BIOVIE INC.
For the period ended Dec 31, 2024. Filed Feb 11, 2025.
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.
Dec 31, 2024 · Filed Feb 11, 2025
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 2024-09-30; filed 2024-11-13.
0001520138-24-000425
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-12-31; filed 2025-02-11.
0001520138-25-000056
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 47 previous paragraphs and 58 current paragraphs.
33 unchanged; 13 reworded; 11 added; 1 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 1 previous and 2 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 (11)
Current report
Selling, general and administrative expenses were approximately $2.5 million and $2.3 million for the three months ended December 31, 2024 and 2023, respectively. The net increase of approximately $200,000 was primarily attributed an increase in other consultancy fees of approximately $593,000, increased audit and accounting fees of approximately $42,000, and increases in expenses for shareholders’ meeting and regulatory filing fees of approximately $25,000. This was offset by declines in the executive team’s compensation totaling approximately $78,000 reflecting the reduction in force in December 2023, director compensation expense of approximately $141,000, investor relations of approximately $90,000, legal fees of approximately $24,000 and conference & meetings and website development totaling approximately $22,000 and $29,000, respectively.
Current report
Comparison of the six months ended December 31, 2024 to the six months ended December 21, 2023
Current report
Net loss
Current report
The net loss for the six months ended December 31, 2024 was approximately $11.3 million as compared to the net loss of $19.1 million for the six months ended December 31, 2023. The net decrease of $7.8 million was comprised of decreases in research and development expenses of $8.7 million, offset by increased selling, general and administrative expenses of approximately $409,000 and a decrease in other income, net of approximately $395,000.
Current report
Total operating expenses for the six months ended December 31, 2024 were approximately $11.4 million as compared to $19.7 million for the six months ended December 31, 2023. The net decrease of approximately $8.3 million was comprised of decreased research and development expenses of approximately $8.7 million primarily due to the completion of clinical trials in the prior fiscal year, offset by increased selling, general and administrative expenses of approximately $409,000.
Current report
Research and Development Expenses
Current report
Research and development expenses were approximately $6.7 million and $15.3 million for the six months ended December 31, 2024 and 2023, respectively. The $8.7 million net decline was primarily attributed to the completion of the clinical studies in the prior fiscal year and comprised of a net decrease in direct study costs of approximately $4.6 million, and decreases in related expenses such as the clinical team payroll of $1.4 million, reflecting the reduction in force in December 2023, and consultants expenses of $1.9 million, reflecting a declining use of consultants and a reduction in the use of regulatory and other consultants totaling approximately $440,000 as the clinical studies completed in the prior fiscal year, a decrease in Chemistry, Manufacturing and Controls (“CMC”) and new drug discovery totaling approximately $179,000, and a decrease in travel & conferences of approximately $93,000 and publications of approximately $93,000.
Current report
Selling, General and Administrative Expenses
Current report
Selling, general and administrative expenses were approximately $4.6 million and $4.2 million for the six months ended December 31, 2024 and 2023, respectively. The net increase of approximately $409,000 was primarily attributed to the net increase in other consultancy fees of approximately $540,000, and other increases in audit and accounting fees of approximately $61,000, legal fees of $376,000, insurance and office expense of approximately $30,000 and $21,000, respectively; offset by declines in the executive team’s compensation totaling approximately $266,000, director compensation expense of approximately $138,000, investor relations of approximately $139,000, conference & meetings and website development totaling approximately $36,000 and $29,000, respectively, and shareholders’ meetings and filing fees totaling approximately $12,000.
Current report
Other Income and Expense
Current report
Other income, net was approximately $150,000 compared to approximately $545,000 for the six months ended December 31, 2024 and 2023, respectively. The net decrease in other income, net of approximately $395,000 is comprised of a change in fair value of the related derivative liabilities of approximately $1.7 million, and a reduction in interest income of approximately $204,000. This was offset by a reduction in interest expense of approximately $1.5 million due to the notes payable being paid in full on December 1, 2024.
Removed paragraphs (1)
Previous 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.
Reworded paragraphs (13)
Previous wording
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 wording
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 July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with the study. The trial is anticipated to commence during the first calendar quarter of 2025.
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 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.
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 the Company 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
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 wording
The net loss for the three months ended December 31, 2024 was approximately $7.1 million as compared to the net loss of $8.4 million for the three months ended December 31, 2023. The net decrease of $1.3 million for the three months ended December 31, 2024 was comprised of a decrease in research and development expenses of $1.8 million, offset by increased selling, general and administrative expenses of approximately $277,000 and a decrease in other income, net of approximately $200,000.
Previous 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.
Current wording
Total operating expenses for the three months ended December 31, 2024 were approximately $7.3 million as compared to $8.8 million for the three months ended December 31, 2023. The net decrease of approximately $1.5 million for the three months ended December 31, 2024 was comprised of decreased research and development expenses of approximately $1.8 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 $277,000.
Previous wording
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 wording
Research and development (“R&D”) expenses were approximately $4.7 million and $6.5 million for the three months ended December 31, 2024 and 2023, respectively. The $1.8 million net decline was primarily attributed to the increase in direct cost related to the development and preparation of the new clinical studies to be launched in the first calendar quarter of 2025 of $3.4 million; offset by the decline in cost of approximately $3.1 million from completed studies; and other decreases in related expenses such as the clinical teams’ payroll of approximately $461,000, reflecting the reduction in force in December 2023, and a decrease in consultancy expense of approximately $1.0 million, resulting from declining use of consultants as the clinical studies were completed in the prior fiscal year, a decrease in Chemistry, Manufacturing and Controls (“CMC”) and new drug discovery totaling approximately $344,000, a reduction in the use of regulatory and other consultants totaling approximately $186,000, and a decrease in related expenses of approximately $59,000 in travel, conferences and publications.
Previous 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.
Current wording
Other income, net was approximately $180,000 compared to other income, net of $380,000, for the three months ended December 31, 2024 and 2023, respectively. The net decrease in other income, net of approximately $200,000 is comprised of a change in fair value of the derivative liabilities of approximately $989,000, which was offset by a reduction in interest expense of approximately $754,000 due to the notes payable being paid off on December 1, 2024, and an increase in interest income of approximately $35,000.
Previous wording
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 wording
The decrease in clinical studies of approximately $4.6 million represented the net decrease in clinical trial studies expense due the completion of the clinical trials in the prior fiscal year offset by the planning and development of the two new clinical studies PD and LC. The table below summarizes the expense amounts for the six months ended December 31, 2024 and 2023 by study:
Previous 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.
Current wording
As of December 31, 2024, the Company had working capital of approximately $23.2 million, cash and cash equivalents totaling approximately $24.4 million, stockholders’ equity of approximately $23.9 million, and an accumulated deficit of approximately $345.9 million.
Previous wording
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 wording
The Company used net cash in operations totaling approximately $12.2 million and net cash provided by financing activities was approximately $12.7 million comprised of net proceeds from the capital raise activities of $15.7 million and proceeds from exercise of warrants of $2.9 million offset by the payment of $5.0 million of the Company’s notes payable and payment of $850,000 loan premium.
Previous 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.
Current wording
During the six months ended December 31, 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 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.
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 were 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
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.
Current wording
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 7,110,000 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 $2.12 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 $2.5 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.
Previous 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.
Current wording
For the six-month period ended December 31, 2024, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting Policies section of this Form 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
The table below summarizes the expenses incurred for the three months ended December 31, 2024 and 2023 by study: