BIOVIE INC.
For the period ended Mar 31, 2026. Filed May 11, 2026.
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.
Mar 31, 2026 · Filed May 11, 2026
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 2025-12-31; filed 2026-02-06.
0001520138-26-000052
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001520138-26-000154
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 55 previous paragraphs and 54 current paragraphs.
28 unchanged; 19 reworded; 7 added; 8 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 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 (7)
Current report
Neurodegenerative Disease Programs
Current report
The Company is conducting a Phase 2b clinical trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD. The trial is designed to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with PD who have not been treated with carbidopa/levodopa. The Phase 2b study is a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design, and is expected to span approximately 20 weeks from initial screening through safety follow-up for each participant. The trial commenced in April 2025 and completed enrollment of 60 patients in December 2025. The Company currently expects to report topline results from the trial in mid-year 2026, although the timing of results is subject to change and there can be no assurance that the trial will yield favorable results or support further development.
Current report
In AD, BioVie has conducted both Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD.
Current report
Liver Cirrhosis Program
Current report
Research and Development Expenses
Current report
R&D expenses were approximately $3.2 million and $1.3 million for the three months ended March 31, 2026 and 2025, respectively. The net increase of approximately $1.9 million was primarily attributed to the increased activities in our clinical studies of approximately $1.1 million in the sunrise PD Phase 2 study as it became fully enrolled and nearing completion and the Long COVID (“LC”) Phase 2 study of a net increase of approximately $677,000. The net increase in the LC study was caused by the timing of reimbursements as amounts submitted for reimbursement are recorded on a cash basis or when recoverability is determined to be probable.
Current report
As the table indicates below, the increase in clinical studies of approximately $2.5 million is attributed to increased activity in both our clinical studies. Sunrise PD Phase 2 study costs increased by approximately $3.4 million as the study completed enrollment in January 2026 and the study is currently nearing completion. Long Covid Phase 2 study activities decreased and the net decrease in cost, net of reimbursements totaled approximately $786,000. The net decrease in costs is caused by the timing of reimbursements as amounts submitted for reimbursement are recorded on a cash basis or when recoverability is determined to be probable. As of March 31, 2026, the total cost incurred since inception was approximately $9.4 million and as of May 4, 2026 the total cost reimbursed was $9.4 million.
Removed paragraphs (8)
Previous report
Neurodegenerative Disease Program
Previous report
To extend this Phase 2 data in progressed patients, the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset PD. In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with the study. The trial commenced in April 2025.
Previous report
Liver Disease Program
Previous 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.
Previous 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.
Previous 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.
Previous report
Research andDevelopmentExpenses
Previous report
As the table indicates below, the increase in clinical studies of approximately $818,000 were comprised of the increased Sunrise PD Phase 2 study cost of approximately $2.3 million and the decline in Long Covid Phase 2 study cost of net of reimbursements totaling approximately $1.5 million that consisted of the large contractual start-up fee paid the CRO and the lag in receiving the reimbursements during the six months ended December 31, 2024.
Reworded paragraphs (19)
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 (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.
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 approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide.
Previous wording
In neurodegenerative disease, bezisterim (NE3107) inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. Bezisterim (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.
Current wording
With respect to the mechanism of action, we believe bezisterim inhibits activation of inflammatory extracellular signal-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. By binding to ERK and selectively modulating NFκB activation and TNF-α production without interfering with their homeostatic functions (e.g., insulin signaling and neuron growth and survival), we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID.
Previous wording
The Phase 2 study of bezisterim (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 bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. 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 measure the potential for adverse interactions of bezisterim (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.
Current wording
The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260) that we completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. 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 measure the potential for adverse interactions of bezisterim (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.
Previous 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 FDA 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.
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, U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. The trial commenced in May 2025.
Previous wording
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 as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was 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.
Current wording
In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin) was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical need. BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months.
Previous wording
After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”). This patient population is not limited to those having refractory ascites. BIV201 is administered as a patent-pending liquid formulation with patents issued in US, China, Japan, Chile and India to date.
Current wording
After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”). Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. BIV201 is administered in a continuous infusion of terlipressin as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India to date. Terlipressin is used in over 40 countries to treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and was approved in the U.S. in 2022 to improve kidney function in adults with hepatorenal syndrome experiencing a rapid reduction in kidney function; it is not currently approved in Japan.
Previous wording
The net loss for the three months ended December 31, 2025 was approximately $6.1 million as compared to the net loss of approximately $7.1 million for the three months ended December 31, 2024. The net decrease of $1.0 million for the three months ended December 31, 2025 was comprised of a net decrease in research and development ("R&D") expenses of approximately $435,000, and a net decrease in general and administrative expenses of approximately $595,000.
Current wording
Net loss for the three months ended March 31, 2026 was approximately $5.3 million as compared to the net loss of approximately $2.8 million for the three months ended March 31, 2025. The net increase of $2.5 million for the three months ended March 31, 2026 was comprised of a net increase in research and development ("R&D") expenses of approximately $1.9 million, and a net increase in general and administrative expenses of approximately $565,000.
Previous wording
Total operating expenses for the three months ended December 31, 2025 were approximately $6.3 million as compared to $7.3 million for the three months ended December 31, 2024. The net decrease of approximately $1.0 million for the three months ended December 31, 2025, was comprised of a net decrease in R&D expenses of approximately $435,000 and a net decrease in general and administrative expenses of approximately $595,000.
Current wording
Total operating expenses for the three months ended March 31, 2026 were approximately $5.4 million as compared to $3.0 million for the three months ended March 31, 2025. The net increase of approximately $2.4 million for the three months ended March 31, 2026 was comprised of a net increase in R&D expenses of approximately $1.9 million and a net increase in general and administrative expenses of approximately $565,000.
Previous wording
R&D expenses were approximately $4.3 million and $4.7 million for the three months ended December 31, 2025 and 2024, respectively. The net decrease of approximately $435,000 was primarily attributed to the Long COVID (“LC”) studies’ decline in net expenses due to the large start-up contractual payments made to the Contract Research Organizations (“CRO”) and no reimbursements received during the three months ended December 31, 2024; offset by increased cost from the Sunrise PD Phase 2 study, from the increased activities in the Sunrise PD Phase 2 study became fully enrolled. The table below indicates the cost incurred by study program.
Current wording
The table below indicates the approximate cost incurred by study program.
Previous wording
General and administrative expenses were approximately $1.9 million and $2.5 million for the three months ended December 31, 2025 and 2024, respectively. The net decrease of approximately $595,000 was primarily attributed to decreases in stock-based compensation for the executive team and directors of approximately $154,000 and $58,000, respectively, consultancy fees of approximately $593,000, investor and public relation fees of approximately $30,000, filing fees of approximately $41,000, offset by increased legal fees related to the class action litigation of approximately $331,000, and insurance premiums of approximately $20,000.
Current wording
General and administrative expenses were approximately $2.2 million and $1.6 million for the three months ended March 31, 2026 and 2025, respectively. The net increase of approximately $565,000 was primarily attributed to increases in the executive team and directors compensation of approximately $313,000 and $401,000, respectively, primarily in the form of stock-based compensation, increased insurance premiums of approximately $20,000 and accounting and auditing fees of approximately $16,000; offset by a decrease in legal fees expense of approximately $123,000, as the Company met its required insurance retention limit for the litigation costs of shareholders class action complaint, other professional and consultancy fees of approximately $38,000 and investor and public relation expense of approximately $24,000.
Previous wording
Other income, net was approximately $193,000 compared to other income, net of approximately $180,000, for the three months ended December 31, 2025 and 2024, respectively. The net increase in other income of approximately $13,000 was primarily comprised of a reduction in interest expense of approximately $61,000 due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $54,000.
Current wording
Other income, net was approximately $115,000 compared to other income, net of approximately $200,000, for the three months ended March 31, 2026 and 2025, respectively. The net decrease in other income of approximately $85,000 was primarily due to a interest income of approximately $76,000.
Previous wording
Comparison of the six months ended December 31, 2025 to the six months ended December 31, 2024
Current wording
Comparison of the nine months ended March 31, 2026 to the nine months ended March 31, 2025
Previous wording
The net loss for the six months ended December 31, 2025 was approximately $11.2 million comparable to the net loss of approximately $11.3 million for the six months ended December 31, 2024. The net decrease of approximately $108,000 for the six months ended December 31, 2025 was comprised of the net increase in operating expenses of approximately $132,000 offset by the increase in other income, net of approximately $240,000.
Current wording
Net loss for the nine months ended March 31, 2026 was approximately $16.4 million comparable to the net loss of approximately $14.1 million for the nine months ended March 31, 2025. The net increase of approximately $2.3 million for the nine months ended March 31, 2026 was comprised of the net increase in operating expenses of approximately $2.5 million offset by the increase in other income, net of approximately $155,000.
Previous wording
Total operating expenses for the six months ended December 31, 2025 were approximately $11.5 million as compared to $11.4 million for the six months ended December 31, 2024. The net R&D increase of approximately $132,000 for the six months ended December 31, 2025, was comprised of net increased research and development expenses of approximately $511,000 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 offset by the decline in general and administrative expenses of approximately $379,000.
Current wording
Total operating expenses for the nine months ended March 31, 2026 were approximately $16.9 million as compared to $14.4 million for the nine months ended March 31, 2025. The net operating expense increase of approximately $2.5 million for the nine months ended March 31, 2026, was comprised of net increased R&D expenses of approximately $2.4 million attributed to the increased activities in both the Sunrise PD Phase 2 study and LC Phase 2 study and an increase in general and administrative expenses of approximately $189,000.
Previous wording
R&D expenses were approximately $7.2 million for the six months ended December 31, 2025, an increase of approximately $511,000 from $6.7 million for six months ended December 31, 2024. The net increase in R&D expenses of approximately $511,000 is comprised of increased direct study costs of approximately $818,000, clinical team compensation of approximately $88,000, travel and conferences of approximately $153,000, offset by approximately $541,000 of Chemistry, Manufacturing and Controls (“CMC”) expenses that have been temporarily curtailed.
Current wording
R&D expenses were approximately $10.4 million for the nine months ended March 31, 2026, an increase of approximately $2.4 million from $8.0 million for nine months ended March 31, 2025. The net increase in R&D expenses is comprised of increased direct study costs of approximately $2.5 million, clinical team compensation of approximately $282,000, abstracts, publications and conferences of approximately $176,000, offset by approximately $619,000 in Chemistry, Manufacturing and Controls (“CMC”) and Discovery expenses that have been curtailed.
Previous wording
General and administrative expenses were approximately $4.2 million and $4.6 million for the six months ended December 31, 2025 and 2024, respectively. The net decrease of approximately $379,000 was primarily attributed to decreases in stock-based compensation for the executive team and directors of approximately $238,000 and $151,000, respectively and consultancy fees of approximately $565,000; offset by a net increase in legal fee expenses of approximately $546,000 that primarily represented legal fees related to the class action litigation.
Current wording
General and administrative expenses were approximately $6.4 million and $6.2 million for the nine months ended March 31, 2026 and 2025, respectively. The net increase of approximately $189,000 was primarily attributed to increases in the executive team and directors compensation of approximately $78,000 and $214,000, respectively, primarily comprised of stock based compensation; legal expenses of approximately $423,000 primarily attributed to the class action litigation; investor and public relations expenses of $71,000; and insurance premiums of approximately $55,000, offset by a decrease in consultancy fees of approximately $603,000 and a decline in other expenses such as meetings and travel totaling $24,000 and accounting and auditing fees of approximately $14,000.
Previous wording
Other income, net was approximately $390,000 compared to other income, net of $150,000, for the six months ended December 31, 2025 and 2024, respectively. The net increase in other income of approximately $240,000 was comprised of a reduction in interest expense of approximately $315,000 due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $79,000.
Current wording
Other income, net was approximately $505,000 compared to other income, net of $350,000, for the nine months ended March 31, 2026 and 2025, respectively. The net increase in other income of approximately $155,000 was comprised of a reduction in interest expense of approximately $314,000 due to the payoff of the notes payable on December 1, 2024, offset by decline in interest income of approximately $155,000.
Previous wording
As of December 31, 2025, the Company had working capital of approximately $18.8 million, cash and cash equivalents totaling approximately $20.5 million, stockholders’ equity of approximately $19.3 million, and an accumulated deficit of approximately $363.3 million.
Current wording
As of March 31, 2026, the Company had working capital of approximately $15.2 million, cash and cash equivalents totaling approximately $13.1 million, stockholders’ equity of approximately $15.6 million, and an accumulated deficit of approximately $368.6 million.
Previous wording
The Company used net cash in operations totaling approximately $7.5 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of $10.5 million.
Current wording
The Company used net cash in operations totaling approximately $14.9 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of approximately $10.5 million.