What changed in this filing

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Item 1. Financial Statements

2022-11-04 compared with 2022-05-11 · 315 added, 633 removed, 294 unchanged (76% of the section changed)

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CURRENT ASSETS:

Prepaids and other assets

Total current assets

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Intangible assets, net

Other assets, non-current

Total other assets

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Operating lease liabilities, net of current portion

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

Note payable net of financing costs and unearned premium

and discount ($ 2,274,586

and $ 2,861,314

as of September 30, 2022 and June 30, 2022, respectively)

TOTAL LIABILITIES

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Common stock, $ 0.0001 par value;

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

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

800,000,000 shares authorized at September 30, 2022 and June 30, 2022, respectively;

30,165,319 and 24,984,083 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively

Additional paid in capital

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Three Months Ended

Nine Months Ended

September 30,

OPERATING EXPENSES:

Research and development expenses

Selling, general and administrative

TOTAL OPERATING

FROM OPERATIONS

( 5,748,834 )

( 3,001,511 )

( 17,961,126 )

( 6,451,631 )

OTHER (INCOME)

Change in fair value of derivative

Selling, general and administrative expenses

TOTAL OPERATING EXPENSES

LOSS FROM OPERATIONS

( 8,834,338 )

( 5,547,284 )

OTHER EXPENSE (INCOME):

Change in fair value of derivative liabilities

Interest expense

OTHER EXPENSE (INCOME), NET

( 7,734,872 )

(LOSS)/INCOME

$ ( 7,040,644 )

$ ( 2,992,868 )

$ ( 17,995,711 )

Deemed dividends - related

LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

Interest income

EXPENSE (INCOME), NET

$ ( 10,415,711 )

$ ( 5,540,753 )

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

$ ( 10,415,711 )

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NET LOSS PER COMMON SHARE

WEIGHTED AVERAGE NUMBER OF

COMMON SHARES OUTSTANDING

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

accompanying notes to unaudited condensed financial statements

Statements of Cash Flows

Nine Months Ended

March 31, 2022

March 31, 2021

Three Months Ended

September 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

Net (loss) income

$ ( 10,415,711 )

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

$ ( 5,540,753 )

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

Amortization of intangible assets

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Accretion of loan premium

Amortization of operating lease, net

Change in fair value of derivative liabilities

( 1,168,804 )

( 8,279,919 )

Amortization of operating lease right-of-use assets

Change in fair value of derivative liability

Changes in operating assets and liabilities:

Accounts payable and accrued expenses

Operating lease liabilities

Other liabilities

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Net proceeds from issuance of common stock

Payment of convertible debenture - related party

( 1,821,818 )

Proceeds from convertible debenture - related party

Proceeds from exercise of warrants

Proceeds from note payable net of financing costs

Net proceeds from issuance of common stock - Related Party

Net cash provided by financing activities

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Cash paid for interest

Cash paid for taxes

SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:

Deemed dividends - related party

Right of use assets obtained in exchange for lease obligations

accompanying notes to unaudited condensed financial statements

Statements of Changes in Stockholders Equity (Deficit)

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

Statements of Changes in Stockholders’ Equity

the Three Months Ended September 30, 2022 and September 30, 2021

Stockholders’

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$ ( 224,885,422 )

Proceeds from issuance of common stock,net of cost

of $ 2,371,790

Redemption of warrants - related party

Deemed dividend for purchase option - related party

( 53,598,320 )

Cashless exercise of options

Balance, September 30, 2020

( 87,302,302 )

Stock-based compensation

( 3,057,807 )

Balance, December 31, 2020

( 90,360,109 )

Stock based compensation

Cashless exercise of warrants

Proceeds from exercise of warrants

( 2,992,868 )

Balance, March 31, 2021

$ 104,753,666

$ ( 93,352,977 )

Balance June, 30, 2021

$ 229,933,505

$ ( 224,885,422 )

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

Proceeds from issuance of common stock, net of cost of

Stock-based compensation - restricted stock

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$ 250,657,973

Stock based compensation - restricted stock

Stock option based compensation

$ ( 230,426,175 )

