BIOVIE INC. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, among others: our research and development activities and distributor channel; compliance with regulatory requirements; and our ability to satisfy our capital needs Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments, except as required by law. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report. Management’s Discussion BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. Neurodegenerative Disease Programs 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 (or “bezisterim”). Bezisterim, the approved generic name for 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 Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from PD, and approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide. With respect to the mechanism of action, we believe bezisterim inhibits activation of inflammatory extracellular signal-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. By binding to ERK and selectively modulating NFκB activation and TNF-α production without interfering with their homeostatic functions (e.g., insulin signaling and neuron growth and survival), we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID. 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. 20 Table of Contents 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. The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260) that we 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 Company is conducting a Phase 2b clinical trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD. The trial is designed to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with PD who have not been treated with carbidopa/levodopa. The Phase 2b study is a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design, and is expected to span approximately 20 weeks from initial screening through safety follow-up for each participant. The trial commenced in April 2025 and completed enrollment of 60 patients in December 2025. The Company currently expects to report topline results from the trial in mid-year 2026, although the timing of results is subject to change and there can be no assurance that the trial will yield favorable results or support further development. Long COVID Program In April 2024, the Company was awarded a clinical trial grant of $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 for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. The trial commenced in May 2025. Alzheimer’s Disease In AD, BioVie has conducted both Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD. Liver Cirrhosis Program In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin) was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical need. BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months. After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”). Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. BIV201 is administered in a continuous infusion of terlipressin as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India to date. Terlipressin is used in over 40 countries to treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and was approved in the U.S. in 2022 to improve kidney function in adults with hepatorenal syndrome experiencing a rapid reduction in kidney function; it is not currently approved in Japan. 21 Table of Contents Comparison of the three months ended March 31, 2026 to the three months ended March 31, 2025 Net loss Net loss for the three months ended March 31, 2026 was approximately $5.3 million as compared to the net loss of approximately $2.8 million for the three months ended March 31, 2025. The net increase of $2.5 million for the three months ended March 31, 2026 was comprised of a net increase in research and development ("R&D") expenses of approximately $1.9 million, and a net increase in general and administrative expenses of approximately $565,000. Total operating expenses for the three months ended March 31, 2026 were approximately $5.4 million as compared to $3.0 million for the three months ended March 31, 2025. The net increase of approximately $2.4 million for the three months ended March 31, 2026 was comprised of a net increase in R&D expenses of approximately $1.9 million and a net increase in general and administrative expenses of approximately $565,000. Research and Development Expenses R&D expenses were approximately $3.2 million and $1.3 million for the three months ended March 31, 2026 and 2025, respectively. The net increase of approximately $1.9 million was primarily attributed to the increased activities in our clinical studies of approximately $1.1 million in the sunrise PD Phase 2 study as it became fully enrolled and nearing completion and the Long COVID (“LC”) Phase 2 study of a net increase of approximately $677,000. The net increase in the LC study was caused by the timing of reimbursements as amounts submitted for reimbursement are recorded on a cash basis or when recoverability is determined to be probable. The table below indicates the approximate cost incurred by study program. Three months ended Three months ended Increase March 31, 2026 March 31, 2025 (Decrease) Sunrise PD Phase 2 $ 2,060,000 $ 973,000 $ 1,087,000 Liver Program Phase 3 1,000 95,000 (94,000 ) Long COVID Phase 2 2,645,000 1,507,000 1,138,000 Long COVID Phase 2 - reimbursements (3,056,000 ) (2,595,000 ) (461,000 ) $ 1,650,000 $ (20,000 ) $ 1,670,000 General and Administrative Expenses General and administrative expenses were approximately $2.2 million and $1.6 million for the three months ended March 31, 2026 and 2025, respectively. The net increase of approximately $565,000 was primarily attributed to increases in the executive team and directors compensation of approximately $313,000 and $401,000, respectively, primarily in the form of stock-based compensation, increased insurance premiums of approximately $20,000 and accounting and auditing fees of approximately $16,000; offset by a decrease in legal fees expense of approximately $123,000, as the Company met its required insurance retention limit for the litigation costs of shareholders class action complaint, other professional and consultancy fees of approximately $38,000 and investor and public relation expense of approximately $24,000. Other Income and Expense Other income, net was approximately $115,000 compared to other income, net of approximately $200,000, for the three months ended March 31, 2026 and 2025, respectively. The net decrease in other income of approximately $85,000 was primarily due to a interest income of approximately $76,000. 