What changed in this filing

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Item 1. Financial Statements

2022-05-11 compared with 2022-02-08 · 737 added, 695 removed, 190 unchanged (88% of the section changed)

Financial Statements

Condensed Balance Sheets

Balance Sheets

CURRENT ASSETS:

1 unchanged sentence

OTHER ASSETS:

Operating lease right-of-use assets

Intangible assets, net

4 unchanged sentences

Current portion of other liabilities

Current portion of operating lease liabilities

Warrant liabilities

1 unchanged sentence

Total current liabilities

Other liabilities

Other liabilities, net of current portion

Operating lease liabilities, net of current portion

Note payable net of financing costs and unearned premium and discount ($3,375,064)

7 unchanged sentences

Common stock, $ 0.0001 par value;

800,000,000 shares authorized at December 31, 2021 and June 30, 2021, respectively;

24,984,083 and 22,333,324 shares issued and outstanding at December 31, 2021 and June 30, 2021, respectively

800,000,000 shares authorized at March 31, 2022 and June 30, 2021, respectively;

24,984,083 and 22,333,324 shares issued and outstanding at March 31, 2022 and June 30, 2021, respectively

Additional paid in capital

4 unchanged sentences

TOTAL LIABILITIES AND STOCKHOLDERS EQUITY

See accompanying notes to unaudited condensed financial

Condensed Statements of Operations

accompanying notes to unaudited condensed financial statements

Statements of Operations

Three Months Ended

Six Months Ended

December 31 2021

December 31 2020

December 31 2021

December 31 2020

OPERATING EXPENSES:

Nine Months Ended

Research and development expenses

Selling, general and administrative expenses

TOTAL OPERATING EXPENSES

LOSS FROM OPERATIONS

( 6,665,010 )

Selling, general and administrative

TOTAL OPERATING

FROM OPERATIONS

( 5,748,834 )

1 unchanged sentence

( 17,961,126 )

OTHER (INCOME) EXPENSE:

Change in fair value of derivative liabilities

( 6,451,631 )

OTHER (INCOME)

Change in fair value of derivative

( 1,168,804 )

1 unchanged sentence

Interest expense

Interest income

TOTAL OTHER EXPENSE (INCOME), NET

( 1,250,693 )

( 1,257,224 )

OTHER EXPENSE (INCOME), NET

( 7,734,872 )

NET (LOSS)/INCOME

(LOSS)/INCOME

$ ( 7,040,644 )

1 unchanged sentence

$ ( 17,995,711 )

Deemed dividends - related party

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

Deemed dividends - related

LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

$ ( 7,040,644 )

3 unchanged sentences

NET LOSS PER COMMON SHARE

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

See accompanying notes to unaudited condensed financial

Condensed Statements of Cash Flows

Six Months Ended

December 31, 2021

December 31, 2020

WEIGHTED AVERAGE NUMBER OF

COMMON SHARES OUTSTANDING

accompanying notes to unaudited condensed financial statements

Statements of Cash Flows

Nine Months Ended

March 31, 2022

March 31, 2021

CASH FLOWS FROM OPERATING ACTIVITIES:

4 unchanged sentences

Stock based compensation - restricted stock

Stock option based compensation expense

Stock based compensation expense - stock options

Amortization of financing costs

1 unchanged sentence

Accretion of loan premium

Change in fair value of embedded derivative liability

Amortization of operating lease, net

Change in fair value of derivative liabilities

( 1,168,804 )

Change in fair value of warrant liability

( 8,279,919 )

10 unchanged sentences

Proceeds from convertible debenture - related party

Proceeds from exercise of warrants

Proceeds from note payable net of financing costs

6 unchanged sentences

Cash paid for taxes

SCHEDULE OF NON-CASH FINANCING ACTIVITIES:

SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:

Deemed dividends - related party

See accompanying notes to unaudited condensed financial

Condensed Statements of Changes in Stockholders

Equity (Deficit)

For the periods July 1, 2020 though December 31,

2020 and July 1, 2021 through December 31, 2021

Right of use assets obtained in exchange for lease obligations

accompanying notes to unaudited condensed financial statements

Statements of Changes in Stockholders Equity (Deficit)

the periods July 1, 2020 though March 31, 2021 and July 1, 2021 through March 31, 2022

Stockholders

2 unchanged sentences

$ ( 21,498,636 )

Proceeds from issuance of common stock,net of cost of $ 2,371,790

Proceeds from issuance of common stock,net of cost

of $ 2,371,790

Redemption of warrants - related party

8 unchanged sentences

( 90,360,109 )

Stock based compensation

Cashless exercise of warrants

Proceeds from exercise of warrants

( 2,992,868 )

Balance, March 31, 2021

$ 104,753,666

$ ( 93,352,977 )

Balance June, 30, 2021

14 unchanged sentences

( 235,840,489 )

Stock option based compensation

( 7,040,644 )

See accompanying notes to unaudited condensed financial

Notes to Condensed Financial Statements

For the Six Months Ended December 31, 2021 and 2020

Background Information

(the Company or we or our)

is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and

neurological and neuro-degenerative disorders and certain cancers.

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion

terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening complications

of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism.

( 7,040,644 )

Balance, March 31, 2022

$ 252,833,422

$ ( 242,881,133 )

accompanying notes to unaudited condensed financial statements

to Condensed Financial Statements

31, 2022 and 2021

(the Company or we or our) is a clinical-stage company developing innovative drug therapies

to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders and certain cancers.

liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option for

patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism.

The initial target for BIV201 therapy is refractory ascites.

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.

The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites.

A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized 30-patient Phase 2b trial is currently underway.

As of December 31, 2021, ten of the thirteen planned US study centers had been activated and are actively screening patients, and multiple

patients have been enrolled in the study.

The FDA has communicated to us that pending positive Phase 2 study results, a sufficiently

large and well-controlled Phase 3 trial, with supportive trend data from the Phase 2b, could

potentially yield the clinical data needed to apply for BIV201 marketing approval.

The Phase 2b clinical trial protocol is summarized

on www.clinicaltrials.gov, trial identifier NCT04112199.

Top-line results from this trial are expected in mid-2022, to be followed by

a proposed single pivotal Phase 3 clinical trial beginning in late 2022, subject to favorable FDA review.

The BIV201 development program was initiated by LAT Pharma LLC.

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

The Company currently owns all development

and marketing rights to its drug candidate.

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between our predecessor

entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous

infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

In neurodegenerative disease, BioVie acquired the biopharmaceutical assets

of NeurMedix, Inc.

(NeurMedix), a privately held clinical-stage pharmaceutical company, in June 2021 (See Note 5 Related

Party Transactions ).

The acquired assets included NE3107, a potentially selective inhibitor of inflammatory ERK signaling that,

based on animal studies, is believed to reduce neuroinflammation.

NE3107 is a 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.

is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimers

and Parkinsons Disease, and NE3107 could, if approved represent an entirely new medical approach to treating these devastating

conditions affecting an estimated 6 million Americans suffering from Alzheimers and 1 million from Parkinsons.

authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107

in subjects who have mild to moderate Alzheimers disease (NCT04669028).

In August 2021, the study was initiated and the Company

is anticipating top line results in the first half of 2023.

On January 20, 2022, the Company initiated by treating the first patient, in its Phase 2

study assessing NE3107s safety and tolerability and potential pro-motoric impact in Parkinsons disease patients.

study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons Disease

Participants will be treated with carbidopa/levodopa and NE3107 or placebo.

Forty patients with a defined PD medication off

state will be randomized 1:1 placebo to:

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.

The US Food and Drug

Administration (FDA) has not approved any drug to treat refractory ascites.

A Phase 2a clinical trial of BIV201 was completed in 2019,

and a multi-center, randomized 30-patient Phase 2b trial is currently underway.

As of March 31, 2022, ten of the thirteen planned US

study centers had been activated and are actively screening and enrolling patients in the study.

Top-line results from this trial are

expected in early 2023.

BIV201 development program was initiated by LAT Pharma LLC.

On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to

its BIV201 development program.

The Company currently owns all development and marketing rights to its drug candidate.

Pursuant to the

Agreement and Plan of Merger entered into on April 11, 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc.,

BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT

Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

neurodegenerative disease, BioVie acquired the biopharmaceutical assets of NeurMedix, Inc.

(NeurMedix), a privately held

clinical-stage pharmaceutical company, in June 2021 (See Note 5 Related Party Transactions ).

The acquired assets included NE3107,

a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies, is believed to reduce neuroinflammation.

NE3107 is a 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 Alzheimers and Parkinsons Disease, and NE3107 could, if approved represent

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

and 1 million from Parkinsons.

The FDA has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled,

parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimers disease (NCT04669028).

August 2021, the study was initiated and the Company is anticipating top line results in the first half of 2023.

January 20, 2022, the Company initiated a study by treating the first patient, in its Phase 2 study assessing NE3107s safety

and tolerability and potential pro-motoric impact in Parkinsons disease patients.

The NM201 study (NCT05083260) is a double-blind,

placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons Disease (PD).

Participants will be treated

with carbidopa/levodopa and NE3107 or placebo.

Forty patients with a defined PD medication off state will be randomized

1:1 placebo to:

active NE3107 20 mg twice daily for 28 days.

Safety assessments will look at standard

measures of patient health and potential for drug-drug interactions affecting L-dopa pharmacokinetics and activity.

Exploratory efficacy

assessments will use the Motor Disease Society Unified Parkinsons Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor

Symptom Scale.

Topline results are expected for the NM201 study in mid-2022.

Inflammation-driven insulin resistance is believed to be implicated in

a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these opportunities

in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase.

NE3107 is patented in the United States,

Australia, Canada, Europe and South Korea.

The Companys operations are subject to a number of factors that

can affect its operating results and financial conditions.

Such factors include, but are not limited to:

the results of clinical testing

and trial activities of the Companys products, the Companys ability to obtain regulatory approval to market its products;

competition from products manufactured and sold or being developed by other companies;

Safety assessments will look at standard measures of patient health and

potential for drug-drug interactions affecting L-dopa pharmacokinetics and activity.

Exploratory efficacy assessments will use the Motor

Disease Society Unified Parkinsons Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale.

Topline results

are expected for the NM201 study in mid-2022.

Inflammation-driven

insulin resistance is believed to be implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer,

and we plan to begin exploring these opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset

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

Companys operations are subject to a number of factors that can affect its operating results and financial conditions.

include, but are not limited to:

the results of clinical testing and trial activities of the Companys products, the Companys

ability to obtain regulatory approval to market its products;

competition from products manufactured and sold or being developed by other

the price of, and demand for, Company products;

the Companys ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products;

Companys ability to raise capital.

The Companys financial statements have been prepared assuming the Company will continue

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

As of December 31, 2021, the Company had working capital of approximately $ 26.2 million , cash of approximately $30.4 million, stockholders

equity of approximately $16.1 million, and an accumulated deficit of approximately $235.8 million.

In addition, the Company has not generated

any revenues to date and no revenues are expected in the foreseeable future.

The Companys future operations are dependent on the

success of the Companys ongoing development and commercialization efforts, as well as its ability to secure additional financing

Although our cash balance could possibly sustain operations over the next 12 months if measures are taken to delay planned

expenditures in our research protocols and slow the progress in the Companys clinical programs, the Companys current planned

operations to meet certain goals and objectives, project cash flows to be depleted within that period of time.

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.

The continual widespread health emergencies or pandemics such as the coronavirus

(COVID-19) pandemic (and its related variants), has lead to continued regional quarantines, business shutdowns, labor shortages,

disruptions to supply chains, and overall economic instability.

Although some jurisdictions have

relaxed these measures, others have not or have reinstated them as COVID-19 cases surge and variants emerge.

The duration and spread

of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial markets and the overall economy are highly

uncertain and cannot be predicted at this time.

If the financial markets and/or the overall economy are impacted for an extended period,

the Companys ability to raise funds may be materially adversely affected.

In addition, the COVID-19 pandemic has created a widespread

labor shortage, including a shortage of medical professionals, which may adversely impact our ability to continue or complete our clinical

the Companys ability to negotiate favorable licensing or other manufacturing

and marketing agreements for its products;

and the Companys ability to raise capital.

The Companys financial statements

have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction

of liabilities in the normal course of business.

As of March 31, 2022, the Company had working capital of approximately $ 20.5 million ,

cash of approximately $24.5 million, stockholders equity of approximately $10.0 million, and an accumulated deficit of approximately

$242.9 million.

In addition, the Company has not generated any revenues to date and no revenues are expected in the foreseeable future.

The Companys future operations are dependent on the success of the Companys ongoing development and commercialization efforts,

as well as its ability to secure additional financing as needed.

Although our cash balance could possibly sustain operations over the

next 12 months if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Companys

clinical programs, the Companys current planned operations to meet certain goals and objectives, project cash flows to be depleted

within that period of time.

future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations.

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

continual widespread health emergencies or pandemics such as the coronavirus (COVID-19) pandemic (and its related variants),

has led to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability.

Although some jurisdictions have relaxed these measures, others have not or have reinstated them as COVID-19 cases and its variants continue

The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial markets

and the overall economy are highly uncertain and cannot be predicted at this time.

If the financial markets and/or the overall economy

are impacted for an extended period, the Companys ability to raise funds may be materially adversely affected.

In addition, the

COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue

to impact the potential patient participation in our studies, which may adversely impact our ability to continue or complete our clinical

trials in the planned timeline.

Although management continues to pursue the Companys strategic plans,

there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at

all, to fund continuing operations.

These circumstances raise substantial doubt on the Companys ability to continue as a going

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

Significant Accounting Policies

Basis of Presentation – Interim Financial Information

These unaudited interim condensed financial statements and related notes have been prepared in

accordance with accounting principles generally accepted in the United State of America (U.S.

GAAP) for interim financial

information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the SEC)

for Interim Reporting.

Accordingly, they do not include all of the information and footnotes required by U.S.

GAAP for complete financial

The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals)

that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented.

Interim results are not necessarily indicative of the results for the full year.

The condensed balance sheet at June 30, 2021 was

derived from audited annual financial statements for the year ended June 30, 2021 but does not contain all the footnote disclosures from

the annual financial statements.

These unaudited interim condensed financial statements and information included under the heading Managements

Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the Companys

audited financial statements for the fiscal years ended June 30, 2021 and 2020 in our Annual Report on Form 10-K filed with the SEC on

August 30, 2021.

For a summary of significant accounting policies, see the Companys Annual Report on Form 10-K for the fiscal year

ended June 30, 2021, filed with the SEC on August 30, 2021.

management continues to pursue the Companys strategic plans, there is no assurance that the Company will be successful in obtaining

sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations.

These circumstances raise substantial

doubt on the Companys ability to continue as a going concern.

The financial statements do not include any adjustments that might

result from the outcome of this uncertainty.

Accounting Policies

of Presentation – Interim Financial Information

unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally

accepted in the United State of America (U.S.

GAAP) for interim financial information and with the instructions to Form

10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the SEC) for Interim Reporting.

they do not include all of the information and footnotes required by U.S.

GAAP for complete financial statements.

The unaudited interim

condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of

management, considered necessary for a fair presentation of the results for the interim periods presented.

Interim results are not necessarily

indicative of the results for the full year.

The condensed balance sheet at June 30, 2021 was derived from audited annual financial statements

for the year ended June 30, 2021 but does not contain all the footnote disclosures from the annual financial statements.

These unaudited

interim condensed financial statements and information included under the heading Managements Discussion and Analysis of

Financial Condition and Results of Operations should be read in conjunction with the Companys audited financial statements

for the fiscal years ended June 30, 2021 and 2020 in our Annual Report on Form 10-K filed with the SEC on August 30, 2021.

For a summary

of significant accounting policies, see the Companys Annual Report on Form 10-K for the fiscal year ended June 30, 2021, filed

with the SEC on August 30, 2021.

prior period amounts have been reclassified for consistency with the current period presentation.

Fair Value of Financial Instruments

Fair value is defined as the price that would be received from selling

an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

When determining

the fair value for applicable assets and liabilities, we consider the principal or most advantageous market in which we would transact

and we consider assumptions.

market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions,

and risk of nonperformance.

This guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as

Observable inputs such as quoted

prices in active markets;

Inputs, other than quoted prices

in active markets, that are observable either directly or indirectly;

Unobservable inputs in which there is little

or no market data, which require the reporting entity to develop its own assumptions

Net loss per Common Share

Basic net loss per common share is computed by dividing the net loss attributable

to common stockholders by the weighted average number of shares of common stock outstanding during the period.

Diluted net loss per common

share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock

outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from

common shares issuable through stock options, warrants, and convertible debentures.

For the three and six months ended December 31, 2021

and 2020, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the

The table below shows the number of outstanding stock options and warrants

as of December 31, 2021 and 2020:

Company determines whether an arrangement contains a lease at inception.

Operating leases are included in operating lease right-of-use

(ROU) assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities

on our balance sheets.

ROU assets represent the Companys right to use an underlying asset for the lease term and lease liabilities

represent an obligation to make lease payments arising from the lease.

Lease ROU assets and lease liabilities are recognized based on

the present value of the future minimum lease payments over the lease term at the commencement date.

As the Companys leases do

not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement date in determining

the present value of lease payments.

The Company does not include options to extend or terminate the lease term unless it is reasonably

certain that the Company will exercise any such options.

Rent expense is recognized under the operating leases on a straight-line basis.

The Company does not recognize right of-use assets or lease liabilities for short-term leases, which have a lease term of twelve months

or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term

Value of Financial Instruments

value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction

between market participants at the measurement date.

When determining the fair value for applicable assets and liabilities, we consider

the principal or most advantageous market in which we would transact and we consider assumptions.

market participants would use when

pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance.

This guidance also establishes

a fair value hierarchy to prioritize inputs used in measuring fair value as follows:

Observable inputs such as quoted prices in active markets;

Inputs, other than quoted prices in active markets, that are observable either directly or indirectly;

Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions

loss per Common Share

net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of

shares of common stock outstanding during the period.

Diluted net loss per common share is computed by dividing the net loss attributable

to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common

stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants,

and convertible debentures.

For the three and nine months ended March 31, 2022 and 2021, such amounts were excluded from the diluted

loss since their effect was considered anti-dilutive due to the net loss for the period.

table below shows the number of outstanding stock options and warrants as of March 31, 2022 and 2021:

Schedule of Dilutive securities were excluded from the computation of diluted loss per share

December 31, 2021

December 31, 2020

March 31, 2022

March 31, 2021

Number of Shares

1 unchanged sentence

Stock Options

Recent Accounting Pronouncements

The Company considers the applicability and impact of all Accounting Standards

Updates (ASUs).

There were no recent ASUs that are expected to have a material impact on the Companys balance

sheets or statements of operations.

Intangible Assets

The Companys intangible assets consist of intellectual property

acquired from LAT Pharma, Inc.

and are amortized over their estimated useful lives.

The following is a summary of the intangible assets

as of December 31, 2021 and June 30, 2021:

December 31, 2021

Accounting Pronouncements

Company considers the applicability and impact of all Accounting Standards Updates (ASUs).

There were no recent

ASUs that are expected to have a material impact on the Companys balance sheets or statements of operations.

Companys intangible assets consist of intellectual property acquired from LAT Pharma, Inc.

and are amortized over their estimated

useful lives.

The following is a summary of the intangible assets as of March 31, 2022 and June 30, 2021:

March 31, 2022

June 30, 2021

4 unchanged sentences

Intellectual Property, Net

Amortization expense was $ 57,344 in each of the three-month periods ended

December 31, 2021 and 2020.

Amortization expense for the six-month period ended December 31, 2021 and 2020 was $ 114,689 and $ 114,688 respectively.

The Company amortizes intellectual property over the expected original useful lives of 10 years .

Estimated future amortization expense is as follows:

expense was $ 57,344 in each of the three-month periods ended March 31, 2022 and 2021.

Amortization expense for the nine-month period

ended March 31, 2022 and 2021 was $ 172,032 and $ 172,032 respectively.

The Company amortizes intellectual property over the expected original

useful lives of 10 years .

future amortization expense is as follows:

Schedule of Future expected Amortization of intangible assets

Year ending June 30, 2022 (Remaining six months)

Year ending June 30, 2022 (Remaining three months)

Intellectual Property, Net

Related Party Transactions

Asset Acquisition with NeurMedix

On April 27, 2021, the Company entered into an Asset Purchase Agreement

(APA) with NeurMedix and Acuitas Group Holdings, LLC (Acuitas), which are related party affiliates, pursuant

to which the Company acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix, in exchange for consideration

of cash and shares of common stock.

The acquired assets include, among others, those related to certain drug candidates being developed

by NeurMedix, including NE3107, a small molecule orally administered inhibitor of insulin resistance and the pathological inflammatory

cascade, with a novel mechanism of action that has potential applications for treatment against Alzheimers Disease and Parkinsons

Subject to the terms and conditions of the APA, following the closing,

the Company was potentially obligated to deliver contingent stock consideration to NeurMedix (or its successor).

Previously, the Company

was obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of shares of the Companys common

stock having an aggregate value of up to $3.0 billion, subject to the Companys achievement of certain clinical, regulatory and

commercial milestones related to the drug candidates to be acquired from NeurMedix, and subject to a cap limiting each issuance of shares

if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 89.9999% of the Companys issued

and outstanding common stock.

Party Transactions

Acquisition with NeurMedix

April 27, 2021, the Company entered into an Asset Purchase Agreement (APA) with NeurMedix and Acuitas Group Holdings, LLC

(Acuitas), which are related party affiliates, pursuant to which the Company acquired certain assets from NeurMedix and

assumed certain liabilities of NeurMedix, in exchange for consideration of cash and shares of common stock.

The acquired assets include,

among others, those related to certain drug candidates being developed by NeurMedix, including NE3107, a small molecule orally administered

inhibitor of insulin resistance and the pathological inflammatory cascade, with a novel mechanism of action that has potential applications

for treatment against Alzheimers Disease and Parkinsons Disease.

to the terms and conditions of the APA, following the closing, the Company was potentially obligated to deliver contingent stock consideration

to NeurMedix (or its successor).

Previously, the Company was obligated to deliver contingent stock consideration to NeurMedix (or its

successor) consisting of shares of the Companys common stock having an aggregate value of up to $3.0 billion, subject to the Companys

achievement of certain clinical, regulatory and commercial milestones related to the drug candidates to be acquired from NeurMedix, and

subject to a cap limiting each issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates

exceeding 89.9999% of the Companys issued and outstanding common stock.

Pursuant to Amendment No.

1 to the APA, dated May 9, 2021, the Company is now obligated to deliver to NeurMedix

(or its successor) 4.5 million shares upon the achievement of each of the four milestones set forth in the APA, for an aggregate of up

to 18 million shares, subject to a cap limiting the issuance of shares if such issuance would result in the beneficial ownership of NeurMedix

and its affiliates exceeding 87.5% of the Companys issued and outstanding common stock.

On June 10, 2021, and pursuant to the APA, the Company issued to Acuitas

(as NeurMedixs assignee) 8,361,308 shares of the Companys common stock and made a cash payment of approximately $2.3 million,

representing NeurMedixs direct and documented cash expenditures to advance certain programs from March 1, 2021 through the closing

date and cash payments to other third parties for expenses totaling approximately $4.0 million for due diligence, legal fees, transaction

fees and the fairness opinion.

Since the transaction was between entities under common control, there were no fair value adjustments of

the purchased assets, and the historical cost basis of the purchased assets was zero.

The total consideration paid was expensed as research and development expense

at the time of the transaction.

Equity Transactions with Acuitas

On September 22, 2020, concurrent with the closing of the Companys

Offering, approximately $1.8 million was paid to Acuitas satisfying all amounts owed on the Debenture due September 24, 2020 held by the

Companys controlling stockholder, Acuitas.

Additionally, in connection with the close of the public offering on September

22, 2020, the Company issued an aggregate of 6,909,582 shares of Common Stock to Acuitas, representing (i) 5.4 million shares issuable

pursuant to Acuitas rights under the Purchase Agreement dated July 3, 2018, as amended on June 24, 2019 and October 9, 2019;

the various extension letters;

which resulted in a deemed dividend at the close of the public offering at price of $10 per share, consistent

with the Companys accounting policy;

and (ii) the automatic exercise of 1.5 million warrants issued to Acuitas in connection with

the Debenture financing at the par value of the Common Stock.

During the year ended June 30, 2021, the Company received additional draws

under the Debenture totaling $436,000.

The total draws as of September 22, 2020 were $1.7 million and the related total number of warrants

issuable at $4.00 per share of common stock was 424,750 of which 328,250 warrants had been issued.

In accordance with the Debenture agreements,

at September 22, 2020 upon the Companys close of its public offering, all the warrants issued related to the debenture totaling

1,453,250 were mandatorily redeemed along with the additional 96,500 shares common stock issued to Acuitas.

Other Liabilities

1 to the APA, dated May 9, 2021,

the Company is now obligated to deliver to NeurMedix (or its successor) 4.5 million shares upon the achievement of each of the four milestones

set forth in the APA, for an aggregate of up to 18 million shares, subject to a cap limiting the issuance of shares if such issuance

would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the Companys issued and outstanding

common stock.

June 10, 2021, and pursuant to the APA, the Company issued to Acuitas (as NeurMedixs assignee) 8,361,308 shares of the Companys

common stock and made a cash payment of approximately $2.3 million, representing NeurMedixs direct and documented cash expenditures

to advance certain programs from March 1, 2021 through the closing date and cash payments to other third parties for expenses totaling

approximately $4.0 million for due diligence, legal fees, transaction fees and the fairness opinion.

Since the transaction was between

entities under common control, there were no fair value adjustments of the purchased assets, and the historical cost basis of the purchased

assets was zero.

The total consideration paid was expensed as research and development expense at the time of the transaction.

Transactions with Acuitas

September 22, 2020, concurrent with the closing of the Companys registered public offering, approximately $1.8 million was paid

to Acuitas satisfying all amounts owed on the Debenture due September 24, 2020 held by the Companys controlling stockholder, Acuitas.

Additionally,

in connection with the close of the public offering on September 22, 2020, the Company issued an aggregate of 6,909,582 shares of Common

Stock to Acuitas, representing (i) 5.4 million shares issuable pursuant to Acuitas rights under the Purchase Agreement dated July

3, 2018, as amended on June 24, 2019 and October 9, 2019;

and the various extension letters;

which resulted in a deemed dividend at the

close of the public offering at price of $10 per share, consistent with the Companys accounting policy;

and (ii) the automatic

exercise of 1.5 million warrants issued to Acuitas in connection with the Debenture financing at the par value of the Common Stock.

the year ended June 30, 2021, the Company received additional draws under the Debenture totaling $436,000.

The total draws as of September

22, 2020 were $1.7 million and the related total number of warrants issuable at $4.00 per share of common stock was 424,750 of which

328,250 warrants had been issued.

In accordance with the Debenture agreements, at September 22, 2020 upon the Companys close of

its public offering, all the warrants issued related to the debenture totaling 1,453,250 were mandatorily redeemed along with the additional

96,500 shares common stock issued to Acuitas.

liabilities represent retention bonus arrangements with certain employees that was recognized in August 2021 totaling $ 1,161,000 and

included in the accompanying statement of operations for six months ended December 31, 2021.

included in the accompanying statement of operations for the nine months ended March 31, 2022.

The payment terms are equal monthly installments

over a 24-month period and began in August 2021.

Notes Payable

On November 30, 2021, (the Closing Date) the Company entered

into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the Loan

Agreement) with Avenue Venture Opportunities Fund, L.P.

The current portion of the liability was $580,625 and the non-current portion was $193,542

in the accompanying balance sheet at March 31, 2022.

November 30, 2021, (the Closing Date) the Company entered into a Loan and Security Agreement and the Supplement to the

Loan and Security Agreement and Promissory Notes (together, the Loan Agreement) with Avenue Venture Opportunities Fund,

(AVOPI and Avenue Venture Opportunities Fund II, L.P.

together (Avenue) for growth capital loans in an aggregate commitment amount of up to $20 million (the Loan).

On the closing date, $15 million funded (Tranche 1) and up to $5 million will be made available to the Company on or prior

to September 15, 2022, subject to the Companys achievement of certain milestones with respect to certain of its ongoing clinical

trials (Tranche 2).

The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime

rate as reported in The Wall Street Journal and (b) 10.75%.

The Loan is secured by a lien upon and security interest in all of the Companys

assets, including intellectual property, subject to agreed exceptions.

(AVOPII) together (Avenue) for growth

capital loans in an aggregate commitment amount of up to $20 million (the Loan).

On the closing date, $15 million funded

(Tranche 1) and up to $5 million will be made available to the Company on or prior to September 15, 2022, subject to the

Companys achievement of certain milestones with respect to certain of its ongoing clinical trials (Tranche 2).

Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street

Journal and (b) 10.75%.

The Loan is secured by a lien upon and security interest in all of the Companys assets, including intellectual

property, subject to agreed exceptions.

The maturity date of the Loan is December 1, 2024.

