What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-08-15 compared with 2024-09-30 · 221 added, 214 removed, 45 unchanged (91% of the section changed)

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elsewhere in this report.

We are a clinical-stage company developing innovative

drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders.

(the “Company” or “we”

or “our”) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative

disorders and advanced liver disease.

Neurodegenerative Disease Program

The Company acquired the biopharmaceutical assets

of NeurMedix a privately held clinical-stage pharmaceutical company and a related party in June 2021 .

The acquired assets included

In April 2024, the Company announced that the United States Adopted Names Council, and the World Health Organization International

Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107.

(NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance

and major pathological inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus that both inflammation

and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could, if approved by FDA,

represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering

from AD and 1 million Americans suffering from PD.

The Company acquired the biopharmaceutical

assets of NeurMedix, Inc.

(“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in

The acquired assets included NE3107 (or “bezisterim”).

Bezisterim, the approved generic name for NE3107 is

an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and

major pathological inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus that both

inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)

and Parkinson’s disease (“PD”), and bezisterim could, if approved by the U.S.

Food and Drug Administration

(“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6

million Americans suffering from AD, 1 million Americans suffering from PD and Long COVID affects approximately 20 million adults in

the US, and millions more worldwide.

In neurodegenerative disease, bezisterim (NE3107)

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inflammation and insulin resistance are drivers of AD and PD.

About Inflammation and Bezisterim’s (NE3107’s)

Mechanism of Action

Neuroinflammation, insulin resistance, and oxidative

stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and ALS.

(NE3107) is an orally bioavailable, blood-brain permeable, small molecule, with potential anti-inflammatory, insulin sensitizing, and

ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.

(NE3107’s) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the

molecule in AD and PD patients.

Parallels exist between AD and PD, among them activated

microglia driving inflammation, involvement of TNFα, oxidative stress, protein misfolding, mitochondrial dysfunction, and insulin

In preclinical and clinical studies, bezisterim (NE3107) reduced inflammation and enhanced insulin sensitivity, both of which

are important to PD pathology.

Preclinical studies in marmoset monkeys have shown bezisterim (NE3107) administered alone to be as pro-motoric

as levodopa, underscoring the apparently critical role of inflammation in expression of PD motor symptoms.

When bezisterim (NE3107) was

administered with levodopa, the combination improved motor control better than either drug alone.

Furthermore, in the marmoset study,

bezisterim (NE3107) reduced the severity of LID concurrent with pro-motoric benefit and decreased neurodegeneration, preserving twice

as many dopaminergic neurons compared to control.

Chronic neuroinflammation, insulin resistance,

and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and

Amyotrophic lateral sclerosis.

Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential

anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated

inflammation.

Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s

work testing the molecule in AD, PD, and long COVID patients.

Bezisterim (NE3107) is patented in the United States, Australia, Canada,

Europe and South Korea.

Parkinson’s Disease

Parkinson’s disease (PD), which affects an estimated

1 million Americans, is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory

cytokines (particularly TNF).

Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard

of care treatment for this movement disorder, but levodopa effectiveness diminishes over time necessitating increased dosage and prolonged

daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID,

which is exacerbated by high dose levodopa.

Although levodopa provides symptomatic benefit, it does not slow PD progression.

PD is driven in large part by neuroinflammation

and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF).

Multiple daily administrations of

levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder.

However, levodopa

effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled

movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa.

Although levodopa

provides symptomatic benefit, it does not slow PD progression.

The Phase 2 study of bezisterim (NE3107) for the

treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics

study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).

Forty-five patients with a defined L-dopa “off

state” were randomized 1:1 to placebo:

bezisterim (NE3107) 20 mg twice daily for 28 days.

This trial was launched with two design

1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for

adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa;

and 2) the secondary objective was to determine if preclinical indications

of promotoric activity and apparent enhancement of levodopa activity could be seen in humans.

Both objectives were met.

To extend this Phase 2 data in progressed patients,

the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset

In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with

The trial commenced in April 2025.

Long COVID Program

In April 2024, the Company announced the grant of

a clinical trial award of up to $13.1 million from the U.S.

Department of Defense, awarded through the Peer Reviewed Medical Research

In April 2024, the Company was awarded a clinical

trial grant of $13.1 million from the U.S.

Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research

Program of the Congressionally Directed Medical Research Programs.

