What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-03-28 compared with 2024-03-28 · 115 added, 195 removed, 179 unchanged (63% of the section changed)

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Our goals, when

this work is complete, are to file an investigational new drug application (“IND”) with the FDA, take an initial systemic

drug product candidate into an early-stage clinical trial for an initial oncology or hematology indication, and/or pursue a co-development

collaboration or out-license arrangement for this route of administration and disease area.

this work is complete, are to file an investigational new drug application (“IND”) with the U.S.

Food and Drug Administration

(“FDA”), take an initial systemic drug candidate into an early-stage clinic trial for an initial oncology or hematology indication,

and/or pursue a co-development collaboration or out-license arrangement for this route of administration and disease area.

Company is developing different formulations of pharmaceutical-grade RBS using different concentrations and different routes of administration

(e.g., PO, IV, IN) for other disease areas by endeavoring to show preclinical activity and lack of toxicity.

Our goals, when each task

of this work is completed, are to file an IND with the FDA, take an initial drug product candidate into an early-stage clinical trial

for an initial indication, and/or pursue a co-development collaboration or out-license arrangement for the respective disease area and

route of administration.

for other disease areas by endeavoring to show non-clinical activity and lack of toxicity.

Our goals, when each task of this work is

completed, are to file an IND with the FDA, take an initial drug candidate into an early-stage clinic trial for an initial indication,

and/or pursue a co-development collaboration or out-license arrangement for the respective disease area and route of administration.

Company is endeavoring to fully elucidate the traits and characteristics of the RBS molecule using different academic medical centers

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RBS and that our pharmaceutical-grade RBS meets the necessary uniformity and purity requirements for commercial pharmaceutical use.

Drug Substance and Drug Product Candidate Manufacturing

API and Drug Candidate Manufacturing

pharmaceutical-grade RBS resulted from the Company’s innovation of a proprietary, patented, commercial-scale process to synthesize

and utilize the RBS molecule into a viable API for commercial pharmaceutical use;

the development of unique chemistry, manufacturing,

and control (“CMC”) specifications for drug substance and drug product candidate manufacturing processes;

the production

and multi-year stability testing of multiple drug substance and drug product candidate lots;

the comprehensive documentation of lot composition

and reproducibility;

and the review and acceptance of CMC data from these lots by seven different national drug regulatory agencies for

use in a prior, multi-country, multi-center Phase 3 randomized control trial of the Company.

Company’s drug substance and drug product candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing

practice (“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements

for Pharmaceuticals for Human Use.

These processes utilize controls that eliminate the formation of historical impurities and avoid the

introduction of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported

amounts in non-pharmaceutical grades of rose bengal.

Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS drug substance and ITU

PV-10 drug product candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of drug

substance and drug product candidate have been reviewed by multiple national drug regulatory agencies prior to granting clinical trial

authorizations for the Company to commence a historical Phase 3 study of ITU PV-10 for the treatment of locally advanced cutaneous melanoma,

including the U.S.

FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s Therapeutic

Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité du Médicament

et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión Federal para

la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos, Alimentos

y Tecnología Médica (ANMAT).

and utilize the RBS molecule into a viable active pharmaceutical ingredient (“API”) for commercial pharmaceutical use;

development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing

the production and multi-year stability testing of multiple API and drug candidate lots;

the comprehensive documentation of

lot composition and reproducibility;

and the review and acceptance of CMC data from these lots by seven different national drug regulatory

agencies for use in a prior, multi-country, multi-center Phase 3 randomized control trial of the Company.

Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice

(“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements for

Pharmaceuticals for Human Use.

These processes utilize controls that eliminate the formation of historical impurities and avoid the introduction

of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported amounts

in non-pharmaceutical grades of rose bengal.

Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and ITU PV-10 drug

candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of API and drug candidate

have been reviewed by multiple national drug regulatory agencies prior to granting clinical trial authorizations for the Company to commence

a historical Phase 3 study of ITU PV-10 for the treatment of the Company’s former lead indication of locally advanced cutaneous

melanoma, including the U.S.

FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s

Therapeutic Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité

du Médicament et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión

Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos,

Alimentos y Tecnología Médica (ANMAT).

Non-proprietary Name

RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the WHO Expert Advisory Panel on the

International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for the non-proprietary name in the third quarter

of 2020 and reached the status of recommended INN.

INN Recommended List 88, which includes the RBS name, was published with the No.

issue of the WHO Drug Information, Volume 36 in the fourth quarter of 2022.

aim of the INN system since inception has been to provide health professionals with a unique and universally available designated name

to identify each pharmaceutical substance or API, according to the WHO.

The existence of an international nomenclature, in the form of

INN, is important for the accurate identification, prescribing, and dispensing of medicines to patients, and for communication and exchange

of information among health professionals and scientists worldwide.

Medical Diagnostic Use of Rose Bengal

Liver Diagnostic Use

1971, 131 I rose bengal (Robengatope ® [rose bengal sodium 131 I injection USP]) was approved by the

FDA (NDA 016224) for use as a diagnostic aid to determine liver function.

In 2009, manufacturer Bracco Diagnostics Inc.

withdrew Robengatope

from the U.S.

market because of the emergence of newer liver imaging methods, such as computed tomography.

Ophthalmic Diagnostic Use

1974, Barnes-Hind Pharmaceuticals, Inc.

(“Barnes-Hind”) introduced a medical device product of 1% rose bengal in an aqueous

solution for the diagnosis of corneal injury, diagnosis of keratitis, keratoconjunctivitis, and sicca, and detection of foreign bodies

In 1981, Barnes-Hind introduced ophthalmic strips of the same concentration for the same indications.

While both the solution

and strip medical device products were accepted by the FDA for marketing, the Company does not believe that the devices or their respective

claims were approved by the FDA because their introductions predated formal FDA review and approval of medical devices.

RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (“WHO”)

Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for a non-proprietary

name in the third quarter of 2020 and reached the status of recommended International Non-proprietary Names (“INN”).

Recommended List 88, which includes the RBS name, was published with the No.

3 issue of the WHO Drug Information, Volume 36 in the fourth

quarter of 2022.

Non-Pharmaceutical

Grades of Rose Bengal

Commercial-Grade

material may be purchased from specialty chemical suppliers in the U.S.

and from other parts of the world;

however, the Company believes

that the material itself is almost exclusively made in China and India under non-cGMP conditions.

Commercial grade rose bengal appears

to have reported purity that may vary between approximately 80% and 95%, and that may contain substantial amounts of unreported impurities

and/or gross contaminants.

Commercial grade rose bengal is typically used by researchers for preclinical study of the rose bengal molecule

for potential biomedical therapeutic applications.

believe that commercial grade rose bengal is still manufactured using the historical process (or a variant thereof) that was developed

by the synthetic molecule’s Swiss creator Rudolph Gnehm in 1881.

Some manufacturers may, however, apply purification techniques

that the Company believes still result in material that may possess questionable purity and contaminants and may also be subject to substantial

grade rose bengal can be purchased from specialty chemical suppliers in the U.S.

and in other parts of the world that manufacture it

under non-cGMP conditions.

Commercial grade rose bengal appears to have reported purities that may vary between 80% and 95% and may contain

substantial amounts of unreported impurities and/or gross contaminants.

Commercial grade rose bengal is typically used by researchers

unaffiliated with the Company for non-clinical study of the rose bengal molecule for potential biomedical therapeutic applications.

believe that commercial grade rose bengal is still manufactured using the original historical process, or a variant thereof, developed

by the molecule’s original Swiss creator Rudolph Gnehm in 1881.

Some chemical manufacturers may, however, apply purification techniques

that the Company believes still result in commercial grade rose bengal possessing questionable purity and contaminants and substantial

lot-to-lot manufacturing variability.