An additional

growth capital loan in an amount equal to $5 million may be available (i) upon the Companys achievement of additional milestones

with respect to certain of its ongoing clinical trials (ii) upon the mutual written agreement of the Company and the Lenders each acting

in its sole discretion, and (iii) subject to execution and delivery by the Company and the Lenders of amendments to the loan documents

and the Warrant (as defined below) to reflect such additional loan and approval of each Lenders investment committee (Tranche

The Loan Agreement requires monthly interest-only payments during the first

eighteen months of the term of the Loan, which may be increased up to an additional six months from the end of such eighteen-month period

prior to receipt of the Tranche 2 Loan.

Following the interest-only period, the Company will make equal monthly payments of principal,

plus accrued interest, until the Loans maturity date when all remaining principal and accrued interest is due.

If the Company prepays

the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal amount of the Loan that is prepaid

during the interest-only period;

and (b) a prepayment fee in an amount equal to 1.0% of the principal amount of the Loan that is prepaid

after the interest-only period.

At the Loans maturity date, or on the date of the prepayment of the Loan, a final payment equal

to 4.25% of the sum of (a) the Loan commitment amount under Tranche 1 and Tranche 2, plus (b) the aggregate principal amount of additional

growth capital loans borrowed under Tranche 3.

The Loan Agreement includes a conversion option to convert up to $5 million

of the principal amount of the Loan outstanding at the option of the Lenders, into shares of the Companys Class A common stock

at a conversion price of $6.98 per share.

On the Closing Date, the Company issued to the Lenders warrants to purchase

361,002 shares of Class A common stock of the Company (the Warrants) at an exercise price per share equal to $5.82 (the

Stock Purchase Price).

The warrants are exercisable until November 30, 2026 (the Expiration Date).

The amount of the carrying value of the notes payable were determined by allocating portions

of the outstanding principal of the notes to the fair value of the warrants of approximately $1.4 million and the fair value of the embedded

conversion option of approximately $2.2 million.

Accordingly, the total amount of unearned discount of approximately $3.7 million, the

total direct financing cost of approximately $390,000 and premium of $850,000 are recognized on an effective interest method over term

The adjusted effective interest rate is 25%.

The carrying value of notes payable at December 31, 2021 was approximately $11.1

million, net of unearned discount of approximately $3.5 million, unamortized direct costs of approximately $376,000 and accreted premium

of approximately $24,000 in the accompanying balance sheets.

The total interest expense of approximately $316,000 for the three and six

months ended December 31, 2021, was recognized in the accompanying statements of operations.

following is a summary of the Note Payable as of December 31, 2021 and June 30, 2021:

December 31, 2021

An additional growth capital loan in an amount

equal to $5 million may be available (i) upon the Companys achievement of additional milestones with respect to certain of its

ongoing clinical trials (ii) upon the mutual written agreement of the Company and the Lenders each acting in its sole discretion, and

(iii) subject to execution and delivery by the Company and the Lenders of amendments to the loan documents and the Warrant (as defined

below) to reflect such additional loan and approval of each Lenders investment committee (Tranche 3).

Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan, which may be increased

up to an additional six months from the end of such eighteen-month period prior to receipt of the Tranche 2 Loan.

Following the interest-only

period, the Company will make equal monthly payments of principal, plus accrued interest, until the Loans maturity date when all

remaining principal and accrued interest is due.

If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in

an amount equal to 3.0% of the principal amount of the Loan that is prepaid during the interest-only period;

and (b) a prepayment fee

in an amount equal to 1.0% of the principal amount of the Loan that is prepaid after the interest-only period.

At the Loans maturity

date, or on the date of the prepayment of the Loan, a final payment equal to 4.25% of the sum of (a) the Loan commitment amount under

Tranche 1 and Tranche 2, plus (b) the aggregate principal amount of additional growth capital loans borrowed under Tranche 3.

Loan Agreement includes a conversion option to convert up to $5 million of the principal amount of the Loan outstanding at the option

of the Lenders, into shares of the Companys Class A common stock at a conversion price of $6.98 per share.

the Closing Date, the Company issued to the Lenders warrants to purchase 361,002 shares of Class A common stock of the Company (the Warrants)

at an exercise price per share equal to $5.82 (the Stock Purchase Price).

The warrants are exercisable until November 30,

2026 (the Expiration Date).

amount of the carrying value of the notes payable were determined by allocating portions of the outstanding principal of the notes to

the fair value of the warrants of approximately $1.4 million and the fair value of the embedded conversion option of approximately $2.2

Accordingly, the total amount of unearned discount of approximately $3.7 million, the total direct financing cost of approximately

$390,000 and premium of $850,000 are recognized on an effective interest method over term of the Loan.

The adjusted effective interest

The carrying value of notes payable at March 31, 2022 was approximately $11.6 million, net of unearned discount of approximately

$3.1 million, unamortized direct costs of approximately $333,000 and accreted premium of approximately $94,000 in the accompanying balance

The total interest expense of approximately $919,000 and $1.2 million for the three and nine months ended March 31, 2022, respectively;

was recognized in the accompanying statements of operations.

The amortization of financing costs was approximately $43,000 and $57,000

for the three and nine months ended March 31, 2022, respectively.

The accretion of loan premium was approximately $71,000 and $94,000

for the three and nine months ended March 31, 2022, respectively.

The accretion of unearned loan discount was approximately $400,000 and $534,000 for the three and nine months ended March 31, 2022, respectively.

As of March 31, 2022, the outstanding principal balance of $15 million would

be paid in 18 monthly equal installments beginning July 1, 2023;

a total of $10 million and $5 million in the fiscal years ended June

30, 2024 and 2025 respectively.

following is a summary of the Note Payable as of March 31, 2022 and June 30, 2021:

March 31, 2022

June 30, 2021

5 unchanged sentences

future amortization expense and accretion of premium is as follows:

Schedule of Estimated

future amortization expense and accretion of premium

Unearned Discount

1 unchanged sentence

Loan accretion Premium

Year ending June 30, 2022 (Remaining six months)

Fair Value Measurements

At December 31,2021 and June 30, 2021, the estimated fair value of

derivative liabilities measured on a recurring basis are as follows:

Year ending June 30, 2022 (Remaining three months)

Value Measurements

March 31,2022 and June 30, 2021, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

Fair Value Measurements at

December 31, 2021

March 31, 2022

Derivative liability - Warrants

Derivative liability -Conversion option

Derivative liability -Conversion option on notes payable

Total derivatives

2 unchanged sentences

Derivative liability - Warrants

Derivative liability -Conversion option on convertible debenture

Derivative liability -Conversion option on note payable

Total derivatives

The following table presents the activity for liabilities measured at fair

value unobservable inputs for the six months ended December 31, 2021:

Derivative liabilities - Warrants

Derivative liability - Conversion Option on Convertible Debenture

following table presents the activity for liabilities measured at fair value unobservable inputs for the nine months ended March 31,

Derivative liabilities -

Derivative liability -

Conversion Option

on Convertible

Balance at July 1, 2021

2 unchanged sentences

Transfer in and/or out of Level 3

Balance at December 31, 2021

The following table presents the activity for liabilities measured at fair

value unobservable inputs for the six months ended December 31, 2020:

Derivative liabilities - Warrants

Derivative liability - Conversion Option on Convertible Debenture

Balance at March 31, 2022

following table presents the activity for liabilities measured at fair value unobservable inputs for the nine months ended March 31,

Derivative liabilities -

Derivative liability -

Conversion Option

on Convertible

Beginning balance at July 1, 2020

6 unchanged sentences

( 2,775,002 )

Balance at December 31, 2020

The fair values of derivative liabilities for the warrants and conversion

option at December 31, 2021 were approximately $897,000 and approximately $1.2 million, respectively.

The total change in the fair value

of the derivative liabilities totaled approximately $1.6 million 2021 and accordingly, was recorded in the accompanying statement of operations

for the three and six months ended December 31, 2021.

The assumptions used in the Black Scholes model to value the derivative liabilities

included the closing stock price of $ 4.50 and for the warrants, the warrant exercise price of $ 5.82 , 5-year term, risk free rate of 1.26 %

risk free and volatility of 74.796 % .

Balance at March 31, 2021

fair values of derivative liabilities for the warrants and conversion option at March 31, 2022 were approximately $1 million and approximately

$1.5 million, respectively.

The total change in the fair value of the derivative liabilities totaled approximately $386,000 and $1.2

million for the three and nine months ended March 31, 2022 respectively, and accordingly, was recorded in the accompanying statement

of operations.

The assumptions used in the Black Scholes model to value the derivative liabilities at March 31, 2022 included the closing

stock price of $ 4.50 per share, and for the warrants the exercise price of $ 5.82 , 5-year term, risk free rate of 1.26 % and volatility

of 74.796 % .

and for the embedded derivative liability of the conversion option, the conversion price of $ 6.98 ;

3-year term, risk free rate of 0.97 % and volatility of 76.15 % .

Derivative liability - Warrants

The Company accounts for stock purchase warrants as either equity instruments

or derivative liabilities depending on the specific terms of the warrant agreements.

Under applicable accounting guidance, stock warrants

that are precluded from being indexed to the Companys own stock because of full-rachet and anti-dilution provisions or adjustments

to the strike price due to an occurrence of a future event;

3-year term, risk free

rate of 0.97 % and volatility of 76.15 % .

liability - Warrants

Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of

the warrant agreements.

Under applicable accounting guidance, stock warrants that are precluded from being indexed to the Companys

own stock because of full-rachet and anti-dilution provisions or adjustments to the strike price due to an occurrence of a future event;

are accounted as derivative financial instruments.

The warrants issued on

November 30, 2021 in connection with the Avenue loan financing were not considered to be indexed to the Companys own stock and

accordingly, recorded as a derivative liability at their fair values in the accompany balance sheets at December 31, 2021.

The Black Scholes model was used to calculate the fair value of the

warrant derivative to bifurcate the warrant derivative amount from the Avenue loan amount funded.

