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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, 2023
☐ |
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. Empl. Ident. No.) |
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) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Class A Common Stock, par value $0.0001 per share |
BIVI |
The Nasdaq Stock Market, LLC |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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, smaller reporting company or 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 whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act).
Yes ☐
No ☒
There were 37,742,695 shares of the Registrant’s
$0.0001 par value Class A common stock outstanding as of November 6, 2023.
TABLE OF CONTENTS
FORWARD-LOOKING STATEMENTS
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 that attempt to advise interested parties of the risks, uncertainties and other factors that may affect
our business.
When used in this report, the terms “BioVie”,
“Company”, “we”, “our”, and “us” refer to BioVie Inc.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
| |
| | | |
| | |
| |
September 30, | | |
June 30, | |
| |
2023 | | |
2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 21,214,670 | | |
$ | 19,460,883 | |
Investments in U.S. Treasury Bills | |
| - | | |
| 14,477,726 | |
Prepaids and other assets | |
| 1,549,287 | | |
| 102,526 | |
Total current assets | |
| 22,763,957 | | |
| 34,041,135 | |
| |
| | | |
| | |
Operating lease right-of-use assets, net | |
| 70,748 | | |
| 80,789 | |
Intangible assets, net | |
| 579,751 | | |
| 637,095 | |
Goodwill | |
| 345,711 | | |
| 345,711 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 23,760,167 | | |
$ | 35,104,730 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 2,714,760 | | |
$ | 3,476,259 | |
Other current liabilities | |
| - | | |
| 48,385 | |
Current portion of operating lease liabilities | |
| 46,548 | | |
| 44,909 | |
Current portion of note payable, net of financing cost, unearned premium and discount of $661,467 at September 30, 2023 and $894,926 at June 30, 2023 | |
| 9,338,533 | | |
| 9,105,074 | |
Warrant liabilities | |
| 622,397 | | |
| 894,280 | |
Embedded derivative liability | |
| 489,843 | | |
| 925,762 | |
Total current liabilities | |
| 13,212,081 | | |
| 14,494,669 | |
| |
| | | |
| | |
Operating lease liabilities, net of current portion | |
| 30,221 | | |
| 42,505 | |
Note payable, net of current portion, financing cost, unearned premium and discount of $469,937 at September 30, 2023 and $227,270 at June 30, 2023 | |
| 2,969,937 | | |
| 5,227,270 | |
TOTAL LIABILITIES | |
| 16,212,239 | | |
| 19,764,444 | |
| |
| | | |
| | |
Commitments and contingencies (Note 12) | |
| | | |
| | |
| |
| | | |
| | |
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, 2023 and June 30, 2023, respectively; 36,922,760 shares issued of which 36,899,880 shares are outstanding at September 30, 2023; and 36,451,829 shares issued of which 36,428,949 shares outstanding at June 30, 2023; | |
| 3,690 | | |
| 3,643 | |
Additional paid in capital | |
| 319,480,409 | | |
| 316,385,759 | |
Accumulated other comprehensive income | |
| - | | |
| 176,591 | |
Accumulated deficit | |
| (311,936,169 | ) | |
| (301,225,705 | ) |
Treasury stock | |
| (2 | ) | |
| (2 | ) |
Total stockholders’ equity | |
| 7,547,928 | | |
| 15,340,286 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 23,760,167 | | |
$ | 35,104,730 | |
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, 2023 | | |
September 30, 2022 | |
| |
| | |
| |
OPERATING EXPENSES: | |
| | | |
| | |
Amortization | |
$ | 57,344 | | |
$ | 57,344 | |
Research and development expenses | |
| 8,875,659 | | |
| 6,769,932 | |
Selling, general and administrative expenses | |
| 1,942,818 | | |
| 2,007,062 | |
TOTAL OPERATING EXPENSES | |
| 10,875,821 | | |
| 8,834,338 | |
| |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (10,875,821 | ) | |
| (8,834,338 | ) |
| |
| | | |
| | |
OTHER EXPENSE (INCOME): | |
| | | |
| | |
Change in fair value of derivative liabilities | |
| (707,802 | ) | |
| 566,542 | |
Interest expense | |
| 1,004,668 | | |
| 1,056,416 | |
Interest income | |
| (462,223 | ) | |
| (41,585 | ) |
TOTAL OTHER (INCOME) EXPENSE, NET | |
| (165,357 | ) | |
| 1,581,373 | |
| |
| | | |
| | |
NET LOSS | |
$ | (10,710,464 | ) | |
$ | (10,415,711 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | |
$ | (10,710,464 | ) | |
$ | (10,415,711 | ) |
| |
| | | |
| | |
NET LOSS PER COMMON SHARE | |
| | | |
| | |
- Basic | |
$ | (0.29 | ) | |
$ | (0.38 | ) |
- Diluted | |
$ | (0.29 | ) | |
$ | (0.38 | ) |
| |
| | | |
| | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |
| | | |
| | |
- Basic | |
| 36,742,812 | | |
| 27,212,445 | |
- Diluted | |
| 36,742,812 | | |
| 27,212,445 | |
| |
| | | |
| | |
NET LOSS | |
$ | (10,710,464 | ) | |
$ | (10,415,711 | ) |
| |
| | | |
| | |
Other comprehensive loss | |
| | | |
| | |
Reclassification of unrealized gains on available-for-sale investments upon settlement | |
| (176,591 | ) | |
| - | |
Total other comprehensive loss | |
| (176,591 | ) | |
| - | |
Comprehensive loss | |
$ | (10,887,055 | ) | |
$ | (10,415,711 | ) |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
| |
| | | |
| | |
| |
Three Months Ended | | |
Three Months Ended | |
| |
September 30, 2023 | | |
September 30, 2022 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (10,710,464 | ) | |
$ | (10,415,711 | ) |
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 | |
| 380,834 | | |
| 17,537 | |
Stock based compensation expense - stock options | |
| 808,027 | | |
| 878,640 | |
Amortization of financing costs | |
| 37,825 | | |
| 42,554 | |
Accretion of unearned loan discount | |
| 355,877 | | |
| 400,361 | |
Accretion of loan premium | |
| 82,424 | | |
| 143,813 | |
Realized gain on maturity of available-for sale | |
| (223,865 | ) | |
| | |
Change in operating lease right-of-use assets | |
| 10,041 | | |
| 8,983 | |
Change in fair value of derivative liabilities | |
| (707,802 | ) | |
| 566,542 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaids and other assets | |
| (1,446,761 | ) | |
| (221,244 | ) |
Accounts payable and accrued expenses | |
| (761,499 | ) | |
| 179,530 | |
Operating lease liabilities | |
| (10,645 | ) | |
| (9,213 | ) |
Other liabilities | |
| (48,385 | ) | |
| (869,456 | ) |
Net cash used in operating activities | |
| (12,177,049 | ) | |
| (9,220,320 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Maturity of U.S. Treasury Bills | |
| 14,525,000 | | |
| - | |
Net cash provided by investing activities | |
| 14,525,000 | | |
| - | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Net proceeds from issuance of common stock | |
| 1,905,836 | | |
| 5,903,682 | |
Payment of note payable | |
| (2,500,000 | ) | |
| - | |
Net proceeds from issuance of common stock - Related Party | |
| - | | |
| 5,905,840 | |
Net cash (used in) provided by financing activities | |
| (594,164 | ) | |
| 11,809,522 | |
| |
| | | |
| | |
Net increase in cash and cash equivalents | |
| 1,753,787 | | |
| 2,589,202 | |
| |
| | | |
| | |
Cash and cash equivalents, beginning of period | |
| 19,460,883 | | |
| 18,641,716 | |
| |
| | | |
| | |
Cash and cash equivalents, end of period | |
$ | 21,214,670 | | |
$ | 21,230,918 | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for interest | |
$ | 528,541 | | |
$ | 469,687 | |
| |
| | | |
| | |
SUPPLEMENTAL
DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
| |
| | | |
| | |
Reclassification of unrealized gains on available-for-sale investments upon settlement | |
$ | 176,591 | | |
$ | - | |
See accompanying notes to unaudited condensed financial
statements
BioVie Inc.
Condensed Statements of Changes in Stockholders’
Equity
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
| | |
| | |
Additional | | |
| | |
| | |
Other | | |
| | |
Total | |
| |
Common Stock | | |
Common Stock | | |
Paid in | | |
Treasury Stock | | |
Treasury Stock | | |
Comprehensive | | |
Accumulated | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Shares | | |
Amount | | |
Income | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, June 30, 2022 | |
| 24,984,083 | | |
$ | 2,496 | | |
$ | 254,638,329 | | |
| - | | |
$ | - | | |
$ | - | | |
$ | (250,969,890 | ) | |
$ | 3,670,935 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock option based compensation | |
| - | | |
| - | | |
| 878,640 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 878,640 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation - restricted stock units | |
| - | | |
| - | | |
| 17,537 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 17,537 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from issuance of common stock, net of costs of $368,370 | |
| 1,544,872 | | |
| 155 | | |
| 5,903,527 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,903,682 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Proceeds from issuance of common stock, net of costs of $94,160
- Related Party | |
| 3,636,364 | | |
| 364 | | |
| 5,905,476 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,905,840 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,415,711 | ) | |
| (10,415,711 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, September 30, 2022 | |
| 30,165,319 | | |
$ | 3,015 | | |
$ | 267,343,509 | | |
| - | | |
| - | | |
| - | | |
$ | (261,385,601 | ) | |
$ | 5,960,923 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 36,451,829 | | |
$ | 3,643 | | |
$ | 316,385,759 | | |
| (22,880 | ) | |
$ | (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 | |
| 432,201 | | |
| 43 | | |
| 1,905,793 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,905,836 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock from vesting of - restricted stock units | |
| 38,730 | | |
| 4 | | |
| (4 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,710,464 | ) | |
| (10,710,464 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Reclassification of unrealized gains on available for sale investments upon settlement | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (176,591 | ) | |
| - | | |
| (176,591 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, September 30, 2023 | |
| 36,922,760 | | |
$ | 3,690 | | |
$ | 319,480,409 | | |
| (22,880 | ) | |
$ | (2 | ) | |
$ | - | | |
$ | (311,936,169 | ) | |
$ | 7,547,928 | |
See accompanying notes to unaudited condensed financial
statements
BIOVIE INC.
Notes to Condensed Financial Statements
For the Three Months Ended September 30, 2023
and 2022
(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”), from a related party privately held clinical-stage pharmaceutical company, in
June 2021. The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular single-regulated
kinase (“ERK”) signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107 is a 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 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.
