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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended: September 30, 2024
| ☐ | 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: 001-39015
BIOVIE INC.
(Exact name of registrant as specified in its charter)
Nevada |
|
46-2510769 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification Number) |
680 W Nye Lane Suite 204 |
Carson City, NV 89703 |
(Address of principal executive offices, Zip Code) |
|
(775)-888-3162 |
(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 |
Class A Common Stock, $0.0001 par value per share |
BIVI |
The NASDAQ Stock Market, LLC |
Securities registered pursuant to Section 12(g)
of the Act:
None
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐
No ☒
Indicate by check mark if the registrant is not required
to file reports pursuant to Section 13 or Section 15(d) of the Act
Yes ☐
No ☒
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.
Yes ☒
No ☐
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).
Yes ☒
No ☐
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 |
☐ |
Non-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 if the registrant has filed
a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7362(b)) by the registered public accounting firm that prepared or issued its
audit report.
Yes ☐
No ☒
If securities are registered pursuant to Section 12(b)
of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of
an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐
No ☒
There were 17,768,174 shares of the Registrant’s
Class A Common Stock, $0.0001 par value per share, outstanding as of November 7, 2024.
TABLE OF CONTENTS
BIOVIE INC.
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934, 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 (the “Commission”) that attempt to advise interested parties of the risks, uncertainties and other factors that
may affect our business.
All statements other than statements of historical
fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these
forward-looking statements, except as required by law. When used in this report, the terms “BioVie”, “Company”,
“we”, “our”, and “us” refer to BioVie, Inc.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
(Unaudited)
| |
| | | |
| | |
| |
September 30, | | |
June 30, | |
| |
2024 | | |
2024 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 20,023,405 | | |
$ | 23,843,798 | |
Prepaid and other current assets | |
| 127,680 | | |
| 204,392 | |
Total current assets | |
| 20,151,085 | | |
| 24,048,190 | |
| |
| | | |
| | |
Operating lease right-of-use assets, net | |
| 390,777 | | |
| 406,726 | |
Intangible assets, net | |
| 350,374 | | |
| 407,718 | |
Goodwill | |
| 345,711 | | |
| 345,711 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 21,237,947 | | |
$ | 25,208,345 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 3,452,972 | | |
$ | 3,586,912 | |
Current portion of operating lease liabilities | |
| 63,664 | | |
| 60,343 | |
Current portion of note payable, net of financing cost, unearned premium and discount of $820,242 at September 30, 2024 and $701,210 at June 30, 2024 | |
| 3,320,242 | | |
| 5,701,210 | |
Warrant liability | |
| 1,254 | | |
| 3,771 | |
Total current liabilities | |
| 6,838,132 | | |
| 9,352,236 | |
| |
| | | |
| | |
Operating lease liabilities, net of current portion | |
| 332,730 | | |
| 349,894 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 7,170,862 | | |
| 9,702,130 | |
| |
| | | |
| | |
Commitments and contingencies (Note 10) | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS' EQUITY : | |
| | | |
| | |
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding | |
| - | | |
| - | |
Common stock, $0.0001 par value; 800,000,000 shares authorized at September 30, 2024 and June 30, 2024, respectively; 7,982,986 shares issued of which 7,956,660 shares are outstanding at September 30, 2024; and 6,216,398 shares issued of which 6,190,072 shares outstanding at June 30, 2024 | |
| 6,406 | | |
| 6,229 | |
Additional paid in capital | |
| 352,770,440 | | |
| 349,732,674 | |
Accumulated deficit | |
| (338,709,734 | ) | |
| (334,232,661 | ) |
Treasury stock | |
| (27 | ) | |
| (27 | ) |
Total stockholders' equity | |
| 14,067,085 | | |
| 15,506,215 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | |
$ | 21,237,947 | | |
$ | 25,208,345 | |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Condensed Statements of Operations and Comprehensive
Loss
(Unaudited)
| |
| | | |
| | |
| |
Three Months Ended | | |
Three Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
| | |
| |
OPERATING EXPENSES: | |
| | | |
| | |
Amortization of intangible assets | |
$ | 57,344 | | |
$ | 57,344 | |
Research and development expenses | |
| 1,990,198 | | |
| 8,875,659 | |
Selling, general and administrative expenses | |
| 2,074,540 | | |
| 1,942,818 | |
TOTAL OPERATING EXPENSES | |
| 4,122,082 | | |
| 10,875,821 | |
| |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (4,122,082 | ) | |
| (10,875,821 | ) |
| |
| | | |
| | |
OTHER EXPENSE (INCOME): | |
| | | |
| | |
Change in fair value of derivative liabilities | |
| (2,517 | ) | |
| (707,802 | ) |
Interest expense | |
| 256,024 | | |
| 1,004,668 | |
Interest income | |
| (223,557 | ) | |
| (462,223 | ) |
TOTAL OTHER EXPENSE (INCOME), NET | |
| 29,950 | | |
| (165,357 | ) |
| |
| | | |
| | |
NET LOSS | |
$ | (4,152,032 | ) | |
$ | (10,710,464 | ) |
| |
| | | |
| | |
Deemed dividend related to ratchet adjustment to warrants | |
| 325,041 | | |
| - | |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | |
$ | (4,477,073 | ) | |
$ | (10,710,464 | ) |
| |
| | | |
| | |
NET LOSS PER COMMON SHARE | |
| | | |
| | |
- Basic | |
$ | (0.70 | ) | |
$ | (2.92 | ) |
- Diluted | |
$ | (0.70 | ) | |
$ | (2.92 | ) |
| |
| | | |
| | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |
| | | |
| | |
- Basic | |
| 6,398,360 | | |
| 3,672,490 | |
- Diluted | |
| 6,398,360 | | |
| 3,672,490 | |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | |
$ | (4,477,073 | ) | |
$ | (10,710,464 | ) |
| |
| | | |
| | |
Other comprehensive loss | |
| | | |
| | |
Unrealized gain on available-for-sale investments | |
| - | | |
| - | |
Reclassification of unrealized gains on available-for-sale investments upon settlement | |
| - | | |
| (176,591 | ) |
Total other comprehensive loss | |
| - | | |
| (176,591 | ) |
Comprehensive loss | |
$ | (4,477,073 | ) | |
$ | (10,887,055 | ) |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Condensed Statements of Changes in Stockholders’
Equity
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
Common Stock | | |
Common Stock | | |
Additional Paid in | | |
Treasury Stock | | |
Treasury Stock | | |
Other Comprehensive | | |
Accumulated | | |
Total Stockholders' | |
| |
Shares | | |
Amount | | |
Capital | | |
Shares | | |
Amount | | |
Income | | |
Deficit | | |
Equity | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 3,645,183 | | |
$ | 3,643 | | |
$ | 316,385,759 | | |
| (2,288 | ) | |
$ | (2 | ) | |
$ | 176,591 | | |
$ | (301,225,705 | ) | |
$ | 15,340,286 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation - stock options | |
| - | | |
| - | | |
| 808,027 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 808,027 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation - restricted stock units | |
| - | | |
| - | | |
| 380,834 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 380,834 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from issuance of common stock, net of costs of $118,891 | |
| 43,220 | | |
| 4 | | |
| 1,905,832 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,905,836 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock from vesting of - restricted stock units | |
| 3,873 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,710,464 | ) | |
| (10,710,464 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Relcassification of unrealized gains on available for sale investments upon settlement | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (176,591 | ) | |
| - | | |
| (176,591 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, September 30, 2023 | |
| 3,692,276 | | |
$ | 3,647 | | |
$ | 319,480,452 | | |
| (2,288 | ) | |
$ | (2 | ) | |
$ | - | | |
$ | (311,936,169 | ) | |
$ | 7,547,928 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2024 | |
| 6,216,398 | | |
$ | 6,229 | | |
$ | 349,732,674 | | |
| (26,326 | ) | |
$ | (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 | |
| 3,408 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation - issuance of common stock for services rendered | |
| 15,000 | | |
| 2 | | |
| 33,448 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 33,450 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from issuance of common stock, net of costs of $747,408 | |
| 1,627,943 | | |
| 163 | | |
| 2,258,900 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 2,259,063 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of additional shares for fractional shares effected by the reverse split | |
| 120,237 | | |
| 12 | | |
| (12 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Deemed dividend for ratchet adjustment to warrants | |
| - | | |
| - | | |
| 325,041 | | |
| - | | |
| - | | |
| - | | |
| (325,041 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,152,032 | ) | |
| (4,152,032 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, September 30, 2024 | |
| 7,982,986 | | |
$ | 6,406 | | |
$ | 352,770,440 | | |
| (26,326 | ) | |
$ | (27 | ) | |
$ | - | | |
$ | (338,709,734 | ) | |
$ | 14,067,085 | |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
| |
| | | |
| | |
| |
Three Months Ended | | |
Three Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (4,152,032 | ) | |
$ | (10,710,464 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Amortization of intangible assets | |
| 57,344 | | |
| 57,344 | |
Stock based compensation - restricted stock units | |
| 301,491 | | |
| 380,834 | |
Stock based compensation expense - stock options | |
| 118,898 | | |
| 808,027 | |
Stock based compensation expense - issuance of common stock for services rendered | |
| 33,450 | | |
| - | |
Amortization of financing costs | |
| 9,456 | | |
| 37,825 | |
Accretion of unearned loan discount | |
| 88,970 | | |
| 355,877 | |
Accretion of loan premium | |
| 20,606 | | |
| 82,424 | |
Realized gain on maturity of available-for sale | |
| - | | |
| (223,865 | ) |
Non-cash lease expense from right-of-use assets | |
| 15,949 | | |
| 10,041 | |
Change in fair value of derivative liabilities | |
| (2,517 | ) | |
| (707,802 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid and other current assets | |
| 76,712 | | |
| (1,446,761 | ) |
Accounts payable and accrued expenses | |
| (133,940 | ) | |
| (761,499 | ) |
Operating lease liabilities | |
| (13,843 | ) | |
| (10,645 | ) |
Other current liabilities | |
| - | | |
| (48,385 | ) |
Net cash used in operating activities | |
| (3,579,456 | ) | |
| (12,177,049 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Proceeds from (purchases of) U.S. Treasury Bills (available-for-sale) | |
| - | | |
| 14,525,000 | |
Net cash provided by (used in) investing activities | |
| - | | |
| 14,525,000 | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Net proceeds from issuance of common stock | |
| 2,259,063 | | |
| 1,905,836 | |
Payments of note payable | |
| (2,500,000 | ) | |
| (2,500,000 | ) |
Net cash used in financing activities | |
| (240,937 | ) | |
| (594,164 | ) |
| |
| | | |
| | |
Net change in cash and cash equivalents | |
| (3,820,393 | ) | |
| 1,753,787 | |
| |
| | | |
| | |
Cash and cash equivalents, beginning of period | |
| 23,843,798 | | |
| 19,460,883 | |
| |
| | | |
| | |
Cash and cash equivalents, end of period | |
$ | 20,023,405 | | |
$ | 21,214,670 | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for interest | |
$ | 136,992 | | |
$ | 528,541 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES: | |
| | | |
| | |
Reclassification of unrealized gains on U.S. Treasury Bills (available-for-sale investments) upon settlement | |
$ | - | | |
$ | 176,591 | |
Deemed dividend for ratchet adjustment to warrants | |
$ | 325,041 | | |
$ | - | |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Notes to Condensed Financial Statements
For the Three Months Ended September 30, 2024 and
2023
(unaudited)
1. |
Background Information |
BioVie Inc. (the “Company” or “we”
or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
neurological and neuro-degenerative disorders and liver disease.
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. 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 NE3107 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 and 1 million Americans suffering from PD.
Neurodengenerative Disease Program
In neurodegenerative disease, the Company’s
drug candidate Bezisterim (NE3107) inhibits activation of inflammatory actions 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.
NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation
and insulin resistance are drivers of AD and PD.
Alzheimer’s Disease
On November 29, 2023, the Company announced the analysis
of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive
sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
twice daily.
Upon trial completion, as the Company began the process
of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
data.
The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change.
Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary
endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to
be collected and analyzed.
Parkinson’s Disease
The Phase 2 study of bezisterim (NE3107) for the treatment
of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives:
1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric
activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.
Long COVID Program
In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed
Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development
Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive
symptoms associated with long covid. The Company anticipates the trial to commence by early 2025. The Company has been reimbursed approximately
$325,000 for the trial during the three months ended September 30, 2024.
Liver Disease Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.
In June 2021, the Company initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period.
In March 2023, the Company announced enrollment was
paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.
In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.
The BIV201 development program was initiated by LAT
Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company 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 our 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 September 30, 2024, the Company had working capital of approximately $13.3 million, cash and cash equivalents of approximately
$20.0 million, stockholders’ equity of approximately $14.1 million, and an accumulated deficit of approximately $338.7 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 on
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 State 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, 2024, 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, 2024 and 2023 in our Annual Report on Form 10-K filed with the SEC on
September 30, 2024 (the “2024 Form 10-K”). A summary of significant accounting policies can also be found in those audited
financial statements in the 2024 Form 10-K.
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.
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities
greater than three months, are accounted for as available-for-sale and are recorded at fair value. Realized gains were included in the
accompanying condensed statements of operations and comprehensive loss from the settlement of available-for-sale investments during the
three months ended September 30, 2023. The Company had no outstanding investment securities with original maturities of greater than three
months at the time of purchase as of and during the three months ended September 30, 2024.
Concentration of Credit Risk in the Financial Service
Industry
As of September 30, 2024, the Company had cash deposited
in certain financial institutions 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, the carrying value of the operating lease liabilities and notes payable. 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 notes payable and 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, and convertible debentures. For the three months ending
September 30, 2024 and 2023, 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
at September 30, 2024 of 6,398,360 includes the weighted average effect of the pre-funded warrants issued in connection with the September
2024 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 8).
The table below shows the potential shares of common
stock, presented based on amounts outstanding at each year 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 | |
| | | |
| | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 517,996 | | |
| 395,286 | |
Warrants | |
| 4,316,002 | | |
| 777,029 | |
Restricted Stock Units | |
| 34,564 | | |
| 55,773 | |
Notes payable conversion option | |
| 35,817 | | |
| 71,633 | |
Total | |
| 4,904,379 | | |
| 1,299,721 | |
Reverse stock split
The company effected a 1:10 reverse split of the issued
and outstanding shares of its Class A commons stock which was approved by the board of directors after the approval obtained from shareholders
at a special meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’
approval was obtained. All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
Grant program
The Company records
expenses related to the DOD long Covid Program as such expenses are incurred. The reimbursement of such expenses is recognized upon receipt
of the reimbursement as a credit against the respective expense account.
Recent Accounting
Pronouncements
In November 2024, the
FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”), which will require additional disclosure of
the nature of expenses included in the income statement in response to longstanding requests from investors for more information about
an entity’s expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented
on the face of the income statement as well as disclosures about selling expenses. The new standard will be effective for public companies
for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The requirements
will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating
the impact of this accounting standard update on its financial statements.
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 | |
| | |
| |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less: Accumulated Amortization | |
| (1,943,396 | ) | |
| (1,886,052 | ) |
Intellectual Property, Net | |
$ | 350,374 | | |
$ | 407,718 | |
Amortization expense was $57,344 in each of the three-month
periods ended September 30, 2024 and 2023. The Company amortizes intellectual property over the expected original useful lives of 10 years.
Estimated future amortization expense is as follows:
Schedule of future amortization expense | |
| | |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 172,033 | |
2026 | |
| 178,341 | |
| |
$ | 350,374 | |
5. |
Related Party Transactions |
Equity Transactions with Acuitas
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 363,636 shares of the Company’s Common
Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years. The down round feature reduced the exercise
price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 and again to $1.53 per share on September 25, 2024 in connection
with the offering further described in Note 8 as the Company sold stock at a price lower than its initial exercise price. 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 $325,041 as a deemed dividend in the accompanying condesnsed 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 $1.20, exercise
price of $1.53 and $10.00, remaining term of 2.9 years, risk free rate of 3.5% and volatility of 93.0%.
On November 30, 2021 (the “Closing Date”),
the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together,
the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities
Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment
amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”).
The Loan provided for an additional $5 million to be available to the Company on or prior to September 15, 2022, subject to the Company’s
achievement of certain milestones with respect to certain of its ongoing clinical trials, which were not achieved. The Loan bears interest
at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%.
The prime rate on September 30, 2024, was 8.50%. The Loan is secured by a lien upon and security interest in all of the Company’s
assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024.
The Loan Agreement required monthly interest-only
payments during the first eighteen months of the term of the Loan. Following the interest-only period, on July 1, 2023, the Company pays
equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued
interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal
amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal
amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment
of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and
Tranche 2, which amounts to $850,000 (the “Loan Premium”).
The Loan Agreement includes a conversion option to
convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
Common Stock at a conversion price of $69.80 per share (the “Conversion Option”).
On the Closing Date, the Company issued to Avenue
warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
to $58.20. The Avenue Warrants are exercisable until November 30, 2026.
The amount of the carrying value of the notes payable
was determined by allocating portions of the outstanding principal of the notes, approximately $1.4 million, to the fair value of the
Avenue Warrants, and approximately $2.2 million to the fair value of the embedded Conversion Option. Accordingly, the total amount of
unearned discount of approximately $3.6 million, the total direct financing cost of approximately $390,000 and the Loan Premium of $850,000
are being amortized using the effective interest method over the term of the Loan. The adjusted effective interest rate is 24%.
Total interest expense associated with this loan was approximately $252,000, which is reflected as a component of interest expense on the accompanying
condensed statements of operations and comprehensive loss for the three months ended September 30, 2024. Interest expense associated with
this loan was comprised of interest incurred on the outstanding principal of the loan of approximately $132,000, amortization of financing
costs of approximately $9,500, amortization of the unearned discount of $89,000, and the accretion of the Loan Premium of approximately
$21,000.
Total interest expense for the three months ended
September 30, 2023 was approximately $1 million on the accompanying condensed statements of operations and comprehensive loss. Interest
expense was comprised of interest incurred on the outstanding principal of the loan of approximately $525,000, amortization of financing
costs of approximately $38,000, amortization of the unearned discount of approximately $356,000 and the accretion of Loan Premium of approximately
$82,000.
As of September 30, 2024, the remaining principal
balance of $2.5 million under the Loan is payable in 3 monthly equal installments. For the three months ended September 30, 2024, the
Company paid back $2.5 million of the original loan of $15 million.
The following is a summary of the Notes Payable as of September 30, 2024
and June 30, 2024:
Current portion of Notes Payable
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less: debt financing costs | |
| (2,364 | ) | |
| (11,820 | ) |
Less: unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus: accretion of Loan Premium | |
| 844,848 | | |
| 824,242 | |
Current portion of Notes Payable, net of financing costs, unearned premium and discount | |
$ | 3,320,242 | | |
$ | 5,701,210 | |
Estimated future amortization expense and accretion of Loan Premium are
as follows:
Schedule of estimated future amortization expense and accretion of premium | |
| | | |
| | | |
| | |
| |
Unearned Discount | | |
Debt Financing Costs | | |
Loan Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
Total | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
7. |
Fair Value Measurements |
At September 30, 2024 and June 30, 2024, the estimated fair value of derivative
liabilities measured on a recurring basis are as follows:
Schedule of derivative liabilities at fair value | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
Derivative liability - Conversion Option | |
| - | | |
| - | | |
| - | | |
| - | |
Total derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
| |
Fair Value Measurements at | |
| |
June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 3,771 | | |
$ | 3,771 | |
Derivative liability - Conversion option | |
| - | | |
| - | | |
| - | | |
| - | |
Total derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 3,771 | | |
$ | 3,771 | |
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the three months ended September 30, 2024:
Fair value, liabilities measured on recurring basis | |
| | | |
| | |
| |
Derivative liabilities -
Warrants | | |
Derivative liability -
Conversion Option on
Convertible Debenture | |
Balance at June 30, 2024 | |
$ | 3,771 | | |
$ | - | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (2,517 | ) | |
| - | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2024 | |
$ | 1,254 | | |
$ | - | |
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the three months ended September 30, 2023:
| |
Derivative liability -
Warrants | | |
Derivative liability -
Conversion Option | |
Balance at June 30, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
The fair values of derivative liabilities for the
Avenue Warrants and Conversion Option at September 30, 2024, in the accompanying condensed balance sheets, were approximately $1,300 and
approximately zero, respectively. The total change in the fair value of the derivative liabilities totaled approximately $2,500 and $708,000
for the three months ended September 30, 2024 and 2023, respectively; and accordingly, was recorded in the accompanying condensed statements
of operations and comprehensive loss. The assumptions used in the Black Scholes model to value the derivative liabilities at September
30, 2024 included the closing stock price of $1.20 per share; for the Avenue Warrants, the exercise price of $58.20, remaining term 2.2
year, risk free rate of 3.7% and volatility of 91.0%; and for the Conversion Option, the conversion price of $69.80; remaining term of
2 months, risk free rate of 4.8% and volatility of 75.0%.
Derivative liability – Avenue Warrants
The Avenue Warrants were not considered to be indexed
to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying condensed
balance sheets at September 30, 2024 and June 30, 2024, respectively.
The Black Scholes model was used to calculate the
fair value of the derivative warrant to bifurcate the amount from the Avenue Loan amount funded. The Avenue Warrants are recorded at their
fair values at the date of issuance and remeasured at each subsequent reporting period end date.
Embedded derivative liability – Conversion
Option
The Conversion Option is accounted for as an embedded
derivative liability and required bifurcation from the Loan amount. The Black Scholes model was used to calculate the fair value of the
Conversion Option to bifurcate it from the Loan.
Financial assets
As of September 30, 2024, 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 | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,326,252 | | |
$ | - | | |
$ | - | | |
$ | 6,326,252 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,697,153 | | |
| - | | |
| - | | |
| 13,697,153 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 20,023,405 | | |
$ | - | | |
$ | - | | |
$ | 20,023,405 | |
| |
Fair Value Measurements at | |
| |
June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 12,763,941 | | |
$ | - | | |
$ | - | | |
$ | 12,763,941 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 11,079,857 | | |
| - | | |
| - | | |
| 11,079,857 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 23,843,798 | | |
$ | - | | |
$ | - | | |
$ | 23,843,798 | |
Issuance of common stock for cash
On August 31, 2022, the Company entered into a Controlled
Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively,
the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock
through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley Securities,
Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During the three
months ended September 30, 2024, the Company sold 2,143 shares of common stock under the Sales Agreement for total net proceeds of $6,400
after 3% commissions and expenses of approximately $200. During the three months ended September 30, 2023, the Company sold 43,220 shares
of common stock under the Sales Agreement for total net proceeds of $1.9 million after 3% commissions and expenses of approximately $119,000.
On September 25, 2024, the Company closed a best
efforts public offering (the “September 2024 Offering”) of 1,360,800
shares of its common stock, par value $0.0001
per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
shares of Common Stock, and warrants to purchase up to 1,960,800
shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53
per Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were
exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds
from issuance of common stock. The September Common Warrants have an
exercise price of $1.53
per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The
gross proceeds to the Company from the September 2024 Offering were approximately $3.0
million, before deducting placement agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the
Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040
shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125%
of the public offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period
commencing 180 days from September 25, 2024.
Issuance of common stock for services
On August 12, 2024, the Company awarded 15,000 shares
of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common Stock at the date of issuance
was $2.23 per share. The stock-based compensation expense related to this Common Stock issuance was $33,450.
Stock Options
The following table summarizes the activity relating to the Company’s
stock options for the three months ended September 30, 2024:
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, 2024 | |
| 518,076 | | |
$ | 54.11 | | |
| 6.1 | | |
$ | - | |
Options Expired | |
| (80 | ) | |
| 87.50 | | |
| - | | |
| - | |
Outstanding at September 30, 2024 | |
| 517,996 | | |
$ | 54.10 | | |
| 5.9 | | |
$ | - | |
Exercisable at September 30, 2024 | |
| 321,382 | | |
$ | 66.77 | | |
| 4.7 | | |
$ | - | |
The Company recorded stock based compensation expense
relating to the vesting of stock options of approximately $119,000 and $808,000 for the three months ended September 30, 2024 and 2023,
respectively.
Restricted stock units:
On November 9, 2023, the Company issued equity awards
for the board of directors’ annual compensation. Four directors received 18,270 RSUs with a grant date fair value of $30.10 per
share. In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $30.10 per
share with a grant date fair value of $18.30 per share. The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024
and earlier of November 9, 2024 or the next annual shareholders’ meeting. During the three months ended September 30, 2024, 3,409
of these RSUs vested. On July 25, 2024, Mr. Gorlin resigned from the Board of Directors, and as a result, 1,159 of his RSUs were cancelled.
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, 2024 | |
| 40,291 | | |
$ | 44.59 | |
Vested | |
| (3,409 | ) | |
| 30.10 | |
Canceled | |
| (1,159 | ) | |
| - | |
Unvested at September 30, 2024 | |
| 35,723 | | |
$ | 46.99 | |
The total stock-based compensation expense from restricted
stock units for the three months ended September 30, 2024 and 2023 was approximately $301,000 and $381,000, respectively.
Stock Warrants
The following table summarizes the warrants activity during the three months
ended September 30, 2024:
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, 2024 | |
| 1,932,029 | | |
| 14.03 | | |
| 4.0 | | |
| - | |
Granted | |
| 2,658,840 | | |
| 1.54 | | |
| 5.0 | | |
| - | |
Exercised | |
| (265,000 | ) | |
| 1.53 | | |
| - | | |
| - | |
Expired | |
| (9,867 | ) | |
| 22.50 | | |
| - | | |
| - | |
Outstanding and exercisable at September 30, 2024 | |
| 4,316,002 | | |
$ | 5.66 | | |
| 4.5 | | |
$ | - | |
Of the above warrants outstanding at September 30,
2024, 271 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the
fiscal year ending June 30, 2027, 1,155,000 expire in the fiscal year ending June 30, 2029 and 2,393,840 expire in the fiscal year ending
June 30, 2030.
As of September 30, 2024, the Company had 335,000
prefunded warrants, 3,882,962 warrants and 98,040 placement agent warrants outstanding.
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 1 one-year term,
commenced on October 1, 2023, and has been subsequently renewed for another year at the same rate.
The Company’s San Diego office lease at 5090
Shoreham Place Suite 212, San Diego, CA 92122 commenced in February 2024. The current monthly base rate for the office space is $9,685,
with an annual increase of four percent. The term for the office lease is 60 months.
Total operating lease expense for the three months
ended September 30, 2024 and 2023 of approximately $32,000 and $13,000, respectively, were included in the accompanying condensed statements
of operations and comprehensive loss as a component of selling, general and administrative expenses.
The right-of-use asset, net and current and non-current
portion of the operating lease liabilities included in the accompanying condensed balance sheets are as follows:
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
Assets | |
| | | |
| | |
Operating lease right-of-use asset, net | |
$ | 390,777 | | |
$ | 406,726 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liability | |
$ | 63,664 | | |
$ | 60,343 | |
Operating lease liability, net of current portion | |
| 332,730 | | |
| 349,894 | |
Total operating lease liability | |
$ | 396,394 | | |
$ | 410,237 | |
At September 30, 2024, 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, 2025 (Remaining 9 months) | |
$ | 89,199 | |
2026 | |
| 122,042 | |
2027 | |
| 126,313 | |
2028 | |
| 130,734 | |
2029 | |
| 77,796 | |
Total minimum lease payments | |
| 546,084 | |
Less amount representing interest | |
| (149,690 | ) |
Present value of future minimum lease payments | |
| 396,394 | |
Less current portion of operating lease liability | |
| (63,664 | ) |
Operating lease liability, net of current portion | |
$ | 332,730 | |
Total cash paid for amounts included in the measurement of lease liabilities
were $29,055 and $12,900 for the three months ended September 30, 2024 and 2023, respectively.
The weighted average remaining lease term and discount
rate as of September 30, 2024 and June 30, 2024 were as follows:
Schedule of weighted average remaining lease term and discount rate | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating lease | |
| 4.3 | | |
| 4.6 | |
Weighted average discount rate | |
| | | |
| | |
Operating lease | |
| 15.00 | % | |
| 15.00 | % |
10. |
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 is obligated to pay a low single digit
royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances, capped at a maximum
of $200,000 per year.
Shareholder class action complaint
On January 19, 2024, a purported shareholder 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, 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 plaintiffs filed their opposition
on October 21, 2024. The defendant’s reply brief is due December 5, 2024.
The Company believes the lawsuit is without merit
and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding
the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying condensed financial statements.
11. |
Employee Benefit Plan |
On August 1, 2021, the Company began sponsoring 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
$34,500 and $30,900, for the three months ended September 30, 2024 and 2023, respectively.
In October 2024, the Company closed three
registered direct offerings totaling 8,256,000
shares of its common stock, par value $0.0001 per
share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares
of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $1.50 to
$2.83 per
share (the “October Offerings”). The October Common Warrants have exercise prices
ranging from $1.37 to
$2.83 per
share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original
issuance dates. The gross proceeds to the Company from the October Offerings totaled approximately $15.9 million,
before deducting placement agent fees and offering expenses of approximately $2.8 million.
Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement
Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging
from $1.88 to
$3.54,
which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s
Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October
Offerings. Additionally in October, 1,216,300 of the common warrants from the September 2024 Offering were exercised at
$1.53 per share for proceeds totaling approximately $1.9 million.
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 to treat chronic debilitating conditions including
neurological and neuro-degenerative disorders and liver disease.
Neurodegenerative Disease Program
The Company acquired the biopharmaceutical assets
of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021.
The acquired assets included NE3107. In April 2024, the Company announced that the United States Adopted Names Council, and the World
Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic)
name for NE3107. Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven
insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus
that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could,
if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million
Americans suffering from AD and 1 million Americans suffering from PD.
In neurodegenerative disease, bezisterim (NE3107)
inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”)
(including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both
inflammation and insulin resistance are drivers of AD and PD.
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.
Parkinson’s Disease
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), 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.
To extend this Phase 2 data in progressed patients,
the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset
PD. In August 2024, the FDA authorized the protocol for this new study.
Long COVID Program
In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed
Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development
Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive
symptoms associated with long covid. The Company anticipates the trial to commence by early 2025.
Liver Disease Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.
In June 2021, the Company initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period.
In March 2023, the Company announced enrollment was
paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.
In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.
While the active agent, terlipressin, is approved
in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The FDA has not approved any drug to treat refractory
ascites.
Comparison of the three months ended September 30, 2024 to the three
months ended September 30, 2023
Net loss
The
net loss for the three months ended September 30, 2024 was approximately $4.2 million and as compared to the net loss of $10.7 million
for the three months ended September 30, 2023. The net decrease of $6.5 million for the three months ended September 30, 2024 was comprised
of a decrease in research and development expenses of $6.9 million, offset by increased selling, general and administrative expenses
of approximately $132,000 and a decrease in other (expense) income, net of approximately $195,000.
Total
operating expenses for the three months ended September 30, 2024 were approximately $4.1 million as compared to $10.9 million for the
three months ended September 30, 2023. The net decrease of approximately $6.8 million for the three months ended September 30, 2024,
was comprised of decreased research and development expenses of approximately $6.9 million primarily due to the completion of clinical
trials in the prior fiscal year, offset by a net increase in selling general and administrative expenses of approximately $132,000, primarily
attributed to increased legal expenses related to regulatory, patent filings and litigation related to the class action suit.
Research
and Development Expenses
Research
and development (“R&D”) expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline
of approximately $6.9 million from $8.9 million for three months ended September 30, 2023. The net decrease in R&D expenses of approximately
$6.9 million is primarily attributed to the completion of clinical trials in the prior fiscal year ended June 30, 2024, causing decreased
clinical trials expenses of $5.2 million, a decline in the clinical team expense consisting of reductions in clinical team payroll of
approximately $915,000, reduction in the use of consultants of approximately $547,000, a reduction in the use of regulatory and other
consultants totaling approximately $274,000, and a decrease in other related expenses of approximately $126,000 in travel, conferences
and publications. This was offset by increased expenses in Chemistry, Manufacturing and Controls (“CMC”) totaling approximately
$155,000 related to drug production and drug discovery development.
The decline in clinical studies of $5.2 million represented
the net decrease in clinical trial studies expense due the completion of the clinical trials in fiscal year 2024 offset by the planning
and development of the two new clinical studies PD and LC. The table below summarizes the expense amounts for the three months ended September
30, 2024 and 2023 by study:
| |
Three Months Ended | | |
Three Months Ended | | |
Increase | |
| |
September 2024 | | |
September 2023 | | |
(Decrease) | |
| |
| | |
| | |
| |
New Development | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Sunrise PD Phase 2 | |
$ | 241,000 | | |
$ | - | | |
$ | 241,000 | |
Long Covid Program, net of $325,000 reimbursement | |
| 145,000 | | |
| - | | |
| 145,000 | |
| |
$ | 386,000 | | |
$ | - | | |
$ | 386,000 | |
| |
| | | |
| | | |
| | |
Completed Studies | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Ascites BIV201 Phase 2b | |
$ | (60,000 | ) | |
$ | 384,000 | | |
$ | (444,000 | ) |
AD mild to moderate pivotal Phase 3 | |
| 27,000 | | |
| 3,636,000 | | |
| (3,609,000 | ) |
PD Phase 2 | |
| - | | |
| 440,000 | | |
| (440,000 | ) |
Investigator-Initiated studies | |
| - | | |
| 1,081,000 | | |
| (1,081,000 | ) |
| |
$ | (33,000 | ) | |
$ | 5,541,000 | | |
$ | (5,574,000 | ) |
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
approximately $2.1 million and $1.9 million for the three months ended September 30, 2024 and 2023, respectively. The net decrease of
approximately $132,000 was primarily attributed to the increases in legal fee expenses of approximately $400,000 and insurance premiums
of approximately $29,000; offset by declines in the executive teams compensation of approximately $188,000, investor relations and other
filing fees of approximately $49,000, and other professional and consulting fees of approximately $52,000.
Other Income and Expense
Other expense, net was approximately $30,000 compared
to other income, net of $165,000, for the three months ended September 30, 2024 and 2023, respectively. The net increase in other expense
of approximately $195,000 is comprised of a reduction in the change in fair value of the related derivative liabilities of approximately
$705,000 and a reduction in interest expense of approximately $749,000, offset by a reduction in interest income of approximately $239,000.
Capital Resources and Liquidity
As of September 30, 2024, the Company had working
capital of approximately $13.3 million, cash and cash equivalents totaling approximately $20.0 million, stockholders’ equity of
approximately $14.1 million, and an accumulated deficit of approximately $338.7 million.
The Company used net cash in operations totaling approximately
$3.6 million and net cash provided by financing activities was approximately $241,000 comprised of net proceeds from capital raise activities
of $2.3 million offset by the payment of $2.5 million of the Company’s notes payable.
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.
Controlled Equity Offering
During the three months ended September 30, 2024,
the Company sold approximately 2,143 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald
& Co for total net proceeds of approximately $6,400 after 3% commissions and offering costs totaling approximately $200. On September
25, 2024, the Company filed a prospectus supplement to suspend sales under the Controlled Equity Offering Sales Agreement.
Registered Direct Offerings
On September 25, 2024, the Company closed a best
efforts public offering (the “September 2024 Offering”) of 1,360,800 shares of its common stock, par value $0.0001 per share,
pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase
up to 1,960,800 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53 per
Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were exercised
in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component
of proceeds from issuance of common stock. The September Common Warrants have an exercise price
of $1.53 per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance
date. The gross proceeds to the Company from the September 2024 Offering were approximately $3.0 million, before deducting placement
agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the Company issued the placement agent warrants
(“September Placement Agent’s Warrants”) to purchase 98,040 shares of Common Stock exercisable at a per share price
of $1.91, which was equal to 125% of the public offering price per share. The September Placement Agent’s Warrants are exercisable
during a five-year period commencing 180 days from September 25, 2024.
In October 2024, the
Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $0.0001 per share, and two
concurrent private placements of warrants to purchase up to 8,256,000 shares of Common Stock (the “October Common Warrants”)
priced at-the-market under Nasdaq rules at prices ranging from $1.50 to $2.83 per share (the “October Offerings”).
The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following
issuance and will expire on the fifth anniversary date of the original issuance dates. The gross proceeds to the Company from
the October Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately
$2.8 million. Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement
Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging from
$1.88 to $3.54, which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s
Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.
Critical Accounting Policies and Estimates
For the three-month
period ended September 30, 2024, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting
Policies section of the 10-Q. There were no other significant changes to the Company’s critical accounting policies as identified
in the Annual Report Form 10-K for the fiscal year ended June 30, 2024.
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 Office 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 judgement
in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and 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 quarter ended September
30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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 shareholder 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, 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 plaintiffs filed their opposition on October 21, 2024.
The defendants’ reply brief is due December 5, 2024. The defendants believe that the claims are without merit and intend 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 Form 10-K. The risks described in our 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.
Risks Relating to Our Business and Industry
We rely and will continue to rely on third parties
to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines
or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize
our product candidates.
We depend, and will continue to depend, on third
parties, including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial
principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials,
including those for our drug candidates bezisterim (NE3107) and BIV201. We rely heavily on these third parties over the course of our
clinical trials, and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring
that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and
regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are
required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities
for the conduct of clinical trials on product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic
inspections and for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the
Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory
requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical
trials to support our marketing applications, which would delay the regulatory approval process. For example, our drug product candidate
bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter
study in subjects who have mild to moderate AD. Enrollment in that trial began in August 2021, with a planned primary completion in late
2022/early 2023. On November 29, 2023, the Company announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim
(NE3107) in the treatment of mild to moderate AD. Upon trial completion, as the Company began the process of analyzing the trial data,
the Company found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one
geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites. We subsequently
notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and the study sites involved.
The identification of significant deviations from study protocol and numerous GCP violations at multiple study sites raised questions
regarding the validity and robustness of data from these study sites. The unplanned exclusion of so many patients left the trial underpowered
for its primary endpoints. However, based on the remaining dataset from those other sites determined to be in compliance with the protocol
and GCP’s, a preliminary signal of efficacy was detected. The Company is considering: (1) employing the adaptive trial feature
of the protocol to continue enrolling patients to achieve statistical significance; and/or (2) designing a new Phase 3 study of bezisterim
(NE3107) that leverages the most recent scientific literature relating to AD along with the company's understanding regarding the effects
of bezisterim (NE3107) in persons with mild-moderate AD.
Although we design the clinical trials for our product
candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects of our clinical development
programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control,
either partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection,
management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees.
Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.
Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including
but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws,
or provide us or government agencies with inaccurate, misleading, or incomplete data.
Adverse Developments Affecting the Financial
Services Industry and Concentration of Risk
As of September 30, 2024,
the Company had cash deposited in a certain financial institution in excess of federally insured levels. The Company regularly monitors
the financial stability of the financial institution and believes that it is not exposed to any significant credit risk in cash and cash
equivalents. Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial
institutions, or concerns or rumors about such events, may lead to liquidity constraints. In 2023, certain U.S. government banking regulators
took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened
uncertainties in financial markets. While previous bank failures have not had a material direct impact on the Company’s operations,
if further 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.
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.
As of September 30, 2024, our Articles of Incorporation,
as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 7,982,986 shares of Common Stock issued and 7,956,660
issued and outstanding. Accordingly, we may issue up to an additional 792,043,340 shares of Common Stock. The future issuance of Common
Stock may result in substantial dilution in the percentage of our Common Stock held by our then existing stockholders. We may value any
Common Stock in the future on an arbitrary basis. The issuance of Common Stock for future services or acquisitions or other corporate
actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect on any trading market
for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities.
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. We may sell
shares or other securities in offerings 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. The sale of additional shares
of our Common Stock or other securities convertible into or exchangeable for our Common Stock would dilute all of our stockholders, and
if such sales of convertible securities into or exchangeable into our Common Stock occur at a deemed issuance price that is lower than
the current exercise price of our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022, the
exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained
within those warrants.
As of September 30, 2024, there were warrants outstanding
to purchase an aggregate of 4,316,002 shares of our Common Stock at exercise prices ranging from $1.53 to $125.00 per share and 517,996
shares issuable upon exercise of outstanding options at exercise prices ranging from $4.70 to $420.90 per share and restricted stock units
totaling 34,566. In addition, pursuant to the Loan and Security Agreement and the Supplement to the Loan and Security Agreement, each
entered into on November 30, 2021, with Avenue Venture Opportunities Fund II, L.P. and Avenue Venture Opportunities Fund, L.P., the lenders
have the option to convert up to $5 million of the outstanding loan amount into shares of our Common Stock at a conversion price of $69.80
per share. 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 1.8
million shares of our Common Stock, further diluting the interest of holders of our Common Stock.
Item 2. Unregistered sales of equity securities
On August 12, 2024,
the Company issued 15,000 shares of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common
Stock at the date of issuance was $2.23 per share. The stock-based compensation expense related to this Common Stock issuance was $33,450.
The offers, sales, and issuances of the securities
described above were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act
and/or Regulation D promulgated thereunder as transactions by an issuer not involving a public offering, as applicable. The recipients
of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection
with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients
of securities in these transactions was an accredited or sophisticated person and had adequate access, through employment, business or
other relationships, to information about us.
Other than equity
securities issued in transactions disclosed above and on our Current Reports on Form 8-K filed with the SEC on October 22, 2024, October
24, 2024 and October 29, 2024, there were no unregistered sales of equity securities during the period.
Item 3. Defaults Upon Senior Securities
None
Item 4. Mine Safety Disclosures
None
Item 5. Other Information
None
Item 6. Exhibits
(a) Exhibit index
Exhibit
4.1 |
|
Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 22, 2024). |
|
|
|
4.2 |
|
Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 24, 2024). |
|
|
|
4.3 |
|
Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 29, 2024). |
|
|
|
10.1*** |
|
Placement Agent Agreement, dated October 21, 2024, by and between the Company and the Placement Agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 22, 2024). |
|
|
|
10.2*** |
|
Placement Agent Agreement, dated October 23, 2024, by and between the Company and the Placement Agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 24, 2024). |
|
|
|
10.3*** |
|
Placement Agent Agreement, dated October 28, 2024, by and between the Company and the Placement Agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 29, 2024). |
|
|
|
31.1* |
|
Certification of Chief Executive Officer (Principal Executive Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended. |
|
|
|
31.2* |
|
Certification of Chief Financial Officer (Principal Financial Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended. |
|
|
|
32.1** |
|
Certifications of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2** |
|
Certification of Chief Financial Officer (Principal Financial Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.INS |
|
XBRL Instance Document |
|
|
|
101.SCH |
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.LAB |
|
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase Document |
* |
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. |
*** |
Certain portions of this Exhibit have been omitted pursuant to Regulation S-K Item 601(a)(6) promulgated under the Exchange Act. The Registrant agrees to furnish supplementally a copy of any omitted schedule to the SEC upon request. |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d)
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 |
|
Titles |
|
Date |
|
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|
|
|
/s/ Cuong V Do |
|
|
|
|
Cuong V Do |
|
Chairman and Chief Executive Officer (Principal Executive Officer) |
|
November 13, 2024 |
|
|
|
|
|
/s/ Joanne Wendy Kim |
|
|
|
|
Joanne Wendy Kim |
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
|
November 13, 2024 |
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; |
|
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|
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 |
|
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|
|
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 |
|
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|
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): |
|
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|
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 |
|
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|
|
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: November 13, 2024
|
|
|
|
|
|
|
|
/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: November 13, 2024
|
|
|
|
|
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|
/s/ Joanne Wendy Kim |
|
|
|
|
|
|
|
|
Joanne Wendy Kim
Chief Financial Officer
(Principal Financial and Accounting 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 September 30, 2024, 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: November 13, 2024
|
|
|
|
|
|
|
|
/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 September 30, 2024, 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: November 13, 2024
|
|
|
|
|
|
|
|
|
/s/ Joanne Wendy Kim |
|
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|
|
|
|
|
|
|
Joanne Wendy Kim
Chief Financial Officer
(Principal Financial and Accounting Officer) |
v3.24.3
Cover - shares
|
3 Months Ended |
|
Sep. 30, 2024 |
Nov. 07, 2024 |
Cover [Abstract] |
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Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
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Document Period End Date |
Sep. 30, 2024
|
|
Document Fiscal Period Focus |
Q1
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--06-30
|
|
Entity File Number |
001-39015
|
|
Entity Registrant Name |
BIOVIE INC.
|
|
Entity Central Index Key |
0001580149
|
|
Entity Tax Identification Number |
46-2510769
|
|
Entity Incorporation, State or Country Code |
NV
|
|
Entity Address, Address Line One |
680 W Nye Lane
|
|
Entity Address, Address Line Two |
Suite 204
|
|
Entity Address, City or Town |
Carson City
|
|
Entity Address, State or Province |
NV
|
|
Entity Address, Postal Zip Code |
89703
|
|
City Area Code |
(775)
|
|
Local Phone Number |
888-3162
|
|
Title of 12(b) Security |
Class A Common Stock, $0.0001 par value per share
|
|
Trading Symbol |
BIVI
|
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Security Exchange Name |
NASDAQ
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Entity Current Reporting Status |
Yes
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Yes
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Entity Filer Category |
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v3.24.3
Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
CURRENT ASSETS: |
|
|
Cash and cash equivalents |
$ 20,023,405
|
$ 23,843,798
|
Prepaid and other current assets |
127,680
|
204,392
|
Total current assets |
20,151,085
|
24,048,190
|
Operating lease right-of-use assets, net |
390,777
|
406,726
|
Intangible assets, net |
350,374
|
407,718
|
Goodwill |
345,711
|
345,711
|
TOTAL ASSETS |
21,237,947
|
25,208,345
|
CURRENT LIABILITIES: |
|
|
Accounts payable and accrued expenses |
3,452,972
|
3,586,912
|
Current portion of operating lease liabilities |
63,664
|
60,343
|
Current portion of note payable, net of financing cost, unearned premium and discount of $820,242 at September 30, 2024 and $701,210 at June 30, 2024 |
3,320,242
|
5,701,210
|
Warrant liability |
1,254
|
3,771
|
Total current liabilities |
6,838,132
|
9,352,236
|
Operating lease liabilities, net of current portion |
332,730
|
349,894
|
TOTAL LIABILITIES |
7,170,862
|
9,702,130
|
STOCKHOLDERS' EQUITY : |
|
|
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding |
|
|
Common stock, $0.0001 par value; 800,000,000 shares authorized at September 30, 2024 and June 30, 2024, respectively; 7,982,986 shares issued of which 7,956,660 shares are outstanding at September 30, 2024; and 6,216,398 shares issued of which 6,190,072 shares outstanding at June 30, 2024 |
6,406
|
6,229
|
Additional paid in capital |
352,770,440
|
349,732,674
|
Accumulated deficit |
(338,709,734)
|
(334,232,661)
|
Treasury stock |
(27)
|
(27)
|
Total stockholders' equity |
14,067,085
|
15,506,215
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ 21,237,947
|
$ 25,208,345
|
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v3.24.3
Balance Sheets (Unaudited) (Parenthetical) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Statement of Financial Position [Abstract] |
|
|
Unearned premium and discount current |
$ 820,242
|
$ 701,210
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
800,000,000
|
800,000,000
|
Common stock, shares issued |
7,982,986
|
6,216,398
|
Common stock, shares outstanding |
7,956,660
|
6,190,072
|
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v3.24.3
Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
OPERATING EXPENSES: |
|
|
Amortization of intangible assets |
$ 57,344
|
$ 57,344
|
Research and development expenses |
1,990,198
|
8,875,659
|
Selling, general and administrative expenses |
2,074,540
|
1,942,818
|
TOTAL OPERATING EXPENSES |
4,122,082
|
10,875,821
|
LOSS FROM OPERATIONS |
(4,122,082)
|
(10,875,821)
|
OTHER EXPENSE (INCOME): |
|
|
Change in fair value of derivative liabilities |
(2,517)
|
(707,802)
|
Interest expense |
256,024
|
1,004,668
|
Interest income |
(223,557)
|
(462,223)
|
TOTAL OTHER EXPENSE (INCOME), NET |
29,950
|
(165,357)
|
NET LOSS |
(4,152,032)
|
(10,710,464)
|
Deemed dividend related to ratchet adjustment to warrants |
325,041
|
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ (4,477,073)
|
$ (10,710,464)
|
NET LOSS PER COMMON SHARE |
|
|
- Basic |
$ (0.70)
|
$ (2.92)
|
- Diluted |
$ (0.70)
|
$ (2.92)
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
|
|
- Basic |
6,398,360
|
3,672,490
|
- Diluted |
6,398,360
|
3,672,490
|
Other comprehensive loss |
|
|
Unrealized gain on available-for-sale investments |
|
|
Reclassification of unrealized gains on available-for-sale investments upon settlement |
|
(176,591)
|
Total other comprehensive loss |
|
(176,591)
|
Comprehensive loss |
$ (4,477,073)
|
$ (10,887,055)
|
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v3.24.3
Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Treasury Stocks [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Jun. 30, 2023 |
$ 3,643
|
$ 316,385,759
|
$ (2)
|
$ 176,591
|
$ (301,225,705)
|
$ 15,340,286
|
Beginning balance, shares at Jun. 30, 2023 |
3,645,183
|
|
(2,288)
|
|
|
|
Stock-based compensation - stock options |
|
808,027
|
|
|
|
808,027
|
Stock-based compensation - restricted stock units |
|
380,834
|
|
|
|
380,834
|
Proceeds from issuance of common stock, net of costs of $747,408 |
$ 4
|
1,905,832
|
|
|
|
1,905,836
|
Proceeds from issuance of common stock, net of costs, shares |
43,220
|
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units |
|
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units, shares |
3,873
|
|
|
|
|
|
Net Loss |
|
|
|
|
(10,710,464)
|
(10,710,464)
|
Relcassification of unrealized gains on available for sale investments upon settlement |
|
|
|
(176,591)
|
|
(176,591)
|
Ending balance, value at Sep. 30, 2023 |
$ 3,647
|
319,480,452
|
$ (2)
|
|
(311,936,169)
|
7,547,928
|
Ending balance, shares at Sep. 30, 2023 |
3,692,276
|
|
(2,288)
|
|
|
|
Beginning balance, value at Jun. 30, 2024 |
$ 6,229
|
349,732,674
|
$ (27)
|
|
(334,232,661)
|
15,506,215
|
Beginning balance, shares at Jun. 30, 2024 |
6,216,398
|
|
(26,326)
|
|
|
|
Stock-based compensation - stock options |
|
118,898
|
|
|
|
118,898
|
Stock-based compensation - restricted stock units |
|
301,491
|
|
|
|
301,491
|
Proceeds from issuance of common stock, net of costs of $747,408 |
$ 163
|
2,258,900
|
|
|
|
2,259,063
|
Proceeds from issuance of common stock, net of costs, shares |
1,627,943
|
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units |
|
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units, shares |
3,408
|
|
|
|
|
|
Stock-based compensation - issuance of common stock for services rendered |
$ 2
|
33,448
|
|
|
|
33,450
|
Stock-based compensation - issuance of common stock for services rendered, shares |
15,000
|
|
|
|
|
|
Issuance of additional shares for fractional shares effected by the reverse split |
$ 12
|
(12)
|
|
|
|
|
Issuance of additional shares for fractional shares effected by the reverse split, shares |
120,237
|
|
|
|
|
|
Deemed dividend for ratchet adjustment to warrants |
|
325,041
|
|
|
(325,041)
|
|
Net Loss |
|
|
|
|
(4,152,032)
|
(4,152,032)
|
Ending balance, value at Sep. 30, 2024 |
$ 6,406
|
$ 352,770,440
|
$ (27)
|
|
$ (338,709,734)
|
$ 14,067,085
|
Ending balance, shares at Sep. 30, 2024 |
7,982,986
|
|
(26,326)
|
|
|
|
X |
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v3.24.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (4,152,032)
|
$ (10,710,464)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Amortization of intangible assets |
57,344
|
57,344
|
Stock based compensation - restricted stock units |
301,491
|
380,834
|
Stock based compensation expense - stock options |
118,898
|
808,027
|
Stock based compensation expense - issuance of common stock for services rendered |
33,450
|
|
Amortization of financing costs |
9,456
|
37,825
|
Accretion of unearned loan discount |
88,970
|
355,877
|
Accretion of loan premium |
20,606
|
82,424
|
Realized gain on maturity of available-for sale |
|
(223,865)
|
Non-cash lease expense from right-of-use assets |
15,949
|
10,041
|
Change in fair value of derivative liabilities |
(2,517)
|
(707,802)
|
Changes in operating assets and liabilities: |
|
|
Prepaid and other current assets |
76,712
|
(1,446,761)
|
Accounts payable and accrued expenses |
(133,940)
|
(761,499)
|
Operating lease liabilities |
(13,843)
|
(10,645)
|
Other current liabilities |
|
(48,385)
|
Net cash used in operating activities |
(3,579,456)
|
(12,177,049)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Proceeds from (purchases of) U.S. Treasury Bills (available-for-sale) |
|
14,525,000
|
Net cash provided by (used in) investing activities |
|
14,525,000
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Net proceeds from issuance of common stock |
2,259,063
|
1,905,836
|
Payments of note payable |
(2,500,000)
|
(2,500,000)
|
Net cash used in financing activities |
(240,937)
|
(594,164)
|
Net change in cash and cash equivalents |
(3,820,393)
|
1,753,787
|
Cash and cash equivalents, beginning of period |
23,843,798
|
19,460,883
|
Cash and cash equivalents, end of period |
20,023,405
|
21,214,670
|
SUPPLEMENTAL CASH FLOW INFORMATION: |
|
|
Cash paid for interest |
136,992
|
528,541
|
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES: |
|
|
Reclassification of unrealized gains on U.S. Treasury Bills (available-for-sale investments) upon settlement |
|
176,591
|
Deemed dividend for ratchet adjustment to warrants |
$ 325,041
|
|
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v3.24.3
Background Information
|
3 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Background Information |
1. |
Background Information |
BioVie Inc. (the “Company” or “we”
or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
neurological and neuro-degenerative disorders and liver disease.
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. 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 NE3107 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 and 1 million Americans suffering from PD.
Neurodengenerative Disease Program
In neurodegenerative disease, the Company’s
drug candidate Bezisterim (NE3107) inhibits activation of inflammatory actions 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.
NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation
and insulin resistance are drivers of AD and PD.
Alzheimer’s Disease
On November 29, 2023, the Company announced the analysis
of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive
sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
twice daily.
Upon trial completion, as the Company began the process
of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
data.
The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change.
Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary
endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to
be collected and analyzed.
Parkinson’s Disease
The Phase 2 study of bezisterim (NE3107) for the treatment
of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives:
1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric
activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.
Long COVID Program
In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed
Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development
Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”)
application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive
symptoms associated with long covid. The Company anticipates the trial to commence by early 2025. The Company has been reimbursed approximately
$325,000 for the trial during the three months ended September 30, 2024.
Liver Disease Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.
In June 2021, the Company initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period.
In March 2023, the Company announced enrollment was
paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.
In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.
The BIV201 development program was initiated by LAT
Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company 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 our 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.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.24.3
Liquidity and Going Concern
|
3 Months Ended |
Sep. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity and Going Concern |
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 September 30, 2024, the Company had working capital of approximately $13.3 million, cash and cash equivalents of approximately
$20.0 million, stockholders’ equity of approximately $14.1 million, and an accumulated deficit of approximately $338.7 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 on
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.
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- DefinitionThe entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern.
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v3.24.3
Significant Accounting Policies
|
3 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Significant Accounting Policies |
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 State 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, 2024, 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, 2024 and 2023 in our Annual Report on Form 10-K filed with the SEC on
September 30, 2024 (the “2024 Form 10-K”). A summary of significant accounting policies can also be found in those audited
financial statements in the 2024 Form 10-K.
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.
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities
greater than three months, are accounted for as available-for-sale and are recorded at fair value. Realized gains were included in the
accompanying condensed statements of operations and comprehensive loss from the settlement of available-for-sale investments during the
three months ended September 30, 2023. The Company had no outstanding investment securities with original maturities of greater than three
months at the time of purchase as of and during the three months ended September 30, 2024.
Concentration of Credit Risk in the Financial Service
Industry
As of September 30, 2024, the Company had cash deposited
in certain financial institutions 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, the carrying value of the operating lease liabilities and notes payable. 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 notes payable and 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, and convertible debentures. For the three months ending
September 30, 2024 and 2023, 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
at September 30, 2024 of 6,398,360 includes the weighted average effect of the pre-funded warrants issued in connection with the September
2024 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 8).
The table below shows the potential shares of common
stock, presented based on amounts outstanding at each year 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 | |
| | | |
| | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 517,996 | | |
| 395,286 | |
Warrants | |
| 4,316,002 | | |
| 777,029 | |
Restricted Stock Units | |
| 34,564 | | |
| 55,773 | |
Notes payable conversion option | |
| 35,817 | | |
| 71,633 | |
Total | |
| 4,904,379 | | |
| 1,299,721 | |
Reverse stock split
The company effected a 1:10 reverse split of the issued
and outstanding shares of its Class A commons stock which was approved by the board of directors after the approval obtained from shareholders
at a special meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’
approval was obtained. All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
Grant program
The Company records
expenses related to the DOD long Covid Program as such expenses are incurred. The reimbursement of such expenses is recognized upon receipt
of the reimbursement as a credit against the respective expense account.
Recent Accounting
Pronouncements
In November 2024, the
FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”), which will require additional disclosure of
the nature of expenses included in the income statement in response to longstanding requests from investors for more information about
an entity’s expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented
on the face of the income statement as well as disclosures about selling expenses. The new standard will be effective for public companies
for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The requirements
will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating
the impact of this accounting standard update on its financial statements.
|
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.3
Intangible Assets
|
3 Months Ended |
Sep. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
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 | |
| | |
| |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less: Accumulated Amortization | |
| (1,943,396 | ) | |
| (1,886,052 | ) |
Intellectual Property, Net | |
$ | 350,374 | | |
$ | 407,718 | |
Amortization expense was $57,344 in each of the three-month
periods ended September 30, 2024 and 2023. The Company amortizes intellectual property over the expected original useful lives of 10 years.
Estimated future amortization expense is as follows:
Schedule of future amortization expense | |
| | |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 172,033 | |
2026 | |
| 178,341 | |
| |
$ | 350,374 | |
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v3.24.3
Related Party Transactions
|
3 Months Ended |
Sep. 30, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
5. |
Related Party Transactions |
Equity Transactions with Acuitas
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 363,636 shares of the Company’s Common
Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years. The down round feature reduced the exercise
price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 and again to $1.53 per share on September 25, 2024 in connection
with the offering further described in Note 8 as the Company sold stock at a price lower than its initial exercise price. 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 $325,041 as a deemed dividend in the accompanying condesnsed 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 $1.20, exercise
price of $1.53 and $10.00, remaining term of 2.9 years, risk free rate of 3.5% and volatility of 93.0%.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.3
Notes Payable
|
3 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
Notes Payable |
On November 30, 2021 (the “Closing Date”),
the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together,
the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities
Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment
amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”).
The Loan provided for an additional $5 million to be available to the Company on or prior to September 15, 2022, subject to the Company’s
achievement of certain milestones with respect to certain of its ongoing clinical trials, which were not achieved. The Loan bears interest
at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%.
The prime rate on September 30, 2024, was 8.50%. The Loan is secured by a lien upon and security interest in all of the Company’s
assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024.
The Loan Agreement required monthly interest-only
payments during the first eighteen months of the term of the Loan. Following the interest-only period, on July 1, 2023, the Company pays
equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued
interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal
amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal
amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment
of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and
Tranche 2, which amounts to $850,000 (the “Loan Premium”).
The Loan Agreement includes a conversion option to
convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
Common Stock at a conversion price of $69.80 per share (the “Conversion Option”).
On the Closing Date, the Company issued to Avenue
warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
to $58.20. The Avenue Warrants are exercisable until November 30, 2026.
The amount of the carrying value of the notes payable
was determined by allocating portions of the outstanding principal of the notes, approximately $1.4 million, to the fair value of the
Avenue Warrants, and approximately $2.2 million to the fair value of the embedded Conversion Option. Accordingly, the total amount of
unearned discount of approximately $3.6 million, the total direct financing cost of approximately $390,000 and the Loan Premium of $850,000
are being amortized using the effective interest method over the term of the Loan. The adjusted effective interest rate is 24%.
Total interest expense associated with this loan was approximately $252,000, which is reflected as a component of interest expense on the accompanying
condensed statements of operations and comprehensive loss for the three months ended September 30, 2024. Interest expense associated with
this loan was comprised of interest incurred on the outstanding principal of the loan of approximately $132,000, amortization of financing
costs of approximately $9,500, amortization of the unearned discount of $89,000, and the accretion of the Loan Premium of approximately
$21,000.
Total interest expense for the three months ended
September 30, 2023 was approximately $1 million on the accompanying condensed statements of operations and comprehensive loss. Interest
expense was comprised of interest incurred on the outstanding principal of the loan of approximately $525,000, amortization of financing
costs of approximately $38,000, amortization of the unearned discount of approximately $356,000 and the accretion of Loan Premium of approximately
$82,000.
As of September 30, 2024, the remaining principal
balance of $2.5 million under the Loan is payable in 3 monthly equal installments. For the three months ended September 30, 2024, the
Company paid back $2.5 million of the original loan of $15 million.
The following is a summary of the Notes Payable as of September 30, 2024
and June 30, 2024:
Current portion of Notes Payable
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less: debt financing costs | |
| (2,364 | ) | |
| (11,820 | ) |
Less: unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus: accretion of Loan Premium | |
| 844,848 | | |
| 824,242 | |
Current portion of Notes Payable, net of financing costs, unearned premium and discount | |
$ | 3,320,242 | | |
$ | 5,701,210 | |
Estimated future amortization expense and accretion of Loan Premium are
as follows:
Schedule of estimated future amortization expense and accretion of premium | |
| | | |
| | | |
| | |
| |
Unearned Discount | | |
Debt Financing Costs | | |
Loan Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
Total | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.3
Fair Value Measurements
|
3 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
7. |
Fair Value Measurements |
At September 30, 2024 and June 30, 2024, the estimated fair value of derivative
liabilities measured on a recurring basis are as follows:
Schedule of derivative liabilities at fair value | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
Derivative liability - Conversion Option | |
| - | | |
| - | | |
| - | | |
| - | |
Total derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
| |
Fair Value Measurements at | |
| |
June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 3,771 | | |
$ | 3,771 | |
Derivative liability - Conversion option | |
| - | | |
| - | | |
| - | | |
| - | |
Total derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 3,771 | | |
$ | 3,771 | |
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the three months ended September 30, 2024:
Fair value, liabilities measured on recurring basis | |
| | | |
| | |
| |
Derivative liabilities -
Warrants | | |
Derivative liability -
Conversion Option on
Convertible Debenture | |
Balance at June 30, 2024 | |
$ | 3,771 | | |
$ | - | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (2,517 | ) | |
| - | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2024 | |
$ | 1,254 | | |
$ | - | |
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the three months ended September 30, 2023:
| |
Derivative liability -
Warrants | | |
Derivative liability -
Conversion Option | |
Balance at June 30, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
The fair values of derivative liabilities for the
Avenue Warrants and Conversion Option at September 30, 2024, in the accompanying condensed balance sheets, were approximately $1,300 and
approximately zero, respectively. The total change in the fair value of the derivative liabilities totaled approximately $2,500 and $708,000
for the three months ended September 30, 2024 and 2023, respectively; and accordingly, was recorded in the accompanying condensed statements
of operations and comprehensive loss. The assumptions used in the Black Scholes model to value the derivative liabilities at September
30, 2024 included the closing stock price of $1.20 per share; for the Avenue Warrants, the exercise price of $58.20, remaining term 2.2
year, risk free rate of 3.7% and volatility of 91.0%; and for the Conversion Option, the conversion price of $69.80; remaining term of
2 months, risk free rate of 4.8% and volatility of 75.0%.
Derivative liability – Avenue Warrants
The Avenue Warrants were not considered to be indexed
to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying condensed
balance sheets at September 30, 2024 and June 30, 2024, respectively.
The Black Scholes model was used to calculate the
fair value of the derivative warrant to bifurcate the amount from the Avenue Loan amount funded. The Avenue Warrants are recorded at their
fair values at the date of issuance and remeasured at each subsequent reporting period end date.
Embedded derivative liability – Conversion
Option
The Conversion Option is accounted for as an embedded
derivative liability and required bifurcation from the Loan amount. The Black Scholes model was used to calculate the fair value of the
Conversion Option to bifurcate it from the Loan.
Financial assets
As of September 30, 2024, 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 | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,326,252 | | |
$ | - | | |
$ | - | | |
$ | 6,326,252 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,697,153 | | |
| - | | |
| - | | |
| 13,697,153 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 20,023,405 | | |
$ | - | | |
$ | - | | |
$ | 20,023,405 | |
| |
Fair Value Measurements at | |
| |
June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 12,763,941 | | |
$ | - | | |
$ | - | | |
$ | 12,763,941 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 11,079,857 | | |
| - | | |
| - | | |
| 11,079,857 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 23,843,798 | | |
$ | - | | |
$ | - | | |
$ | 23,843,798 | |
|
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.3
Equity Transactions
|
3 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Equity Transactions |
Issuance of common stock for cash
On August 31, 2022, the Company entered into a Controlled
Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively,
the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock
through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley Securities,
Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During the three
months ended September 30, 2024, the Company sold 2,143 shares of common stock under the Sales Agreement for total net proceeds of $6,400
after 3% commissions and expenses of approximately $200. During the three months ended September 30, 2023, the Company sold 43,220 shares
of common stock under the Sales Agreement for total net proceeds of $1.9 million after 3% commissions and expenses of approximately $119,000.
On September 25, 2024, the Company closed a best
efforts public offering (the “September 2024 Offering”) of 1,360,800
shares of its common stock, par value $0.0001
per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
shares of Common Stock, and warrants to purchase up to 1,960,800
shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53
per Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were
exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds
from issuance of common stock. The September Common Warrants have an
exercise price of $1.53
per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The
gross proceeds to the Company from the September 2024 Offering were approximately $3.0
million, before deducting placement agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the
Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040
shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125%
of the public offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period
commencing 180 days from September 25, 2024.
Issuance of common stock for services
On August 12, 2024, the Company awarded 15,000 shares
of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common Stock at the date of issuance
was $2.23 per share. The stock-based compensation expense related to this Common Stock issuance was $33,450.
Stock Options
The following table summarizes the activity relating to the Company’s
stock options for the three months ended September 30, 2024:
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, 2024 | |
| 518,076 | | |
$ | 54.11 | | |
| 6.1 | | |
$ | - | |
Options Expired | |
| (80 | ) | |
| 87.50 | | |
| - | | |
| - | |
Outstanding at September 30, 2024 | |
| 517,996 | | |
$ | 54.10 | | |
| 5.9 | | |
$ | - | |
Exercisable at September 30, 2024 | |
| 321,382 | | |
$ | 66.77 | | |
| 4.7 | | |
$ | - | |
The Company recorded stock based compensation expense
relating to the vesting of stock options of approximately $119,000 and $808,000 for the three months ended September 30, 2024 and 2023,
respectively.
Restricted stock units:
On November 9, 2023, the Company issued equity awards
for the board of directors’ annual compensation. Four directors received 18,270 RSUs with a grant date fair value of $30.10 per
share. In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $30.10 per
share with a grant date fair value of $18.30 per share. The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024
and earlier of November 9, 2024 or the next annual shareholders’ meeting. During the three months ended September 30, 2024, 3,409
of these RSUs vested. On July 25, 2024, Mr. Gorlin resigned from the Board of Directors, and as a result, 1,159 of his RSUs were cancelled.
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, 2024 | |
| 40,291 | | |
$ | 44.59 | |
Vested | |
| (3,409 | ) | |
| 30.10 | |
Canceled | |
| (1,159 | ) | |
| - | |
Unvested at September 30, 2024 | |
| 35,723 | | |
$ | 46.99 | |
The total stock-based compensation expense from restricted
stock units for the three months ended September 30, 2024 and 2023 was approximately $301,000 and $381,000, respectively.
Stock Warrants
The following table summarizes the warrants activity during the three months
ended September 30, 2024:
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, 2024 | |
| 1,932,029 | | |
| 14.03 | | |
| 4.0 | | |
| - | |
Granted | |
| 2,658,840 | | |
| 1.54 | | |
| 5.0 | | |
| - | |
Exercised | |
| (265,000 | ) | |
| 1.53 | | |
| - | | |
| - | |
Expired | |
| (9,867 | ) | |
| 22.50 | | |
| - | | |
| - | |
Outstanding and exercisable at September 30, 2024 | |
| 4,316,002 | | |
$ | 5.66 | | |
| 4.5 | | |
$ | - | |
Of the above warrants outstanding at September 30,
2024, 271 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the
fiscal year ending June 30, 2027, 1,155,000 expire in the fiscal year ending June 30, 2029 and 2,393,840 expire in the fiscal year ending
June 30, 2030.
As of September 30, 2024, the Company had 335,000
prefunded warrants, 3,882,962 warrants and 98,040 placement agent warrants outstanding.
|
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- DefinitionThe entire disclosure for equity.
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v3.24.3
Leases
|
3 Months Ended |
Sep. 30, 2024 |
Leases |
|
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 1 one-year term,
commenced on October 1, 2023, and has been subsequently renewed for another year at the same rate.
The Company’s San Diego office lease at 5090
Shoreham Place Suite 212, San Diego, CA 92122 commenced in February 2024. The current monthly base rate for the office space is $9,685,
with an annual increase of four percent. The term for the office lease is 60 months.
Total operating lease expense for the three months
ended September 30, 2024 and 2023 of approximately $32,000 and $13,000, respectively, were included in the accompanying condensed statements
of operations and comprehensive loss as a component of selling, general and administrative expenses.
The right-of-use asset, net and current and non-current
portion of the operating lease liabilities included in the accompanying condensed balance sheets are as follows:
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
Assets | |
| | | |
| | |
Operating lease right-of-use asset, net | |
$ | 390,777 | | |
$ | 406,726 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liability | |
$ | 63,664 | | |
$ | 60,343 | |
Operating lease liability, net of current portion | |
| 332,730 | | |
| 349,894 | |
Total operating lease liability | |
$ | 396,394 | | |
$ | 410,237 | |
At September 30, 2024, 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, 2025 (Remaining 9 months) | |
$ | 89,199 | |
2026 | |
| 122,042 | |
2027 | |
| 126,313 | |
2028 | |
| 130,734 | |
2029 | |
| 77,796 | |
Total minimum lease payments | |
| 546,084 | |
Less amount representing interest | |
| (149,690 | ) |
Present value of future minimum lease payments | |
| 396,394 | |
Less current portion of operating lease liability | |
| (63,664 | ) |
Operating lease liability, net of current portion | |
$ | 332,730 | |
Total cash paid for amounts included in the measurement of lease liabilities
were $29,055 and $12,900 for the three months ended September 30, 2024 and 2023, respectively.
The weighted average remaining lease term and discount
rate as of September 30, 2024 and June 30, 2024 were as follows:
Schedule of weighted average remaining lease term and discount rate | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating lease | |
| 4.3 | | |
| 4.6 | |
Weighted average discount rate | |
| | | |
| | |
Operating lease | |
| 15.00 | % | |
| 15.00 | % |
|
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v3.24.3
Commitments and Contingencies
|
3 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
10. |
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 is obligated to pay a low single digit
royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances, capped at a maximum
of $200,000 per year.
Shareholder class action complaint
On January 19, 2024, a purported shareholder 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, 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 plaintiffs filed their opposition
on October 21, 2024. The defendant’s reply brief is due December 5, 2024.
The Company believes the lawsuit is without merit
and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding
the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying condensed financial statements.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.3
Employee Benefit Plan
|
3 Months Ended |
Sep. 30, 2024 |
Employee Benefit Plan |
|
Employee Benefit Plan |
11. |
Employee Benefit Plan |
On August 1, 2021, the Company began sponsoring 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
$34,500 and $30,900, for the three months ended September 30, 2024 and 2023, respectively.
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v3.24.3
Subsequent Events
|
3 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
In October 2024, the Company closed three
registered direct offerings totaling 8,256,000
shares of its common stock, par value $0.0001 per
share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares
of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $1.50 to
$2.83 per
share (the “October Offerings”). The October Common Warrants have exercise prices
ranging from $1.37 to
$2.83 per
share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original
issuance dates. The gross proceeds to the Company from the October Offerings totaled approximately $15.9 million,
before deducting placement agent fees and offering expenses of approximately $2.8 million.
Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement
Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging
from $1.88 to
$3.54,
which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s
Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October
Offerings. Additionally in October, 1,216,300 of the common warrants from the September 2024 Offering were exercised at
$1.53 per share for proceeds totaling approximately $1.9 million.
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v3.24.3
Significant Accounting Policies (Policies)
|
3 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation – Interim Financial Information |
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 State 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, 2024, 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, 2024 and 2023 in our Annual Report on Form 10-K filed with the SEC on
September 30, 2024 (the “2024 Form 10-K”). A summary of significant accounting policies can also be found in those audited
financial statements in the 2024 Form 10-K.
|
Cash and cash equivalents |
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.
|
Investments in U.S. Treasury Bills |
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities
greater than three months, are accounted for as available-for-sale and are recorded at fair value. Realized gains were included in the
accompanying condensed statements of operations and comprehensive loss from the settlement of available-for-sale investments during the
three months ended September 30, 2023. The Company had no outstanding investment securities with original maturities of greater than three
months at the time of purchase as of and during the three months ended September 30, 2024.
|
Concentration of Credit Risk in the Financial Service Industry |
Concentration of Credit Risk in the Financial Service
Industry
As of September 30, 2024, the Company had cash deposited
in certain financial institutions 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 |
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, the carrying value of the operating lease liabilities and notes payable. 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 notes payable and 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 |
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, and convertible debentures. For the three months ending
September 30, 2024 and 2023, 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
at September 30, 2024 of 6,398,360 includes the weighted average effect of the pre-funded warrants issued in connection with the September
2024 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 8).
The table below shows the potential shares of common
stock, presented based on amounts outstanding at each year 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 | |
| | | |
| | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 517,996 | | |
| 395,286 | |
Warrants | |
| 4,316,002 | | |
| 777,029 | |
Restricted Stock Units | |
| 34,564 | | |
| 55,773 | |
Notes payable conversion option | |
| 35,817 | | |
| 71,633 | |
Total | |
| 4,904,379 | | |
| 1,299,721 | |
|
Reverse stock split |
Reverse stock split
The company effected a 1:10 reverse split of the issued
and outstanding shares of its Class A commons stock which was approved by the board of directors after the approval obtained from shareholders
at a special meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’
approval was obtained. All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
|
Grant program |
Grant program
The Company records
expenses related to the DOD long Covid Program as such expenses are incurred. The reimbursement of such expenses is recognized upon receipt
of the reimbursement as a credit against the respective expense account.
|
Recent Accounting Pronouncements |
Recent Accounting
Pronouncements
In November 2024, the
FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”), which will require additional disclosure of
the nature of expenses included in the income statement in response to longstanding requests from investors for more information about
an entity’s expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented
on the face of the income statement as well as disclosures about selling expenses. The new standard will be effective for public companies
for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The requirements
will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating
the impact of this accounting standard update on its financial statements.
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v3.24.3
Significant Accounting Policies (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Schedule of dilutive securities were excluded from the computation of diluted loss per share |
Schedule of dilutive securities were excluded from the computation of diluted loss per share | |
| | | |
| | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 517,996 | | |
| 395,286 | |
Warrants | |
| 4,316,002 | | |
| 777,029 | |
Restricted Stock Units | |
| 34,564 | | |
| 55,773 | |
Notes payable conversion option | |
| 35,817 | | |
| 71,633 | |
Total | |
| 4,904,379 | | |
| 1,299,721 | |
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v3.24.3
Intangible Assets (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of intangible assets |
Schedule of intangible assets | |
| | |
| |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less: Accumulated Amortization | |
| (1,943,396 | ) | |
| (1,886,052 | ) |
Intellectual Property, Net | |
$ | 350,374 | | |
$ | 407,718 | |
|
Schedule of future amortization expense |
Schedule of future amortization expense | |
| | |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 172,033 | |
2026 | |
| 178,341 | |
| |
$ | 350,374 | |
|
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v3.24.3
Notes Payable (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
Schedule of note payable |
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less: debt financing costs | |
| (2,364 | ) | |
| (11,820 | ) |
Less: unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus: accretion of Loan Premium | |
| 844,848 | | |
| 824,242 | |
Current portion of Notes Payable, net of financing costs, unearned premium and discount | |
$ | 3,320,242 | | |
$ | 5,701,210 | |
|
Schedule of estimated future amortization expense and accretion of premium |
Schedule of estimated future amortization expense and accretion of premium | |
| | | |
| | | |
| | |
| |
Unearned Discount | | |
Debt Financing Costs | | |
Loan Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
Total | |
$ | 22,242 | | |
$ | 2,364 | | |
$ | 5,152 | |
|
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v3.24.3
Fair Value Measurements (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
Schedule of derivative liabilities at fair value |
Schedule of derivative liabilities at fair value | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
Derivative liability - Conversion Option | |
| - | | |
| - | | |
| - | | |
| - | |
Total derivative liabilities | |
$ | - | | |
$ | - | | |
$ | 1,254 | | |
$ | 1,254 | |
|
Fair value, liabilities measured on recurring basis |
Fair value, liabilities measured on recurring basis | |
| | | |
| | |
| |
Derivative liabilities -
Warrants | | |
Derivative liability -
Conversion Option on
Convertible Debenture | |
Balance at June 30, 2024 | |
$ | 3,771 | | |
$ | - | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (2,517 | ) | |
| - | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2024 | |
$ | 1,254 | | |
$ | - | |
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the three months ended September 30, 2023:
| |
Derivative liability -
Warrants | | |
Derivative liability -
Conversion Option | |
Balance at June 30, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in fair value of level 3 liabilities | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
|
Measured at fair value on a recurring basis |
Measured at fair value on a recurring basis | |
| | | |
| | | |
| | | |
| | |
| |
Fair Value Measurements at | |
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,326,252 | | |
$ | - | | |
$ | - | | |
$ | 6,326,252 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,697,153 | | |
| - | | |
| - | | |
| 13,697,153 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 20,023,405 | | |
$ | - | | |
$ | - | | |
$ | 20,023,405 | |
| |
Fair Value Measurements at | |
| |
June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 12,763,941 | | |
$ | - | | |
$ | - | | |
$ | 12,763,941 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 11,079,857 | | |
| - | | |
| - | | |
| 11,079,857 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 23,843,798 | | |
$ | - | | |
$ | - | | |
$ | 23,843,798 | |
|
X |
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v3.24.3
Equity Transactions (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Schedule of summarizes the activity relating to the Company’s stock options |
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, 2024 | |
| 518,076 | | |
$ | 54.11 | | |
| 6.1 | | |
$ | - | |
Options Expired | |
| (80 | ) | |
| 87.50 | | |
| - | | |
| - | |
Outstanding at September 30, 2024 | |
| 517,996 | | |
$ | 54.10 | | |
| 5.9 | | |
$ | - | |
Exercisable at September 30, 2024 | |
| 321,382 | | |
$ | 66.77 | | |
| 4.7 | | |
$ | - | |
|
Schedule of vesting of restricted common stock |
Schedule of vesting of restricted common stock | |
| | | |
| | |
| |
Number of Shares | | |
Weighted Average Grant
Date Fair Value Per Share | |
| |
| | |
| |
Unvested at June 30, 2024 | |
| 40,291 | | |
$ | 44.59 | |
Vested | |
| (3,409 | ) | |
| 30.10 | |
Canceled | |
| (1,159 | ) | |
| - | |
Unvested at September 30, 2024 | |
| 35,723 | | |
$ | 46.99 | |
|
Summary of warrants activity |
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, 2024 | |
| 1,932,029 | | |
| 14.03 | | |
| 4.0 | | |
| - | |
Granted | |
| 2,658,840 | | |
| 1.54 | | |
| 5.0 | | |
| - | |
Exercised | |
| (265,000 | ) | |
| 1.53 | | |
| - | | |
| - | |
Expired | |
| (9,867 | ) | |
| 22.50 | | |
| - | | |
| - | |
Outstanding and exercisable at September 30, 2024 | |
| 4,316,002 | | |
$ | 5.66 | | |
| 4.5 | | |
$ | - | |
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v3.24.3
Leases (Tables)
|
3 Months Ended |
Sep. 30, 2024 |
Leases |
|
Schedule of deferred tax assets |
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
Assets | |
| | | |
| | |
Operating lease right-of-use asset, net | |
$ | 390,777 | | |
$ | 406,726 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liability | |
$ | 63,664 | | |
$ | 60,343 | |
Operating lease liability, net of current portion | |
| 332,730 | | |
| 349,894 | |
Total operating lease liability | |
$ | 396,394 | | |
$ | 410,237 | |
|
Schedule of future estimated minimum lease payments under non-cancelable operating leases |
Schedule of future estimated minimum lease payments under non-cancelable operating leases | |
| | |
Year ending June 30, 2025 (Remaining 9 months) | |
$ | 89,199 | |
2026 | |
| 122,042 | |
2027 | |
| 126,313 | |
2028 | |
| 130,734 | |
2029 | |
| 77,796 | |
Total minimum lease payments | |
| 546,084 | |
Less amount representing interest | |
| (149,690 | ) |
Present value of future minimum lease payments | |
| 396,394 | |
Less current portion of operating lease liability | |
| (63,664 | ) |
Operating lease liability, net of current portion | |
$ | 332,730 | |
|
Schedule of weighted average remaining lease term and discount rate |
Schedule of weighted average remaining lease term and discount rate | |
| | | |
| | |
| |
September 30, 2024 | | |
June 30, 2024 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating lease | |
| 4.3 | | |
| 4.6 | |
Weighted average discount rate | |
| | | |
| | |
Operating lease | |
| 15.00 | % | |
| 15.00 | % |
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v3.24.3
Liquidity and Going Concern (Details Narrative)
|
Sep. 30, 2024
USD ($)
|
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Working capital |
$ 13,300,000
|
Cash and cash equivalent |
20,000,000.0
|
Stockholders' equity |
14,100,000
|
Accumulated deficit |
$ 338,700,000
|
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v3.24.3
Significant Accounting Policies (Details) - shares
|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
4,904,379
|
1,299,721
|
Equity Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
517,996
|
395,286
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
4,316,002
|
777,029
|
Restricted Stock Units (RSUs) [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
34,564
|
55,773
|
Notespayable Conversion Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
35,817
|
71,633
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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v3.24.3
Intangible Assets (Details) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
Intellectual Property |
$ 2,293,770
|
$ 2,293,770
|
Less: Accumulated Amortization |
(1,943,396)
|
(1,886,052)
|
Intellectual Property, Net |
$ 350,374
|
$ 407,718
|
X |
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v3.24.3
Related Party Transactions (Details Narrative) - USD ($)
|
3 Months Ended |
|
|
|
Sep. 30, 2024 |
Sep. 25, 2024 |
Jun. 30, 2024 |
Jul. 15, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
Common stock, shares issued |
7,982,986
|
1,360,800
|
6,216,398
|
|
Deemed dividend |
$ 325,041
|
|
|
|
Exercise price |
|
$ 1.53
|
|
|
Warrants [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Stock price |
$ 1.20
|
|
|
|
Remaining term |
2 years 10 months 24 days
|
|
|
|
Risk free rate |
3.50%
|
|
|
|
Volatility |
93.00%
|
|
|
|
Warrants [Member] | Minimum [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Exercise price |
$ 1.53
|
|
|
|
Warrants [Member] | Maximum [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Exercise price |
$ 10.00
|
|
|
|
Acuitas Group Holdings, LLC [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Common stock, shares issued |
|
|
|
363,636
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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v3.24.3
Notes Payable (Details) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
|
Current portion of Notes Payable |
$ 2,500,000
|
$ 5,000,000
|
Less: debt financing costs |
(2,364)
|
(11,820)
|
Less: unearned discount |
(22,242)
|
(111,212)
|
Plus: accretion of Loan Premium |
844,848
|
824,242
|
Current portion of Notes Payable, net of financing costs, unearned premium and discount |
$ 3,320,242
|
$ 5,701,210
|
X |
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Notes Payable (Details 1)
|
Sep. 30, 2024
USD ($)
|
Unearned Discount [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
Year ending June 30, 2025 (Remaining 9 months) |
$ 22,242
|
Total |
22,242
|
Financing Receivable [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
Year ending June 30, 2025 (Remaining 9 months) |
2,364
|
Total |
2,364
|
Loan Accretion Premium [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
Year ending June 30, 2025 (Remaining 9 months) |
5,152
|
Total |
$ 5,152
|
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v3.24.3
Notes Payable (Details Narrative) - USD ($)
|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Debt Instrument [Line Items] |
|
|
Interest rate |
8.50%
|
|
Fair value of warrants |
$ 1,400,000
|
|
Fair value of embedded conversion option |
2,200,000
|
|
Direct financing cost |
390,000
|
|
Unamortized premium recognized |
850,000
|
|
Interest expense |
252,000
|
$ 1,000,000
|
Interest payment |
132,000
|
525,000
|
Amortization of financing costs |
9,500
|
38,000
|
Unearned discount |
89,000
|
356,000
|
Accretion of loan premium |
21,000
|
82,000
|
Remaining principal balance |
2,500,000
|
|
Repayments of notes payable |
$ 2,500,000
|
2,500,000
|
Original debt |
|
$ 15,000,000
|
Prime Rate [Member] |
|
|
Debt Instrument [Line Items] |
|
|
Interest rate |
7.00%
|
|
X |
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v3.24.3
Fair Value Measurements (Details) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
$ 1,254
|
$ 3,771
|
|
|
Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
1,254
|
3,771
|
|
|
Derivative liability - Warrants [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
1,254
|
3,771
|
|
|
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
1,254
|
3,771
|
$ 622,397
|
$ 894,280
|
Derivative Liability Conversion Option [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Derivative Liability Conversion Option [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Derivative Liability Conversion Option [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
|
|
Derivative Liability Conversion Option [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
|
|
$ 489,843
|
$ 925,762
|
X |
- DefinitionFair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.
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v3.24.3
Fair Value Measurements (Details 1) - USD ($)
|
3 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
$ 3,771
|
|
Balance at ending |
1,254
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
3,771
|
|
Balance at ending |
1,254
|
|
Derivative liability - Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
3,771
|
|
Balance at ending |
1,254
|
|
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
3,771
|
$ 894,280
|
Additions to level 3 liabilities |
|
|
Change in in fair value of level 3 liabilities |
(2,517)
|
(271,883)
|
Transfer in and/or out of Level 3 |
|
|
Balance at ending |
1,254
|
622,397
|
Derivative Liability Conversion Option [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
|
|
Balance at ending |
|
|
Derivative Liability Conversion Option [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
|
925,762
|
Additions to level 3 liabilities |
|
|
Change in in fair value of level 3 liabilities |
|
(435,919)
|
Transfer in and/or out of Level 3 |
|
|
Balance at ending |
|
$ 489,843
|
X |
- DefinitionFair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.
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v3.24.3
Fair Value Measurements (Details 2) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
$ 20,023,405
|
|
US Treasury Bill Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
13,697,153
|
$ 11,079,857
|
U.S. Treasury Bills due in 3 months or less at purchase [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
23,843,798
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
20,023,405
|
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Bill Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
13,697,153
|
11,079,857
|
Fair Value, Inputs, Level 1 [Member] | U.S. Treasury Bills due in 3 months or less at purchase [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
23,843,798
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Bill Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 2 [Member] | U.S. Treasury Bills due in 3 months or less at purchase [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] | US Treasury Bill Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Fair Value, Inputs, Level 3 [Member] | U.S. Treasury Bills due in 3 months or less at purchase [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Cash [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
6,326,252
|
12,763,941
|
Cash [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
6,326,252
|
12,763,941
|
Cash [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
Cash [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
|
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v3.24.3
Equity Transactions (Details) - Stock Options [Member]
|
3 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Offsetting Assets [Line Items] |
|
Options outstanding at beginning | shares |
518,076
|
Weighted average exercise price, options outstanding at beginning | $ / shares |
$ 54.11
|
Weighted remaining average contractual term, beginning |
6 years 1 month 6 days
|
Aggregate intrinsic value, outstanding at beginning | $ |
|
Options expired | shares |
(80)
|
Weighted average exercise price, expired | $ / shares |
$ 87.50
|
Options outstanding at ending | shares |
517,996
|
Weighted average exercise price, options outstanding at ending | $ / shares |
$ 54.10
|
Weighted remaining average contractual term, ending |
5 years 10 months 24 days
|
Aggregate intrinsic value, outstanding at ending | $ |
|
Options exercisable | shares |
321,382
|
Weighted average exercise price, options exercisable | $ / shares |
$ 66.77
|
Weighted average remaining contractual term, options exercisable |
4 years 8 months 12 days
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v3.24.3
Equity Transactions (Details 2) - Warrant [Member]
|
3 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
Number of shares, beginning | shares |
1,932,029
|
Weighted average exercise price, beginning | $ / shares |
$ 14.03
|
Weighted average remaining life (Years) |
4 years
|
Aggregate intrinsic value, outstanding at beginning | $ |
|
Number of shares, granted | shares |
2,658,840
|
Weighted average exercise price, granted | $ / shares |
$ 1.54
|
Weighted average remaining life (Years), granted |
5 years
|
Number of shares, exercised | shares |
(265,000)
|
Weighted average exercise price, exercised | $ / shares |
$ 1.53
|
Number of shares, expired | shares |
(9,867)
|
Weighted average exercise price, expired | $ / shares |
$ 22.50
|
Number of shares, ending | shares |
4,316,002
|
Weighted average exercise price, ending | $ / shares |
$ 5.66
|
Weighted average remaining life (Years) |
4 years 6 months
|
Aggregate intrinsic value, outstanding at ending | $ |
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v3.24.3
Equity Transactions (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
|
Nov. 09, 2023 |
Aug. 12, 2023 |
Sep. 25, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jun. 30, 2024 |
Class of Stock [Line Items] |
|
|
|
|
|
|
Common stock shares |
|
|
1,360,800
|
7,982,986
|
|
6,216,398
|
Common stock per value |
|
|
$ 0.0001
|
$ 0.0001
|
|
$ 0.0001
|
Warrants exercise price |
|
|
$ 1.53
|
|
|
|
Proceeds from public offering |
|
|
$ 3,000,000.0
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 118,898
|
$ 808,027
|
|
Prefunded warrants |
|
|
|
335,000
|
|
|
Warrants |
|
|
|
3,882,962
|
|
|
Warrants outstanding |
|
|
|
98,040
|
|
|
Stock Options [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 119,000
|
808,000
|
|
Vendor [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Stock issued during period for service |
|
15,000
|
|
|
|
|
Share price |
|
$ 2.23
|
|
|
|
|
Stock-based compensation expense |
|
$ 33,450
|
|
|
|
|
Placement Agents Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Warrants exercise price |
|
|
$ 125
|
|
|
|
Warrant issued |
|
|
98,040
|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 301,000
|
$ 381,000
|
|
Restricted Stock Units (RSUs) [Member] | Four Director [Member] | N 2019 Omnibus Incentive Equity Plan [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Rsu granted |
18,270
|
|
|
|
|
|
Rsu granted, grant date fair value |
$ 30.10
|
|
|
|
|
|
Shares issued over the vesting period |
|
|
|
3,409
|
|
|
Restricted Stock Units (RSUs) [Member] | Two Directors [Member] | N 2019 Omnibus Incentive Equity Plan [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Rsu granted |
18,325
|
|
|
|
|
|
Rsu granted, grant date fair value |
$ 30.10
|
|
|
|
|
|
Common Class A [Member] | Sales Agreement [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Issuance of common stock for cash, shares |
|
|
|
2,143
|
43,220
|
|
Issuance of common stock for cash |
|
|
|
$ 6,400
|
$ 1,900,000
|
|
Commissions percentage |
|
|
|
3.00%
|
3.00%
|
|
Issuance costs |
|
|
|
$ 200
|
$ 119,000
|
|
Prefunded Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Purchase of shares |
|
|
600,000
|
|
|
|
Common Warrants [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Common stock per value |
|
|
$ 1.53
|
|
|
|
Purchase of shares |
|
|
1,960,800
|
|
|
|
X |
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v3.24.3
Leases (Details) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Leases |
|
|
Operating lease right-of-use asset, net |
$ 390,777
|
$ 406,726
|
Current portion of operating lease liability |
63,664
|
60,343
|
Operating lease liability, net of current portion |
332,730
|
349,894
|
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$ 396,394
|
$ 410,237
|
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v3.24.3
Leases (Details 1) - USD ($)
|
Sep. 30, 2024 |
Jun. 30, 2024 |
Leases |
|
|
Year ending June 30, 2025 (Remaining 9 months) |
$ 89,199
|
|
2026 |
122,042
|
|
2027 |
126,313
|
|
2028 |
130,734
|
|
2029 |
77,796
|
|
Total minimum lease payments |
546,084
|
|
Less amount representing interest |
(149,690)
|
|
Present value of future minimum lease payments |
396,394
|
$ 410,237
|
Less current portion of operating lease liability |
(63,664)
|
(60,343)
|
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$ 332,730
|
$ 349,894
|
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v3.24.3
Leases (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
|
Feb. 29, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Oct. 01, 2023 |
Operating lease cost |
|
$ 32,000
|
$ 13,000
|
|
Cash paid for amounts included in measurement of operating lease liabilities |
|
29,055
|
$ 12,900
|
|
Office Leases [Member] |
|
|
|
|
Annual rent |
|
$ 2,200
|
|
|
Lease term |
60 months
|
|
|
1 year
|
Monthly rent |
$ 9,685
|
|
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v3.24.3
Subsequent Events (Details Narrative) - USD ($)
|
1 Months Ended |
Oct. 31, 2024 |
Sep. 25, 2024 |
Class of Warrant or Right [Line Items] |
|
|
[custom:OfferingShares] |
8,256,000
|
|
[custom:OfferingPricePerShare-0] |
$ 0.0001
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
$ 1.53
|
Proceeds from offering |
|
$ 3,000,000.0
|
October Common Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Proceeds from Issuance of Warrants |
$ 8,256,000
|
|
Warrant, Exercise Price, Decrease |
$ 1.37
|
|
Warrant, Exercise Price, Increase |
$ 2.83
|
|
Proceeds from offering |
$ 15,900,000
|
|
[custom:AgentFeesAndOfferingExpenses] |
$ 2,800,000
|
|
October Common Warrants [Member] | Minimum [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
$ 1.50
|
|
October Common Warrants [Member] | Maximum [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
2.83
|
|
October Placement Agents Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrant, Exercise Price, Decrease |
1.88
|
|
Warrant, Exercise Price, Increase |
3.54
|
|
September Common Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Warrant, Exercise Price, Increase |
$ 1.53
|
|
Proceeds from offering |
$ 1,900,000
|
|
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BioVie (NASDAQ:BIVI)
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