The warrants are recorded at their

fair values at the date of issuance and remeasured at December 31, 2021.

The assumptions used for the fair value calculation at

November 30, 2021 follows:

the closing stock price of $ 6.44

the exercise price of $ 5.82 ;

a risk free rate of 1.14 %

and volatility of 74.4 % .

Embedded derivative liability – Conversion Option

The embedded derivative represents the optional

conversion feature of up to $5.0 million of the outstanding Avenue note amounts meets the definition of a derivative and requires bifurcation

from the loan amount.

The Black Scholes model was used to calculate the fair value of the embedded

derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue loan amount funded.

The assumption

used for the fair value calculation at November 30, 2021 follows:

The warrants issued on November 30, 2021 in connection with the Avenue loan financing

were not considered to be indexed to the Companys own stock, and accordingly, were recorded as a derivative liability at fair

value in the accompany balance sheet at March 31, 2022.

Black Scholes model was used to calculate the fair value of the warrant derivative to bifurcate the warrant derivative amount from the

Avenue loan amount funded.

The warrants are recorded at their fair values at the date of issuance and remeasured at March 31, 2022.

assumptions used for the fair value calculation at November 30, 2021 follows:

the closing stock price of $ 6.44 per share;

price of $ 5.82 ;

a risk free rate of 1.14 % and volatility of 74.4 % .

derivative liability – Conversion Option

embedded derivative represents the optional conversion feature of up to $5.0 million of the outstanding Avenue note amounts meets the

definition of a derivative and requires bifurcation from the loan amount.

Black Scholes model was used to calculate the fair value of the embedded derivative to bifurcate the embedded derivative amount representing

the conversion option from the Avenue loan amount funded.

The assumption used for the fair value calculation at November 30, 2021 follows:

the closing stock price of $ 6.44 per share;

the conversion price of $ 6.98 ;

$ 6.98 , 3 year term, risk free rate of 0.81 % risk free and volatility of 76.85 % .

Equity Transactions

Stock Options

The following table summarizes the activity relating to the Companys

stock options for the six months ended December 31, 2021:

Weighted-Average Exercise Price

Weighted Remaining Average Contractual Term

Aggregate Intrinsic Value

risk free rate of 0.81 % and volatility of 76.85 % .

following table summarizes the activity relating to the Companys stock options for the nine months ended March 31, 2022:

Outstanding at June 30, 2021

Options Expired

Options Forfeited

Outstanding at December 31, 2021

Exercisable at December 31, 2021

The fair value of each option grant on the date of grant is estimated using

the Black-Scholes option.

The pricing model reflects the following weighted-average assumptions for the six months ended December 31,

2021 and 2020:

December 31, 2021

December 31, 2020

Outstanding at March 31, 2022

Exercisable at March 31, 2022

fair value of each option grant on the date of grant is estimated using the Black-Scholes option.

The pricing model reflects the following

weighted-average assumptions for the nine months ended March 31, 2022 and 2021:

March 31, 2022

March 31, 2021

Expected life of options (In years)

2 unchanged sentences

Dividend Yield

Expected volatility is based on the historical volatilities of the daily

closing price of the common stock of three comparable companies and the expected life of options is based on historical data with respect

to employee exercise periods.

The Company accounts for forfeitures as they are incurred.

The Company recorded stock option-based compensation expense of $1,147,422

and $1,536,929 for three-month periods ended December 31, 2021 and 2020, respectively;

and of $3,074,384 and $1,536,929 for six-month

periods ended December 31, 2021 and 2020, respectively.

As of December 31, 2021, there was approximately $ 5.7 million of unrecognized

compensation cost related to non-vested stock options granted to Directors and Officers, which is expected to be recognized over a weighted-average

period of approximately 4.5 years.

The following is a summary of stock options outstanding and exercisable

by exercise price as of December 31, 2021:

volatility is based on the historical volatilities of the daily closing price of the common stock of three comparable companies and the

expected life of options is based on historical data with respect to employee exercise periods.

The Company accounts for forfeitures

as they are incurred.

Company recorded stock option-based compensation expense of approximately $930,000 and $804,000 for three-month periods ended March 31,

2022 and 2021, respectively;

and of approximately $4.0 million and $2.3 million for nine-month periods ended March 31, 2022 and 2021,

respectively.

of March 31, 2022, there was approximately $ 7.1 million of unrecognized compensation cost related to non-vested stock options granted

to Directors and Officers and other employees, which is expected to be recognized over a weighted-average period of approximately 4.1

following is a summary of stock options listed by exercise price , the number options outstanding and exercisable as of March 31, 2022:

Exercise Price

Weighted Average Contract Life

Stock Warrants

The following table summarizes warrant activity during the six months ended

December 31, 2021:

Number of Shares

Weighted Average Exercise Price

Weighted Average Remaining Life (Years)

Aggregate Intrinsic Value

following table summarizes warrant activity during the nine months ended March 31, 2022:

Outstanding and exercisable at June 30, 2021

Outstanding and exercisable at December 31, 2021

Of the above warrants, 9,391 expire in the fiscal year ending June 30,

2022, 4,815 expire in the fiscal year ending June 30, 2023, 2,714 expire in the fiscal year ending June 30, 2025, and 502,843 expire in

the fiscal year ending June 30, 2026.

Issuance of common stock for cash

On August 11, 2021, the Company closed a registered public offering issuing

2,500,000 of its Class A common stock at $8.00 per share, resulting in net proceeds to the Company of approximately $17.8 million,

net of issuance costs of approximately $2.2 million.

On September 24, 2021, the Company issued 92,000 of its Class A common

stock at $8.00 per share in connection with the underwriters exercise of its over-allotment option in for the August 2021

registered public offering, resulting in net proceeds to the Company of approximately $707,000, net of issuance cost of approximately

Issuance of Shares for Services

On August 20, 2021, the Company awarded 58,759 restricted stock units (RSUs)

to the President and CEO under the Companys 2019 Omnibus Incentive Equity Plan (the 2019 Omnibus Plan) as his salary

for the period from April 27, 2021, the date of his appointment, through December 31, 2021.

The number of RSUs awarded was based on a

prorated annual base salary of $600,000 at a 10% discount to the grant date fair value of $7.74 per share of the Companys common

Each RSU awarded the to the CEO entitles him to receive one share of common stock upon vesting.

A total of 15,339 RSUs (representing

the pro rata portion of the RSU award for the period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at

September 30, 2021 and 21,710 vested at December 31, 2021.

Accordingly, as of December 31, 2021, 58,759 shares of common had been issued

The Company recorded stock-based compensation expense related to these

RSUs of $97,695 and $384, 454 for three and six month periods ended December 31, 2021, respectively.

Issuance of Stock Options

On August 20, 2021, the Company granted, under the 2019 Omnibus Plan, stock

options to purchase 1,365,835 shares of common stock to the executive management team.

Twenty percent (20%) of the shares underlying the

options awarded vested on the grant date, and the remaining 80% vest equally over a 5-year period, on the first, second, third, fourth

and fifth anniversary of the grant date.

The option price per share is $7.74 per share, the grant date fair value, and the options terminate

on the tenth anniversary of the grant date.

Forfeiture of Stock Options

On August 27, 2021, the Chief Executive Officer forfeited unvested stock

options to purchase up to 73,125 shares of common stock that were previously granted to him as compensation as an independent director

of the board.

Commitments and Contingencies

From July 1, 2019 to October 31, 2021, the Company paid monthly rent

of $1,000 to Acuitas for its headquarter office at 2120 Colorado Avenue Suite 230, Santa Monica, CA 90404.

Effective November 1,

2021, the Company relocated its headquarters to Nevada at 9120 Double Diamond Parkway, Suite 1400, Reno Nevada 89521.

On June 1, 2021, the Company assumed a NeurMedix

office lease that was extended to February 2022 at 6165 Greenwich Dr Suite 150, San Diego, CA 92122.

The lease agreement requires monthly

payments of $8,782.

The Company will be relocating to 5090 Shoreham Place, San Diego, CA 92122 on February 26, 2022, its new office

space, (New Office).

The Company on December 21, 2021, entered into

a lease agreement for the New Office.

The term of the lease is for 40 months commencing on March 1, 2022.

Monthly base rate

of $4,175 begins on May 1, 2022, with three percent increases at the end of each 12 month period.

Challenge to US Patent

On April 30, 2018, we received notice that Mallinckrodt had petitioned

Patent and Trademark Office (USPTO) to institute an Inter Partes Review (IPR) of our U.S.

9,655,945 titled Treatment of Ascites (the 945 patent).

On November 13, 2019, the Patent Trial

and Appeal Board of USPTO issued a written decision in the IPR from which no appeal was taken.

The decision revoked all of the claims

of the patent as lacking novelty or as obvious.

This ruling is unrelated to the Companys Orphan

drug designations for ascites and hepatorenal syndrome (HRS), which remain unchanged.

An Orphan drug that is first-to-market

typically receives 7 years of market exclusivity in the United States for the designated use(s).

In addition, the ruling does not affect

the Companys rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its

planned Phase 2 and Phase 3 trials, subject to FDA review and authorization, which could eventually provide up to 20 years of patent coverage

in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application

according to the patent laws of each issuing count.

Royalty Agreements

Pursuant to the Agreement and Plan of Merger entered into on April 11,

2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty

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

Pursuant to the Technology Transfer Agreement entered into on July 25,

2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales of all terlipressin

products covered by US patent no.

9,655,645 and any future foreign issuances capped at a maximum of $200,000 per year.

Employee Benefit Plan

On August 1, 2021, the Company began sponsoring an employee benefit plan

subject to Section 401(K) of the Internal Revenue Service Code (the 401K Plan) pursuant to which, all employees meeting

eligibility requirements are able to participate.

