BIOVIE INC.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 10, 2025
BIVI$1.33+9.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001520138-25-000144
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001520138-25-000343
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 52 previous paragraphs and 45 current paragraphs.
24 unchanged; 11 reworded; 10 added; 16 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
C. Alzheimer’s Disease (NCT05083260)
Current report
On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild to moderate AD. The study had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of bezisterim 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.
Current report
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 potential 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.
Current report
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 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.
Current report
Research andDevelopmentExpenses
Current report
Research and development (“R&D”) expenses were approximately $2.9 million for the three months ended September 30, 2025, an increase of approximately $946,000 from $2.0 million for three months ended September 30, 2024. The net increase in R&D expenses of approximately $946,000 is comprised of increased direct study costs of approximately $1.2 million for the Parkinson Disease (PD) and Long COVID (“LC”) studies and clinical team stock compensation of approximately $270,000, travel and conferences of approximately $49,000, offset by CMC of approximately $407,000, clinical team payroll of approximately $87,000 and other clinical consultants of approximately $57,000.
Current report
General and Administrative Expenses
Current report
General and administrative expenses were approximately $2.3 million and $2.1 million for the three months ended September 30, 2025 and 2024, respectively. The net increase of approximately $216,000 was primarily attributed to increases in legal fee expenses of approximately $215,000, investor and public relation fees of approximately $124,000, filing fees of approximately $35,000 and insurance premiums of approximately $14,000; offset by decreases in stock-based compensation for the executive team and directors of approximately $83,000 and $93,000, respectively.
Current report
Registered Offering
Current report
On August 11, 2025, the Company closed an underwritten public offering (the “Offering”) of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant (the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of one pre-funded warrant and one Warrant. The underwriter also exercised its over-allotment option in part and purchased an additional 667,300 Warrants. The Offering resulted in net proceeds of approximately $10.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses. Each Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold to the public at a price of $1.999 per Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per share nominal exercise price for each Pre-Funded Warrant). On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market under the symbol “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an exercise price of $2.50 per share and expires five years from the date of issuance. Each Pre-Funded Warrant is immediately exercisable, entitles the holder to purchase one share of common stock and may be exercised at any time until exercised in full.
Removed paragraphs (16)
Previous report
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. The primary endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment on May 2023.
Previous report
In March 2023, 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 period.
Previous report
Research and Development Expenses
Previous report
Research and development (“R&D”) expenses were approximately $1.3 million and $5.7 million for the three months ended March 31, 2025 and 2024, respectively. The $4.4 million net decrease was primarily attributed to a decline in expenses of approximately $2.9 million from studies that completed in prior fiscal year and other related expenses such as the clinical teams’ payroll of approximately $262,000, reflecting the reduction in force in December 2023, and a decrease in consultancy expense of approximately $678,000, resulting from declining use of consultants as the clinical studies were completed, a decrease in Chemistry, Manufacturing and Controls (“CMC”) and new drug discovery totaling approximately $354,000, a reduction in the use of regulatory and other consultants totaling approximately $29,000, and a decrease in related expenses of approximately $18,000 in travel, conferences and publications.
Previous report
Selling, General and Administrative Expenses
Previous report
Selling, general and administrative expenses were approximately $1.6 million and $2.0 million for the three months ended March 31, 2025 and 2024, respectively. The net decrease in expenses of approximately $388,000 were primarily attributed to decreases in directors’ compensation of approximately $201,000, executive teams’ compensation of $148,000 and legal fees of approximately $121,000, offset by increased expenses comprising of increased audit, accounting and regulatory filing fees of approximately $19,000, other consulting and professional fees of approximately $25,000, public and investor relations fees of $8,000 and miscellaneous expenses for website development, travel and other banking fees totaling approximately $23,000.
Previous report
Comparison of the nine months ended March 31, 2025 to the nine months ended March 31, 2024
Previous report
Net loss
Previous report
The net loss for the nine months ended March 31, 2025 was approximately $14.1 million as compared to the net loss of $27.2 million for the nine months ended March 31, 2024. The net decrease of $13.1 million was primarily attributed to decline in research and development expenses of $13.0 million, and a net increase in other income, net of approximately $140,000.
Previous report
Total operating expenses for the nine months ended March 31, 2025 were approximately $14.4 million and $27.4 million for the nine months ended March 31, 2024. The net decrease of approximately $13.0 million was primarily due to decreased research and development expenses of approximately $13.0 million due to the completion of clinical trials in the prior fiscal year.
Previous report
Research and Development Expenses
Previous report
Research and development expenses were approximately $8.0 million and $21.0 million for the nine months ended March 31, 2025 and 2024, respectively. The $13.0 million reduction was primarily attributed to the completion of the clinical studies in the prior fiscal year and comprised of a declines in direct study costs of approximately $7.6 million, and the related expenses such as the clinical team payroll of $1.6 million, reflecting the reduction in force in December 2023, and consultants expenses of $2.6 million, reflecting a declining use of consultants and a reduction in the use of regulatory and other consultants totaling approximately $469,000 as the clinical studies completed in the prior fiscal year. Other decrease included a decrease in CMC and new drug discovery totaling approximately $535,000, and a decrease in travel & conferences of approximately $76,000 and publications of approximately $127,000.
Previous report
Selling, General and Administrative Expenses
Previous report
Selling, general and administrative expenses for the nine months ended March 31, 2025, was approximately $6.2 million and was comparable to approximately $6.2 million for the nine months ended March 31, 2024. The net fluctuations in expenses were primarily comprised of decreases in directors’ compensation of approximately $339,000, executive teams’ compensation of approximately $416,000, investor and public relation fees of $131,000 offset by increases in other professional and consultancy fees of $566,000, legal fees of approximately $255,000, audit and accounting fees of approximately $72,000, and insurance premiums of approximately $31,000.
Previous report
Other Income and Expense
Previous report
Other income, net was approximately $350,000 for the nine months ended March 31, 2025, compared to approximately $210,000 for the nine months ended March 31, 2024. The net increase in other income of approximately $140,000 was comprised of a decrease in the change in fair value of the related derivative liabilities of approximately $1.8 million, and an increase in interest income of approximately $190,000, offset by a reduction in interest expense of approximately $2.1 million due to the pay-off of the notes on December 1, 2024.
Reworded paragraphs (11)
Previous wording
BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease.
Current wording
BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.
Previous wording
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. In April 2024, the Company announced that the United States Adopted Names Council, and the World Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107. Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.
Current wording
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 (or “bezisterim”). Bezisterim, the approved generic name for 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 Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from PD and Long COVID (“LC”) affects approximately 20 million adults in the US, and millions more worldwide.
Previous wording
Parkinson’s disease (“PD”) is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa provides symptomatic benefit, it does not slow PD progression.
Current wording
PD is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa provides symptomatic benefit, it does not slow PD progression.
Previous wording
In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim (NE3107) allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence in May 2025.
Current wording
In April 2024, the Company was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, the FD&A and the U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. The trial commenced in May 2025.
Previous wording
The net loss for the three months ended March 31, 2025 was approximately $2.8 million as compared to the net loss of $8.1 million for the three months ended March 31, 2024. The net decrease of $5.3 million is due to a decrease in research and development expenses of $4.4 million, decrease in selling, general and administrative expenses of approximately $388,000, and a decline in other expense of approximately $536,000.
Current wording
The net loss for the three months ended September 30, 2025 was approximately $5.1 million and as compared to the net loss of $4.2 million for the three months ended September 30, 2024. The net increase of $900,000 for the three months ended September 30, 2025 was comprised of the net increase in research and development expenses of $946,000, net increase in general and administrative expenses of approximately $216,000 offset by a decrease in other (income) expense, net of approximately $227,000.
Previous wording
Total operating expenses for the three months ended March 31, 2025 were approximately $3.0 million as compared to $7.7 million for the three months ended March 31, 2024. The net decrease of approximately $4.7 million for the three months ended March 31, 2025 was comprised of decreased research and development expenses of approximately $4.4 million primarily due to the completion of clinical trials in the prior fiscal year and a net decrease in selling, general and administrative expenses of approximately $388,000.
Current wording
Total operating expenses for the three months ended September 30, 2025 were approximately $5.3 million as compared to $4.1 million for the three months ended September 30, 2024. The net increase of approximately $1.2 million for the three months ended September 30, 2025, was comprised of net increased research and development expenses of approximately $946,000 primarily attributed to the development and launch of both the Long COVID program in April 2025 and Sunrise PD Phase 2 studies in May 2025 and the net increase in general and administrative expenses of approximately $216,000.
Previous wording
The decrease in clinical studies of approximately $7.6 million represented the net decrease in clinical trial studies expense of approximately $11.6 million due the completion of the clinical trials in the prior fiscal year offset by the planning and development of the two new clinical studies, Sunrise PD Phase 2 and Long Covid Program, totaling approximately $4.0 million. The table below summarizes the expense amounts for the nine months ended March 31, 2025 and 2024 by study:
Current wording
The increase in clinical studies of approximately $1.2 million represented planning, development and launch of the two new clinical studies, Sunrise PD Phase 2 and Long Covid Program. The table below summarizes the expense amounts for the three months ended September 30, 2025 and 2024 by study:
Previous wording
Other income, net was approximately $200,000 compared to other expense, net of $336,000, for the three months ended March 31, 2025 and 2024, respectively. The net decrease in other expense of approximately $536,000 was comprised of the decrease in the change in fair value of the derivative liabilities of approximately $102,000, offset by a decline in interest expense of approximately $624,000 due to the payoff of the notes payable on December 1, 2024, and an increase in interest income of approximately $14,000.
Current wording
Other income, net was approximately $197,000 compared to other expenses, net of $30,000, for the three months ended September 30, 2025 and 2024, respectively. The net increase in other income of approximately $227,000 was comprised of a reduction in interest expense of approximately $254,000 due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $25,000.
Previous wording
As of March 31, 2025, the Company had working capital of approximately $21.2 million, cash and cash equivalents totaling approximately $23.2 million, stockholders’ equity of approximately $21.8 million, and an accumulated deficit of approximately $348.7 million.
Current wording
As of September 30, 2025, the Company had working capital of approximately $24.4 million, cash and cash equivalents totaling approximately $25.0 million, stockholders’ equity of approximately $24.9 million, and an accumulated deficit of approximately $357.3 million.
Previous wording
The Company used net cash in operations totaling approximately $13.4 million and net cash provided by financing activities was approximately $12.7 million comprised of net proceeds from the capital raise activities of $15.7 million and proceeds from exercise of warrants of $2.9 million offset by the payment of $5.0 million of the Company’s notes payable and payment of the $850,000 loan premium.
Current wording
The Company used net cash in operations totaling approximately $3.0 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of $10.5 million.
Previous wording
For the nine-month period ended March 31, 2025, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting Policies section of this Form 10-Q. There were no other 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, 2024.
Current wording
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, 2025 (the “2025 Form 10-K”).
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The table below summarizes the expenses incurred for the three months ended March 31, 2025 and 2024 by study: