Item 1. Financial Statements
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
(Unaudited)
December 31,
June 30,
2023
2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 20,226,698
$ 19,460,883
Investments in U.S. Treasury Bills
-
14,477,726
Prepaids and other current assets
334,963
102,526
Total current assets
20,561,661
34,041,135
Operating lease right-of-use assets, net
60,418
80,789
Intangible assets, net
522,407
637,095
Goodwill
345,711
345,711
TOTAL ASSETS
$ 21,490,197
$ 35,104,730
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 3,608,096
$ 3,476,259
Other current liabilities
-
48,385
Current portion of operating lease liabilities
48,231
44,909
Current portion of note payable, net of financing cost, unearned premium and discount of $ 195,325 at December 31, 2023 and $ 894,926 at June 30, 2023
10,195,325
9,105,074
Warrant liabilities
123,158
894,280
Embedded derivative liability
6,548
925,762
Total current liabilities
13,981,358
14,494,669
Operating lease liabilities, net of current portion
17,604
42,505
Note payable, net of current portion, financing cost, unearned premium and discount of $ 0 and $ 227,270 at December 31, 2023 and June 30, 2023, respectively.
-
5,227,270
TOTAL LIABILITIES
13,998,962
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 December 31, 2023 and June 30, 2023, respectively; 39,866,714 shares issued of which 39,843,834 shares are outstanding at December 31, 2023; and 36,451,829 shares issued of which 36,428,949 shares outstanding at June 30, 2023;
3,984
3,643
Additional paid in capital
327,824,867
316,385,759
Accumulated other comprehensive income
-
176,591
Accumulated deficit
( 320,337,614 )
( 301,225,705 )
Treasury stock
( 2 )
( 2 )
Total stockholders' equity
7,491,235
15,340,286
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 21,490,197
$ 35,104,730
See accompanying notes to unaudited condensed financial
statements
3
Table of Contents
BioVie Inc.
Condensed Statements of Operations and Comprehensive
Loss
(Unaudited)
Three Months Ended
Three Months Ended
Six Months Ended
Six Months Ended
December 31, 2023
December 31, 2022
December 31, 2023
December 31, 2022
OPERATING EXPENSES:
Amortization
$ 57,344
$ 57,344
$ 114,688
$ 114,688
Research and development expenses
6,470,262
7,032,898
15,345,922
13,802,830
Selling, general and administrative expenses
2,253,802
4,404,564
4,196,619
6,411,626
TOTAL OPERATING EXPENSES
8,781,408
11,494,806
19,657,229
20,329,144
LOSS FROM OPERATIONS
( 8,781,408 )
( 11,494,806 )
( 19,657,229 )
( 20,329,144 )
OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
( 982,534 )
3,222,010
( 1,690,336 )
3,788,552
Interest expense
820,600
1,053,455
1,825,268
2,109,871
Interest income
( 218,029 )
( 83,269 )
( 680,252 )
( 124,854 )
TOTAL OTHER (INCOME) EXPENSE, NET
( 379,963 )
4,192,196
( 545,320 )
5,773,569
NET LOSS
$ ( 8,401,445 )
$ ( 15,687,002 )
$ ( 19,111,909 )
$ ( 26,102,713 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 8,401,445 )
$ ( 15,687,002 )
$ ( 19,111,909 )
$ ( 26,102,713 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 0.22 )
$ ( 0.50 )
$ ( 0.51 )
$ ( 0.89 )
- Diluted
$ ( 0.22 )
$ ( 0.50 )
$ ( 0.51 )
$ ( 0.89 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
38,170,766
31,168,826
37,444,764
29,201,445
- Diluted
38,170,766
31,168,826
37,444,764
29,201,445
NET LOSS
$ ( 8,401,445 )
$ ( 15,687,002 )
$ ( 19,111,909 )
$ ( 26,102,713 )
Other comprehensive loss
Reclassification of unrealized gains on available-for-sale investments upon settlement
-
-
( 176,591 )
-
Total other comprehensive loss
-
-
( 176,591 )
-
Comprehensive loss
$ ( 8,401,445 )
$ ( 15,687,002 )
$ ( 19,288,500 )
$ ( 26,102,713 )
See accompanying notes to unaudited condensed financial
statements
4
Table of Contents
BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
Six Months Ended
Six Months Ended
December 31, 2023
December 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 19,111,909 )
$ ( 26,102,713 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets
114,688
114,688
Stock based compensation - restricted stock units
684,007
1,571,990
Stock based compensation expense - stock options
1,427,728
2,591,427
Amortization of financing costs
68,560
85,110
Accretion of unearned loan discount
645,027
800,722
Accretion of loan premium
149,394
236,540
Realized gain on maturity of available-for sale
( 223,865 )
-
Change in operating lease right-of-use assets
20,371
18,216
Change in fair value of derivative liabilities
( 1,690,336 )
3,788,552
Changes in operating assets and liabilities:
Prepaids and other assets
( 232,437 )
( 103,403 )
Accounts payable and accrued expenses
131,837
802,610
Operating lease liabilities
( 21,579 )
( 18,675 )
Other liabilities
( 48,385 )
( 1,014,612 )
Net cash used in operating activities
( 18,086,899 )
( 17,229,548 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from 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
9,327,714
38,428,343
Payment of note payable
( 5,000,000 )
-
Proceeds from exercise of stock options
2,240
Net proceeds from issuance of common stock - Related Party
-
5,905,840
Net cash provided by financing activities
4,327,714
44,336,423
Net increase in cash and cash equivalents
765,815
27,106,875
Cash and cash equivalents, beginning of period
19,460,883
18,641,716
Cash and cash equivalents, end of period
$ 20,226,698
$ 45,748,591
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 962,288
$ 987,498
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
5
Table of Contents
BioVie Inc.
Condensed Statements of Changes in Stockholders’
Equity
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Common Stock
Paid in
Treasury Stock
Treasury Stock
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
Shares
Amount
Income
Deficit
Equity
Balance, June 30, 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
Stock-based compensation - restricted stock units
-
-
1,554,453
-
-
-
-
1,554,453
Stock option based compensation
-
-
1,712,787
-
-
-
-
1,712,787
Cashless exercise of options
21,882
3
( 3 )
-
-
-
-
-
Cashless exercise of warrants
3,590
-
-
-
-
-
-
-
Proceeds from exercise of options
800
-
2,240
-
-
-
-
2,240
Proceeds from issuance of common stock, net of costs of $1,206,206
4,312,741
431
32,254,230
-
-
-
-
32,524,661
Net loss
-
-
-
-
-
-
( 15,687,002 )
( 15,687,002 )
Balance, December 31, 2022
34,504,332
$ 3,449
$ 303,137,216
-
$ -
$ -
$ ( 277,072,603 )
$ 26,068,062
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 )
Relcassification 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
Stock - based compensation - stock options
-
-
619,701
-
-
-
-
619,701
Stock-based compensation - restricted stock units
-
-
303,173
-
-
-
-
303,173
Proceeds from issuance of common stock, net of costs of $258,254
2,900,902
290
7,421,588
-
-
-
-
7,421,878
Issuance of common stock from vesting of - restricted stock units
43,052
4
( 4 )
-
-
-
-
-
Net loss
-
-
-
-
-
-
( 8,401,445 )
( 8,401,445 )
Balance, December 31, 2023
39,866,714
$ 3,984
$ 327,824,867
( 22,880 )
$ ( 2 )
$ -
$ ( 320,337,614 )
$ 7,491,235
See accompanying notes to unaudited condensed financial
statements
6
Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Three and Six Months Ended December
31, 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”) a privately held clinical-stage pharmaceutical company and a
related party in June 2021 . The acquired assets included NE3107. NE3107 is an investigational, novel, orally administered
small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel
mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in
the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and NE3107 could, if
approved by U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating
conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.
Neurodengenerative
Disease Program
In neurodegenerative disease, the Company’s
drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear
factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”)
signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. NE3107 does not interfere with
their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers
of AD and PD.
Alzheimer’s
Disease (NCT05083260)
On November 29, 2023,
the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in
the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment
Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned,
1:1 versus placebo, to receive sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days,
followed by 26 weeks of 20 mg orally twice daily.
Upon trial completion, as the Company began the process of unblinding
the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations
at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the
Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in
the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.
The trial was originally designed to be 80% powered with 125 patients
in each of the treatment and placebo arms. The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints.
In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the
study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss;
these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. Age deceleration is
used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath
DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint,
other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected
and analyzed.
Parkinson’s
Disease (NCT05083260)
The Phase 2 study of
NE3107 for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability,
and pharmacokinetics study in PD participants treated with carbidopa/levodopa and 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 measure the potential for adverse interactions
of NE3107 with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity
and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.
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Table of Contents
Neuroinflammation, insulin
resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia,
and Amyotrophic lateral sclerosis. NE3107 is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory,
insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
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.
Liver Disease Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.
In June 2021, the Company initiated a Phase 2
study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period.
In March 2023 the company announced enrollment
was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites
fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.
In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.
While the active agent, terlipressin, is approved
in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The FDA has not approved any drug to treat refractory
ascites.
The BIV201 development program was initiated by
LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently
owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11,
2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty
on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
Edge, Inc.
8
Table of Contents
2. 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 December 31, 2023, the Company had working capital of approximately $ 6.6 million, cash and cash equivalents
of approximately $ 20.2 million, stockholders’ equity of approximately $ 7.5 million, and an accumulated deficit of approximately
$ 320.3 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 six to nine months from
the balance sheet date if further measures are taken to delay planned expenditures in our research protocols and slow the progress in
the Company’s development and launch of next phase clinical programs, the 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 condensed 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.
9
Table of Contents
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 six months ended December 31, 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 December 31, 2023 and 2022:
Schedule of dilutive securities were excluded from the computation of diluted loss per share
December 31, 2023
December 31, 2022
Number of Shares
Number of Shares
Stock Options
4,173,325
3,448,797
Warrants
7,770,285
7,770,285
Restricted Stock Units
687,428
660,028
Total
12,631,038
11,879,110
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 on the date of purchase, are accounted for as available for sale and are recorded at fair value. Unrealized
gains were included in other comprehensive income in the accompanying condensed 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 December 31, 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:
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Table of Contents
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 in 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. 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.
5. 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
December 31, 2023
June 30, 2023
Intellectual Property
$ 2,293,770
$ 2,293,770
Less Accumulated Amortization
( 1,771,363 )
( 1,656,675 )
Intellectual Property, Net
$ 522,407
$ 637,095
Amortization expense was $ 57,344 in each of the
three-month periods ended December 31, 2023 and 2022. Amortization expense was $ 114,688 in each of the six-month periods ended December
31, 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 6 months)
$ 114,689
2025
229,377
2026
178,341
$ 522,407
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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 initial 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.
7. 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.
8. 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 December 31, 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 $ 682,000 for the three months ended December 31, 2023, was recognized in the accompanying condensed statements
of operations and comprehensive loss and included the interest only payments totaling approximately $ 429,000 , the amortization of financing
costs of approximately $ 31,000 , unearned discount of approximately $ 289,000 and the accretion of loan premium of approximately $ 67,000 .
The total interest expense of approximately $ 1.5 million for the six months ended December 31, 2023, was recognized in the accompanying
condensed statements of operations and comprehensive loss and included the interest only payments totaling approximately $ 955,000 , the
amortization of financing costs of approximately $ 69,000 , accretion of unearned discount of approximately $ 645,000 and the accretion of
loan premium of approximately $ 149,000 .
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The total interest expense of approximately $ 1.1
million for the three months ended December 31, 2022, was recognized in the accompanying condensed statements of operations and included
the interest only payments totaling approximately $ 518,000 , the amortization of financing costs of approximately $ 43,000 , unearned discount
of approximately $ 400,000 and the accretion of loan premium of approximately $ 93,000 . The total interest expense of approximately $ 2.1
million for the six- months ended December 31, 2022, was recognized in the accompanying condensed statements of operations and included
interest only payments totaling approximately $ 987,000 , the amortization of financing costs of approximately $ 85,000 , unearned discount
of approximately $ 801,000 and the accretion of loan premium of approximately $ 237,000 .
As of December 31, 2023, the remaining principal
balance of $10 million under the Loan is payable in 12 monthly equal installments. For the three and six months ended December 31, 2023,
the Company paid back $2.5 million and $5 million respectively, of the original loan of $15 million.
The following is a summary of the Notes Payable as of December 31,
2023 and June 30, 2023:
Current portion of Notes Payable
Schedule of note payable
December 31, 2023
June 30, 2023
Current portion of Notes Payable
$ 10,000,000
$ 10,000,000
Less debt financing costs
( 52,011 )
( 108,751 )
Less unearned discount
( 489,330 )
( 1,023,145 )
Plus accretion of loan premium
736,666
236,970
Current portion of Notes Payable, net of financing costs, unearned premiums and discount
$ 10,195,325
$ 9,105,074
Non-current portion of Notes Payable
December 31, 2023
June 30, 2023
Notes Payable
$ -
$ 5,000,000
Less debt financing costs
-
( 11,820 )
Less unearned discount
-
( 111,212 )
Plus accretion of loan premium
-
350,302
Notes Payable, net of the current portion financing costs, unearned premiums and discount
$ -
$ 5,227,270
Estimated future amortization expense and accretion of premium and
discount 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 6 months)
$ 378,118
$ 40,191
$ 87,576
2025
111,212
11,820
25,758
Total
$ 489,330
$ 52,011
$ 113,334
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9. Fair Value Measurements
At December 31, 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
December 31, 2023
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ -
$ -
$ 123,158
$ 123,158
Derivative liability - Conversion option on note payable
-
-
6,548
6,548
Total derivatives
$ -
$ -
$ 129,706
$ 129,706
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 six months ended December 31, 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
( 771,122 )
( 919,214 )
Transfer in and/or out of Level 3
-
-
Balance at December 31, 2023
$ 123,158
$ 6,548
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The following table presents the activity for
liabilities measured at fair value using unobservable inputs for the six months ended December 31, 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
1,648,029
2,140,523
Transfer in and/or out of Level 3
-
-
Balance at December 31, 2022
$ 1,842,560
$ 2,328,553
The fair values of derivative liabilities for
the Avenue Warrants and the conversion option of the Note at December 31, 2023 in the accompanying condensed balance sheet, were approximately
$123,000 and approximately $7,000, respectively. The total change in the fair value of the derivative liabilities totaled approximately
$983,000 and $1.7 million for the three and six months ended December 31, 2023, respectively; 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 December 31, 2023 included the closing stock price of $ 1.26 per share; for the Avenue Warrants, the exercise price of $ 5.82 , remaining
term 2.9 years, risk free rate of 4.0 % and volatility of 93.0 % ; and for the embedded derivative liability of the conversion option, the
conversion price of $ 6.98 ; remaining term 0.92 years, risk free rate of 4.87 % and volatility of 84.0 % .
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 December 31, 2023 and June 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 December 31, 2023 and June 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 December 31, 2023, investments in U.S. Treasury
Bills were valued through use of quoted prices and are classified as Level 1.
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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
December 31, 2023
Level 1
Level 2
Level 3
Total
Cash
$ 10,553,367
$ -
$ -
$ 10,553,367
U.S. Treasury Bills due in 3 months or less at purchase
9,673,331
-
-
9,673,331
Total
$ 20,226,698
$ -
$ -
$ 20,226,698
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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10. 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 December 31, 2023, the Company sold 2,900,902 shares of common stock under the Sales Agreement for total net proceeds
of $ 7.4 million after 3 % commissions and expenses of approximately $ 258,000 . During the six months ended December 31, 2023, the Company
sold 3,333,103 shares of common stock under the Sales Agreement for total net proceeds of $ 9.3 million after 3 % commissions and expenses
of approximately $ 377,000 .
During the three months ended December 31, 2022,
the Company sold 4,312,741 shares of common stock under the Sales Agreement for total net proceeds of $ 32.5 million after 3 % commissions
and expenses of approximately $ 1.2 million. During the six months ended December 31, 2022, the Company sold 5,857,613 shares of common
stock under the Sales Agreement for total net proceeds of $ 38.4 million after 3 % commissions and expenses of approximately $ 1.6 million.
Stock Options
The following table summarizes the activity relating
to the Company’s stock options for the six months ended December 31, 2023:
Schedule of summarizes the activity relating to the Company’s stock options
Options
Weighted-Average Exercise Price
Weighted Remaining Average Contractual Term
Aggregate Intrinsic Value
Outstanding at June 30, 2023
3,952,864
$ 7.10
6.3
$ 1,067,966
Granted
394,417
3.22
6.1
-
Options Expired
( 2,400 )
7.08
-
-
Options Canceled
( 171,556 )
4.60
-
-
Outstanding at December 31, 2023
4,173,325
$ 6.84
5.6
$ -
Exercisable at December 31, 2023
2,155,162
$ 8.31
4.4
$ -
The fair value of each option grant on the date
of grant is estimated using the Black-Scholes option pricing model. The pricing model reflects the following weighted-average assumptions
for the six months ended December 31, 2023 and 2022:
Schedule of assumptions used
December 31, 2023
June 30, 2023
Expected life of options (In years)
5
6
Expected volatility
87.11 %
81.65 %
Risk free interest rate
4.80 %
3.82 %
Dividend Yield
0 %
0 %
The total stock option-based compensation expense
for three-months ended December 31, 2023 and 2022 was of $ 619,701 and $ 1,712,787 , respectively.
The total stock option-based compensation expense
for six-months ended December 31, 2023 and 2022 was of $ 1,427,728 and $ 2,591,427 , respectively.
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Issuance and modification 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 was 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 total stock compensation cost of these stock options of $ 791,700 was recognized as
stock compensation in the three months ended December 31, 2022. The equity awards vest quarterly over the annual service period from November
9, 2023 to 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 November 9, 2023, the Company issued equity
awards for the board of directors’ annual compensation. Four directors received restricted stick units (“RSUs”) to purchase
a total of 182,696 shares of common stock at the grant date fair value of $ 3.01 per share, a total cost of $ 77,905 was recognized as stock
compensation in the three months ended December 31, 2023. Two directors received stock options to purchase 183,250 shares of common stock
at an exercise price of $ 3.01 per share. The total stock compensation cost related to these stock options of $ 34,466 was recognized in
the three months ended December 31, 2023. The equity awards vest quarterly over the annual service period from November 9, 2023, on February
9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting.
In December 2023, the Company terminated five
employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
The modifications included the acceleration of certain tranche vesting of stock option awards to purchase a total of 56,233 shares of
common stock (“Accelerated Options”), effective on the December Separation Date, as defined in severance agreement (“Separation
Date”); and extended the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and
unexercised stock options held by the terminated employees as of the Separation Date. Accordingly, the Company remeasured the modified
awards based on the stock price of $1.54 per share at the close on the Separation Date and a one-year life. The net adjustment for both
stock option modifications was a net credit of $127,199 and was recognized as adjustment to stock compensation expense for the three months
ended December 31, 2023.
The modification also included the acceleration
of an additional tranche vesting of 10,302 Restricted Stock Units, (“RSUs”) as of the Separation date. The modified RSUs were
remeasured based on the stock price of $1.54 per share at close on the Separation Date and totaled $15,865, representing an additional
in stock-based compensation for the three months ended December 31, 2023. The Company canceled 171,556 unvested stock options and 10,303
unvested RSUs.
The following table summarizes vesting of restricted
stock units:
Schedule of vesting of restricted common stock
Number of Shares
Weighted Average Grant Date Fair Value Per Share
Unvested at June 30, 2023
596,457
$ 5.24
Issued
182,696
3.01
Vested
( 81,422 )
6.12
Canceled
( 10,303 )
6.12
Unvested at December 31, 2023
687,428
$ 4.71
The total stock based compensation – restricted
stock expense for the three-months ended December 31, 2023 and 2022 was of $ 303,173 and $ 1,554,453 , respectively. The total stock based
compensation – restricted stock expense for the six-months ended December 31, 2023 and 2022 was $ 684,007 and $ 1,571,990 , respectively.
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There were 147,508 RSU that vested on November
23, 2023 and the related shares of common stock will issued and delivered by March 15, 2024.
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 six months
ended December 31, 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 December 31, 2023
7,770,285
$ 2.06
3.5
$ -
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 and six months ended December 31, 2023.
11. 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 89703. 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 December 31, 2023 and 2022, respectively and $ 26,000 and $ 26,000
for the six months ended December 31, 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
December 31, 2023
June 30, 2023
Assets
Operating lease, right-of-use asset, net
$ 60,418
$ 80,789
Liabilities
Current portion of operating lease liabilities
$ 48,231
$ 44,909
Operating lease liabilities, net of current portion
17,604
42,505
Total operating lease liabilities
$ 65,835
$ 87,414
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At December 31, 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 6 months)
$ 26,356
2025
44,636
Total minimum lease payments
70,992
Less amount representing interest
( 5,157 )
Present value of future minimum lease payments
65,835
Less current portion of operating lease liabilities
( 48,231 )
Operating lease liabilities, net of current portion
$ 17,604
Total cash paid for amounts included in the measurement of lease liabilities
were $ 25,800 and $ 25,050 for the six months ended December 31, 2023 and 2022, respectively.
The weighted average remaining lease term and
discount rate as of December 31, 2023 and June 30, 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate
December 31, 2023
June 30, 2023
Weighted average remaining lease term (Years)
Operating leases
1.3
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.
Shareholder class action complaint
On January 19, 2024, a purported shareholder class
action complaint, captioned Eric Olmstead v. BioVie Inc. et al. , No. 3:24-cv-00035, was filed in the U.S. District Court for the
District of Nevada, naming Company and certain of its officers and/or directors as defendants. The lawsuit alleges that the Company made
material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects,
including information related to the study and trial of NE3107, in violation of Sections 10(b) and
20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers
of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and seeks unspecified monetary damages
on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
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The Company believes the lawsuit is without merit
and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding
the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying condensed financial statements.
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
$ 20,500 and $ 19,000 ,
for the three months ended December 31, 2023 and 2022, respectively. The Company made contributions of approximately $ 51,400
and $ 64,200 , for the six
months ended December 31, 2023 and 2022, respectively.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.