32 unchanged sentences
neurological and neuro-degenerative disorders and liver disease.
−Removed: The Company acquired the biopharmaceutical assets of NeurMedix, Inc.
−Removed: (“NeurMedix”)
−Removed: a privately held clinical-stage pharmaceutical company and a related party in June 2021 .
+Added: Neurodegenerative 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 .
The acquired assets included NE3107.
−Removed: In April 2024, the Company announced that the United States Adopted Names (“USAN”) Council, and the World Health Organization
−Removed: (“WHO”) International Nonproprietary Names (INN) expert committee had approved “bezisterim” as the non-proprietary
−Removed: (generic) name for NE3107.
−Removed: Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit
−Removed: inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.
−Removed: There is emerging
−Removed: scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim
−Removed: (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated
−Removed: 6 million Americans suffering from AD and 1 million Americans suffering from PD.
−Removed: Neurodengenerative Disease Program
−Removed: 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)
−Removed: On November 29, 2023, the Company announced the analysis
−Removed: of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild
−Removed: to moderate AD.
−Removed: The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive
−Removed: Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
−Removed: Patients were randomly assigned, 1:1 versus
−Removed: placebo, to receive sequentially 5 mg of bezisterim (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
−Removed: of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
−Removed: violations at 15 study sites (virtually all of which were from one geographic area).
−Removed: This highly unusual level of suspected improprieties
−Removed: 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.
−Removed: The trial was originally designed to be 80% powered
−Removed: 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;
−Removed: 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: Based on the efficacy signal seen in this trial, the
−Removed: Company is exploring (1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling
−Removed: patients to achieve statistical significance;
−Removed: and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most
−Removed: recent data and understanding of the potential effect bezisterim (NE3107) may have in helping persons with AD.
−Removed: Parkinson’s Disease (NCT05083260)
+Added: In April 2024, the Company announced that the United States Adopted Names Council, and the World
+Added: Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic)
+Added: name for NE3107.
+Added: Bezisterim (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 AD and PD, and bezisterim (NE3107) could,
+Added: if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million
+Added: Americans suffering from AD and 1 million Americans suffering from PD.
+Added: In neurodegenerative disease, bezisterim (NE3107)
+Added: inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”)
+Added: (including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
+Added: Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival).
+Added: inflammation and insulin resistance are drivers of AD and PD.
+Added: Chronic neuroinflammation, insulin resistance, and
+Added: oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic
+Added: lateral sclerosis.
+Added: Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory,
+Added: insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation.
+Added: Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work
+Added: testing the molecule in AD, PD, and long COVID patients.
+Added: Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe
+Added: and South Korea.
+Added: Parkinson’s Disease
+Added: Parkinson’s disease (“PD”) is driven
+Added: in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF).
+Added: Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement
+Added: However, levodopa effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads
+Added: to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high
+Added: dose levodopa.
+Added: Although levodopa provides symptomatic benefit, it does not slow PD progression.
The Phase 2 study of bezisterim (NE3107) for the treatment
10 unchanged sentences
Both objectives were met.
−Removed: The initiation of trial design
−Removed: for a Phase 3 study of bezisterim (NE3107) for the treatment of PD is currently on hold, pending additional funding.
+Added: To extend this Phase 2 data in progressed patients,
+Added: the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset
+Added: In August 2024, the FDA authorized the protocol for this new study.
Long COVID Program
2 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.
Liver Disease Program
26 unchanged sentences
annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.
−Removed: FDA has not approved any drug to treat
−Removed: refractory ascites.
−Removed: The BIV201 development program was initiated by LAT
−Removed: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
−Removed: The Company currently
−Removed: owns all development and marketing rights to this drug candidate.
−Removed: Pursuant to the Agreement and Plan of Merger entered into on April 11,
−Removed: 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty
−Removed: on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
−Removed: Comparison of the three months ended March 31, 2024 to the three months
−Removed: ended March 31, 2023
−Removed: The net loss for the three months ended March 31,
−Removed: 2024 and 2023, was approximately $8.1 million compared to a net loss of $15.0 million, respectively.
−Removed: The net decrease in net loss of approximately
−Removed: $6.9 million was due to reduced research and development expenses of approximately $5.5 million, a decrease in selling, general and administrative
−Removed: expenses of approximately $546,000, a reduction in interest expense of approximately $454,000 and the change in the fair value of derivative
−Removed: liabilities of approximately $475,000.
−Removed: Total operating expenses for the three months ended
−Removed: March 31, 2024, were approximately $7.7 million as compared to $13.8 million for the three months ended March 31, 2023.
−Removed: The net decrease
−Removed: of approximately $6.1 million for the three months ended March 31, 2024, represented a net decrease in research and development expenses
−Removed: of approximately $5.5 million due to the completion of clinical trials and a decrease in selling general and administrative expenses of
−Removed: approximately $546,000 from a decline in investor relations expense of approximately $365,000 and a decline in legal expenses of $129,000.
−Removed: Research and Development Expenses
−Removed: Research and development expenses were approximately
−Removed: $5.7 million and $11.2 million for the three months ended March 31, 2024, and 2023, respectively.
−Removed: The net decrease of approximately $5.5
−Removed: million for three months ended March 31, 2024, was primarily attributed to reduction in expenses totaling approximately $6.0 million due
−Removed: to completion of clinical studies and offset by increased expenses in CMC and clinical team compensation totaling approximately $520,000.
−Removed: The decreased expenses from completed clinical studies were comprised of approximately $868,000 from Ascites BIV201 Phase 2b study which
−Removed: was paused in March 2023;
−Removed: approximately $577,000 from completing PD Phase 2 study during the three months ended March 31, 2023;
−Removed: approximately
−Removed: $160,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.8 million from the completing
−Removed: AD pivotal Phase 3 clinical study and approximately $581,000 for the development of a new PD study which launch was delayed.
−Removed: The net decrease
−Removed: in clinical study expenses were offset by increased net expenses totaling approximately $520,000 and was comprised of increased expense
−Removed: in CMC for drug production and development of approximately $336,000;
−Removed: the increased clinical team compensation of $285,000 from the expansion
−Removed: of the clinical team subsequent to March 31, 2023;
−Removed: reduced by approximately $51,000 for consultancy expenses and approximately $50,000
−Removed: from less travel and publications in the three months ended March 31, 2024.
+Added: The FDA has not approved any drug to treat refractory
+Added: Comparison of the three months ended September 30, 2024 to the three
+Added: months ended September 30, 2023
+Added: net loss for the three months ended September 30, 2024 was approximately $4.2 million and as compared to the net loss of $10.7 million
+Added: for the three months ended September 30, 2023.
+Added: The net decrease of $6.5 million for the three months ended September 30, 2024 was comprised
+Added: of a decrease in research and development expenses of $6.9 million, offset by increased selling, general and administrative expenses
+Added: of approximately $132,000 and a decrease in other (expense) income, net of approximately $195,000.
+Added: operating expenses for the three months ended September 30, 2024 were approximately $4.1 million as compared to $10.9 million for the
+Added: three months ended September 30, 2023.
+Added: The net decrease of approximately $6.8 million for the three months ended September 30, 2024,
+Added: was comprised of decreased research and development expenses of approximately $6.9 million primarily due to the completion of clinical
+Added: trials in the prior fiscal year, offset by a net increase in selling general and administrative expenses of approximately $132,000, primarily
+Added: attributed to increased legal expenses related to regulatory, patent filings and litigation related to the class action suit.
+Added: and Development Expenses
+Added: and development (“R&D”) expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline
+Added: of approximately $6.9 million from $8.9 million for three months ended September 30, 2023.
+Added: The net decrease in R&D expenses of approximately
+Added: $6.9 million is primarily attributed to the completion of clinical trials in the prior fiscal year ended June 30, 2024, causing decreased
+Added: clinical trials expenses of $5.2 million, a decline in the clinical team expense consisting of reductions in clinical team payroll of
+Added: approximately $915,000, reduction in the use of consultants of approximately $547,000, a reduction in the use of regulatory and other
+Added: consultants totaling approximately $274,000, and a decrease in other related expenses of approximately $126,000 in travel, conferences
+Added: and publications.
+Added: This was offset by increased expenses in Chemistry, Manufacturing and Controls (“CMC”) totaling approximately
+Added: $155,000 related to drug production and drug discovery development.
+Added: The decline in clinical studies of $5.2 million represented
+Added: the net decrease in clinical trial studies expense due the completion of the clinical trials in fiscal year 2024 offset by the planning
+Added: and development of the two new clinical studies PD and LC.
+Added: The table below summarizes the expense amounts for the three months ended September
+Added: 30, 2024 and 2023 by study:
+Added: Three Months Ended
+Added: Three Months Ended
+Added: September 2024
+Added: September 2023
+Added: New Development
+Added: Sunrise PD Phase 2
+Added: Long Covid Program, net of $325,000 reimbursement
+Added: Completed Studies
+Added: Ascites BIV201 Phase 2b
+Added: AD mild to moderate pivotal Phase 3
+Added: Investigator-Initiated studies
+Added: $ (5,574,000 )
Selling, General and Administrative Expenses
Selling, general and administrative expenses were
−Removed: approximately $2.0 million and $2.5 million for the three months ended March 31, 2024, and 2023, respectively.
−Removed: The net decrease of approximately
−Removed: $546,000 was primarily attributed from a decline in investor relations expense of approximately $365,000 and decline in legal expenses
+Added: approximately $2.1 million and $1.9 million for the three months ended September 30, 2024 and 2023, respectively.
+Added: The net decrease of
+Added: approximately $132,000 was primarily attributed to the increases in legal fee expenses of approximately $400,000 and insurance premiums
+Added: of approximately $29,000;
+Added: offset by declines in the executive teams compensation of approximately $188,000, investor relations and other
+Added: filing fees of approximately $49,000, and other professional and consulting fees of approximately $52,000.
Other Income and Expense
Other expense, net was approximately $30,000 compared
−Removed: to other expense, net of $1.3 million, for the three months ended March 31, 2024 and 2023, respectively.
−Removed: The net decrease in other expense
−Removed: of approximately $931,000 represented a change in fair value of the related derivative liabilities of approximately $475,000 and a decrease
−Removed: in interest expense of approximately $454,000 as the principal payments of the debt balance began July 1, 2023.
−Removed: Comparison of the nine months ended March 31, 2024 to the nine months
−Removed: ended March 31, 2023
−Removed: The net loss for the nine months ended March 31, 2024,
−Removed: was approximately $27.2 million compared to a net loss of $41.1 million for the nine months ended March 31, 2023.
−Removed: The decrease in net
−Removed: loss of approximately $13.9 million was comprised of a net decrease in research and development expenses of approximately $4.0 million
−Removed: and selling, general and administrative expenses of approximately $2.8 million, and further reduced by an increase in interest income
−Removed: of approximately $557,000, a reduction in interest expense of approximately $739,000 and the change in the fair value of derivative liabilities
−Removed: of $6.0 million.
−Removed: Total operating expenses for the nine months ended
−Removed: March 31, 2024, were approximately $27.4 million as compared to $34.1 million for the nine months ended March 31, 2023.
−Removed: The net decrease
−Removed: of approximately $6.7 million for the nine months ended March 31, 2024, was comprised of a decrease in research and development expenses
−Removed: of approximately $4.0 million and a decrease in selling general and administrative expenses of approximately $2.8 million.
−Removed: Research and Development Expenses
−Removed: Research and development expenses were approximately
−Removed: $21.0 million and $25.0 million for the nine months ended March 31, 2024, and 2023, respectively.
−Removed: The net decrease of approximately $4.0
−Removed: million for the nine months ended March 31, 2024, was primarily attributed to a reduction in expenses totaling approximately $8.0 million
−Removed: due to completion of clinical studies and increased expenses in development of new studies, CMC and clinical team expansion and offset
−Removed: by the use of consultants totaling approximately $4.1 million.
−Removed: The decreased expenses totaling approximately $8.0 million from completed
−Removed: clinical studies were comprised of approximately $2.3 million from Ascites BIV201 Phase 2b study which was paused in March 2023, approximately
−Removed: $1.9 million from completing PD Phase 2 study during the three months ended March 31, 2023 , approximately $195,000 from the Investigator-Initiated
−Removed: Trial in MCI and Mild Alzheimer’s Disease, approximately $3.6 million from the completing AD pivotal Phase 3 clinical study of approximately
−Removed: $3.8 million.
−Removed: The increased expenses totaling approximately $4.1 million was comprised of the planning and development of new studies
−Removed: of approximately $822,000, increases from the expansion of the clinical team employees and consultants of $1.3 million and $835,000, respectively;
−Removed: and other increases in regulatory and other consultants of approximately $412,000 and publications and travel of approximately $133,000.
−Removed: Selling, General and Administrative Expenses
−Removed: Selling, general and administrative expenses were
−Removed: approximately $6.2 million and $8.9 million for the nine months ended March 31, 2024, and 2023, respectively.
−Removed: The net decrease of approximately
−Removed: $2.7 million was primarily attributed to decreases in directors stock compensation of approximately $2.3 million, investor relations fees
−Removed: of $517,000 offset by insurance expenses of approximately $181,000.
−Removed: Other Income and Expense
−Removed: Other income, net was approximately $210,000 compared
−Removed: to other expense, net of $7.0 million, for the nine months ended March 31, 2024 and 2023, respectively.
−Removed: The net increase in other income
−Removed: of approximately $7.2 million was primarily driven by the change in fair value of the derivative liabilities of approximately $6.0 million,
−Removed: as well as an increase in interest income of approximately $557,000 which was primarily from the investments in U.S.
−Removed: Treasury Bills and
−Removed: a reduction in interest expense of approximately $739,000 due to amortization and accretion of the financing costs, unearned discount,
−Removed: and premium relating to the note payable.
+Added: to other income, net of $165,000, for the three months ended September 30, 2024 and 2023, respectively.
+Added: The net increase in other expense
+Added: of approximately $195,000 is comprised of a reduction in the change in fair value of the related derivative liabilities of approximately
+Added: $705,000 and a reduction in interest expense of approximately $749,000, offset by a reduction in interest income of approximately $239,000.
Capital Resources and Liquidity
−Removed: As of March 31, 2024 the Company had working capital
−Removed: of approximately $18.1 million, cash and cash equivalents totaling approximately $30.4 million, stockholders’ equity of approximately
−Removed: $18.9 million, and an accumulated deficit of approximately $329.3 million.
−Removed: During the nine months ended March 31, 2024, the Company
−Removed: sold approximately 3.3 million shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald
−Removed: & Co for total net proceeds of approximately $9.3 million after 3% commissions and offering costs totaling approximately $377,000.
−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 class A common stock, par value $0.0001
−Removed: per share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of
−Removed: Common Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public
−Removed: offering price of $1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
−Removed: The gross proceeds to the Company from the
−Removed: Offering were approximately $21.0 million, before deducting placement agent fees and offering expenses of approximately $2.5 million.
−Removed: Additionally, upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase
−Removed: 1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal to 125% of the public offering price per share.
−Removed: The Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.
+Added: As of September 30, 2024, the Company had working
+Added: capital of approximately $13.3 million, cash and cash equivalents totaling approximately $20.0 million, stockholders’ equity of
+Added: approximately $14.1 million, and an accumulated deficit of approximately $338.7 million.
+Added: The Company used net cash in operations totaling approximately
+Added: $3.6 million and net cash provided by financing activities was approximately $241,000 comprised of net proceeds from capital raise activities
+Added: of $2.3 million offset by the payment of $2.5 million of the Company’s notes payable.
The Company has not generated any revenue and no revenues
10 unchanged sentences
The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: Controlled Equity Offering
+Added: During the three months ended September 30, 2024,
+Added: the Company sold approximately 2,143 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald
+Added: & Co for total net proceeds of approximately $6,400 after 3% commissions and offering costs totaling approximately $200.
+Added: 25, 2024, the Company filed a prospectus supplement to suspend sales under the Controlled Equity Offering Sales Agreement.
+Added: Registered Direct Offerings
+Added: On September 25, 2024, the Company closed a best
+Added: efforts public offering (the “September 2024 Offering”) of 1,360,800 shares of its common stock, par value $0.0001 per share,
+Added: pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase
+Added: up to 1,960,800 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53 per
+Added: Share, or September Pre-funded Warrant, and the associated September Common Warrant.
+Added: 265,000 September Pre-funded Warrants were exercised
+Added: in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component
+Added: of proceeds from issuance of common stock.
+Added: The September Common Warrants have an exercise price
+Added: of $1.53 per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance
+Added: The gross proceeds to the Company from the September 2024 Offering were approximately $3.0 million, before deducting placement
+Added: agent fees and offering expenses of approximately $747,000.
+Added: Additionally, upon closing, the Company issued the placement agent warrants
+Added: (“September Placement Agent’s Warrants”) to purchase 98,040 shares of Common Stock exercisable at a per share price
+Added: of $1.91, which was equal to 125% of the public offering price per share.
+Added: The September Placement Agent’s Warrants are exercisable
+Added: during a five-year period commencing 180 days from September 25, 2024.
+Added: In October 2024, the
+Added: Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $0.0001 per share, and two
+Added: concurrent private placements of warrants to purchase up to 8,256,000 shares of Common Stock (the “October Common Warrants”)
+Added: priced at-the-market under Nasdaq rules at prices ranging from $1.50 to $2.83 per share (the “October Offerings”) .
+Added: The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following
+Added: issuance and will expire on the fifth anniversary date of the original issuance dates.
+Added: The gross proceeds to the Company from
+Added: the October Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately
+Added: $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 from
+Added: $1.88 to $3.54, 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 Offerings.
Critical Accounting Policies and Estimates
−Removed: For the nine-month period ended March 31, 2024, there
−Removed: were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal
−Removed: year ended June 30, 2023.
+Added: For the three-month
+Added: period ended September 30, 2024, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting
+Added: Policies section of the 10-Q.
+Added: There were no other significant changes to the Company’s critical accounting policies as identified
+Added: in the Annual Report Form 10-K for the fiscal year ended June 30, 2024.
New Accounting Pronouncements
6 unchanged sentences
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.