Balance, June 30, 2022

$ 254,638,329

Balance, December 31, 2021

$ ( 250,969,890 )

Stock option based compensation

Stock-based compensation - restricted stock

Proceeds from issuance of common stock, net of costs of $ 368,370

Proceeds from issuance of common stock, net of costs of $ 94,160 - Related Party

( 10,415,711 )

Balance, March 31, 2022

Balance, September 30, 2022

$ 267,343,509

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to Condensed Financial Statements

31, 2022 and 2021

the Three Months Ended September 30, 2022 and 2021

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

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

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

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

The initial target for BIV201 therapy is refractory ascites.

These patients suffer from frequent life-threatening complications, generate

more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.

The US Food and Drug

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

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

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

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

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

Top-line results from this trial are

expected in early 2023.

BIV201 development program was initiated by LAT Pharma LLC.

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

its BIV201 development program.

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

Pursuant to the

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

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

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

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

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

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The acquired assets included NE3107,

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

NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological

inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus that both inflammation and insulin resistance

may play fundamental roles in the development of Alzheimers and Parkinsons Disease, and NE3107 could, if approved represent

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

and 1 million from Parkinsons.

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

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

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

a potentially selective inhibitor of inflammatory extracellular single-regulated kinase(“ERK”) signaling that, based on animal

studies, is believed to reduce neuroinflammation.

NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven

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

There is emerging scientific consensus

that both inflammation and insulin resistance may play fundamental roles in the development of 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.

The FDA has authorized a potentially

pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have

mild to moderate Alzheimer’s disease (NCT04669028).

In August 2021, the study was initiated and the Company is anticipating top

line results in mid-calendar year 2023.

January 20, 2022, the Company initiated a study by treating the first patient, in it’s Phase 2 study assessing NE3107’s safety

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Topline results

are expected for the NM201 study in mid-2022.

are expected for the NM201 study in December 2022.

Inflammation-driven

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

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

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.

Top-line results

from this trial are expected in mid-calendar year 2023.

BIV201 development program was initiated by LAT Pharma LLC.

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

its BIV201 development program.

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

Pursuant to the

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

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

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

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

include, but are not limited to:

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

ability to obtain regulatory approval to market its products;

competition from products manufactured and sold or being developed by other

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 Companys ability to negotiate favorable licensing or other manufacturing

and marketing agreements for its products;

and the Companys ability to raise capital.

The Companys financial statements

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

of liabilities in the normal course of business.

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

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

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.

As of September 30,

2022, the Company had working capital of approximately $ 17.5

million, cash of approximately $21.2 21,230,918

million, stockholders’ equity of approximately $6.0

5,960,923 million, and an accumulated deficit of approximately $261.4

261,385,601 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.

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

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

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

Although our cash balance may possibly

sustain operations over the next 12 months from the balance sheet date if measures are taken to delay planned

expenditures in our research protocols and slow the progress in the Company’s clinical programs, the Company’s current

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

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

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

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

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

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

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

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

If the financial markets and/or the overall economy

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

In addition, the

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

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

trials in the planned timeline.

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 Company’s ability to raise funds may be materially adversely affected.

In addition, the COVID-19 pandemic

has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the

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

the planned timeline.

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

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The condensed balance sheet at June 30, 2022 was derived from audited annual financial statements

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

These unaudited

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

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

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

For a summary

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

with the SEC on August 30, 2021.

but does not contain all the footnote disclosures from the annual financial statements.

These unaudited interim condensed financial statements

should be read in conjunction with the Company’s audited financial statements for the fiscal years ended June 30, 2022 and 2021

in our Annual Report on Form 10-K filed with the SEC on September 27, 2022.

For a summary of significant accounting policies, see the

Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2022 and 2021, filed with the SEC on September 27, 2022.

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

Company determines whether an arrangement contains a lease at inception.

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

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

on our balance sheets.

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

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

Lease ROU assets and lease liabilities are recognized based on

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

As the Companys leases do

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

the present value of lease payments.

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

certain that the Company will exercise any such options.

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

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

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

Value of Financial Instruments

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

between market participants at the measurement date.

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

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

market participants would use when

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

This guidance also establishes

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

Observable inputs such as quoted prices in active markets;

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

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

loss per Common Share

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and convertible debentures.

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

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

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

For the three months ended September 30, 2022 and 2021, such amounts were excluded from the diluted loss

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

table below shows the number of outstanding stock options and warrants as of September 30, 2022 and 2021:

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

March 31, 2022

March 31, 2021

September 30,

Number of Shares

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useful lives.

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

March 31, 2022

June 30, 2021

following is a summary of the intangible assets as of September 30, 2022 and June 30, 2022:

Schedule of intangible assets

September 30,

Intellectual Property

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Intellectual Property, Net

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

Amortization expense for the nine-month period

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

The Company amortizes intellectual property over the expected original

useful lives of 10 years .

expense was $ 57,344 in each of the three-month periods ended September 30, 2022 and 2021.

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 three months)

Intellectual Property, Net

Schedule of future amortization expense

Year ending June 30, 2023 (Remaining nine months)

Party Transactions

Transactions with Acuitas

July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group

Holdings, LLC, (Acuitas), the company’s majority shareholder, pursuant to which Acuitas agreed to purchase from the Company,

in a private placement (i) an aggregate of 3,636,364

shares of the Company’s Class A common stock, par value $0.0001 per share at a price of $1.65 per share (“PIPE

Shares”), and (ii) a warrant to purchase 7,272,728 shares of Common Stock (“Warrant Shares”), at an exercise price

of $1.82, with a term of exercise of five years;

(collectively, the “Securities”).

The warrant has a down round feature

that reduces the exercise price if the Company sells stock for lower price.

On August 15, 2022, the Company received net proceeds of

approximately $5.9 million net of costs of approximately $94,000 and entered into an amended and restated registration statement

with Acuitas, which amended and restated that certain Registration Rights Agreement, dated as of June 10, 2021, by and between the

Company and Acuitas (the “Existing Registration Rights Agreement”), to amend the definition of “Registrable

Securities” in the Existing Registration Rights Agreement to include the PIPE Shares and the Warrant Shares as Registrable

Securities thereunder.

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

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

Agreement (“APA”) with NeurMedix and 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.

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

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

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

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

Since the transaction was between

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

assets was zero.

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

Transactions with Acuitas

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

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

Additionally,

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

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

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

and the various extension letters;

which resulted in a deemed dividend at the

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

and (ii) the automatic

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

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

The total draws as of September

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

328,250 warrants had been issued.

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

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

96,500 shares common stock issued to Acuitas.

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

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

The payment terms are equal monthly installments

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

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

in the accompanying balance sheet at March 31, 2022.

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.

On June 10, 2021, and pursuant to the APA, the Company issued to Acuitas (as NeurMedix’s assignee)

8,361,308 shares of the Company’s common stock and made a cash payment of approximately $2.3 million.

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 in process research and development expense in

the year ended June 30, 2021.

to the terms and conditions of the Asset Purchase Agreement, following the closing, the Company may be 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 Company’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, 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 Company’s issued and outstanding common stock.

Pursuant to Amendment

1 to the APA, dated May 9, 2021, the Company may now be obligated to deliver contingent stock consideration to NeurMedix (or its

successor) consisting of up to 18 million shares of BioVie’s common stock, with 4.5 million shares issuable upon the achievement

of each of the four milestones set forth in the APA, 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 Company’s issued and outstanding common stock.

current portion of other liabilities at September 30, 2022 of $ 483,854

and $724,330 of the $1.3

1,304,925 million of the current portion of other liabilities at June 30, 2022, represented retention bonus arrangements with

certain employees that were recognized in August 2021 totaling $ 1,161,000 .

The payment terms of the retention bonus arrangement are equal monthly installments over a 24-month period and began in August

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

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On the closing date, $15 million funded

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

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

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

Journal and (b) 10.75%.