Subject to certain limitations in the Internal Revenue Code, eligible employees

are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5%

of an employees contributions to the 401K Plan.

For the three and six months ended December 31, 2021, the Companys contributions

to the 401K Plan totaled approximately $ 22,800 and $ 46,600 , respectively.

Managements 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, and Section 27A of the Securities Act of 1933.

Any statements contained in this report that

are not statements of historical fact may be 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

Outstanding and exercisable at March 31, 2022

the above warrants, 1,091 expire in the fiscal year ending June 30, 2022, 4,815 expire in the fiscal year ending June 30, 2023, 2,714

expire in the fiscal year ending June 30, 2025, and 502,843 expire in the fiscal year ending June 30, 2026.

of common stock for cash

August 11, 2021, the Company closed a registered public offering issuing 2,500,000 of its Class A common stock at $8.00 per share,

resulting in net proceeds to the Company of approximately $17.8 million, net of issuance costs of approximately $2.2 million.

September 24, 2021, the Company issued 92,000 of its Class A common stock at $8.00 per share in connection with the underwriters

exercise of its over-allotment option in for the August 2021 registered public offering, resulting in net proceeds to the Company of

approximately $707,000, net of issuance cost of approximately $29,000.

of Shares for Services

August 20, 2021, the Company awarded 58,759 restricted stock units (RSUs) to the President and CEO under the Companys

2019 Omnibus Incentive Equity Plan (the 2019 Omnibus Plan) as his salary for the period from April 27, 2021, the date of

his appointment, through December 31, 2021.

The number of RSUs awarded was based on a prorated annual base salary of $600,000 at a 10%

discount to the grant date fair value of $7.74 per share of the Companys common stock.

Each RSU awarded to the CEO entitles him

to receive one share of common stock upon vesting.

A total of 15,339 RSUs (representing the pro rata portion of the RSU award for the

period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at September 30, 2021 and 21,710 vested at December

Accordingly, the common stock was issued to the CEO at each of the quarter end vesting dates.

stock-based compensation expense related to these RSUs totaled $97,695 for the fiscal year ended June 30, 2021 and $384,454 for the nine

month period ended March 31, 2022, respectively.

There were no stock-based compensation expense related to these RSUs for the three month

period ended March 31, 2022 and 2021.

of Stock Options

August 20, 2021, the Company granted, under the 2019 Omnibus Plan, stock options to purchase 1,365,835 shares of common stock to the

executive management team.

Twenty percent (20%) of the shares underlying the options awarded vested on the grant date, and the remaining

80% vest equally over a 5-year period, on the first, second, third, fourth and fifth anniversary of the grant date.

The exercise price

of the options is $7.74 per share, the grant date fair value of the stock, and the options terminate on the earlier of the tenth anniversary

of the grant date or the date as of which the options were fully exercised.

February 1, 2022, the Company granted stock options to purchase 124,167 shares of common stock to a new employee.

Twenty percent (20%)

of the shares underlying the options awarded vested on the grant date, and the remaining 80% vest equally over a 5-year period, on the

first, second, third, fourth and fifth anniversary of the grant date.

The exercise price is $3.20 per share, the grant date fair value,

and the options terminate on the tenth anniversary of the grant date.

the three months ended March 31, 2022, the Company granted, stock options to purchase shares of common stock totaling 273,167 to four

new employees.

exercise prices per share are $3.20;

$2.74 and $3.24, which were fair values of the Companys common stock on the respective grant

Twenty percent (20%) of the shares underlying the options awarded vest on the one year anniversary of the grant date, and the

remaining 80% vest in equal monthly installments over 48 month.

options terminate on the tenth anniversary of the grant date or date

as of which the options were fulling exercised.

of Stock Options

August 27, 2021, the Chief Executive Officer forfeited unvested stock options to purchase up to 73,125 shares of common stock that were

previously granted to him as compensation as an independent director of the board.

July 1, 2019 to October 31, 2021, the Company paid monthly rent of $1,000 to Acuitas for its headquarter office at 2120 Colorado Avenue

Suite 230, Santa Monica, CA 90404.

Effective November 1, 2021, the Company relocated its headquarters to Nevada.

The Company paid an

annual rent of $2,200 for the address at 680 W Nye Lane, Suite 201, Carson City Nevada 897603.

The Nevada lease is an annual lease.

June 1, 2021, the Company assumed a NeurMedix office lease that was extended to February 2022 at 6165 Greenwich Dr Suite 150, San Diego,

The lease agreement required monthly payments of $8,782.

On February 26, 2022 the Companys San Diego office relocated

to 5090 Shoreham Place, San Diego, CA 92122.

(the New Office).

New Office lease term for 38 months, commenced on March 1, 2022 with a 2 month rent abatement.

The monthly base rate payment of $4,175

begins June 1, with annual increases of three percent.

operating lease cost recognized in our statement of operations was approximately $23,000 and $76,500 for the three and nine months

ended March 31, 2022, and approximately $3,000 and $9,000 for the three and nine months ended March 31, 2021.

following table provides balance sheet information related to leases as of March 31, 2022 and June 30, 2021:

March 31, 2022

June 30, 2021

Operating lease, right-of-use asset, net

Current portion of operating lease liabilities

Operating lease liabilities, net of current portion

Total operating lease liabilities

March 31, 2022, the future estimated minimum lease payments under non-cancelable operating leases are as follows:

Year ending June 30:

2022 (remaining 3 months)

Total minimum lease payments

Less amount representing interest

Present value of future minimum lease payments

Less current portion of operating lease liabilities

Operating lease liabilities, net of current portion

weighted average remaining lease term and discount rate as of March 31, 2022 and 2021 were as follows:

March 31, 2022

June 30, 2021

Weighted average remaining lease term (Years)

Operating leases

Weighted average discount rate

Operating leases

and Contingencies

April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S.

Patent and Trademark Office (USPTO) to institute

an Inter Partes Review (IPR) of our U.S.

9,655,945 titled Treatment of Ascites (the 945

On November 13, 2019, the Patent Trial and Appeal Board of USPTO issued a written decision in the IPR from which no appeal

The decision revoked all of the claims of the patent as lacking novelty or as obvious.

ruling is unrelated to the Companys Orphan drug designations for ascites and hepatorenal syndrome (HRS), which remain

An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated

In addition, the ruling does not affect the Companys rights in its pending patent application directed to proprietary

liquid formulations of terlipressin for use in its planned Phase 2 and Phase 3 trials, subject to FDA review and authorization, which

could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the

United States, if a patent issues from a patent application according to the patent laws of each issuing count.

to the Agreement and Plan of Merger entered into on April 11, 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics,

Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among

LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

to the Technology Transfer Agreement entered into on July 25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated

to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no.

9,655,645 and any future foreign

issuances capped at a maximum of $200,000 per year.

August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code

(the 401K Plan) pursuant to which, all employees meeting eligibility requirements are able to participate.

to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax

salary reduction basis and the Company will match 5% of the first 5% of an employees contributions to the 401K Plan.

For the three

and nine months ended March 31, 2022, the Companys contributions to the 401K Plan totaled approximately $ 28,700 and $ 75,100 , respectively.

April 5, 2022, the Company granted stock options to purchase 755,000 shares of common stock to the independent directors of the board

as compensation for services at an exercise price of $5.04 per share, the grant date fair value.

Twenty-five percent (25%) of the shares

underlying the options awarded vested on the grant date, and the remaining 75% vest ratably over three years on the first, second, and

third anniversary of the grant date.

The options terminate on the earlier of the fifth anniversary of the grant date or the date as of

which the options are fully exercised.

Managements Discussion and Analysis of Financial Condition and Results of Operations

report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A

of the Securities Act of 1933.

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

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

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 among others, include our;

research and development activities and, distributor channel;

compliance with regulatory

impositions requirements;

and 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.

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.

Thus, you should not assume that our silence over time means

that actual events are bearing out as expressed or implied in such forward-looking statements.

You should carefully review and consider

the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the SEC)

that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

The following discussion of the Companys financial condition and

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

Managements Discussion

is a clinical-stage company developing innovative drug therapies

to overcome unmet medical needs in chronic debilitating conditions.

In liver disease , our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being

developed as a future treatment option for patients suffering from ascites and other life-threatening complications of advanced liver

cirrhosis caused by NASH, hepatitis, and alcoholism.

and development activities and, distributor channel;

compliance with regulatory impositions requirements;

and 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.

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.

Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking

You should carefully review and consider the various disclosures we make in this report and our other reports filed with

the Securities and Exchange Commission (the SEC) that attempt to advise interested parties of the risks, uncertainties

and other factors that may affect our business.

following discussion of the Companys financial condition and the results of operations should be read in conjunction with the

Financial Statements and Notes thereto appearing elsewhere in this report.

is a clinical-stage company developing innovative drug therapies to overcome unmet medical needs in chronic debilitating conditions.

liver disease , our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option

for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and

The initial target for BIV201 therapy is 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.

The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites.

clinical trial of BIV201 was completed in 2019, and a multi-center, randomized and controlled Phase 2b trial is currently underway at

ten of thirteen planned US medical centers including Vanderbilt University, the Mayo Clinic, and the University of Pennsylvania (NCT04112199).

Top-line results from this trial are expected in mid-2022, to be followed by a proposed single pivotal Phase 3 clinical trial beginning

in late 2022, subject to favorable FDA review.

In neurodegenerative disease, BioVie acquired the biopharmaceutical

assets of NeurMedix, Inc., a privately held clinical-stage pharmaceutical company, in June 2021.

The acquired assets include NE3107, a

potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies, is believed to reduce neuroinflammation.

NE3107is a 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 Alzheimers and Parkinsons Disease, and NE3107 could, if approved, represent

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

and 1 million from Parkinsons.

The FDA has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled,

parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimers disease (NCT04669028).

initiated this trial on August 5, 2021 and are targeting primary completion in the first half of 2023.

In addition to Alzheimers disease, the FDA has authorized a Phase 2 study assessing NE3107s potential pro-motoric

impact in Parkinsons disease patients, and to assess its safety and tolerability.

The NM201 study (NCT05083260) Initiated by the

Company on January 20, 2022;

is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons

Disease (PD).

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.

and Drug Administration (FDA) has not approved any drug to treat refractory ascites.

A Phase 2a clinical trial of BIV201 was completed

in 2019, and a multi-center, randomized and controlled Phase 2b trial is currently underway at ten of thirteen planned US medical centers

including Vanderbilt University, the Mayo Clinic, and the University of Pennsylvania (NCT04112199).

Top-line results from this trial

are expected in early 2023, to be followed by a proposed single pivotal Phase 3 clinical trial, subject to favorable FDA review.

neurodegenerative disease, BioVie acquired the biopharmaceutical assets of NeurMedix, Inc., a privately held clinical-stage pharmaceutical

company and related party affiliate, in June 2021.

The acquired assets include NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based

on animal studies, is believed to reduce neuroinflammation.

NE3107is a 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 Alzheimers

and Parkinsons Disease, and NE3107 could, if approved, represent an entirely new medical approach to treating these devastating

conditions affecting an estimated 6 million Americans suffering from Alzheimers and 1 million from Parkinsons.

has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate

NE3107 in subjects who have mild to moderate Alzheimers disease (NCT04669028).

We initiated this trial on August 5, 2021 and are

targeting primary completion in the first half of 2023.

addition to Alzheimers disease, the FDA has authorized a Phase 2 study assessing NE3107s potential pro-motoric impact in

Parkinsons disease patients, and to assess its safety and tolerability.

The NM201 study (NCT05083260) Initiated by the Company

on January 20, 2022;

is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons Disease

Participants will be treated with carbidopa/levodopa and NE3107 or placebo.

8 unchanged sentences

initiated on January 20, 2022 and topline results are expected in mid 2022.

Inflammation-driven insulin resistance is believed to be implicated

in a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these opportunities

in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase.

Comparison of the three months ended December 31, 2021 to the three

months ended December 31, 2020

Net income (loss)

The net loss for the three months ended December 31, 2021, was approximately $5.4 million as

compared to net loss of $3.1million for the three months ended December 31 2020.

The net loss increase of $2.3 million for the three month

period ended December 31, 2021 resulted from the increased loss from operations of $3.6 million primarily attributed to increased research

and development activities, reduced by a $1.3 million increase in other income attributed to a change in fair value of the derivative

liabilities and increased by interest expense of approximately $316,000 both related to the new debt financing that funded on November

Total operating expenses for the three months ended December 31 2021 and

2020 were approximately $6.7 million and $3.1 million respectively.

The net increase of approximately $3.6 million during the three months

ended December 31 2021 included an increase in research and development expenses of approximately $3.6 million, primarily attributed to

the Alzheimer pivotal Phase 3 clinical trial that was initiated in August 2021 and continuation of our Orphan Drug candidate BIV201s

Phase 2b clinical trial, which was initiated earlier in the 2021 calendar year.

Research and Development Expenses

Inflammation-driven insulin resistance is believed to be

implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these

opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase.

of the three months ended March 31, 2022 to the three months ended March 31, 2021

net loss for the three months ended March 31, 2022, was approximately $7.0 million as compared to net loss of $3.0 million for the

three months ended March 31, 2021.

The net loss increase of $4.0 million for the three month period ended March 31, 2022 resulted

from an increased loss from operations of $2.7 million primarily attributed to increased research and development activities,

$919,000 increase in interest expense related to the new debt financing that funded on November 30, 2021, and $ 386,000

increase in change in fair value of the derivative liabilities.

Total operating expenses for the three months ended March 31, 2022

and 2021 were approximately $5.7 million and $3.0 million respectively.

The net increase of approximately $2.7 million during the three

months ended March 31, 2022 was comprised of a net increase in research and development expenses of approximately $2.8 million and net

decrease in selling general and administration of approximately $40,000.

Approximately $1.0 million in selling, general and administration included

expense related to the neuroscience operations and development of the biopharmaceutical assets purchased in June 2021.

The increase in

research and development related to the Alzheimer pivotal Phase 3 clinical trial that was initiated in August 2021, the initiation of

the Phase 2 Parkinson study in January 2022, and the continuation of our Orphan Drug candidate BIV201s Phase 2b clinical trial,

which was initiated in the 2021 calendar year.

and Development Expenses

Research and development expenses were approximately $3.6 million and

$938,000 for the three months ended December 31, 2021 and 2020, respectively.

The net increase of approximately $3.7 million, for

the three months period ended December 31, 2021 was comprised of Neuroscience operations of approximately $2.6 million from the

increased activity in the Alzheimer pivotal Phase 3 clinical trial and the preparations for the Parkinsons Phase 2 clinical

trial initiated in January 2022;

increased activities in the Liver Cirrhosis operations totaling approximately $556,000 for the

continuation of Orphan Drug candidate BIV201s Phase 2b clinical trial initiated in June 2021;

and increases in compensation

expense of approximately $452,000 due to neuroscience personnel hired to oversee the development of the biopharmaceutical assets

purchased in June 2021 and hiring of our CMO who came on board on November 1, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $2.0 million in each of the

three month periods ended December 31, 2021 and 2020.

The components of a net nil change in selling, general and administrative expenses

resulted primarily from a decline in stock compensation expense of approximately $451,000, representing a reduction in stock compensation

expense from $969,000 for the three months ended December 31, 2020 to $518,000 for the three months ended December 31, 2021;

$458,000 representing the total increases in legal expenses of $325,000 and investor relations expense and annual shareholders meeting

expenses of $133,000 for the three months ended December 31, 2021.

Other Income/Expense

Other income, net for the three months ended December 31, 2021 was $1.3

million compared to approximately $0.0 for the three months ended December 31, 2020.

The increase for the three months ended December

31, 2021, was comprised of the change in fair value of the derivative liabilities of $1.6 million offset by interest expense of approximately

In the three month period ended December 31, 2020 there were no derivative liabilities or debt outstanding.

Comparison of the six months ended December 31, 2021 to the six months

ended December 31, 2020

Net income (loss)

net loss for the six months ended December 31, 2021 was approximately $11 million as compared to net income of $4.3 million for the six

months ended December 31, 2020.

The decline from net income to net loss of approximately $15.2 million was attributed to an increase

in the loss from operations of approximately 8.8 million and the change in the fair value of derivative liabilities of approximately

$6.7 million, offset by a decrease in interest expense of approximately 242,000.

Total operating expenses for the six months ended December 31, 2021 were

approximately $12.2 million as compared to $3.5 million for the six months ended December 31, 2020.

$790,000 for the three months ended March 31, 2022 and 2021, respectively.

The net increase of approximately $2.8 million, for the

three months period ended March 31, 2022 was comprised of Neuroscience operational expenses of approximately $1.7 million attributed to

increased activity in the Alzheimer pivotal Phase 3 clinical trial and the initiation of the Parkinsons Phase 2 clinical trial

in January 2022;

an increase of $300,000 related to the continuation of Orphan Drug candidate BIV201s Phase 2b clinical trial initiated

in June 2021;

and increases in salary and employee benefit expenses of $522,000 and stock-based compensation expense of $258,000.

Company expanded clinical team personnel by the hiring of the neuroscience personnel to oversee the development of the biopharmaceutical

assets purchased in June 2021, our CMO who came on board on November 1, 2021 and other related clinical personnel during the three months

ended March 31, 2022.

General and Administrative Expenses

general and administrative expenses were approximately $2.1 million and $2.2 million for the three month periods ended March 31,

2022 and 2021, respectively.

The components of the approximate $100,000 net decrease was comprised of increases in salary and

employee benefit expenses of $250,000 and stock-based compensation expense of $364,000;

an increase in investor relations and

advisory fees of $527,000, and an increase in legal and other consultants, office and insurance expenses totaling $347,000;

by $518,000 of directors’ stock-based compensation decline from 2021 and approximately $1 million related to the purchase of

Neuroscience biopharmaceutical assets which closed on June 10, 2021 recognized in the three months ended March 31, 2021.

Income/Expense

expense, net for the three months ended March 31, 2022 was $1.3 million compared to approximately $35,000 for the three months ended

March 31, 2021.

The increase for the three months ended March 31, 2022, was comprised of the change in fair value of the derivative liabilities

of approximately $386,000 and interest expense of approximately $918,000.

In the three month period ended March 31, 2021 there were no

derivative liabilities or debt outstanding.

of the nine months ended March 31, 2022 to the nine months ended March 31, 2021

(loss)/Income

The net loss for the nine months ended March 31, 2022 was approximately

$18.0 million as compared to net income of $1.3 million for the nine months ended March 31, 2021.

The decline from net income to net loss

of approximately $19.3 million was attributed to an increase in the loss from operations of approximately $11.5 million and the change

in the fair value of derivative liabilities of $7.1 million and an increase in interest expense of approximately $677,000.

Total operating expenses for the nine months ended March 31, 2022 were

approximately $18 million as compared to $6.5 million for the nine months ended March 31, 2021.

The net increase of approximately

$8.7 million during the six months ended December 31, 2021 was comprised of increased research and development expenses of approximately

$6.3 million, primarily attributed to the Alzheimer pivotal Phase 3 clinical trial that was initiated in August 2021 and continuation

of our Orphan Drug candidate BIV201s Phase 2b clinical trial, which was initiated earlier in the 2021 calendar year and an increase

in selling, general and administrative expenses of $2.4 million.

Research and Development Expenses

Research and development expenses were approximately $7.4 million and $1.1 million for

the six months ended December 31, 2021, and 2020, respectively.

