BIOVIE's Q3 Loss Widens Amid R&D Surge, Cash Boosted by Equity Raise

TL;DR

**BIOVIE is burning cash on R&D, but a fresh equity raise keeps the lights on, despite a major Alzheimer's trial setback that screams 'caution'.**

AI Summary

BIOVIE INC. (BIVIW) reported a net loss of $5,087,557 for the three months ended September 30, 2025, an increase from a net loss of $4,152,032 for the same period in 2024. Research and development expenses rose significantly to $2,936,370 in Q3 2025 from $1,990,198 in Q3 2024, reflecting increased clinical trial activity for bezisterim in Parkinson's disease and Long COVID. General and administrative expenses also increased to $2,290,881 from $2,074,540 year-over-year. The company's cash and cash equivalents substantially increased to $24,978,302 as of September 30, 2025, up from $17,544,547 at June 30, 2025, primarily due to $10,457,629 in net proceeds from common stock issuance. A $13.1 million grant from the U.S. Department of Defense for the Long COVID program was awarded in April 2024, with $336,000 recognized as reimbursement for R&D expenses in Q3 2025. The Phase 3 Alzheimer's trial faced significant protocol deviations at 15 study sites, leading to patient exclusions and an underpowered trial, though an observed descriptive change suggested a slowing of cognitive loss in the Per-Protocol population. The company is also finalizing a Phase 3 protocol for BIV201 in liver cirrhosis.

Why It Matters

BIOVIE's increased R&D spending and significant net loss highlight the capital-intensive nature of clinical-stage biopharma. The substantial cash infusion from common stock issuance is critical for funding ongoing trials, particularly for bezisterim in Parkinson's and Long COVID, and the planned Phase 3 for BIV201. However, the integrity issues in the Alzheimer's trial raise serious questions about data reliability and trial execution, potentially impacting investor confidence and future regulatory pathways. For patients, the progress in Parkinson's and Long COVID trials offers hope, but the AD trial setback underscores the high risks in drug development, especially against competitors like Eli Lilly and Biogen in neurodegenerative diseases.

Risk Assessment

Risk Level: high — The company reported a net loss of $5,087,557 for the three months ended September 30, 2025, and has an accumulated deficit of $357,275,347. Furthermore, the Phase 3 Alzheimer's trial for bezisterim experienced "significant deviation from protocol and current good clinical practices (cGCPs) violations at 15 study sites," leading to patient exclusions and an underpowered trial, which is a critical operational and regulatory risk.

Analyst Insight

Investors should exercise extreme caution and closely monitor the progress of BIOVIE's ongoing clinical trials for bezisterim in Parkinson's and Long COVID, as well as the planned Phase 3 for BIV201. Given the significant net losses and the critical issues in the Alzheimer's trial, new investments should be deferred until there is clear evidence of successful trial outcomes and robust data integrity from other programs.

Financial Highlights

debt To Equity

0.08

revenue

$0

operating Margin

-99.8%

total Assets

$ 26,820,098

total Debt

$ 1,899,094

net Income

$ -5,087,557

eps

$ -0.98

gross Margin

N/A

cash Position

$ 24,978,302

revenue Growth

N/A

Key Numbers

• $5,087,557 — Net Loss (for the three months ended September 30, 2025, increased from $4,152,032 in 2024)
• $2,936,370 — Research and Development Expenses (for the three months ended September 30, 2025, up from $1,990,198 in 2024)
• $24,978,302 — Cash and Cash Equivalents (as of September 30, 2025, up from $17,544,547 at June 30, 2025)
• $10,457,629 — Net Proceeds from Common Stock Issuance (for the three months ended September 30, 2025)
• $13.1 million — Clinical Trial Grant (awarded from U.S. Department of Defense for Long COVID program in April 2024)
• 7,540,316 — Shares of Class A Common Stock Outstanding (as of November 7, 2025)
• 15 — Study Sites (with significant protocol deviations in the Phase 3 Alzheimer's trial)
• 81 — Patients (remaining in the Modified Intent to Treat population after exclusions in the AD trial)
• $357,275,347 — Accumulated Deficit (as of September 30, 2025)
• $336,000 — Grant Reimbursements (recognized for R&D expenses in Q3 2025 for Long COVID program)

Key Players & Entities

• BIOVIE INC. (company) — registrant
• U.S. Department of Defense (regulator) — awarded $13.1 million grant
• FDA (regulator) — approved IND for bezisterim in Long COVID
• NeurMedix, Inc. (company) — acquired biopharmaceutical assets
• LAT Pharma LLC (company) — acquired BIV201 development program from
• NASDAQ Stock Market, LLC (regulator) — exchange where Class A Common Stock and Warrants are registered
• OSI (regulator) — FDA Office of Scientific Investigations

FAQ

Risk Factors

• Clinical Trial Protocol Deviations [high — operational]: The Phase 3 Alzheimer's trial experienced significant protocol deviations at 15 study sites, leading to patient exclusions. This resulted in an underpowered trial, impacting the reliability of the results. While a descriptive change suggested a slowing of cognitive loss in the Per-Protocol population, the protocol deviations pose a substantial risk to the trial's validity and future development.
• High Burn Rate and Net Loss [high — financial]: BIOVIE INC. reported a net loss of $5,087,557 for Q3 2025, an increase from $4,152,032 in Q3 2024. This widening loss is driven by increased R&D expenses ($2,936,370 vs $1,990,198) and G&A expenses ($2,290,881 vs $2,074,540). The company's accumulated deficit stands at $357,275,347 as of September 30, 2025, indicating a significant reliance on external funding.
• Reliance on Stock Issuance for Funding [medium — financial]: The company's cash position increased to $24,978,302 as of September 30, 2025, primarily due to $10,457,629 in net proceeds from common stock issuance. This highlights a dependence on equity financing to sustain operations and fund its extensive R&D activities, which can be volatile.
• Drug Development and Regulatory Approval [high — regulatory]: The company is developing novel therapies for Parkinson's disease, Long COVID, and liver cirrhosis. The success of these programs is contingent on successful clinical trials and subsequent regulatory approvals, which are complex, lengthy, and uncertain processes. Failures in any of these stages can significantly impact the company's prospects.
• Clinical Trial Execution and Patient Recruitment [medium — operational]: Beyond the Alzheimer's trial issues, the company is also finalizing a Phase 3 protocol for BIV201 in liver cirrhosis. Successful execution of this trial, including patient recruitment and adherence to protocols, is critical. Any setbacks in trial design or execution could delay development and increase costs.

Industry Context

The biotechnology sector is characterized by high R&D investment, long development cycles, and significant regulatory hurdles. Companies like BioVie Inc. operate in a competitive landscape where innovation is key, but success is often dependent on clinical trial outcomes and securing substantial funding. The focus on neurodegenerative diseases and unmet medical needs presents both opportunity and risk.

Regulatory Implications

BioVie Inc. faces significant regulatory risks inherent in drug development. The success of its pipeline, particularly for bezisterim in Parkinson's disease and Long COVID, hinges on navigating the rigorous FDA approval process. Protocol deviations in ongoing trials, such as the Alzheimer's study, can lead to delays, increased costs, and potential rejection by regulatory bodies.

What Investors Should Do

1. Monitor Clinical Trial Progress Closely
2. Assess Burn Rate and Funding Needs
3. Evaluate Management's Strategy for Addressing Trial Deficiencies
4. Scrutinize Pipeline Diversification and Success Probability

Key Dates

• 2025-09-30: End of Q3 2025 — Reported net loss of $5,087,557 and cash balance of $24,978,302. R&D expenses increased significantly.
• 2025-06-30: End of Q2 2025 — Reported cash balance of $17,544,547, showing substantial increase in Q3.
• 2024-04-01: Grant Awarded — Received $13.1 million grant from U.S. Department of Defense for Long COVID program, contributing to funding.

Glossary

Accumulated deficit

The total net losses of a company since its inception, minus any net profits. It represents a negative retained earnings balance. (Indicates the company has historically spent more than it has earned, requiring ongoing funding to cover operational costs.)

Research and development expenses

Costs incurred by a company in the process of developing new products or services, or improving existing ones. (Represents significant investment in future growth, but also a major driver of current losses for BioVie.)

Per-Protocol population

A group of participants in a clinical trial who have adhered to the study's protocol as closely as possible. (Used to assess treatment effects in an ideal scenario, but can be misleading if the population is small due to protocol deviations.)

Modified Intent to Treat (mITT) population

A group of participants in a clinical trial who have received at least one dose of the study medication and for whom baseline efficacy data are available. (Represents a more realistic assessment of treatment effect in a clinical setting compared to the Per-Protocol population.)

Net proceeds from common stock issuance

The amount of money a company receives from selling its stock, after deducting any underwriting fees and other issuance costs. (Shows how the company is raising capital, in this case, significantly boosting its cash reserves.)

Year-Over-Year Comparison

Compared to the prior period (likely Q2 2025 or Q3 2024 based on context), BioVie Inc. has seen a significant increase in its net loss, rising from $4,152,032 to $5,087,557 for the three months ended September 30, 2025. This is primarily driven by a substantial increase in Research and Development expenses, up by nearly $1 million year-over-year, reflecting heightened clinical trial activity. General and administrative expenses also saw an increase. However, the company's cash position improved considerably, growing from $17,544,547 to $24,978,302, largely due to proceeds from stock issuance, which helps offset the increased operational costs.

Key Financial Figures

• $0.0001 — hich registered Class A Common Stock, $0.0001 par value per share BIVI The NASDAQ S
• $747,408 — suance of common stock, net of costs of $747,408 162,794 16 2,259,047 - - - - 2,
• $1,543,038 — suance of common stock, net of costs of $1,543,038 5,620,000 562 10,457,067 - - - -
• $13.1 million — y was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense ("D
• $5 billion — ening complications, generate more than $5 billion in annual treatment costs, and have an

Filing Documents

• bivi-20250930_10q.htm (10-Q) — 543KB
• bivi-20250930_10qex31z1.htm (EX-31.1) — 12KB
• bivi-20250930_10qex31z2.htm (EX-31.2) — 12KB
• bivi-20250930_10qex32z1.htm (EX-32.1) — 5KB
• bivi-20250930_10qex32z2.htm (EX-32.2) — 5KB
• 0001520138-25-000343.txt ( ) — 3446KB
• bivi-20250930_cal.xml (EX-101.CAL) — 44KB
• bivi-20250930_def.xml (EX-101.DEF) — 122KB
• bivi-20250930_lab.xml (EX-101.LAB) — 241KB
• bivi-20250930_pre.xml (EX-101.PRE) — 197KB
• bivi-20250930.xsd (EX-101.SCH) — 33KB
• bivi-20250930_10q_htm.xml (XML) — 431KB

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION Item 1. Unaudited Financial Statements Condensed Balance Sheets at September 30, 2025 and June 30, 2025 4 Condensed Statements of Operations - for the three months ended September 30, 2025 and 2024 5 Condensed Statements of Changes in Stockholders' Equity - for the three months ended September 30, 2025 and 2024 6 Condensed Statements of Cash Flows - for the three months ended September 30, 2025 and 2024 7 Notes to Unaudited Condensed Financial Statements 8 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 21 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 26 Item 4.

Controls and Procedures

Controls and Procedures 26

– OTHER INFORMATION

PART II – OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 27 Item 1A.

Risk Factors

Risk Factors 27 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 30 Item 3. Defaults Upon Senior Securities 30 Item 4. Mine Safety Disclosures 30 Item 5. Other Information 30 Item 6. Exhibits 31

SIGNATURES

SIGNATURES 32 2 Table of Contents BIOVIE INC.

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 27A of the Securities Act of 1933, as amended (the "Securities Act"). Any statements contained in this report that are not statements of historical fact may be forward-looking statements. 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 statements. 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 include our research and development activities, distributor channel; compliance with regulatory impositions; 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. Except 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 our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. 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 that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. All statements other than statements of historical fact are statements

forward-looking statements, except as required by law. When used in this report, the terms "BioVie", "Company",

forward-looking statements, except as required by law. When used in this report, the terms "BioVie", "Company", "we", "our", and "us" refer to BioVie Inc. 3 Table of Contents

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION

Financial Statements

Item 1. Financial Statements BioVie Inc. Condensed Balance Sheets (Unaudited) September 30, June 30, 2025 2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 24,978,302 $ 17,544,547 Grant receivable 179,804 2,104,050 Prepaid and other current assets 873,884 1,049,897 Total current assets 26,031,990 20,698,494 Operating lease right-of-use asset, net 321,400 339,653 Intangible assets, net 120,997 178,341 Goodwill 345,711 345,711 TOTAL ASSETS $ 26,820,098 $ 21,562,199 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accrued expenses $ 1,566,364 $ 2,200,320 Current portion of operating lease liability 78,357 74,464 Total current liabilities 1,644,721 2,274,784 Operating lease liability, net of current portion 254,373 275,430 TOTAL LIABILITIES 1,899,094 2,550,214 Commitments and contingencies (Note 9) STOCKHOLDERS' EQUITY: Preferred stock; $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding - - Common stock, $ 0.0001 par value; 800,000,000 shares authorized at September 30, 2025 and June 30, 2025; 7,540,316 shares issued of which 7,537,479 shares outstanding at September 30, 2025; and 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025 754 192 Additional paid in capital 382,195,626 371,156,068 Accumulated deficit ( 357,275,347 ) ( 352,144,246 ) Treasury stock ( 29 ) ( 29 ) Total stockholders' equity 24,921,004 19,011,985 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 26,820,098 $ 21,562,199 See accompanying notes to unaudited condensed financial 4 Table of Contents BioVie Inc. Condensed Statements of Operations (Unaudited) Three Months Ended Three Months Ended September 30, 2025 September 30, 2024 OPERATING EXPENSES: Amortization of intangible assets $ 57,344 $ 57,344 Research and development expenses 2,936,370 1,990,198 General and adminis

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