What changed in this filing

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Item 1. Financial Statements

2021-11-10 compared with 2021-05-10 · 519 added, 740 removed, 97 unchanged (93% of the section changed)

Financial Statements

Condensed Balance Sheets

Balance Sheets

September 30,

CURRENT ASSETS:

3 unchanged sentences

Total other assets

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

LIABILITIES AND STOCKHOLDERS EQUITY

CURRENT LIABILITIES:

Accounts payable and accrued expenses

Derivative liability - warrants

Derivative liability - conversion option on convertible debenture

Convertible debenture - related party, net of unearned discount of $ 0 and $ 462,864 and capitalized accrued interest of $ 0 and $ 48,407 at March 31, 2021 and June 30, 2020, respectively

Current portion of other liabilities

Total current liabilities

Other liabilities

TOTAL LIABILITIES

Commitments and contingencies (Note 8)

STOCKHOLDERS' EQUITY (DEFICIT)

STOCKHOLDERS EQUITY :

Preferred stock;

3 unchanged sentences

Common stock, $ 0.0001 par value;

800,000,000 shares authorized at March 31, 2021 and June 30, 2020;

13,957,792 and 5,204,392 shares issued and outstanding at March 31, 2021 and June 30, 2020, respectively

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

24,962,373 and 22,333,324 shares issued and outstanding at September 30, 2021 and June 30, 2021, respectively

Additional paid in capital

2 unchanged sentences

( 224,885,422 )

Total stockholders' equity (deficit)

( 21,498,636 )

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

See accompanying notes to unaudited condensed

financial statements

Condensed Statements of Operations

Three Months Ended

Nine Months Ended

March 31 2021

March 31 2020

March 31 2021

March 31 2020

Total stockholders equity

TOTAL LIABILITIES AND STOCKHOLDERS EQUITY

accompanying notes to unaudited condensed financial statements

Statements of Operations

OPERATING EXPENSES:

Amortization expense

Research and development expenses

3 unchanged sentences

( 5,547,284 )

( 6,451,631 )

( 2,115,918 )

OTHER (INCOME) EXPENSE:

OTHER EXPENSE (INCOME) EXPENSE:

Change in fair value of derivative liabilities

( 8,279,919 )

( 8,125,328 )

Interest expense

Interest income

TOTAL OTHER (INCOME) EXPENSE, NET

( 7,734,872 )

TOTAL OTHER INCOME, NET

( 7,720,671 )

1 unchanged sentence

$ ( 5,540,753 )

$ ( 366,402 )

Deemed dividends - related party

NET (LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS

$ ( 2,992,868 )

$ ( 366,402 )

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

$ ( 5,540,753 )

$ ( 46,264,404 )

NET (LOSS) INCOME PER COMMON SHARE

NET LOSS PER COMMON SHARE

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

See accompanying notes to unaudited condensed

financial statements

Condensed Statements of Cash Flows

Nine Months Ended

March 31, 2021

March 31, 2020

accompanying notes to unaudited condensed financial statements

Statements of Cash Flows

September 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments to reconcile net income to net cash used in operating activities:

Net (loss)/income

$ ( 5,540,753 )

Adjustments to reconcile net (loss) income to net cash used in operating activities:

Amortization of intangible assets

Stock based compensation

Common shares issued for interest payment

Common shares issued for service

Stock based compensation - restricted stock

Stock option based compensation expense

Interest expense from convertible debenture

1 unchanged sentence

( 8,279,919 )

( 8,125,328 )

Changes in operating assets and liabilities:

Accounts payable and accrued expenses

( 1,056,032 )

Other liabilities

Net cash used in operating activities

3 unchanged sentences

Net proceeds from issuance of common stock

Proceeds from exercise of warrants

Payment of convertible debenture - related party

( 1,821,818 )

Proceeds from loan payable - related party

Proceeds from convertible debenture - related party

Net cash provided by financing activities

Net increase (decrease) in cash

Net increase in cash

Cash, beginning of period

5 unchanged sentences

Deemed dividends - related party

Stock warrants classified as derivative liability

See accompanying notes to unaudited condensed

financial statements

Condensed Statements of Changes in Stockholders’

(Deficit) Equity

For the periods July 1, 2019 through March

31, 2020 and July 1, 2020 through March 31, 2021

Additional Paid in

Total Stockholders' Equity

Balance, June 30, 2019

$ ( 7,262,072 )

Issuance of commitment shares

Deemed dividend for commitment shares

( 17,099,058 )

Net loss for the three months ended September 30, 2019

( 3,821,227 )

Balance, September 30, 2019

( 28,182,357 )

( 8,720,628 )

Stock option compensation

Net income for the three months ended December 31, 2019

Balance, December 31, 2019

$ ( 21,517,319 )

$ ( 2,044,428 )

Stock based compensation

Issuance of shares for services

Issuance of shares for interest payment

Net loss for the three months ended March 31, 2020

Balance, March 31, 2020

$ ( 21,883,721 )

$ ( 2,344,459 )

accompanying notes to unaudited condensed financial statements

Statements of Changes in Stockholders (Deficit) Equity

the Three Months Ended September 30, 2021 and September 30, 2020

Stockholders

Balance, June 30, 2020

1 unchanged sentence

$ ( 21,498,636 )

