BIOVIE INC
For the period ended Mar 31, 2024. Filed May 14, 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.
Mar 31, 2024 · Filed May 14, 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 2023-12-31; filed 2024-02-13.
0001520138-24-000069
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 53 previous paragraphs and 58 current paragraphs.
34 unchanged; 17 reworded; 7 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 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 (7)
Current report
Long COVID Program
Current report
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 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.
Current 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.
Current 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.
Current 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.
Current report
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.
Removed paragraphs (2)
Previous report
Research and development expenses were approximately $6.5 million and $7.0 million for the three months ended December 31, 2023, and 2022, respectively. The net decrease for the three months ended December 31, 2023 of approximately $563,000, was comprised of decreases from the completion of the clinical studies: the BIV201 Phase 2b study in the prior fiscal year ended June 30, 2023 of approximately $1.2 million, the AD Phase 3 clinical study completed during the three months ended December 31, 2023 of approximately $131,000, and the PD Phase 2 study that completed in the three months ended December 31, 2022 of approximately $492,000; offset by increased expenses of the clinical team employee and consultant compensation of approximately $272,000 and $635,000, respectively; and other increases in regulatory and other consultancy expense of approximately $148,000; Chemistry, Manufacturing and Control of approximately $110,000 and publications and travel of approximately $84,000.
Previous report
Selling, general and administrative expenses were approximately $2.3 million and $4.4 million for the three months ended December 31, 2023, and 2022, respectively. The net decrease of approximately $2.1 million was primarily attributed to a decline in directors and the executive team’s stock compensation expense of approximately $2.1 million.
Reworded paragraphs (17)
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. 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 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 (“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.
Previous wording
On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily.
Current wording
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 wording
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 NE3107 that leverages the most recent data and understanding of the potential effect NE3017 may have in helping persons with AD.
Current wording
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 wording
The Phase 2 study of NE3107 for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to to measure the potential for adverse interactions of NE3107 with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met. The initiation of trial design for a Phase 3 study of 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. 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.
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. NE3107 is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. NE3107’s potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD and PD patients. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.
Current 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.
Previous wording
The net loss for the three months ended December 31, 2023, was approximately $8.4 million compared to a net loss of $15.7 million for the three months ended December 31, 2022. The decrease in net loss of approximately $7.3 million was comprised of reduced research and development expenses of approximately $563,000, a decrease in selling, general and administrative expenses of approximately $2.2 million, an increase in interest income of approximately $135,000, a reduction in interest expense of approximately $233,000 and the change in the fair value of derivative liabilities of $4.2 million.
Current wording
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 wording
Total operating expenses for the three months ended December 31, 2023, were approximately $8.8 million as compared to $11.5 million for the three months ended December 31, 2022. The net decrease of approximately $2.7 million for the three months ended December 31, 2023 represented a net decrease in research and development expenses of approximately $563,000 due to the completion of clinical trials and a decrease in selling general and administrative expenses of approximately $2.2 million from a decline in stock compensation expense of approximately $2.1 million.
Current 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.
Previous wording
Other income, net was approximately $380,000 compared to other expense, net of $4.2 million, for the three months ended December 31, 2023 and 2022, respectively. The net increase in other income of approximately $4.6 million represented change in fair value of the related derivative liabilities of approximately $4.2 million.
Current 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.
Previous wording
Comparison of the six months ended December 31, 2023 to the six months ended December 31, 2022
Current wording
Comparison of the nine months ended March 31, 2024 to the nine months ended March 31, 2023
Previous wording
The net loss for the six months ended December 31, 2023, was approximately $19.1 million compared to a net loss of $26.1 million for the six months ended December 31, 2022. The decrease in net loss of approximately $7.0 million was comprised of a net decrease in research and development expenses of approximately $1.5 million and selling, general and administrative expenses of approximately $2.2 million, an increase in interest income of approximately $555,000, a reduction in interest expense of approximately $285,000 and the change in the fair value of derivative liabilities of $5.5 million.
Current wording
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 wording
Total operating expenses for the six months ended December 31, 2023, were approximately $19.7 million as compared to $20.3 million for the six months ended December 31, 2022. The net decrease of approximately $671,000 for the six months ended December 31, 2023 was comprised of an increase in research and development expenses of approximately $1.5 million offset by a decrease in selling general and administrative expenses of approximately $2.2 million.
Current wording
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 wording
Research and development expenses were approximately $15.3 million and $13.8 million for the six months ended December 31, 2023, and 2022, respectively. The net increase for the six months ended December 31, 2023 of approximately $1.5 million was comprised of increases from the expansion of the clinical team employees and consultants of $1.1 million and $874,000, respectively; planning and development of new clinical studies of approximately $1.4 million, and other increases in regulatory and other consultants of approximately $394,000 and publications and travel of approximately $215,000; offset by a reduction in costs from the completion in the prior fiscal year ended June 30, 2023 of PD Phase 2 study of approximately $1.3 million and the BIV201 Phase 2b study of approximately $1.4 million.
Current wording
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 wording
Selling, general and administrative expenses were approximately $4.2 million and $6.4 million for the six months ended December 31, 2023, and 2022, respectively. The net decrease of approximately $2.2 million was primarily attributed to decreases in the administrative team and directors stock compensation of approximately $2.4 million, other professional and advisory fees of $152,000 offset by increased legal fees of $92,000, and insurance expenses of approximately $111,000.
Current wording
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 wording
Other income, net was approximately $545,000 compared to other expense, net of $5.8 million, for the six months ended December 31, 2023 and 2022, respectively. The net increase in other income of approximately $6.3 million was primarily driven by the change in fair value of the derivative liabilities of approximately $5.5 million, as well as an increase in interest income of approximately $555,000 which was primarily from the investments in U.S. Treasury Bills and a reduction in interest expense of approximately $285,000 due to amortization and accretion of the financing costs, unearned discount, and premium relating to the note payable.
Current wording
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.
Previous wording
As of December 31, 2023 the Company had working capital of approximately $6.6 million, cash and cash equivalents totaling approximately $20.2 million, stockholders’ equity of approximately $7.5 million, and an accumulated deficit of approximately $320.3 million.
Current 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.
Previous wording
During the six months ended December 31, 2023, 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 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.
Previous wording
For the six-month period ended December 31, 2023, 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 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.