14 unchanged sentences
Current portion of operating lease liabilities
−Removed: 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
+Added: 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
Warrant liabilities
2 unchanged sentences
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 December 31, 2023 and June 30, 2023, respectively.
+Added: 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 December 31, 2023 and June 30, 2023, respectively;
−Removed: 39,866,714 shares issued of which 39,843,834 shares are outstanding at December 31, 2023;
+Added: 800,000,000 shares authorized at March 31, 2024 and June 30, 2023, respectively;
+Added: 61,018,606 shares issued of which 60,969,846 shares are outstanding at March 31, 2024;
and 36,451,829 shares issued of which 36,428,949 shares outstanding at June 30, 2023;
11 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
−Removed: Six Months Ended
−Removed: December 31, 2023
−Removed: December 31, 2022
−Removed: December 31, 2023
−Removed: December 31, 2022
+Added: Nine Months Ended
+Added: Nine Months Ended
+Added: March 31, 2024
+Added: March 31, 2023
+Added: March 31, 2024
+Added: March 31, 2023
OPERATING EXPENSES:
17 unchanged sentences
$ ( 41,143,876 )
+Added: Deemed dividend related to ratchet adjustment to warrants
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
5 unchanged sentences
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
+Added: NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 8,954,253 )
2 unchanged sentences
$ ( 41,143,876 )
−Removed: Other comprehensive loss
+Added: Other comprehensive (loss) income
+Added: Unrealized gain on investments for available-for-sale
Reclassification of unrealized gains on available-for-sale investments upon settlement
−Removed: Total other comprehensive loss
+Added: Total other comprehensive (loss) income
Comprehensive loss
5 unchanged sentences
Condensed Statements of Cash Flows
−Removed: Six Months Ended
−Removed: Six Months Ended
−Removed: December 31, 2023
−Removed: December 31, 2022
+Added: Nine Months Ended
+Added: Nine Months Ended
+Added: March 31, 2024
+Added: March 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
10 unchanged sentences
Change in operating lease right-of-use assets
+Added: Gain on termination of operating lease
Change in fair value of derivative liabilities
4 unchanged sentences
Operating lease liabilities
−Removed: Other liabilities
+Added: Other current liabilities
( 1,159,768 )
3 unchanged sentences
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Proceeds from maturity of U.S.
+Added: Proceeds from (purchases of) U.S.
Treasury Bills
−Removed: Net cash provided by investing activities
+Added: ( 12,504,943 )
+Added: Net cash provided by (used in) investing activities
+Added: ( 12,504,943 )
CASH FLOWS FROM FINANCING ACTIVITIES:
11 unchanged sentences
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
+Added: Right of use assets obtained in exchange for lease obligations
+Added: Unrealized gain on U.S.
+Added: Treasury Bills
Reclassification of unrealized gains on available-for-sale investments upon settlement
+Added: Deemed dividend of ratchet adjustment to warrants
See accompanying notes to unaudited condensed financial
Condensed Statements of Changes in Stockholders’
+Added: Additional Paid in
Treasury Stock
Treasury Stock
−Removed: Comprehensive
−Removed: Stockholders'
+Added: Other Comprehensive
+Added: Total Stockholders'
Balance, June 30, 2022
19 unchanged sentences
( 277,072,603 )
+Added: Stock-based compensation - restricted stock units
+Added: Issuance of restricted stock units
+Added: Stock option based compensation
+Added: Proceeds from issuance of common stock, net of costs of $338,846
( 15,041,163 )
+Added: ( 15,041,163 )
+Added: Unrealized gain on available-for-sale securities
+Added: Balance, March 31, 2023
+Added: $ 313,811,910
+Added: $ ( 292,113,766 )
Balance, June 30, 2023
7 unchanged sentences
( 10,710,464 )
−Removed: Relcassification of unrealized gains on available for sale investments upon settlement
−Removed: $ ( 176,591 )
+Added: Reclassification of unrealized gains on available for sale investments upon settlement
Balance, September 30, 2023
8 unchanged sentences
( 320,337,614 )
+Added: Stock - based compensation - stock options
+Added: Stock-based compensation - restricted stock units
+Added: Issuance of common stock from vesting of - restricted stock units
+Added: Proceeds from issuance of common stock, net of costs of $2,530,996
+Added: Deemed dividend for ratchet adjustment to warrants
( 8,067,830 )
+Added: ( 8,067,830 )
+Added: Balance, March 31, 2024
+Added: $ 348,211,684
+Added: $ ( 329,291,867 )
See accompanying notes to unaudited condensed financial
Notes to Condensed Financial Statements
−Removed: For the Three and Six Months Ended December
−Removed: 31, 2023 and 2022
+Added: For the Three and Nine Months Ended March 31, 2024
Background Information
2 unchanged sentences
neurological and neuro-degenerative disorders and liver disease.
−Removed: The Company acquired
−Removed: the biopharmaceutical assets of NeurMedix, Inc.
−Removed: (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a
−Removed: related party in June 2021 .
−Removed: The acquired assets included NE3107.
−Removed: NE3107 is an investigational, novel, orally administered
−Removed: small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel
−Removed: mechanism of action.
−Removed: There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in
−Removed: the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and NE3107 could, if
−Removed: approved by U.S.
−Removed: Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating
−Removed: conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.
−Removed: Neurodengenerative
−Removed: Disease Program
+Added: The Company acquired the biopharmaceutical assets
+Added: of NeurMedix, Inc.
+Added: (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021 .
+Added: acquired assets included NE3107.
+Added: NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven
+Added: insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.
+Added: There is emerging scientific consensus
+Added: that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)
+Added: and Parkinson’s disease (“PD”), and NE3107 could, if approved by U.S.
+Added: Food and Drug Administration (“FDA”),
+Added: represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering
+Added: from AD and 1 million Americans suffering from PD.
+Added: Neurodengenerative Disease Program
In neurodegenerative disease, the Company’s
6 unchanged sentences
of AD and PD.
−Removed: Disease (NCT05083260)
−Removed: On November 29, 2023,
−Removed: the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in
−Removed: the treatment of mild to moderate AD.
−Removed: The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment
−Removed: Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
−Removed: Patients were randomly assigned,
−Removed: 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,
−Removed: followed by 26 weeks of 20 mg orally twice daily.
−Removed: Upon trial completion, as the Company began the process of unblinding
−Removed: the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations
−Removed: at 15 study sites (virtually all of which were from one geographic area).
−Removed: This highly unusual level of suspected improprieties led the
−Removed: Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
+Added: Alzheimer’s Disease (NCT05083260)
+Added: On November 29, 2023, the Company announced the analysis
+Added: of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
+Added: The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
+Added: 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
+Added: Patients were randomly assigned, 1:1 versus placebo, to receive
+Added: 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
+Added: Upon trial completion, as the Company began the process
+Added: of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
+Added: violations at 15 study sites (virtually all of which were from one geographic area).
+Added: This highly unusual level of suspected improprieties
+Added: 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.
1 unchanged sentence
the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.
−Removed: The trial was originally designed to be 80% powered with 125 patients
−Removed: in each of the treatment and placebo arms.
−Removed: The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints.
−Removed: In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the
−Removed: study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss;
+Added: The trial was originally designed to be 80% powered
+Added: with 125 patients in each of the treatment and placebo arms.
+Added: The unplanned exclusion of so many patients has left the trial underpowered
+Added: for the primary endpoints.
+Added: In the Per-Protocol population, which included those patients who completed the trial and who were further
+Added: verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest
+Added: a slowing of cognitive loss;
these same patients experienced an advantage in age deceleration vs.
−Removed: placebo as measured by DNA epigenetic change.
−Removed: Age deceleration is
−Removed: used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath
−Removed: DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
−Removed: This test was a non-primary/secondary endpoint,
−Removed: other-outcome measure, done via blood test collected at week 30 (end of study).
−Removed: Additional DNA methylation data continues to be collected
−Removed: and analyzed.
−Removed: Disease (NCT05083260)
−Removed: The Phase 2 study of
−Removed: NE3107 for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability,
−Removed: and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107.
−Removed: Forty-five patients with a defined L-dopa “off
−Removed: state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days.
+Added: placebo as measured by DNA epigenetic
+Added: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
+Added: case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
+Added: was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
+Added: Additional DNA methylation
+Added: data continues to be collected and analyzed.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Background Information (continued)
+Added: Parkinson’s Disease (NCT05083260)
+Added: The Phase 2 study of bezisterim (NE3107) for the treatment
+Added: of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
+Added: in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).
+Added: Forty-five patients with a defined L-dopa “off state”
+Added: were randomized 1:1 to placebo:
+Added: bezisterim (NE3107) 20 mg twice daily for 28 days.
This trial was launched with two design objectives:
1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
−Removed: of NE3107 with carbidopa/ levodopa;
−Removed: and 2) the secondary objective was to determine if preclinical indications of promotoric activity
−Removed: and apparent enhancement of levodopa activity could be seen in humans.
+Added: of bezisterim (NE3107) with carbidopa/ levodopa;
+Added: and 2) the secondary objective was to determine if preclinical indications of promotoric
+Added: activity and apparent enhancement of levodopa activity could be seen in humans.
Both objectives were met.
−Removed: Neuroinflammation, insulin
−Removed: resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia,
−Removed: and Amyotrophic lateral sclerosis.
−Removed: NE3107 is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory,
−Removed: insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
−Removed: NE3107’s potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the
−Removed: molecule in AD and PD patients.
−Removed: NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.
+Added: Long COVID Program
+Added: In April 2024, the Company announced the grant of
+Added: a clinical trial award of up to $13.1 million from the U.S.
+Added: Department of Defense (“DOD”), awarded through the Peer Reviewed
+Added: Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”).
+Added: can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment
+Added: of neurological symptoms that are associated with long COVID.
+Added: The Company anticipates the trial to commence by early 2025.
+Added: Long COVID is a condition in which symptoms of COVID-19,
+Added: the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more.
+Added: The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently
+Added: or previously had long COVID.
+Added: Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating.
+Added: in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars.
+Added: there are no therapies proven effective for treatment.
+Added: Chronic inflammation is one of the main hypotheses
+Added: that researchers have proposed to explain the persistence of symptoms in long COVID.
+Added: Specifically in individuals with “brain fog,”
+Added: sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features.
+Added: Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel
+Added: oral treatment targeting an underlying cause of long COVID symptoms.
+Added: Neuroinflammation, insulin resistance, and oxidative stress are common
+Added: features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis.
+Added: Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin
+Added: sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
+Added: (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule
+Added: in AD, PD, and long COVID patients.
+Added: Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.
Liver Disease Program
4 unchanged sentences
BIV201 is administered as a patent-pending liquid formulation.
−Removed: In June 2021, the Company initiated a Phase 2
−Removed: study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
+Added: In June 2021, the Company initiated a Phase 2 study
+Added: (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.
1 unchanged sentence
to a pre-treatment period.
−Removed: In March 2023 the company announced enrollment
−Removed: 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
−Removed: fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.
+Added: In March 2023 the company announced enrollment was
+Added: 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
+Added: during the 28 days after treatment initiation compared to the 28 days prior to treatment.
The change in ascites volume was significantly
7 unchanged sentences
of ascites due to chronic liver cirrhosis.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Background Information (continued)
While the active agent, terlipressin, is approved
4 unchanged sentences
The FDA has not approved any drug to treat refractory
−Removed: The BIV201 development program was initiated by
−Removed: LAT Pharma LLC.
+Added: The BIV201 development program was initiated by LAT
On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
4 unchanged sentences
on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
−Removed: The Company’s operations are subject to
−Removed: a number of factors that can affect its operating results and financial conditions.
+Added: The Company’s operations are subject to a number
+Added: of factors that can affect its operating results and financial conditions.
Such factors include, but are not limited to:
−Removed: results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval
−Removed: to market its products;
−Removed: competition from products manufactured and sold or being developed by other companies;
−Removed: the price of, and demand
−Removed: for, Company products;
−Removed: the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for
+Added: the results of
+Added: clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market
its products;
+Added: competition from products manufactured and sold or being developed by other companies;
+Added: the price of, and demand for, Company
+Added: 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.
−Removed: The Company’s financial statements have been prepared assuming the
−Removed: Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
−Removed: course of business.
−Removed: As of December 31, 2023, the Company had working capital of approximately $ 6.6 million, cash and cash equivalents
−Removed: of approximately $ 20.2 million, stockholders’ equity of approximately $ 7.5 million, and an accumulated deficit of approximately
−Removed: $ 320.3 million.
+Added: The Company’s financial statements have been prepared assuming the Company will
+Added: continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of
+Added: As of March 31, 2024, the Company had working capital of approximately $ 18.1 million, cash and cash equivalents of approximately
+Added: $ 30.4 million, stockholders’ equity of approximately $ 18.9 million, and an accumulated deficit of approximately $ 329.3 million.
