What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-02-13 compared with 2023-11-08 · 187 added, 81 removed, 64 unchanged (81% of the section changed)

31 unchanged sentences

neurological and neuro-degenerative disorders and liver disease.

The Company acquired the biopharmaceutical assets

of NeurMedix, Inc.

(“NeurMedix”), a privately held clinical-stage pharmaceutical company, in June 2021 .

assets included NE3107, 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.

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

Disease (AD) and Parkinson’s Disease (PD), and NE3107 could, if approved represent an entirely new medical approach to treating

these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

in September 2023, the last patient completed the last treatment at week 30 in the Company’s multicenter, randomized, double-blind,

placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients who have mild to moderate Alzheimer’s disease.

cleaning process remains underway, with the clinical team resolving outstanding queries and entering final data into the electronic data

Final database lock, unblinding, and subsequent release of topline results is anticipated to occur during the fourth quarter of

calendar year 2023.

The Phase 2 study of NE3107 in Parkinson’s

disease (“PD”) (NCT05083260), completed in December 2022 was a double-blind, placebo-controlled, safety, tolerability, and

pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107.

The Company acquired

the biopharmaceutical assets of NeurMedix, Inc.

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

related party in June 2021 .

The acquired assets included NE3107.

NE3107 is an investigational, novel, orally administered

small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel

mechanism of action.

There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in

the development of AD and PD, and NE3107 could, if approved by FDA, represent an entirely new medical approach to treating these devastating

conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

Neurodengenerative

Disease Program

In neurodegenerative disease, the Company’s

drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear

factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”)

signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.

NE3107 does not interfere with

their homeostatic functions (e.g., insulin signaling and neuron growth and survival).

Both inflammation and insulin resistance are drivers

of AD and PD.

Disease (NCT05083260)

On November 29, 2023,

the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in

the treatment of mild to moderate AD.

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

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

Patients were randomly assigned,

1:1 versus placebo, to receive sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days,

followed by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the process of unblinding

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

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

This highly unusual level of suspected improprieties led the

Company to exclude all patients from these sites and to refer the sites to the FDA Office

of Scientific Investigations (“OSI”) for further action.

After the patient exclusions, 81 patients remained in the Modified

Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified

to take study drug from pharmacokinetic data.

The trial was originally designed to be 80% powered with 125 patients

in each of the treatment and placebo arms.

The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints.

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

study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss;

these same patients experienced an advantage in age deceleration vs.

placebo as measured by DNA epigenetic change.

Age deceleration is

used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath

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

This test was a non-primary/secondary endpoint,

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

Additional DNA methylation data continues to be collected

and analyzed.

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

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

statistical significance;

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

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

Disease (NCT05083260)

The Phase 2 study

of NE3107 for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability,

and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107.

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

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This trial was launched with two design objectives:

1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to demonstrate the absence of adverse interactions

of NE3107 with levodopa;

and 2) the secondary objective is to determine if preclinical indications of promotoric activity and apparent

enhancement of levodopa activity can be seen in humans.

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

interactions of NE3107 with carbidopa/ levodopa;

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

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

Both objectives were met.

The Company continues to process its findings from its

completed study as it prepares for the next round of clinical studies in PD.

Neuroinflammation, insulin resistance, and oxidative

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

sclerosis (ALS).

NE3107 is an oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing,

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

potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD

and PD patients.

The initiation of trial design

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

Neuroinflammation, insulin

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

and Amyotrophic lateral sclerosis.

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

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

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

molecule in AD and PD patients.

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

The Company’s Orphan Drug candidate BIV201

(continuous infusion terlipressin), with FDA Fast Track designation status, is being evaluated and discussed after receiving guidance

from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

is administered as a patent-pending liquid formulation.

The Phase 2b study was closed before full enrollment, without clinically meaningful

adverse effects associated with BIV201 treatment.

The active agent is approved in the U.S.

and in about 40 countries for related complications

of advanced liver cirrhosis.

Comparison of the three months ended September 30, 2023 to the three

months ended September 30, 2022

net loss for the three months ended September 30, 2023, was approximately $10.7 million and was comparable to the net loss of $10.4 million

for the three months ended September 30, 2022.

The increase in net loss was comprised of increased research and development expenses

of $2.1 million offset from a decrease in selling, general and administrative expenses of approximately $64,000, an increase in interest

income of approximately $420,000 and the change in the fair value of derivative liabilities of $1.3 million for the three months ended

September 30, 2023 from the three months ended September 30, 2022.

operating expenses for the three months ended September 30, 2023, were approximately $10.9 million as compared to $8.8 million for the

three months ended September 30, 2022.

The net increase of approximately $2.1 million for the three months ended September 30, 2023

was comprised of increased research and development expenses of approximately $2.1 million offset by a decrease in selling general and

administrative expenses of approximately $64,000.

and Development Expenses

and development expenses were approximately $8.9 million and $6.8 million for the three months ended September 30, 2023, and 2022, respectively.

The net increase of approximately $2.1 million, represented an approximate decline of $1.4 million in expenses from the completion of

the PD Phase 2 and Ascites Phase 2b studies and the near completion of the AD Phase 3, offset by increased expenditures of $1.7 million

related to development of next clinical studies and other research;

increased expenses attributed to publication of our abstracts and

posters presented at various conferences totaling approximately $172,000, and increased expenses in Chemistry, Manufacturing and Control

of approximately $46,000 and the Clinical Teams compensation of approximately $1.5 million.

The total clinical team employee and outside

consultants’ compensation increased by approximately $780,000 and $712,000, respectively;

for the three months ended September

representing an increase in the employee headcount by 7 to 15 and the expanded use in the number of outside consultants.

General and Administrative Expenses

general and administrative expenses were approximately $1.9 million and $2.0 million for the three months ended September 30, 2023, and

2022, respectively.

The net decrease of approximately $64,000 was primarily attributed to decline in directors stock compensation of

approximately $313,000,and other professional and advisory fees of $37,000 offset by general administrative compensations of $31,000,

increased legal fees of $155,000, other consultants of approximately $58,000 and insurance expenses of approximately $41,000.

Liver Disease Program

In liver disease, our investigational drug candidate

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

being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the

treatment of ascites due to chronic liver cirrhosis.

BIV201 is administered as a patent-pending liquid formulation.

In June 2021, the Company initiated a Phase 2

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

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

endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared

to a pre-treatment period.

In March 2023 the company announced enrollment

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

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

The change in ascites volume was significantly

different from those patients receiving SOC treatment.

Patients who completed the treatment with BIV201 experienced a 53% reduction in

ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment

In June 2023, the Company requested and subsequently

received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites

due to chronic liver cirrhosis.

The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment

of ascites due to chronic liver cirrhosis.

While the active agent, terlipressin, is approved

and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these

authorizations.

Patients with refractory ascites 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.

FDA has not approved any drug to treat

refractory ascites.

The 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 this 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

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

months ended December 31, 2022

The net loss for the three months ended December

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

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

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

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

Total operating expenses for the three months

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

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

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

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

Research and Development Expenses

Research and development expenses were approximately

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

The net decrease for the three months

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

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

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

December 31, 2022 of approximately $492,000;

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

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

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

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

Selling, General and Administrative Expenses

Selling, general and administrative expenses were

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

The net decrease of

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

of approximately $2.1 million.

Other Income and Expense

Other income, net was approximately $380,000 compared

to other expense, net of $1.6 million, for the three months ended September 30, 2023 and 2022, respectively.

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

The net increase in other

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

and increase in interest income of approximately $420,000 which was primarily comprised of $223,865 realized gain on settlement of investments in U.S.

Treasury Bills.

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

months ended December 31, 2022

The net loss for the six months ended December

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

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

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

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

Total operating expenses for the six months ended

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

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

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

Research and Development Expenses

Research and development expenses were approximately

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

The net increase for the six months

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

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

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

and other increases in regulatory and other consultants of approximately $394,000 and publications and travel of approximately $215,000;

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

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

Selling, General and Administrative Expenses

Selling, general and administrative expenses were

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

The net decrease of approximately

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

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

Other Income and Expense

Other income, net was approximately $545,000 compared

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

The net increase in other income

of approximately $6.3 million was primarily driven by the change in fair value of the derivative liabilities of approximately $5.5 million,

as well as an increase in interest income of approximately $555,000 which was primarily from the investments in U.S.

Treasury Bills and

a reduction in interest expense of approximately $285,000 due to amortization and accretion of the financing costs, unearned discount,

and premium relating to the note payable.

Capital Resources and Liquidity

As of September 30, 2023 the Company had working

As of December 31, 2023 the Company had working

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

$7.5 million, and an accumulated deficit of approximately $320.3 million.

During the three months ended September 30, 2023,

the Company sold approximately 432,000 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald

& Co for total net proceeds of approximately $1.9 million after 3% commissions and offering costs totaling approximately $119,000.

During the six months ended December 31, 2023,

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

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

The Company has not generated any revenue and

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Critical Accounting Policies and Estimates

For the three-month period ended September 30,

2023, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K

for the fiscal year ended June 30, 2023.

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

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

the fiscal year ended June 30, 2023.

New Accounting Pronouncements

6 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis