1 unchanged sentence
Condensed Balance Sheets
+Added: September 30,
CURRENT ASSETS:
Cash and cash equivalents
−Removed: Investments in U.S.
−Removed: Treasury Bills
−Removed: Prepaids and other current assets
+Added: Prepaid and other current assets
Total current assets
4 unchanged sentences
Accounts payable and accrued expenses
−Removed: Other current liabilities
Current portion of operating lease liabilities
−Removed: Current portion of note payable, net of financing cost, unearned premium and discount of $ 492,905 at March 31, 2024 and $ 894,926 at June 30, 2023
−Removed: Warrant liabilities
−Removed: Embedded derivative liability
+Added: Current portion of note payable, net of financing cost, unearned premium and discount of $ 820,242 at September 30, 2024 and $ 701,210 at June 30, 2024
+Added: Warrant liability
Total current liabilities
Operating lease liabilities, net of current portion
−Removed: Note payable, net of current portion, financing cost, unearned premium and discount of $ 0 and $ 227,270 at March 31, 2024 and June 30, 2023, respectively.
TOTAL LIABILITIES
6 unchanged sentences
Common stock, $ 0.0001 par value;
−Removed: 800,000,000 shares authorized at March 31, 2024 and June 30, 2023, respectively;
−Removed: 61,018,606 shares issued of which 60,969,846 shares are outstanding at March 31, 2024;
+Added: 800,000,000 shares authorized at September 30, 2024 and June 30, 2024, respectively;
+Added: 7,982,986 shares issued of which 7,956,660 shares are outstanding at September 30, 2024;
and 6,216,398 shares issued of which 6,190,072 shares outstanding at June 30, 2024
Additional paid in capital
−Removed: Accumulated other comprehensive income
Accumulated deficit
8 unchanged sentences
Three Months Ended
−Removed: Nine Months Ended
−Removed: Nine Months Ended
−Removed: March 31, 2024
−Removed: March 31, 2023
−Removed: March 31, 2024
−Removed: March 31, 2023
+Added: September 30, 2024
+Added: September 30, 2023
OPERATING EXPENSES:
+Added: Amortization of intangible assets
Research and development expenses
4 unchanged sentences
( 10,875,821 )
−Removed: ( 27,389,285 )
−Removed: ( 34,103,655 )
−Removed: OTHER (INCOME) EXPENSE:
+Added: OTHER EXPENSE (INCOME):
Change in fair value of derivative liabilities
−Removed: ( 1,799,339 )
Interest expense
Interest income
−Removed: TOTAL OTHER (INCOME) EXPENSE, NET
−Removed: $ ( 8,067,830 )
−Removed: $ ( 15,041,163 )
+Added: TOTAL OTHER EXPENSE (INCOME), NET
$ ( 4,152,032 )
4 unchanged sentences
$ ( 10,710,464 )
−Removed: $ ( 28,066,162 )
−Removed: $ ( 41,143,876 )
NET LOSS PER COMMON SHARE
3 unchanged sentences
$ ( 10,710,464 )
−Removed: $ ( 28,066,162 )
−Removed: $ ( 41,143,876 )
−Removed: Other comprehensive (loss) income
−Removed: Unrealized gain on investments for available-for-sale
+Added: Other comprehensive loss
+Added: Unrealized gain on available-for-sale investments
Reclassification of unrealized gains on available-for-sale investments upon settlement
−Removed: Total other comprehensive (loss) income
+Added: Total other comprehensive loss
Comprehensive loss
1 unchanged sentence
$ ( 10,887,055 )
−Removed: $ ( 28,242,753 )
−Removed: $ ( 41,127,371 )
See accompanying notes to unaudited condensed financial
−Removed: Condensed Statements of Cash Flows
−Removed: Nine Months Ended
−Removed: Nine Months Ended
−Removed: March 31, 2024
−Removed: March 31, 2023
−Removed: CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: $ ( 27,179,739 )
−Removed: $ ( 41,143,876 )
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Amortization of intangible assets
−Removed: Stock based compensation - restricted stock units
−Removed: Stock based compensation expense - stock options
−Removed: Amortization of financing costs
−Removed: Accretion of unearned loan discount
−Removed: Accretion of loan premium
−Removed: Realized gain on maturity of available-for sale
−Removed: Change in operating lease right-of-use assets
−Removed: Gain on termination of operating lease
−Removed: Change in fair value of derivative liabilities
−Removed: ( 1,799,339 )
−Removed: Changes in operating assets and liabilities:
−Removed: Prepaids and other assets
−Removed: Accounts payable and accrued expenses
−Removed: Operating lease liabilities
−Removed: Other current liabilities
−Removed: ( 1,159,768 )
−Removed: Net cash used in operating activities
−Removed: ( 23,938,485 )
−Removed: ( 28,965,321 )
−Removed: CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Proceeds from (purchases of) U.S.
−Removed: Treasury Bills
−Removed: ( 12,504,943 )
−Removed: Net cash provided by (used in) investing activities
−Removed: ( 12,504,943 )
−Removed: CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Net proceeds from issuance of common stock
−Removed: Payment of note payable
−Removed: ( 7,500,000 )
−Removed: Proceeds from exercise of stock options
−Removed: Net proceeds from issuance of common stock - Related Party
−Removed: Net cash provided by financing activities
−Removed: Net increase in cash and cash equivalents
−Removed: Cash and cash equivalents, beginning of period
−Removed: Cash and cash equivalents, end of period
−Removed: SUPPLEMENTAL CASH FLOW INFORMATION:
−Removed: Cash paid for interest
−Removed: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
−Removed: Right of use assets obtained in exchange for lease obligations
−Removed: Unrealized gain on U.S.
−Removed: Treasury Bills
−Removed: Reclassification of unrealized gains on available-for-sale investments upon settlement
−Removed: Deemed dividend of ratchet adjustment to warrants
−Removed: See accompanying notes to unaudited condensed financial
Condensed Statements of Changes in Stockholders’
7 unchanged sentences
$ ( 301,225,705 )
−Removed: Stock option based compensation
+Added: Stock-based compensation - stock options
Stock-based compensation - restricted stock units
Proceeds from issuance of common stock, net of costs of $118,891
−Removed: Proceeds from issuance of common stock, net of costs of $94,160 - Related Party
+Added: Issuance of common stock from vesting of - restricted stock units
( 10,710,464 )
( 10,710,464 )
+Added: Relcassification of unrealized gains on available for sale investments upon settlement
Balance, September 30, 2023
$ 319,480,452
−Removed: Stock-based compensation - restricted stock units
−Removed: Stock option based compensation
−Removed: Cashless exercise of options
−Removed: Cashless exercise of warrants
−Removed: Proceeds from exercise of options
−Removed: Proceeds from issuance of common stock, net of costs of $1,206,206
$ ( 311,936,169 )
−Removed: ( 15,687,002 )
−Removed: Balance, December 31, 2022
−Removed: ( 277,072,603 )
−Removed: Stock-based compensation - restricted stock units
−Removed: Issuance of restricted stock units
−Removed: Stock option based compensation
−Removed: Proceeds from issuance of common stock, net of costs of $338,846
−Removed: ( 15,041,163 )
−Removed: ( 15,041,163 )
−Removed: Unrealized gain on available-for-sale securities
−Removed: Balance, March 31, 2023
−Removed: $ 313,811,910
−Removed: $ ( 292,113,766 )
Balance, June 30, 2024
3 unchanged sentences
Stock-based compensation - restricted stock units
−Removed: Proceeds from issuance of common stock, net of costs of $118,891
Issuance of common stock from vesting of - restricted stock units
+Added: Stock-based compensation - issuance of common stock for services rendered
+Added: Proceeds from issuance of common stock, net of costs of $747,408
+Added: Issuance of additional shares for fractional shares effected by the reverse split
+Added: Deemed dividend for ratchet adjustment to warrants
( 4,152,032 )
( 4,152,032 )
−Removed: Reclassification of unrealized gains on available for sale investments upon settlement
Balance, September 30, 2024
$ 352,770,440
−Removed: Stock - based compensation - stock options
−Removed: Stock-based compensation - restricted stock units
−Removed: Proceeds from issuance of common stock, net of costs of $258,254
−Removed: Issuance of common stock from vesting of - restricted stock units
$ ( 338,709,734 )
+Added: See accompanying notes to unaudited condensed financial
+Added: Condensed Statements of Cash Flows
+Added: Three Months Ended
+Added: Three Months Ended
+Added: September 30, 2024
+Added: September 30, 2023
+Added: CASH FLOWS FROM OPERATING ACTIVITIES:
$ ( 4,152,032 )
−Removed: Balance, December 31, 2023
$ ( 10,710,464 )
−Removed: Stock - based compensation - stock options
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Amortization of intangible assets
Stock based compensation - restricted stock units
−Removed: Issuance of common stock from vesting of - restricted stock units
−Removed: Proceeds from issuance of common stock, net of costs of $2,530,996
−Removed: Deemed dividend for ratchet adjustment to warrants
+Added: Stock based compensation expense - stock options
+Added: Stock based compensation expense - issuance of common stock for services rendered
+Added: Amortization of financing costs
+Added: Accretion of unearned loan discount
+Added: Accretion of loan premium
+Added: Realized gain on maturity of available-for sale
+Added: Non-cash lease expense from right-of-use assets
+Added: Change in fair value of derivative liabilities
+Added: Changes in operating assets and liabilities:
+Added: Prepaid and other current assets
( 1,446,761 )
+Added: Accounts payable and accrued expenses
+Added: Operating lease liabilities
+Added: Other current liabilities
+Added: Net cash used in operating activities
( 3,579,456 )
−Removed: Balance, March 31, 2024
( 12,177,049 )
+Added: CASH FLOWS FROM INVESTING ACTIVITIES:
+Added: Proceeds from (purchases of) U.S.
+Added: Treasury Bills (available-for-sale)
+Added: Net cash provided by (used in) investing activities
+Added: CASH FLOWS FROM FINANCING ACTIVITIES:
+Added: Net proceeds from issuance of common stock
+Added: Payments of note payable
( 2,500,000 )
+Added: ( 2,500,000 )
+Added: Net cash used in financing activities
+Added: Net change in cash and cash equivalents
+Added: ( 3,820,393 )
+Added: Cash and cash equivalents, beginning of period
+Added: Cash and cash equivalents, end of period
+Added: SUPPLEMENTAL CASH FLOW INFORMATION:
+Added: Cash paid for interest
+Added: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
+Added: Reclassification of unrealized gains on U.S.
+Added: Treasury Bills (available-for-sale investments) upon settlement
+Added: Deemed dividend for ratchet adjustment to warrants
See accompanying notes to unaudited condensed financial
Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
+Added: For the Three Months Ended September 30, 2024 and
Background Information
10 unchanged sentences
that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)
−Removed: and Parkinson’s disease (“PD”), and NE3107 could, if approved by U.S.
+Added: and Parkinson’s disease (“PD”), and NE3107 could, if approved by the U.S.
Food and Drug Administration (“FDA”),
3 unchanged sentences
In neurodegenerative disease, the Company’s
−Removed: drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear
−Removed: factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”)
−Removed: signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
−Removed: NE3107 does not interfere with
−Removed: their homeostatic functions (e.g., insulin signaling and neuron growth and survival).
−Removed: Both inflammation and insulin resistance are drivers
−Removed: of AD and PD.
−Removed: Alzheimer’s Disease (NCT05083260)
+Added: drug candidate Bezisterim (NE3107) inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”)
+Added: and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis
+Added: factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
+Added: NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival).
+Added: Both inflammation
+Added: and insulin resistance are drivers of AD and PD.
+Added: Alzheimer’s Disease
On November 29, 2023, the Company announced the analysis
9 unchanged sentences
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
−Removed: for further action.
−Removed: After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in
−Removed: the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.
+Added: for potential further action.
+Added: After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
+Added: were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms.
−Removed: The unplanned exclusion of so many patients has left the trial underpowered
−Removed: for the primary endpoints.
−Removed: In the Per-Protocol population, which included those patients who completed the trial and who were further
−Removed: verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest
−Removed: a slowing of cognitive loss;
+Added: The unplanned exclusion of so many patients left the trial underpowered for
+Added: the primary endpoints.
+Added: In the Per-Protocol population, which included those patients who completed the trial and who were further verified
+Added: to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
+Added: of cognitive loss;
these same patients experienced an advantage in age deceleration vs.
−Removed: placebo as measured by DNA epigenetic
−Removed: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
−Removed: case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
−Removed: was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
−Removed: Additional DNA methylation
−Removed: data continues to be collected and analyzed.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Background Information (continued)
−Removed: Parkinson’s Disease (NCT05083260)
+Added: placebo as measured by DNA epigenetic change.
+Added: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
+Added: measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
+Added: This test was a non-primary/secondary
+Added: endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
+Added: Additional DNA methylation data continues to
+Added: be collected and analyzed.
+Added: Parkinson’s Disease
The Phase 2 study of bezisterim (NE3107) for the treatment
14 unchanged sentences
Department of Defense (“DOD”), awarded through the Peer Reviewed
−Removed: Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”).
−Removed: can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment
−Removed: of neurological symptoms that are associated with long COVID.
+Added: Medical Research Program of the Congressionally Directed Medical Research Programs.
+Added: In August 2024, U.S.
+Added: Army Medical Research and Development
+Added: Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for
+Added: the treatment of neurological symptoms that are associated with long COVID.
+Added: and the FDA authorized our Investigational New Drug (“IND”)
+Added: application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive
+Added: symptoms associated with long covid.
The Company anticipates the trial to commence by early 2025.
−Removed: Long COVID is a condition in which symptoms of COVID-19,
−Removed: the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more.
−Removed: The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently
−Removed: or previously had long COVID.
−Removed: Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating.
−Removed: in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars.
−Removed: there are no therapies proven effective for treatment.
−Removed: Chronic inflammation is one of the main hypotheses
−Removed: that researchers have proposed to explain the persistence of symptoms in long COVID.
−Removed: Specifically in individuals with “brain fog,”
−Removed: sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features.
−Removed: Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel
−Removed: oral treatment targeting an underlying cause of long COVID symptoms.
−Removed: Neuroinflammation, insulin resistance, and oxidative stress are common
−Removed: features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis.
−Removed: Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin
−Removed: sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
−Removed: (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule
−Removed: in AD, PD, and long COVID patients.
−Removed: Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.
+Added: The Company has been reimbursed approximately
+Added: $325,000 for the trial during the three months ended September 30, 2024.
Liver Disease Program
21 unchanged sentences
of ascites due to chronic liver cirrhosis.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Background Information (continued)
−Removed: While the active agent, terlipressin, is approved
−Removed: and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
−Removed: authorizations.
−Removed: Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
−Removed: annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.
−Removed: The FDA has not approved any drug to treat refractory
The BIV201 development program was initiated by LAT
5 unchanged sentences
on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
+Added: Liquidity and Going Concern
The Company’s operations are subject to a number
10 unchanged sentences
continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of
−Removed: As of March 31, 2024, the Company had working capital of approximately $ 18.1 million, cash and cash equivalents of approximately
+Added: As of September 30, 2024, the Company had working capital of approximately $ 13.3 million, cash and cash equivalents of approximately
$ 20.0 million, stockholders’ equity of approximately $ 14.1 million, and an accumulated deficit of approximately $ 338.7 million.
3 unchanged sentences
additional financing as needed.
−Removed: Although our cash balance is projected to sustain operations over the next nine months from the balance
−Removed: Projected cash flows could be extended beyond that period of time, if further measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s
−Removed: development and launch of next phase clinical programs, the Company’s current planned operations to meet certain goals and objectives.
+Added: Projected cash flows could be extended if further measures are taken to delay planned expenditures on
+Added: our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
The future viability of the Company is largely dependent
7 unchanged sentences
as a going concern.
−Removed: The condensed financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
+Added: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Significant Accounting Policies
16 unchanged sentences
audited financial statements for the fiscal years ended June 30, 2024 and 2023 in our Annual Report on Form 10-K filed with the SEC on
−Removed: August 16, 2023 (the “2023 Form 10-K”).
−Removed: A summary of significant accounting policies can also be found in those audited financial
−Removed: statements in the 2023 Form 10-K.
−Removed: Net loss per Common Share
−Removed: Basic net loss per common share is computed by
−Removed: dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock, par value $ 0.0001
−Removed: per share (“common stock”), outstanding during the period.
−Removed: Diluted net loss per common share is computed by dividing the
−Removed: net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially
−Removed: outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable
−Removed: through stock options, warrants, and restricted stock units.
−Removed: For the three and nine months ended March 31, 2024 and 2023, such
−Removed: amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.
−Removed: The table below shows the number of outstanding stock
−Removed: options, warrants and restricted stock units as of March 31, 2024 and 2023:
−Removed: Schedule of dilutive securities were excluded from the computation of diluted loss per share
−Removed: March 31, 2024
−Removed: March 31, 2023
−Removed: Number of Shares
−Removed: Number of Shares
−Removed: Stock Options
−Removed: Restricted Stock Units
−Removed: Recent Accounting Pronouncements
−Removed: The Company considers the applicability and impact
−Removed: of all Accounting Standards Updates (“ASUs”).
−Removed: There have been no recent ASUs that are expected to have a material impact on
−Removed: the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 Form 10-K.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Significant Accounting Policies (continued)
+Added: September 30, 2024 (the “2024 Form 10-K”).
+Added: A summary of significant accounting policies can also be found in those audited
+Added: financial statements in the 2024 Form 10-K.
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits
−Removed: and money market funds held at banks and funds held in brokerage accounts which included a U.S.
+Added: 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.
−Removed: Bills with original maturities of three months or less.
+Added: Treasury Bills with original maturities of three months or less.
Investments in U.S.
1 unchanged sentence
Investments in U.S.
−Removed: Treasury Bills with
−Removed: maturities greater than three months on the date of purchase, are accounted for as available for sale and are recorded at fair
−Removed: Unrealized gains were included in other comprehensive (loss) income in the accompanying condensed statements of operations
−Removed: and comprehensive loss.
−Removed: Upon the maturity and settlement of these investments, realized gains were recorded as a component of
−Removed: interest income on the accompanying condensed statement of operations and comprehensive loss.
+Added: Treasury Bills with maturities
+Added: greater than three months, are accounted for as available-for-sale and are recorded at fair value.
+Added: Realized gains were included in the
+Added: accompanying condensed statements of operations and comprehensive loss from the settlement of available-for-sale investments during the
+Added: three months ended September 30, 2023.
+Added: The Company had no outstanding investment securities with original maturities of greater than three
+Added: months at the time of purchase as of and during the three months ended September 30, 2024.
Concentration of Credit Risk in the Financial Service
−Removed: As of March 31, 2024, the Company had cash deposited
+Added: As of September 30, 2024, the Company had cash deposited
in certain financial institutions in excess of federally insured levels.
1 unchanged sentence
financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
−Removed: However, in March
−Removed: and April 2023, certain U.S.
−Removed: government banking regulators took steps to intervene in the operations of certain financial institutions
−Removed: due to liquidity concerns, which caused general heightened uncertainties in financial markets.
−Removed: While these and other current events have
−Removed: not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect
−Removed: to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into
−Removed: new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results
−Removed: of operations.
+Added: However, if liquidity
+Added: and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the
+Added: Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse
+Added: effect on its business, financial condition and results of operations.
Fair value measurement of assets and liabilities
11 unchanged sentences
The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
−Removed: Level 1 – Inputs are unadjusted quoted prices
−Removed: in active markets for identical assets or liabilities.
−Removed: Level 2 – Inputs are quoted prices for similar
−Removed: assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through
−Removed: market corroboration, for substantially the full term of the financial instrument.
−Removed: Level 3 – Inputs are unobservable inputs based
−Removed: on our assumptions.
+Added: Level 1 - Inputs are unadjusted quoted prices in active
+Added: markets for identical assets or liabilities.
+Added: Level 2 - Inputs are quoted prices for similar assets
+Added: and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market
+Added: corroboration, for substantially the full term of the financial instrument.
+Added: Level 3 - Inputs are unobservable inputs based on
+Added: our assumptions.
The Company’s financial instruments include
−Removed: cash, accounts payable, the carrying value of the operating lease liabilities, notes payable and other derivative liabilities (see Note
−Removed: The carrying amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items.
−Removed: amounts of notes payable and operating lease liabilities approximate their fair values since they bear interest at rates which approximate
−Removed: market rates for similar debt instruments.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Investments in U.S.
−Removed: Treasury Bills Available for Sale
−Removed: The following is a summary of the U.S.
−Removed: Treasury Bills
−Removed: held at June 30, 2023:
−Removed: Schedule of U.S.
−Removed: treasury bills held
−Removed: Amortized Cost Basis
−Removed: Gross Unrealized Gain
−Removed: Total Accumulated Other Comprehensive Income
−Removed: Treasury Bills due in 3 - 6 months
−Removed: During the fiscal year ended June 30, 2023, the Company
−Removed: purchased a total of approximately $ 46 million of U.S.
−Removed: Treasury Bills.
−Removed: All outstanding investments in U.S.
−Removed: Treasury Bills available for
−Removed: sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of
−Removed: $ 223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
+Added: cash, accounts payable, the carrying value of the operating lease liabilities and notes payable.
+Added: The carrying amounts of cash and accounts
+Added: payable approximate their fair value, due to the short-term nature of these items.
+Added: The carrying amounts of notes payable and operating
+Added: lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments.
+Added: Net Loss per Common Share
+Added: Basic net loss per common share is computed by dividing
+Added: the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period.
+Added: Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number
+Added: of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the potential dilution
+Added: that could occur from common shares issuable through stock options, warrants, and convertible debentures.
+Added: For the three months ending
+Added: September 30, 2024 and 2023, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the
+Added: net loss for the periods presented.
+Added: The weighted average number of common shares outstanding
+Added: at September 30, 2024 of 6,398,360 includes the weighted average effect of the pre-funded warrants issued in connection with the September
+Added: 2024 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 8).
+Added: The table below shows the potential shares of common
+Added: stock, presented based on amounts outstanding at each year end, which were excluded from the computation of diluted net loss per share
+Added: attributable to common stockholders because including them would have had an anti-dilutive effect:
+Added: Schedule of dilutive securities were excluded from the computation of diluted loss per share
+Added: September 30, 2024
+Added: September 30, 2023
+Added: Number of Shares
+Added: Number of Shares
+Added: Stock Options
+Added: Restricted Stock Units
+Added: Notes payable conversion option
+Added: Reverse stock split
+Added: The company effected a 1:10 reverse split of the issued
+Added: and outstanding shares of its Class A commons stock which was approved by the board of directors after the approval obtained from shareholders
+Added: at a special meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’
+Added: approval was obtained.
+Added: All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
+Added: Grant program
+Added: The Company records
+Added: expenses related to the DOD long Covid Program as such expenses are incurred.
+Added: The reimbursement of such expenses is recognized upon receipt
+Added: of the reimbursement as a credit against the respective expense account.
+Added: Recent Accounting
+Added: Pronouncements
+Added: In November 2024, the
+Added: FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”), which will require additional disclosure of
+Added: the nature of expenses included in the income statement in response to longstanding requests from investors for more information about
+Added: an entity’s expenses.
+Added: The new standard requires disclosures about specific types of expenses included in the expense captions presented
+Added: on the face of the income statement as well as disclosures about selling expenses.
+Added: The new standard will be effective for public companies
+Added: for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027.
+Added: The requirements
+Added: will be applied prospectively with the option for retrospective application.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating
+Added: the impact of this accounting standard update on its financial statements.
Intangible Assets
−Removed: The Company’s intangible assets consist of intellectual
−Removed: property acquired from LAT Pharma and are amortized over their estimated useful lives.
+Added: The Company’s intangible assets consist of intellectual property
+Added: acquired from LAT Pharma, Inc.
+Added: and are amortized over their estimated useful lives.
The following is a summary of the Company’s intangible assets:
Schedule of intangible assets
−Removed: March 31, 2024
+Added: September 30, 2024
June 30, 2024
Intellectual Property
−Removed: Less Accumulated Amortization
+Added: Accumulated Amortization
( 1,943,396 )
2 unchanged sentences
Amortization expense was $ 57,344 in each of the three-month
−Removed: periods ended March 31, 2024 and 2023.
−Removed: Amortization expense was $ 172,033 in each of the nine-month periods ended March 31, 2024 and 2023.
+Added: periods ended September 30, 2024 and 2023.
The Company amortizes intellectual property over the expected original useful lives of 10 years.
2 unchanged sentences
Year ending June 30, 2025 (Remaining 9 months)
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
Related Party Transactions
Equity Transactions with Acuitas
−Removed: On July 15, 2022, the Company entered into a
−Removed: securities purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s majority stockholder,
−Removed: pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364
−Removed: shares of the Company’s Common Stock, at a price of $1.65 per share (the “PIPE Shares”), and (ii) a warrant to
−Removed: purchase 7,272,728 shares of Common Stock (“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of
−Removed: exercise of five years.
−Removed: The warrant’s down round feature reduced the exercise price of the warrant to $1.00 per share on March
−Removed: 6, 2024 in connection with the offering further described in Note 10 as the Company sold stock at a price lower than the initial exercise price of the warrant.
−Removed: The Company calculated the difference in fair value of the
−Removed: warrants between the stated exercise price and the reduced exercise price and recorded $ 886,423
−Removed: as a deemed dividend.
−Removed: The fair value of the warrants were estimated using the Black Scholes Method with the following inputs, the
−Removed: stock price of $ 1.07 ,
−Removed: exercise price of $ 1.82
−Removed: remaining term 3.4
−Removed: years, risk free rate of 4.4 %
−Removed: and volatility of 95.0 % .
−Removed: On August 15, 2022, the Company received net proceeds
−Removed: of approximately $5.9 million, net of costs of approximately $94,000, and entered into an amended and restated registration agreement
−Removed: with Acuitas, which amended and restated that certain registration rights agreement, dated as of June 10, 2021, by and between the Company
−Removed: and Acuitas (the “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities”
−Removed: in the Existing Registration Rights Agreement to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
−Removed: Other Liabilities
−Removed: The current portion of other liabilities at June 30,
−Removed: 2023 was approximately $ 48,000 and represented the remaining balance of a retention bonus payable for arrangements with certain employees,
−Removed: which was paid in July 2023.
+Added: On July 15, 2022, the Company entered into a securities
+Added: purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which
+Added: Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 363,636 shares of the Company’s Common
+Added: Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
+Added: Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years.
+Added: The down round feature reduced the exercise
+Added: price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 and again to $1.53 per share on September 25, 2024 in connection
+Added: with the offering further described in Note 8 as the Company sold stock at a price lower than its initial exercise price.
+Added: calculated the difference in fair value of the PIPE Warrant Shares between the stated exercise price and the reduced exercise price and
+Added: recorded $ 325,041 as a deemed dividend in the accompanying condesnsed statement of changes in stockholders’ equity.
+Added: The fair value
+Added: of the PIPE Warrant Shares were estimated using the Black Scholes Method with the following inputs, the stock price of $ 1.20 , exercise
+Added: price of $ 1.53 and $ 10.00 , remaining term of 2.9 years, risk free rate of 3.5 % and volatility of 93.0 % .
Notes Payable
11 unchanged sentences
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%.
−Removed: The prime rate at March 31, 2024 was 8.50 % .
−Removed: The Loan is secured by a lien upon and security interest in all of the Company’s assets,
−Removed: including intellectual property, subject to agreed exceptions.
+Added: The prime rate on September 30, 2024, was 8.50 % .
+Added: The Loan is secured by a lien upon and security interest in all of the Company’s
+Added: assets, including intellectual property, subject to agreed exceptions.
The maturity date of the Loan is December 1, 2024.
10 unchanged sentences
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
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Notes Payable (continued)
+Added: Tranche 2, which amounts to $850,000 (the “Loan Premium”).
The Loan Agreement includes a conversion option to
convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
−Removed: Common Stock at a conversion price of $6.98 per share.
+Added: Common Stock at a conversion price of $69.80 per share (the “Conversion Option”).
On the Closing Date, the Company issued to Avenue
−Removed: warrants to purchase 361,002 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
−Removed: equal to $5.82.
+Added: warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
The Avenue Warrants are exercisable until November 30, 2026.
The amount of the carrying value of the notes payable
−Removed: was determined by allocating portions of the outstanding principal of the notes;
−Removed: approximately $ 1.4 million to the fair value of the Avenue
−Removed: Warrants and approximately $ 2.2 million to the fair value of the embedded conversion option.
−Removed: Accordingly, the total amount of unearned
−Removed: discount of approximately $ 3.6 million, the total direct financing cost of approximately $ 390,000 and premium of $ 850,000 being recognized
−Removed: on an effective interest method over the term of the Loan.
+Added: was determined by allocating portions of the outstanding principal of the notes, approximately $ 1.4 million, to the fair value of the
+Added: Avenue Warrants, and approximately $ 2.2 million to the fair value of the embedded Conversion Option.
+Added: Accordingly, the total amount of
+Added: unearned discount of approximately $3.6 million, the total direct financing cost of approximately $ 390,000 and the Loan Premium of $ 850,000
+Added: are being amortized using the effective interest method over the term of the Loan.
The adjusted effective interest rate is 24%.
−Removed: The total interest expense of approximately $ 629,000
−Removed: and $ 1.1 million for the three months ended March 31, 2024 and 2023, respectively, was recognized in the accompanying condensed statements
−Removed: of operations and comprehensive loss.
−Removed: Interest expense for the three months ended March 31, 2024 and 2023 included the interest payments
−Removed: totaling approximately $ 327,000 and $ 547,000 , the amortization of financing costs of approximately $ 24,000 and $ 43,000 , unearned discount
−Removed: of approximately $ 222,000 and $ 400,000 and the accretion of loan premium of approximately $ 52,000 and $ 93,000 , respectively.
−Removed: interest expense of approximately $ 2.5 million and $ 3.2 million for the nine months ended March 31, 2024 and 2023, respectively, was recognized
−Removed: in the accompanying condensed statements of operations and comprehensive loss.
−Removed: Interest expense for the nine months ended March 31, 2024
−Removed: and 2023 included interest payments totaling approximately $ 1.3 million and $ 1.5 million, the amortization of financing costs of approximately
−Removed: $ 92,000 and $ 128,000 , unearned discount of approximately $ 867,000 and $ 1.2 million and the accretion of loan premium of approximately
−Removed: $ 201,000 and $ 329,000 , respectively.
−Removed: As of March 31, 2024, the remaining principal balance
−Removed: of $7.5 million under the Loan is payable in 9 monthly equal installments.
−Removed: For the three and nine months ended March 31, 2024, the Company
−Removed: paid back $2.5 million and $7.5 million respectively, of the original loan of $15 million.
−Removed: The following is a summary of the Notes Payable as of March 31, 2024 and
−Removed: June 30, 2023:
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Notes Payable (continued)
+Added: Total interest expense associated with this loan was approximately $ 252,000 , which is reflected as a component of interest expense on the accompanying
+Added: condensed statements of operations and comprehensive loss for the three months ended September 30, 2024.
+Added: Interest expense associated with
+Added: this loan was comprised of interest incurred on the outstanding principal of the loan of approximately $ 132,000 , amortization of financing
+Added: costs of approximately $ 9,500 , amortization of the unearned discount of $ 89,000 , and the accretion of the Loan Premium of approximately
+Added: Total interest expense for the three months ended
+Added: September 30, 2023 was approximately $ 1 million on the accompanying condensed statements of operations and comprehensive loss.
+Added: expense was comprised of interest incurred on the outstanding principal of the loan of approximately $ 525,000 , amortization of financing
+Added: costs of approximately $ 38,000 , amortization of the unearned discount of approximately $ 356,000 and the accretion of Loan Premium of approximately
+Added: As of September 30, 2024, the remaining principal
+Added: balance of $ 2.5 million under the Loan is payable in 3 monthly equal installments.
+Added: For the three months ended September 30, 2024, the
+Added: Company paid back $ 2.5 million of the original loan of $ 15 million.
+Added: The following is a summary of the Notes Payable as of September 30, 2024
+Added: and June 30, 2024:
Current portion of Notes Payable
Schedule of note payable
−Removed: March 31, 2024
+Added: September 30, 2024
June 30, 2024
Current portion of Notes Payable
−Removed: Less debt financing costs
−Removed: Less unearned discount
−Removed: ( 1,023,145 )
−Removed: Plus accretion of loan premium
−Removed: Current portion of Notes Payable, net of financing costs, unearned premiums and discount
−Removed: Non-current portion of Notes Payable
−Removed: March 31, 2024
−Removed: June 30, 2023
−Removed: Notes Payable
−Removed: Less debt financing costs
−Removed: Less unearned discount
−Removed: Plus accretion of loan premium
−Removed: Notes Payable, net of the current portion financing costs, unearned premiums and discount
−Removed: Estimated future amortization expense and accretion of premium and discount
−Removed: is as follows:
+Added: debt financing costs
+Added: unearned discount
+Added: accretion of Loan Premium
+Added: Current portion of Notes Payable, net of financing costs, unearned premium and discount
+Added: Estimated future amortization expense and accretion of Loan Premium are
Schedule of estimated future amortization expense and accretion of premium
1 unchanged sentence
Debt Financing Costs
−Removed: Loan accretion Premium
Year ending June 30, 2025 (Remaining 9 months)
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
Fair Value Measurements
−Removed: At March 31, 2024 and June 30, 2023, the estimated
−Removed: fair value of derivative liabilities measured on a recurring basis are as follows:
+Added: At September 30, 2024 and June 30, 2024, the estimated fair value of derivative
+Added: liabilities measured on a recurring basis are as follows:
Schedule of derivative liabilities at fair value
Fair Value Measurements at
−Removed: March 31, 2024
+Added: September 30, 2024
Derivative liability - Warrants
−Removed: Derivative liability - Conversion option on note payable
−Removed: Total derivatives
+Added: Derivative liability - Conversion Option
+Added: Total derivative liabilities
Fair Value Measurements at
1 unchanged sentence
Derivative liability - Warrants
−Removed: Derivative liability - Conversion option on note payable
−Removed: Total derivatives
−Removed: The following table presents the activity for liabilities
−Removed: measured at fair value using unobservable inputs for the nine months ended March 31, 2024:
+Added: Derivative liability - Conversion option
+Added: Total derivative liabilities
+Added: The following table presents the activity for level 3 liabilities measured
+Added: at fair value using unobservable inputs for the three months ended September 30, 2024:
Fair value, liabilities measured on recurring basis
5 unchanged sentences
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liabilities
+Added: Change in fair value of level 3 liabilities
Transfer in and/or out of Level 3
−Removed: Balance at March 31, 2024
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Fair Value Measurements (continued)
−Removed: The following table presents the activity for liabilities
−Removed: measured at fair value using unobservable inputs for the nine months ended March 31, 2023:
−Removed: Derivative liabilities -
+Added: Balance at September 30, 2024
+Added: The following table presents the activity for level 3 liabilities measured
+Added: at fair value using unobservable inputs for the three months ended September 30, 2023:
Derivative liability -
−Removed: Conversion Option on
−Removed: Convertible Debenture
+Added: Derivative liability -
+Added: Conversion Option
Balance at June 30, 2023
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liabilities
+Added: Change in fair value of level 3 liabilities
Transfer in and/or out of level 3
−Removed: Balance at March 31, 2023
+Added: Balance at September 30, 2023
The fair values of derivative liabilities for the
−Removed: Avenue Warrants and the conversion option of the Note at March 31, 2024 in the accompanying condensed balance sheet, were approximately
−Removed: $21,000 and approximately zero, respectively.
−Removed: The total change in the fair value of the derivative liabilities totaled approximately $109,000
−Removed: and $1.8 million for the three and nine months ended March 31, 2024, respectively;
−Removed: and accordingly, was recorded in the accompanying condensed
−Removed: statement of operations and comprehensive loss.
−Removed: The assumptions used in the Black Scholes model to value the derivative liabilities at
−Removed: March 31, 2024 included the closing stock price of $ 0.53 per share;
+Added: Avenue Warrants and Conversion Option at September 30, 2024, in the accompanying condensed balance sheets, were approximately $1,300 and
+Added: approximately zero, respectively.