Net proceeds from issuance of common stock

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

Redemption of warrants - related party

2 unchanged sentences

Cashless exercise of options

Net income for the three months ended September 30, 2020

Balance, September 30, 2020

$ 101,896,586

Stock based compensation

Net loss for the three months ended December 31, 2020

$ ( 87,302,302 )

( 3,057,807 )

Balance, December 31, 2020

Balance June, 30, 2021

$ 229,933,505

$ ( 224,885,422 )

Stock based compensation

Cashless exercise of warrants

Proceeds from exercise of warrants

Net loss for the three months ended March 31, 2021

Proceeds from issuance of common stock, net cost of $ 2,224,992

Stock based compensation - restricted stock

Stock option based compensation

( 5,540,753 )

Balance, March 31, 2021

Balance, September 30, 2021

$ 250,657,973

$ ( 230,426,175 )

See accompanying notes to unaudited condensed

financial statements

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Background Information

(the “Company”) 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.

We are currently focused on developing and commercializing

BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites due to chronic liver cirrhosis.

BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the

same disease pathway as ascites), but not yet available in the United States.

BIV201’s active agent is a potent vasoconstrictor

and has shown efficacy for reducing portal hypertension in studies around the world.

The goal is for BIV201 to interrupt the ascites

disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

BioVie completed a Phase 2a clinical trial

of BIV201 in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute in Richmond, VA

The Company met with representatives of the Food and Drug Administration (“FDA”) in a Type C Guidance Meeting

to discuss the study results and plan our next clinical study.

Subsequently we requested a Type B Meeting and submitted an extensive

pre-meeting information package.

In April 2020, the FDA provided a written response that provided new guidance regarding primary

and secondary endpoints, BIV201 dosing levels, quality of life measures and other key aspects of the clinical trial design.

further communications, the Company completed the clinical trial design protocol and was cleared to begin a Phase 2 clinical study.

We activated the first trial sites in the first calendar quarter of 2021 and patient screening is now underway.

The Phase 2 study

results will be used to guide the design of a pivotal Phase 3 clinical trial.

We have developed a patent-pending novel liquid formulation

of BIV201 for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation

errors that may occur when pharmacists reconstitute the powder version of terlipressin.

BIV201 has the potential to improve the health

of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis

(NASH), and alcoholism.

It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites,

which represents a significant unmet medical need.

An Orphan drug that is first-to-market typically receives 7 years of market

exclusivity in the United States for the designated use(s).

The FDA has never approved any drug specifically for treating ascites.

addition, the Company is applying for global patent coverage of a proprietary liquid formulation of terlipressin for use in the

Phase 2 and Phase 3 clinical trials, which has been cleared by the FDA.

This could eventually provide up to 20 years of patent

protection in countries where the Company seeks patent issuance according to local patent laws.

The BIV201 development program began at LAT

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.

and PharmaIN, Corp.

(“PharmaIN”), LAT Pharma’s former partner focused on the development of new modified drug

candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future

net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of

each company's net license revenues.

On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified

terlipressin development program and simultaneously paid the remaining balance due on a related debt.

PharmaIN, Corp.’s rights

to our program remain unchanged.

On April 27, 2021, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”)

with NeurMedix, Inc.

(“NeurMedix”) and Acuitas Group Holdings, LLC (“Acuitas”), which are related party

affiliates, pursuant to which the Company has agreed to acquire certain assets from NeurMedix and assume certain liabilities of

NeurMedix, in exchange for the consideration of cash and shares of common stock.

(collectively, the “Transaction”).

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 Alzheimer’s Disease and Parkinson’s Disease.

9 - Subsequent Events.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Liquidity and Going Concern

accompanying notes to unaudited condensed financial statements

to Condensed Financial Statements

the Three Months Ended September 30, 2021 and 2020

(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.

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 October 31, 2021, the nine planned US study centers

have 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 (statistical significance not required), could potentially yield the clinical data needed to apply for BIV201 marketing

The Phase 2b clinical trial protocol is summarized on www.clinicaltrials.gov, trial identifier NCT04112199.at nine US study

(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.

In June 2021, BioVie received written feedback from the FDA in response to a Type B meeting

request to conduct a pivotal US Phase 3 clinical trial in HRS-AKI, which is a life-threatening complication of advanced ascites.

on the guidance received in subsequent communications with the FDA, we are revising certain elements of our proposed study and are planning

to initiate this study in early 2022.

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 Alzheimer’s

and Parkinson’s 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 Alzheimer’s and 1 million from Parkinson’s.

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 Alzheimer’s disease (NCT04669028).

In August 2021, the study was initiated and the Company

is anticipating top line results in late calendar year 2022.

In September 2021, the FDA authorized the Company to initiate a Phase 2

study assessing NE3107’s potential pro-motoric impact in Parkinson’s disease patients, and to assess its safety and tolerability.

The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s

Disease (PD) participants treated with carbidopa/levodopa and NE3107.

Forty patients with a defined L-dopa “off state” will

be randomized 1:1 placebo:

active 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 PK and activity.

Efficacy assessments will use the Motor Disease Society Unified

Parkinson’s Disease Rating (MDS-UPDRS) parts 1-4, Hauser ON/OFF Diary, and Non-Motor Symptom Scale.

This study is planned to start

in early 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.

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

factors include, but are not limited to:

the results of clinical testing and trial activities of the Company’s products,

the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold

or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate

favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise

The Company’s 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.

31, 2021, the Company had working capital of approximately $10 million and cash of $11.4 million and, stockholders’ equity

was approximately $11.4 million, and its accumulated deficit was approximately $93.4 million.

In addition, the Company has not

generated any revenues and no revenues are expected in the foreseeable future.

The Company’s future operations are dependent

on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional

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;

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 September 30, 2021, the Company had working capital of approximately $ 19.3 million ,

cash of approximately $20.5 million, stockholders equity of approximately $20.2 million, and an accumulated deficit of approximately

$230.4 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.

emergence of widespread health emergencies or pandemics of the coronavirus ("Covid-19"), may lead to continued regional

quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, including the

duration and spread of the outbreak and restrictions and the impact of Covid-19 on the financial markets and the overall economy,

all of which are highly uncertain and cannot be predicted.

If the financial markets and/or the overall economy are impacted for

an extended period, the Company’s ability to raise funds may be materially adversely affected.

management continues to pursue these 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

Company’s ability to continue as a going concern.

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 Exchange Commission for Interim Reporting.

Accordingly, they do not include all of the information

and footnotes required by U.S.

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

may 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.

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 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, 2020 was derived from audited annual financial statements 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:

“Management’s Discussion and Analysis of Financial Condition and Results of Operations”

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

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

2019 in our Annual Report on form 10-K filed with Securities Exchange Commission (“SEC”) on August 6, 2020, and as

amended by Amendment No.

1 on Form 10-K/A and filed with the SEC on August 7, 2020.

For a summary of significant accounting policies,

see the Company’s Annual Report on Form 10K for the fiscal year ended June 30, 2020 filed with the SEC on August 6, 2020,

and as amended by Amendment No.

1 on Form 10-K/A and filed with the SEC on August 7, 2020.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Significant Accounting Policies (continued)

Loan Pursuant to Paycheck Protection Program

The Company received $62,500 in loan proceeds

pursuant to the Paycheck Protection Program (“PPP”), under the Coronavirus Aid Relief and Economic Security (CARES)

The PPP Loan is evidenced by a loan application and payment agreement by and between the Company and Lender.

The Company applied

for the loan in May 2020 and received funding for its maximum amount of $62,500 on May 21, 2020.

The term of the loan is for 60

months and matures on the fifth-year anniversary from the date of funding.

It bears interest at an annual rate of 1%.

is subject to 100% forgiveness.

The Company has filed the application for forgiveness, in February 2021 and is pending confirmation

of forgiveness by the SBA.

There can be no assurance that such forgiveness will occur.

The Company is accounting for the loan as

debt and if forgiveness is granted the Company will recognize a gain on extinguishment.

Net (loss) income per Common Share

Basic net (loss) income per common share

is computed by dividing the net (loss) income attributable to common stockholders by the weighted average number of shares of common

stock outstanding during the period.

Diluted net (loss) income per common share is computed by dividing the net (loss) income 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 nine months ended March 31, 2021 and 2020, all potential securities were

anti-dilutive as a result of the effect of the change in fair value of the derivative liability creating a net loss available to

common shareholders.

For the three months ended March 31, 2021 and 2020, such amounts were excluded from the diluted loss since

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

The table below shows the number of

outstanding stock options and warrants as of March 31, 2021 and 2020:

March 31, 2021

March 31, 2020

Number of Shares

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.

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 months ended September 30, 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 period.

table below shows the number of outstanding stock options and warrants as of September 30, 2021 and 2020:

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

September 30,

Stock Options

Recent accounting pronouncements

The Company considers the applicability

and impact of all Accounting Standard Updates (“ASU’s”).

ASU’s not discussed below were assessed and determined

to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

In August 2018, the FASB issued ASU 2018-13,

“Fair value measurement (Topic 820):

Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”.

The new guidance modifies the disclosure requirements on fair value measurements.

ASU 2018-13 is effective for fiscal years beginning

after December 15, 2019.

Early adoption is permitted.

This ASU was adopted as of July 1, 2020.

There has been no impact to its

condensed financial statements and related disclosures.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Intangible Assets

The Company’s 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, 2021 and June 30, 2020:

Summary of the intangible assets

March 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 September 30, 2021 and June 30, 2021 :

September 30,

June 30, 2021

2 unchanged sentences

( 1,255,265 )

( 1,197,921 )

Intellectual Property, Net

Amortization expense for the three-month period

ended March 31, 2021 and 2020 was $57,344 and $57,344 respectively.

Amortization expense for the nine-month period ended March

31, 2021 and 2020 was $172,032 and $172,032 respectively.

Estimated future amortization expense is as

Year ending June 30, 2021 (Remaining three months)

expense was $57,344 in each of the three-month periods ended September 30, 2021 and 2020.

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 nine months)

Intellectual Property, Net

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Related Party Transactions

Equity Transactions with Acuitas

On September 22, 2020, concurrent with the

closing of the Company’s Offering, approximately $1.8 million was paid to Acuitas satisfying all amounts owed on the Debenture

due September 24, 2020 held by the Company’s 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 as more fully described below;

which resulted in a deemed

dividend at the close of the public offering at price of $10 per share, consistent with the Company’s 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 three months ended September 30,

2020, 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

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.

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.

Transactions with Acuitas

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;

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, as more fully described below;

at September 22, 2020 upon

the Company’s close of its public offering, al1 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.

The following paragraphs summarize the background of those financings

and arrangements which were settled and redeemed on September 22, 2020.

On July 3, 2018, we entered into a Securities

Purchase Agreement (the “Purchase Agreement”) with Acuitas and certain other purchasers identified in the Purchase

Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the Purchasers agreed to purchase an aggregate

of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred Stock”) at a price per share of

$1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to issue warrants (the “Warrants”)

to purchase 1,706,666 shares of common stock, each subject to the terms and conditions set forth in the Purchase Agreement, for

an aggregate consideration of $3.2 million.

We received $160,000 of the $3.2 million in April and May 2018 as prepaid equity.

also received an additional 6,667 Warrants in connection with the payoff of a note issued by us in favor of Acuitas.

Sale and issuance of the Warrants occurred on July 3, 2018.

In addition, Acuitas had the option to purchase up to an additional

1,600,000 shares of common stock at a price per share of $1.88, and warrants on the same terms as the Warrants, within two weeks

following the one year anniversary of the closing of the Initial Sale (the “Subsequent Sale”) in the event that we

did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year anniversary of the closing of the

Initial Sale, less any federal or FDA grant funding received by the Company.

Acuitas is controlled by our Chairman and Chief Executive

Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and Michael Sherman, who are members of

The Purchase Agreement contained customary

representations and warranties.

In connection with the disclosure schedule associated with the representations and warranties,

we also disclosed customary information, including the following:

(i) the existence of the Mallinckrodt petition before the U.S.

Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales

of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge,

pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation

to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000

per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy),

and (v) certain recent issuances of common stock by us.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Related Party Transactions (continued)

Each share of Preferred Stock automatically

converted into 1 share of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment

to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares

of common stock to 800,000,000.

The Amendment was approved by the written consent of the holders of more than a majority of our

issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar

days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13,

Pursuant to a letter agreement dated June 24,

2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:

Acuitas agreed to immediately exchange its

existing 1,606,667 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless

exercise thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares

covered thereby, or 1,526,094 shares of common stock;

Acuitas agreed to (i) waive its rights to a

50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price

per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights,

and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase”

at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock

on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later

than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of

the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent

Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to

Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;

Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Related Party Transactions (continued)

Convertible Debenture Transaction with Acuitas

On September 24, 2019, the Company entered

into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed

to purchase a 10% OID Convertible Delayed Draw Debenture due September 24, 2020 for an aggregate commitment amount of up to $2.0

million, and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of the Company’s common stock

and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms and conditions

set forth in the 2019 Purchase Agreement.

The Debenture accrues additional principal at the rate of 6% per annum and interest at

the rate of 10% per annum, is convertible into shares of common stock at $4.00 per share prior to the completion of the company’s

planned public offering of units (the “Public Offering”) or, subsequent to the closing of the Public Offering, the

lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering and are mandatorily redeemable upon such

closing at 100% of the accrued principal amount and unpaid interest to the date of redemption.

The Commitment Warrants are five-year

warrants, exercisable upon the earlier of the effectiveness of the Company’s current reverse stock split or December 1, 2019,

at an amount equal to the lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering.

Upon entering

into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase

Agreement, Acuitas received an additional 125,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment

Any future draws under the Debenture, which

may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle

Acuitas to receive additional Bridge Warrants in equal amount upon such funding.

In addition, the 2019 Purchase Agreement provides

that, should the underwriters in the Public Offering exercise their option to purchase additional securities during the 45 days

following closing and the issuance of such securities would result in Acuitas' beneficial ownership (on a fully diluted basis)

of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock and warrants having

the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common

stock equaling 60%.

The issuance of 1,125,000 shares of the Company’s

commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing

was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value

of the consideration given for the financing, net of debt discount;

was recorded in accumulated deficit for the year ended June

30, 2020, accordingly.

A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of

the debenture using the effective interest method.

The Company recognized amortization of the unearned discount for the three-month

period ended March 31, 2021 and 2020 of $0 and $20,307, respectively, and for the nine months period ended March 31, 2021 and 2020

of $21,336 and $41,902, respectively.

The Company received draws under the Debenture

that totaled approximately $1.3 million during the year ended June 30, 2020.

The total interest expense related to the draws under

the Debenture was approximately $99,000 for the year ended June 30, 2020.

On April 1, 2020, the Company entered an amendment to

modify the payment of accrued interest amounts under the original terms of the Debenture to capitalize all such amounts as would

otherwise accrue on the Debenture.

On January 4, 2020, payment of $13,487 accrued interest due was paid through the issuance of

4,422 shares of the Company’s common stock.

Acuitas and the Company continue to discuss the need and timing for some or all the

remaining draws under the Debenture Agreement.

Subsequent to the initial $500,000 draw on September 24, 2019, the Company received

draws that totaled $813,000 as July 13, 2020, and accordingly;

the Company issued additional Bridge Warrants to purchase 203,250

shares of common stock to its controlling stockholder under the terms of the Bridge Financing.

Accordingly, on April 16, 2020,

the Company recorded the warrants to purchase 125,000 common stock related to the second $500,000 draw under the debenture as a

derivative warrant liability as of June 30, 2020.

The Company recorded the warrants related to the draws totaling $313,000 to purchase

78,250 common shares as derivative liabilities.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Related Party Transactions (continued)

Pursuant to the 2019 Purchase Agreement, Acuitas

agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’

previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July

2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event

of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase

securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately

$11.25 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0

million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that

Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale

and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an

aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas,

upon the closing of the Public Offering.

Pursuant to an amendment to the 2019 Purchase

Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:

The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;

Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement);

The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’ beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’ fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.

On July 14, 2020, the Company, entered into

a further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated February 10,

2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase Agreement dated

July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to

its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share

should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the

Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Offering and commitment

to purchase such additional securities would remain effective until October 31, 2020, and accordingly Acuitas was entitled to receive

an aggregate of 5,359,832 shares of Common Stock at such closing.

In addition, the parties agreed that certain draws under the

Company’s current bridge financing with Acuitas were to be made based with respect to the Company’s ongoing capital

requirements and current market conditions, notwithstanding certain scheduled availability dates set forth in the 10% OID Convertible

Delayed Draw Debenture issued in connection therewith.

The letter agreement of July 14, 2020 also confirmed the understanding between

the Company and Acuitas regarding certain amounts funded to BioVie that were intended as “partial draws” of credit

available under the Debenture which, as of July 14, 2020 hereof aggregated $813,000 in aggregate principal amount in additional

to amounts initial funded under the Debenture.

Accordingly, such “partial draws” accrued additional principal as amounts

otherwise funded pursuant to the original schedule of draws included in the Debenture (as modified by the letter agreement between

BioVie and Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise payable) and shall entitle Acuitas to

receive a pro rata amount of Bridge Warrants.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Fair Value Measurements

On September 22, 2020, concurrent with the

closing of the Offering;

the warrants related to derivative liabilities were automatically exercised in full and the convertible

Debenture was paid off in cash expiring the conversion option.

The fair value of the derivative liabilities - warrants and derivative

liability - conversion option on convertible Debenture prior to redemption at September 22, 2020 was $13.1 million, and the change

in the fair value of $8.3 million from June 30, 2020 was recorded in the accompanying condensed Statements of Operations.

22, 2020, the derivative liabilities, both the warrants and expired conversion option totaling $ 13.1 million were then recorded

as additional paid in capital upon automatic exercise of the warrants and payoff of the Debenture.

At March 31, 2021 and June 30, 2020, the estimated fair value of

derivative liabilities measured on a recurring basis are as follows:

Fair Value Measurements at

Derivative liability - Warrants

Derivative liability -Conversion option on convertible debenture

Total derivatives

Fair Value Measurements at

June 30, 2020

Derivative liability - Warrants

Derivative liability -Conversion option on convertible debenture

Total derivatives

The following table presents the activity for liabilities measured

at fair value using unobservable inputs for the nine months ended March 31, 2021:

Derivative liabilities - Warrants

Derivative liability - Conversion Option on Convertible Debenture

Beginning balance at July 1, 2020

Additions to level 3 liabilities

Change in in fair value of level 3 liability

( 6,054,121 )

( 2,225,798 )

Transfer in and/or out of Level 3

( 10,357,383 )

( 2,775,002 )

Balance at March 31, 2021

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Fair Value Measurements (continued)

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 Company’s own stock because of full-rachet

anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event;

are accounted for as derivative

financial instruments.

The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because

of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.

The warrants associated with the level 3 liability

were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model.

The valuation at June 30, 2020 used the

following assumptions:

stock price of $ 14 , exercise price of $ 4.00 , term of 5 year expiring April 2025, volatility of 76.61 % , dividend

yield of 0 % , and risk-free interest rate of 0.29 % .

The valuation at September 22, 2020 of the

warrants associated with equity financing prior to their automatic exercise in full used were the following assumptions:

price of $ 9.55 , exercise price of $ 4.00 , term of 4 year expiring September 2024, volatility of 79.69 % , dividend yield of 0 % , and

risk-free interest rate of 0.21 % .

(See note 5 “Related Party Transactions”)

Derivative liability – Conversion

option in convertible debenture

The Company recognized a derivative liability

for the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture;

which may be convertible into shares of

common stock at $4.00 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower

of $4.00 or 80% of the offering price per unit to the public in such offering and are mandatorily redeemable upon such closing

at 100% of the accrued principal amount and unpaid interest to the date of redemption.

The valuation at June 30, 2020 used the

following assumptions:

stock price of $ 14 , conversion price of $ 4.00 , term of 0.25 year expiring September 2020, volatility of

62.47 % , dividend yield of 0 % , and risk-free interest rate of 0.16 % .

The valuation at September 22, 2020 used the

following assumptions:

stock price of $ 9.55 , conversion price of $ 4.00 , term of 0.008 year expiring September 2020, volatility

of 45.49 % , dividend yield of 0 % , and risk-free interest rate of 0.01 % .

The related Debenture was paid off in cash

on September 22, 2020, expiring the conversion option.

(See note 5 “Related Party Transactions ” )

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Equity Transactions

Stock Options

The following table summarizes the activity

relating to the Company’s stock options for the nine months ended March 31, 2021:

Weighted-Average Exercise Price

Weighted Remaining Average Contractual Term

Aggregate Intrinsic Value

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.

Retention bonuses of $ 1,161,000 were expensed in the accompanying

statements of operations for three months ended September 30, 2021, and will be paid in equal monthly installments, which began in August

2021, over a 24-month period.

following table summarizes the activity relating to the Companys stock options for the three months ended September 30, 2021:

Exercise Price

Intrinsic Value

Outstanding at June 30, 2021

Options Exercised or Forfeited

Outstanding at March 31, 2021

Exercisable at March 31, 2021

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

using the Black-Scholes option.

The pricing model reflected the following weighted-average assumptions for the nine months ended

March 31, 2021 and 2020:

March 31, 2021

March 31, 2020

Options Forfeited

Outstanding at September 30, 2021

Exercisable at September 30, 2021

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 three months ended September 30, 2021:

September 30,

June 30, 2021

Expected life of options (In years)

2 unchanged sentences

Dividend Yield

Expected volatility is based on the

historical volatilities of three comparable companies of the daily closing price of their respective common stock 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-based compensation

expense of $ 803,604 and $ 2,340,533 for the three- and nine- month periods ended March 31, 2021, respectively, and $ 13,684 and $ 24,846

for the three- and nine- month periods ended March 31, 2020, respectively.

As of March 31, 2021, unrecognized stock-based

compensation cost was $ 3,721,620 which is expected to be recognized over a weighted-average period of approximately 3 years .

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Equity Transactions (continued)

The following is a summary of stock

options outstanding and exercisable by exercise price as of March 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 $1,926,962 and $0 for three-month periods ended September 30, 2021 and 2020,

respectively.

of September 30, 2021, there was approximately $ 6.8 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 4.7 years .

following is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2021:

Exercise Price

Weighted Average Contract Life

Stock Warrants

The following table summarizes the warrants

activity during the nine months ended March 31, 2021:

Number of Shares

Weighted Average Exercise Price

Weighted Average Remaining Life (Years)

Aggregate Intrinsic Value

Weighted Average

Contract Life

following table summarizes warrant activity during the three months ended September 30, 2021:

Exercise Price

Intrinsic Value

Outstanding and exercisable at June 30, 2021

Exercised - Acuitas

( 1,453,250 )

Outstanding and exercisable at March 31, 2020

Of the above warrants, 9,391 expire in fiscal

year ending June 30, 2022, 4,815 expire in fiscal year ending June 30, 2023, 110,140 expire in fiscal year ending June 30, 2025

and 48,675 expire in fiscal year ending June 30, 2026.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Equity Transactions (continued)

Issuance of common stock through

exercise of Stock Options and Warrants

On July 28, 2020, the Company issued 2,210

shares of common stock pursuant to a cashless exercise of stock options to purchase 3,200 shares at an average exercise price of

$ 4.76 per share.

On January 27, 2021, the Company issued 304

shares of common stock pursuant to a cashless exercise of warrants to purchase 320 shares at an average exercise price of $ 1.88

On March 23, 2021, the Company issued 27,000

shares of common stock pursuant to a cash exercise of warrants to purchase 27,000 shares at an average exercise price of $ 12.50

On March 24, 2021, the Company issued 14,324

shares of common stock pursuant to a cash exercise of warrants to purchase 14,324 shares at an average exercise price of $ 12.50

Issuance of warrants

On July 13, 2020, the Company issued

Warrants to purchase 203,250 shares of common stock to its controlling stockholder under the terms of the Bridge Financing.

warrants were exercisable at an exercise price of $ 4 at any time from the date of issuance until 5 years from the date of issuance.

(See Note 5 Related Party Transactions.)

On September 22, 2020, the Company issued

warrants to purchase 89,998 shares of common stock to the underwriters of the Offering in connection with the close of the Offering

of registered Common Stock The warrants are exercisable at an exercise price of $ 12.50 at any time from date of issuance until

5 years from the date of issuance.

Issuance of stock options

On October 1, 2020, the Company issued stock

options to purchase 800 shares of common stock to the Chief Financial Officer as part of her compensation.

The stock options were

issued and are exercisable at an exercise price of $ 9.54 at any time from date of issuance and expire 5 years from the date of

On October 13, 2020, the Company issued stock

options to purchase 800 shares of common stock as part of the annual board of director compensation.

The stock options were issued

and are exercisable at $ 9.90 at any time from date of issuance and expire 5 years from the date of issuance.

On December 18, 2020, the Company issued stock

options to purchase 691,600 shares of common stock as part of the annual board of director compensation.

The stock options have

a vesting period, where 25% of the stock options vest on the grant date, and the remaining 75% vest over a 3 year period, on the

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

The stock options were issued and are exercisable at $ 13.91 at any time

from date of issuance and expire 5 years from the date of issuance.

The amortization for the quarter ended March 31, 2021 was $679,276.

The remaining amortization over the next 5 years is $3,721,610.

On January 19, 2021, the Company issued stock

option grants to purchase a total of 4,800 shares of common stock, granting 800 shares each to the Chief Operations Officer, the

Chief Scientific Officer and to four of its key consultants as part of their annual compensation.

The stock options were issued

and are exercisable at $ 42.09 at any time from date of issuance and expire 5 years from the date of issuance.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Commitments and Contingencies

On July 1, 2019, the Company’s

office moved with Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404.

There is no lease agreement

for the new premises and the Company continues to accrue monthly lease payments of $1,000 for the new office under the terms of

the previous month-to-month lease for the previous premises which may be cancelled upon 30 days’ written notice.

Challenge to US Patent

On April 30, 2018, we received notice that

Mallinckrodt had petitioned the U.S.

Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our

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

Inter Partes Review

is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more

claims of a patent.

Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents

and printed publications.

On November 13, 2019, the Patent Trial and

Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter

partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”)

against BioVie Inc.

(“BioVie” or “Company”).

In that action, Mallinckrodt sought to invalidate BioVie’s

9,655,945, “Treatment of Ascites”) (the “’945 Patent”).

In its decision, the

Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in

light of prior art.

The Board also denied BioVie’s Motion to Amend the claims on similar grounds.

The result of the Board’s

decision is that the ‘945 patent is no longer valid or enforceable.

Acuitas Group Holdings, LLC was aware of this patent

challenge when it purchased a majority ownership interest in the company in July 2018.

This ruling is unrelated to the Company’s

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).

the ruling does not affect the Company’s 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 clearance, 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 country.

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 Edge, Inc.

Notes to Condensed Financial Statements

For the Nine Months Ended March 31, 2021

Commitments and Contingencies (continued)

The Company and PharmaIN Corporation, LAT Pharma’s

former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201,

had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if

such program is licensed to a third party, less than 5% of each company's net license revenues.

On December 24, 2018, the Company

returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining

balance due on a related debt.

Outstanding and exercisable at September 30, 2021

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 141,841 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 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 RSUs vested at September 30, 2021, and 21,710 will

vest at December 31, 2021.

Accordingly, during the three months ended September 30, 2021, 37,049 RSUs vested and 37,049 shares of common

were issued to the CEO.

Company recorded stock-based compensation expense related to these RSUs of $286,759 and $0 for three- month periods ended September 30,

2021 and 2020, respectively.

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 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.

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.

and Contingencies

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.

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 requires monthly payments of $8,782.

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 Company’s 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 Company’s 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

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.

Company and PharmaIN Corporation, LAT Pharmas former partner focused on the development of new modified drug candidates in the same

therapeutic field but not including BIV201 and on December 24, 2018, the Company returned its partial ownership rights to the PharmaIN

modified terlipressin development program and simultaneously paid the remaining balance due on a related debt.

PharmaIN, Corp.

rights to our program remain unchanged.

Additionally, the Company obligation to

pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC

members, and The Barrett Edge, Inc.

pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma

The Company has an obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified

patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between

us and the University of Padova (Italy).

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

Subsequent Events

On April 19, 2021, the Company issued

724 shares of common stock pursuant to a cashless exercise of warrants to purchase 760 shares at an average exercise price of $ 1.88

On April 30, 2021, the Company issued 13,500

shares of common stock pursuant a cash exercise of warrants at $ 12.50 per share.

On April 27, 2021, the Company entered into a Purchase Agreement with NeurMedix, and Acuitas,

which are related party affiliates, pursuant to which the Company has agreed to acquire certain assets from NeurMedix and assume

certain liabilities of NeurMedix, in exchange for the consideration described below.

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 Alzheimer’s Disease and Parkinson’s Disease.

At the closing of the Transaction, BioVie will

issue to NeurMedix 8,361,308 shares of the Company’s common stock and make a cash payment equal to the aggregate amount of

NeurMedix’s direct and documented cash expenditures to advance certain clinical programs from March 1, 2021 through the closing,

which cash payment is estimated to be approximately $3.0 million.

Subject to the terms and conditions of the Purchase Agreement,

following the closing, BioVie will also be obligated to deliver contingent consideration to NeurMedix (or its successor) consisting

of (i) a cash payment of approximately $7.3 million, subject to a pivotal clinical trial for NE3107 meeting its primary endpoint(s)

and BioVie having successfully raised at least $50 million in new capital, and (ii) shares of BioVie’s common stock having

an aggregate value of up to $3.0 billion, subject to the achievement of certain clinical, regulatory and commercial milestones

related to the drug candidates to be acquired by the Company from NeurMedix, as more fully set forth in the Purchase Agreement.

May 9, 2021, the Company, NeurMedix and Acuitas entered into Amendment No.

1 to the APA (the Amendment and the APA as so

amended, the Purchase Agreement), pursuant to which the parties agreed, among other things, to modify the contingent stock

consideration that BioVie may be obligated to deliver to NeurMedix (or its successor) pursuant to the Purchase Agreement.

BioVie was obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of shares of BioVies

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

milestones related to the drug candidates to be acquired by BioVie 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 BioVies issued

and outstanding common stock.

Pursuant to the Amendment, BioVie will be obligated to deliver contingent stock consideration to NeurMedix

(or its successor) consisting of up to 18.0 million shares of BioVies common stock, with 4.5 million shares issuable upon the

achievement of each of the four milestones set forth in the Purchase Agreement, 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 BioVies issued and outstanding

common stock.

The Transaction is expected to close twenty

calendar days after a related definitive information statement on Schedule 14C is mailed to the Company’s stockholders and

is anticipated to close in the second calendar quarter of 2021.

to our program remain unchanged and the Company remains obligated to pay royalties equal to less than 1% of future net sales of each

companys ascites drug development programs, or if such program is licensed to a third party, less than 5% of each companys net license

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

months ended September 30, 2021, the Company made contributions of approximately $ 23,600 .

