What changed in this filing

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Item 8. Financial Statements and Supplementary Data

2025-03-28 compared with 2024-03-28 · 558 added, 438 removed, 581 unchanged (63% of the section changed)

3 unchanged sentences

Consolidated Balance Sheets as of December 31, 2024 and 2023

Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022

Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2023 and 2022

Consolidated Statements of Changes In Stockholders’ Deficit for the Years Ended December 31, 2023 and 2022

Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022

Statements of Operations for the Years Ended December 31, 2024 and 2023

Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023

Statements of Changes In Stockholders’ Deficit for the Years Ended December 31, 2024 and 2023

Statements of Cash Flows for the Years Ended December 31, 2024 and 2023

Notes to Consolidated Financial Statements

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have audited the accompanying consolidated balance sheets of Provectus Biopharmaceuticals, Inc.

(the “Company”) as of December

31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ deficit, and

cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial

statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the

Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period

ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

(the “Company”) as of

December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive loss, changes in stockholders’

deficit, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively

referred to as the “financial statements”).

In our opinion, based on our audits, the financial statements present

fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its

operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting

principles generally accepted in the United States of America.

Paragraph – Going Concern

accompanying financial statements have been prepared assuming that the Company will continue as a going concern.

As more fully described

in Note 2, the Company has a working capital deficit, has incurred losses from operations, and needs to raise additional funds to meet

its obligations and sustain its operations.

These conditions raise substantial doubt about the Company’s ability to continue as

a going concern.

Management’s plans in regard to these matters are also described in Note 2.

The financial statements do not include

any adjustments that might result from the outcome of this uncertainty.

As more fully

described in Note 2, the Company has a significant working capital deficit, has incurred significant losses and

needs to raise additional funds to meet its obligations and sustain its operations.

These conditions raise substantial doubt about

the Company’s ability to continue as a going concern.

Management’s plans in regard to these matters are also described

The financial statements do not include any adjustments that might result from the outcome of this

financial statements are the responsibility of the Company’s management.

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Accrued interest - related parties

Accrued interest

Notes payable

1 unchanged sentence

Convertible notes payable - related parties

Convertible notes payable

Operating lease liability, current portion

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Stockholders’ Deficit:

P referred stock;

par value $ 0.001

Preferred stock;

par value $ 0.001 per share;

25,000,000 shares authorized;

Series D Convertible Preferred Stock;

shares designated;

12,373,247 shares issued and outstanding at December 31, 2023 and 2022;

aggregate liquidation preference of $ 14,164,889

at December 31, 2023 and 2022

957,100 and 12,374,000 shares designated at December 31, 2024 and 2023, respectively;

956,985 and 12,373,247 shares issued and outstanding at December 31, 2024 and 2023, respectively;

aggregate liquidation preference of $ 1,095,556 and $ 14,164,889 at December 31, 2024 and 2023, respectively

Series D-1 Convertible Preferred Stock;

11,241,000 shares designated;

10,361,097 and 9,746,626

shares issued and outstanding at December 31, 2023 and 2022, respectively;

aggregate liquidation preference of $ 118,613,136 and $ 111,578,880

at December 31, 2023 and 2022, respectively

23,042,900 and 11,241,000 shares designated at December

31, 2024 and 2023, respectively;

13,106,223 and 10,361,097 shares issued and outstanding at December 31, 2024 and 2023, respectively;

aggregate liquidation preference of $ 150,040,045 and $ 118,613,136 at December 31, 2024 and 2023, respectively

Preferred stock, value

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1,000,000,000 shares authorized;

419,522,119 and 419,447,119

shares issued and outstanding at December 31, 2023 and 2022, respectively

420,279,879 and 419,522,119 shares issued and

outstanding at December 31, 2024 and 2023

Additional paid-in capital

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( 252,690,409 )

Total stockholders’ deficit attributable to Provectus Biopharmaceuticals,

( 5,959,332 )

( 7,593,351 )

Non-controlling interest

Total Stockholders’ Deficit

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Research and development tax credit

Interest expense, net

Total Other Expense, Net

Interest expense

Total Other Income (Expense), Net

( 4,762,137 )

( 3,101,768 )

Net loss attributable to noncontrolling interest

Net loss attributable to Provectus Biopharmaceuticals, Inc.

$ ( 4,732,552 )

$ ( 3,101,768 )

Basic and Diluted Loss Per Common Share

Weighted Average Number of Common Shares Outstanding - Basic and Diluted

Weighted Average Number of Common

Shares Outstanding - Basic and Diluted

accompanying notes to consolidated financial statements.

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Foreign currency translation adjustments

Total Comprehensive Loss

Comprehensive loss

( 4,762,713 )

( 3,126,254 )

Comprehensive loss attributed to non-controlling interest

Comprehensive loss attributed to controlling interests

$ ( 4,733,128 )

$ ( 3,126,254 )

accompanying notes to consolidated financial statements.

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Comprehensive

Noncontrolling

Balance at January 1, 2023

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$ ( 6,228,510 )

Series D-1 Preferred Stock issued for cash

Stock-based compensation:

Conversion of 2021 Notes to Series D-1 Preferred Stock

Conversion of 2022 Notes to Series D-1 Preferred Stock

Comprehensive loss:

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( 252,690,409 )

( 7,593,351 )

Forfeited shares of Series D Preferred Stock

( 11,416,262 )

Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred

Issuance of common stock of majority-owned subsidiary

Stock-based compensation:

Conversion of 2021 Notes to Series D-1 Preferred Stock

Conversion of accrued directors’ fees to Series D-1 Preferred Stock

Conversion of 2022 Notes to Series D-1 Preferred Stock

Conversion of Series D-1 Preferred Stock to Common Stock

Comprehensive loss:

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Stock-based compensation

Non-cash lease expense

Non-cash operating lease expense

Changes in operating assets and liabilities

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Accrued interest

Net Cash Used In Operating Activities

Cash Used In Operating Activities

( 3,284,091 )

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Proceeds from issuance of convertible notes payable

Proceeds from issuance of convertible notes payable - related parties

Proceeds from issuance of convertible notes payable - related party

Proceeds from issuance of common stock of majority-owned subsidiary

Repayment of short-term note payable

Net Cash Provided By Financing Activities

Effect of exchange rates on cash and restricted cash

Net Decrease In Cash and Restricted Cash

( 1,675,235 )

Repayment of 2021 convertible note payable - related party

Cash Provided By Financing Activities

of exchange rates on cash and restricted cash

Decrease In Cash and Restricted Cash

Cash and Restricted Cash, Beginning of Period

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Non-cash investing and financing activities:

Deposit applied to equity issuances

$ ( 150,000 )

Right-of-use assets obtained in exchange for operating lease liabilities

Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock

Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock

Conversion of accrued directors’ fees to Series D-1 Preferred Stock

Conversion of Series D-1 Preferred Stock to common stock

Forfeited shares of Series D Preferred Stock

Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock

Issuance of common stock of majority-owned subsidiary

Purchase of insurance policies financed by short-term note payable

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Business Organization and Nature of Operations

Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiary Provectus Biopharmaceuticals Australia Pty Ltd,

“Provectus” or “the Company”), is a clinical-stage biotechnology company developing immunotherapy medicines

for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes

Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”),

is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases based on a class of bioactive synthetic

small molecule halogenated xanthenes (“HXs”).

Our lead HX molecule is named rose bengal sodium (“RBS”).

Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient in the drug product candidates

of our current clinical development programs and the preclinical formulations of our current drug discovery programs.

Importantly, our

pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different

routes of administration.

Company believes that RBS targets disease in a bifunctional manner.

First, direct contact may lead to cell death or repair, depending

on the disease being treated and the concentration of the RBS utilized in the treatment.

Second, multivariate immune signaling, activation,

and response may follow that may manifest as stimulatory, inhibitory, or both.

Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug

candidates of our current clinical development programs and the formulations of our current non-clinical in vivo proof-of-concept

and in vitro early discovery programs.

Importantly, our pharmaceutical-grade RBS displays different therapeutic effects at different

concentrations and can be formulated for delivery by different routes of administration.

Company believes that RBS targets disease in a bifunctional multi-modal manner.

Direct contact by RBS with disease may lead to cell death

or repair, depending on the disease being treated and the concentration of RBS being utilized in the therapeutic formulation, by one

or more targeting mechanisms.

Multivariate innate and adaptive immune activation, signaling, and response may follow that may manifest

as stimulatory, inhibitory, or both.

Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such

as those trials reported on the clinical trials registry at ClinicalTrials.gov.

Company believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently

at a purity of nearly 100%.

Company’s small molecule HX medical science platform comprises several different drug product candidates and preclinical pharmaceutical-grade

RBS formulations using different concentrations delivered by different routes of administration specific to each disease area and/or

The Company’s HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology;

in vivo proof-of-concept programs in oncology, hematology, wound healing, and animal health;

and in vitro drug discovery

programs in infectious diseases and tissue regeneration and repair.

The Company believes that it is the first and only entity

to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%.

Company’s small molecule platform comprises several different drug candidates and non-clinical targets using different concentrations

delivered by different routes of administration specific to each disease area and/or disease indication, including:

development programs in oncology (intratumoral administration), dermatology (topical), and ophthalmology (topical),

Proof-of-concept programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral),

Early discovery programs in infectious diseases and tissue regeneration and repair.

and Uncertainties

date, the Company has not generated any revenues or profits from planned principal operations.

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.

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.

Liquidity and Going Concern

Company’s cash and restricted cash were $ 1,026,799

To date, the Company has not generated any revenues

or profits from planned principal operations.

Company’s aggregate cash and restricted cash balance was $ 489,726

at December 31, 2024 which includes $ 182,284

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$ 5,998,712 and

as of December 31, 2023 and 2022, respectively.

The decline in working capital is primarily driven by lower cash on hand and higher

convertible notes outstanding.

$ 7,652,098 as

of December 31, 2024 and 2023, respectively, Net loss for the years ended December 31, 2024 and 2023 were $ 4,762,137 and $ 3,101,768 ,

respectively, and cash used in operations was $ 3,284,091 and $ 2,571,978 for the years ended December 31, 2024 and 2023,

respectively.

Since the Company’s inception, there has been a history of recurring net losses from operations, recurring use

of cash in operating activities and working capital deficits.

cash requirements for our current liabilities include approximately $ 3.3

million for accounts payable and accrued expenses, approximately $ 0.2

million for notes payable and approximately $ 26,000

for future payments under operating leases.

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 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

halogenated xanthene-based drug products, and to raise additional capital.

Company plans to access capital resources through possible public or private equity offerings, including the 2022 Financing (as defined

in Note 5), exchange offers, debt financings, corporate collaborations, or other means.

In addition, the Company continues to explore

opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions,

although there can be no assurance that the Company will be successful with such plans.

The Company has historically been able to raise

capital through equity and debt offerings, although no assurance can be provided 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.

Under ASC Subtopic 205-40, Presentation of Financial

Statements—Going Concern (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events

raise substantial doubt about its ability to meet future financial obligations as they become due within one year after the date that

these financial statements are issued.

The accompanying consolidated financial statements have been prepared on the basis that we will

continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business.

However, since the Company’s inception we have had a history of recurring net losses from operations, recurring use of cash in operating

activities and declining working capital.

The accompanying financial statements have been prepared

in conformity with accounting principles generally accepted in the United States of America (“U.S.

GAAP”), which contemplate

continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business.

The financial statements do not include any adjustment that might become necessary should the Company be unable to continue as a going

primary business objective of management is to build the Company into a commercial-stage biotechnology company;

however, the Company

cannot assure that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other halogenated

xanthene-based drug candidate developed by the Company or entering into any financial transaction.

Moreover, even if the Company is successful

in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements

in 2023 and beyond.

The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions,

the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities.

While the Company

believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide

assurance that it will be able to complete additional financing in a timely manner.

In addition, any such financing may result in significant

dilution to stockholders.

These factors raise substantial doubt about our ability to continue as a going concern.

Further, Management expects

that significant on-going operating expenditures will be necessary to successfully implement the Company’s business plan and

develop and market its products.

circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date

that these consolidated financial statements are issued.

The Company plans to access capital resources through possible public or

private equity offerings, including additional convertible debt issuance pursuant to the 2025 Financing (see Note 5 and Note 10), exchange

offers, debt financings, corporate collaborations, or other means.

In addition, the Company continues to explore opportunities to strategically

monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions, although there can be

no assurance that the Company will be successful with such plans.

The Company has historically been able to raise capital through equity

offerings, although there can be no assurance that it will continue to be successful in the future.

If the Company is unable to raise

sufficient capital, it will not be able to pay its obligations as they become due.

ASC Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility

to evaluate whether conditions and/or events raise substantial doubt about its ability to meet future financial obligations as they become

due within one year after the date that these financial statements are issued.

The accompanying consolidated financial statements have

been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of

liabilities in the normal course of business.

The financial statements do not include any adjustment that might become necessary should

the Company be unable to continue as a going concern.

factors raise substantial doubt about the Company’s our ability to continue as a going concern.

Management’s plans to mitigate

the factors which raise substantial doubt include (1) raising funds from the proceeds of private placement transactions, the exercise

of outstanding stock options, or public offerings of debt or equity securities, and (2) monetizing the Company’s

lead drug candidates.

While the Company believes that it has a reasonable basis for its expectation that it will be able to raise additional

funds, the Company cannot provide assurance that such financing will be available when needed or on acceptable terms, or that it will

be able to complete additional financing in a timely manner.

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

consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that

may be necessary should we be unable to continue as a going concern.

Our consolidated financial statements included elsewhere in this Annual Report on Form 10-K 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.

carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent

realizable or settlement values.

may be necessary should the Company be unable to continue as a going concern.

Significant Accounting Policies

of Consolidation

balances and transactions have been eliminated in consolidation.

Basis of Presentation

The consolidated financial statements include the consolidated results

of Provectus, its wholly owned subsidiaries, and its newly created majority-owned subsidiary, VisiRose (see Note 16).

The interests of

non-controlling shareholders in VisiRose are presented as net income attributable to noncontrolling interest in the Consolidated Statements

of Operations and as noncontrolling interest in the Consolidated Balance Sheets.

Intercompany balances and transactions have been eliminated

in consolidation.

preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”)

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assets, stock-based compensation, accrued liabilities and the valuation allowance related to the Company’s deferred tax assets.

cash consists of a grant award of $ 2,500,000 received in cash from the State of Tennessee less payments to vendors for expenses and deposits

in the amount of $ 1,549,777 .

cash consists of a grant award received from the State of Tennessee.

Restricted cash available as of December 31, 2024 is $ 182,284 .

See Note 15, Grants.

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carrying amounts or fair value less cost to sell.

Management has determined there to be no impairment during the years ended December

31, 2023 and 2022.

Management has determined there to be no impairment of its long-lived assets during

the years ended December 31, 2024 and 2023.

estimates expected credit losses immediately based on existing economic conditions in addition to current and future economic conditions

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expenses related to making such applications) and such costs are included in general and administrative expenses in the accompanying

statements of operations and comprehensive loss.

The Company leases properties under operating

For leases in effect upon adoption of Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)”

at January 1, 2020 and for any leases commencing thereafter, the Company recognizes a liability to make lease payments, the “lease

liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use asset”.

The lease liability is measured at the present value of the remaining lease payments, discounted at the Company’s incremental borrowing

The right-of-use asset is measured at the amount of the lease liability adjusted for the remaining balance of any lease incentives

received, any cumulative prepaid or accrued rent if the lease payments are uneven throughout the lease term, any unamortized initial direct

costs, and any impairment of the right-of-use-asset.

Operating lease expense consists of a single lease cost calculated so that the remaining

cost of the lease is allocated over the remaining lease term on a straight-line basis, variable lease payments not included in the lease

liability, and any impairment of the right-of-use asset.

statements of operations.

Company leases properties under operating leases.

The Company recognizes a liability to make lease payments, the “lease

liability”, and an asset representing the right to use the underlying asset during the lease term, the “right-of-use

asset” upon the commencement of a lease.

The lease liability is measured at the present value of the remaining lease payments, discounted at the

Company’s incremental borrowing rate.

The right-of-use asset is measured at the amount of the lease liability adjusted for the

remaining balance of any lease incentives received, any cumulative prepaid or accrued rent if the lease payments are uneven

throughout the lease term, any unamortized initial direct costs, and any impairment of the right-of-use-asset.

Operating lease

expense consists of a single lease cost calculated so that the remaining cost of the lease is allocated over the remaining lease

term on a straight-line basis, variable lease payments not included in the lease liability, and any impairment of the right-of-use

Company accounts for income taxes under the liability method in accordance with Accounting Standards Codification (“ASC”)

740 “ Income Taxes ”.

Under this method, deferred income tax assets and liabilities are determined based on differences between

financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect

when the differences are expected to reverse.

A valuation allowance is established if it is more likely than not that all, or some portion,

of deferred income tax assets will not be realized.

The Company has recorded a full valuation allowance to reduce its net deferred income

tax assets to zero.

In the event the Company were to determine that it would be able to realize some or all its deferred income tax assets

in the future, an adjustment to the deferred income tax asset would increase income in the period such determination was made.

Under this method, deferred income tax assets and liabilities are determined based on differences

between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be

in effect when the differences are expected to reverse.

A valuation allowance is established if it is more likely than not that all,

or some portion, of deferred income tax assets will not be realized.

The Company has recorded a full valuation allowance to reduce its

net deferred income tax assets to zero.

In the event the Company were to determine that it would be able to realize some or all its deferred

income tax assets in the future, an adjustment to the deferred income tax asset would increase income in the period such determination

Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination.

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are classified as temporary equity.

At all other times, preferred shares are classified as stockholders’ deficit.

At all other times, preferred shares are classified as equity.

and Diluted Loss Per Common Share

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Convertible preferred stock

2021 unsecured convertible notes

2022 unsecured convertible notes

2021 unsecured convertible notes and accrued interest

2022 unsecured convertible notes and accrued interest

2024 unsecured convertible notes and accrued interest

Total potentially dilutive shares

Value of Financial Instruments

Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements and

Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures

about fair value measurements.

The Company determines the estimated fair value of amounts presented in these consolidated financial statements

using available market information and appropriate methodologies.

However, considerable judgment is required in interpreting market data

to develop the estimates of fair value.

The estimates presented in the financial statements are not necessarily indicative of the amounts

that could be realized in a current exchange between buyer and seller.

The use of different market assumptions and/or estimation methodologies

may have a material effect on the estimated fair value amounts.

These fair value estimates were based upon pertinent information available

as of December 31, 2023 and 2022.

The carrying amounts of the Company’s financial assets and liabilities, such as cash and cash

equivalents, restricted cash, receivables, other current assets, accounts payable, unearned grant income, and accrued expenses approximate

fair value due to the short-term nature of these instruments.

The Company measures the fair value of financial assets and liabilities

based on the guidance of ASC 820 “ Fair Value Measurements and Disclosures ” (“ASC 820”) which defines fair

value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

The Company determines

the estimated fair value of amounts presented in these consolidated financial statements using available market information and appropriate

methodologies.

However, considerable judgment is required in interpreting market data to develop the estimates of fair value.

The estimates

presented in the financial statements are not necessarily indicative of the amounts that could be realized in a current exchange between

buyer and seller.

The use of different market assumptions and/or estimation methodologies may have a material effect on the estimated

fair value amounts.

These fair value estimates were based upon pertinent information available as of December 31, 2024 and 2023.

amounts of the Company’s financial assets and liabilities, such as cash, restricted cash, receivables, other current assets, accounts

payable, unearned grant income, and accrued expenses approximate fair value due to the short-term nature of these instruments.

carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include contractual

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Australian Dollar denominated assets and liabilities of $ 7,295

and $ 389,540 at December 31, 2023 and $ 17,373 and $ 383,447 at December 31, 2022, respectively) are translated into the United States

Dollar at the balance sheet date, and net expense accounts of $ 9,763 and $ 4,503 for the years ended December 31, 2023 and 2022, respectively)

are translated at a weighted average exchange rate for the years then ended.

Equity is translated at historical rates and the resulting

foreign currency translation adjustments are included as a component of accumulated other comprehensive loss (“AOCL”), which

is a separate component of stockholders’ deficit.

at December 31, 2024 and $ 13,916

at December 31, 2023, respectively are translated

into the United States Dollar at the balance sheet date, and net expense accounts of ($ 1,745 )

for the years ended December 31, 2024 and 2023,

respectively are translated at a weighted average exchange rate for the years then ended.

Equity is translated at historical rates and

the resulting foreign currency translation adjustments are included as a component of accumulated other comprehensive loss (“AOCL”),

which is a separate component of stockholders’ deficit.

Therefore, the U.S.

dollar value of the non-equity translated items in the Company’s

consolidated financial statements will fluctuate from period to period, depending on the changing value of the U.S.

dollar versus these

dollar value of the non-equity translated items in

the Company’s consolidated financial statements will fluctuate from period to period, depending on the changing value of the U.S.

dollar versus these currencies.

Company engages in foreign currency denominated transactions with its Australian subsidiary.

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provided in exchange for the award, usually the vesting period.

The Company computes the fair value of equity-classified warrants and

options granted using the Black-Scholes option pricing model.

The Company computes the fair value of equity-classified options granted using the Black-Scholes option pricing model.

Option valuation models require the input of highly subjective assumptions

1 unchanged sentence

historical public market closing prices.

Recently Issued Accounting Pronouncements

In November 2023, the FASB issued

ASU 2023-07 “Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures.” These amendments require a public

entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods

all disclosures about a reportable segment’s profit or loss and assets that are currently required annually.

Public entities with a single

reporting segment are required to provide both the new disclosures and all of the existing disclosures required under ASC 280.

is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15,

2024, with early adoption permitted.

Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU

to have any material effects on its financial condition, results of operations or cash flows.

The Company is currently evaluating any

new disclosures that may be required upon adoption of ASU 2023-07.

In December 2023, the FASB issued

ASU 2023-09, Income Taxes (Topic 740):

Company has one operating and reporting segment (clinical stage biotechnology), namely, the development of immunotherapy medicines.

accounting policies of the segment are the same as those described in the summary of significant accounting policies.

The chief operating

decision maker (“CODM”), who is the Company’s chief executive officer, utilizes the Company’s financial information

on an aggregate, consolidated basis for purposes of making operating decisions, allocating resources and assessing financial performance,

as well as for making strategic operations decisions and managing the organization.

The CODM is not regularly provided with

disaggregated expense information, other than the expense information included in the consolidated statements of operations

and comprehensive loss.

The measure of segment assets is reported on the balance sheet as total assets.

Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures .

The amendments in this update address investor requests

for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation

and income taxes paid information.

The amendments in this update address investor requests for more transparency about income

tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information.

This update also includes certain other amendments to improve the effectiveness of income tax disclosures.

The amendments in ASU 2023-09 are effective for the Company on December 15, 2024, with early adoption permitted.

Since this new ASU addresses

only disclosures, the Company does not expect the adoption to have any material effects on its financial condition, results of operation

or cash flows.

The amendments in ASU 2023-09

are effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted.

The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09.

In November 2024, the FASB issued ASU

2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures .

ASU 2024-03 is intended to improve

disclosures about a public business entity’s expenses and provide more detailed information to investors about the types of expenses

in commonly presented expense captions.

The amendments in this ASU will be applied retrospectively and are effective for fiscal years

beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted.

The Company is currently evaluating the impact of implementing this guidance.

Adopted Accounting Pronouncements

August 2020, FASB issued Accounting Standards Update (“ASU”) No.

2020-06, “Debt—Debt with Conversion and

Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ” (“ASU 2020-06”).

ASU 2020-06, the embedded conversion features are no longer separated from the host contract for convertible instruments with

conversion features that are not required to be accounted for as derivatives under Topic 815, or that do not result in substantial

premiums accounted for as paid-in capital.

Consequently, a convertible debt instrument will be accounted for as a single liability

measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives.

The new guidance

also requires the if-converted method to be applied for all convertible instruments.

ASU 2020-06 is effective for fiscal years

beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted.

the standard requires using either a modified retrospective or a full retrospective approach.

The Company adopted ASU 2020-06 on

January 1, 2023, using the modified retrospective approach and it did not have a material impact on its consolidated financial

statements and disclosures.

November 2023, the FASB issued ASU 2023-07 “ Segment Reporting (Topic 280):

Improvements to Reportable Segment

Disclosures .” These amendments require a public entity to disclose significant segment expenses and other segment items on

an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and

assets that are currently required annually.

Public entities with a single reporting segment are required to provide both the new

disclosures and all of the existing disclosures required under ASC 280.

The amendments in ASU2023-07 require, among other things,

disclosure of significant segment expenses that are regularly provided to an entity’s chief operating decision maker

(“CODM”) and a description of other segment items (the difference between segment revenue less the segment expenses

disclosed under the significant expense principle and each reported measure of segment profit or loss) by reportable segment, as

well as disclosure of the title and position of the CODM, and an explanation of how the CODM uses the reported measure(s) of segment

profit or loss in assessing segment performance and deciding how to allocate resources.

Annual disclosures are required for fiscal

years beginning after December 15, 2023 and interim periods are required for periods within fiscal years beginning after December

The Company has adopted this guidance on December 31, 2024, which did not have an impact on its financial position, results of operations, or

cash flows, although it did result in expanded reportable segment disclosures,

Other Accrued Expenses

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Related Party

Balance as of January 1, 2022

( 1,260,000 )

Balance as of December 31, 2022

Convertible notes payable, beginning balance

Balance as of December 31, 2023

Convertible notes payable, ending balance

Non-Related Party

Related Party

Non-Related Party

Related Party

Non-Related Party

Related Party

2021 Financing

2022 Financing

2024 Financing

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, 2023

Principal converted

( 1,002,500 )

Balance as of December 31, 2023

Convertible notes payable, beginning balance

Principal repaid

Principal converted

( 1,675,000 )

Balance as of December 31, 2024

Convertible notes payable, ending balance

August 13, 2021, the Board approved a Financing Term Sheet (the “2021 Term Sheet”), which set forth the terms under which

the Company will use its best efforts to arrange for financing of a maximum of $ 5,000,000 (the “2021 Financing”), which amounts

will be obtained in several tranches.

to the 2021 Term Sheet, the 2021 Notes will either be paid back, convert into shares of the Company’s Series D-1 Preferred Stock,

or convert into Company equity securities and/or debt instruments of certain future financings on or before twelve months after the issue

date of a 2021 Note, subject to certain exceptions.

2021 Financing is in the form of unsecured convertible loans from the investors and evidenced by convertible promissory notes (individually,

a “2021 Note” and collectively, the “2021 Notes”).

In addition to customary provisions, the 2021 Notes will contain

the following provisions:

of December 31, 2024 and December 31, 2023, accrued interest on the convertible notes was $ 172,687 and $ 146,428 , respectively.

party investors in the Company’s convertible notes consist of an officer and an officer/director of the Company.

2021 Financing is in the form of unsecured convertible notes (individually, a “2021 Note” and collectively, the “2021

Pursuant to the 2021 Term Sheet, the 2021 Notes will either be paid back, convert into shares of the Company’s Series

D-1 Preferred Stock, or convert into Company equity securities and/or debt instruments of certain future financings on or before twelve

months after the issue date of a 2021 Note, subject to certain exceptions.

addition to customary provisions, the 2021 Notes contain the following provisions:

2021 Notes bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the loan that has been

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outstanding principal amount and interest payment under the 2021 Notes may be paid back at maturity at the investors’ option;

outstanding principal amount and interest payable under the 2021 Notes are convertible at the investors’ option into shares

of Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

outstanding principal amount and interest payable under the 2021 Notes are convertible at the holders’ option into shares of

Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares

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terms as those investors.

embedded conversion options associated with the 2021 Notes do not require bifurcation and treatment as a derivative liability.

September 20, 2022, the Board approved the closure of the 2021 Financing.

Through December 31, 2023, the Company received aggregate proceeds

of $ 2,335,000 ,

of which $ 525,000

is from related party investors (an officer and

director of the Company), in connection with the 2021 Notes.

For the years ended December 31, 2023 and 2022, the Company recorded interest

expense of $ 46,189

and $ 147,340 ,

respectively, related to the 2021 Notes.

September 20, 2022, the Board approved a Financing Term Sheet (the “2022 Term Sheet”), which set forth the terms under which

the Company will use its best efforts to arrange for financing of a maximum of $ 5,000,000

(the “2022 Financing”), which amounts

will be obtained in several tranches.

Through December 31, 2023, the Company received proceeds of $ 3,227,500 ,

of which $ 2,352,500

was from a related party investor (a Company

director) in connection with the 2022 Notes.

For the years ended December 31, 2023 and 2022, the Company recorded interest expense of

$ 159,466 and $ 9,514 , respectively, related to the 2022 Notes.

The embedded conversion options associated with the

2021 Notes do not require bifurcation and treatment as a derivative liability.

On September 20, 2022, the Board approved the closure

of the 2021 Financing.

During the year ended December 31, 2024, the Company repaid $ 100,000 of

principal owed on the 2021 Note.

As of December 31, 2024, principal and interest in the amount of $ 100,000 and $ 51,444 , respectively,

remains outstanding on the 2021 Note.

the year ended December 31, 2023, principal and interest in the aggregate amount of $ 945,464 ,

owed in connection with the 2021 Notes were converted into 330,354

shares of Series D-1 Preferred Stock at the Conversion Price

Any fractional shares issuable pursuant to the formula

were rounded up to the next whole share of Series D-1 Preferred Stock.

See Note 10, Stockholders’ Deficit for additional information

on the Series D-1 Preferred Stock.

the years ended December 31, 2024 and 2023, the Company recorded interest expense of $ 13,400 and $ 46,189 , respectively, related to the

to the 2022 Term Sheet, the 2022 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve

months after the issue date of a 2022 Note, subject to certain exceptions.

2022 Financing will be in the form of unsecured convertible loans from the investors (the “2022 Note Investors”) and evidenced

by convertible promissory notes (individually, a “2022 Note” and collectively, the “2022 Notes”).

to customary provisions, the 2022 Notes will contain the following provisions:

2022 Notes will bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has

been funded to the Company;

2022 Financing is in the form of unsecured convertible promissory notes (individually, a “2022 Note” and collectively, the

“2022 Notes”).

In addition to customary provisions, the 2022 Notes will contain the following provisions:

2022 Notes bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has been

funded to the Company;

the event there is a change of control of the Board, the term of the 2022 Notes will be accelerated and all amounts due under the

2022 Notes may be immediately due and payable at the 2022 Note Investors’ option;

outstanding principal amount and interest payable under the 2022 Notes may be convertible at the 2022 Note Investors’ option

into shares of Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

The Series D-1 Preferred Stock is convertible into

ten ( 10 ) shares of common stock;

outstanding principal amount and interest payable under the 2022 Notes is convertible at the holders’ option into shares of

Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares

of common stock;

outstanding principal amount and interest payable under the 2022 Notes will be automatically convertible into shares of the Company’s

Series D-1 Preferred Stock twelve (12) months after the issue date of a 2022 Note.

embedded conversion options associated with the 2022 Notes do not require bifurcation and treatment as a derivative liability.

Conversions of 2021 Notes into Preferred Stock

following summarizes the conversion activity during the year ended December 31, 2022:

Schedule of Conversion of Notes into Preferred Stock

Principal converted

Accrued interest converted

Total converted

Conversion price

the year ended December 31, 2022, principal and interest in the aggregate amount of $ 1,361,640 , representing two 2021 Notes were converted

into 475,766 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 Shares.

See Note 9, Stockholders’ Deficit for additional information

on the Series D-1 Preferred Stock.

Conversions of 2021 Notes into Preferred Stock

following summarizes the conversion activity during the year ended December 31, 2023:

Principal converted

Accrued interest converted

Total converted

Conversion price

The embedded conversion options associated with the

2022 Notes do not require bifurcation and treatment as a derivative liability.

On July 11, 2024, the Board approved the closure of the 2022 Financing.

the year ended December 31, 2024, principal and interest in the aggregate amount of $ 2,674,224 ,

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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 Shares.

Note 9, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.

Conversions of 2022 Notes into Preferred Stock

following summarizes the conversion activity during the year ended December 31, 2023:

Principal converted

Accrued interest converted

Total converted

Conversion price

the year ended December 31, 2023, principal and interest in the aggregate amount of $ 813,098 ,

During the year ended December 31, 2023, principal and interest in the aggregate amount of $ 813,099 ,

owed in connection with the 2022 Notes were converted into 284,117

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 Shares.

Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock.

Note 10, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.

As of December 31, 2024, principal and interest in the amount of $ 1,638,000

and $ 95,815 , respectively, remains outstanding on the 2022 Note.

the years ended December 31, 2024 and 2023, the Company recorded interest expense of $ 186,654 and $ 159,466 , respectively, related to

the 2022 Notes.

July 11, 2024, the Board approved a Financing Term Sheet (the “2024 Term Sheet”), which set forth the terms under which the

Company will use its best efforts to arrange for financing of a maximum of $ 10,000,000 (the “2024 Financing”), which amounts

will be obtained in several tranches.

Pursuant to the 2024 Term Sheet, the 2024 Notes (defined below) will convert into shares of the

Company’s Series D-1 Preferred Stock twelve months after the issue date of a 2024 Note, subject to certain exceptions.

2024 Financing is in the form of unsecured convertible promissory notes (individually, a “2024 Note” and collectively, the

“2024 Notes”).

In addition to customary provisions, the 2024 Notes contain the following provisions:

2024 Notes bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has been

funded to the Company;

the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the

2024 Notes may be immediately due and payable at the option of the holder;

outstanding principal amount and interest payable under the 2024 Notes is convertible at the holder’s option into shares of

Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

The Series D-1 Preferred Stock is convertible into ten ( 10 ) shares

of common stock;

outstanding principal amount and interest payable under the 2024 Notes will be automatically convertible into shares of the Company’s

Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note.

The embedded conversion options associated

with the 2024 Notes do not require bifurcation and treatment as a derivative liability.

of December 31, 2024, principal and interest in the amount of $ 1,215,000 and $ 25,428 , respectively, remains outstanding on the 2024

For the year ended December 31, 2024, the Company recorded interest expense of $ 25,428 ,

related to the 2024 Notes.

On January 15, 2025, the Board approved the closure of the 2024 Financing.

Notes Payable

Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies.

Company obtained short-term financing from First Insurance Funding in 2024 for our commercial insurance policies.

As of December 31,

and December 31, 2022, the balance of the note payable was $ 277,815

and $ 239,394 ,

respectively.

For the years ended December 31, 2023 and 2022, the Company recorded interest expense of $ 5,650 and $ 3,409 , respectively,

related to the notes payable.

2024, the balance of the note payable was $ 206,463 .

The Company obtained short-term financing from AFCO in 2023 for our commercial insurance policies.

As of December 31, 2023, the

balance of the note payable was $ 277,815 .

For the years

ended December 31, 2024 and 2023, the Company recorded interest expense of $ 13,591 and

respectively, related to the notes payable.

Related Party Transactions

the years ended December 31, 2023 and 2022, the Company accrued Capital Strategists consulting fees of $ 254,400 and

respectively, for services rendered.

The total amount owed to Capital Strategists as of December 31, 2023 and 2022 were

the years ended December 31, 2024 and 2023, the Company incurred consulting fees of $ 63,600 and $ 254,400 , for services rendered by Bruce

Horowitz (Capital Strategists) a former member of the Board and former Chief Operating Officer (“COO”).

As of March 25, 2024,

Horowitz resigned as COO and member of the Board.

On March 26, 2024, the Company paid Mr.

Horowitz $ 250,000 and on June 27, 2024,

the Company paid $ 258,000 for outstanding consulting fees.

Horowitz for the years ended December 31, 2024 and 2023 were $ 0

and $ 75,000 ,

respectively.

Bruce Horowitz, the Managing Director of Capital Strategists, previously served as both the Chief Operating Officer and a director

of the Company until March 25, 2024.

Director fees for Mr.

Horowitz for the years ending December 31, 2023 and 2022 were $ 75,000

and $ 75,000 , respectively.

Accrued director fees for Mr.

Horowitz as of December 31, 2023 and 2022 were $ 431,250 and $ 356,250 , respectively.

Horowitz as of December 31, 2024 and 2023 were $ 0

and $ 431,250 ,

respectively.

Horowitz waived the amount of $ 450,000

due to him in director fees upon his

March 25, 2024, the Board retained Dominic Rodrigues as the Company’s interim chief operations consultant pursuant to an

Independent Contractor Agreement entered into with Mr.

In this role, Mr.

Rodrigues will serve as the Company’s

principal executive officer and will be paid $ 20,000

per calendar month for his services as principal executive officer.

During the year ended December 31, 2024, the Company incurred fees of $ 13,800

for interim consulting services rendered by Mr.

In April 2024, Mr.

Rodrigues was hired as an employee to serve in the

role of president and principal executive officer.

Note 5 for details of other related party transactions.

fees during the years ended December 31, 2023 and 2022 were $ 385,000 and $ 385,000 , respectively.

Accrued directors’ fees as of

December 31, 2023 and 2022 were $ 2,330,589 and $ 1,945,589 , respectively.

fees incurred during the year ended December 31, 2024 and 2023, were $ 328,750 and $ 385,000 , respectively.

In the first quarter of 2024, the Company recognized a net gain of $ 121,250 ,

primarily attributable to the $ 450,000 in fees waived by Mr.

Accrued directors’ fees

as of December 31, 2024 and December 31, 2023 were $ 77,500 and $ 2,330,589 , respectively.

Short-term Receivables

at December 31, 2023 and 2022, include the Australian VAT tax credit and approximately $ 2,100,000

receivables at December 31, 2024 and 2023, include the Australian VAT tax credit and $ 2,100,000

that is owed from Peter Culpepper, the former Interim Chief Executive Officer of the Company.

The Company has established a reserve

of approximately $ 2,100,000

Company has established a reserve of approximately $ 2,100,000

as of December 31, 2024 and 2023, which represents the amount Culpepper owes to the Company in connection with a derivative lawsuit

settlement (excluding the amount of attorneys’ fees incurred in enforcing the terms of the derivative lawsuit

Prepaid Expenses and Other Current Assets

The following table summarizes the pre-paid expenses and other current

assets at December 31, 2024 and 2023:

of Prepaid Expenses And Other Current Assets

the Years Ended

subscriptions

current assets

Prepaid Expenses and Other Current Assets

Other current assets at December 31, 2024 include a refund due from the

University of Tennessee College of Veterinary Medicine upon termination of contract.

Stockholders’ Deficit

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The preferred stock is designated as follows:

12,374,000 shares to Series D Convertible Preferred Stock (the “Series

D Preferred Stock”), and 11,241,000 shares of Series D-1 Convertible Preferred Stock (the “Series D-1 Preferred Stock”)

and 1,385,000 shares undesignated.

shares to Series D Convertible Preferred Stock

(the “Series D Preferred Stock”), and 23,042,900

shares of Series D-1 Convertible Preferred Stock

(the “Series D-1 Preferred Stock”) and 1,000,000

shares undesignated.

D and Series D-1 Preferred Stock

The preferred stock is designated as

shares are designated as Series D Convertible Preferred Stock (the “Series D Preferred Stock”), 11,241,000

shares are designated as Series D-1 Convertible Preferred Stock (the “Series D-1 Preferred Stock”).

rights, preferences and privileges of the Series D Preferred Stock and Series D-1 Preferred Stock (collectively, the “D-Series

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of common stock upon the fifth anniversary of the date of issuance.

the year ended December 31, 2021, the Company received consideration of $ 150,000 from an investor in exchange for an aggregate of 52,411

shares of restricted Series D-1 Preferred Stock that were issued during the first quarter of 2022.

the year ended December 31, 2022, the Company issued 475,766 shares of Series D-1 Preferred Stock upon the automatic conversion of $ 1,260,000

of principal and $ 101,640 accrued interest outstanding on the 2021 Notes.

the year ended December 31, 2023, the Company issued 330,354 shares of Series D-1 Preferred Stock upon the automatic conversion of $ 875,000

of principal and $ 70,464 accrued interest outstanding on the 2021 Notes.

the year ended December 31, 2023, the Company issued 284,117 shares of Series D-1 Preferred Stock upon the automatic conversion of $ 752,500

of principal and $ 60,598 accrued interest outstanding on the 2022 Notes.

Stock Issuances

the year ended December 31, 2022, the Company issued an aggregate of 50,000 shares of immediately vested restricted common stock with

a grant date fair value of $ 3,025 for services.

the year ended December 31, 2024, the Company issued 744,878 shares of Series D-1 Preferred Stock in satisfaction of accrued directors’

fees in the amount of $ 2,131,839 .

the year ended December 31, 2024, the Company issued 1,141,262

shares of Series D-1 Preferred Stock in exchange

of 11,416,262

shares of Series D Preferred Stock.

During the year ended December 31, 2024, principal

and interest in the aggregate amount of $ 2,674,224 , converted into 934,398 shares of Series D-1 Preferred Stock.

During the year ended December 31, 2023, principal

and interest in the aggregate amount of $ 1,758,563 , converted into 614,471 shares of Series D-1 Preferred Stock.

Stock Issuances

During the year ended December 31, 2024,

the Company issued 757,760 shares of common stock upon the conversion of 75,776 shares of Series D-1 Preferred Stock.

the year ended December 31, 2023, the Company issued an aggregate of 25,000 shares of immediately vested restricted common stock with

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within the meaning of Section 422 of the Internal Revenue Code or options which are not incentive stock options.

Vested stock options are

exercisable over a period determined by the Board of Directors (through its Compensation Committee), but generally no longer than 10 years

after the date they are granted.

As of December 31, 2023, there were 16,587,500 shares available for issuance under the 2017 Equity Compensation

were no stock options granted during the years ended December 31, 2023 and 2022.

Vested stock options

are exercisable over a period determined by the Board of Directors (through its Compensation Committee), but generally no longer than

10 years after the date they are granted.

The 2017 Equity Compensation Plan, as amended, expired on April 25, 2023.

Equity Compensation Plan

the shareholder meeting held on June 20, 2024, the proposal for the new 2024 Equity Compensation Plan was approved.

The approval gives

the Company the authority to grant Options and award Restricted Stock under the 2024 Equity Compensation Plan for up to 100,000,000

shares of our common stock.

As of December

31, 2024, there were 49,681,898

shares available for issuance under the 2024

Equity Compensation Plan.

following table summarizes option activity during the years ended December 31, 2024 and 2023:

Schedule of Option Activity

Weighted Average Exercise Price

Weighted Average Remaining Life in Years

of Option Activity

Weighted Average

Weighted Average Remaining

Aggregate Intrinsic

Exercise Price

Life in Years

Outstanding and exercisable at January 1, 2023

Outstanding and exercisable at December 31, 2023

Options outstanding at December 31, 2024

Options exercisable at December 31, 2024

December 2, 2024, the Company granted five and ten-year options for the purchase of 50,318,102

shares of the Company’s common stock exercisable at $ 0.2862

per share, as follows:

options for the purchase of 1,550,164 shares of the Company’s common stock, with an aggregate grant date value of $ 112,070

were granted to certain directors of the Company.

The options were fully vested upon grant.

options for the purchase of 47,953,253 shares of the Company’s common stock, with an aggregate grant date value of $ 3,466,802

were granted to certain Company executives.

One-third of the options were fully vested upon grant;

the remaining two-thirds vested

on each of the next two anniversaries of the date of grant.

options for the purchase of 814,685 shares of the Company’s common stock, with an aggregate grant date value of $ 39,317 were

granted to an employee of the Company.

One-third of the options were fully vested upon grant;

the remaining two-thirds vested on

each of the next two anniversaries of the date of grant.

grant date value of the stock options was calculated using the Black Sholes valuation model with the following assumptions:

of Grant Date Value of Stock Option using Black Sholes Valuation Model

free interest rate

forfeitures are accounted for at the time of occurrence.

The expected term used is the estimated period of time that options granted

are expected to be outstanding.

The Company utilizes the “simplified” method to develop an estimate of the expected term

of employee option grants.

The Company utilizes an expected volatility figure based on the historical volatility of its common stock

over a period of time equivalent to the expected term of the instrument being valued.

The risk-free interest rate was determined from

the implied yields from U.S.

Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being

the year ended December 31, 2024, the Company recognized stock-based compensation expense of $ 1,280,786 .

As of December 31, 2024, there

was $ 2,337,412 of unrecognized stock-based compensation related to the above stock options, which will be recognized over the weighted

average remaining vesting period of 1.9 years.

of December 31, 2024, the intrinsic value of outstanding and exercisable options was $ 0 .

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following table summarizes warrant activity during the years ended December 31, 2024 and 2023:

Schedule of Warrant Activity

of Warrant Activity

Number of Warrants

4 unchanged sentences

Outstanding and exercisable at December 31, 2024

of December 31, 2023, the intrinsic value of outstanding and exercisable warrants was $ 0 .

following table summarizes information about warrants outstanding at December 31, 2023:

Schedule of Warrants Outstanding

Warrants Outstanding

Warrants Exercisable

Weighted Average

Remaining Life

Exercise Price

of the outstanding warrants are not entitled to vote and the exercise prices of such warrants are subject to customary anti-dilution

1 unchanged sentence

Schedule of Domestic and Foreign Loss Before Income Taxes

Years ended December 31

Year ended December 31

Components of Pre-Tax Income (Loss):

$ ( 4,763,882 )

5 unchanged sentences

Schedule of Income Tax Provision (Benefit)

Years ended December 31

Year ended December 31

State and local:

Change in valuation allowance

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Prior year true-up

Expiration of federal and state net operating loss carryforwards

Expiration of federal & state net operating loss carryforwards

Expiration of warrants and options

Issuance of options

Miscellaneous

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Deferred Tax Liabilities:

Intangible assets

Prepaid expenses

5 unchanged sentences

Change in valuation allowance

$ ( 704,628 )

valuation allowance against deferred tax assets is required if, based on the weight of available evidence, it is more likely than not

4 unchanged sentences

the net deferred tax asset.

A portion of the valuation allowance relates to Research and Development credit carryovers.

been no formal Research and Development studies performed related to the amounts calculated for these credits.

While management

believes the amounts taken as credits are accurate, it is possible a future adjustment would be necessary to reduce the value of the

of these credit carryovers.

inception of the Company on January 17, 2002, the Company has generated federal, state, and Australian tax net operating losses of approximately

26 unchanged sentences

no additional federal income taxes (net of available tax attributes) would be payable if such earnings were to be repatriated.

Company leased 4,500 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of

five years ending on June 30, 2022.

Payments were approximately $ 6,100 per month due to the Company negotiating a continued reduced rent

from January 1, 2022 through June 30, 2022.

June 30, 2022, the lease expired and was not renewed.

On June 18, 2022, the Company moved into 2,700 square feet of leased corporate

office space in Knoxville, Tennessee through an operating lease agreement for a term of three years ending June 30, 2025.

base rent ranges from $ 4,053 to $ 4,278 over the term on the lease.

June 18, 2022, the Company moved into 2,700 square feet of leased corporate office space in Knoxville, Tennessee through an operating

lease agreement for a term of three years ending June 30, 2025.

The monthly base rent ranges from $ 4,053 to $ 4,278 over the term on the

expense for operating leases for the year ended December 31, 2024 was $ 51,446 , of which $ 34,297 was included within research and development

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Total expense for operating

leases for the year ended December 31, 2022 was $ 63,066 , of which, $ 42,044 was included within research and development and $ 21,022

was included within general and administrative expenses on the consolidated statements of operations.

leases for the year ended December 31, 2023 was $ 51,393 , of which, $ 34,262 was included within research and development and $ 17,131 was

included within general and administrative expenses on the consolidated statements of operations.

of December 31, 2024, the Company had no leases that were classified as a financing lease.

2 unchanged sentences

summary of the Company’s right-of-use assets and liabilities is as follows:

Schedule of Right-of-use Assets and Liabilities

of Right-of-use Assets and Liabilities

For The Years Ended

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Schedule of Future Minimum Payments Under Non-cancellable Lease

Total lease payments

Payments during the year ended December 31, 2025

amount representing imputed interest

17 unchanged sentences

The Company has elected gross presentation of the Tennessee Grant income earned and

the related research and development expenses, with Grant income presented as Grant revenue in the period in which it is earned, and

qualifying costs presented as research and development expenses included in the Company’s statement of operations in the

period that such costs are incurred.

As of December 31, 2023, $ 953,248 has

been recorded as unearned Grant revenue liability on the accompanying audited consolidated balance sheets.

The Company recorded

$ 557,710 and

the related research and development expenses, with Tennessee Grant income presented as grant revenue in the period in which it is

earned, and qualifying costs presented as research and development expenses included in the Company’s statement of operations

in the period that such costs are incurred.

As of December 31, 2024 and 2023, the Company recorded $ 336,108 and

$ 953,248 , respectively, as unearned grant revenue liability on the accompanying audited consolidated balance sheets.

recorded $ 617,140 and

grant revenue during the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2022, $ 1,510,958 has been

recorded as unearned Grant revenue liability on the accompanying audited consolidated balance sheets.

License Transactions

the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration

on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS.

On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”)

for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”)

of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade

RBS for the treatment of bacterial, fungal, and viral infections of the eye.

Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company paid $5,000 for the option

that expires on May 31, 2023;

agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option and up

to $25,000 of past UM patent expenses for this IP;

and entered into a sponsored research agreement with UM on September 16, 2022 to study

the combination of OBC’s PDAT and TOP PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment

of infectious keratitis.

March 21, 2024, the Company entered into an exclusive worldwide license agreement (the License Agreement”) with the University

of Miami (“UM”) for the license and development of the UM’s intellectual property related to photodynamic antimicrobial

therapy in ophthalmology.

The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell

Licensed Products and/or Licensed Processes (as defined in the License Agreement) based upon patent-related rights.

consideration for the rights granted in the License Agreement, the Company must pay an upfront fee of $ 10,000 , royalties equal to 10%

of net sales of Licensed Products and/or Licensed Processes, and annual payments of $ 1,000 on the first through fourth anniversaries

of the License Agreement and $ 10,000 on every anniversary thereafter.

In the event of a sublicense to a third party, the Company is obligated

to pay royalties to the University equal to a percentage of sublicense income ranging from 10 % to 30 % depending on the phase of clinical

to the requirements of the License Agreement, the Company created a new subsidiary “VisiRose” for the purpose of developing

and commercializing Licensed Products and Licensed Processes, assigned the License Agreement to VisiRose, and entered into an equity agreement

with respect to VisiRose’s securities.

Pursuant to the equity agreement, VisiRose will be required to issue to the University 5 %

of the total number of issued and outstanding shares of VisiRose.

The University will have certain anti-dilution rights related to additional

issuances of VisiRose securities before VisiRose receives a total of $ 2,000,000 in cash.

On December 5, 2024, the Board approved the formation of a subsidiary of

the Company to be incorporated under the laws of the State of Delaware under the name VisiRose and to pursue the development and commercialization

of the Company’s pharmaceutical-grade API RBS for the treatments of ophthalmology diseases and disorders.

The certificate of incorporation

of VisiRose was filed with the secretary of state of Delaware on December 5, 2024.

holds a majority ownership interest in its subsidiary, VisiRose, with a 93.4 %

stake, while the University of Miami retains a 5.0 %

ownership interest, and two additional investors hold approximately 1.6 %.

In accordance with U.S.

Generally Accepted Accounting Principles (GAAP), the Company consolidates

VisiRose’s financial results within its consolidated financial statements.

For the reporting period, the Company recorded a

net loss of $ 29,585

attributable to the noncontrolling interest in VisiRose, reflecting the noncontrolling interests’ proportionate share of the

subsidiary’s losses.

License Agreement sets forth certain diligence milestones that include forming VisiRose, creating a Licensed Product suitable for submission

to the Food and Drug Administration (“FDA”), generating Licensed Product data suitable for required submission to the FDA,

submitting a drug-device combination application to the FDA, and receiving clearance, approval or other authorization from the FDA for

the Licensed Product portion of the drug-device combination.

The License Agreement also provides for development milestone payments of

$5,000 upon the first commercial sale of approved Licensed Product and $50,000 upon net sales of Licensed Product of at least $500,000.

Pursuant to the License Agreement,

the Board approved the transfer of certain assets to VisiRose, such as the License Agreement, and the Company’s exclusive

master supply agreement for API and investigational drug product, subject to final review and contract finalization by the Board.

The Company and VisiRose entered into an agreement on December 20, 2024 whereby the Company assigned the License Agreement to

VisiRose, which the University approved.

term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related

to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years

from the first commercial sale of Licensed Product and/or Licensed Process.

The License Agreement provides that the Company may terminate

the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement

if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after

receipt of written notice.

Commitments, Contingencies and Litigation

7 unchanged sentences

or disclosure in the financial statements, except as disclosed below.

Financing Note

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 $ 5,000,000 (the “2025 Financing”), which amounts

will be obtained in several tranches.

to the 2025 Term Sheet, the 2025 Notes (defined below) will convert into shares of the Company’s Series D-1 Preferred Stock twelve

months after the issue date of a 2025 Note.

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”).

to customary provisions, the 2025 Notes will contain the following provisions:

2025 Notes will bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the Loan that has

been funded to the Company;

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;

outstanding principal amount and interest payable under the 2025 Notes may be convertible at the 2025 Note Investors’ option

into shares of Series D-1 Preferred Stock at a price per share equal to $ 2.862 .

The Series D-1 Preferred Stock is convertible into

ten ( 10 ) shares of common stock;

outstanding principal amount and interest payable under the 2025 Notes will be automatically convertible into shares of the Company’s

Series D-1 Preferred Stock twelve (12) months after the issue date of a 2025 Note.

Notes Payable

to December 31, 2023, the Company entered into 2022 Notes with non-related party investors in the aggregate principal amount of $ 153,000 .

to December 31, 2023, the Company entered into a 2022 Note with a related party investor (a director of the Company) in the aggregate

to December 31, 2024, the Company entered into 2025 Notes with a related party investor (a director of the Company) in the aggregate

principal amount of $ 455,000 .

Subsequent to December 31, 2023, the Company paid back $ 75,000 against a 2021 Note with a related party investor

(an officer of the Company).

to December 31, 2023, principal and interest in the aggregate amount of $ 648,162 representing 2022 Notes were converted into 226,474 shares

of Series D-1 Convertible Preferred Stock upon automatic conversion of the 2022 Notes.

Horowitz – Resignation and Termination Agreement

March 25, 2024, Bruce Horowitz resigned from the Board and as the Company’s Chief Operating Officer.

Horowitz, through

counsel, had requested that the Company pay him $ 977,000 ,

representing $ 508,000

for amounts owed under the Independent Contractor Agreement, dated as of April 19, 2017, by and between Mr.

Horowitz and the

Company, as amended by Amendment No.

1, dated as of May 9, 2017, and Amendment No.

2, dated as of May 8, 2019 (the “Horowitz

Agreement”), and $ 469,000

for accrued director fees.

On March 25, 2024, the Company and Mr.

Horowitz entered into an Independent Contractor and Director Fee

Termination Agreement and Release (the “Termination Agreement”) to resolve Mr.

Horowitz’s claims and terminate the

Horowitz Agreement.

The Termination Agreement provides, among other things, for the Company to pay Mr.

Horowitz an initial payment

within two business days of the Termination Agreement and a discounted second payment in the amount of $ 258,000

so long as it is paid prior to June 30, 2024, after which the amount of the second payment is $ 500,000 .

The Company has paid the initial payment of $ 250,000 .

Rodrigues – Appointment and Independent Contractor Agreement

March 25, 2024, the Board retained Dominic Rodrigues as the Company’s chief operations consultant pursuant to an Independent Contractor

Agreement entered into with Mr.

In this role, Mr.

Rodrigues will serve as the Company’s principal executive officer

and will be paid $ 20,000 per calendar month.

License Transactions

On March 21, 2024, the Company entered into an exclusive

worldwide license for UM’s IP.

Details of the license agreement are reported in the Company’s

Current Report on Form 8-K filed with the Commission on March 27, 2024.

to December 31, 2024, principal and interest in the aggregate amount of $ 1,046,695 representing 2022 Notes were converted into 365,400

shares of Series D-1 Convertible Preferred Stock upon automatic conversion of the 2022 Notes.

Subsequent to December 31, 2024, the Company’s majority-owned subsidiary,

VisiRose, received investments totaling $ 700,000 in exchange for the issuance of 3,694 shares of VisiRose common stock.

In accordance

with the licensing agreement, VisiRose also issued an additional 188 shares of common stock to the University of Miami to maintain the

University’s 5 % ownership interest.

IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

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 8. Financial Statements and Supplementary Data