+Added: The total change in the fair value of the derivative liabilities totaled approximately $2,500 and $708,000
+Added: for the three months ended September 30, 2024 and 2023, respectively;
+Added: and accordingly, was recorded in the accompanying condensed statements
+Added: of operations and comprehensive loss.
+Added: The assumptions used in the Black Scholes model to value the derivative liabilities at September
+Added: 30, 2024 included the closing stock price of $ 1.20 per share;
for the Avenue Warrants, the exercise price of $ 58.20 , remaining term 2.2
−Removed: 2.7 years, risk free rate of 4.5 % and volatility of 93.0 % ;
−Removed: and for the embedded derivative liability of the conversion option, the conversion
−Removed: price of $ 6.98 ;
−Removed: remaining term 0.67 years, risk free rate of 5.3 % and volatility of 104.0 % .
+Added: year, risk free rate of 3.7 % and volatility of 91.0 % ;
+Added: and for the Conversion Option, the conversion price of $ 69.80 ;
+Added: remaining term of
+Added: 2 months, risk free rate of 4.8 % and volatility of 75.0 % .
Derivative liability – Avenue Warrants
−Removed: The Company accounts for stock purchase warrants as
−Removed: either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements.
−Removed: Under applicable accounting
−Removed: guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet and anti-dilution
−Removed: provisions or adjustments to the strike price due to an occurrence of a future event are accounted for as derivative financial instruments.
−Removed: The Avenue Warrants were not considered to be indexed to the Company’s own stock, and accordingly, were recorded as a derivative
−Removed: liability at fair value in the accompanying condensed balance sheets at March 31, 2024 and June 30, 2023.
+Added: The Avenue Warrants were not considered to be indexed
+Added: to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying condensed
+Added: balance sheets at September 30, 2024 and June 30, 2024, respectively.
The Black Scholes model was used to calculate the
−Removed: fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded.
−Removed: The Avenue Warrants
−Removed: are recorded at their fair values at the date of issuance and remeasured at March 31, 2024 and June 30, 2023.
+Added: fair value of the derivative warrant to bifurcate the amount from the Avenue Loan amount funded.
+Added: The Avenue Warrants are recorded at their
+Added: fair values at the date of issuance and remeasured at each subsequent reporting period end date.
Embedded derivative liability – Conversion
−Removed: The embedded derivative liability represents the optional
−Removed: conversion feature of up to $5.0 million of the outstanding Loan, which meets the definition of a derivative and requires bifurcation
−Removed: from the loan amount.
−Removed: The Black Scholes model was used to calculate the
−Removed: fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue Loan
−Removed: amount funded.
+Added: The Conversion Option is accounted for as an embedded
+Added: derivative liability and required bifurcation from the Loan amount.
+Added: The Black Scholes model was used to calculate the fair value of the
+Added: Conversion Option to bifurcate it from the Loan.
Financial assets
−Removed: As of March 31, 2024, investments in U.S.
+Added: As of September 30, 2024, investments in U.S.
Bills were valued through use of quoted prices and are classified as Level 1.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Fair Value Measurements (continued)
−Removed: The following table presents information about our
−Removed: assets that are measured at fair value on a recurring basis.
+Added: The following table presents information about our assets
+Added: that are measured at fair value on a recurring basis using the above input categories.
Measured at fair value on a recurring basis
Fair Value Measurements at
−Removed: March 31, 2024
+Added: September 30, 2024
Treasury Bills due in 3 months or less at purchase
2 unchanged sentences
Treasury Bills due in 3 months or less at purchase
−Removed: Treasury Bills due in 3 - 6 months at purchase
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
Equity Transactions
11 unchanged sentences
During the three
−Removed: months ended March 31, 2024, the Company sold 4,384 shares of common stock under the Sales Agreement for total net proceeds of approximately
+Added: months ended September 30, 2024, the Company sold 2,143 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400
after 3 % commissions and expenses of approximately $ 200 .
−Removed: During the nine months ended March 31, 2024, the Company sold 3,337,487
−Removed: shares of common stock under the Sales Agreement for total net proceeds of $ 9.3 million after 3 % commissions and expenses of approximately
−Removed: During the three months ended March 31, 2023, the
−Removed: Company sold 1,515,078 shares of common stock under the Sales Agreement for total net proceeds of $ 9.8 million after 3 % commissions and
−Removed: expenses of approximately $ 339,000 .
−Removed: During the nine months ended March 31, 2023, the Company sold 7,372,691 shares of common stock under
−Removed: the Sales Agreement for total net proceeds of $ 48.2 million after 3 % commissions and expenses of approximately $ 1.9 million.
−Removed: On March 6, 2024, the Company closed a best efforts
−Removed: public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its common stock, par value $ 0.0001 per
−Removed: share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of Common
−Removed: Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public offering
−Removed: price of $ 1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
−Removed: The Common Warrants
−Removed: have an exercise price of $1.50 per share and are immediately exercisable upon issuance for a period of five years following the date
−Removed: The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement agent
−Removed: fees and offering expenses of approximately $2.5 million.
−Removed: Additionally, upon closing the Company issued the placement agent warrants (“Placement
−Removed: Agent’s warrants”) to purchase 1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal
−Removed: to 125% of the public offering price per share.
−Removed: The Placement Agent’s Warrants are exercisable during a five-year period commencing
−Removed: 180 days from March 6, 2024.
+Added: During the three months ended September 30, 2023, the Company sold 43,220 shares
+Added: of common stock under the Sales Agreement for total net proceeds of $ 1.9 million after 3 % commissions and expenses of approximately $ 119,000 .
+Added: On September 25, 2024, the Company closed a best
+Added: efforts public offering (the “September 2024 Offering”) of 1,360,800
+Added: shares of its common stock, par value $ 0.0001
+Added: per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
+Added: shares of Common Stock, and warrants to purchase up to 1,960,800
+Added: shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 1.53
+Added: per Share, or September Pre-funded Warrant, and the associated September Common Warrant.
+Added: 265,000 September Pre-funded Warrants were
+Added: exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds
+Added: from issuance of common stock.
+Added: The September Common Warrants have an
+Added: exercise price of $ 1.53
+Added: per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
+Added: gross proceeds to the Company from the September 2024 Offering were approximately $ 3.0
+Added: million, before deducting placement agent fees and offering expenses of approximately $747,000.
+Added: Additionally, upon closing, the
+Added: Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040
+Added: shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125 %
+Added: of the public offering price per share.
+Added: The September Placement Agent’s Warrants are exercisable during a five-year period
+Added: commencing 180 days from September 25, 2024.
+Added: Issuance of common stock for services
+Added: On August 12, 2024, the Company awarded 15,000 shares
+Added: of Common Stock to a vendor as part of their fees in exchange for services.
+Added: The fair value of the Common Stock at the date of issuance
+Added: was $ 2.23 per share.
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 33,450 .
Stock Options
−Removed: The following table summarizes the activity relating
−Removed: to the Company’s stock options for the nine months ended March 31, 2024:
+Added: The following table summarizes the activity relating to the Company’s
+Added: stock options for the three months ended September 30, 2024:
Schedule of summarizes the activity relating to the Company’s stock options
6 unchanged sentences
Options Expired
−Removed: Options Canceled
−Removed: Outstanding at March 31, 2024
−Removed: Exercisable at March 31, 2024
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Equity Transactions (continued)
−Removed: The fair value of each option grant on the date of
−Removed: grant is estimated using the Black-Scholes option pricing model.
−Removed: The pricing model reflects the following weighted-average assumptions
−Removed: for the nine months ended March 31, 2024 and 2023:
−Removed: Schedule of assumptions used
−Removed: March 31, 2024
−Removed: June 30, 2023
−Removed: Expected life of options (in years)
−Removed: Expected volatility
−Removed: Risk free interest rate
−Removed: Dividend Yield
−Removed: The total stock based compensation expense from stock
−Removed: options for the three-months ended March 31, 2024 and 2023 was of $ 690,921 and $ 888,998 , respectively and for nine-months ended March
−Removed: 31, 2024 and 2023 was of $ 2,118,649 and $ 3,480,425 , respectively.
−Removed: Issuance and modification of restricted stock units and options:
−Removed: On November 23, 2022, the Company issued equity awards
−Removed: for the board of directors’ annual compensation.
−Removed: Four directors received restricted stock units (“RSUs”) to purchase
−Removed: 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
−Removed: stock compensation in the three months ended December 31, 2022.
−Removed: Three directors received stock options to purchase 195,000 shares of common
−Removed: stock at an exercise price of $ 6.12 per share.
−Removed: The total stock compensation cost of these stock options of $ 791,700 was recognized as
−Removed: stock compensation in the three months ended December 31, 2022.
−Removed: The equity awards vest quarterly over the annual service period from November
−Removed: 9, 2023 to the next annual shareholders’ meeting.
−Removed: While the agreements contain certain contractual vesting terms, there are circumstances
−Removed: where the vesting can be accelerated that is not within the Company’s control and as a result, for accounting purposes, the awards
−Removed: are assumed to have been fully vested on the grant date, accordingly, the Company recognized the total compensation cost of $ 1,744,192
−Removed: on November 23, 2022.
+Added: Outstanding at September 30, 2024
+Added: Exercisable at September 30, 2024
+Added: The Company recorded stock based compensation expense
+Added: relating to the vesting of stock options of approximately $ 119,000 and $ 808,000 for the three months ended September 30, 2024 and 2023,
+Added: respectively.
+Added: Restricted stock units:
On November 9, 2023, the Company issued equity awards
for the board of directors’ annual compensation.
−Removed: Four directors received restricted stock units (“RSUs”) to purchase
−Removed: a total of 182,696 shares of common stock at the grant date fair value of $ 3.01 per share, a total cost of $ 137,479 and $ 215,383 was recognized
−Removed: as stock compensation in the three and nine months ended March 31, 2024, respectively.
−Removed: Two directors received stock options to purchase
−Removed: 183,250 shares of common stock at an exercise price of $ 3.01 per share.
−Removed: The total stock compensation cost related to these stock options
−Removed: of $ 83,837 and $ 118,303 was recognized in the three months and nine ended March 31, 2024 and 2023, respectively.
−Removed: The equity awards vest
−Removed: quarterly over the annual service period from November 9, 2023, on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November
−Removed: 9, 2024 or the next annual shareholders’ meeting.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Equity Transactions (continued)
−Removed: In December 2023, the Company terminated five employees
−Removed: and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
−Removed: The modifications
−Removed: included the acceleration of certain tranche vesting of stock option awards to purchase a total of 56,233 shares of common stock (“Accelerated
−Removed: Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”);
−Removed: the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options
−Removed: held by the terminated employees as of the Separation Date.
−Removed: Accordingly, the Company remeasured the modified awards based on the stock
−Removed: price of $1.54 per share at the close on the Separation Date and a one-year life.
−Removed: The net adjustment for both stock option modifications
−Removed: was a net credit of $127,199 and was recognized as adjustment to stock compensation expense for the three months ended December 31, 2023.
−Removed: The modification also included the acceleration of
−Removed: an additional tranche vesting of 10,302 Restricted Stock Units, (“RSUs”) as of the Separation date.
−Removed: The modified RSUs were
−Removed: remeasured based on the stock price of $1.54 per share at close on the Separation Date and totaled $15,865, representing an additional
−Removed: in stock-based compensation for the three months ended December 31, 2023.
−Removed: The Company canceled 171,556 unvested stock options and 10,303
−Removed: unvested RSUs.
+Added: Four directors received 18,270 RSUs with a grant date fair value of $ 30.10 per
+Added: In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $ 30.10 per
+Added: share with a grant date fair value of $18.30 per share.
+Added: The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024
+Added: and earlier of November 9, 2024 or the next annual shareholders’ meeting.
+Added: During the three months ended September 30, 2024, 3,409
+Added: of these RSUs vested.
+Added: On July 25, 2024, Mr.
+Added: Gorlin resigned from the Board of Directors, and as a result, 1,159 of his RSUs were cancelled.
The following table summarizes vesting of restricted
4 unchanged sentences
Unvested at June 30, 2024
−Removed: Unvested at March 31, 2024
+Added: Unvested at September 30, 2024
The total stock-based compensation expense from restricted
−Removed: stock units for the three-months ended March 31, 2024 and 2023 was of $ 336,376 and $ 17,537 , respectively, and for the nine-months ended
−Removed: March 31, 2024 and 2023 was $ 1,020,383 and $ 1,589,527 , respectively.
−Removed: There were 45,675 RSU that vested on February 9, 2024
−Removed: and the related shares of common stock were issued and delivered by March 31, 2024.
−Removed: There were 101,833 RSUs that vested on the second
−Removed: anniversary date of RSUs that were awarded on November 23, 2022 and 25,880 shares of common stock were withheld for federal income
−Removed: tax withholdings;
−Removed: and delivered on February 15, 2024.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Equity Transactions (continued)
−Removed: Issuance of Stock Options under the 2019 Omnibus Plan.
−Removed: On October 3, 2023, the Company granted stock options
−Removed: to purchase 211,167 shares of Common Stock to new hire employees.
−Removed: 20 % of the shares underlying the options awarded vest on the one-year
−Removed: anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
−Removed: 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
−Removed: of which the options are fully exercised.
+Added: stock units for the three months ended September 30, 2024 and 2023 was approximately $ 301,000 and $ 381,000 , respectively.
Stock Warrants
−Removed: The following table summarizes warrant activity during the nine months
−Removed: ended March 31, 2024:
+Added: The following table summarizes the warrants activity during the three months
+Added: ended September 30, 2024:
Summary of warrants activity
4 unchanged sentences
Outstanding and exercisable at June 30, 2024
−Removed: Outstanding and exercisable at March 31, 2024
−Removed: Of the above warrants, 101,380 expire in the fiscal
−Removed: year ending June 30, 2025, 35,175 expire in the fiscal year ending June 30, 2026, 7,633,730 expire in the fiscal year ending June 30,
−Removed: 2027 and 11,550,000 expire in the fiscal year ending June 30, 2029.
−Removed: On March 6, 2024, the Company issued 11,550,000 warrants
−Removed: at a weighted average exercise price of $1.48 as part of the Offering (see Note 10).
−Removed: The Company pays an annual rent of $2,200 for its
−Removed: headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
−Removed: The rental agreement was for a one-year term and commenced on October
−Removed: 1, 2022 and has been subsequently renewed for another year at the same rate.
+Added: Outstanding and exercisable at September 30, 2024
+Added: Of the above warrants outstanding at September 30,
+Added: 2024, 271 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the
+Added: fiscal year ending June 30, 2027, 1,155,000 expire in the fiscal year ending June 30, 2029 and 2,393,840 expire in the fiscal year ending
+Added: June 30, 2030.
+Added: As of September 30, 2024, the Company had 335,000
+Added: prefunded warrants, 3,882,962 warrants and 98,040 placement agent warrants outstanding.
+Added: Office Leases
+Added: The Company pays an annual rent of $ 2,200
+Added: for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
+Added: The rental agreement was for a 1 one-year term,
+Added: commenced on October 1, 2023, and has been subsequently renewed for another year at the same rate.
The Company’s San Diego office lease at 5090
−Removed: Shoreham Place Suite 212, San Diego, CA 92122 which commenced on March 1, 2022, was for a term of 38 months with a base rate of $4,300,
−Removed: and annual increases of three percent.
−Removed: In February 2024, the Company amended the lease agreement which allowed the Company to vacate the
−Removed: then current space and move to a larger space at Suite 206.
−Removed: The current monthly base rate for the new office space is $9,685, with an
−Removed: annual increase of four percent.
−Removed: The term for the new office lease is 60 months and commenced on February 12, 2024.
−Removed: The lease that was
−Removed: in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space lease
−Removed: on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability of $ 56,909
−Removed: and $ 62,124 , respectively, and a gain to selling, general and administrative expenses of $ 5,215 for the three months ending March 31,
+Added: Shoreham Place Suite 212, San Diego, CA 92122 commenced in February 2024.
+Added: The current monthly base rate for the office space is $ 9,685 ,
+Added: with an annual increase of four percent.
+Added: The term for the office lease is 60 months.
Total operating lease expense for the three months
−Removed: ended March 31, 2024 and 2023 of approximately $ 20,000 and $ 13,000 , respectively;
−Removed: and for the nine months ended March 31, 2024 and 2023,
−Removed: of approximately $ 46,000 and $ 37,000 respectively were included in the accompanying condensed statements of operations and comprehensive
−Removed: loss as a component of selling, general and administrative expenses.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Leases (continued)
+Added: ended September 30, 2024 and 2023 of approximately $ 32,000 and $ 13,000 , respectively, were included in the accompanying condensed statements
+Added: 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
−Removed: portion of the operating lease liabilities included in the accompany condensed balance sheets are as follows:
+Added: portion of the operating lease liabilities included in the accompanying condensed balance sheets are as follows:
Schedule of deferred tax assets
−Removed: March 31, 2024
+Added: September 30, 2024
June 30, 2024
Operating lease right-of-use asset, net
−Removed: Current portion of operating lease liabilities
−Removed: Operating lease liabilities, net of current portion
−Removed: Total operating lease liabilities
−Removed: At March 31, 2024, the future estimated minimum lease payments under non-cancelable
−Removed: operating leases are as follows:
+Added: Current portion of operating lease liability
+Added: Operating lease liability, net of current portion
+Added: Total operating lease liability
+Added: At September 30, 2024, the future estimated minimum lease payments under
+Added: non-cancelable operating leases are as follows:
Schedule of future estimated minimum lease payments under non-cancelable operating leases
3 unchanged sentences
Present value of future minimum lease payments
−Removed: Less current portion of operating lease liabilities
−Removed: Operating lease liabilities, net of current portion
−Removed: Total cash paid for amounts included in the measurement of operating lease
−Removed: liabilities for the three months ended March 31, 2024 and 2023, were $ 23,670 and $ 12,650 , respectively, and for the nine months ended
−Removed: March 31, 2024 and 2023 were $ 49,470 and $ 37,700 , respectively.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
−Removed: Leases (continued)
+Added: Less current portion of operating lease liability
+Added: Operating lease liability, net of current portion
+Added: Total cash paid for amounts included in the measurement of lease liabilities
+Added: were $ 29,055 and $ 12,900 for the three months ended September 30, 2024 and 2023, respectively.
The weighted average remaining lease term and discount
−Removed: rate as of March 31, 2024 and June 30, 2023 were as follows:
+Added: rate as of September 30, 2024 and June 30, 2024 were as follows:
Schedule of weighted average remaining lease term and discount rate
−Removed: March 31, 2024
+Added: September 30, 2024
June 30, 2024
Weighted average remaining lease term (Years)
−Removed: Operating leases
+Added: Operating lease
Weighted average discount rate
−Removed: Operating leases
+Added: Operating lease
Commitments and Contingencies
13 unchanged sentences
3:24-cv-00035, was filed in the U.S.
−Removed: District Court for the
−Removed: District of Nevada, naming the Company and certain of its officers and/or directors as defendants.
−Removed: On April 15, 2024 the court ordered
−Removed: the motion to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned
−Removed: BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v.
−Removed: BioVie Inc., et al., Case No.
−Removed: 2:24-cv-00361-LRH-CSD.
−Removed: alleges that the Company made material misrepresentations and/or omissions of material fact relating to the Company’s business,
−Removed: operations, compliance, and prospects, including information related to the study and trial of bezisterim (NE3107), in
−Removed: violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder.
−Removed: action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and
−Removed: seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
+Added: District Court for
+Added: the District of Nevada, naming the Company and certain of its officers as defendants.
+Added: On February 22, 2024, a second, related putative
+Added: securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v.
+Added: 2:24-cv-00361.
+Added: On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc.
+Added: Litigation , No.
+Added: 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
+Added: On June 21, 2024, the lead
+Added: plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact
+Added: relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study
+Added: and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections
+Added: 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
+Added: The class action is on behalf of purchasers
+Added: of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages
+Added: on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
+Added: The defendants filed a motion to
+Added: dismiss the amended complaint on August 21, 2024 , and plaintiffs filed their opposition
+Added: on October 21, 2024 .
+Added: The defendant’s reply brief is due December 5, 2024.
The Company believes the lawsuit is without merit
3 unchanged sentences
No adjustment or accruals have been reflected in the accompanying condensed financial statements.
−Removed: Notes to Condensed Financial Statements
−Removed: For the Three and Nine Months Ended March 31, 2024
Employee Benefit Plan
4 unchanged sentences
Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will
−Removed: match 5% of the first 5% of an employee’s contributions to the 401K Plan., The Company made contributions for the three months ended
−Removed: March 31, 2024 and 2023 of approximately $ 53,915 and $ 16,000 , respectively;
−Removed: and for the nine months ended March 31, 2024 and 2023 of approximately
−Removed: $ 105,000 and $ 80,100 , respectively.
+Added: match 5% of the first 5% of an employee’s contributions to the 401K Plan.
+Added: The Company made contributions into the plan of approximately
+Added: $ 34,500 and $ 30,900 , for the three months ended September 30, 2024 and 2023, respectively.
+Added: Subsequent Events
+Added: In October 2024, the Company closed three
+Added: registered direct offerings totaling 8,256,000
+Added: shares of its common stock, par value $ 0.0001 per
+Added: share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares
+Added: of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $ 1.50 to
+Added: share (the “October Offerings”) .
+Added: The October Common Warrants have exercise prices
+Added: ranging from $ 1.37 to
+Added: share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original
+Added: issuance dates.
+Added: The gross proceeds to the Company from the October Offerings totaled approximately $ 15.9 million,
+Added: before deducting placement agent fees and offering expenses of approximately $ 2.8 million.
+Added: Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement
+Added: Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging
+Added: from $ 1.88 to
+Added: which was equal to 125% of the offering price per share in the applicable October Offering.
+Added: The October Placement Agent’s
+Added: Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October
+Added: Additionally in October, 1,216,300 of the common warrants from the September 2024 Offering were exercised at
+Added: $ 1.53 per share for proceeds totaling approximately $ 1.9 million.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.