What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-13 compared with 2024-05-14 · 253 added, 186 removed, 181 unchanged (71% of the section changed)

9 unchanged sentences

Development and Drug Discovery

Company’s small molecule HX medical science platform, which comprises several different drug candidates and preclinical

formulations made from pharmaceutical-grade RBS using different concentrations and delivered by different routes of administration specific

to each disease area and/or indication, includes:

Company’s small molecule HX medical science platform, which comprises different drug candidates and non-clinical formulations made

from pharmaceutical-grade RBS using different concentrations and delivered by different routes of administration specific to each disease

and/or disease indication, includes:

Development Programs

(“ITU”) formulation PV-10 ® (“ITU PV-10”) has undergone and is undergoing multiple, monotherapy

and combination therapy, early- to late-stage clinical trials, expanded access programs (“EAPs”) for groups of and individual

patients, and/or quality of life (“QOL”) study at multiple clinical sites in Australia, Europe, and the U.S.

treatments of Stage III and IV melanoma and different types of liver cancers.

ITU PV-10 has undergone clinical monotherapy and combination

therapy mechanism of action and mechanism of immune response study for melanoma, metastatic uveal melanoma, and metastatic neuroendocrine

tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen Elizabeth Hospital in Adelaide, Australia, and

MD Anderson Cancer Center in Houston, Texas.

Topical (“TOP”) formulation PH-10 ® (“TOP PH-10”) has undergone multiple mid-stage, monotherapy

clinical trials for the treatments of psoriasis and atopic dermatitis at different clinical sites in the U.S.

TOP PH-10 has undergone

clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University in New

York, New York (“TRU”).

formulations have undergone preclinical combination therapy study for psoriasis and are undergoing preclinical monotherapy study

Intratumoral (“ITU”) formulation PV-10 ® (“ITU PV-10”) has undergone and is undergoing

multiple, monotherapy and combination therapy, early- to late-stage clinical trials, expanded access programs (“EAPs”)

for groups of and individual patients, and/or quality of life (“QOL”) study at multiple clinical sites in Australia,

Europe, and the U.S.

for the treatments of Stage III and IV melanoma and different types of liver cancers.

ITU PV-10 has undergone

clinical monotherapy and combination therapy mechanism of action and mechanism of immune response study for melanoma, metastatic

uveal melanoma, and metastatic neuroendocrine tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen

Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas.

Topical (“TOP”) formulation PH-10 ® (“TOP PH-10”)

has undergone multiple mid-stage, monotherapy clinical trials for the treatments of psoriasis

and atopic dermatitis at different clinical sites in the U.S.

TOP PH-10 has undergone clinical

monotherapy mechanism of action and mechanism of immune response study for psoriasis at The

Rockefeller University in New York, New York (“TRU”).

formulations have undergone non-clinical combination therapy study for psoriasis and are undergoing non-clinical monotherapy study

for skin inflammation at TRU.

Ophthalmology:

Company believes that clinical monotherapy proof-of-concept (“POC”) of TOP administration of non-pharmaceutical grade

rose bengal for the treatment of infectious keratitis has been shown by clinicians and researchers at the University of Miami’s

The Company believes that clinical monotherapy proof-of-concept (“POC”) of TOP administration of non-pharmaceutical

grade rose bengal for the treatment of infectious keratitis has been shown by clinicians and researchers at the University of Miami’s

Bascom Palmer Eye Institute (“BPEI”) in Miami, Florida, who are now collaborating with the Company to evaluate the potential

use of our pharmaceutical-grade RBS.

PV-305 has undergone preclinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis, at

In Vivo Proof-of-Concept Programs

has undergone preclinical monotherapy and combination therapy study for the treatment of pancreatic cancer and

human papillomavirus-positive and negative head and neck squamous cell carcinoma at Moffitt.

ITU PV-10 has undergone preclinical

monotherapy study for the treatment of penile squamous cell carcinoma at an academic medical center.

ITU PV-10 has undergone preclinical

monotherapy and combination therapy study for the treatment of relapsed and refractory pediatric solid tumor cancers at the University

of Calgary’s Cumming School of Medicine in Calgary, Canada (“UCal”).

The Company believes that the UCal researchers

have achieved in vivo monotherapy POC of ITU administration.

formulations are undergoing preclinical monotherapy study for high-risk and refractory adult solid tumor cancers at UCal.

believes that the UCal researchers and the Company have both achieved in vivo monotherapy POC of PO administration, that the

Company has achieved in vivo monotherapy POC of PO administration in both prophylactic and therapeutic settings, and that

the Company has achieved in vivo monotherapy POC of intravenous (“IV”) administration.

PO formulations

have undergone preclinical monotherapy study for the treatment of refractory and relapsed pediatric and other blood cancers, including

leukemias, at UCal.

The Company believes that the UCal researchers have achieved in vivo monotherapy POC of PO administration.

Wound Healing:

formulations are undergoing preclinical monotherapy study for the healing of full-thickness cutaneous wounds.

The Company believes

that in vivo monotherapy POC of TOP administration of non-pharmaceutical grade rose bengal for the treatment of this indication

has been shown by researchers at the University of Texas Medical Branch in Galveston, Texas, who are now collaborating with the Company

to use our pharmaceutical-grade RBS.

Animal Health:

formulations are undergoing preclinical monotherapy study for the treatment of canine soft tissue sarcomas at the University of Tennessee’s

College of Veterinary Medicine in Knoxville, Tennessee.

The Company believes that it has achieved monotherapy POC of ITU

administration in canines.

In Vitro Drug Discovery Programs

Immune vaccine adjuvant:

Different formulations have undergone and are undergoing preclinical study as a vaccine adjuvant to enhance T cell responses

for anti-viral and anti-cancer vaccines.

PO and intranasal (“IN”) formulations have undergone and are undergoing preclinical monotherapy study for

the treatment of SARS-CoV-2 at UCal, another Canadian academic research center, the University of Tennessee Health Science Center

(“UTHSC”) in Memphis, Tennessee, and a U.S.

PV-305 has undergone non-clinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis, at BPEI.

Proof-of-Concept In Vivo Programs

ITU PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of pancreatic cancer and human

papillomavirus-positive and negative head and neck squamous cell carcinoma at Moffitt.

ITU PV-10 has undergone non-clinical monotherapy

study for the treatment of penile squamous cell carcinoma at an academic medical center.

ITU PV-10 has undergone non-clinical monotherapy

and combination therapy study for the treatment of relapsed and refractory pediatric solid tumor cancers at the University of Calgary’s

Cumming School of Medicine in Calgary, Canada (“UCal”).

The Company believes that the UCal researchers have achieved

in vivo monotherapy POC of ITU administration.

(“PO”) formulations are undergoing non-clinical monotherapy study for high-risk and refractory adult solid tumor cancers

The Company believes that the UCal researchers and the Company have both achieved in vivo monotherapy POC of PO administration,

that the Company has achieved in vivo monotherapy POC of PO administration in both prophylactic and therapeutic settings,

and that the Company has achieved in vivo monotherapy POC of intravenous (“IV”) administration.

PO formulations have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric and other

blood cancers, including leukemias, at UCal.

The Company believes that the UCal researchers have achieved in vivo monotherapy

POC of PO administration.

Different formulations are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds.

The Company believes that in vivo monotherapy POC of TOP administration of non-pharmaceutical grade rose bengal for the treatment

of this indication has been shown by researchers at the University of Texas Medical Branch in Galveston, Texas, who are now collaborating

with the Company to use our pharmaceutical-grade RBS.

Different formulations are undergoing non-clinical monotherapy study for the treatment of canine soft tissue sarcomas

at the University of Tennessee’s College of Veterinary Medicine in Knoxville, Tennessee.

The Company believes that it has achieved

monotherapy POC of ITU administration in canines.

Early Drug Discovery (In Vitro) Programs

vaccine adjuvant:

Different formulations have undergone and are undergoing non-clinical study as a vaccine adjuvant to enhance

T cell responses for anti-viral and anti-cancer vaccines.

PO and intranasal (“IN”) formulations have undergone and are undergoing

non-clinical monotherapy study for the treatment of SARS-CoV-2 at UCal, another Canadian

academic research center, the University of Tennessee Health Science Center (“UTHSC”)

in Memphis, Tennessee, and a U.S.

contract research organization.

formulations have undergone preclinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative

bacterial infections (including multi-drug resistant strains) and have undergone preclinical monotherapy study for the treatment

formulations have undergone non-clinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative

bacterial infections (including multi-drug resistant strains) and have undergone non-clinical monotherapy study for the treatment

of oral bacterial infections at UTHSC.

formulations have undergone preclinical monotherapy study for the treatment of fungal infections at UTHSC.

Tissue Regeneration

Different formulations have undergone preclinical monotherapy study for vertebrate development, wound healing, and

tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada.

Proprietary :

formulations are undergoing preclinical study for a proprietary disease at an academic medical

formulations have undergone non-clinical monotherapy study for the treatment of fungal infections at UTHSC.

Regeneration and Repair :

Different formulations have undergone non-clinical monotherapy study for vertebrate development, wound

healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada.

Different formulations are undergoing non-clinical study for a proprietary disease at an academic medical center.

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

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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.

(“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.

(e.g., PO, IV, IN) 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.

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

10 unchanged sentences

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 processes;

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

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 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).

Nonproprietary Name

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 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 World Health Organization (“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 International Nonproprietary Names (“INN”).

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

INN Recommended

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and/or gross contaminants.

Commercial grade rose bengal is typically used by researchers unaffiliated with the Company for preclinical

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 historical process (or a variant thereof) that was

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

Some manufacturers may, however, apply

purification techniques that the Company believes still result in materials that may possess questionable purity and contaminants and

may also be subject to substantial lot-to-lot manufacturing variability.

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 original Swiss creator Rudolph Gnehm in 1881.

Some manufacturers may, however, apply purification techniques

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

substantial lot-to-lot manufacturing variability.

Diagnostic-Grade

9 unchanged sentences

contract development and manufacturing organization to assess rigorously

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

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

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

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These expenses consist primarily of:

Costs of conducting clinical

trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others;

Salaries and related expenses

for personnel, including stock-based compensation expense;

Other outside service costs

including cost of contract manufacturing;

The costs of supplies and

Occupancy and depreciation

of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among

and related expenses for personnel, including stock-based compensation expense;

outside service costs including cost of contract manufacturing;

costs of supplies and reagents;

and depreciation charges.

expense research and development costs as incurred.

13 unchanged sentences

of Operations

of the Three Months Ended March 31, 2024 and March 31, 2023

revenue was $238,072 for the three months ended March 31, 2024, an increase of $33,047 or 16.1% compared to the three months ended March

Total operating expenses were $685,337 for the three months ended March 31, 2024, a decrease of $301,901 or 30.6% compared

to the three months ended March 31, 2023.

The decrease was driven primarily by (i) reduced professional fees, (ii) decrease in director

fees due to write-off of Bruce Horowitz accrued fees, partially offset by (iii) higher clinical trial costs related to study closure,

(iv) increased payroll and taxes, (v) higher legal costs related to patents and general corporate counsel, and (vi) higher other general

and administrative cost.

Net loss for the three months ended March 31, 2024 was $504,042, a decrease of $323,412 or 39.1% compared to

the three months ended March 31, 2023.

of the Three Months Ended June 30, 2024 and June 30, 2023

revenue was $254,991 for the three months ended June 30, 2024, an increase of $93,149 or 57.6% compared to the three months ended

June 30, 2023.