The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future.
−Removed: The Company’s future
−Removed: operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability
−Removed: to secure additional financing as needed.
−Removed: Although our cash balance may possibly sustain operations over the next six to nine months from
−Removed: the balance sheet date if further measures are taken to delay planned expenditures in our research protocols and slow the progress in
−Removed: the Company’s development and launch of next phase clinical programs, the Company’s current planned operations to meet certain
−Removed: goals and objectives, project cash flows to be depleted within that period of time.
−Removed: The future viability of the Company is largely
−Removed: dependent upon its ability to raise additional capital to finance its operations.
−Removed: Management expects that future sources of funding may
−Removed: include sales of equity, obtaining loans, or other strategic transactions.
+Added: The Company’s future operations
+Added: are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure
+Added: additional financing as needed.
+Added: Although our cash balance is projected to sustain operations over the next nine months from the balance
+Added: 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
+Added: development and launch of next phase clinical programs, the Company’s current planned operations to meet certain goals and objectives.
+Added: The future viability of the Company is largely dependent
+Added: upon its ability to raise additional capital to finance its operations.
+Added: Management expects that future sources of funding may include
+Added: sales of equity, obtaining loans, or other strategic transactions.
Although management continues to pursue the Company’s
4 unchanged sentences
The condensed financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
Significant Accounting Policies
23 unchanged sentences
per share (“common stock”), outstanding during the period.
−Removed: Diluted net loss per common share is computed by dividing the net
−Removed: loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding
−Removed: shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock
−Removed: options, warrants, and restricted stock units.
−Removed: For the six months ended December 31, 2023 and 2022, such amounts were excluded from the
−Removed: 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
−Removed: stock options, warrants and restricted stock units as of December 31, 2023 and 2022:
+Added: Diluted net loss per common share is computed by dividing the
+Added: net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially
+Added: outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable
+Added: through stock options, warrants, and restricted stock units.
+Added: For the three and nine months ended March 31, 2024 and 2023, such
+Added: amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.
+Added: The table below shows the number of outstanding stock
+Added: options, warrants and restricted stock units as of March 31, 2024 and 2023:
Schedule of dilutive securities were excluded from the computation of diluted loss per share
−Removed: December 31, 2023
−Removed: December 31, 2022
+Added: March 31, 2024
+Added: March 31, 2023
Number of Shares
7 unchanged sentences
the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 Form 10-K.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Significant Accounting Policies (continued)
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits
−Removed: and money market funds held at a bank and funds held in a brokerage account which included a U.S.
+Added: and money market funds held at banks and funds held in brokerage accounts which included a U.S.
treasury money market fund and U.S.
−Removed: Treasury Bills with original maturities of three months or less.
+Added: Bills with original maturities of three months or less.
Investments in U.S.
1 unchanged sentence
Investments in U.S.
−Removed: Treasury Bills with maturities
−Removed: greater than three months on the date of purchase, are accounted for as available for sale and are recorded at fair value.
−Removed: gains were included in other comprehensive income in the accompanying condensed statements of operations and comprehensive loss.
−Removed: the maturity and settlement of these investments, realized gains were recorded as a component of interest income on the accompanying condensed
−Removed: statement of operations and comprehensive loss.
−Removed: Concentration of Credit Risk in the Financial
−Removed: Service Industry
−Removed: As of December 31, 2023, the Company had cash
−Removed: deposited in certain financial institutions in excess of federally insured levels.
−Removed: The Company regularly monitors the financial stability
−Removed: of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
−Removed: in March and April 2023, certain U.S.
+Added: Treasury Bills with
+Added: maturities greater than three months on the date of purchase, are accounted for as available for sale and are recorded at fair
+Added: Unrealized gains were included in other comprehensive (loss) income in the accompanying condensed statements of operations
+Added: and comprehensive loss.
+Added: Upon the maturity and settlement of these investments, realized gains were recorded as a component of
+Added: interest income on the accompanying condensed statement of operations and comprehensive loss.
+Added: Concentration of Credit Risk in the Financial Service
+Added: As of March 31, 2024, the Company had cash deposited
+Added: in certain financial institutions in excess of federally insured levels.
+Added: The Company regularly monitors the financial stability of these
+Added: financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
+Added: However, in March
+Added: 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.
−Removed: While these events have not had a material
−Removed: direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and
−Removed: financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing
−Removed: arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
+Added: While these and other current events have
+Added: not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect
+Added: to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into
+Added: new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results
+Added: of operations.
Fair value measurement of assets and liabilities
−Removed: We determine the fair values of our financial
−Removed: instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use
−Removed: of unobservable inputs when measuring fair value.
−Removed: Fair value is defined as the price that would be received to sell an asset or paid to
−Removed: transfer a liability in an orderly transaction between market participants at the measurement date.
−Removed: The fair value assumes that the transaction
−Removed: to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes
−Removed: that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing
−Removed: the asset or liability.
−Removed: The classification of a financial asset or liability within the hierarchy is based upon the lowest level input
−Removed: that is significant to the fair value measurement.
−Removed: The fair value hierarchy prioritizes the inputs into three levels that may be used
−Removed: to measure fair value:
+Added: We determine the fair values of our financial instruments
+Added: based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable
+Added: inputs when measuring fair value.
+Added: Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability
+Added: in an orderly transaction between market participants at the measurement date.
+Added: The fair value assumes that the transaction to sell the
+Added: asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the
+Added: fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset
+Added: or liability.
+Added: The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant
+Added: to the fair value measurement.
+Added: The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
Level 1 – Inputs are unadjusted quoted prices
3 unchanged sentences
market corroboration, for substantially the full term of the financial instrument.
−Removed: Level 3 – Inputs are unobservable inputs
−Removed: based on our assumptions.
+Added: Level 3 – Inputs are unobservable inputs based
+Added: on our assumptions.
The Company’s financial instruments include
3 unchanged sentences
market rates for similar debt instruments.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
Investments in U.S.
1 unchanged sentence
The following is a summary of the U.S.
−Removed: Bills held at June 30, 2023:
+Added: Treasury Bills
+Added: held at June 30, 2023:
Schedule of U.S.
4 unchanged sentences
Treasury Bills due in 3 - 6 months
−Removed: During the fiscal year ended June 30, 2023, the
−Removed: Company purchased a total of approximately $ 46 million of U.S.
+Added: During the fiscal year ended June 30, 2023, the Company
+Added: purchased a total of approximately $ 46 million of U.S.
Treasury Bills.
All outstanding investments in U.S.
−Removed: Treasury Bills available
−Removed: for sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain
−Removed: of $ 223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
+Added: Treasury Bills available for
+Added: sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of
+Added: $ 223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.
Intangible Assets
−Removed: The Company’s intangible assets consist
−Removed: of intellectual property acquired from LAT Pharma and are amortized over their estimated useful lives.
+Added: The Company’s intangible assets consist of intellectual
+Added: 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
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
4 unchanged sentences
Intellectual Property, Net
−Removed: Amortization expense was $ 57,344 in each of the
−Removed: three-month periods ended December 31, 2023 and 2022.
−Removed: Amortization expense was $ 114,688 in each of the six-month periods ended December
−Removed: 31, 2023 and 2022.The Company amortizes intellectual property over the expected, original useful lives of 10 years.
+Added: Amortization expense was $ 57,344 in each of the three-month
+Added: periods ended March 31, 2024 and 2023.
+Added: Amortization expense was $ 172,033 in each of the nine-month periods ended March 31, 2024 and 2023.
+Added: The Company amortizes intellectual property over the expected, original useful lives of 10 years.
Estimated future amortization expense is as follows:
1 unchanged sentence
Year ending June 30, 2024 (Remaining 3 months)
+Added: Notes to Condensed Financial Statements
+Added: 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 securities
−Removed: purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s majority stockholder, pursuant to which
−Removed: Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364 shares of the Company’s Common
−Removed: 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
−Removed: (“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of exercise of five years.
−Removed: The warrant has a down round
−Removed: feature that reduces the exercise price of the warrant if the Company sells stock at a price lower than the initial exercise price of
−Removed: On August 15, 2022, the Company received net proceeds of approximately $5.9 million, net of costs of approximately $94,000,
−Removed: and entered into an amended and restated registration agreement with Acuitas, which amended and restated that certain registration rights
−Removed: agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the “Existing Registration Rights Agreement”),
−Removed: to amend the definition of “Registrable Securities” in the Existing Registration Rights Agreement to include the PIPE Shares
−Removed: and the PIPE Warrant Shares as Registrable Securities thereunder.
+Added: On July 15, 2022, the Company entered into a
+Added: securities purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s majority stockholder,
+Added: pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364
+Added: shares of the Company’s Common Stock, at a price of $1.65 per share (the “PIPE Shares”), and (ii) a warrant to
+Added: purchase 7,272,728 shares of Common Stock (“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of
+Added: exercise of five years.
+Added: The warrant’s down round feature reduced the exercise price of the warrant to $1.00 per share on March
+Added: 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.
+Added: The Company calculated the difference in fair value of the
+Added: warrants between the stated exercise price and the reduced exercise price and recorded $ 886,423
+Added: as a deemed dividend.
+Added: The fair value of the warrants were estimated using the Black Scholes Method with the following inputs, the
+Added: stock price of $ 1.07 ,
+Added: exercise price of $ 1.82
+Added: remaining term 3.4
+Added: years, risk free rate of 4.4 %
+Added: and volatility of 95.0 % .
+Added: On August 15, 2022, the Company received net proceeds
+Added: of approximately $5.9 million, net of costs of approximately $94,000, and entered into an amended and restated registration agreement
+Added: with Acuitas, which amended and restated that certain registration rights agreement, dated as of June 10, 2021, by and between the Company
+Added: and Acuitas (the “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities”
+Added: in the Existing Registration Rights Agreement to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
Other Liabilities
15 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 December 31, 2023 was 8.50 % .
−Removed: The Loan is secured by a lien upon and security interest in all of the Company’s
−Removed: assets, including intellectual property, subject to agreed exceptions.
+Added: The prime rate at March 31, 2024 was 8.50 % .
+Added: The Loan is secured by a lien upon and security interest in all of the Company’s assets,
+Added: 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: The Loan Agreement includes a conversion option
−Removed: 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
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Notes Payable (continued)
+Added: The Loan Agreement includes a conversion option to
+Added: 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.
3 unchanged sentences
The Avenue Warrants are exercisable until November 30, 2026.
−Removed: The amount of the carrying value of the notes
−Removed: payable was determined by allocating portions of the outstanding principal of the notes;
−Removed: approximately $ 1.4 million to the fair value
−Removed: of the Avenue Warrants and approximately $ 2.2 million to the fair value of the embedded conversion option.
−Removed: Accordingly, the total amount
−Removed: of unearned discount of approximately $ 3.6 million, the total direct financing cost of approximately $ 390,000 and premium of $ 850,000
−Removed: are recognized on an effective interest method over the term of the Loan.
+Added: The amount of the carrying value of the notes payable
+Added: was determined by allocating portions of the outstanding principal of the notes;
+Added: approximately $ 1.4 million to the fair value of the Avenue
+Added: Warrants and approximately $ 2.2 million to the fair value of the embedded conversion option.
+Added: Accordingly, the total amount of unearned
+Added: discount of approximately $ 3.6 million, the total direct financing cost of approximately $ 390,000 and premium of $ 850,000 being recognized
+Added: on an effective interest method over the term of the Loan.
The adjusted effective interest rate is 25%.
−Removed: The total interest
−Removed: expense of approximately $ 682,000 for the three months ended December 31, 2023, was recognized in the accompanying condensed statements
−Removed: of operations and comprehensive loss and included the interest only payments totaling approximately $ 429,000 , the amortization of financing
−Removed: costs of approximately $ 31,000 , unearned discount of approximately $ 289,000 and the accretion of loan premium of approximately $ 67,000 .
−Removed: The total interest expense of approximately $ 1.5 million for the six months ended December 31, 2023, was recognized in the accompanying
−Removed: condensed statements of operations and comprehensive loss and included the interest only payments totaling approximately $ 955,000 , the
−Removed: amortization of financing costs of approximately $ 69,000 , accretion of unearned discount of approximately $ 645,000 and the accretion of
−Removed: loan premium of approximately $ 149,000 .
The total interest expense of approximately $ 629,000
−Removed: million for the three months ended December 31, 2022, was recognized in the accompanying condensed statements of operations and included
−Removed: the interest only payments totaling approximately $ 518,000 , the amortization of financing costs of approximately $ 43,000 , unearned discount
−Removed: of approximately $ 400,000 and the accretion of loan premium of approximately $ 93,000 .
