Biovie Inc 10-Q for FY2026 Q3
Biovie Inc. (BIVI)
About this 10-Q
Biovie Inc filed this 10-Q on May 11, 2026, covering the quarter ended March 31, 2026 (FY2026 Q3).
Headline figures
Quarter ended March 31, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $5.27M
- compared with a net loss of $2.79M a year earlier
- Diluted EPS
- -$0.70
- compared with -$1.51 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended:
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________to _____________
Commission File Number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
| (Address of principal executive offices, Zip Code) |
| ( |
| (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| The Stock Market, LLC | ||
| The Stock Market, LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated Filer | ☐ | Accelerated Filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company | |||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐
There were shares of the Registrant’s Class A Common Stock, $0.0001 par value per share, outstanding as of May 11, 2026.
TABLE OF CONTENTS
2
BIOVIE INC.
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 statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking 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.
When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc.
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PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
(Unaudited)
| March 31, | June 30, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Grant receivable | ||||||||
| Prepaid and other current assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use asset, net | ||||||||
| Intangible assets, net | ||||||||
| Goodwill | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Current portion of operating lease liability | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability, net of current portion | ||||||||
| TOTAL LIABILITIES | ||||||||
| Commitments and contingencies (Note 8) | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock; $ par value; shares authorized; shares issued and outstanding | ||||||||
| Common stock, $ par value; shares authorized at March 31, 2026 and June 30, 2025; shares issued of which shares outstanding at March 31, 2026; and shares issued of which shares are outstanding at June 30, 2025 | ||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock | ( | ) | ( | ) | ||||
| Total stockholders' equity | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | $ | ||||||
See accompanying notes to unaudited condensed financial statements
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BioVie Inc.
Condensed Statements of Operations
(Unaudited)
| Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | |||||||||||||
| March 31, 2026 | March 31, 2025 | March 31, 2026 | March 31, 2025 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Amortization of intangible assets | $ | $ | $ | $ | ||||||||||||
| Research and development expenses | ||||||||||||||||
| General and administrative expenses | ||||||||||||||||
| TOTAL OPERATING EXPENSES | ||||||||||||||||
| LOSS FROM OPERATIONS | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| OTHER (INCOME) EXPENSE: | ||||||||||||||||
| Change in fair value of derivative liabilities | ( | ) | ( | ) | ||||||||||||
| Interest expense | ||||||||||||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| TOTAL OTHER INCOME, NET | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Deemed dividend related to ratchet adjustment to warrants | ||||||||||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||||||||
| - Basic | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| - Diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||||||||||
| - Basic | ||||||||||||||||
| - Diluted | ||||||||||||||||
See accompanying notes to unaudited condensed financial statements
5
BioVie Inc.
Condensed Statements of Changes in Stockholders’ Equity
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||
| Additional | Other | Total | ||||||||||||||||||||||||||||||
| Common Stock | Common Stock | Paid in | Treasury Stock | Treasury Stock | Comprehensive | Accumulated | Stockholders' | |||||||||||||||||||||||||
| Shares | Amount | Capital | Shares | Amount | Income | Deficit | Equity | |||||||||||||||||||||||||
| Balance, June 30, 2024 | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Stock-based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of - restricted stock units | - | |||||||||||||||||||||||||||||||
| Stock-based compensation - issuance of common stock for services rendered | - | |||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $747,408 | - | |||||||||||||||||||||||||||||||
| Issuance of additional shares for fractional shares effected by the reverse split | ( | ) | - | |||||||||||||||||||||||||||||
| Deemed dividend for ratchet adjustment to warrants | - | - | ( | ) | ||||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, September 30, 2024 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of - restricted stock units | - | |||||||||||||||||||||||||||||||
| Exercise of warrants | - | |||||||||||||||||||||||||||||||
| Cashless exercise of warrants | - | |||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $2,492,880 | - | |||||||||||||||||||||||||||||||
| Deemed dividend for ratchet adjustment to warrants | - | - | ( | ) | ||||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, December 31, 2024 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units and restricted shares | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of - restricted stock units | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, March 31, 2025 | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||
| Stock - based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units and restricted shares | - | - | ||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $1,543,038 | - | |||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of restricted stock units | - | |||||||||||||||||||||||||||||||
| Deemed dividend for ratchet adjustment to warrants | - | - | ( | ) | ||||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, September 30, 2025 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock - based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units and restricted shares | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of restricted stock units | - | |||||||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, December 31, 2025 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock - based compensation - stock options | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation - restricted stock units and restricted shares | - | - | ||||||||||||||||||||||||||||||
| Issuance of common stock from vesting of restricted stock units | - | |||||||||||||||||||||||||||||||
| Net Loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, March 31, 2026 | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||
See accompanying notes to unaudited condensed financial statements
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BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
| Nine Months Ended | Nine Months Ended | |||||||
| March 31, 2026 | March 31, 2025 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Amortization of intangible assets | ||||||||
| Stock based compensation - restricted stock units and restricted shares | ||||||||
| Stock based compensation expense - stock options | ||||||||
| Stock based compensation expense - issuance of common stock for services rendered | ||||||||
| Amortization of financing costs | ||||||||
| Accretion of unearned loan discount | ||||||||
| Accretion of loan premium | ||||||||
| Non-cash lease expense from right-of-use assets | ||||||||
| Change in fair value of derivative liabilities | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Grant receivable | ( | ) | ||||||
| Prepaid and other current assets | ( | ) | ( | ) | ||||
| Accounts payable and accrued expenses | ( | ) | ( | ) | ||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from issuance of common stock | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Payment of loan premium | ( | ) | ||||||
| Payment of loan premium | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents, beginning of period | ||||||||
| Cash and cash equivalents, end of period | $ | $ | ||||||
| SUPPLEMENTAL CASH FLOW INFORMATION: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITIES: | ||||||||
| Deemed dividend for ratchet adjustment to warrants | $ | $ | ||||||
See accompanying notes to unaudited condensed financial statements
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BioVie Inc.
Notes to Condensed Financial Statements
For the Three and Nine Months Ended March 31, 2026 and 2025
(unaudited)
| 1. | Background Information |
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.
Neurodegenerative Disease Programs
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.
With respect to the mechanism of action, we believe Bezisterim inhibits activation of inflammatory action 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. By binding to ERK and selectively modulating NFκB activation and TNF-α production without interfering with their homeostatic functions, we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID.
Parkinson’s Disease
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.
The Phase 2 study of bezisterim 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. Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim 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 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.
Long COVID Program
Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more. Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented.
8
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. Individuals who have been diagnosed with long COVID and have neurocognitive dysfunction and self-reported fatigue may meet qualification criteria.
As of March 31, 2026, the total cost incurred
was approximately $
Alzheimer’s Disease
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.
Liver Cirrhosis Program
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.
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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.
The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and 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 predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
| 2. | Liquidity and Going Concern |
The Company’s operations are subject to
a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the
results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval
to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand
for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for
its products; and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the
Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. As of March 31, 2026, the Company had working capital of approximately $
The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
| 3. | Significant Accounting Policies |
Basis of Presentation – Interim Financial Information
These unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”) for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2025, was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. These unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements for the fiscal years ended June 30, 2025 and 2024 in our Annual Report on Form 10-K filed with the SEC on August 15, 2025 (the “2025 Form 10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2025 Form 10-K.
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Reverse stock split
The Company effected a
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of three months or less.
Concentration of Credit Risk in the Financial Service Industry
As of March 31, 2026, the Company had cash deposited in a certain financial institution in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, if liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
Fair value measurement of assets and liabilities
We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3 - Inputs are unobservable inputs based on our assumptions.
The Company’s financial instruments include cash, accounts payable, and the carrying value of the operating lease liabilities. The carrying amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items. The carrying amounts of operating lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments.
Basic net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, restricted stock units, and convertible debentures. For the three and nine months ending March 31, 2026 and 2025, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods presented.
The weighted average number of common shares outstanding for the three and nine months ended March 31, 2026 of and , respectively, includes the weighted average effect of the pre-funded warrants issued in connection with the August 2025 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 6).
11
The table below shows the potential shares of common stock, presented based on amounts outstanding at each period end, which were excluded from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:
| Schedule of dilutive securities were excluded from the computation of diluted loss per share | ||||||||
| March 31, 2026 | March 31, 2025 | |||||||
| Number of Shares | Number of Shares | |||||||
| Stock Options | ||||||||
| Warrants | ||||||||
| Restricted Stock Units | ||||||||
Grant program
The Company records expenses related to the DOD Long Covid Program as incurred. The reimbursements of such expenses are recognized as a credit against the respective expense account upon receipt, or when it is probable the reimbursement will be received.
Segment Reporting
The Company operates as one operating segment with a focus on its efforts to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. The Company's Chief Executive Officer (“CEO”), as the chief operating decision maker, manages and allocates resources to the operations of the Company based on the line items included within these financial statements. This enables the CEO to assess the overall level of available resources and determine how best to deploy these resources across functions, clinical trials, and development projects in line with the long-term company-wide strategic goals.
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| 4. | Intangible Assets |
The Company’s intangible assets consist of intellectual property acquired from LAT Pharma, Inc. and are amortized over their estimated useful lives.
The following is a summary of the Company’s intangible assets:
| Schedule of intangible assets | ||||||||
| March 31, 2026 | June 30, 2025 | |||||||
| Intellectual Property | $ | $ | ||||||
| Less: Accumulated Amortization | ( | ) | ( | ) | ||||
| Intellectual Property, net | $ | $ | ||||||
Amortization expense was $
| 5. | Fair Value Measurements |
Financial assets
As of March 31, 2026, investments in U.S. Treasury Bills were valued through use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured at fair value on a recurring basis using the above input categories.
| Measured at fair value on a recurring basis | ||||||||||||||||
| Fair Value Measurements at | ||||||||||||||||
| March 31, 2026 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Cash | $ | $ | $ | $ | ||||||||||||
| U.S. Treasury Bills due in 3 months or less at purchase | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| Fair Value Measurements at | ||||||||||||||||
| June 30, 2025 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Cash | $ | $ | $ | $ | ||||||||||||
| U.S. Treasury Bills due in 3 months or less at purchase | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
13
| 6. | Equity Transactions |
Equity Transactions with Acuitas (former related party)
On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of shares of the Company’s Common Stock, at a price of $165.00 per share (the “PIPE Shares”), and (ii) a warrant to purchase 72,728 shares of Common Stock (“PIPE Warrant Shares”), at an original exercise price of $182.00, with a term of exercise of five years.
As a result of the Company’s subsequent capital raises, the warrants’ down round features (the “ratchet adjustment”) resulted in deemed dividends recognized in the accompanying condensed statements of changes in stockholders’ equity for the three months ended September 30, 2025 and 2024.
For the three months ended September 30, 2024,
the deemed dividend of $
The October 22, 2024 capital raise further reduced
the exercise prices from $
For the three months ended September 30, 2025,
the deemed dividend of $
Issuance of common stock for cash
On August 11, 2025, the Company closed an underwritten
public offering of (i) units (the “Units”), with each Unit consisting of one share of common stock and one warrant
(the “Warrants”) and (ii)
14
Stock Options
The following table summarizes the activity relating to the Company’s stock options for the nine months ended March 31, 2026:
| Schedule of summarizes the activity relating to the Company’s stock options | ||||||||||||||||
| Options | Weighted-Average Exercise Price | Weighted Remaining Average Contractual Term | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at June 30, 2025 | $ | $ | ||||||||||||||
| Options Granted | $ | $ | ||||||||||||||
| Options Expired | ) | $ | 0.0 | $ | - | |||||||||||
| Outstanding at March 31, 2026 | $ | $ | ||||||||||||||
| Exercisable at March 31, 2026 | $ | $ | ||||||||||||||
The Company recorded stock-based compensation expense relating to the vesting of stock options of approximately $ million and $ for the three months ended March 31, 2026 and 2025, respectively. The Company recorded stock-based compensation expense relating to the vesting of stock options of approximately $million and $ for the nine months ended March 31, 2026 and 2025, respectively.
The fair value of each option on the date of grant is estimated using the Black-Scholes option pricing model. The pricing model reflects the following weighted-average assumptions for the nine months ended March 31, 2026 and 2025:
| Schedule of assumptions used | ||||||||
| March 31, 2026 | March 31, 2025 | |||||||
| Expected life of options (in years) | ||||||||
| Expected volatility | % | % | ||||||
| Risk free interest rate | % | % | ||||||
| Dividend Yield | % | % | ||||||
On January 5, 2026 (the “Grant Date”),
directors’ annual compensation was approved and the directors were granted stock options to purchase a total of shares of
common stock, at an exercise price of $
On January 5, 2026 (the “Grant Date”),
the Company awarded bonus and retention incentive stock options to certain directors and employees to purchase a total of
Restricted stock units:
On September 2, 2025 (the “Grant Date”), the Company awarded a total of Restricted Stock Units (“RSUs”) to a consultant at the grant date fair value of $ per RSU. The RSUs vest in five equal installments beginning on the Grant Date and over the following four calendar quarters beginning December 31, 2025.
15
The following table summarizes vesting of restricted stock units:
| Schedule of vesting of restricted common stock | ||||||||
| Number of Shares | Weighted Average Grant Date Fair Value Per Share | |||||||
| Unvested at June 30, 2025 | $ | |||||||
| Granted | ||||||||
| Vested | ) | |||||||
| Unvested at March 31, 2026 | $ | |||||||
The total stock-based compensation expense from restricted stock units for the three months ended March 31, 2026 and 2025 was approximately $ and $, respectively. The total stock-based compensation expense from restricted stock units for the nine months ended March 31, 2026 and 2025 was approximately $ and $, respectively.
Stock Warrants
The following table summarizes the warrants activity during the nine months ended March 31, 2026:
| Summary of warrants activity | ||||||||||||||||
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding and exercisable at June 30, 2025 | $ | $ | ||||||||||||||
| Granted | - | |||||||||||||||
| Canceled | ) | - | - | |||||||||||||
| Expired | ) | - | - | |||||||||||||
| Outstanding and exercisable at March 31, 2026 | $ | $ | ||||||||||||||
The table below shows the expiration of the warrants outstanding as of March 31, 2026:
| Schedule of expiration of the warrants outstanding | ||||
| Number of Warrants | ||||
| Expiring June 30, | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| 2030 | ||||
| 2031 | ||||
| Total outstanding warrants | ||||
The warrants table excludes
16
| 7. | Leases |
Office Leases
The Company pays an annual rent of $
The Company’s San Diego office lease at
5090 Shoreham Place Suite 206, San Diego, CA 92122 was amended on February 12, 2024 for a larger space. The current monthly base rate
for the office space is $
Total operating lease expense for the three months
ended March 31, 2026 and 2025 of approximately $
The right-of-use asset, net and current and long-term portion of the operating lease liabilities included in the accompanying condensed balance sheets are as follows:
| Schedule of deferred tax assets | ||||||||
| March 31, 2026 | June 30, 2025 | |||||||
| Assets | ||||||||
| Operating lease right-of-use asset, net | $ | $ | ||||||
| Liabilities | ||||||||
| Current portion of operating lease liability | $ | $ | ||||||
| Operating lease liability, net of current portion | ||||||||
| Total operating lease liability | $ | $ | ||||||
At March 31, 2026, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
| Schedule of future estimated minimum lease payments under non-cancelable operating leases | ||||
| Year ending June 30, 2026 (Remaining 3 months) | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Total minimum lease payments | ||||
| Less amount representing interest | ( | ) | ||
| Present value of future minimum lease payments | $ |
Total cash paid for amounts included in the measurement of lease liabilities
were $
The weighted average remaining lease term and discount rate as of March 31, 2026 and June 30, 2025 were as follows:
| Schedule of weighted average remaining lease term and discount rate | ||||||||
| March 31, 2026 | June 30, 2025 | |||||||
| Weighted average remaining lease term (Years) | ||||||||
| Operating lease | ||||||||
| Weighted average discount rate | ||||||||
| Operating lease | % | % | ||||||
17
| 8. | Commitments and Contingencies |
Royalty Agreements
Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company was obligated to pay a 5% on net sales (capped at a maximum of $200,000 per year) of all terlipressin products covered by US Patent No. 11364277, expiring in 2036 and the European Patent No. EP3347032, expiring in 2036 and pending patent applications in the U.S., Europe, China and Japan, related to the administration of terlipressin as a continuous infusion for the treatment of ascites.
Pursuant to the Intellectual Property Rights Agreement entered into on April 18, 2019, by and between the Company and DOCUCHEM SLU, the Company is obligated to pay DOCUCHEM SLU $25,000 on the issuance of the U.S. patent for terlipressin and $50,000 each calendar year in which the gross sales in the U.S. of a product covered by a claim of an issued U.S. patent as directed to terlipressin exceeds $10,000,000.
Shareholder class action complaint and shareholder derivative complaints
On January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035 (the “Securities Class Action”), appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion. The parties are now engaged in fact discovery. On February 13, 2026, Plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the motion for leave to amend, and that motion is now fully briefed and pending before the court. Defendants’ opposition to the motion for class certification is due June 15, 2026.
Three shareholder derivative lawsuits piggy-backing on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11, 2025, (collectively the “Related Derivative Lawsuits”). Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims: that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control. On September 29, 2025, at the request of the parties, the court consolidated all three Related Derivative Lawsuits under the caption In re BioVie Inc. Derivative Litigation, Case No. 3:24-cv-0602-CSD (the “Consolidated Derivative Action”). On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending resolution of a summary judgment motion by defendants in the Securities Class Action.
The Company believes that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
18
| 9. | Employee Benefit Plan |
The Company sponsors an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which, all employees meeting eligibility requirements are able to participate.
Subject to certain limitations in the Internal
Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company
will match 5% of the first 5% of an employee’s contributions to the 401K Plan. The Company made contributions into the plan of approximately
$
| 10. | Segment Reporting |
The Company operates as one operating segment with a focus on its efforts to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. The Company's CEO, as the chief operating decision maker, manages and allocates resources to the operations of the Company based on the line items included within these condensed financial statements and segment performance is evaluated based on net loss. This enables the CEO to assess the overall level of available resources and determine how best to deploy these resources across functions, clinical trials, and development projects in line with the long-term company-wide strategic goals. The measurement of segment assets is reported on the condensed balance sheet as total assets. All of the Company’s tangible assets are held in the United States.
The following table presents selected financial information with respect to the Company’s single operating segment and its significant segment approximated expenses for the nine months ended March 31, 2026 and 2025:
| Schedule of segment reporting information | ||||||||
| Nine months ended | Nine months ended | |||||||
| March 31, 2026 | March 31, 2025 | |||||||
| Clinical studies | $ | $ | ||||||
| Clinical teams | ||||||||
| Chemistry, manufacturing and controls | ||||||||
| Other research and development expenses | ||||||||
| General and administrative expenses | ||||||||
| Amortization of intangible assets | ||||||||
| Other income, net | ( | ) | ( | ) | ||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. 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, among others: our research and development activities and distributor channel; compliance with regulatory requirements; and our ability to satisfy 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.
You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. 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 statements contained in this report as a result of new information or future events or developments, except as required by law. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking 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 (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.
The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report.
Management’s Discussion
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.
Neurodegenerative Disease Programs
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.
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.
Chronic neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (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. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.
20
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.
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.
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.
Long COVID Program
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.
Alzheimer’s Disease
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.
Liver Cirrhosis Program
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.
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.
21
Comparison of the three months ended March 31, 2026 to the three months ended March 31, 2025
Net loss
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.
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.
Research and Development Expenses
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.
The table below indicates the approximate cost incurred by study program.
| Three months ended | Three months ended | Increase | ||||||||||
| March 31, 2026 | March 31, 2025 | (Decrease) | ||||||||||
| Sunrise PD Phase 2 | $ | 2,060,000 | $ | 973,000 | $ | 1,087,000 | ||||||
| Liver Program Phase 3 | 1,000 | 95,000 | (94,000 | ) | ||||||||
| Long COVID Phase 2 | 2,645,000 | 1,507,000 | 1,138,000 | |||||||||
| Long COVID Phase 2 - reimbursements | (3,056,000 | ) | (2,595,000 | ) | (461,000 | ) | ||||||
| $ | 1,650,000 | $ | (20,000 | ) | $ | 1,670,000 | ||||||
General and Administrative Expenses
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.
Other Income and Expense
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.
22
Comparison of the nine months ended March 31, 2026 to the nine months ended March 31, 2025
Net loss
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.
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.
Research and Development Expenses
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.
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.
| Nine months ended | Nine months ended | Increase | ||||||||||
| March 31, 2026 | March 31, 2025 | (Decrease) | ||||||||||
| Sunrise PD Phase 2 | $ | 6,055,000 | $ | 2,648,000 | $ | 3,407,000 | ||||||
| Liver Program Phase 3 | 16,000 | 138,000 | (122,000 | ) | ||||||||
| Long COVID Phase 2 | 4,625,000 | 4,233,000 | 392,000 | |||||||||
| Long COVID Phase 2 - reimbursements | (4,098,000 | ) | (2,920,000 | ) | (1,178,000 | ) | ||||||
| $ | 6,598,000 | $ | 4,099,000 | $ | 2,499,000 | |||||||
General and Administrative Expenses
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.
Other Income and Expense
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.
23
Capital Resources and Liquidity
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.
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.
The Company has not generated any revenue and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Registered Offering
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. Additionally, upon closing, the Company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price of $2.50, which was equal to 125% of the public offering price per share. The underwriter's Warrants are exercisable during a five-year period commencing 180 days from August 11, 2025.
Critical Accounting Policies and Estimates
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").
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New Accounting Pronouncements
The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations and comprehensive loss.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable to smaller reporting companies.
Item 4. Controls and Procedures
We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act) that occurred during the three months ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
To our knowledge, other than described below, neither the Company nor any of its officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation, other than as described below. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.
On January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035 (the “Securities Class Action”), appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion. The parties are now engaged in fact discovery. On February 13, 2026, Plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the motion for leave to amend, and that motion is now fully briefed and pending before the court. Defendants’ opposition to the motion for class certification is due June 15, 2026.
Three shareholder derivative lawsuits piggy-backing on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11, 2025, (collectively the “Related Derivative Lawsuits”). Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims: that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control. On September 29, 2025, at the request of the parties, the court consolidated all three Related Derivative Lawsuits under the caption In re BioVie Inc. Derivative Litigation, Case No. 3:24-cv-0602-CSD (the “Consolidated Derivative Action”). On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending resolution of a summary judgment motion by defendants in the Securities Class Action.
The Company believes that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
Item 1A. Risk Factors
Except as described below, there have been no material changes to the Risk Factors previously disclosed in our 2025 Form 10-K. The risks described in our 2025 Form 10-K and below are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.
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Risks Relating To Our Common Stock
You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.
In order to raise additional capital, we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock in any other offering at a price per share that is less than the current market price of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
As of March 31, 2026, there were warrants outstanding to purchase an aggregate of 8,282,037 shares (including 380,000 prefunded warrants) of our Common Stock at exercise prices ranging from $2.50 to $582.00 per share, 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.31 to $774.00 per share and restricted stock units totaling 1,099. We may also grant additional options, warrants or equity awards. To the extent such shares are issued, the interest of holders of our Common Stock will be diluted.
Moreover, we are obligated to issue shares of our Common Stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates (i.e., bezisterim (NE3107), NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix and Acuitas, as amended on May 9, 2021. The achievement of these milestones could result in the issuance of up to 180,000 shares of our Common Stock, further diluting the interest of holders of our Common Stock.
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Item 2. Unregistered sales of equity securities
There were no unregistered sales of equity securities during the three-month period ended March 31, 2026.
Item 3. Defaults Upon Senior Securities
None
Item 4. Mine Safety Disclosures
None
Item 5. Other Information
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Item 6. Exhibits
(a) Exhibit index
Exhibit
| * | Filed herewith. |
| ** | Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioVie Inc.
| Signature | Title | Date | ||
| /s/ Cuong V Do | ||||
| Cuong V Do | Chairman and Chief Executive Officer (Principal Executive Officer) | May 11, 2026 | ||
| /s/ Joanne Wendy Kim | ||||
| Joanne Wendy Kim | Chief Financial Officer (Principal Financial and Accounting Officer) | May 11, 2026 |
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Exhibit 31.1
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934
CERTIFICATION
| I, Cuong V Do, certify that: | ||
| 1. | I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
Date: May 11, 2026
| /s/ Cuong V Do | ||||||||
Cuong V Do Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934
CERTIFICATION
| I, Joanne Wendy Kim, certify that: | ||
| 1. | I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
Date: May 11, 2026
| /s/ Joanne Wendy Kim | ||||||||
|
Joanne Wendy Kim Chief Financial Officer |
Exhibit 32.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Cuong V Do, Chief Executive Officer of the Company certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:
| (1) | The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 11, 2026
| /s/ Cuong V Do | ||||||||
|
Cuong V Do Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joanne Wendy Kim, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:
| (1) | The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 11, 2026
| /s/ Joanne Wendy Kim | |||||||||
|
Joanne Wendy Kim Chief Financial Officer |