Total operating expenses were $1,049,845 for the three months ended June 30, 2024, an increase of $87,800 or 9.1%

compared to the three months ended June 30, 2023.

The increase was driven primarily by (i) increased payroll and taxes for the

addition of two officers, (ii) higher clinical trial costs related to study closure, partially offset by (iii) lower directors’

fees and professional fees due to the resignation of Bruce Horowitz, our former Chief Operating Officer, (iv) lower legal

costs related to patents, and (v) lower insurance costs.

Net loss for the three months ended June 30, 2024 was $846,848, an increase

of $11,786 or 1.4% compared to the three months ended June 30, 2023.

For the Three Months Ended

6 unchanged sentences

Total Operating Loss

Other Expense:

Interest expense, net

Other Income/(Expense):

Research and development tax credit

Interest expense

Total Other Expense, Net

the three months ended March 31, 2024 and March 31, 2023, there was $238,072 and $205,025, respectively, of grant revenue recognized

related to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated

statements of operations.

the three months ended June 30, 2024 and June 30, 2023, there was $254,991 and $161,842, respectively, of grant revenue recognized related

to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements

of operations.

and Development Expenses

and development expenses were $555,535 for the three months ended March 31, 2024, a decrease of $7,142 or 1.3% compared to $548,393

for the three months ended March 31, 2023.

The decrease was primarily due to (i) lower insurance costs, partially offset by (ii)

higher clinical trial costs associated with study closure, and (iii) higher payroll and taxes.

The following table summarizes

research and development expenses for the three months ended March 31, 2024 and 2023.

and development expenses were $472,927 for the three months ended June 30, 2024, an increase of $38,713 or 8.9% compared to $434,214

for the three months ended June 30, 2023.

The increase was primarily due to (i) higher clinical trial costs associated with study

closure, and (ii) increased insurance costs.

following table summarizes research and development expenses for the three months ended June 30, 2024 and 2023.

For the Three Months Ended

Increase/(Decrease)

Operating Expenses:

Research and development:

5 unchanged sentences

and Administrative Expenses

and administrative expenses were $129,802 for the three months ended March 31, 2024, a decrease of $309,043 or 70.4% compared to $438,845

for the three months ended March 31, 2023.

The decrease was primarily due to (i) lower professional fees, (ii) reversal of director fees

Horowitz upon his resignation on March 25, 2024, partially offset by (iii) higher legal fees related to patents and corporate

matters pertaining to the 2024 proxy statement and officer’s resignation, and (iv) higher other general and administrative costs.

The following table summarizes

general and administrative expenses for the three months ended March 31, 2024 and 2023.

and administrative expenses were $576,918 for the three months ended June 30, 2024, an increase of $49,087 or 9.3% compared to

$527,831 for the three months ended June 30, 2023.

The increase was primarily due to (i) increased payroll and taxes for the

addition of two new officers, and (ii) increased other general and administrative costs, partially offset by (iii) lower

directors’ fees and professional fees due to the resignation of Bruce Horowitz, our prior Chief Operating Officer, (iv) lower

insurance costs, and (v) lower legal costs related to patents.

following table summarizes general and administrative expenses for the three months ended June 30, 2024 and 2023.

For the Three Months Ended

Increase/(Decrease)

Operating Expenses:

General and administrative:

5 unchanged sentences

Rent and utilities

Foreign currency translation

Foreign currency transactions

Total general and administrative

interest expense increased by $11,536 or 25.5% from $45,241 for the three months ended March 31, 2023 to $56,777 for the three

months ended March 31, 2024.

Interest expense increased by $10,471 or 20.6% from $50,824 for the three months ended June 30, 2023 to $61,295 for the three months

ended June 30, 2024.