The net increase of approximately $6.3 million, was comprised of the Neuroscience

clinical operations of approximately $3.1 million for the activities in the Alzheimer pivotal Phase 3 clinical trial and the preparations

for the initiation of the Parkinsons Phase 2 clinical that launched in January 2022;

an increase in the Liver Cirrhosis operating

expenses totaling approximately $1.1 million for the ongoing Orphan Drug candidate BIV201s Phase 2b clinical trial;

and increases

in compensation expense of approximately $2.1 million due to the neuroscience personnel hired to oversee the development of the biopharmaceutical

assets purchased in June 2021, the hiring of our CMO who came on board in November 1, 2021 and included related stock based compensation

awarded the management that totaled $579,000.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $4.7 million

and $2.3 million for the six months ended December 31, 2021 and 2020, respectively.

$11.5 million during the nine months ended March 31, 2022 was primarily attributed to the expanded operations of the Company from the

purchase of the Neuroscience pharmaceutical assets that was completed in June 2021.

The net increase was comprised of increased research

and development expenses of approximately $9.4 million, attributed to the Alzheimer pivotal Phase 3 clinical trial that was initiated

in August 2021 and the continuation of our Orphan Drug candidate BIV201s Phase 2b clinical trial, which was initiated earlier in

the 2021 calendar year, and an increase in selling, general and administrative expenses of $2.1 million.

and Development Expenses

Research and development expenses were approximately $11.4 million

and $2.0 million for the nine months ended March 31, 2022, and 2021, respectively.

The net increase of approximately $9.4 million, was

primarily attributed to increased compensation expense of approximately $ 1.5 million, of which $1.2 million related to stock based compensation

and a total net increase of approximately $765,000 expenses related to being listed on a national exchange including listing

fees, investor relations, legal and professional fees and office and website development expenses, as the Company expanded its operations

with the development of the recent neuroscience pharmaceutical assets.

Other (Income)/Expense

Other income, net for the six months ended December 31, 2021 and 2020 was

$1.3 million compared to approximately $7.7 million, respectively.

The net decrease of $6.4 million was comprised of the change in fair

value of the derivative liabilities of $6.7 million and decrease interest expense of approximately $242,000.

Capital Resources and Liquidity

As of December 31, 2021, the Company had working capital of approximately

$26.2 million, cash of approximately $30.4 million, stockholders equity of approximately $16.1 million, and an accumulated deficit

of approximately $235.8 million.

In addition, the Company has not generated any revenues to date and no revenues are expected in the

foreseeable future.

The Companys future operations are dependent on the success of the Companys ongoing development and

commercialization efforts, as well as its ability to secure additional financing as needed.

In November 2021, the Company closed a debt financing, pursuant to which

it received a loan in the aggregate principal amount of $15 million and incurred direct financing costs of approximately $390,000.

the increase in the Companys cash balance could possibly sustain operations over the next 12 months if measures are taken to delay

planned expenditures in our research protocols and slow the progress in the Companys clinical programs, given the Companys

current planned operations to meet certain goals and objectives, we expect projected cash flows to be depleted within that period of time.

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

to raise additional capital to finance its operations.

We cannot assure you that our drug candidate will be developed, work, or receive

regulatory approval;

that we will ever earn revenues sufficient to support our operations or that we will ever be profitable.

since we have no committed source of sufficient financing, we cannot assure that we will be able to raise money as and when we need it

to continue our operations.

If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease,

our operations.

Although management continues to pursue its strategic plans, there is no

assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund

continuing operations.

Management intends to attempt to secure additional required funding primarily through additional equity or debt

We may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking

partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar

transactions.

However, there can be no assurance that we will be able to obtain required funding.

If we are unsuccessful

in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures in our research protocols.

we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that

could result in our stockholders losing some or all of their investment in us.

The emergence of widespread health emergencies or pandemics such as the

coronavirus (COVID-19) pandemic (and its related variants), has lead to continued regional quarantines, business shutdowns,

labor shortages, disruptions to supply chains, and overall economic instability.

Although some jurisdictions

have relaxed these measures, particularly as more and more people are vaccinated, others have not or have reinstated them as COVID-19

cases surge and variants emerge The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants

on the financial markets and the overall economy, are highly uncertain and cannot be predicted at this time.

If the financial markets

and/or the overall economy are impacted for an extended period, the Companys ability to raise funds may be materially adversely

These circumstances raise substantial doubt on our ability to continue

as a going concern.

The financial statements included in this report do not include any adjustments relating to the recoverability and

classification of recorded asset amounts or amounts and classification of liabilities that might result from this uncertainty.

Off-Balance Sheet Arrangements

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 Companys 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.

Critical Accounting Policies and Estimates

For the three-month and six month periods ended December 31, 2021, there

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

year ended June 30, 2021.

New Accounting Pronouncements

The Company considered the applicability and impact of recent accounting

pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement

of operations.

Quantitative and Qualitative Disclosures About Market

Not applicable to smaller reporting companies.

comprised of the Neuroscience clinical operations of approximately $4.9 million for the activities in the Alzheimer pivotal Phase 3 clinical

trial and the preparations for the initiation of the Parkinsons Phase 2 clinical that launched in January 2022;

an increase of

approximately $1.3 million for the ongoing Orphan Drug candidate BIV201s Phase 2b clinical trial;

and increases in salary and employee

benefit expenses of $2.1 million and stock based compensation expense of $1.0 million.

The Company expanded the clinical team personnel

by the hiring of the neuroscience personnel to oversee the development of the biopharmaceutical assets purchased in June 2021, our CMO

who came on board on November 1, 2021 and other related clinical personnel during the three months ended March 31, 2022.

General and Administrative Expenses

Selling, general and administrative expenses were approximately $6.4

million and $4.3 million for the nine months ended March 31, 2022 and 2021, respectively.

The net increase of approximately $2.1 million

was primarily comprised of increased salary and employee benefit expenses of approximately $546,000, stock based compensation expense

of $2.0 million ;

increased legal expense of $620,000;

investor relations and advisory of $729,000;

and approximately $442,000 of increased

expenses related to other consulting fees, insurance premiums, office and website development expenses, as the Company operations were

expanded during the nine months ended March 31, 2022 with the addition of Neuroscience operations in June 2021.

These increases were offset

by $1.1 million of directors stock-based compensation and $1.1 million related to the purchase of Neuroscience biopharmaceutical

assets which closed on June 10, 2021.

Expense/(Income)

expense, net for the nine months ended March 31, 2022 was a nominal amount and comprised of net interest expense of $1.2 million offset

by the change in fair valued of the derivative liabilities of $1.2 million compared to other income, net of $7.7 million for the nine

months ended March 31, 2021 which was comprised of net interest expense of $545,000 offset by the change in fair value of $8.3 million.

increase in net interest expense and change in fair value of the derivative liabilities is related to debt financing that was funded

in November 30, 2021.

Resources and Liquidity

of March 31, 2022, the Company had working capital of approximately $20.5 million, cash of approximately $24.5 million, stockholders

equity of approximately $10.0 million, and an accumulated deficit of approximately $242.9 million.

In addition, the Company has not generated

any revenues to date and no revenues are expected in the foreseeable future.

The Companys future operations are dependent on the

success of the Companys ongoing development and commercialization efforts, as well as its ability to secure additional financing

November 2021, the Company closed a debt financing, pursuant to which it received a loan in the aggregate principal amount of $15 million

and incurred direct financing costs of approximately $390,000.

Although the increase in the Companys cash balance could possibly

sustain operations over the next 12 months if measures are taken to delay planned expenditures in our research protocols and slow the

progress in the Companys clinical programs, given the Companys current planned operations to meet certain goals and objectives,

we expect projected cash flows to be depleted within that period of time.

future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations.

assure you that our drug candidate will be developed, work, or receive regulatory approval;

that we will ever earn revenues sufficient

to support our operations or that we will ever be profitable.

Furthermore, since we have no committed source of sufficient financing,

we cannot assure that we will be able to raise money as and when we need it to continue our operations.

If we cannot raise funds as and

when we need them, we may be required to severely curtail, or even to cease, our operations.

management continues to pursue its strategic plans, there is no assurance that the Company will be successful in obtaining sufficient

financing on terms acceptable to the Company, if at all, to fund continuing operations.

Management intends to attempt to secure additional

required funding primarily through additional equity or debt financings.

We may also seek to secure required funding through

sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to

co-develop and fund research and development efforts, or similar transactions.

However, there can be no assurance that we

will be able to obtain required funding.

If we are unsuccessful in securing funding from any of these sources, we will defer,

reduce or eliminate certain planned expenditures in our research protocols.

If we do not have sufficient funds to continue

operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some

or all of their investment in us.

continual widespread health emergencies or pandemics such as the coronavirus (COVID-19) pandemic (and its related variants),

has lead to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability.

Although some jurisdictions have relaxed these measures, others have not or have reinstated them

as COVID-19 cases and its variants continue to emerge The duration and spread of the COVID-19 pandemic and the long-term impact

of COVID-19 and its variants on the financial markets and the overall economy, are highly uncertain and cannot be predicted at this time.

If the financial markets and/or the overall economy are impacted for an extended period, the Companys ability to raise funds may

be materially adversely affected.

In addition, the COVID-19 pandemic has created a widespread labor shortage, including a shortage of

medical professionals, and may possibly impact the potential patient participation in our studies of which may adversely impact our ability

to continue or complete our clinical trials in the planned timeline.

circumstances raise substantial doubt on our ability to continue as a going concern.

The financial statements included in this report

do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification

of liabilities that might result from this uncertainty.

Sheet Arrangements

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

Companys 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;

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 assets.

Accounting Policies and Estimates

the three-month and nine month periods ended March 31, 2022, there were no significant changes to the Companys critical accounting

policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2021.

Accounting Pronouncements

Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable

or expected to have minimal impact on our balance sheets or statement of operations.

Quantitative and Qualitative Disclosures About Market Risk

applicable to smaller reporting companies.

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 1. Financial Statements