What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-14 compared with 2024-02-13 · 205 added, 157 removed, 94 unchanged (79% of the section changed)

Management’s Discussion and Analysis of Financial

Condition and Results of Operations

This report contains forward-looking statements

within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as

Management’s Discussion and Analysis of Financial Condition

and Results of Operations

This report contains forward-looking statements within

the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended.

Any statements contained in this report that are not statements of historical fact may be forward-looking statements.

use the words “intends,” “estimates,” “predicts,” “potential,” “continues,”

“anticipates,” “plans,” “expects,” “believes,” “should,” “could,”

“may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking

Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements

to be materially different from those expressed or implied by forward-looking statements.

When we use the

words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,”

“plans,” “expects,” “believes,” “should,” “could,” “may,” “will”

or the negative of these terms or other comparable terminology, we are identifying forward-looking statements.

Forward-looking statements

involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those

expressed or implied by forward-looking statements.

These factors include, among others:

and development activities and distributor channel;

our research and development activities and distributor

compliance with regulatory requirements;

and our ability to satisfy our capital needs

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results,

levels of activity, performance or achievements.

You are cautioned not to place undue reliance

on the forward-looking statements in this report, which speak only as of the date of this report.

Except as may be required by applicable

law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking

and our ability to satisfy our capital needs Although we believe that the expectations

reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

You are cautioned not to place undue reliance on the

forward-looking statements in this report, which speak only as of the date of this report.

Except as may be required by applicable law,

we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking

statements contained in this report as a result of new information or future events or developments, except as required by law.

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factors that may affect our business.

The following discussion of the Company’s

financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing

elsewhere in this report.

The following discussion of the Company’s financial

condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere

in this report.

Management’s Discussion

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neurological and neuro-degenerative disorders and liver disease.

The Company acquired

the biopharmaceutical assets of NeurMedix, Inc.

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

related party in June 2021 .

The Company acquired the biopharmaceutical assets of NeurMedix, Inc.

(“NeurMedix”)

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

The acquired assets included 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 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.

Neurodengenerative

Disease Program

In April 2024, the Company announced that the United States Adopted Names (“USAN”) Council, and the World Health Organization

(“WHO”) International Nonproprietary Names (INN) expert committee had approved “bezisterim” as the non-proprietary

(generic) name for NE3107.

Bezisterim (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.

Neurodengenerative Disease Program

In neurodegenerative disease, the Company’s

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of AD and PD.

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 NE3107 in

the treatment of mild to moderate AD.

The study has 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 NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days,

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 (NE3107) in the treatment of mild

to moderate AD.

The study has 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 (NE3107) 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 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 data.

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 has 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;

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 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 data.

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 has 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.

Based on the efficacy signal seen in this trial, the Company is exploring

(1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling patients to achieve

statistical significance;

and/or (2) designing a new Phase 3 study of NE3107 that leverages the most recent data and understanding of

the potential effect NE3017 may have in helping persons with AD.

Disease (NCT05083260)

The Phase 2 study

of 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 NE3107.

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

state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days.

placebo as measured by DNA epigenetic

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.

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.

Based on the efficacy signal seen in this trial, the

Company is exploring (1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling

patients to achieve statistical significance;

and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most

recent data and understanding of the potential effect bezisterim (NE3107) may have in helping persons with AD.

Parkinson’s Disease (NCT05083260)

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 objectives:

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

interactions of NE3107 with carbidopa/ levodopa;

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

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The initiation of trial design

for a Phase 3 study of NE3107 for the treatment of PD is currently on hold, pending additional funding.

Neuroinflammation, insulin

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

and Amyotrophic lateral sclerosis.

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.

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.

NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.

for a Phase 3 study of bezisterim (NE3107) for the treatment of PD is currently on hold, pending additional funding.

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 (“DOD”), awarded through the Peer Reviewed

Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”).

can provide up to 2 years of non-dilutive funding for a Phase 2b 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.

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 activation of NF-kB, thus representing a novel

oral treatment targeting an underlying cause of long COVID symptoms.

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.

(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.

Liver Disease Program

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BIV201 is administered as a patent-pending liquid formulation.

In June 2021, the Company initiated a Phase 2

study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment

In June 2021, the Company initiated a Phase 2 study

(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment

cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites.

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to a pre-treatment period.

In March 2023 the company announced enrollment

was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites

fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.

In March 2023 the company announced enrollment was

paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid

during the 28 days after treatment initiation compared to the 28 days prior to treatment.

The change in ascites volume was significantly

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refractory ascites.

The BIV201 development program was initiated by

LAT Pharma LLC.

The BIV201 development program was initiated by LAT

On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.

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on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett

Comparison of the three months ended December 31, 2023 to the three

months ended December 31, 2022

The net loss for the three months ended December

31, 2023, was approximately $8.4 million compared to a net loss of $15.7 million for the three months ended December 31, 2022.

in net loss of approximately $7.3 million was comprised of reduced research and development expenses of approximately $563,000, a decrease

in selling, general and administrative expenses of approximately $2.2 million, an increase in interest income of approximately $135,000,

a reduction in interest expense of approximately $233,000 and the change in the fair value of derivative liabilities of $4.2 million.

Total operating expenses for the three months

ended December 31, 2023, were approximately $8.8 million as compared to $11.5 million for the three months ended December 31, 2022.

net decrease of approximately $2.7 million for the three months ended December 31, 2023 represented a net decrease in research and development

expenses of approximately $563,000 due to the completion of clinical trials and a decrease in selling general and administrative expenses

of approximately $2.2 million from a decline in stock compensation expense of approximately $2.1 million.

Comparison of the three months ended March 31, 2024 to the three months

ended March 31, 2023

The net loss for the three months ended March 31,

2024 and 2023, was approximately $8.1 million compared to a net loss of $15.0 million, respectively.

The net decrease in net loss of approximately

$6.9 million was due to reduced research and development expenses of approximately $5.5 million, a decrease in selling, general and administrative

expenses of approximately $546,000, a reduction in interest expense of approximately $454,000 and the change in the fair value of derivative

liabilities of approximately $475,000.

Total operating expenses for the three months ended

March 31, 2024, were approximately $7.7 million as compared to $13.8 million for the three months ended March 31, 2023.

The net decrease

of approximately $6.1 million for the three months ended March 31, 2024, represented a net decrease in research and development expenses

of approximately $5.5 million due to the completion of clinical trials and a decrease in selling general and administrative expenses of

approximately $546,000 from a decline in investor relations expense of approximately $365,000 and a decline in legal expenses of $129,000.

Research and Development Expenses

Research and development expenses were approximately

$6.5 million and $7.0 million for the three months ended December 31, 2023, and 2022, respectively.

The net decrease for the three months

ended December 31, 2023 of approximately $563,000, was comprised of decreases from the completion of the clinical studies:

Phase 2b study in the prior fiscal year ended June 30, 2023 of approximately $1.2 million, the AD Phase 3 clinical study completed during

the three months ended December 31, 2023 of approximately $131,000, and the PD Phase 2 study that completed in the three months ended

December 31, 2022 of approximately $492,000;

offset by increased expenses of the clinical team employee and consultant compensation of

approximately $272,000 and $635,000, respectively;

and other increases in regulatory and other consultancy expense of approximately $148,000;

Chemistry, Manufacturing and Control of approximately $110,000 and publications and travel of approximately $84,000.

$5.7 million and $11.2 million for the three months ended March 31, 2024, and 2023, respectively.

The net decrease of approximately $5.5

million for three months ended March 31, 2024, was primarily attributed to reduction in expenses totaling approximately $6.0 million due

to completion of clinical studies and offset by increased expenses in CMC and clinical team compensation totaling approximately $520,000.

The decreased expenses from completed clinical studies were comprised of approximately $868,000 from Ascites BIV201 Phase 2b study which

was paused in March 2023;

approximately $577,000 from completing PD Phase 2 study during the three months ended March 31, 2023;

approximately

$160,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.8 million from the completing

AD pivotal Phase 3 clinical study and approximately $581,000 for the development of a new PD study which launch was delayed.

The net decrease

in clinical study expenses were offset by increased net expenses totaling approximately $520,000 and was comprised of increased expense

in CMC for drug production and development of approximately $336,000;

the increased clinical team compensation of $285,000 from the expansion

of the clinical team subsequent to March 31, 2023;

reduced by approximately $51,000 for consultancy expenses and approximately $50,000

from less travel and publications in the three months ended March 31, 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were

approximately $2.3 million and $4.4 million for the three months ended December 31, 2023, and 2022, respectively.

The net decrease of

approximately $2.1 million was primarily attributed to a decline in directors and the executive team’s stock compensation expense

of approximately $2.1 million.

approximately $2.0 million and $2.5 million for the three months ended March 31, 2024, and 2023, respectively.

The net decrease of approximately

$546,000 was primarily attributed from a decline in investor relations expense of approximately $365,000 and decline in legal expenses

Other Income and Expense

Other income, net was approximately $380,000 compared

to other expense, net of $4.2 million, for the three months ended December 31, 2023 and 2022, respectively.

The net increase in other

income of approximately $4.6 million represented change in fair value of the related derivative liabilities of approximately $4.2 million.

Comparison of the six months ended December 31, 2023 to the six

months ended December 31, 2022

The net loss for the six months ended December

31, 2023, was approximately $19.1 million compared to a net loss of $26.1 million for the six months ended December 31, 2022.

in net loss of approximately $7.0 million was comprised of a net decrease in research and development expenses of approximately $1.5 million

and selling, general and administrative expenses of approximately $2.2 million, an increase in interest income of approximately $555,000,

a reduction in interest expense of approximately $285,000 and the change in the fair value of derivative liabilities of $5.5 million.

Total operating expenses for the six months ended

December 31, 2023, were approximately $19.7 million as compared to $20.3 million for the six months ended December 31, 2022.

net decrease of approximately $671,000 for the six months ended December 31, 2023 was comprised of an increase in research and development

expenses of approximately $1.5 million offset by a decrease in selling general and administrative expenses of approximately $2.2 million.

Other expense, net was approximately $336,000 compared

to other expense, net of $1.3 million, for the three months ended March 31, 2024 and 2023, respectively.

The net decrease in other expense

of approximately $931,000 represented a change in fair value of the related derivative liabilities of approximately $475,000 and a decrease

in interest expense of approximately $454,000 as the principal payments of the debt balance began July 1, 2023.

Comparison of the nine months ended March 31, 2024 to the nine months

ended March 31, 2023

The net loss for the nine months ended March 31, 2024,

was approximately $27.2 million compared to a net loss of $41.1 million for the nine months ended March 31, 2023.

The decrease in net

loss of approximately $13.9 million was comprised of a net decrease in research and development expenses of approximately $4.0 million

and selling, general and administrative expenses of approximately $2.8 million, and further reduced by an increase in interest income

of approximately $557,000, a reduction in interest expense of approximately $739,000 and the change in the fair value of derivative liabilities

of $6.0 million.

Total operating expenses for the nine months ended

March 31, 2024, were approximately $27.4 million as compared to $34.1 million for the nine months ended March 31, 2023.

The net decrease

of approximately $6.7 million for the nine months ended March 31, 2024, was comprised of a decrease in research and development expenses

of approximately $4.0 million and a decrease in selling general and administrative expenses of approximately $2.8 million.

Research and Development Expenses

Research and development expenses were approximately

$15.3 million and $13.8 million for the six months ended December 31, 2023, and 2022, respectively.

The net increase for the six months

ended December 31, 2023 of approximately $1.5 million was comprised of increases from the expansion of the clinical team employees and

consultants of $1.1 million and $874,000, respectively;

planning and development of new clinical studies of approximately $1.4 million,

$21.0 million and $25.0 million for the nine months ended March 31, 2024, and 2023, respectively.

The net decrease of approximately $4.0

million for the nine months ended March 31, 2024, was primarily attributed to a reduction in expenses totaling approximately $8.0 million

due to completion of clinical studies and increased expenses in development of new studies, CMC and clinical team expansion and offset

by the use of consultants totaling approximately $4.1 million.

The decreased expenses totaling approximately $8.0 million from completed

clinical studies were comprised of approximately $2.3 million from Ascites BIV201 Phase 2b study which was paused in March 2023, approximately

$1.9 million from completing PD Phase 2 study during the three months ended March 31, 2023 , approximately $195,000 from the Investigator-Initiated

Trial in MCI and Mild Alzheimer’s Disease, approximately $3.6 million from the completing AD pivotal Phase 3 clinical study of approximately

$3.8 million.

The increased expenses totaling approximately $4.1 million was comprised of the planning and development of new studies

of approximately $822,000, increases from the expansion of the clinical team employees and consultants of $1.3 million and $835,000, respectively;

and other increases in regulatory and other consultants of approximately $412,000 and publications and travel of approximately $133,000.

offset by a reduction in costs from the completion in the prior fiscal year ended June 30, 2023 of PD Phase 2 study of approximately $1.3

million and the BIV201 Phase 2b study of approximately $1.4 million.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were

approximately $4.2 million and $6.4 million for the six months ended December 31, 2023, and 2022, respectively.

approximately $6.2 million and $8.9 million for the nine months ended March 31, 2024, and 2023, respectively.

The net decrease of approximately

$2.2 million was primarily attributed to decreases in the administrative team and directors stock compensation of approximately $2.4 million,

other professional and advisory fees of $152,000 offset by increased legal fees of $92,000, and insurance expenses of approximately $111,000.

$2.7 million was primarily attributed to decreases in directors stock compensation of approximately $2.3 million, investor relations fees

of $517,000 offset by insurance expenses of approximately $181,000.

Other Income and Expense

Other income, net was approximately $210,000 compared

to other expense, net of $5.8 million, for the six months ended December 31, 2023 and 2022, respectively.

to other expense, net of $7.0 million, for the nine months ended March 31, 2024 and 2023, respectively.

The net increase in other income

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Capital Resources and Liquidity

As of December 31, 2023 the Company had working

capital of approximately $6.6 million, cash and cash equivalents totaling approximately $20.2 million, stockholders’ equity of approximately

As of March 31, 2024 the Company had working capital

of approximately $18.1 million, cash and cash equivalents totaling approximately $30.4 million, stockholders’ equity of approximately

$18.9 million, and an accumulated deficit of approximately $329.3 million.

During the six months ended December 31, 2023,

the Company sold approximately 3.3 million shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor

Fitzgerald & Co for total net proceeds of approximately $9.3 million after 3% commissions and offering costs totaling approximately

The Company has not generated any revenue 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.

Management expects that

future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

During the nine months ended March 31, 2024, the Company

sold approximately 3.3 million shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald

& Co for total net proceeds of approximately $9.3 million after 3% commissions and offering costs totaling approximately $377,000.

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

public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its class A common stock, par value $0.0001

per share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of

Common Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public

offering price of $1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.

The gross proceeds to the Company from the

Offering were approximately $21.0 million, before deducting placement agent fees and offering expenses of approximately $2.5 million.

Additionally, upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase

1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal to 125% of the public offering price per share.

The Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.

The Company has not generated any revenue 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.

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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Critical Accounting Policies and Estimates

For the six-month period ended December 31, 2023,

there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for

the fiscal year ended June 30, 2023.

For the nine-month period ended March 31, 2024, there

were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal

year ended June 30, 2023.

New Accounting Pronouncements

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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-Q

Item 2. Management’s Discussion and Analysis