The increase was mainly due to the interest expense costs incurred in connection with the higher notes payable

and convertible debt balances.

and development tax credit in Australia decreased by $6,664 or 41.7% from $15,965 for the three months ended June 30, 2023 to $9,301

for the three months ended June 30, 2024.

The decrease was mainly due to no active clinical trials currently in Australia.

of the Six Months Ended June 30, 2024 and June 30, 2023

revenue was $493,063 for the six months ended June 30, 2024, an increase of $126,196 or 34.4% compared to the six months ended June

Total operating expenses were $1,735,182 for the six months ended June 30, 2024, a decrease of $214,101 or 11.0% compared

to the six months ended June 30, 2023.

The decrease was driven primarily by (i) reduced directors’ fees and professional fees

due to the resignation of Bruce Horowitz, our former Chief Operating Officer, partially offset by (ii) higher clinical trial costs related to study

closure, (iii) increased payroll and taxes due to the addition of two new officers, (iv) higher legal costs related to patents and

general corporate counsel, and (v) higher other general and administrative cost.

Net loss for the six months ended June 30, 2024

was $1,350,890, a decrease of $311,626 or 18.7% compared to the six months ended June 30, 2023.

For the Six Months Ended

Increase/(Decrease)

Grant Revenue

Operating Expenses:

Research and development

General and administrative

Total Operating Expenses

Total Operating Loss

Other Income/(Expense):

Research and development tax credit

Interest expense

Total Other Expense, Net

$ (1,350,890 )

$ (1,662,516 )

the six months ended June 30, 2024 and June 30, 2023, there was $493,063 and $366,867, respectively, of grant revenue recognized related

to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements

of operations.

and Development Expenses

and development expenses were $1,028,462 for the six months ended June 30, 2024, an increase of $45,855 or 4.7% compared to $982,607

for the six months ended June 30, 2023.

The increase was primarily due to (i) higher clinical trial costs associated with study closure,

and (ii) higher payroll and taxes.

following table summarizes research and development expenses for the six months ended June 30, 2024 and 2023.

the Six Months Ended

Increase/(Decrease)

and development:

trial and research expenses

Depreciation/amortization

and utilities

research and development

and Administrative Expenses

and administrative expenses were $706,720 for the six months ended June 30, 2024, a decrease of $259,956 or 26.9% compared to

$966,676 for the six months ended June 30, 2023.

The decrease was primarily due to (i) lower directors’ fees and professional

fees due to the resignation of Bruce Horowitz, our prior Chief Operating Officer partially offset by (ii) higher legal fees related

to patents and corporate matters pertaining to the 2024 proxy statement and officer’s resignation, (iii) higher payroll and

taxes due to addition of two new officers, and (iv) higher other general and administrative costs due to a refund received in 2023

for employee retention.

following table summarizes general and administrative expenses for the six months ended June 30, 2024 and 2023.

the Six Months Ended

Increase/(Decrease)

and administrative:

and litigation

general and administrative cost

and utilities

currency transactions

general and administrative

Interest expense increased by $22,007 or 22.9% from $96,065 for the six months ended June 30, 2023 to $118,072 for the six months

ended June 30, 2024.

The increase was mainly due to the interest expense costs incurred in connection with the higher notes payable

and convertible debt balances.

and development tax credit in Australia decreased by $6,664 or 41.7% from $15,965 for the six months ended June 30, 2023 to $9,301 for

the six months ended June 30, 2024.

The decrease was mainly due to no active clinical trials currently in Australia.

and Capital Resources

Company’s cash and restricted cash were $762,752 at March 31, 2024 which includes $744,717 of restricted cash resulting from a

grant received from the State of Tennessee, compared to $1,026,799 at December 31, 2023, which included $950,223 of restricted cash.

The Company’s working capital deficit was $7,507,105 and $7,652,098 as of March 31, 2024 and December 31, 2023, respectively.

condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q have been prepared on a

basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.

We have continuing net losses and negative cash flows from operating activities.

In addition, we have an accumulated deficit of $253,194,451

as of March 31, 2024.

These conditions raise substantial doubt about our ability to continue as a going concern for a period within one

year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued.

Our financial statements

do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable

to continue as a going concern.

Our ability to continue as a going concern depends on our ability to obtain additional financing as may

be required to fund current operations.

of March 31, 2024, cash required for our current liabilities included approximately $4,515,249 for accounts payable and other accrued

Company’s cash and restricted cash were $589,283 at June 30, 2024 which includes $559,702 of restricted cash resulting from a grant

received from the State of Tennessee, compared to $1,026,799 at December 31, 2023, which included $950,223 of restricted cash.

The Company’s

working capital deficit was $7,569,256 and $7,652,098 as of June 30, 2024 and December 31, 2023, respectively.

We have continuing net

losses and negative cash flows from operating activities.

In addition, we have an accumulated deficit of $254,041,299 as of June 30,

These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year from the

date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued.

The condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q

have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal

course of business.

Our financial statements do not

include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue

as a going concern.

Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required

to fund current operations.

of June 30, 2024, cash required for our current liabilities included approximately $4,760,347 for accounts payable and other accrued

expenses (including operating lease liabilities) and a $109,862 note payable related to our short-term financing of our commercial insurance

1 unchanged sentence

year from the date of the notes.

As of March 31, 2024, cash required for our long-term liabilities consists of $12,729 for our operating

The Company intends to meet these cash requirements from its current cash balance and from future financing.

1 unchanged sentence

(the “2024 Financing”), to fund our capital requirements and on-going operations;

however, there can be no assurance that

the Company will be successful in these efforts.

Significant funds will be needed to continue and complete our ongoing and planned clinical

however, there can be no assurance that the Company

will be successful in these efforts.

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

plans to access capital resources through possible public or private equity offerings, including the 2024 Financing, equity financings,

3 unchanged sentences

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

however, there can

be no assurance that management will be successful in implementing the Company’s business plan of developing, licensing,

and/or commercializing our prescription drug candidates.

Moreover, even if we are successful in improving our current cash flow

position, we nonetheless plan to seek additional funds to meet our current and long-term requirements in 2024 and beyond.

anticipate 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 we believe that we have a reasonable

basis for our expectation that we will be able to raise additional funds, there can be no assurance that we will be able to obtain

funds on commercially acceptable terms, or complete additional financing in a timely manner.

In addition, any such financing may

result in significant dilution to stockholders.

however, there can be

no assurance that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing

our prescription drug candidates.

Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan

to seek additional funds to meet our current and long-term requirements in 2024 and beyond.

We anticipate that these funds will otherwise

come from the proceeds of private placement transactions, the exercise of outstanding stock options, or public

offerings of debt or equity securities.

While we believe that we have a reasonable basis for our expectation that we will be able to

raise additional funds, there can be no assurance that we will be able to obtain funds on commercially acceptable terms, or complete

additional financing in a timely manner.

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

Accounting Estimates

prepare our consolidated financial statements in accordance with U.S.

GAAP, which require our management to make estimates that

affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as

well as the reported amounts of revenues and expenses during the reporting periods.

To the extent that there are material differences

between these estimates and actual results, our financial condition or results of operations would be affected.

We base our estimates

on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations

for the future based on available information.

We evaluate these estimates on an ongoing basis.

prepare our condensed consolidated financial statements in accordance with U.S.

GAAP, which require our management to make estimates

that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet

dates, as well as the reported amounts of revenues and expenses during the reporting periods.

To the extent that there are material

differences between these estimates and actual results, our financial condition or results of operations would be affected.

our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our

circumstances and expectations for the future based on available information.

We evaluate these estimates on an ongoing

consider an accounting estimate to be critical if:

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What changed 10-Q

Item 2. Management’s Discussion and Analysis