related party convertible note 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 $2,510,000 plus $107,824 of

accrued interest will mature one year from the date of the notes if not converted prior to maturity.

plans to access capital resources through possible public or private equity offerings, including the 2025 Financing, exchange offers,

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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

In addition, any such financing may result in significant dilution to stockholders.

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.

the years ended December 31, 2025 and 2024, our sources and uses of cash were as follows:

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$3,325,991 and $3,284,091, respectively.

The net cash used in operating activities for the year ended December 31, 2024 was primarily due to cash

used to fund a net loss of $4,762,137, adjusted for non-cash items in the aggregate amount of $1,335,335, plus $156,942 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, 2023 was primarily due to cash used to fund a net loss of $3,101,768, adjusted for non-cash expenses in the aggregate amount of $56,868,

The net cash used in operating activities for the year ended December 31, 2025 was

primarily due to cash used to fund a net loss of $5,505,123, adjusted for non-cash items in the aggregate amount of $1,287,537 mainly driven by stock-based compensation,

plus $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, 2024 was primarily due to cash used to fund a net loss of $4,762,137, adjusted for

non-cash expenses in the aggregate amount of $1,335,335 mainly driven by stock-based compensation, plus $142,711 of cash generated from changes in the levels of operating

assets and liabilities.

Cash Provided by Financing Activities

Net cash provided by financing activities during the years ended December

31, 2024 and 2023 was $2,733,158 and $2,191,555, respectively.

During the year ended December 31, 2024, we received $2,853,000 proceeds

from the issuance of convertible notes payable, $300,000 from the issuance of common stock of our majority-owned subsidiary, VisiRose,

and offset by $100,000 repayment of a 2021 convertible note payable and $305,135 for repayment of the short-term note payable.

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.

cash provided by financing activities during the years ended December 31, 2025 and 2024 was $3,087,006 and $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 and received

$300,000 from the issuance of common stock of our majority-owned subsidiary, VisiRose.

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.

Accounting Estimates

prepare our 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

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.

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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.

There are items within our consolidated financial statements that require estimation

but are not deemed critical, as defined above.

AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis