Item 1. Financial Statements
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
(Unaudited)
March 31,
June 30,
2026
2025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 13,098,976
$ 17,544,547
Grant receivable
2,173,684
2,104,050
Prepaid and other current assets
1,607,032
1,049,897
Total current assets
16,879,692
20,698,494
Operating lease right-of-use asset, net
282,910
339,653
Intangible assets, net
6,308
178,341
Goodwill
345,711
345,711
TOTAL ASSETS
$ 17,514,621
$ 21,562,199
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 1,611,312
$ 2,200,320
Current portion of operating lease liability
82,398
74,464
Total current liabilities
1,693,710
2,274,784
Operating lease liability, net of current portion
213,319
275,430
TOTAL LIABILITIES
1,907,029
2,550,214
Commitments and contingencies (Note 8)
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 March 31, 2026 and June 30, 2025; 7,544,675 shares issued of which 7,541,839 shares outstanding at March 31, 2026; and 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025
754
192
Additional paid in capital
384,221,988
371,156,068
Accumulated deficit
( 368,615,121 )
( 352,144,246 )
Treasury stock
( 29 )
( 29 )
Total stockholders' equity
15,607,592
19,011,985
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 17,514,621
$ 21,562,199
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
$ 57,344
$ 57,344
$ 172,033
$ 172,033
Research and development expenses
3,176,945
1,344,991
10,382,794
8,042,379
General and administrative expenses
2,151,088
1,585,869
6,377,450
6,188,703
TOTAL OPERATING EXPENSES
5,385,377
2,988,204
16,932,277
14,403,115
LOSS FROM OPERATIONS
( 5,385,377 )
( 2,988,204 )
( 16,932,277 )
( 14,403,115 )
OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
-
( 7,290 )
-
( 3,771 )
Interest expense
5,967
4,998
13,923
327,722
Interest income
( 121,045 )
( 197,494 )
( 518,869 )
( 674,087 )
TOTAL OTHER INCOME, NET
( 115,078 )
( 199,786 )
( 504,946 )
( 350,136 )
NET LOSS
$ ( 5,270,299 )
$ ( 2,788,418 )
$ ( 16,427,331 )
$ ( 14,052,979 )
Deemed dividend related to ratchet adjustment to warrants
-
-
43,544
369,465
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 5,270,299 )
$ ( 2,788,418 )
$ ( 16,470,875 )
$ ( 14,422,444 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 0.70 )
$ ( 1.51 )
$ ( 2.35 )
$ ( 10.68 )
- Diluted
$ ( 0.70 )
$ ( 1.51 )
$ ( 2.35 )
$ ( 10.68 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
7,543,923
1,850,722
7,019,677
1,350,352
- Diluted
7,543,923
1,850,722
7,019,677
1,350,352
See accompanying notes to unaudited condensed financial
statements
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Table of Contents
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
621,640
$ 62
349,738,841
( 2,633 )
$ ( 27 )
$ -
$ ( 334,232,661 )
$ 15,506,215
Stock-based compensation - stock options
-
-
118,898
-
-
-
-
118,898
Stock-based compensation - restricted stock units
-
-
301,491
-
-
-
-
301,491
Issuance of common stock from vesting of - restricted stock units
341
-
-
-
-
-
-
-
Stock-based compensation - issuance of common stock for services rendered
1,500
-
33,450
-
-
-
-
33,450
Proceeds from issuance of common stock, net of costs of $747,408
162,794
16
2,259,047
-
-
-
-
2,259,063
Issuance of additional shares for fractional shares effected by the reverse split
12,024
1
( 1 )
-
-
-
-
-
Deemed dividend for ratchet adjustment to warrants
-
-
325,041
-
-
-
( 325,041 )
-
Net Loss
-
-
-
-
-
-
( 4,152,032 )
( 4,152,032 )
Balance, September 30, 2024
798,299
79
352,776,767
( 2,633 )
( 27 )
-
( 338,709,734 )
14,067,085
Stock-based compensation - stock options
-
-
385,328
-
-
-
-
385,328
Stock-based compensation - restricted stock units
-
-
265,804
-
-
-
-
265,804
Issuance of common stock from vesting of - restricted stock units
381
-
-
-
-
-
-
-
Exercise of warrants
223,130
22
2,901,319
-
-
-
-
2,901,341
Cashless exercise of warrants
422
-
-
-
-
-
-
-
Proceeds from issuance of common stock, net of costs of $2,492,880
825,600
83
13,415,467
-
-
-
-
13,415,550
Deemed dividend for ratchet adjustment to warrants
-
-
44,424
-
-
-
( 44,424 )
-
Net Loss
-
-
-
-
-
-
( 7,112,529 )
( 7,112,529 )
Balance, December 31, 2024
1,847,832
184
369,789,109
( 2,633 )
( 27 )
-
( 345,866,687 )
23,922,579
Stock-based compensation - stock options
-
-
338,412
-
-
-
-
338,412
Stock-based compensation - restricted stock units and restricted shares
-
-
345,372
-
-
-
-
345,372
Issuance of common stock from vesting of - restricted stock units
6,743
7
( 5 )
( 203 )
( 2 )
-
-
-
Net Loss
-
-
-
-
-
-
( 2,788,418 )
( 2,788,418 )
Balance, March 31, 2025
1,854,575
$ 191
$ 370,472,888
( 2,836 )
$ ( 29 )
$ -
$ ( 348,655,105 )
$ 21,817,945
Balance, June 30, 2025
1,917,061
$ 192
$ 371,156,068
( 2,836 )
$ ( 29 )
$ -
$ ( 352,144,246 )
$ 19,011,985
Stock - based compensation - stock options
-
-
268,388
-
-
-
-
268,388
Stock-based compensation - restricted stock units and restricted shares
-
-
270,559
-
-
-
-
270,559
Proceeds from issuance of common stock, net of costs of $1,543,038
5,620,000
562
10,457,067
-
-
-
-
10,457,629
Issuance of common stock from vesting of restricted stock units
3,255
-
-
-
-
-
-
-
Deemed dividend for ratchet adjustment to warrants
-
-
43,544
-
-
-
( 43,544 )
-
Net Loss
-
-
-
-
-
-
( 5,087,557 )
( 5,087,557 )
Balance, September 30, 2025
7,540,316
754
382,195,626
( 2,836 )
( 29 )
-
( 357,275,347 )
24,921,004
Stock - based compensation - stock options
-
-
197,336
-
-
-
-
197,336
Stock-based compensation - restricted stock units and restricted shares
-
-
216,169
-
-
-
-
216,169
Issuance of common stock from vesting of restricted stock units
3,255
-
-
-
-
-
-
-
Net Loss
-
-
-
-
-
-
( 6,069,475 )
( 6,069,475 )
Balance, December 31, 2025
7,543,571
754
382,609,131
( 2,836 )
( 29 )
-
( 363,344,822 )
19,265,034
Stock - based compensation - stock options
-
-
1,561,366
-
-
-
-
1,561,366
Stock-based compensation - restricted stock units and restricted shares
-
-
51,491
-
-
-
-
51,491
Issuance of common stock from vesting of restricted stock units
1,104
-
-
-
-
-
-
-
Net Loss
-
-
-
-
-
-
( 5,270,299 )
( 5,270,299 )
Balance, March 31, 2026
7,544,675
$ 754
$ 384,221,988
( 2,836 )
$ ( 29 )
$ -
$ ( 368,615,121 )
$ 15,607,592
See accompanying notes to unaudited condensed financial
statements
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Table of Contents
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
$ ( 16,427,331 )
$ ( 14,052,979 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets
172,033
172,033
Stock based compensation - restricted stock units and restricted shares
538,219
912,667
Stock based compensation expense - stock options
2,027,090
842,638
Stock based compensation expense - issuance of common stock for services rendered
-
33,450
Amortization of financing costs
-
11,820
Accretion of unearned loan discount
-
111,212
Accretion of loan premium
-
25,758
Non-cash lease expense from right-of-use assets
56,743
49,448
Change in fair value of derivative liabilities
-
( 3,771 )
Changes in operating assets and liabilities:
Grant receivable
( 69,634 )
-
Prepaid and other current assets
( 557,135 )
( 365,135 )
Accounts payable and accrued expenses
( 589,008 )
( 1,111,072 )
Operating lease liabilities
( 54,177 )
( 43,807 )
Net cash used in operating activities
( 14,903,200 )
( 13,417,738 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
10,457,629
15,674,613
Proceeds from exercise of warrants
-
2,901,341
Payment of loan premium
-
( 850,000 )
Payment of loan premium
-
( 5,000,000 )
Net cash provided by financing activities
10,457,629
12,725,954
Net change in cash and cash equivalents
( 4,445,571 )
( 691,784 )
Cash and cash equivalents, beginning of period
17,544,547
23,843,798
Cash and cash equivalents, end of period
$ 13,098,976
$ 23,152,014
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 13,923
$ 178,932
SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITIES:
Deemed dividend for ratchet adjustment to warrants
$ 43,544
$ 369,465
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.
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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 $ 9.4 million and as of May 4, 2026 the total cost reimbursed was $ 9.4 million. Grant reimbursements recognized for the
corresponding research and development expenses in the accompanying condensed statements of operations totaled approximately $ 3.1 million
and $ 2.5 million for the three months ended March 31, 2026 and 2025, respectively. Grant reimbursements recognized for the corresponding
research and development expenses in the accompanying condensed statements of operations totaled approximately $ 4.1 million and $ 2.9 million
for the nine months ended March 31, 2026 and 2025, respectively.
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 $ 15.2 million, cash and cash equivalents of
approximately $ 13.1 million, stockholders’ equity of approximately $ 15.6 million, and an accumulated deficit of approximately $ 368.6
million. The Company is in the pre-revenue stage 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 as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures in
our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
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 1:10 reverse stock split of the issued and outstanding
shares of its Common Stock on July 7, 2025 which was approved by the board of directors prior to shareholders’ approval at the special
meeting on June 23, 2025. All historical share and earnings per share amounts presented have been retroactively adjusted to reflect the
reverse stock split.
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.
Net Loss per Common Share
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 7,543,923 and 7,019,677 , 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).
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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
2,785,363
88,713
Warrants
7,902,037
960,057
Restricted Stock Units
1,099
10,904
10,688,499
1,059,674
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
$ 2,293,770
$ 2,293,770
Less: Accumulated Amortization
( 2,287,462 )
( 2,115,429 )
Intellectual Property, net
$ 6,308
$ 178,341
Amortization expense was $ 57,344 in each of the
three-month periods ended March 31, 2026 and 2025. Amortization expense was $ 172,033 in each of the nine-month periods ended March 31,
2026 and 2025. The Company amortizes intellectual property over the expected original useful lives of 10 years and the remaining amortization
expense for the year ending June 30, 2026 is $ 6,308 .
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
$ 2,130,109
$ -
$ -
$ 2,130,109
U.S. Treasury Bills due in 3 months or less at purchase
10,968,867
-
-
10,968,867
Total
$ 13,098,976
$ -
$ -
$ 13,098,976
Fair Value Measurements at
June 30, 2025
Level 1
Level 2
Level 3
Total
Cash
$ 3,978,271
$ -
$ -
$ 3,978,271
U.S. Treasury Bills due in 3 months or less at purchase
13,566,276
-
-
13,566,276
Total
$ 17,544,547
$ -
$ -
$ 17,544,547
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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 36,364 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 $ 325,041 was recognized based on ratchet adjustments from the September 25, 2024 capital raises, that reduced the
exercise prices from $ 100.00 to $ 15.30 per share. The fair value of the PIPE Warrant Shares were estimated using the Black Scholes Method
with the following inputs at September 2024, the stock price of $12.00, exercise price of $ 15.30 and $ 100.00 , remaining term of 2.9 years,
risk free rate of 3.5 % and volatility of 93.0 % , resulting in a $ 325,041 deemed dividend.
The October 22, 2024 capital raise further reduced
the exercise prices from $ 15.30 per share to $ 13.70 per share which drove an additional ratchet adjustment in the second quarter of fiscal
year 2025. For the three months ended December 31, 2024, the Company calculated the difference in fair value of the PIPE Warrant Shares
between the stated exercise price and the reduced exercise price and recorded $ 44,424 as a deemed dividend in the accompanying condensed
statement of changes in stockholders’ equity. The fair value of the PIPE Warrant Shares were estimated using the Black Scholes Method
with the following inputs, the stock price of $ 33.60 , exercise price of $ 15.30 and $ 13.70 , remaining term of 2.8 years, risk free rate
of 3.99 % and volatility of 94.0 % .
For the three months ended September 30, 2025,
the deemed dividend of $ 43,544 was recognized from the ratchet adjustment resulting from the August 2025 capital raise, which reduced
the exercise price from $ 13.70 to $ 2.50 per share. The fair value of the PIPE Warrant Shares was estimated using the Black Scholes Method
with the following inputs, the stock price of $ 1.79 , exercise price of $ 13.70 and reduced exercise price of $ 2.50, remaining term of 2.0
years, risk free rate of 3.8 % and volatility of 94.0 % .
Issuance of common stock for cash
On August 11, 2025, the Company closed an underwritten
public 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.
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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
84,872
$ 286.20
6.2
$ -
Options Granted
2,706,550
$ 1.31
7.6
$ 243,590
Options Expired
( 6,059 )
$ 1,091.98
0.0
$ -
Outstanding at March 31, 2026
2,785,363
$ 7.62
7.6
$ 243,590
Exercisable at March 31, 2026
1,606,299
$ 10.51
7.4
$ 139,018
The Company recorded stock-based
compensation expense relating to the vesting of stock options of approximately $ 1.6
million and $ 338,000
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 $ 2.0 million
and $ 843,000
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)
5
4
Expected volatility
89.31 %
93.44 %
Risk free interest rate
3.69 %
4.34 %
Dividend Yield
0 %
0 %
On January 5, 2026 (the “Grant Date”),
directors’ annual compensation was approved and the directors were granted stock options to purchase a total of 355,000 shares of
common stock, at an exercise price of $ 1.31 per share, the closing stock price on the grant date. The stock options vest from the beginning
of service on November 11, 2025 in four equal installments on February 11, 2026, May 11, 2026, August 11, 2026 and the earlier of November
11, 2026 or the 2026 annual shareholders' meeting.
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 812,700 and
1,538,850 , respectively; shares of common stock, at an exercise price of $1.31 per share, the closing stock price on the Grant Date. The
directors’ stock options vested 75 % on the Grant Date with the remaining balance vesting in equal installments on the first, second
and third Grant Date anniversary. The employees’ stock options vested 55 % on grant date with the remaining balance vesting in equal
installments on the first, second and third Grant Date anniversary.
Restricted stock units:
On September 2, 2025 (the “Grant Date”),
the Company awarded a total of 1,500 Restricted Stock Units (“RSUs”) to a consultant at the grant date fair value of $ 1.58
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.
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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
7,213
$ 116.41
Granted
1,500
1.58
Vested
( 7,614 )
83.67
Unvested at March 31, 2026
1,099
$ 187.02
The total stock-based compensation expense from
restricted stock units for the three months ended March 31, 2026 and 2025 was approximately $ 51,000 and $ 321,000 , respectively. The
total stock-based compensation expense from restricted stock units for the nine months ended March 31, 2026 and 2025 was approximately
$ 538,000 and $ 888,000 , 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
960,098
$ 35.02
4.1
$ -
Granted
6,967,300
2.50
5.0
-
Canceled
( 25,001 )
150.00
-
-
Expired
( 360 )
1,250.00
-
-
Outstanding and exercisable at March 31, 2026
7,902,037
$ 5.82
4.2
$ -
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
3,610
2028
72,728
2029
90,508
2030
767,891
2031
6,967,300
Total outstanding warrants
7,902,037
The warrants table excludes 380,000 prefunded warrants with an exercise
price of $ 0.0001 and no expiration. None of the prefunded warrants were exercised during the nine months ended March 31, 2026.
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7. Leases
Office Leases
The Company pays an annual rent of $ 2,200 for
its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a one-year term, commenced on October
1, 2022 and has been subsequently renewed at each annual maturity date at the same rate.
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 $ 10,024 , with annual increases of four percent. The term of the lease is 60 months.
Total operating lease expense for the three months
ended March 31, 2026 and 2025 of approximately $ 35,000 and $ 32,000 , respectively, and for the nine months ended March 31, 2026 and 2025
of approximately $ 99,000 and $ 95,000 , respectively, were included in the accompanying condensed statements of operations as a component
of general and administrative expenses.
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
$ 282,910
$ 339,653
Liabilities
Current portion of operating lease liability
$ 82,398
$ 74,464
Operating lease liability, net of current portion
213,319
275,430
Total operating lease liability
$ 295,717
$ 349,894
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)
$ 31,124
2027
126,313
2028
130,734
2029
77,796
Total minimum lease payments
365,967
Less amount representing interest
( 70,250 )
Present value of future minimum lease payments
$ 295,717
Total cash paid for amounts included in the measurement of lease liabilities
were $ 90,917 and $ 87,843 for the nine months ended March 31, 2026 and 2025, respectively.
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
2.8
3.6
Weighted average discount rate
Operating lease
15.00 %
15.00 %
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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.
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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
$ 49,700 and $ 46,800 , for the three months ended March 31, 2026 and 2025, respectively. The Company made contributions into the plan of
approximately $ 124,900 and $ 108,800 , for the nine months ended March 31, 2026 and 2025, respectively.
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
$ 6,602,000
$ 4,097,000
Clinical teams
3,255,000
2,968,000
Chemistry, manufacturing and controls
142,000
726,000
Other research and development expenses
384,000
251,000
General and administrative expenses
6,377,000
6,189,000
Amortization of intangible assets
172,000
172,000
Other income, net
( 505,000 )
( 350,000 )
Net loss
$ ( 16,427,000 )
$ ( 14,053,000 )
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.