The award can provide up to 2 years of non-dilutive funding for a Phase

2 clinical trial that will assess bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID.

The Company anticipates the trial to commence by early 2025.

The study protocol has been finalized and submitted to the FDA for regulatory

review in July 2024.

The FDA notified the Company that the study can proceed on August 22, 2024.

Long COVID is a condition in which symptoms of COVID-19,

the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more.

The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently

or previously had long COVID.

Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating.

in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars.

there are no therapies proven effective for treatment.

Chronic inflammation is one of the main hypotheses

that researchers have proposed to explain the persistence of symptoms in long COVID.

Specifically in individuals with “brain fog,”

sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features.

Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the inhibition of NF-kB activation, thus representing

a novel oral treatment targeting an underlying cause of long COVID symptoms.

Chronic neuroinflammation, insulin resistance, and

oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic

lateral sclerosis.

Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory,

insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.

Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work

testing the molecule in AD, PD, and long COVID patients.

Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe

and South Korea.

In August 2024, the FD&A and the U.S.

Army Medical Research and

Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving

the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms

that are associated with long COVID.

The trial commenced in May 2025.

Liver Disease Program

In liver disease, our investigational drug candidate

BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is

being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis

caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism.

The initial target for BIV201 therapy was refractory ascites.

These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have

an estimated 50% mortality rate within 6 to 12 months.

After receiving guidance from the FDA regarding

the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting

a broader ascites patient population.

The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus

on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis

and ascites who have recently recovered from acute kidney injury (“AKI”).

This patient population is not limited to those

having refractory ascites.

BIV201 is administered as a patent-pending liquid formulation with patents issued in US, China, Japan, Chile

and India to date.

Alzheimer’s Disease (NCT05083260)

On November 29, 2023, the Company announced the

analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild

to moderate AD.

The study had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive

Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

Patients were randomly assigned, 1:1 versus

placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed

by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the

process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)

violations at 15 study sites (virtually all of which were from one geographic area).

This highly unusual level of suspected improprieties

led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)

for potential further action.

After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom

were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic

The trial was originally designed to be 80% powered

with 125 patients in each of the treatment and placebo arms.

The unplanned exclusion of so many patients left the trial underpowered for

the primary endpoints.

In the Per-Protocol population, which included those patients who completed the trial and who were further verified

to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing

of cognitive loss;

these same patients experienced an advantage in age deceleration vs.

placebo as measured by DNA epigenetic change.

Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as

measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.

This test was a non-primary/secondary

endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).

Additional DNA methylation data continues to

be collected and analyzed.

Results of Operations

Comparison of the Year Ended June 30, 2024 to

the Year Ended June 30, 2023

The net loss was approximately $33.0 million and $50.3

million for the years ended June 30, 2024 and 2023, respectively.

The decrease in net loss of approximately $17.3 million was comprised

of a net decrease in research and development expenses of approximately $10.2 million and selling, general and administrative expenses

of approximately $2.7 million, and further reduced by an increase in interest income of approximately $574,000, a reduction in interest

expense of approximately $1.4 million and the reduction in the fair value of derivative liabilities of approximately $3.3 million.

Total operating expenses were approximately $32.2

million and $45.1 million for the year ended June 30, 2024, and 2023, respectively.

The net decrease of approximately $12.9 million

for the year ended June 30, 2024, was comprised of a decrease in research and development expenses of approximately $10.2 million and

a decrease in selling, general and administrative expenses of approximately $2.7 million.

Comparison of the Year Ended June 30, 2025

to the Year Ended June 30, 2024

The net loss for the year ended June 30, 2025,

was approximately $17.5 million as compared to the net loss of $32.1 million for the year ended June 30, 2024.

The net decrease of $14.6

million was primarily attributed to decline in research and development expenses of $13.8 million, and a net increase in other income,

net of approximately $465,000.

Total operating expenses for the years ended June

30, 2025 and 2024 were approximately $18.1 million and $32.2, respectively.

The net decrease of approximately $14.1 million was

primarily due to the decrease in research and development expenses as a result of the completion of clinical trials in the prior fiscal

Research and Development Expenses

Research and development expenses were approximately $23.1 million

and $33.3 million for the year ended June 30, 2024, and 2023, respectively.

The net decrease of approximately $10.2 million for the year

ended June 30, 2024, was primarily attributed to a reduction in expenses totaling approximately $13.8 million due to the completion of

clinical studies, offset by increased expenses of approximately $3.6 million primarily comprised of the planning and development of new

studies of approximately $836,000 which included the development of Sunrise 1 PD PH2b and Radiance 1 AD MCI Ph2b/3 studies which have

been put on hold in the first quarter of the fiscal year ended June 30,2024 pending financing and were designed to be large potentially

registrational studies.

an increase in Chemistry, Manufacturing and Controls (“CMC”) expense of approximately $1.0 million

for drug production and development, an increase in clinical team compensation from the clinical team expansion and the use of consultants

totaling approximately $732,000 and $474,000, respectively, and other increases in regulatory and other consultants of approximately $362,000

and publications and travel of approximately $187,000.

The decreased expenses from completed clinical studies of approximately $13.8 million

were comprised of approximately $2.7 million from Ascites BIV201 Phase 2b study, approximately $2.1 million from the PD Phase 2 study,

both studies were completed in the prior fiscal year ended June 30, 2023, approximately $238,000 from the Investigator-Initiated Trial

in MCI and Mild Alzheimer’s Disease, and approximately $8.8 million from the AD pivotal Phase 3 clinical study that completed on

December 31, 2023.

The following summarizes the expenses incurred during the fiscal years

ending June 30, 2024 and 2023 for new developmental studies and the completed studies:

New Development

Research and development expenses were approximately $9.3 million and

$23.1 million for the years ended June 30, 2025 and 2024, respectively.

The $13.8 million reduction was primarily attributed to the completion

of the clinical studies in the prior fiscal year and comprised of a declines in direct study costs of approximately $7.4 million, and

the related expenses such as the clinical team payroll of approximately $1.4 million, and consultants expenses of approximately $3.0 million,

reflecting a declining use of consultants and a reduction in the use of regulatory and other consultants totaling approximately $496,000.

Other decreases included a decrease in Chemistry, Manufacturing and Controls (“CMC”) and new drug discovery totaling approximately

$1.2 million, and a decrease in travel & conferences of approximately $123,000, as well as publications of approximately $166,000.

The decrease in clinical studies of approximately $7.4 million represented

the net decrease in clinical trial studies expense of approximately $10.8 million due to the completion of the clinical trials in the

prior fiscal year offset primarily by the planning, development and launch of the two new clinical studies, Sunrise PD Phase 2 and Long

Covid Program, totaling approximately $3.3 million.

The table below summarizes the approximate expense amounts for the years ended June

30, 2025 and 2024 by study:

For the Year Ended

June 30, 2025

June 30, 2024

Current Studies

Sunrise PD Phase 2

Long Covid Program

Sunrise 1 PD PH2b (On hold)

Radiance 1 AD MCI-301 Ph2b/3 (On hold)

Liver Program Phase 3

Long COVID Program, net of $5.3 million reimbursement

Investigator-Initiated studies

Completed Studies

Ascites BIV201 Phase 2b

$ (2,705,000 )

AD mild to moderate pivotal Phase 3

PD NM201 Phase 2

Investigator-Initiated studies

Other studies in development/canceled

$ (10,754,000 )

Selling, General and Administrative Expenses

Selling, general and administrative expenses were

approximately $8.8 million and $11.6 million for the year ended June 30, 2024 and 2023, respectively.

The net decrease of approximately

$2.7 million was primarily attributed to decreased stock and cash compensation of approximately $2.8 million of the executives and directors,

and a decline in investor relations fees of approximately $396,000, offset by insurance expense of approximately $248,000 and legal fees

of approximately $306,000.

Selling, general and administrative expenses for the year ended June

30, 2025, was approximately $8.6 million and was comparable to approximately $8.8 million for the year ended June 30, 2024.

The net fluctuations

in expenses were primarily comprised of decreases in stock-based compensation for the executive team and directors of approximately $436,000

and $595,000, respectively, and investor and public relation fees of $210,000, offset by increases in directors’ cash compensation

of approximately $101,000, other professional and consultancy fees of approximately $582,000, legal fees of approximately $468,000, and

audit and accounting fees of approximately $82,000.

Other Income and Expense

Other income, net was approximately $59,000 compared

to other expense, net of $5.2 million, for the year ended June 30, 2024 and 2023, respectively.

The net increase in other income of approximately

$5.2 million was primarily driven by the change in fair value of the derivative liabilities of approximately $3.3 million, reduction in

interest expense of approximately $1.4 million due to amortization and accretion of the financing costs, unearned discount, and premium

relating to the note payable, and an increase in interest income of approximately $574,000 from the investment in U.S.

Treasury Bills.

Other income, net was approximately $524,000 for

the year ended June 30, 2025, compared to approximately $59,000 for the year ended June 30, 2024.

The net increase in other income of

approximately $465,000 was comprised of a decrease in the change in fair value of the related derivative liabilities of approximately

$1.8 million, offset by the decline in interest expense, net $2.6 million due to the payoff of the notes payable on December 1, 2024 and

decline in interest income of approximately $284,000.

Capital Resources and Liquidity

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$19.0 million, and an accumulated deficit of approximately $352.1 million.

Additionally, the Company had a net loss of approximately $32.1 million and net cash used in operating activities of approximately $27.9

million during the year ended June 30, 2024.

In addition, the Company has not generated any revenues to

date and no revenues are expected in the foreseeable future.

The Company’s future operations are dependent on the success of the

Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed.

cash flows could be extended if further measures are taken to delay planned expenditures in our research protocols and slow the progress

in the Company’s development and launch of next phase clinical programs.

The future viability of the Company is largely dependent

upon its ability to raise additional capital to finance its operations.

Management expects that future sources of funding may include

sales of equity, obtaining loans, or other strategic transactions.

Additionally, the Company had a net loss of approximately $17.5

million and net cash used in operating activities of approximately $19.0 million during the year ended June 30, 2025.

The Company has

not generated any revenues to date and no revenues are expected in the foreseeable future.

The Company’s future operations are dependent

on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing

The future viability of the Company is largely dependent upon its ability

to raise additional capital to finance its operations.

Management expects that future sources of funding may include sales of equity,

obtaining loans, or other strategic transactions.

Although management continues to pursue the Company’s

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the outcome of this uncertainty.

At-The-Market Facility

On August 31, 2022, the Company entered into a Sales

Agreement with Cantor, pursuant to which the Company may issue and sell from time-to-time shares of the Company’s Common Stock through

Cantor, subject to the terms and conditions of the Sales Agreement.

During the year ended June 30, 2024, the Company sold 333,749 shares

of its Common Stock under the ATM Agreement with Cantor for total net proceeds of approximately $9.3 million after 3% commissions and

cost totaling approximately $377,000.

Underwritten Offering

On March 6, 2024, the Company closed the best efforts

public offering (the “March 2024 Offering”) of 1,500,000 shares (the “Shares”) of Common Stock, pre-funded warrants

(the “Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase up to 1,050,000 shares of

Common Stock (the “Common Warrants”) (CUSIP 09074F132) at a combined public offering price of $10.00 per Share, or Pre-funded

Warrant, and the associated Common Warrant.

The gross proceeds to the Company from the March 2024 Offering were approximately $21 million,

before deducting placement agent fees and offering expenses of approximately $2.5 million.

Upon closing of the March 2024 Offering, the

Company issued the placement agent a warrant (“Placement Agent’s Warrant”) to purchase 105,000 shares of Common Stock

exercisable at a per share price of $12.50, which was equal to 125% of the public offering price per Share.

The Placement Agent’s

Warrant is exercisable during a five-year period commencing 180 days from March 6, 2024.

Registered Direct Offerings

On September 25, 2024, the Company closed a best

efforts public offering (the “September 2024 Offering”) of 136,080 shares of its common stock, par value $0.0001 per share,

pre-funded warrants (the “September Pre-funded Warrants”) to purchase 60,000 shares of Common Stock, and warrants to purchase

up to 196,080 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $15.30 per share,

or September Pre-funded Warrant, and the associated September Common Warrant.

26,500 September Pre-funded Warrants were exercised shortly

thereafter and reflected on the statement of changes in stockholders’ equity as a component of proceeds from issuance of common

The September Common Warrants have an exercise price of $15.30 per share and were immediately

exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.

The gross proceeds to the

Company from the September 2024 Offering was approximately $3.0 million, before deducting placement agent fees and offering expenses of

approximately $747,000.

Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s

Warrants”) to purchase 9,809 shares of Common Stock exercisable at a per share price of $19.10, which was equal to 125% of the public

offering price per share.

The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days

from September 25, 2024.

Subsequently, 189,630 of common warrants from the September 2024 Offering were exercised at $15.30 per

share for proceeds totaling approximately $2.9 million, and 33,500 September Pre-funded Warrants were also exercised.