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

property, subject to agreed exceptions.

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

An additional growth capital loan in an amount

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

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

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

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

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

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

(“Tranche 1”).

The Loan had the additional capacity of up to $5 million available to the Company on or prior to September

15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials which

were not achieved.

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

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

The prime rate at September 30, 2022 was 5.5%.

The Loan is secured by a lien upon and security

interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions.

The maturity date of the

Loan is December 1, 2024.

Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan,.

Following the interest-only

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

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

Loan Agreement includes a conversion option to convert up to $5.0 million of the principal amount of the Loan outstanding at the option

2 unchanged sentences

at an exercise price per share equal to $5.82, the stock purchase price.

The warrants are exercisable until November 30,

2026 (the Expiration Date).

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

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

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

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

The adjusted effective interest

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

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

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

was recognized in the accompanying statements of operations.

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

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

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

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

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

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

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

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

30, 2024 and 2025 respectively.

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

March 31, 2022

June 30, 2021

The warrants are exercisable until November 30, 2026, the expiration

The amount of the carrying value of the notes payable were determined

by allocating portions of the outstanding principal of the notes to the fair value of the warrants of approximately $ 1.4 million and

the fair value of the embedded conversion option of approximately $ 2.2 million.

Accordingly, the total amount of unearned discount of

approximately $3.7 million, the total direct financing cost of approximately $ 390,000 and premium of $ 850,000 are recognized on an effective

interest method over term of the Loan.

The adjusted effective interest rate is 25%.

The total interest expense of approximately $ 1.1

million for the three months ended September 30, 2022;

was recognized in the accompanying statements of operations and included the interest

only payments totaling approximately $ 470,000 , the amortization of financing costs of approximately $ 43,000 , unearned discount of approximately

$ 400,000 and the accretion of loan premium totaled of approximately $ 144,000 .

As of September 30, 2022, the outstanding principal balance

of $15 million would be paid in 18 monthly equal installments beginning July 1, 2023;

a total of $10.0 million and $5.0 million in the

fiscal years ended June 30, 2024 and 2025 respectively.

following is a summary of the Notes Payable as of September 30, 2022 and June 30, 2022:

Schedule of note payable

September 30,

Notes Payable

Less debt financing costs

1 unchanged sentence

( 2,335,441 )

( 2,735,802 )

Plus accretion of loan premium

Note Payable, net of financing costs and premiums

Notes Payable, net of financing costs, unearned premiums and discount

future amortization expense and accretion of premium is as follows:

Schedule of Estimated

future amortization expense and accretion of premium

Schedule of Estimated future amortization expense and accretion of premium

Unearned Discount

Debt Financing

Debt Financing Costs

Loan accretion Premium

Year ending June 30, 2022 (Remaining three months)

Year ending June 30, 2023 (Remaining 9 months)

Value Measurements

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

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

Schedule of derivative liabilities at fair value

Fair Value Measurements at

March 31, 2022

September 30, 2022

Derivative liability - Warrants

Derivative liability -Conversion option on notes payable

liability - Conversion option on notes payable

Total derivatives

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Derivative liability - Warrants

Derivative liability -Conversion option on note payable

liability - Conversion option on note payable

Total derivatives

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

Derivative liabilities -

Derivative liability -

Conversion Option

on Convertible

following table presents the activity for liabilities measured at fair value using unobservable inputs for the three months ended September

30, 2022 and 2021:

Fair value, liabilities measured on recurring basis

Derivative liabilities - Warrants

Derivative liability - Conversion Option on Convertible Debenture

Balance at July 1, 2022

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Transfer in and/or out of Level 3

Balance at March 31, 2022

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

Derivative liabilities -

Derivative liability -

Conversion Option

on Convertible

Beginning balance at July 1, 2020

Balance at September 30, 2022

Derivative liabilities - Warrants

Derivative liability - Conversion Option on Convertible Debenture

Balance at July 1, 2021

Additions to level 3 liabilities

Change in in fair value of level 3 liability

( 6,054,121 )

( 2,225,798 )

Change in fair value of level 3 liability

Transfer in and/or out of Level 3

( 10,357,383 )

( 2,775,002 )

Balance at March 31, 2021

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

$1.5 million, respectively.

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

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

Balance at September 30, 2021

fair values of derivative liabilities for the warrants and conversion option at September 30, 2022 in the accompanying balance sheet,

were approximately $443,000 and approximately $507,000, respectively.

The total change in the fair value of the derivative liabilities

totaled approximately $567,000 for the three months ended September 30, 2022, and accordingly, was recorded in the accompanying statement

of operations.

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

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

of 74.796 % .

The assumptions used in the Black Scholes model to value the derivative liabilities at September 30, 2022 included the

closing stock price of $ 2.49 per share, and for the warrants the exercise price of $ 5.82 , 5 -year term, risk free rate of 4.06 % and volatility

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

3-year term, risk free

rate of 0.97 % and volatility of 76.15 % .

3 -year term, risk free rate

of 4.3 % and volatility of 83.9 %.

liability – Warrants

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

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

value in the accompany balance sheet at September 30, 2022.

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

Avenue loan amount funded.

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

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

The warrants are recorded at their fair values at the date of issuance and remeasured at September 30, 2022.

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

the closing stock price of $ 6.44 per share;

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

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

following table summarizes the activity relating to the Company’s stock options for the three months ended September 30, 2022:

Schedule of summarizes the activity relating to the Company’s stock options

Average Exercise Price

Weighted Remaining Average Contractual Term

Aggregate Intrinsic Value

Outstanding at June 30, 2022

Options Expired

Options Canceled

Options Forfeited

Outstanding at March 31, 2022

Exercisable at March 31, 2022

Outstanding at September 30, 2022

Exercisable at September 30, 2022

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

The pricing model reflects the following

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

March 31, 2022

March 31, 2021

weighted-average assumptions for the three months ended September 30, 2021 and no stock options were issued for the three months ended

September 30, 2022:

Schedule of assumptions used

September 30, 2021

Expected life of options (In years)

6 unchanged sentences

as they are incurred.

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

Company recorded stock option-based compensation expense of $ 878,640 and $ 1,926,962 for three-month periods ended September 30, 2022

and 2021, respectively.

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

respectively.

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

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

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

following is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2022:

Schedule of summary of stock options outstanding and exercisable

Exercise Price

Weighted Average Contract Life

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

Outstanding and exercisable at June 30, 2021

Outstanding and exercisable at March 31, 2022

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

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

of common stock for cash

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

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

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

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

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

the 3 months ended September 30,2021, the Company issued 2,592,000 of its Class A common stock at $ 8.00 per share in connection with

its registered public offering of approximately $ 18.5 million, net of issuance costs of approximately $ 2.2 million.

August 31, 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor

Fitzgerald & Co.

Riley Securities, Inc.

(collectively, the “Agents”), pursuant to which the Company may issue

and sell from time-to-time shares of Company’s Class A common stock, par value $ 0.0001 per share, through the Agents, subject to

the terms and conditions of the Sales Agreement.

As of September 30, 2022, the Company has issued 1,544,872 shares under the Sales Agreement

for a total net proceeds of $ 5.9 million after commissions and expenses of approximately $ 400,000 .

of Shares for Services

9 unchanged sentences

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

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

month period ended March 31, 2022, respectively.

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

period ended March 31, 2022 and 2021.

June 21, 2022, the Company awarded 124,520 RSUs to the President and CEO under the Company’s 2019 Omnibus.

Each RSU awarded to

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

The RSUs vest in equal installments over three years on the anniversary

The grant date fair value was $ 1.69 per share of the Company’s common stock.

The stock-based compensation expense related

to these RSUs totaled $ 17,537 for the three months ended September 30, 2022.

of Stock Options

6 unchanged sentences

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

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

Twenty percent (20%)

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

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

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

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

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

new employees.

exercise prices per share are $3.20;

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

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

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

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

as of which the options were fulling exercised.

of Stock Options

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

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

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

Suite 230, Santa Monica, CA 90404.

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

The Company paid an

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

The Nevada lease is an annual lease.

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

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

On February 26, 2022 the Companys San Diego office relocated

to 5090 Shoreham Place, San Diego, CA 92122.

(the New Office).

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

The monthly base rate payment of $4,175

begins June 1, with annual increases of three percent.

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

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

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

March 31, 2022

Pursuant to a former employee Separation Agreement, dated April 11, 2022,

the Company modified a former employee’s stock option award granted on August 20, 2021 pursuant to the 2019 Omnibus Plan (“2021

Options Grant”).

Pursuant to the terms of the Separation Agreement of the employee, effective on July 8, 2022, (“the Separation

Date”), the Company accelerated the vesting of options to purchase 74,500 shares of common stock as deemed vested, (“Accelerated

Options”) and after giving effect to the Accelerated Options, extended the exercise period of the total vested outstanding and unexercised

options totaling 99,333 of the 2021 Options Grant as of July 8, 2022 to one year following the Separation Date.

The unvested portion of

the 2021 option grant of 24,834 was canceled.

The modification were remeasured as of the July 8, 2022 and the incremental difference totaled

$181,154, net credit;

due to the original exercise price of $7.74 is greater than the stock price of $1.80 on the remeasurement date and

accordingly was recognized on July 8, 2022.

following table summarizes warrant activity during the three months ended September 30, 2022:

Summary of warrants activity

Number of Shares

Weighted Average Exercise Price

Weighted Average Remaining Life (Years)

Aggregate Intrinsic Value

Outstanding and exercisable at June 30, 2022

Outstanding and exercisable at September 30, 2022

the above warrants, 909 expire in the fiscal year ending June 30, 2023, 109,380 expire in the fiscal year ending June 30, 2025, 35,175

expire in the fiscal year ending June 30, 2026, and 7,633,730 expire in the fiscal year ending June 30, 2027.

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

The Company paid an annual rent of $2,200 for the address at 680

W Nye Lane, Suite 201, Carson City Nevada 897603.

The rental agreement is for a one year term.

February 26, 2022, the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122.

The office lease term

for 38 months, commenced on March 1, 2022.

The monthly base rate of $4,175 begins June 1, 2022, with annual increases of three percent.

operating lease cost recognized in in our statement of operations was approximately $ 12,800 and $ 25,400 for the three months ended September

30, 2022 and 2021, respectively.

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

Schedule of balance sheet information related to leases

September 30, 2022

June 30, 2022

3 unchanged sentences

Total operating lease liabilities

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

Year ending June 30:

2022 (remaining 3 months)

September 30, 2022, the future estimated minimum lease payments under non-cancelable operating leases are as follows:

Schedule of future estimated minimum lease payments under non-cancelable operating leases

Year ending June 30, 2023 (Remaining 9 months)

Total minimum lease payments

3 unchanged sentences

Operating lease liabilities, net of current portion

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

March 31, 2022

weighted average remaining lease term and discount rate as of September 30, 2022 and June 30, 2022 were as follows:

Schedule of weighted average remaining lease term and discount rate

September 30, 2022

June 30, 2022

4 unchanged sentences

and Contingencies

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

Patent and Trademark Office (USPTO) to institute

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

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

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

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

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

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

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

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

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

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

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

10 unchanged sentences

For the three

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

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

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

Twenty-five percent (25%) of the shares

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

third anniversary of the grant date.

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

which the options are fully exercised.

Managements Discussion and Analysis of Financial Condition and Results of Operations

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

of the Securities Act of 1933.

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

When we use the words intends, estimates, predicts, potential, continues,

anticipates, plans, expects, believes, should, could,

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

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

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

These factors among others, include our;

and development activities and, distributor channel;

compliance with regulatory impositions requirements;

and our capital needs Although

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

of activity, performance or achievements.

as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume

no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments.

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

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

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

and other factors that may affect our business.

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

Financial Statements and Notes thereto appearing elsewhere in this report.

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

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

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

The initial target for BIV201 therapy is refractory ascites.