Late in September 2023, the final patient completed
the last treatment at week 30 in the Company’s multicenter, randomized, double-blind, placebo-controlled Phase 3 study (NCT04669028)
of NE3107 in patients who have mild to moderate Alzheimer’s disease. The database cleaning process remains underway, with the clinical
team resolving outstanding queries and entering final data into the electronic data system. Final database lock, unblinding and subsequent
release of topline results is anticipated to occur during the fourth quarter of calendar year 2023.
The Company completed its Phase 2 study assessing
NE3107 in PD patients in the fourth quarter of calendar year 2022. The NM201 study (NCT05083260) was a double-blind, placebo-controlled,
safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. The study was primarily
designed to assess safety (general safety in the patient population and potential for drug-drug interactions of NE3107 with levodopa);
and secondary, to look for indications of promotoric activity akin to promotoric activity and apparent enhancement of levodopa activity
observed in preclinical models. Both the safety and efficacy objectives of the study were met.
Neuroinflammation, insulin resistance, and oxidative
stress are common features in the major neurodegenerative diseases, including AD, PD frontotemporal lobar dementia, and Amyotrophic lateral
sclerosis (ALS). NE3107 is an orally bioavailable, blood-brain permeable, small molecule, with potential anti-inflammatory, insulin sensitizing,
and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. NE3107’s
potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD
and PD patients. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.
The Company’s Orphan Drug candidate BIV201
(continuous infusion terlipressin), has been granted Fast Track designation status by the U.S. Food and Drug Administration (“FDA”),
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. The Phase 2b study
was closed before full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment. While the active agent
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.
The BIV201 development program was initiated by
LAT Pharma LLC (“LAT Pharma”). On April 11, 2016, the Company acquired LAT Pharma 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 and NanoAntibiotics, Inc., the Company is obligated
to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin), if approved, to be shared by the members
of LAT Pharma, PharmaIn Corporation and The Barrett Edge, Inc.
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, 2023, the Company had working capital of approximately $9.6 million, cash and cash equivalents
totaling of approximately $21.2 million, stockholders’ equity of approximately $7.5 million, and an accumulated deficit of approximately
$311.9 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. Although our cash balance may possibly sustain operations over the next 12 months from the balance
sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s
development of next phase clinical programs, the Company’s current planned operations to meet certain goals and objectives, project
cash flows to be depleted within that period of time.
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, 2023 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, 2023 and 2022 in our Annual Report on Form 10-K filed with the SEC on August 16, 2023 (the “2023 Form
10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2023 Form
10-K.
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, par value $0.0001
per share (“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 restricted stock units. For the three months ended September 30, 2023 and 2022, such amounts were excluded from
the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.
The table below shows the number of outstanding
stock options, warrants and restricted stock units as of September 30, 2023 and 2022:
Schedule of dilutive securities were excluded from the computation of diluted loss per share | |
| | | |
| | |
| |
September 30, 2023 | | |
September 30, 2022 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 3,952,864 | | |
| 3,348,330 | |
Warrants | |
| 7,770,285 | | |
| 7,779,194 | |
Restricted Stock Units | |
| 557,727 | | |
| 124,520 | |
Total | |
| 12,280,876 | | |
| 11,252,044 | |
Recent Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standards Updates (“ASUs”). There have been no recent ASUs that are expected to have a material impact on
the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 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. Unrealized gain were included in other
comprehensive income in the accompanying statements of operations and comprehensive loss. Upon the maturity and settlement of these investments,
realized gains were recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
Concentration of Credit Risk in the Financial
Service Industry
As of September 30, 2023, 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,
in March and April 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 these events 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.
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, notes payable and other derivative liabilities (see Note 9). 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.
4. | Investments in U.S. Treasury Bills Available for Sale |
The following is a summary of the U.S. Treasury
Bills held at June 30, 2023:
Schedule of U.S. treasury bills held | |
| | |
| | |
| | |
| |
| |
Amortized Cost
Basis | | |
Gross Unrealized
Gain | | |
Fair Value | | |
Total Accumulated
Other
Comprehensive
Income | |
U.S. Treasury Bills due is 3 - 6 months | |
$ | 14,301,136 | | |
$ | 176,591 | | |
$ | 14,477,726 | | |
$ | 176,591 | |
During the fiscal year ended June 30, 2023, the Company purchased a
total of approximately $46 million of U.S. Treasury Bills during the year ended June 30, 2023. All outstanding investments in U.S. Treasury
Bills available for sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in
a realized gain of $223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
The Company’s intangible assets consist
of intellectual property acquired from LAT Pharma 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, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less Accumulated Amortization | |
| (1,714,019 | ) | |
| (1,656,675 | ) |
Intellectual Property, Net | |
$ | 579,751 | | |
$ | 637,095 | |
Amortization expense was $57,344 in each of the
three-month periods ended September 30, 2023 and 2022. 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, 2024 (Remaining 9 months) | |
$ | 172,033 | |
2025 | |
| 229,377 | |
2026 | |
| 178,341 | |
| |
$ | 579,751 | |
6. |
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 majority stockholder, pursuant to which
Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364 shares of the Company’s Common
Stock, at a price of $1.65 per share (the “PIPE Shares”), and (ii) a warrant to purchase 7,272,728 shares of Common Stock
(“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of exercise of five years. The warrant has a down round
feature that reduces the exercise price of the warrant if the Company sells stock at a price lower than the exercise price of the warrant.
On August 15, 2022, the Company received net proceeds of approximately $5.9 million, net of costs of approximately $94,000, and entered
into an amended and restated registration agreement with Acuitas, which amended and restated that certain registration rights agreement,
dated as of June 10, 2021, by and between the Company and Acuitas (the “Existing Registration Rights Agreement”), to amend
the definition of “Registrable Securities” in the Existing Registration Rights Agreement to include the PIPE Shares and the
PIPE Warrant Shares as Registrable Securities thereunder.
The current portion of other liabilities at June
30, 2023 was approximately $48,000 and represented the remaining balance of a retention bonus payable for arrangements with certain employees,
which was paid in July 2023.
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 at September 30, 2023 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.
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 $6.98 per share.
On the Closing Date, the Company issued to Avenue
warrants to purchase 361,002 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
equal to $5.82. 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 premium of $850,000
are recognized on an effective interest method over the term of the Loan. The adjusted effective interest rate is 25%. The total interest
expense of approximately $1 million for the three months ended September 30, 2023, was recognized in the accompanying condensed statements
of operations and comprehensive loss and included the interest only payments totaling approximately $525,000, the amortization of financing costs of approximately
$38,000, unearned discount of approximately $356,000 and the accretion of loan premium of approximately $82,000.
The total interest expense of approximately $1.1
million for the three months ended September 30, 2022; was recognized in the accompanying condensed statements of operations and comprehensive loss and included
the interest payments totaling approximately $470,000, the amortization of financing costs of approximately $43,000, unearned discount
of approximately $400,000 and the accretion of loan premium totaled of approximately $144,000.
As of September 30, 2023, the remaining principal
balance of $12.5 million under the Loan is payable in 15 monthly equal installments. For the three months ended September 30, 2023, 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,
2023 and June 30, 2023:
Current portion of Notes Payable
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 10,000,000 | | |
$ | 10,000,000 | |
Less debt financing costs | |
| (80,381 | ) | |
| (108,751 | ) |
Less unearned discount | |
| (756,238 | ) | |
| (1,023,145 | ) |
Plus accretion of loan premium | |
| 175,152 | | |
| 236,970 | |
Current portion of Notes Payable, net of financing costs, unearned premiums and discount | |
$ | 9,338,533 | | |
$ | 9,105,074 | |
Non-current portion of Notes Payable
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less debt financing costs | |
| (2,365 | ) | |
| (11,820 | ) |
Less unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus accretion of loan premium | |
| 494,544 | | |
| 350,302 | |
Notes Payable, net of the current portion financing costs, unearned premiums and discount | |
$ | 2,969,937 | | |
$ | 5,227,270 | |
Estimated future amortization expense and accretion of premium is as
follows:
Schedule of estimated future amortization expense and accretion of premium | |
| | |
| | |
| |
| |
Unearned Discount | | |
Debt Financing
Costs | | |
Loan accretion
Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2024 (Remaining 9 months) | |
$ | 667,268 | | |
$ | 70,926 | | |
$ | 154,546 | |
2025 | |
| 111,212 | | |
| 11,820 | | |
| 25,758 | |
Total | |
$ | 778,480 | | |
$ | 82,746 | | |
$ | 180,304 | |
9. | Fair Value Measurements |
At September 30, 2023 and June 30, 2023, 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, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 622,397 | | |
$ | 622,397 | |
Derivative liability - Conversion option on notes payable | |
| - | | |
| - | | |
| 489,843 | | |
| 489,843 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,112,240 | | |
$ | 1,112,240 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 894,280 | | |
$ | 894,280 | |
Derivative liability - Conversion option on note payable | |
| - | | |
| - | | |
| 925,762 | | |
| 925,762 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,820,042 | | |
$ | 1,820,042 | |
The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2023:
Fair value, liabilities measured on recurring basis | |
| | | |
| | |
| |
Derivative liabilities
- Warrants | | |
Derivative liability -
Conversion Option
on Convertible
Debenture | |
Balance at June 30, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2022:
| |
Derivative liabilities
- Warrants | | |
Derivative liability -
Conversion Option
on Convertible
Debenture | |
Balance at June 30, 2022 | |
$ | 194,531 | | |
$ | 188,030 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| 248,061 | | |
| 318,481 | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2022 | |
$ | 442,592 | | |
$ | 506,511 | |
The fair values of derivative liabilities for
the Avenue Warrants and the conversion option at September 30, 2023 in the accompanying condensed balance sheet, were approximately $622,000
and approximately $490,000, respectively. The total change in the fair value of the derivative liabilities totaled approximately $708,000
for the three months ended September 30, 2023; and accordingly, was recorded in the accompanying condensed statement of operations and comprehensive loss. The
assumptions used in the Black Scholes model to value the derivative liabilities at September 30, 2023 included the closing stock price
of $3.41 per share; for the Avenue Warrants, the exercise price of $5.82, remaining term 3.2 years, risk free rate of 4.8% and volatility
of 92.0%; and for the embedded derivative liability of the conversion option, the conversion price of $6.98; remaining term 1.17 years,
risk free rate of 5.39% and volatility of 93.0%.
Derivative liability – Avenue Warrants
The Company accounts for stock purchase warrants
as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting
guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet and anti-dilution
provisions or adjustments to the strike price due to an occurrence of a future event are accounted for as derivative financial instruments.
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 accompany condensed balance sheet at September 30, 2023.
The Black Scholes model was used to calculate
the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded. The Avenue Warrants
are recorded at their fair values at the date of issuance and remeasured at September 30, 2023.
Embedded derivative liability – Conversion
Option
The embedded derivative liability represents the
optional conversion feature of up to $5.0 million of the outstanding Loan, which meets the definition of a derivative and requires bifurcation
from the loan amount.