Diagnostic-Grade

Company coined this phrase to describe non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions

and strips, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic

diagnostic tests such as the rose bengal test in human brucellosis.

grade rose bengal describes non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions, strips,

and devices, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic

diagnostic tests such as the rose bengal test for human brucellosis.

presume, but have not yet confirmed, that diagnostic grade rose bengal is derived from commercial grade rose bengal that may have undergone

a form of purification and/or may have been compounded under cGMP regulations by a pharmacist, academic medical researcher, or commercial

Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy of rose bengal purity

and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.

a form of purification under cGMP regulations and/or may have been compounded by a pharmacist, academic medical researcher, or commercial

entity under cGMP regulations.

Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy

of diagnostic grade rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.

Analytical Comparison

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and methodically three lots of commercial grade rose bengal, one each from three different specialty chemical suppliers, and compare

and contrast these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS.

This chemical analytical work

was substantially completed by the end of the third quarter of 2022.

The Company believes that the preliminary results of these analyses

indicate that all three lots of commercial grade rose bengal had rose bengal purity that was drastically different from what was represented

on their respective certificates of analysis (“CofAs”), and that one of the three lots contained gross contaminants that

were not represented on its CofA.

these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS.

This chemical analytical work was substantially

completed by the end of the third quarter of 2022.

The Company believes that the preliminary results of these analyses indicate that

all three lots of commercial grade rose bengal had rose bengal purity that was drastically different from what was represented on their

respective certificates of analysis (“CofAs”), and that one of the three lots contained gross contaminants that were not

represented on its CofA.

Barriers to Entry

Company believes that the Company’s proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over

non-pharmaceutical-grades of rose bengal that researchers, clinicians, and academic, business, and/or governmental competitors have used,

are using, and/or may attempt to use for potential biomedical applications.

The Company believes that non-pharmaceutical-grades of rose

bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants, substantial lot-to-lot manufacturing

variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible, consistent, and fulsome CMC

specifications and documentation.

Company believes that historical and potentially hazardous impurities and other manufacturing and handling issues facing non-pharmaceutical

grades of rose bengal may pose significant scientific, technological, and economic challenges to overcome and validate for compliance

with modern drug regulatory standards.

non-pharmaceutical-grade rose bengal (i.e., commercial and diagnostic grades) that researchers, clinicians, and academic, business, and/or

governmental competitors have used, are using, and/or may attempt to use for potential biomedical applications.

The Company believes

that non-pharmaceutical-grade rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants,

substantial lot-to-lot manufacturing variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible,

consistent, and fulsome CMC specifications and documentation.

The Company believes that historical and potentially hazardous impurities

and other manufacturing and handling issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological,

and economic challenges to overcome and validate for compliance with modern drug regulatory standards.

of Operating Results

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and Administrative Expenses

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

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 expense, insurance, and professional fees for legal, patent

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

and accounting services.

of the Years Ended December 31, 2024 and 2023

Refer to tables below for year over year comparison

of revenues and expenses.

to tables below for year-over-year comparison of revenues and expenses.

For the Years Ended

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Research and development tax credit

Interest expense, net

Total Other Expense, Net

Interest expense

Total Other Income (Expense), Net

Net loss attributable to noncontrolling interest

Net loss attributable to common stockholders

$ (4,732,552 )

$ (3,101,768 )

$ (1,630,784 )

the years ended December 31, 2024 and 2023, there was $617,140 and $557,710 respectively, of grant revenue recognized related to qualifying

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and Development

and development expenses were $1,749,240 for the year ended December 31, 2023, a decrease of $640,120 or 26.8% compared to

$2,389,360 for the year ended December 31, 2022.

The decrease was due to lower clinical trial costs associated with full enrollment

of open trials, write-off of old accounts payable, and lower rent expense, partially offset by increased payroll taxes.

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.

following table summarizes our research and development expenses incurred during the years ended December 31, 2024 and 2023:

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and Administrative

and administrative expenses were $1,709,720 for the year ended December 31, 2023, a decrease of $317,908 or 15.7% compared to

$2,027,628 for the year ended December 31, 2022.

The decrease was due to (i) lower legal cost relating to patent application and

general business fees, (ii) lower rent expense, (iii) lower professional fees, (iv) write off of old accounts payable, and (v) more

favorable foreign currency translation cost, partially offset by (vi) higher other general and administrative costs.

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.

following table summarizes our general and administrative expenses incurred during the years ended December 31, 2024 and 2023:

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Rent and utilities

Stock based compensation

Foreign currency translation

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Income/(Expense)

and development tax credits were $15,696 for the year ended December 31, 2023, a decrease of $21,258, compared to $36,954 for the year

ended December 31, 2022.

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.

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

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.

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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 requirement and on-going operations, including

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

the 2025 Financing discussed above;

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

requirements for our current liabilities include approximately $4,964,404 for accounts payable and accrued expenses (including lease

liabilities) and a $277,815 note payable related to our short-term financing of our commercial insurance policies.

converted prior to maturity, convertible debt in the amount of $2,675,000 plus accrued interest will mature one year from the date

of the notes.

The 2022 Notes are only subject to repayment in the event of a change of control or event of default.

Cash requirements for long-term

liabilities include $25,299 for operating lease liabilities.

The Company intends to meet these cash requirements from its current

cash balance and from future financing.

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

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 2022 Financing, the exercise of existing warrants and outstanding

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.

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Cash Provided by Financing Activities

cash provided by financing activities during the years ended December 31, 2023 and 2022 was $2,207,371 and $1,367,841, respectively.

During the year ended December 31, 2023, we received $2,475,000 of proceeds from the issuance of convertible notes payable and paid

$267,629 for the repayment of the short-term note payable.

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 and paid $259,659 for the repayment of the short-term note payable.

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.

Accounting Estimates

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not deemed critical, as defined above.

Accounting Policies

following is not intended to be a comprehensive list of all of our accounting policies or estimates.

Our accounting policies are more

fully described in Note 3 – Summary of Significant Accounting Policies, in our financial statements included at the end of this

Annual Report.

The following represent our most critical accounting policies:

measure the cost of services received in exchange for an award of equity instruments based on the fair value of the award on the date

The fair value amount of the shares expected to ultimately vest is then recognized over the period for which services are required

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

The estimation of stock-based awards that will ultimately vest

requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as

a cumulative adjustment in the period that the estimates are revised.

We account for forfeitures as they occur.

and Development

and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits

for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing

expenses, fees paid to third parties and other outside expenses.

We accrue for costs incurred as the services are being provided by monitoring

the status of the clinical trial or project and the invoices received from our external service providers.

We adjust our accrual as actual

costs become known.

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.

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

Any recognized income tax positions would be measured at the largest amount that is greater than 50% likely of being realized.

in recognition or measurement would be reflected in the period in which the change in judgment occurs.

The Company would recognize any

corresponding interest and penalties associated with its income tax positions in income tax expense.

Company evaluates its convertible instruments to determine if those contracts or embedded components of those contracts qualify as derivative

financial instruments to be separately accounted for in accordance with ASC Topic 815:

Derivatives and Hedging .

The accounting

treatment of derivative financial instruments requires that the Company record qualifying embedded conversion options and any related

freestanding instruments at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance

Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance

The Company reassesses the classification of its derivative instruments at each balance sheet date.

If the classification

changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification.

Embedded conversion options classified as derivative liabilities and any related equity classified freestanding instruments are recorded

as a discount to the host instrument.

Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement

of its preferred stock.

Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at

Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within

the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control)

are classified as temporary equity.

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

revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been

Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as grant

revenue when qualifying costs are incurred.

Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting

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.

Accounting Pronouncements

issued accounting standards are included in Note 3 – Significant Accounting Policies of our consolidated financial statements included

within this annual report.

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