22 Table of Contents Comparison of the nine months ended March 31, 2026 to the nine months ended March 31, 2025 Net loss Net loss for the nine months ended March 31, 2026 was approximately $16.4 million comparable to the net loss of approximately $14.1 million for the nine months ended March 31, 2025. The net increase of approximately $2.3 million for the nine months ended March 31, 2026 was comprised of the net increase in operating expenses of approximately $2.5 million offset by the increase in other income, net of approximately $155,000. Total operating expenses for the nine months ended March 31, 2026 were approximately $16.9 million as compared to $14.4 million for the nine months ended March 31, 2025. The net operating expense increase of approximately $2.5 million for the nine months ended March 31, 2026, was comprised of net increased R&D expenses of approximately $2.4 million attributed to the increased activities in both the Sunrise PD Phase 2 study and LC Phase 2 study and an increase in general and administrative expenses of approximately $189,000. Research and Development Expenses R&D expenses were approximately $10.4 million for the nine months ended March 31, 2026, an increase of approximately $2.4 million from $8.0 million for nine months ended March 31, 2025. The net increase in R&D expenses is comprised of increased direct study costs of approximately $2.5 million, clinical team compensation of approximately $282,000, abstracts, publications and conferences of approximately $176,000, offset by approximately $619,000 in Chemistry, Manufacturing and Controls (“CMC”) and Discovery expenses that have been curtailed. As the table indicates below, the increase in clinical studies of approximately $2.5 million is attributed to increased activity in both our clinical studies. Sunrise PD Phase 2 study costs increased by approximately $3.4 million as the study completed enrollment in January 2026 and the study is currently nearing completion. Long Covid Phase 2 study activities decreased and the net decrease in cost, net of reimbursements totaled approximately $786,000. The net decrease in costs is caused by the timing of reimbursements as amounts submitted for reimbursement are recorded on a cash basis or when recoverability is determined to be probable. As of March 31, 2026, the total cost incurred since inception was approximately $9.4 million and as of May 4, 2026 the total cost reimbursed was $9.4 million. Nine months ended Nine months ended Increase March 31, 2026 March 31, 2025 (Decrease) Sunrise PD Phase 2 $ 6,055,000 $ 2,648,000 $ 3,407,000 Liver Program Phase 3 16,000 138,000 (122,000 ) Long COVID Phase 2 4,625,000 4,233,000 392,000 Long COVID Phase 2 - reimbursements (4,098,000 ) (2,920,000 ) (1,178,000 ) $ 6,598,000 $ 4,099,000 $ 2,499,000 General and Administrative Expenses General and administrative expenses were approximately $6.4 million and $6.2 million for the nine months ended March 31, 2026 and 2025, respectively. The net increase of approximately $189,000 was primarily attributed to increases in the executive team and directors compensation of approximately $78,000 and $214,000, respectively, primarily comprised of stock based compensation; legal expenses of approximately $423,000 primarily attributed to the class action litigation; investor and public relations expenses of $71,000; and insurance premiums of approximately $55,000, offset by a decrease in consultancy fees of approximately $603,000 and a decline in other expenses such as meetings and travel totaling $24,000 and accounting and auditing fees of approximately $14,000. Other Income and Expense Other income, net was approximately $505,000 compared to other income, net of $350,000, for the nine months ended March 31, 2026 and 2025, respectively. The net increase in other income of approximately $155,000 was comprised of a reduction in interest expense of approximately $314,000 due to the payoff of the notes payable on December 1, 2024, offset by decline in interest income of approximately $155,000. 23 Table of Contents Capital Resources and Liquidity As of March 31, 2026, the Company had working capital of approximately $15.2 million, cash and cash equivalents totaling approximately $13.1 million, stockholders’ equity of approximately $15.6 million, and an accumulated deficit of approximately $368.6 million. The Company used net cash in operations totaling approximately $14.9 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of approximately $10.5 million. The Company has not generated any revenue and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions. Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Registered Offering On August 11, 2025, the Company closed an underwritten public offering (the “Offering”) of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant (the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of one pre-funded warrant and one Warrant. The underwriter also exercised its over-allotment option in part and purchased an additional 667,300 Warrants. The Offering resulted in net proceeds of approximately $10.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses. Each Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold to the public at a price of $1.999 per Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per share nominal exercise price for each Pre-Funded Warrant). On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market under the symbol “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an exercise price of $2.50 per share and expires five years from the date of issuance. Each Pre-Funded Warrant is immediately exercisable, entitles the holder to purchase one share of common stock and may be exercised at any time until exercised in full. Additionally, upon closing, the Company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price of $2.50, which was equal to 125% of the public offering price per share. The underwriter's Warrants are exercisable during a five-year period commencing 180 days from August 11, 2025. Critical Accounting Policies and Estimates 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, 2025 (the "2025 Form 10-K"). 24 Table of Contents New Accounting Pronouncements The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations and comprehensive loss. Item 3. Quantitative and Qualitative Disclosures About Market Risk Not applicable to smaller reporting companies.