These patients suffer from frequent life-threatening complications,

generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.

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

A Phase 2a clinical trial of BIV201 was completed

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

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

Top-line results from this trial

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

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

company and related party affiliate, in June 2021.

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

on animal studies, is believed to reduce neuroinflammation.

NE3107is a novel orally administered small molecule that is thought to inhibit

inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.

There is emerging

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

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

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

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

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

We initiated this trial on August 5, 2021 and are

targeting primary completion in the first half of 2023.

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

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

The NM201 study (NCT05083260) Initiated by the Company

on January 20, 2022;

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

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

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

state will be randomized 1:1placebo:

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

The study was

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

Inflammation-driven insulin resistance is believed to be

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

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

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

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

three months ended March 31, 2021.

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

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

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

increase in change in fair value of the derivative liabilities.

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

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

The net increase of approximately $2.7 million during the three

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

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

Approximately $1.0 million in selling, general and administration included

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

The increase in

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

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

which was initiated in the 2021 calendar year.

and Development Expenses

Research and development expenses were approximately $3.6 million and

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

The net increase of approximately $2.8 million, for the

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

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

in January 2022;

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

in June 2021;

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

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

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

ended March 31, 2022.

General and Administrative Expenses

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

2022 and 2021, respectively.

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

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

an increase in investor relations and

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

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

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

Income/Expense

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

March 31, 2021.

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

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

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

derivative liabilities or debt outstanding.

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

(loss)/Income

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

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

The decline from net income to net loss

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

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

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

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

The net increase of approximately

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

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

The net increase was comprised of increased research

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

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

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

and Development Expenses

Research and development expenses were approximately $11.4 million

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

The net increase of approximately $9.4 million, was

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

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

an increase of

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

and increases in salary and employee

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

The Company expanded the clinical team personnel

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

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

General and Administrative Expenses

Selling, general and administrative expenses were approximately $6.4

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

The net increase of approximately $2.1 million

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

of $2.0 million ;

increased legal expense of $620,000;

investor relations and advisory of $729,000;

and approximately $442,000 of increased

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

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

These increases were offset

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

assets which closed on June 10, 2021.

Expense/(Income)

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

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

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

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

in November 30, 2021.

Resources and Liquidity

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

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

In addition, the Company has not generated

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

The Companys future operations are dependent on the

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

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

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

Although the increase in the Companys cash balance could possibly

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

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

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

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

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

that we will ever earn revenues sufficient

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

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

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

If we cannot raise funds as and

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

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

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

Management intends to attempt to secure additional

required funding primarily through additional equity or debt financings.

We may also seek to secure required funding through

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

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

However, there can be no assurance that we

will be able to obtain required funding.

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

reduce or eliminate certain planned expenditures in our research protocols.

If we do not have sufficient funds to continue

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

or all of their investment in us.

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

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

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

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

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

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

be materially adversely affected.

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

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

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

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

The financial statements included in this report

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

of liabilities that might result from this uncertainty.

Sheet Arrangements

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

Companys financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources

that are material to investors.

The term off-balance sheet arrangement generally means any transaction, agreement or other

contractual arrangement to which an entity unconsolidated with the Company is a party, under which the Company has (i) any obligation

arising under a guarantee contract, derivative instrument or variable interest;

or (ii) a retained or contingent interest in assets transferred

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

Accounting Policies and Estimates

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

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

Accounting Pronouncements

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

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

Quantitative and Qualitative Disclosures About Market Risk

applicable to smaller reporting companies.

months ended September 30, 2022 and 2021, the Company made contributions of approximately $ 45,479 and $ 23,613 , respectively.

November 4, 2022, the Company issued 367,511 shares of common stock for net proceeds of $ 1.2 million net of cost of approximately

$ 26,000 under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.

Riley Securities, Inc.

(collectively, the “Agents”), pursuant to which the Company may issue and sell from

time-to-time shares of Company’s Class A common stock, par value $ 0.0001 per share, through the Agents, subject to the terms

and conditions of the Sales Agreement.

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