−Removed: The total interest expense of approximately $ 2.1
−Removed: million for the six- months ended December 31, 2022, was recognized in the accompanying condensed statements of operations and included
−Removed: interest only payments totaling approximately $ 987,000 , the amortization of financing costs of approximately $ 85,000 , unearned discount
−Removed: of approximately $ 801,000 and the accretion of loan premium of approximately $ 237,000 .
−Removed: As of December 31, 2023, the remaining principal
−Removed: balance of $10 million under the Loan is payable in 12 monthly equal installments.
−Removed: For the three and six months ended December 31, 2023,
−Removed: the Company paid back $2.5 million and $5 million respectively, of the original loan of $15 million.
−Removed: The following is a summary of the Notes Payable as of December 31,
−Removed: 2023 and June 30, 2023:
+Added: and $ 1.1 million for the three months ended March 31, 2024 and 2023, respectively, was recognized in the accompanying condensed statements
+Added: of operations and comprehensive loss.
+Added: Interest expense for the three months ended March 31, 2024 and 2023 included the interest payments
+Added: totaling approximately $ 327,000 and $ 547,000 , the amortization of financing costs of approximately $ 24,000 and $ 43,000 , unearned discount
+Added: of approximately $ 222,000 and $ 400,000 and the accretion of loan premium of approximately $ 52,000 and $ 93,000 , respectively.
+Added: interest expense of approximately $ 2.5 million and $ 3.2 million for the nine months ended March 31, 2024 and 2023, respectively, was recognized
+Added: in the accompanying condensed statements of operations and comprehensive loss.
+Added: Interest expense for the nine months ended March 31, 2024
+Added: and 2023 included interest payments totaling approximately $ 1.3 million and $ 1.5 million, the amortization of financing costs of approximately
+Added: $ 92,000 and $ 128,000 , unearned discount of approximately $ 867,000 and $ 1.2 million and the accretion of loan premium of approximately
+Added: $ 201,000 and $ 329,000 , respectively.
+Added: As of March 31, 2024, the remaining principal balance
+Added: of $7.5 million under the Loan is payable in 9 monthly equal installments.
+Added: For the three and nine months ended March 31, 2024, the Company
+Added: paid back $2.5 million and $7.5 million respectively, of the original loan of $15 million.
+Added: The following is a summary of the Notes Payable as of March 31, 2024 and
+Added: June 30, 2023:
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Notes Payable (continued)
Current portion of Notes Payable
Schedule of note payable
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
6 unchanged sentences
Non-current portion of Notes Payable
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
4 unchanged sentences
Notes Payable, net of the current portion financing costs, unearned premiums and discount
−Removed: Estimated future amortization expense and accretion of premium and
−Removed: discount is as follows:
+Added: Estimated future amortization expense and accretion of premium and discount
+Added: is as follows:
Schedule of estimated future amortization expense and accretion of premium
3 unchanged sentences
Year ending June 30, 2024 (Remaining 3 months)
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
Fair Value Measurements
−Removed: At December 31, 2023 and June 30, 2023, the estimated
+Added: At March 31, 2024 and June 30, 2023, the estimated
fair value of derivative liabilities measured on a recurring basis are as follows:
1 unchanged sentence
Fair Value Measurements at
−Removed: December 31, 2023
+Added: March 31, 2024
Derivative liability - Warrants
6 unchanged sentences
Total derivatives
−Removed: The following table presents the activity for
−Removed: liabilities measured at fair value using unobservable inputs for the six months ended December 31, 2023:
+Added: The following table presents the activity for liabilities
+Added: measured at fair value using unobservable inputs for the nine months ended March 31, 2024:
Fair value, liabilities measured on recurring basis
−Removed: Derivative liabilities - Warrants
−Removed: Derivative liability - Conversion Option on Convertible Debenture
+Added: Derivative liabilities -
+Added: Derivative liability -
+Added: Conversion Option on
+Added: Convertible Debenture
Balance at June 30, 2023
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liability
+Added: Change in in fair value of level 3 liabilities
Transfer in and/or out of Level 3
−Removed: Balance at December 31, 2023
−Removed: The following table presents the activity for
−Removed: liabilities measured at fair value using unobservable inputs for the six months ended December 31, 2022:
−Removed: Derivative liabilities - Warrants
−Removed: Derivative liability - Conversion Option on Convertible Debenture
+Added: Balance at March 31, 2024
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Fair Value Measurements (continued)
+Added: The following table presents the activity for liabilities
+Added: measured at fair value using unobservable inputs for the nine months ended March 31, 2023:
+Added: Derivative liabilities -
+Added: Derivative liability -
+Added: Conversion Option on
+Added: Convertible Debenture
Balance at June 30, 2022
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liability
+Added: Change in in fair value of level 3 liabilities
Transfer in and/or out of Level 3
−Removed: Balance at December 31, 2022
−Removed: The fair values of derivative liabilities for
−Removed: the Avenue Warrants and the conversion option of the Note at December 31, 2023 in the accompanying condensed balance sheet, were approximately
−Removed: $123,000 and approximately $7,000, respectively.
+Added: Balance at March 31, 2023
+Added: The fair values of derivative liabilities for the
+Added: Avenue Warrants and the conversion option of the Note at March 31, 2024 in the accompanying condensed balance sheet, were approximately
+Added: $21,000 and approximately zero, respectively.
The total change in the fair value of the derivative liabilities totaled approximately $109,000
−Removed: $983,000 and $1.7 million for the three and six months ended December 31, 2023, respectively;
−Removed: and accordingly, was recorded in the accompanying
−Removed: condensed statement of operations and comprehensive loss.
−Removed: The assumptions used in the Black Scholes model to value the derivative liabilities
−Removed: at December 31, 2023 included the closing stock price of $ 1.26 per share;
−Removed: for the Avenue Warrants, the exercise price of $ 5.82 , remaining
−Removed: term 2.9 years, risk free rate of 4.0 % and volatility of 93.0 % ;
−Removed: and for the embedded derivative liability of the conversion option, the
−Removed: conversion price of $ 6.98 ;
+Added: and $1.8 million for the three and nine months ended March 31, 2024, respectively;
+Added: and accordingly, was recorded in the accompanying condensed
+Added: statement of operations and comprehensive loss.
+Added: The assumptions used in the Black Scholes model to value the derivative liabilities at
+Added: March 31, 2024 included the closing stock price of $ 0.53 per share;
+Added: for the Avenue Warrants, the exercise price of $ 5.82 , remaining term
+Added: 2.7 years, risk free rate of 4.5 % and volatility of 93.0 % ;
+Added: and for the embedded derivative liability of the conversion option, the conversion
+Added: price of $ 6.98 ;
remaining term 0.67 years, risk free rate of 5.3 % and volatility of 104.0 % .