The Black Scholes model was used to calculate
the fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue
Loan amount funded.
Financial assets
As of September 30, 2023, 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.
Measured at fair value on a recurring basis | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 7,764,886 | | |
$ | - | | |
$ | - | | |
$ | 7,764,886 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,449,784 | | |
| - | | |
| - | | |
| 13,449,784 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| - | | |
| - | | |
| - | | |
| - | |
Total | |
$ | 21,214,670 | | |
$ | - | | |
$ | - | | |
$ | 21,214,670 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,304,543 | | |
$ | - | | |
$ | - | | |
$ | 6,304,543 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,156,340 | | |
| - | | |
| - | | |
| 13,156,340 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| 14,477,726 | | |
| - | | |
| - | | |
| 14,477,726 | |
Total | |
$ | 33,938,609 | | |
$ | - | | |
$ | - | | |
$ | 33,938,609 | |
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, 2023, the Company sold 432,201 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. During the three months ended September 30, 2022, the Company
sold 1,544,872 shares of common stock under the Sales Agreement for total net proceeds of $5.9 million after 3% commissions and expenses
of approximately $400,000.
Stock Options
The following table summarizes the activity relating
to the Company’s stock options for the three months ended September 30, 2023:
Schedule of summarizes the activity relating to the Company’s stock options | |
| | | |
| | | |
| | | |
| | |
| |
Options | | |
Weighed-
Average
Exercise
Price | | |
Weighted
Remaining
Average
Contractual
Term | | |
Aggregate
Intrinsic
Value | |
Outstanding at June 30, 2023 | |
| 3,952,864 | | |
$ | 7.10 | | |
| 6.3 | | |
$ | 1,067,966 | |
Outstanding at September 30, 2023 | |
| 3,952,864 | | |
| 7.10 | | |
| 6.0 | | |
| 477,247 | |
Exercisable at September 30, 2023 | |
| 1,689,339 | | |
$ | 7.64 | | |
| 5.5 | | |
$ | 154,404 | |
The fair value of each option grant on the date
of grant is estimated using the Black-Scholes option. No stock options were issued, expired, canceled or exercised during the three months ended September 30, 2023.
The total stock option-based compensation expense
for three-months ended September 30, 2023 and 2022 was of $808,027 and $878,640, respectively.
Issuance of restricted stock units and options :
On November 23, 2022, the Company issued equity
awards for the board of directors’ annual compensation. Four directors received restricted stick units (“RSUs”) to purchase
a total of 155,636 shares of common stock at the grant date fair value of $6.12 per share, a total cost of $952,492 recognized as stock
compensation in the three months ended December 31, 2022. Three directors received stock options to purchase 195,000 shares of common
stock at an exercise price of $6.12 per share, the grant date fair value. The total stock compensation cost of stock options of $791,700
was recognized in the three months ended December 31, 2022. The equity awards vest every three months beginning from the last annual shareholders’
meeting on November 9, 2022, on February 9, 2023, May 9, 2023, August 9, 2023 and earlier of November 9, 2023 or the next annual shareholders’
meeting. While the agreements contain certain contractual vesting terms, there are circumstances where the vesting can be accelerated
that is not within the Company’s control and as a result, for accounting purposes, the awards are assumed to have been fully vested
on the grant date, accordingly, the Company recognized the total compensation cost of $1,744,192 on November 23, 2022. On August 9, 2023,
the Company delivered the vested portion and issued 38,730 shares of common stock.
The following table summarizes 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, 2023 | |
| 596,457 | | |
$ | 5.24 | |
Vested | |
| (38,730 | ) | |
| 6.12 | |
Unvested at September 30, 2023 | |
| 557,727 | | |
$ | 5.40 | |
The total stock based compensation – restricted
stock expense for three-months ended September 30, 2023 and 2022 was of $380,834 and $17,537, respectively.
Issuance of Stock Options under the 2019 Omnibus Plan.
On October 3, 2023, the Company granted stock
options to purchase 211,167 shares of Common Stock to new hire employees. 20% of the shares underlying the options awarded vest on the
one-year anniversary of the grant date, and the remaining 80% will vest in equal monthly installments over 48 months each month thereafter.
The exercise price of the options is $3.41 per share and the options terminate on the earlier of the tenth grant date anniversary or the
date of which the options are fully exercised.
Stock Warrants
The following table summarizes warrant activity during the three months
ended September 30, 2023:
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, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 4.0 | | |
$ | 18,318,954 | |
Outstanding and exercisable at September 30, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 3.8 | | |
$ | 11,682,257 | |
Of the above warrants, 101,380 expire in the fiscal
year ending June 30, 2025, 35,175 expire in the fiscal year ending June 30, 2026, and 7,633,730 expire in the fiscal year ending June
30, 2027. No warrants were granted, expired, or were exercised during the three months ended September 30, 2023.
Office Lease
The Company pays an annual rent of $2,200 for
its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 897603. The rental agreement was for a one-year term and commenced on
October 1, 2022 and has been subsequently renewed for another year at the same rate.
On February 26, 2022,
the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122. The term for the office lease is 38 months
and commenced on March 1, 2022. The monthly base rate currently is $4,300, with annual increases of three percent.
Total operating lease
expense of approximately $13,000 and $13,000 for the three months ended September 30, 2023 and 2022, 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 accompany condensed balance sheets are as follows:
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 70,748 | | |
$ | 80,789 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 46,548 | | |
$ | 44,909 | |
Operating lease liabilities, net of current portion | |
| 30,221 | | |
| 42,505 | |
Total operating lease liabilities | |
$ | 76,769 | | |
$ | 87,414 | |
At September 30, 2023, 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, 2024 (Remaining 9 months) | |
$ | 39,256 | |
2025 | |
| 44,636 | |
Total minimum lease payments | |
| 83,892 | |
| |
| | |
Less amount representing interest | |
| (7,123 | ) |
Present value of future minimum lease payments | |
| 76,769 | |
| |
| | |
Less current portion of operating lease liabilities | |
| (46,548 | ) |
Operating lease liabilities, net of current portion | |
$ | 30,221 | |
Total cash paid for amounts included in the measurement of lease liabilities
were $12,900 and $12,525 for the three months ended September 30, 2023 and 2022, respectively.
The weighted average remaining lease term and
discount rate as of September 30, 2023 and June 30, 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate | |
| | |
| |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating leases | |
| 1.5 | | |
| 1.8 | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 10.75 | % | |
| 10.75 | % |
12. |
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.
13. |
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 of approximately
$30,900 and $45,500, for the three months ended September 30, 2023 and 2022, respectively.
Subsequent to September 30, 2023, the Company sold 819,935 shares of common
stock for net proceeds of $3.5 million net of 3% commission and expenses totaling approximately $105,000 under the Sales Agreement with
the Agent.
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.
The Company acquired the biopharmaceutical assets
of NeurMedix, Inc. (“NeurMedix”), a privately held clinical-stage pharmaceutical company, in June 2021. The acquired
assets included NE3107, a potentially selective inhibitor of inflammatory extracellular single-regulated kinase (ERK) signaling that,
based on animal studies, is believed to reduce neuroinflammation. NE3107 is a 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 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. Late
in September 2023, the last patient completed the last treatment at week 30 in the Company’s multicenter, randomized, double-blind,
placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients who have mild to moderate Alzheimer’s disease. The database
cleaning process remains underway, with the clinical team resolving outstanding queries and entering final data into the electronic data
system. Final database lock, unblinding, and subsequent release of topline results is anticipated to occur during the fourth quarter of
calendar year 2023.
The Phase 2 study of NE3107 in Parkinson’s
disease (“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 NE3107. Forty-five patients with a defined L-dopa “off
state” were randomized 1:1 to placebo: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 demonstrate the absence of adverse interactions
of NE3107 with levodopa; and 2) the secondary objective is to determine if preclinical indications of promotoric activity and apparent
enhancement of levodopa activity can be seen in humans. Both objectives were met. The Company continues to process its findings from its
completed study as it prepares for the next round of clinical studies in PD.
Neuroinflammation, insulin resistance, and oxidative
stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral
sclerosis (ALS). NE3107 is an 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. NE3107’s
potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD
and PD patients. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.
The Company’s Orphan Drug candidate BIV201
(continuous infusion terlipressin), with FDA Fast Track designation 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. The Phase 2b study was closed before full enrollment, without clinically meaningful
adverse effects associated with BIV201 treatment. The active agent is approved in the U.S. and in about 40 countries for related complications
of advanced liver cirrhosis.
Comparison of the three months ended September 30, 2023 to the three
months ended September 30, 2022
Net loss
The
net loss for the three months ended September 30, 2023, was approximately $10.7 million and was comparable to the net loss of $10.4 million
for the three months ended September 30, 2022. The increase in net loss was comprised of increased research and development expenses
of $2.1 million offset from a decrease in selling, general and administrative expenses of approximately $64,000, an increase in interest
income of approximately $420,000 and the change in the fair value of derivative liabilities of $1.3 million for the three months ended
September 30, 2023 from the three months ended September 30, 2022.
Total
operating expenses for the three months ended September 30, 2023, were approximately $10.9 million as compared to $8.8 million for the
three months ended September 30, 2022. The net increase of approximately $2.1 million for the three months ended September 30, 2023
was comprised of increased research and development expenses of approximately $2.1 million offset by a decrease in selling general and
administrative expenses of approximately $64,000.
Research
and Development Expenses
Research
and development expenses were approximately $8.9 million and $6.8 million for the three months ended September 30, 2023, and 2022, respectively.
The net increase of approximately $2.1 million, represented an approximate decline of $1.4 million in expenses from the completion of
the PD Phase 2 and Ascites Phase 2b studies and the near completion of the AD Phase 3, offset by increased expenditures of $1.7 million
related to development of next clinical studies and other research; increased expenses attributed to publication of our abstracts and
posters presented at various conferences totaling approximately $172,000, and increased expenses in Chemistry, Manufacturing and Control
of approximately $46,000 and the Clinical Teams compensation of approximately $1.5 million. The total clinical team employee and outside
consultants’ compensation increased by approximately $780,000 and $712,000, respectively; for the three months ended September
30 2023; representing an increase in the employee headcount by 7 to 15 and the expanded use in the number of outside consultants.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $1.9 million and $2.0 million for the three months ended September 30, 2023, and
2022, respectively. The net decrease of approximately $64,000 was primarily attributed to decline in directors stock compensation of
approximately $313,000,and other professional and advisory fees of $37,000 offset by general administrative compensations of $31,000,
increased legal fees of $155,000, other consultants of approximately $58,000 and insurance expenses of approximately $41,000.
Other Income and Expense
Other income, net was approximately $165,000 compared
to other expense, net of $1.6 million, for the three months ended September 30, 2023 and 2022, respectively. The net increase in other
income of approximately $1.8 million represented change in fair value of the related derivative liabilities of approximately $1.3 million,
and increase in interest income of approximately $420,000 which was primarily comprised of $223,865 realized gain on settlement of investments in U.S. Treasury Bills.
Capital Resources and Liquidity
As of September 30, 2023 the Company had working
capital of approximately $9.6 million, cash and cash equivalents totaling approximately $21.2 million, stockholders’ equity of approximately
$7.5 million, and an accumulated deficit of approximately $311.9 million.
During the three months ended September 30, 2023,
the Company sold approximately 432,000 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald
& Co for total net proceeds of approximately $1.9 million after 3% commissions and offering costs totaling approximately $119,000.
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.
Critical Accounting Policies and Estimates
For the three-month period ended September 30,
2023, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K
for the fiscal year ended June 30, 2023.
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, 2023, 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, 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. 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.
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 contract research organizations (“CROs”), clinical trial sites and clinical trial
principal investigators, contract laboratories, and other third parties to conduct our clinical trials. 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 are responsible
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 current good clinical practices (“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 we or any of these third parties fail to comply with applicable cGCPs or fail to enroll a sufficient number of patients, we
may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval
process. Moreover, our business may be implicated if any of these third parties violates federal, state, or foreign fraud and abuse or
false claims laws and regulations or healthcare privacy and security laws, or provide us or government agencies with inaccurate, misleading,
or incomplete data. For example, during routine monitoring of blinded data from our Phase 3 study (NCT04669028) of NE3107, we uncovered
what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites. We have alerted
the FDA’s Office of Scientific Integrity (“OSI”) about these issues and believe OSI will perform a thorough, competent,
objective and fair research of any potential scientific misconduct and non-compliance of GCPs and regulation. Sensitivity analysis excluding
data from these six problematic sites has been performed and accounted for in the statistical analysis plan for the study (NCT04669028).
Nonetheless, these findings of potential scientific misconduct and significant GCP violations may call into question the rigor, robustness
and validity of the entire data set for this study (NCT04669028) and may require additional clinical studies to confirm the final results
of the study.
Although we design the clinical trials for our
product candidates, our CROs are tasked with facilitating and monitoring our clinical trials. As a result, many important aspects of our clinical
development programs, including site and investigator selection, and the conduct and timing and monitoring of the study, will be partly
or completely outside our direct control. 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.
Successful development
of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.
Product candidates that
appear promising in the early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show
the product candidate to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic
side effects. Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals.
Among other things, such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional
time requirements for data analysis; IND and later NDA preparation; discussions with the FDA; an FDA request for additional pre-clinical
or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites
deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements – which can
render data from those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary
rights of others and their competing products and technologies may also prevent the product from being commercialized.
Success in pre-clinical
and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible
to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies
and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product
to the next, and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure
to develop our products will have a materially adverse effect on our business and will cause you to lose all of your investment.
Adverse Developments Affecting the Financial
Services Industry and Concentration of Risk
As of September 30, 2023, 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,
in March and April 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 these events 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.
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, including
under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, with Cantor Fitzgerald
& Co. (the “Agent”), pursuant to which the Company may issue and sell from time to time shares of common stock
through the Agent. We may sell shares or other securities in any other offering at a price per share that is less than the current market
price of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
The sale of additional shares of 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.
In addition, as of September 30, 2023, there
were warrants outstanding to purchase an aggregate of 7,770,285 shares of common stock at exercise prices ranging from $1.82 to
$12.50 per share and 3,952,864 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per
share and restricted stock units totaling 557,727. Our Loan Agreement entered into on November 30, 2021 contains a conversion feature
whereby at the option of lender, up to $5 million of the outstanding loan amount may be converted into shares of common stock at a conversion
price of $6.98 per share. We may 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
common stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates
(i.e., NE3107, NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix,
Inc. and Acuitas, as amended on May 9, 2021. The achievement of these milestones could result in the issuance of up to 18 million shares
of our common stock, further diluting the interest of holders of our common stock.
Certain stockholders who are also officers
and directors of the Company may have significant control over our management.
As of September 30, 2023, our directors and executive
officers and affiliates currently own aggregate 23,587,296 shares of our Common Stock, which currently constitutes 64.0% of our issued
and outstanding Common Stock. As a result, directors and executive officers and affiliates may have a significant influence on our affairs
and management, as well as on all matters requiring member approval, including electing and removing members of our Board of Directors,
causing us to engage in transactions with affiliates entities, causing or restricting our sale or merger, and certain other matters. Our
majority shareholder, Mr. Terren Peizer, may be deemed to beneficially own the 23,166,210 shares of Common Stock held by Acuitas, which
constitutes 63.0% of our issued and outstanding Common Stock Such concentration of ownership and control could have the effect of delaying,
deferring or preventing a change in control of us even when such a change of control would be in the best interests of our stockholders.
We may, in the future, issue additional
common stock, which would reduce investors’ percent of ownership and may dilute our share value.
As of September 30, 2023, our Articles of Incorporation,
as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 36,922,760 shares of Common Stock issued and
36,899,880 issued and outstanding. Accordingly, we may issue up to an additional 763,100,120 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.
Item 2. Unregistered sales of equity securities
None.
Item 3. Defaults Upon Senior Securities
None
Item 4. Mine Safety Disclosures
None
Item 5. Other Information
None
Item 6. Exhibits
(a) Exhibit index
* |
Filed herewith. |
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** |
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. |
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 |
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Date |
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/s/ Cuong V Do |
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Cuong V Do |
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Chairman and Chief Executive Officer (Principal Executive Officer) |
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November 8, 2023 |
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/s/ Joanne Wendy Kim |
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Joanne Wendy Kim |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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November 8, 2023 |
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: |
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1. |
I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; |
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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; |
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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; |
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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: |
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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; |
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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. |
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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 8, 2023
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/s/ Cuong V Do |
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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: |
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1. |
I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; |
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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; |
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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; |
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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: |
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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; |
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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. |
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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 8, 2023
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/s/ Joanne Wendy Kim |
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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, 2023, 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 |
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(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 8, 2023
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/s/ Cuong V Do |
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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, 2023, 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 |
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(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 8, 2023
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/s/ Joanne Wendy Kim |
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Joanne Wendy Kim
Chief Financial Officer
(Principal Financial and Accounting Officer) |
v3.23.3
Cover - shares
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3 Months Ended |
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Sep. 30, 2023 |
Nov. 06, 2023 |
Cover [Abstract] |
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Document Fiscal Period Focus |
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Document Fiscal Year Focus |
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Current Fiscal Year End Date |
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Entity File Number |
001-39015
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Entity Registrant Name |
BIOVIE INC.
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Entity Central Index Key |
0001580149
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Entity Tax Identification Number |
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Entity Incorporation, State or Country Code |
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v3.23.3
Condensed Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
CURRENT ASSETS: |
|
|
Cash and cash equivalents |
$ 21,214,670
|
$ 19,460,883
|
Investments in U.S. Treasury Bills |
|
14,477,726
|
Prepaids and other assets |
1,549,287
|
102,526
|
Total current assets |
22,763,957
|
34,041,135
|
Operating lease right-of-use assets, net |
70,748
|
80,789
|
Intangible assets, net |
579,751
|
637,095
|
Goodwill |
345,711
|
345,711
|
TOTAL ASSETS |
23,760,167
|
35,104,730
|
CURRENT LIABILITIES: |
|
|
Accounts payable and accrued expenses |
2,714,760
|
3,476,259
|
Other current liabilities |
|
48,385
|
Current portion of operating lease liabilities |
46,548
|
44,909
|
Current portion of note payable, net of financing cost, unearned premium and discount of $661,467 at September 30, 2023 and $894,926 at June 30, 2023 |
9,338,533
|
9,105,074
|
Warrant liabilities |
622,397
|
894,280
|
Embedded derivative liability |
489,843
|
925,762
|
Total current liabilities |
13,212,081
|
14,494,669
|
Operating lease liabilities, net of current portion |
30,221
|
42,505
|
Note payable, net of current portion, financing cost, unearned premium and discount of $469,937 at September 30, 2023 and $227,270 at June 30, 2023 |
2,969,937
|
5,227,270
|
TOTAL LIABILITIES |
16,212,239
|
19,764,444
|
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, 2023 and June 30, 2023, respectively; 36,922,760 shares issued of which 36,899,880 shares are outstanding at September 30, 2023; and 36,451,829 shares issued of which 36,428,949 shares outstanding at June 30, 2023; |
3,690
|
3,643
|
Additional paid in capital |
319,480,409
|
316,385,759
|
Accumulated other comprehensive income |
|
176,591
|
Accumulated deficit |
(311,936,169)
|
(301,225,705)
|
Treasury stock |
(2)
|
(2)
|
Total stockholders’ equity |
7,547,928
|
15,340,286
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 23,760,167
|
$ 35,104,730
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v3.23.3
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Statement of Financial Position [Abstract] |
|
|
Unearned premium and discount current |
$ 661,467
|
$ 894,926
|
Unearned premium and discount |
$ 469,937
|
$ 227,270
|
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 |
36,922,760
|
36,451,829
|
Common stock, shares outstanding |
36,899,880
|
36,428,949
|
X |
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v3.23.3
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
OPERATING EXPENSES: |
|
|
Amortization |
$ 57,344
|
$ 57,344
|
Research and development expenses |
8,875,659
|
6,769,932
|
Selling, general and administrative expenses |
1,942,818
|
2,007,062
|
TOTAL OPERATING EXPENSES |
10,875,821
|
8,834,338
|
LOSS FROM OPERATIONS |
(10,875,821)
|
(8,834,338)
|
OTHER EXPENSE (INCOME): |
|
|
Change in fair value of derivative liabilities |
(707,802)
|
566,542
|
Interest expense |
1,004,668
|
1,056,416
|
Interest income |
(462,223)
|
(41,585)
|
TOTAL OTHER (INCOME) EXPENSE, NET |
(165,357)
|
1,581,373
|
NET LOSS |
(10,710,464)
|
(10,415,711)
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ (10,710,464)
|
$ (10,415,711)
|
NET LOSS PER COMMON SHARE |
|
|
- Basic |
$ (0.29)
|
$ (0.38)
|
- Diluted |
$ (0.29)
|
$ (0.38)
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
|
|
- Basic |
36,742,812
|
27,212,445
|
- Diluted |
36,742,812
|
27,212,445
|
NET LOSS |
$ (10,710,464)
|
$ (10,415,711)
|
Other comprehensive loss |
|
|
Reclassification of unrealized gains on available-for-sale investments upon settlement |
(176,591)
|
|
Total other comprehensive loss |
(176,591)
|
|
Comprehensive loss |
$ (10,887,055)
|
$ (10,415,711)
|
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v3.23.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (10,710,464)
|
$ (10,415,711)
|
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 |
380,834
|
17,537
|
Stock based compensation expense - stock options |
808,027
|
878,640
|
Amortization of financing costs |
37,825
|
42,554
|
Accretion of unearned loan discount |
355,877
|
400,361
|
Accretion of loan premium |
82,424
|
143,813
|
Realized gain on maturity of available-for sale |
(223,865)
|
|
Change in operating lease right-of-use assets |
10,041
|
8,983
|
Change in fair value of derivative liabilities |
(707,802)
|
566,542
|
Changes in operating assets and liabilities: |
|
|
Prepaids and other assets |
(1,446,761)
|
(221,244)
|
Accounts payable and accrued expenses |
(761,499)
|
179,530
|
Operating lease liabilities |
(10,645)
|
(9,213)
|
Other liabilities |
(48,385)
|
(869,456)
|
Net cash used in operating activities |
(12,177,049)
|
(9,220,320)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Maturity of U.S. Treasury Bills |
14,525,000
|
|
Net cash provided by investing activities |
14,525,000
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Net proceeds from issuance of common stock |
1,905,836
|
5,903,682
|
Payment of note payable |
(2,500,000)
|
|
Net proceeds from issuance of common stock - Related Party |
|
5,905,840
|
Net cash (used in) provided by financing activities |
(594,164)
|
11,809,522
|
Net increase in cash and cash equivalents |
1,753,787
|
2,589,202
|
Cash and cash equivalents, beginning of period |
19,460,883
|
18,641,716
|
Cash and cash equivalents, end of period |
21,214,670
|
21,230,918
|
SUPPLEMENTAL CASH FLOW INFORMATION: |
|
|
Cash paid for interest |
528,541
|
469,687
|
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES: |
|
|
Reclassification of unrealized gains on available-for-sale investments upon settlement |
$ 176,591
|
|
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v3.23.3
Condensed 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, 2022 |
$ 2,496
|
$ 254,638,329
|
|
|
$ (250,969,890)
|
$ 3,670,935
|
Beginning balance, shares at Jun. 30, 2022 |
24,984,083
|
|
|
|
|
|
Stock - based compensation - stock options |
|
878,640
|
|
|
|
878,640
|
Stock-based compensation - restricted stock units |
|
17,537
|
|
|
|
17,537
|
Proceeds from issuance of common stock, net of costs of $118,891 |
$ 155
|
5,903,527
|
|
|
|
5,903,682
|
Proceeds from issuance of common stock, shares |
1,544,872
|
|
|
|
|
|
Proceeds from issuance of common stock, net of costs of $94,160 - Related Party |
$ 364
|
5,905,476
|
|
|
|
5,905,840
|
Proceeds from issuance of common stock related party, shares |
3,636,364
|
|
|
|
|
|
Net loss |
|
|
|
|
(10,415,711)
|
(10,415,711)
|
Ending balance, value at Sep. 30, 2022 |
$ 3,015
|
267,343,509
|
|
|
(261,385,601)
|
5,960,923
|
Ending balance, shares at Sep. 30, 2022 |
30,165,319
|
|
|
|
|
|
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 |
36,451,829
|
|
(22,880)
|
|
|
|
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
|
1,905,793
|
|
|
|
1,905,836
|
Proceeds from issuance of common stock, shares |
432,201
|
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units |
$ 4
|
(4)
|
|
|
|
|
Issuance of common stock from vesting of - restricted stock units, shares |
38,730
|
|
|
|
|
|
Net loss |
|
|
|
|
(10,710,464)
|
(10,710,464)
|
Reclassification of unrealized gains on available for sale investments upon settlement |
|
|
|
(176,591)
|
|
(176,591)
|
Ending balance, value at Sep. 30, 2023 |
$ 3,690
|
$ 319,480,409
|
$ (2)
|
|
$ (311,936,169)
|
$ 7,547,928
|
Ending balance, shares at Sep. 30, 2023 |
36,922,760
|
|
(22,880)
|
|
|
|
X |
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v3.23.3
Background Information
|
3 Months Ended |
Sep. 30, 2023 |
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”), from a related party privately held clinical-stage pharmaceutical company, in
June 2021. The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular single-regulated
kinase (“ERK”) signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107 is a 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 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.
Late in September 2023, the final patient completed
the last treatment at week 30 in the Company’s multicenter, randomized, double-blind, placebo-controlled Phase 3 study (NCT04669028)
of NE3107 in patients who have mild to moderate Alzheimer’s disease. The database cleaning process remains underway, with the clinical
team resolving outstanding queries and entering final data into the electronic data system. Final database lock, unblinding and subsequent
release of topline results is anticipated to occur during the fourth quarter of calendar year 2023.
The Company completed its Phase 2 study assessing
NE3107 in PD patients in the fourth quarter of calendar year 2022. The NM201 study (NCT05083260) was a double-blind, placebo-controlled,
safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. The study was primarily
designed to assess safety (general safety in the patient population and potential for drug-drug interactions of NE3107 with levodopa);
and secondary, to look for indications of promotoric activity akin to promotoric activity and apparent enhancement of levodopa activity
observed in preclinical models. Both the safety and efficacy objectives of the study were met.
Neuroinflammation, insulin resistance, and oxidative
stress are common features in the major neurodegenerative diseases, including AD, PD frontotemporal lobar dementia, and Amyotrophic lateral
sclerosis (ALS). NE3107 is an orally bioavailable, blood-brain permeable, small molecule, with potential anti-inflammatory, insulin sensitizing,
and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. NE3107’s
potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD
and PD patients. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.
The Company’s Orphan Drug candidate BIV201
(continuous infusion terlipressin), has been granted Fast Track designation status by the U.S. Food and Drug Administration (“FDA”),
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. The Phase 2b study
was closed before full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment. While the active agent
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.
The BIV201 development program was initiated by
LAT Pharma LLC (“LAT Pharma”). On April 11, 2016, the Company acquired LAT Pharma 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 and NanoAntibiotics, Inc., the Company is obligated
to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin), if approved, to be shared by the members
of LAT Pharma, PharmaIn Corporation and The Barrett Edge, Inc.
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v3.23.3
Liquidity
|
3 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Liquidity |
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, 2023, the Company had working capital of approximately $9.6 million, cash and cash equivalents
totaling of approximately $21.2 million, stockholders’ equity of approximately $7.5 million, and an accumulated deficit of approximately
$311.9 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. Although our cash balance may possibly sustain operations over the next 12 months from the balance
sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s
development of next phase clinical programs, the Company’s current planned operations to meet certain goals and objectives, project
cash flows to be depleted within that period of time.
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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v3.23.3
Significant Accounting Policies
|
3 Months Ended |
Sep. 30, 2023 |
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, 2023 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, 2023 and 2022 in our Annual Report on Form 10-K filed with the SEC on August 16, 2023 (the “2023 Form
10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2023 Form
10-K.
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, par value $0.0001
per share (“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 restricted stock units. For the three months ended September 30, 2023 and 2022, such amounts were excluded from
the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.
The table below shows the number of outstanding
stock options, warrants and restricted stock units as of September 30, 2023 and 2022:
Schedule of dilutive securities were excluded from the computation of diluted loss per share | |
| | | |
| | |
| |
September 30, 2023 | | |
September 30, 2022 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 3,952,864 | | |
| 3,348,330 | |
Warrants | |
| 7,770,285 | | |
| 7,779,194 | |
Restricted Stock Units | |
| 557,727 | | |
| 124,520 | |
Total | |
| 12,280,876 | | |
| 11,252,044 | |
Recent Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standards Updates (“ASUs”). There have been no recent ASUs that are expected to have a material impact on
the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 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. Unrealized gain were included in other
comprehensive income in the accompanying statements of operations and comprehensive loss. Upon the maturity and settlement of these investments,
realized gains were recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
Concentration of Credit Risk in the Financial
Service Industry
As of September 30, 2023, 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,
in March and April 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 these events 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.
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, notes payable and other derivative liabilities (see Note 9). 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.
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v3.23.3
Investments in U.S. Treasury Bills Available for Sale
|
3 Months Ended |
Sep. 30, 2023 |
Investments In U.s. Treasury Bills Available For Sale |
|
Investments in U.S. Treasury Bills Available for Sale |
4. | Investments in U.S. Treasury Bills Available for Sale |
The following is a summary of the U.S. Treasury
Bills held at June 30, 2023:
Schedule of U.S. treasury bills held | |
| | |
| | |
| | |
| |
| |
Amortized Cost
Basis | | |
Gross Unrealized
Gain | | |
Fair Value | | |
Total Accumulated
Other
Comprehensive
Income | |
U.S. Treasury Bills due is 3 - 6 months | |
$ | 14,301,136 | | |
$ | 176,591 | | |
$ | 14,477,726 | | |
$ | 176,591 | |
During the fiscal year ended June 30, 2023, the Company purchased a
total of approximately $46 million of U.S. Treasury Bills during the year ended June 30, 2023. All outstanding investments in U.S. Treasury
Bills available for sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in
a realized gain of $223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
|
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v3.23.3
Intangible Assets
|
3 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
The Company’s intangible assets consist
of intellectual property acquired from LAT Pharma 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, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less Accumulated Amortization | |
| (1,714,019 | ) | |
| (1,656,675 | ) |
Intellectual Property, Net | |
$ | 579,751 | | |
$ | 637,095 | |
Amortization expense was $57,344 in each of the
three-month periods ended September 30, 2023 and 2022. 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, 2024 (Remaining 9 months) | |
$ | 172,033 | |
2025 | |
| 229,377 | |
2026 | |
| 178,341 | |
| |
$ | 579,751 | |
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v3.23.3
Related Party Transactions
|
3 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
6. |
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 majority stockholder, pursuant to which
Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364 shares of the Company’s Common
Stock, at a price of $1.65 per share (the “PIPE Shares”), and (ii) a warrant to purchase 7,272,728 shares of Common Stock
(“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of exercise of five years. The warrant has a down round
feature that reduces the exercise price of the warrant if the Company sells stock at a price lower than the exercise price of the warrant.
On August 15, 2022, the Company received net proceeds of approximately $5.9 million, net of costs of approximately $94,000, and entered
into an amended and restated registration agreement with Acuitas, which amended and restated that certain registration rights agreement,
dated as of June 10, 2021, by and between the Company and Acuitas (the “Existing Registration Rights Agreement”), to amend
the definition of “Registrable Securities” in the Existing Registration Rights Agreement to include the PIPE Shares and the
PIPE Warrant Shares as Registrable Securities thereunder.
|
X |
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v3.23.3
Other Liabilities
|
3 Months Ended |
Sep. 30, 2023 |
Other Liabilities Disclosure [Abstract] |
|
Other Liabilities |
The current portion of other liabilities at June
30, 2023 was approximately $48,000 and represented the remaining balance of a retention bonus payable for arrangements with certain employees,
which was paid in July 2023.
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v3.23.3
Notes Payable
|
3 Months Ended |
Sep. 30, 2023 |
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 at September 30, 2023 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.
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 $6.98 per share.
On the Closing Date, the Company issued to Avenue
warrants to purchase 361,002 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
equal to $5.82. 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 premium of $850,000
are recognized on an effective interest method over the term of the Loan. The adjusted effective interest rate is 25%. The total interest
expense of approximately $1 million for the three months ended September 30, 2023, was recognized in the accompanying condensed statements
of operations and comprehensive loss and included the interest only payments totaling approximately $525,000, the amortization of financing costs of approximately
$38,000, unearned discount of approximately $356,000 and the accretion of loan premium of approximately $82,000.
The total interest expense of approximately $1.1
million for the three months ended September 30, 2022; was recognized in the accompanying condensed statements of operations and comprehensive loss and included
the interest payments totaling approximately $470,000, the amortization of financing costs of approximately $43,000, unearned discount
of approximately $400,000 and the accretion of loan premium totaled of approximately $144,000.
As of September 30, 2023, the remaining principal
balance of $12.5 million under the Loan is payable in 15 monthly equal installments. For the three months ended September 30, 2023, 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,
2023 and June 30, 2023:
Current portion of Notes Payable
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 10,000,000 | | |
$ | 10,000,000 | |
Less debt financing costs | |
| (80,381 | ) | |
| (108,751 | ) |
Less unearned discount | |
| (756,238 | ) | |
| (1,023,145 | ) |
Plus accretion of loan premium | |
| 175,152 | | |
| 236,970 | |
Current portion of Notes Payable, net of financing costs, unearned premiums and discount | |
$ | 9,338,533 | | |
$ | 9,105,074 | |
Non-current portion of Notes Payable
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less debt financing costs | |
| (2,365 | ) | |
| (11,820 | ) |
Less unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus accretion of loan premium | |
| 494,544 | | |
| 350,302 | |
Notes Payable, net of the current portion financing costs, unearned premiums and discount | |
$ | 2,969,937 | | |
$ | 5,227,270 | |
Estimated future amortization expense and accretion of premium is as
follows:
Schedule of estimated future amortization expense and accretion of premium | |
| | |
| | |
| |
| |
Unearned Discount | | |
Debt Financing
Costs | | |
Loan accretion
Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2024 (Remaining 9 months) | |
$ | 667,268 | | |
$ | 70,926 | | |
$ | 154,546 | |
2025 | |
| 111,212 | | |
| 11,820 | | |
| 25,758 | |
Total | |
$ | 778,480 | | |
$ | 82,746 | | |
$ | 180,304 | |
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v3.23.3
Fair Value Measurements
|
3 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
9. | Fair Value Measurements |
At September 30, 2023 and June 30, 2023, 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, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 622,397 | | |
$ | 622,397 | |
Derivative liability - Conversion option on notes payable | |
| - | | |
| - | | |
| 489,843 | | |
| 489,843 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,112,240 | | |
$ | 1,112,240 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 894,280 | | |
$ | 894,280 | |
Derivative liability - Conversion option on note payable | |
| - | | |
| - | | |
| 925,762 | | |
| 925,762 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,820,042 | | |
$ | 1,820,042 | |
The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2023:
Fair value, liabilities measured on recurring basis | |
| | | |
| | |
| |
Derivative liabilities
- Warrants | | |
Derivative liability -
Conversion Option
on Convertible
Debenture | |
Balance at June 30, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2022:
| |
Derivative liabilities
- Warrants | | |
Derivative liability -
Conversion Option
on Convertible
Debenture | |
Balance at June 30, 2022 | |
$ | 194,531 | | |
$ | 188,030 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| 248,061 | | |
| 318,481 | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2022 | |
$ | 442,592 | | |
$ | 506,511 | |
The fair values of derivative liabilities for
the Avenue Warrants and the conversion option at September 30, 2023 in the accompanying condensed balance sheet, were approximately $622,000
and approximately $490,000, respectively. The total change in the fair value of the derivative liabilities totaled approximately $708,000
for the three months ended September 30, 2023; and accordingly, was recorded in the accompanying condensed statement of operations and comprehensive loss. The
assumptions used in the Black Scholes model to value the derivative liabilities at September 30, 2023 included the closing stock price
of $3.41 per share; for the Avenue Warrants, the exercise price of $5.82, remaining term 3.2 years, risk free rate of 4.8% and volatility
of 92.0%; and for the embedded derivative liability of the conversion option, the conversion price of $6.98; remaining term 1.17 years,
risk free rate of 5.39% and volatility of 93.0%.
Derivative liability – Avenue Warrants
The Company accounts for stock purchase warrants
as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting
guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet and anti-dilution
provisions or adjustments to the strike price due to an occurrence of a future event are accounted for as derivative financial instruments.
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 accompany condensed balance sheet at September 30, 2023.
The Black Scholes model was used to calculate
the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded. The Avenue Warrants
are recorded at their fair values at the date of issuance and remeasured at September 30, 2023.
Embedded derivative liability – Conversion
Option
The embedded derivative liability represents the
optional conversion feature of up to $5.0 million of the outstanding Loan, which meets the definition of a derivative and requires bifurcation
from the loan amount.
The Black Scholes model was used to calculate
the fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue
Loan amount funded.
Financial assets
As of September 30, 2023, 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.
Measured at fair value on a recurring basis | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 7,764,886 | | |
$ | - | | |
$ | - | | |
$ | 7,764,886 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,449,784 | | |
| - | | |
| - | | |
| 13,449,784 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| - | | |
| - | | |
| - | | |
| - | |
Total | |
$ | 21,214,670 | | |
$ | - | | |
$ | - | | |
$ | 21,214,670 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,304,543 | | |
$ | - | | |
$ | - | | |
$ | 6,304,543 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,156,340 | | |
| - | | |
| - | | |
| 13,156,340 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| 14,477,726 | | |
| - | | |
| - | | |
| 14,477,726 | |
Total | |
$ | 33,938,609 | | |
$ | - | | |
$ | - | | |
$ | 33,938,609 | |
|
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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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v3.23.3
Equity Transactions
|
3 Months Ended |
Sep. 30, 2023 |
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, 2023, the Company sold 432,201 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. During the three months ended September 30, 2022, the Company
sold 1,544,872 shares of common stock under the Sales Agreement for total net proceeds of $5.9 million after 3% commissions and expenses
of approximately $400,000.
Stock Options
The following table summarizes the activity relating
to the Company’s stock options for the three months ended September 30, 2023:
Schedule of summarizes the activity relating to the Company’s stock options | |
| | | |
| | | |
| | | |
| | |
| |
Options | | |
Weighed-
Average
Exercise
Price | | |
Weighted
Remaining
Average
Contractual
Term | | |
Aggregate
Intrinsic
Value | |
Outstanding at June 30, 2023 | |
| 3,952,864 | | |
$ | 7.10 | | |
| 6.3 | | |
$ | 1,067,966 | |
Outstanding at September 30, 2023 | |
| 3,952,864 | | |
| 7.10 | | |
| 6.0 | | |
| 477,247 | |
Exercisable at September 30, 2023 | |
| 1,689,339 | | |
$ | 7.64 | | |
| 5.5 | | |
$ | 154,404 | |
The fair value of each option grant on the date
of grant is estimated using the Black-Scholes option. No stock options were issued, expired, canceled or exercised during the three months ended September 30, 2023.
The total stock option-based compensation expense
for three-months ended September 30, 2023 and 2022 was of $808,027 and $878,640, respectively.
Issuance of restricted stock units and options :
On November 23, 2022, the Company issued equity
awards for the board of directors’ annual compensation. Four directors received restricted stick units (“RSUs”) to purchase
a total of 155,636 shares of common stock at the grant date fair value of $6.12 per share, a total cost of $952,492 recognized as stock
compensation in the three months ended December 31, 2022. Three directors received stock options to purchase 195,000 shares of common
stock at an exercise price of $6.12 per share, the grant date fair value. The total stock compensation cost of stock options of $791,700
was recognized in the three months ended December 31, 2022. The equity awards vest every three months beginning from the last annual shareholders’
meeting on November 9, 2022, on February 9, 2023, May 9, 2023, August 9, 2023 and earlier of November 9, 2023 or the next annual shareholders’
meeting. While the agreements contain certain contractual vesting terms, there are circumstances where the vesting can be accelerated
that is not within the Company’s control and as a result, for accounting purposes, the awards are assumed to have been fully vested
on the grant date, accordingly, the Company recognized the total compensation cost of $1,744,192 on November 23, 2022. On August 9, 2023,
the Company delivered the vested portion and issued 38,730 shares of common stock.
The following table summarizes 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, 2023 | |
| 596,457 | | |
$ | 5.24 | |
Vested | |
| (38,730 | ) | |
| 6.12 | |
Unvested at September 30, 2023 | |
| 557,727 | | |
$ | 5.40 | |
The total stock based compensation – restricted
stock expense for three-months ended September 30, 2023 and 2022 was of $380,834 and $17,537, respectively.
Issuance of Stock Options under the 2019 Omnibus Plan.
On October 3, 2023, the Company granted stock
options to purchase 211,167 shares of Common Stock to new hire employees. 20% of the shares underlying the options awarded vest on the
one-year anniversary of the grant date, and the remaining 80% will vest in equal monthly installments over 48 months each month thereafter.
The exercise price of the options is $3.41 per share and the options terminate on the earlier of the tenth grant date anniversary or the
date of which the options are fully exercised.
Stock Warrants
The following table summarizes warrant activity during the three months
ended September 30, 2023:
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, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 4.0 | | |
$ | 18,318,954 | |
Outstanding and exercisable at September 30, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 3.8 | | |
$ | 11,682,257 | |
Of the above warrants, 101,380 expire in the fiscal
year ending June 30, 2025, 35,175 expire in the fiscal year ending June 30, 2026, and 7,633,730 expire in the fiscal year ending June
30, 2027. No warrants were granted, expired, or were exercised during the three months ended September 30, 2023.
|
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- DefinitionThe entire disclosure for equity.
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v3.23.3
Leases
|
3 Months Ended |
Sep. 30, 2023 |
Leases |
|
Leases |
Office Lease
The Company pays an annual rent of $2,200 for
its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 897603. The rental agreement was for a one-year term and commenced on
October 1, 2022 and has been subsequently renewed for another year at the same rate.
On February 26, 2022,
the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122. The term for the office lease is 38 months
and commenced on March 1, 2022. The monthly base rate currently is $4,300, with annual increases of three percent.
Total operating lease
expense of approximately $13,000 and $13,000 for the three months ended September 30, 2023 and 2022, 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 accompany condensed balance sheets are as follows:
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 70,748 | | |
$ | 80,789 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 46,548 | | |
$ | 44,909 | |
Operating lease liabilities, net of current portion | |
| 30,221 | | |
| 42,505 | |
Total operating lease liabilities | |
$ | 76,769 | | |
$ | 87,414 | |
At September 30, 2023, 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, 2024 (Remaining 9 months) | |
$ | 39,256 | |
2025 | |
| 44,636 | |
Total minimum lease payments | |
| 83,892 | |
| |
| | |
Less amount representing interest | |
| (7,123 | ) |
Present value of future minimum lease payments | |
| 76,769 | |
| |
| | |
Less current portion of operating lease liabilities | |
| (46,548 | ) |
Operating lease liabilities, net of current portion | |
$ | 30,221 | |
Total cash paid for amounts included in the measurement of lease liabilities
were $12,900 and $12,525 for the three months ended September 30, 2023 and 2022, respectively.
The weighted average remaining lease term and
discount rate as of September 30, 2023 and June 30, 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate | |
| | |
| |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating leases | |
| 1.5 | | |
| 1.8 | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 10.75 | % | |
| 10.75 | % |
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v3.23.3
Commitments and Contingencies
|
3 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
12. |
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.
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v3.23.3
Employee Benefit Plan
|
3 Months Ended |
Sep. 30, 2023 |
Employee Benefit Plan |
|
Employee Benefit Plan |
13. |
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 of approximately
$30,900 and $45,500, for the three months ended September 30, 2023 and 2022, respectively.
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v3.23.3
Subsequent Events
|
3 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Subsequent to September 30, 2023, the Company sold 819,935 shares of common
stock for net proceeds of $3.5 million net of 3% commission and expenses totaling approximately $105,000 under the Sales Agreement with
the Agent.
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v3.23.3
Significant Accounting Policies (Policies)
|
3 Months Ended |
Sep. 30, 2023 |
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, 2023 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, 2023 and 2022 in our Annual Report on Form 10-K filed with the SEC on August 16, 2023 (the “2023 Form
10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2023 Form
10-K.
|
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, par value $0.0001
per share (“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 restricted stock units. For the three months ended September 30, 2023 and 2022, such amounts were excluded from
the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.
The table below shows the number of outstanding
stock options, warrants and restricted stock units as of September 30, 2023 and 2022:
Schedule of dilutive securities were excluded from the computation of diluted loss per share | |
| | | |
| | |
| |
September 30, 2023 | | |
September 30, 2022 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 3,952,864 | | |
| 3,348,330 | |
Warrants | |
| 7,770,285 | | |
| 7,779,194 | |
Restricted Stock Units | |
| 557,727 | | |
| 124,520 | |
Total | |
| 12,280,876 | | |
| 11,252,044 | |
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standards Updates (“ASUs”). There have been no recent ASUs that are expected to have a material impact on
the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 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. Unrealized gain were included in other
comprehensive income in the accompanying statements of operations and comprehensive loss. Upon the maturity and settlement of these investments,
realized gains were recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
|
Concentration of Credit Risk in the Financial Service Industry |
Concentration of Credit Risk in the Financial
Service Industry
As of September 30, 2023, 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,
in March and April 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 these events 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.
|
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, notes payable and other derivative liabilities (see Note 9). 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.
|
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v3.23.3
Significant Accounting Policies (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
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, 2023 | | |
September 30, 2022 | |
| |
Number of Shares | | |
Number of Shares | |
Stock Options | |
| 3,952,864 | | |
| 3,348,330 | |
Warrants | |
| 7,770,285 | | |
| 7,779,194 | |
Restricted Stock Units | |
| 557,727 | | |
| 124,520 | |
Total | |
| 12,280,876 | | |
| 11,252,044 | |
|
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v3.23.3
Intangible Assets (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of intangible assets |
Schedule of intangible assets | |
| | |
| |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Intellectual Property | |
$ | 2,293,770 | | |
$ | 2,293,770 | |
Less Accumulated Amortization | |
| (1,714,019 | ) | |
| (1,656,675 | ) |
Intellectual Property, Net | |
$ | 579,751 | | |
$ | 637,095 | |
|
Schedule of future amortization expense |
Schedule of future amortization expense | |
| | |
Year ending June 30, 2024 (Remaining 9 months) | |
$ | 172,033 | |
2025 | |
| 229,377 | |
2026 | |
| 178,341 | |
| |
$ | 579,751 | |
|
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v3.23.3
Notes Payable (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of note payable |
Schedule of note payable | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Current portion of Notes Payable | |
$ | 10,000,000 | | |
$ | 10,000,000 | |
Less debt financing costs | |
| (80,381 | ) | |
| (108,751 | ) |
Less unearned discount | |
| (756,238 | ) | |
| (1,023,145 | ) |
Plus accretion of loan premium | |
| 175,152 | | |
| 236,970 | |
Current portion of Notes Payable, net of financing costs, unearned premiums and discount | |
$ | 9,338,533 | | |
$ | 9,105,074 | |
Non-current portion of Notes Payable
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Notes Payable | |
$ | 2,500,000 | | |
$ | 5,000,000 | |
Less debt financing costs | |
| (2,365 | ) | |
| (11,820 | ) |
Less unearned discount | |
| (22,242 | ) | |
| (111,212 | ) |
Plus accretion of loan premium | |
| 494,544 | | |
| 350,302 | |
Notes Payable, net of the current portion financing costs, unearned premiums and discount | |
$ | 2,969,937 | | |
$ | 5,227,270 | |
|
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 accretion
Premium | |
| |
| | |
| | |
| |
Year ending June 30, 2024 (Remaining 9 months) | |
$ | 667,268 | | |
$ | 70,926 | | |
$ | 154,546 | |
2025 | |
| 111,212 | | |
| 11,820 | | |
| 25,758 | |
Total | |
$ | 778,480 | | |
$ | 82,746 | | |
$ | 180,304 | |
|
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v3.23.3
Fair Value Measurements (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of derivative liabilities at fair value |
Schedule of derivative liabilities at fair value | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 622,397 | | |
$ | 622,397 | |
Derivative liability - Conversion option on notes payable | |
| - | | |
| - | | |
| 489,843 | | |
| 489,843 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,112,240 | | |
$ | 1,112,240 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Derivative liability - Warrants | |
$ | - | | |
$ | - | | |
$ | 894,280 | | |
$ | 894,280 | |
Derivative liability - Conversion option on note payable | |
| - | | |
| - | | |
| 925,762 | | |
| 925,762 | |
Total derivatives | |
$ | - | | |
$ | - | | |
$ | 1,820,042 | | |
$ | 1,820,042 | |
|
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, 2023 | |
$ | 894,280 | | |
$ | 925,762 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| (271,883 | ) | |
| (435,919 | ) |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2023 | |
$ | 622,397 | | |
$ | 489,843 | |
The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2022:
| |
Derivative liabilities
- Warrants | | |
Derivative liability -
Conversion Option
on Convertible
Debenture | |
Balance at June 30, 2022 | |
$ | 194,531 | | |
$ | 188,030 | |
Additions to level 3 liabilities | |
| - | | |
| - | |
Change in in fair value of level 3 liability | |
| 248,061 | | |
| 318,481 | |
Transfer in and/or out of Level 3 | |
| - | | |
| - | |
Balance at September 30, 2022 | |
$ | 442,592 | | |
$ | 506,511 | |
|
Measured at fair value on a recurring basis |
Measured at fair value on a recurring basis | |
| | |
| | |
| | |
| |
| |
Fair Value Measurements at | |
| |
September 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 7,764,886 | | |
$ | - | | |
$ | - | | |
$ | 7,764,886 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,449,784 | | |
| - | | |
| - | | |
| 13,449,784 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| - | | |
| - | | |
| - | | |
| - | |
Total | |
$ | 21,214,670 | | |
$ | - | | |
$ | - | | |
$ | 21,214,670 | |
| |
Fair Value Measurements at | |
| |
June 30, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
| |
| | |
| | |
| | |
| |
Cash | |
$ | 6,304,543 | | |
$ | - | | |
$ | - | | |
$ | 6,304,543 | |
U.S. Treasury Bills due in 3 months or less at purchase | |
| 13,156,340 | | |
| - | | |
| - | | |
| 13,156,340 | |
U.S. Treasury Bills due in 3 - 6 months at purchase | |
| 14,477,726 | | |
| - | | |
| - | | |
| 14,477,726 | |
Total | |
$ | 33,938,609 | | |
$ | - | | |
$ | - | | |
$ | 33,938,609 | |
|
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v3.23.3
Equity Transactions (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
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 | | |
Weighed-
Average
Exercise
Price | | |
Weighted
Remaining
Average
Contractual
Term | | |
Aggregate
Intrinsic
Value | |
Outstanding at June 30, 2023 | |
| 3,952,864 | | |
$ | 7.10 | | |
| 6.3 | | |
$ | 1,067,966 | |
Outstanding at September 30, 2023 | |
| 3,952,864 | | |
| 7.10 | | |
| 6.0 | | |
| 477,247 | |
Exercisable at September 30, 2023 | |
| 1,689,339 | | |
$ | 7.64 | | |
| 5.5 | | |
$ | 154,404 | |
|
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, 2023 | |
| 596,457 | | |
$ | 5.24 | |
Vested | |
| (38,730 | ) | |
| 6.12 | |
Unvested at September 30, 2023 | |
| 557,727 | | |
$ | 5.40 | |
|
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, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 4.0 | | |
$ | 18,318,954 | |
Outstanding and exercisable at September 30, 2023 | |
| 7,770,285 | | |
$ | 2.06 | | |
| 3.8 | | |
$ | 11,682,257 | |
|
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v3.23.3
Leases (Tables)
|
3 Months Ended |
Sep. 30, 2023 |
Leases |
|
Schedule of deferred tax assets |
Schedule of deferred tax assets | |
| | | |
| | |
| |
September 30, 2023 | | |
June 30, 2023 | |
Assets | |
| | | |
| | |
Operating lease, right-of-use asset, net | |
$ | 70,748 | | |
$ | 80,789 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 46,548 | | |
$ | 44,909 | |
Operating lease liabilities, net of current portion | |
| 30,221 | | |
| 42,505 | |
Total operating lease liabilities | |
$ | 76,769 | | |
$ | 87,414 | |
|
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, 2024 (Remaining 9 months) | |
$ | 39,256 | |
2025 | |
| 44,636 | |
Total minimum lease payments | |
| 83,892 | |
| |
| | |
Less amount representing interest | |
| (7,123 | ) |
Present value of future minimum lease payments | |
| 76,769 | |
| |
| | |
Less current portion of operating lease liabilities | |
| (46,548 | ) |
Operating lease liabilities, net of current portion | |
$ | 30,221 | |
|
Schedule of weighted average remaining lease term and discount rate |
Schedule of weighted average remaining lease term and discount rate | |
| | |
| |
| |
September 30, 2023 | | |
June 30, 2023 | |
| |
| | |
| |
Weighted average remaining lease term (Years) | |
| | | |
| | |
Operating leases | |
| 1.5 | | |
| 1.8 | |
Weighted average discount rate | |
| | | |
| | |
Operating leases | |
| 10.75 | % | |
| 10.75 | % |
|
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v3.23.3
Liquidity (Details Narrative)
|
Sep. 30, 2023
USD ($)
|
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Working capital |
$ 9,600,000
|
Cash and cash equivalent |
21,200,000
|
Stockholders' equity |
7,500,000
|
Accumulated deficit |
$ 311,900,000
|
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v3.23.3
Significant Accounting Policies (Details) - shares
|
3 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
12,280,876
|
11,252,044
|
Equity Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
3,952,864
|
3,348,330
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
7,770,285
|
7,779,194
|
Restricted Stock Units (RSUs) [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
557,727
|
124,520
|
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v3.23.3
Intangible Assets (Details) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
Intellectual Property |
$ 2,293,770
|
$ 2,293,770
|
Less Accumulated Amortization |
(1,714,019)
|
(1,656,675)
|
Intellectual Property, Net |
$ 579,751
|
$ 637,095
|
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v3.23.3
Related Party Transactions (Details Narrative) - shares
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Jul. 15, 2022 |
Related Party Transaction [Line Items] |
|
|
|
Common Stock, shares issued |
36,922,760
|
36,451,829
|
|
Acuitas Group Holdings L L C [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Common Stock, shares issued |
|
|
3,636,364
|
X |
- DefinitionTotal number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury.
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v3.23.3
Notes Payable (Details) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
|
Current portion of Notes Payable |
$ 10,000,000
|
$ 10,000,000
|
Less debt financing costs |
(80,381)
|
(108,751)
|
Less unearned discount |
(756,238)
|
(1,023,145)
|
Plus accretion of loan premium |
175,152
|
236,970
|
Current portion of Notes Payable, net of financing costs, unearned premiums and discount |
9,338,533
|
9,105,074
|
Notes Payable |
2,500,000
|
5,000,000
|
Less debt financing costs |
(2,365)
|
(11,820)
|
Less unearned discount |
(22,242)
|
(111,212)
|
Plus accretion of loan premium |
494,544
|
350,302
|
Notes Payable, net of the current portion financing costs, unearned premiums and discount |
$ 2,969,937
|
$ 5,227,270
|
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v3.23.3
Notes Payable (Details 1)
|
Sep. 30, 2023
USD ($)
|
Unearned Discount [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
Year ending June 30, 2024 (Remaining 9 months) |
$ 667,268
|
2025 |
111,212
|
Total |
778,480
|
Financing Receivable [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
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70,926
|
2025 |
11,820
|
Total |
82,746
|
Loan Accretion Premium [Member] |
|
Accounts, Notes, Loans and Financing Receivable [Line Items] |
|
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154,546
|
2025 |
25,758
|
Total |
$ 180,304
|
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v3.23.3
Notes Payable (Details Narrative) - USD ($)
|
3 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jun. 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
|
|
|
Unearned discount |
356,000
|
$ 400,000
|
$ 3,600,000
|
Direct financing cost |
390,000
|
|
|
Unamortized premium recognized |
850,000
|
|
|
Interest expense |
1,000,000
|
1,100,000
|
|
Interest payment |
525,000
|
470,000
|
|
Amortization of financing costs |
38,000
|
43,000
|
|
Accretion of loan premium |
$ 82,000
|
$ 144,000
|
|
Prime Rate [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Interest rate |
7.00%
|
|
|
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v3.23.3
Fair Value Measurements (Details) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
$ 1,112,240
|
$ 1,820,042
|
|
|
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 |
1,112,240
|
1,820,042
|
|
|
Derivative Liability Warrants [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
622,397
|
894,280
|
|
|
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 |
622,397
|
894,280
|
$ 442,592
|
$ 194,531
|
Derivative Liability Conversion Option On Note Payable [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Total derivatives |
489,843
|
925,762
|
|
|
Derivative Liability Conversion Option On Note Payable [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 On Note Payable [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 On Note Payable [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 |
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v3.23.3
Fair Value Measurements (Details 1) - USD ($)
|
3 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
$ 1,820,042
|
|
Balance at ending |
1,112,240
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
1,820,042
|
|
Balance at ending |
1,112,240
|
|
Derivative Liability Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Balance at beginning |
894,280
|
|
Balance at ending |
622,397
|
|
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 |
894,280
|
$ 194,531
|
Additions to level 3 liabilities |
|
|
Change in in fair value of level 3 liability |
(271,883)
|
248,061
|
Transfer in and/or out of Level 3 |
|
|
Balance at ending |
622,397
|
442,592
|
Derivative Liability Conversion Option On Convertible Debenture [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
|
188,030
|
Additions to level 3 liabilities |
|
|
Change in in fair value of level 3 liability |
(435,919)
|
318,481
|
Transfer in and/or out of Level 3 |
|
|
Balance at ending |
$ 489,843
|
$ 506,511
|
X |
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v3.23.3
Fair Value Measurements (Details 2) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
$ 21,214,670
|
$ 33,938,609
|
US Treasury Bill Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
13,449,784
|
13,156,340
|
U S Treasury Bill Securities 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
14,477,726
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
21,214,670
|
33,938,609
|
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 |
13,449,784
|
13,156,340
|
Fair Value, Inputs, Level 1 [Member] | U S Treasury Bill Securities 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
|
14,477,726
|
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 Bill Securities 1 [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 Bill Securities 1 [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 |
7,764,886
|
6,304,543
|
Cash [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total |
7,764,886
|
6,304,543
|
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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v3.23.3
Equity Transactions (Details) - Stock Options [Member] - USD ($)
|
3 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Offsetting Assets [Line Items] |
|
|
Options outstanding at beginning |
3,952,864
|
3,952,864
|
Weighted average exercise price, Options outstanding at beginning |
$ 7.10
|
$ 7.10
|
Weighted Remaining Average Contractual Term, Ending Balance |
6 years
|
6 years 3 months 18 days
|
Aggregate Intrinsic Value, Outstanding at beginning of period |
$ 477,247
|
$ 1,067,966
|
Options Exercisable |
1,689,339
|
|
Weighted Average Exercise Price, Options Exercisable |
$ 7.64
|
|
Weighted Average Remaining Contractual Term, Options Exercisable |
5 years 6 months
|
|
Aggregate Intrinsic Value, Options Exercisable |
$ 154,404
|
|
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v3.23.3
Equity Transactions (Details 2) - Warrant [Member] - USD ($)
|
3 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Warrant Outstanding |
7,770,285
|
7,770,285
|
Weighted average exercise price, warrants outstanding |
$ 2.06
|
$ 2.06
|
Weighted average remaining life (Years), warrants outstanding |
3 years 9 months 18 days
|
4 years
|
Aggregate intrinsic value, otstanding |
$ 11,682,257
|
$ 18,318,954
|
X |
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v3.23.3
Equity Transactions (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
Oct. 03, 2023 |
Aug. 09, 2023 |
Nov. 23, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 808,027
|
$ 878,640
|
Total compensation cost |
|
|
$ 1,744,192
|
|
|
Stock based compensation - restricted stock units |
|
|
|
380,834
|
17,537
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Shares issued over the vesting period |
|
38,730
|
|
|
|
Restricted Stock Units (RSUs) [Member] | Four Directors [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Stock-based compensation expense |
|
|
952,492
|
|
|
Restricted Stock Units (RSUs) [Member] | Three Directors [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Stock-based compensation expense |
|
|
$ 791,700
|
|
|
Restricted Stock Units (RSUs) [Member] | N 2019 Omnibus Incentive Equity Plan [Member] | Four Directors [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Rsu granted |
|
|
155,636
|
|
|
Rsu granted, grant date fair value |
|
|
$ 6.12
|
|
|
Restricted Stock Units (RSUs) [Member] | N 2019 Omnibus Incentive Equity Plan [Member] | Three Directors [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Rsu granted |
|
|
195,000
|
|
|
Rsu granted, grant date fair value |
|
|
$ 6.12
|
|
|
Stock Options [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 808,027
|
$ 878,640
|
Equity Option [Member] | New Employee [Member] | Subsequent Event [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Stock option to purchase |
211,167
|
|
|
|
|
Weighted Average Contractual Term, Granted (in Years) |
48 months
|
|
|
|
|
Weighted Average Exercise Price, Options Grants |
$ 3.41
|
|
|
|
|
Equity Option [Member] | New Employee [Member] | Subsequent Event [Member] | Minimum [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Awarded Vested rights, percentage |
20.00%
|
|
|
|
|
Equity Option [Member] | New Employee [Member] | Subsequent Event [Member] | Maximum [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Awarded Vested rights, percentage |
80.00%
|
|
|
|
|
Common Class A [Member] | Sales Agreement [Member] |
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
Issuance of common stock for cash, shares |
|
|
|
432,201
|
1,544,872
|
Issuance of common stock for cash |
|
|
|
$ 1,900,000
|
$ 5,900,000
|
Commissions percentage |
|
|
|
3.00%
|
3.00%
|
Issuance costs |
|
|
|
$ 119,000
|
$ 400,000
|
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v3.23.3
Leases (Details) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Leases |
|
|
Operating lease, right-of-use asset, net |
$ 70,748
|
$ 80,789
|
Current portion of operating lease liabilities |
46,548
|
44,909
|
Operating lease liabilities, net of current portion |
30,221
|
42,505
|
Total operating lease liabilities |
$ 76,769
|
$ 87,414
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v3.23.3
Leases (Details 1) - USD ($)
|
Sep. 30, 2023 |
Jun. 30, 2023 |
Leases |
|
|
Year ending June 30, 2024 (Remaining 9 months) |
$ 39,256
|
|
2025 |
44,636
|
|
Total minimum lease payments |
83,892
|
|
Less amount representing interest |
(7,123)
|
|
Present value of future minimum lease payments |
76,769
|
$ 87,414
|
Less current portion of operating lease liabilities |
(46,548)
|
(44,909)
|
Operating lease liabilities, net of current portion |
$ 30,221
|
$ 42,505
|
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BioVie (NASDAQ:BIVI)
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