BIOVIE INC
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 13, 2024
BIVI$1.33+9.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0001520138-24-000204
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001520138-24-000425
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 58 previous paragraphs and 47 current paragraphs.
23 unchanged; 12 reworded; 12 added; 23 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
Neurodegenerative Disease Program
Current report
Parkinson’s Disease
Current report
Parkinson’s disease (“PD”) is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa provides symptomatic benefit, it does not slow PD progression.
Current report
To extend this Phase 2 data in progressed patients, the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset PD. In August 2024, the FDA authorized the protocol for this new study.
Current report
The 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 for the three months ended September 30, 2023. The net decrease of $6.5 million for the three months ended September 30, 2024 was comprised of a decrease in research and development expenses of $6.9 million, offset by increased selling, general and administrative expenses of approximately $132,000 and a decrease in other (expense) income, net of approximately $195,000.
Current report
Research and development (“R&D”) expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline of approximately $6.9 million from $8.9 million for three months ended September 30, 2023. The net decrease in R&D expenses of approximately $6.9 million is primarily attributed to the completion of clinical trials in the prior fiscal year ended June 30, 2024, causing decreased clinical trials expenses of $5.2 million, a decline in the clinical team expense consisting of reductions in clinical team payroll of approximately $915,000, reduction in the use of consultants of approximately $547,000, a reduction in the use of regulatory and other consultants totaling approximately $274,000, and a decrease in other related expenses of approximately $126,000 in travel, conferences and publications. This was offset by increased expenses in Chemistry, Manufacturing and Controls (“CMC”) totaling approximately $155,000 related to drug production and drug discovery development.
Current report
The decline in clinical studies of $5.2 million represented the net decrease in clinical trial studies expense due the completion of the clinical trials in fiscal year 2024 offset by the planning and development of the two new clinical studies PD and LC. The table below summarizes the expense amounts for the three months ended September 30, 2024 and 2023 by study:
Current report
Selling, general and administrative expenses were approximately $2.1 million and $1.9 million for the three months ended September 30, 2024 and 2023, respectively. The net decrease of approximately $132,000 was primarily attributed to the increases in legal fee expenses of approximately $400,000 and insurance premiums of approximately $29,000; offset by declines in the executive teams compensation of approximately $188,000, investor relations and other filing fees of approximately $49,000, and other professional and consulting fees of approximately $52,000.
Current report
The Company used net cash in operations totaling approximately $3.6 million and net cash provided by financing activities was approximately $241,000 comprised of net proceeds from capital raise activities of $2.3 million offset by the payment of $2.5 million of the Company’s notes payable.
Current report
Controlled Equity Offering
Current report
Registered Direct Offerings
Current report
In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $0.0001 per share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $1.50 to $2.83 per share (the “October Offerings”). The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original issuance dates. The gross proceeds to the Company from the October Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately $2.8 million. Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging from $1.88 to $3.54, which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.
Removed paragraphs (23)
Previous report
Neurodengenerative Disease Program
Previous report
Alzheimer’s Disease (NCT05083260)
Previous report
On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of bezisterim (NE3107) orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily.
Previous report
Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”) for further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.
Previous report
The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected and analyzed.
Previous report
Based on the efficacy signal seen in this trial, the Company is exploring (1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance; and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most recent data and understanding of the potential effect bezisterim (NE3107) may have in helping persons with AD.
Previous report
Parkinson’s Disease (NCT05083260)
Previous report
Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously had long COVID. Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating. The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars. To date there are no therapies proven effective for treatment.
Previous report
Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID. Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features. Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting an underlying cause of long COVID symptoms.
Previous report
The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
Previous report
The net loss for the three months ended March 31, 2024 and 2023, was approximately $8.1 million compared to a net loss of $15.0 million, respectively. The net decrease in net loss of approximately $6.9 million was due to reduced research and development expenses of approximately $5.5 million, a decrease in selling, general and administrative expenses of approximately $546,000, a reduction in interest expense of approximately $454,000 and the change in the fair value of derivative liabilities of approximately $475,000.
Previous report
Research and development expenses were approximately $5.7 million and $11.2 million for the three months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $5.5 million for three months ended March 31, 2024, was primarily attributed to reduction in expenses totaling approximately $6.0 million due to completion of clinical studies and offset by increased expenses in CMC and clinical team compensation totaling approximately $520,000. The decreased expenses from completed clinical studies were comprised of approximately $868,000 from Ascites BIV201 Phase 2b study which was paused in March 2023; approximately $577,000 from completing PD Phase 2 study during the three months ended March 31, 2023; approximately $160,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.8 million from the completing AD pivotal Phase 3 clinical study and approximately $581,000 for the development of a new PD study which launch was delayed. The net decrease in clinical study expenses were offset by increased net expenses totaling approximately $520,000 and was comprised of increased expense in CMC for drug production and development of approximately $336,000; the increased clinical team compensation of $285,000 from the expansion of the clinical team subsequent to March 31, 2023; reduced by approximately $51,000 for consultancy expenses and approximately $50,000 from less travel and publications in the three months ended March 31, 2024.
Previous report
Selling, general and administrative expenses were approximately $2.0 million and $2.5 million for the three months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $546,000 was primarily attributed from a decline in investor relations expense of approximately $365,000 and decline in legal expenses of $129,000.
Previous report
Comparison of the nine months ended March 31, 2024 to the nine months ended March 31, 2023
Previous report
Net loss
Previous report
The net loss for the nine months ended March 31, 2024, was approximately $27.2 million compared to a net loss of $41.1 million for the nine months ended March 31, 2023. The decrease in net loss of approximately $13.9 million was comprised of a net decrease in research and development expenses of approximately $4.0 million and selling, general and administrative expenses of approximately $2.8 million, and further reduced by an increase in interest income of approximately $557,000, a reduction in interest expense of approximately $739,000 and the change in the fair value of derivative liabilities of $6.0 million.
Previous report
Total operating expenses for the nine months ended March 31, 2024, were approximately $27.4 million as compared to $34.1 million for the nine months ended March 31, 2023. The net decrease of approximately $6.7 million for the nine months ended March 31, 2024, was comprised of a decrease in research and development expenses of approximately $4.0 million and a decrease in selling general and administrative expenses of approximately $2.8 million.
Previous report
Research and Development Expenses
Previous report
Research and development expenses were approximately $21.0 million and $25.0 million for the nine months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $4.0 million for the nine months ended March 31, 2024, was primarily attributed to a reduction in expenses totaling approximately $8.0 million due to completion of clinical studies and increased expenses in development of new studies, CMC and clinical team expansion and offset by the use of consultants totaling approximately $4.1 million. The decreased expenses totaling approximately $8.0 million from completed clinical studies were comprised of approximately $2.3 million from Ascites BIV201 Phase 2b study which was paused in March 2023, approximately $1.9 million from completing PD Phase 2 study during the three months ended March 31, 2023 , approximately $195,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.6 million from the completing AD pivotal Phase 3 clinical study of approximately $3.8 million. The increased expenses totaling approximately $4.1 million was comprised of the planning and development of new studies of approximately $822,000, increases from the expansion of the clinical team employees and consultants of $1.3 million and $835,000, respectively; and other increases in regulatory and other consultants of approximately $412,000 and publications and travel of approximately $133,000.
Previous report
Selling, General and Administrative Expenses
Previous report
Selling, general and administrative expenses were approximately $6.2 million and $8.9 million for the nine months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $2.7 million was primarily attributed to decreases in directors stock compensation of approximately $2.3 million, investor relations fees of $517,000 offset by insurance expenses of approximately $181,000.
Previous report
Other Income and Expense
Previous report
Other income, net was approximately $210,000 compared to other expense, net of $7.0 million, for the nine months ended March 31, 2024 and 2023, respectively. The net increase in other income of approximately $7.2 million was primarily driven by the change in fair value of the derivative liabilities of approximately $6.0 million, as well as an increase in interest income of approximately $557,000 which was primarily from the investments in U.S. Treasury Bills and a reduction in interest expense of approximately $739,000 due to amortization and accretion of the financing costs, unearned discount, and premium relating to the note payable.
Reworded paragraphs (12)
Previous wording
The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021*.* The acquired assets included NE3107. In April 2024, the Company announced that the United States Adopted Names (“USAN”) Council, and the World Health Organization (“WHO”) International Nonproprietary Names (INN) expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107. Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.
Current wording
The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021*.* The acquired assets included NE3107. In April 2024, the Company announced that the United States Adopted Names Council, and the World Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107. Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.
Previous wording
In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD.
Current wording
In neurodegenerative disease, bezisterim (NE3107) inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD.
Previous wording
Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.
Current wording
Chronic neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.
Previous wording
The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: 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 of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met. The initiation of trial design for a Phase 3 study of bezisterim (NE3107) for the treatment of PD is currently on hold, pending additional funding.
Current wording
The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: 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 of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.
Previous wording
In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”). The award can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.
Current wording
In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence by early 2025.
Previous wording
While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The U.S. FDA has not approved any drug to treat refractory ascites.
Current wording
While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The FDA has not approved any drug to treat refractory ascites.
Previous wording
Total operating expenses for the three months ended March 31, 2024, were approximately $7.7 million as compared to $13.8 million for the three months ended March 31, 2023. The net decrease of approximately $6.1 million for the three months ended March 31, 2024, represented a net decrease in research and development expenses of approximately $5.5 million due to the completion of clinical trials and a decrease in selling general and administrative expenses of approximately $546,000 from a decline in investor relations expense of approximately $365,000 and a decline in legal expenses of $129,000.
Current wording
Total operating expenses for the three months ended September 30, 2024 were approximately $4.1 million as compared to $10.9 million for the three months ended September 30, 2023. The net decrease of approximately $6.8 million for the three months ended September 30, 2024, was comprised of decreased research and development expenses of approximately $6.9 million primarily due to the completion of clinical trials in the prior fiscal year, offset by a net increase in selling general and administrative expenses of approximately $132,000, primarily attributed to increased legal expenses related to regulatory, patent filings and litigation related to the class action suit.
Previous wording
Other expense, net was approximately $336,000 compared to other expense, net of $1.3 million, for the three months ended March 31, 2024 and 2023, respectively. The net decrease in other expense of approximately $931,000 represented a change in fair value of the related derivative liabilities of approximately $475,000 and a decrease in interest expense of approximately $454,000 as the principal payments of the debt balance began July 1, 2023.
Current wording
Other expense, net was approximately $30,000 compared to other income, net of $165,000, for the three months ended September 30, 2024 and 2023, respectively. The net increase in other expense of approximately $195,000 is comprised of a reduction in the change in fair value of the related derivative liabilities of approximately $705,000 and a reduction in interest expense of approximately $749,000, offset by a reduction in interest income of approximately $239,000.
Previous wording
As of March 31, 2024 the Company had working capital of approximately $18.1 million, cash and cash equivalents totaling approximately $30.4 million, stockholders’ equity of approximately $18.9 million, and an accumulated deficit of approximately $329.3 million.
Current wording
As of September 30, 2024, the Company had working capital of approximately $13.3 million, cash and cash equivalents totaling approximately $20.0 million, stockholders’ equity of approximately $14.1 million, and an accumulated deficit of approximately $338.7 million.
Previous wording
During the nine months ended March 31, 2024, the Company sold approximately 3.3 million shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co for total net proceeds of approximately $9.3 million after 3% commissions and offering costs totaling approximately $377,000.
Current wording
During the three months ended September 30, 2024, the Company sold approximately 2,143 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co for total net proceeds of approximately $6,400 after 3% commissions and offering costs totaling approximately $200. On September 25, 2024, the Company filed a prospectus supplement to suspend sales under the Controlled Equity Offering Sales Agreement.
Previous wording
On March 6, 2024, the Company closed a best efforts public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its class A common stock, par value $0.0001 per share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of Common Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price of $1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant. The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement agent fees and offering expenses of approximately $2.5 million. Additionally, upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 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. The Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.
Current wording
On September 25, 2024, the Company closed a best efforts public offering (the “September 2024 Offering”) of 1,360,800 shares of its common stock, par value $0.0001 per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase up to 1,960,800 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53 per Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds from issuance of common stock. The September Common Warrants have an exercise price of $1.53 per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The gross proceeds to the Company from the September 2024 Offering were approximately $3.0 million, before deducting placement agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040 shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125% of the public offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from September 25, 2024.
Previous wording
For the nine-month period ended March 31, 2024, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2023.
Current wording
For the three-month period ended September 30, 2024, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting Policies section of the 10-Q. There were no other significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2024.