In addition, 667

September Placement Agent’s Warrants were exercised on a cashless exercise basis and 422 common shares were issued.

In October 2024, the Company closed three registered

direct offerings totaling 825,600 shares of its common stock, par value $0.0001 per share, and two concurrent private placements of warrants

to purchase up to 711,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at

prices ranging from $15.00 to $28.30 per share (the “October Offerings”) .

Common Warrants have exercise prices ranging from $13.70 to $21.20 per share and are exercisable beginning six months following issuance

and will expire on the fifth anniversary date of the original issuance dates.

The gross proceeds to the Company from the October

Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately $2.5 million.

Additionally, upon closing of the October Offerings, the Company issued placement agent warrants (the “October Placement Agent’s

Warrants”) to purchase 41,321 shares of Common Stock in the aggregate exercisable at a per share price ranging from $18.80 to $35.40,

which was equal to 125% of the offering price per share in the applicable October Offering.

The October Placement Agent’s Warrants

are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.

Off-Balance Sheet Arrangements

The term “off-balance sheet arrangement” generally means any

transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party, under which the

Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest;

or (ii) a retained or contingent

interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect or change

on the Company’s financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources

that are material to investors.

The term “off-balance sheet arrangement”

generally means any transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party,

under which the Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest;

a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market

risk support for such assets.

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or

future effect or change on the Company’s financial condition, revenues or expenses, results of operations, liquidity, capital expenditures

or capital resources that are material to investors.

Critical Accounting Policies and Estimates

Cash and cash equivalents

Cash and cash equivalents consisted of cash deposits

and money market funds held at a bank and funds held in a brokerage account which included a U.S.

treasury money market fund and U.S.

Treasury Bills with original maturities of three months or less.

Concentration of Credit Risk in the Financial Service

As of June 30, 2024, the Company had cash deposited

in certain financial institutions in excess of federally insured levels.

The Company regularly monitors the financial stability of these

financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.

However, in March

and April 2023, certain U.S.

government banking regulators took steps to intervene in the operations of certain financial institutions

due to liquidity concerns, which caused general heightened uncertainties in financial markets.

While these events have not had a material

direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and

financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing

arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

Investments in U.S.

Treasury Bills

Investments in U.S.

Treasury Bills with maturities

greater than three months, are accounted for as available for sale and are recorded at fair value.

Unrealized gains were included in other

comprehensive income in the accompanying statements of operations and comprehensive loss.

Research and Development

Research and development expenses consist primarily of costs associated with the preclinical and/or clinical

trials of drug candidates, compensation and other expenses for research and development, personnel, supplies and development materials,

costs for consultants and related contract research and facility costs.

Accounting for Stock-based Compensation

The Company follows the provision of Accounting Standards

Codification (“ASC”) Topic 718 - Stock Compensation (“ASC 718”), which requires the measurement of compensation

Research and development expenses and corresponding

accrued expenses, consist primarily of costs associated with the preclinical and/or clinical trials of drug candidates, compensation and

other expenses for research and development, personnel, supplies and development materials, costs for consultants and related contract

research costs.

Stock-based Compensation

The Company follows the provision of Accounting

Standards Codification (“ASC”) Topic 718 - Stock Compensation (“ASC 718”), which requires the measurement of compensation

expense for all share-based payment awards made to employees and non-employee director, including employee stock options.

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as an expense over the requisite service period, net of forfeitures which are recorded as they occur.

Fair value measurement of assets and liabilities

We determine the fair values of our financial instruments

based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable

inputs when measuring fair value.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability

in an orderly transaction between market participants at the measurement date.

The fair value assumes that the transaction to sell the

asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the

fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset

or liability.

The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant

to the fair value measurement.

The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:

Level 1 - Inputs are unadjusted quoted prices in active

markets for identical assets or liabilities.

Level 2 - Inputs are quoted prices for similar assets

and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market

corroboration, for substantially the full term of the financial instrument.

Level 3 - Inputs are unobservable inputs based on

our assumptions.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

1 unchanged sentence

FINANCIAL STATEMENTS

Our financial information required to be filed hereunder

are indexed under Item 15 of this report and are incorporated herein by reference.

Our financial information required to be filed

hereunder are indexed under Item 15 of this report and are incorporated herein by reference.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES

1 unchanged sentence

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