Derivative liability – Avenue Warrants
−Removed: The Company accounts for stock purchase warrants
−Removed: as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements.
+Added: The Company accounts for stock purchase warrants as
+Added: either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements.
Under applicable accounting
2 unchanged sentences
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 accompany condensed balance sheet at December 31, 2023 and June 30, 2023.
−Removed: The Black Scholes model was used to calculate
−Removed: the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded.
+Added: liability at fair value in the accompanying condensed balance sheets at March 31, 2024 and June 30, 2023.
+Added: The Black Scholes model was used to calculate the
+Added: fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded.
The Avenue Warrants
−Removed: are recorded at their fair values at the date of issuance and remeasured at December 31, 2023 and June 30, 2023.
+Added: are recorded at their fair values at the date of issuance and remeasured at March 31, 2024 and June 30, 2023.
Embedded derivative liability – Conversion
−Removed: The embedded derivative liability represents the
−Removed: optional conversion feature of up to $5.0 million of the outstanding Loan, which meets the definition of a derivative and requires bifurcation
+Added: The embedded derivative liability represents the optional
+Added: 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.
−Removed: The Black Scholes model was used to calculate
−Removed: the fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue
−Removed: Loan amount funded.
+Added: The Black Scholes model was used to calculate the
+Added: fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue Loan
+Added: amount funded.
Financial assets
−Removed: As of December 31, 2023, investments in U.S.
+Added: As of March 31, 2024, investments in U.S.
Bills were valued through use of quoted prices and are classified as Level 1.
−Removed: The following table presents information about
−Removed: our assets that are measured at fair value on a recurring basis.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Fair Value Measurements (continued)
+Added: The following table presents information about our
+Added: assets that are measured at fair value on a recurring basis.
Measured at fair value on a recurring basis
Fair Value Measurements at
−Removed: December 31, 2023
+Added: March 31, 2024
Treasury Bills due in 3 months or less at purchase
3 unchanged sentences
Treasury Bills due in 3 - 6 months at purchase
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
Equity Transactions
Issuance of common stock for cash
−Removed: On August 31, 2022, the Company entered into a
−Removed: Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
−Removed: Riley Securities,
−Removed: (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s
−Removed: common stock through the Agents, subject to the terms and conditions of the Sales Agreement.
+Added: On August 31, 2022, the Company entered into a Controlled
+Added: Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
+Added: Riley Securities, Inc.
+Added: (collectively,
+Added: the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock
+Added: through the Agents, subject to the terms and conditions of the Sales Agreement.
On April 6, 2023, the Company and B.
−Removed: Securities, Inc.
+Added: Riley Securities,
mutually agreed to terminate B.
Riley Securities, Inc.’s role as a sales agent under the Sales Agreement.
−Removed: 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
−Removed: of $ 7.4 million after 3 % commissions and expenses of approximately $ 258,000 .
−Removed: During the six months ended December 31, 2023, the Company
−Removed: 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
−Removed: of approximately $ 377,000 .
−Removed: During the three months ended December 31, 2022,
−Removed: 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
−Removed: and expenses of approximately $ 1.2 million.
−Removed: During the six months ended December 31, 2022, the Company sold 5,857,613 shares of common
−Removed: stock under the Sales Agreement for total net proceeds of $ 38.4 million after 3 % commissions and expenses of approximately $ 1.6 million.
+Added: During the three
+Added: 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: $ 6,500 after 3 % commissions and expenses of approximately $ 201 .
+Added: During the nine months ended March 31, 2024, the Company sold 3,337,487
+Added: shares of common stock under the Sales Agreement for total net proceeds of $ 9.3 million after 3 % commissions and expenses of approximately
+Added: During the three months ended March 31, 2023, the
+Added: 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
+Added: expenses of approximately $ 339,000 .
+Added: During the nine months ended March 31, 2023, the Company sold 7,372,691 shares of common stock under
+Added: the Sales Agreement for total net proceeds of $ 48.2 million after 3 % commissions and expenses of approximately $ 1.9 million.
+Added: On March 6, 2024, the Company closed a best efforts
+Added: public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its common stock, par value $ 0.0001 per
+Added: share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of Common
+Added: Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public offering
+Added: price of $ 1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
+Added: The Common Warrants
+Added: have an exercise price of $1.50 per share and are immediately exercisable upon issuance for a period of five years following the date
+Added: The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement agent
+Added: fees and offering expenses of approximately $2.5 million.
+Added: Additionally, upon closing the Company issued the placement agent warrants (“Placement
+Added: Agent’s warrants”) to purchase 1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal
+Added: to 125% of the public offering price per share.
+Added: The Placement Agent’s Warrants are exercisable during a five-year period commencing
+Added: 180 days from March 6, 2024.
Stock Options
The following table summarizes the activity relating
−Removed: to the Company’s stock options for the six months ended December 31, 2023:
+Added: to the Company’s stock options for the nine months ended March 31, 2024:
Schedule of summarizes the activity relating to the Company’s stock options
−Removed: Weighted-Average Exercise Price
−Removed: Weighted Remaining Average Contractual Term
−Removed: Aggregate Intrinsic Value
+Added: Weighted-Average
+Added: Exercise Price
+Added: Weighted Remaining
+Added: Average Contractual
+Added: Aggregate Intrinsic
Outstanding at June 30, 2023
1 unchanged sentence
Options Canceled
−Removed: Outstanding at December 31, 2023
−Removed: Exercisable at December 31, 2023
−Removed: The fair value of each option grant on the date
−Removed: of grant is estimated using the Black-Scholes option pricing model.
+Added: Outstanding at March 31, 2024
+Added: Exercisable at March 31, 2024
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Equity Transactions (continued)
+Added: The fair value of each option grant on the date of
+Added: grant is estimated using the Black-Scholes option pricing model.
The pricing model reflects the following weighted-average assumptions
−Removed: for the six months ended December 31, 2023 and 2022:
+Added: for the nine months ended March 31, 2024 and 2023:
Schedule of assumptions used
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
3 unchanged sentences
Dividend Yield
−Removed: The total stock option-based compensation expense
−Removed: for three-months ended December 31, 2023 and 2022 was of $ 619,701 and $ 1,712,787 , respectively.
−Removed: The total stock option-based compensation expense
−Removed: for six-months ended December 31, 2023 and 2022 was of $ 1,427,728 and $ 2,591,427 , respectively.
+Added: The total stock based compensation expense from stock
+Added: 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
+Added: 31, 2024 and 2023 was of $ 2,118,649 and $ 3,480,425 , respectively.
Issuance and modification of restricted stock units and options:
−Removed: On November 23, 2022, the Company issued equity
−Removed: awards for the board of directors’ annual compensation.
−Removed: Four directors received restricted stick units (“RSUs”) to purchase
+Added: On November 23, 2022, the Company issued equity awards
+Added: for the board of directors’ annual compensation.
+Added: Four directors received restricted stock 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
10 unchanged sentences
on November 23, 2022.
−Removed: On November 9, 2023, the Company issued equity
−Removed: awards for the board of directors’ annual compensation.
−Removed: Four directors received restricted stick 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 $ 77,905 was recognized as stock
−Removed: compensation in the three months ended December 31, 2023.
−Removed: Two directors received stock options to purchase 183,250 shares of common stock
−Removed: at an exercise price of $ 3.01 per share.
−Removed: The total stock compensation cost related to these stock options of $ 34,466 was recognized in
−Removed: the three months ended December 31, 2023.
−Removed: The equity awards vest quarterly over the annual service period from November 9, 2023, on February
−Removed: 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting.
−Removed: In December 2023, the Company terminated five
−Removed: employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
−Removed: The modifications included the acceleration of certain tranche vesting of stock option awards to purchase a total of 56,233 shares of
−Removed: common stock (“Accelerated Options”), effective on the December Separation Date, as defined in severance agreement (“Separation
−Removed: and extended the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and
−Removed: unexercised stock options held by the terminated employees as of the Separation Date.
−Removed: Accordingly, the Company remeasured the modified
−Removed: awards based on the stock price of $1.54 per share at the close on the Separation Date and a one-year life.
−Removed: The net adjustment for both
−Removed: stock option modifications was a net credit of $127,199 and was recognized as adjustment to stock compensation expense for the three months
−Removed: ended December 31, 2023.
−Removed: The modification also included the acceleration
−Removed: of an additional tranche vesting of 10,302 Restricted Stock Units, (“RSUs”) as of the Separation date.
+Added: On November 9, 2023, the Company issued equity awards
+Added: for the board of directors’ annual compensation.
+Added: Four directors received restricted stock units (“RSUs”) to purchase
+Added: 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
+Added: as stock compensation in the three and nine months ended March 31, 2024, respectively.
+Added: Two directors received stock options to purchase
+Added: 183,250 shares of common stock at an exercise price of $ 3.01 per share.
+Added: The total stock compensation cost related to these stock options
+Added: of $ 83,837 and $ 118,303 was recognized in the three months and nine ended March 31, 2024 and 2023, respectively.
+Added: The equity awards vest
+Added: quarterly over the annual service period from November 9, 2023, on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November
+Added: 9, 2024 or the next annual shareholders’ meeting.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Equity Transactions (continued)
+Added: In December 2023, the Company terminated five employees
+Added: and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
+Added: The modifications
+Added: included the acceleration of certain tranche vesting of stock option awards to purchase a total of 56,233 shares of common stock (“Accelerated
+Added: Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”);
+Added: the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options
+Added: held by the terminated employees as of the Separation Date.
+Added: Accordingly, the Company remeasured the modified awards based on the stock
+Added: price of $1.54 per share at the close on the Separation Date and a one-year life.
+Added: The net adjustment for both stock option modifications
+Added: was a net credit of $127,199 and was recognized as adjustment to stock compensation expense for the three months ended December 31, 2023.
+Added: The modification also included the acceleration of
+Added: an additional tranche vesting of 10,302 Restricted Stock Units, (“RSUs”) as of the Separation date.
The modified RSUs were
6 unchanged sentences
Number of Shares
−Removed: Weighted Average Grant Date Fair Value Per Share
+Added: Weighted Average Grant
+Added: Date Fair Value Per Share
Unvested at June 30, 2023
−Removed: Unvested at December 31, 2023
−Removed: The total stock based compensation – restricted
−Removed: stock expense for the three-months ended December 31, 2023 and 2022 was of $ 303,173 and $ 1,554,453 , respectively.
−Removed: The total stock based
−Removed: compensation – restricted stock expense for the six-months ended December 31, 2023 and 2022 was $ 684,007 and $ 1,571,990 , respectively.
−Removed: There were 147,508 RSU that vested on November
−Removed: 23, 2023 and the related shares of common stock will issued and delivered by March 15, 2024.
+Added: Unvested at March 31, 2024
+Added: The total stock-based compensation expense from restricted
+Added: 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
+Added: March 31, 2024 and 2023 was $ 1,020,383 and $ 1,589,527 , respectively.
+Added: There were 45,675 RSU that vested on February 9, 2024
+Added: and the related shares of common stock were issued and delivered by March 31, 2024.
+Added: There were 101,833 RSUs that vested on the second
+Added: anniversary date of RSUs that were awarded on November 23, 2022 and 25,880 shares of common stock were withheld for federal income
+Added: tax withholdings;
+Added: and delivered on February 15, 2024.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Equity Transactions (continued)
Issuance of Stock Options under the 2019 Omnibus Plan.
−Removed: On October 3, 2023, the Company granted stock
−Removed: options to purchase 211,167 shares of Common Stock to new hire employees.
−Removed: 20 % of the shares underlying the options awarded vest on the
−Removed: one-year anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
−Removed: 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
−Removed: date of which the options are fully exercised.
+Added: On October 3, 2023, the Company granted stock options
+Added: to purchase 211,167 shares of Common Stock to new hire employees.
+Added: 20 % of the shares underlying the options awarded vest on the one-year
+Added: anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
+Added: 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
+Added: of which the options are fully exercised.
Stock Warrants
−Removed: The following table summarizes warrant activity during the six months
−Removed: ended December 31, 2023:
+Added: The following table summarizes warrant activity during the nine months
+Added: ended March 31, 2024:
Summary of warrants activity
4 unchanged sentences
Outstanding and exercisable at June 30, 2023
−Removed: Outstanding and exercisable at December 31, 2023
+Added: Outstanding and exercisable at March 31, 2024
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, and 7,633,730 expire in the fiscal year ending June
−Removed: No warrants were granted, expired, or were exercised during the three and six months ended December 31, 2023.
−Removed: The Company pays an annual rent of $2,200 for
−Removed: its 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
−Removed: October 1, 2022 and has been subsequently renewed for another year at the same rate.
−Removed: On February 26, 2022,
−Removed: the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122.
−Removed: The term for the office lease is 38 months
−Removed: and commenced on March 1, 2022.
−Removed: The monthly base rate currently is $4,300, with annual increases of three percent.
−Removed: Total operating lease
−Removed: 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
−Removed: for the six months ended December 31, 2023 and 2022, respectively;
−Removed: were included in the accompanying condensed statements of operations
−Removed: and comprehensive loss as a component of selling, general and administrative expenses.
−Removed: The right-of-use asset,
−Removed: net and current and non current portion of the operating lease liabilities included in the accompany condensed balance sheets are as follows:
+Added: 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,
+Added: 2027 and 11,550,000 expire in the fiscal year ending June 30, 2029.
+Added: On March 6, 2024, the Company issued 11,550,000 warrants
+Added: at a weighted average exercise price of $1.48 as part of the Offering (see Note 10).
+Added: The Company pays an annual rent of $2,200 for its
+Added: headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
+Added: The rental agreement was for a one-year term and commenced on October
+Added: 1, 2022 and has been subsequently renewed for another year at the same rate.
+Added: The Company’s San Diego office lease at 5090
+Added: 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,
+Added: and annual increases of three percent.
+Added: In February 2024, the Company amended the lease agreement which allowed the Company to vacate the
+Added: then current space and move to a larger space at Suite 206.
+Added: The current monthly base rate for the new office space is $9,685, with an
+Added: annual increase of four percent.
+Added: The term for the new office lease is 60 months and commenced on February 12, 2024.
+Added: The lease that was
+Added: in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space lease
+Added: on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability of $ 56,909
+Added: and $ 62,124 , respectively, and a gain to selling, general and administrative expenses of $ 5,215 for the three months ending March 31,
+Added: Total operating lease expense for the three months
+Added: ended March 31, 2024 and 2023 of approximately $ 20,000 and $ 13,000 , respectively;
+Added: and for the nine months ended March 31, 2024 and 2023,
+Added: of approximately $ 46,000 and $ 37,000 respectively were included in the accompanying condensed statements of operations and comprehensive
+Added: loss as a component of selling, general and administrative expenses.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Leases (continued)
+Added: The right-of-use asset, net and current and non-current
+Added: portion of the operating lease liabilities included in the accompany condensed balance sheets are as follows:
Schedule of deferred tax assets
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
3 unchanged sentences
Total operating lease liabilities
−Removed: At December 31, 2023, the future estimated minimum lease payments under
−Removed: non-cancelable operating leases are as follows:
+Added: At March 31, 2024, the future estimated minimum lease payments under non-cancelable
+Added: operating leases are as follows:
Schedule of future estimated minimum lease payments under non-cancelable operating leases
5 unchanged sentences
Operating lease liabilities, net of current portion
−Removed: Total cash paid for amounts included in the measurement of lease liabilities
−Removed: were $ 25,800 and $ 25,050 for the six months ended December 31, 2023 and 2022, respectively.
−Removed: The weighted average remaining lease term and
−Removed: discount rate as of December 31, 2023 and June 30, 2023 were as follows:
+Added: Total cash paid for amounts included in the measurement of operating lease
+Added: liabilities for the three months ended March 31, 2024 and 2023, were $ 23,670 and $ 12,650 , respectively, and for the nine months ended
+Added: March 31, 2024 and 2023 were $ 49,470 and $ 37,700 , respectively.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
+Added: Leases (continued)
+Added: The weighted average remaining lease term and discount
+Added: rate as of March 31, 2024 and June 30, 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate
−Removed: December 31, 2023
+Added: March 31, 2024
June 30, 2023
9 unchanged sentences
PharmaIn Corporation, and The Barrett Edge, Inc.
−Removed: Pursuant to the Technology Transfer Agreement
−Removed: 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
−Removed: single digit royalty on net sales of all terlipressin products covered by US patent no.
−Removed: 9,655,645 and any future foreign issuances, capped
−Removed: at a maximum of $200,000 per year.
+Added: Pursuant to the Technology Transfer Agreement entered
+Added: 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
+Added: royalty on net sales of all terlipressin products covered by US patent no.
+Added: 9,655,645 and any future foreign issuances, capped at a maximum
+Added: of $200,000 per year.
Shareholder class action complaint
3 unchanged sentences
District Court for the
−Removed: District of Nevada, naming Company and certain of its officers and/or directors as defendants.
−Removed: The lawsuit alleges that the Company made
−Removed: material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects,
−Removed: including information related to the study and trial of NE3107, in violation of Sections 10(b) and
−Removed: 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder.
−Removed: The class action is on behalf of purchasers
−Removed: of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and seeks unspecified monetary damages
−Removed: on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
+Added: District of Nevada, naming the Company and certain of its officers and/or directors as defendants.
+Added: On April 15, 2024 the court ordered
+Added: the motion to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned
+Added: BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v.
+Added: BioVie Inc., et al., Case No.
+Added: 2:24-cv-00361-LRH-CSD.
+Added: alleges that the Company made material misrepresentations and/or omissions of material fact relating to the Company’s business,
+Added: operations, compliance, and prospects, including information related to the study and trial of bezisterim (NE3107), in
+Added: violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder.
+Added: action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and
+Added: seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
The Company believes the lawsuit is without merit
3 unchanged sentences
No adjustment or accruals have been reflected in the accompanying condensed financial statements.
+Added: Notes to Condensed Financial Statements
+Added: For the Three and Nine Months Ended March 31, 2024
Employee Benefit Plan
−Removed: On August 1, 2021, the Company began sponsoring
−Removed: an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which,
+Added: On August 1, 2021, the Company began sponsoring an
+Added: 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.
−Removed: Subject to certain limitations in the Internal
−Removed: Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company
−Removed: will match 5% of the first 5% of an employee’s contributions to the 401K Plan., The Company made contributions of approximately
−Removed: $ 20,500 and $ 19,000 ,
−Removed: for the three months ended December 31, 2023 and 2022, respectively.
−Removed: The Company made contributions of approximately $ 51,400
−Removed: and $ 64,200 , for the six
−Removed: months ended December 31, 2023 and 2022, respectively.
+Added: Subject to certain limitations in the Internal Revenue
+Added: Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will
+Added: match 5% of the first 5% of an employee’s contributions to the 401K Plan., The Company made contributions for the three months ended
+Added: March 31, 2024 and 2023 of approximately $ 53,915 and $ 16,000 , respectively;
+Added: and for the nine months ended March 31, 2024 and 2023 of approximately
+Added: $ 105,000 and $ 80,100 , respectively.
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.