November 1, 2021, the Company relocated its headquarters to Nevada at 9120 Double Diamond Parkway, Suite 1400, Reno Nevada 89521.

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;

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 alcoholism.

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.

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 nine US medical centers including

Vanderbilt University, the Mayo Clinic, and 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.

In June 2021, we received written

feedback from the FDA in response to a Type B meeting request to conduct a pivotal US Phase 3 clinical trial in HRS-AKI, which is a life-threatening

complication of advanced ascites.

Based on the guidance received in subsequent communications with the FDA, we are revising certain elements

of our proposed study and planning to initiate this study in early 2022.

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.

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

and Parkinson’s 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 Alzheimer’s and 1 million from Parkinson’s.

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 Alzheimer’s disease (NCT04669028).

We initiated this trial on August 5, 2021, and are targeting

primary completion in late 2022.

In addition to Alzheimer’s disease, in September 2021, the FDA authorized the company to initiate

a Phase 2 study assessing NE3107’s potential pro-motoric impact in Parkinson’s disease patients, and to assess its safety

and tolerability.

The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study

in Parkinson’s Disease (PD) participants treated with carbidopa/levodopa and NE3107.

Forty (40) patients with a defined L-dopa “off

state” will be randomized 1:1 placebo:

active 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 PK and activity.

Efficacy assessments will use the Motor Disease

Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-4, Hauser ON/OFF Diary, and Non-Motor Symptom Scale.

This study is

planned to start in early 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.

of the three months ended September 30, 2021 to the three months ended September 30, 2020

income (loss)

net loss for the three months ended September 30, 2021 was approximately $5.5 million as compared to net income of $7.3 million for the

three months ended September 30, 2020.

The decrease in net income of approximately $12.8 million was primarily due to a change in fair

value of derivative liabilities of approximately $8.3 million and an increase in operating expenses of approximately $5.1 million, offset

by a decrease in interest expense of approximately $558,000.

operating expenses for the three months ended September 30, 2021 were approximately $5.5 million as compared to $387,000 for the three

months ended September 30, 2020.

The net increase of approximately $5.2 million during the three months ended September 30,

2021 was primarily due to an increase in research and development expenses of approximately $2.7 million, primarily attributed to the

development of the recently purchased Neuroscience biopharmaceutical assets and continuation of our Orphan Drug candidate BIV201s

Phase 2b clinical trial, which was initiated earlier in the 2021 calendar year, as well as an increase in selling, general and administration

expenses of $2.4 million, primarily due to stock-based compensation awarded to the management team.

and Development Expenses

and development expenses were approximately $2.8 million and $101,000 for the three months ended September 30, 2021 and 2020, respectively.

The net increase of approximately $2.7 million, was primarily due to additional operating expenses related to our Neuroscience operations

totaling approximately $2 million and the increased activities of our Liver Cirrhosis operations totaling approximately $700,000, as

our Orphan Drug candidate BIV201s Phase 2b clinical trial initiated in June 2021 continues to ramp up.

The level of research and

development activity for the three months ended September 30, 2021 strongly contrasts to the three months ended September 30, 2020, when

the Company was focused on closing its capital raise.

Approximately

$1.7 million of the $2.7 million increase in research and development expenses was attributed to increased compensation expense in connection

with the hiring of two executives that oversee our Neuroscience research and development and product development.

The $1.7 million increase

consisted of an increase in payroll expense by approximately $151,000, bonus expense of approximately $1.1 million, including a retention

bonus to certain employees totaling $1.0 million to be paid in 24 equal monthly installments, and stock compensation granted to the management

team totaling approximately $420,000.

The remaining increase in research and development expense of approximately $1 million consisted

of expenses for the clinical operations related to BIV201s Phase 2b clinical trials totaling approximately $506,000 and the preparation

and initiation of the Alzheimer potentially pivotal Phase 3 study, which was initiated in August 2021 totaling approximately $533,000.

General and Administrative Expenses

general and administrative expenses were approximately $2.6 million and $228,000 for the three months ended September 30, 2021 and 2020,

respectively.

The net increase of approximately $2.4 million was primarily attributed to increased compensation expense of approximately

$1.9 million, which consisted of stock-based compensation expense of approximately $1.7 million representing restricted stock units and

stock options awarded to the executive management team of approximately $1.3 million and the amortization cost of $385,000 for the stock

option granted the directors in the prior fiscal year;

and approximately $227,000 related to bonus and salary increases.

The remaining

net increase of approximately $500,000 is attributed to increased expenses related to being listed on a national exchange including listing

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

operations in the development of the recent neuroscience pharmaceutical assets.

Resources and Liquidity

of September 30, 2021, the Company had working capital of approximately $19.3 million, cash of approximately $20.5 million, stockholders

equity of approximately $20.2 million, and an accumulated deficit of approximately $230.4 million.

In addition, the Company has not generated

any revenues 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 to secure additional financing as

August and September of 2021, the Company closed two capital raises issuing an aggregate of 2.6 million shares of its common stock at

a price of $8.00 per share for aggregate net proceeds of approximately $18.5 million.

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, 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.

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.

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

may 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 affected.

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 period ended September 30, 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.

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