BIOVIE INC.

BioVie Inc. is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Alzheimer's disease (AD), Parkinson's disease (PD), and Long COVID, as well as advanced liver disease. The company's core business model revolves around the research, development, and clinical testing of its investigational drug candidates, primarily bezisterim (NE3107) and BIV201. Revenue generation is currently non-existent, as the company has no products approved for commercial sale and does not expect to generate revenues in the foreseeable future ¹. The company's operations are subject to the inherent risks of a development-stage enterprise, including the absence of an operating history, lack of commercialized products, insufficient capital, and expected substantial and continual losses ².

The company's neurodegenerative disease program centers on bezisterim (NE3107), an orally administered small molecule thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades. Bezisterim is being investigated for AD, PD, and Long COVID, conditions affecting an estimated 6 million Americans with AD, 1 million Americans with PD, and approximately 20 million adults in the US with Long COVID ³. The drug candidate is orally bioavailable, Blood Brain Barrier (BBB)-permeable, anti-inflammatory, and an insulin-sensitizer, with a low risk of drug-drug interaction ⁴. BioVie believes bezisterim may offer clinical improvements by inhibiting activation of inflammatory extracellular single regulated kinase (ERK) and nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) without interfering with their homeostatic functions ⁵.

In Parkinson's Disease, BioVie completed a Phase 2 study (NCT05083260) in December 2022, which was a double-blind, placebo-controlled study evaluating safety, tolerability, and pharmacokinetics of bezisterim in PD patients treated with carbidopa/levodopa. This study met its primary objective of safety and drug-drug interaction, and its secondary objective of showing preclinical indications of promotoric activity and enhancement of levodopa activity in humans ⁶. A new Phase 2b study of bezisterim as a potential first-line therapy for new-onset PD patients, who have not been treated with carbidopa/levodopa, commenced in April 2025 ⁷. For Long COVID, the company was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense (DOD) in April 2024 ⁸. The Phase 2 ADDRESS-LC study, fully funded by this grant, is a randomized, placebo-controlled, multicenter trial evaluating bezisterim for neurological symptoms, cognitive impairment, and fatigue in adult participants with Long COVID, which commenced in May 2025 ⁹. In Alzheimer's Disease, a Phase 3 clinical trial (NCT04669028) of bezisterim in mild to moderate AD patients faced significant protocol deviations and cGCP violations at 15 study sites, leading to the exclusion of patients from these sites and referral to the FDA Office of Scientific Investigations (OSI) ¹⁰. After exclusions, 81 patients remained in the Modified Intent to Treat population, and 57 in the Per-Protocol population, which left the trial underpowered for its primary endpoints ¹¹. However, in the Per-Protocol population, a descriptive change from baseline suggested a slowing of cognitive decline and an advantage in age deceleration ¹².

The Liver Cirrhosis Program features BIV201 (continuous infusion terlipressin), which has FDA Fast Track and Orphan Drug designation status ¹³. It is being evaluated for ascites and other life-threatening complications of advanced liver cirrhosis, a condition with over $5 billion in annual treatment costs and a 50% mortality rate within 6 to 12 months for refractory ascites patients ¹⁴. A Phase 2 study (NCT04112199) of BIV201 for refractory ascites, which completed patient treatment in May 2023, showed a 30% reduction in ascites fluid during treatment compared to pre-treatment, with patients completing treatment experiencing a 53% reduction sustained for three months ¹⁵. The company is finalizing the protocol design for a Phase 3 study of BIV201, targeting a broader ascites patient population, focusing on a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (AKI) ¹⁶. BIV201 is a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile, and India ¹⁷. The estimated total addressable ascites market size for BIV201 therapy exceeds $650 million based on company estimates ¹⁸.

For the fiscal year ended June 30, 2025, the company reported a net loss of approximately $17.5 million ¹⁹, a significant decrease from the net loss of $32.1 million for the year ended June 30, 2024 ²⁰. Total operating expenses for the year ended June 30, 2025, were approximately $18.1 million, compared to $32.2 million for the prior year ²¹. Research and development expenses decreased by $13.8 million, from approximately $23.1 million in 2024 to $9.3 million in 2025 ²². This reduction was primarily due to the completion of clinical studies in the prior fiscal year, with direct study costs declining by approximately $7.4 million ²³. Selling, general and administrative expenses were approximately $8.6 million in 2025, comparable to $8.8 million in 2024 ²⁴. Other income, net, increased by approximately $465,000, from $59,000 in 2024 to $524,000 in 2025 ²⁵. The net loss per common share (basic and diluted) was $(12.12) for 2025, an improvement from $(73.05) in 2024 ²⁶. As of June 30, 2025, the company had cash and cash equivalents of approximately $17.5 million ²⁷, working capital of approximately $18.4 million ²⁸, and stockholders' equity of approximately $19.0 million ²⁹. The accumulated deficit stood at approximately $352.1 million ³⁰. Net cash used in operating activities for the year ended June 30, 2025, was approximately $19.0 million ³¹.

During the year ended June 30, 2025, the company closed a best efforts public offering in September 2024, raising approximately $3.0 million in gross proceeds before deducting placement agent fees and offering expenses of approximately $747,000 ³². This offering included 136,080 shares of common stock, pre-funded warrants to purchase 60,000 shares, and warrants to purchase up to 196,080 shares ³³. Subsequently, 189,630 common warrants from this offering were exercised at $15.30 per share, generating approximately $2.9 million in proceeds ³⁴. In October 2024, the company closed three registered direct offerings, raising approximately $15.9 million in gross proceeds before deducting placement agent fees and offering expenses of approximately $2.5 million ³⁵. These offerings included 825,600 shares of common stock and warrants to purchase up to 711,000 shares ³⁶. The company also paid off notes payable totaling $5.0 million on December 1, 2024, along with a final payment of $850,000 ³⁷.

The company's future viability is largely dependent upon its ability to raise additional capital to finance its operations, as it has not generated any revenues to date and does not expect to in the foreseeable future ³⁸. Management anticipates that future funding sources may include sales of equity, obtaining loans, or other strategic transactions ³⁹. There is no assurance that the company will be successful in obtaining sufficient financing on acceptable terms, if at all, to fund continuing operations, which raises substantial doubt about its ability to continue as a going concern ⁴⁰.

A major growth area for BioVie is the new Phase 2b study of bezisterim for new-onset Parkinson's Disease (PD) patients who have not been treated with carbidopa/levodopa. The company submitted the new protocol in July 2024 and received FDA approval to proceed with the study, which commenced in April 2025 ⁴¹. This trial aims to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in this patient population ⁴². Another significant growth vector is the Long COVID Program, where the company was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense (DOD) in April 2024 ⁴³. The Phase 2 ADDRESS-LC study, fully funded by this grant, commenced in May 2025 and will evaluate bezisterim for the treatment of neurological symptoms, cognitive impairment, and fatigue in adult participants with Long COVID ⁴⁴. As of June 30, 2025, approximately $5.3 million of the total cost incurred for this program had been reimbursed ⁴⁵.

In the liver disease program, the company is finalizing the protocol design for a Phase 3 study of BIV201, focusing on a broader ascites patient population beyond refractory ascites. The primary endpoint will be a composite of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (AKI) ⁴⁶. This strategic shift follows guidance from the FDA received in June 2023 and December 2024 ⁴⁷. The company believes BIV201, with its novel room temperature stable formulation in a pre-filled syringe, could provide a superior terlipressin drug delivery system globally, differentiating it from other terlipressin products that require refrigeration ⁴⁸. The estimated total addressable ascites market size for BIV201 therapy exceeds $650 million based on company estimates ⁴⁹.

Regarding operational outlook, research and development expenses are expected to be managed in line with the progress of clinical trials. The $13.8 million reduction in R&D expenses for the year ended June 30, 2025, was primarily due to the completion of clinical studies in the prior fiscal year, offset by the planning, development, and launch of the two new clinical studies (Sunrise PD Phase 2 and Long COVID Program) totaling approximately $3.3 million ⁵⁰. The company's fixed expenses, such as rent and other contractual commitments, are likely to increase in the future as it may enter into leases for new facilities and capital equipment, and additional licenses and collaborative agreements ⁵¹. The company's San Diego office lease, which commenced in February 2024, has a current monthly base rate of $10,024 with an annual increase of four percent over a 60-month term ⁵².

Planned capital allocation includes continued investment in research and development for its product candidates. The company will require additional financing to further the clinical development of BIV201 and bezisterim (NE3107) ⁵³. To the extent additional funds are raised by issuing equity securities, stockholders may experience significant dilution ⁵⁴. The company does not intend to pay any cash dividends on its Common Stock in the foreseeable future, intending to retain any future earnings to finance business development and expansion ⁵⁵.

Management has explicitly flagged several structural headwinds and execution risks to its growth plan. The successful development of biopharmaceuticals is highly uncertain, with product candidates potentially failing to reach the market due to preclinical study results, harmful side effects, or failure to receive necessary regulatory approvals ⁵⁶. Delays can be caused by slow enrollment in clinical studies, lengthy time to achieve study endpoints, additional data analysis requirements, and FDA requests for more data ⁵⁷. The company relies heavily on third parties, including CROs and clinical trial sites, to conduct its clinical trials, and any failure by these third parties to carry out contractual duties or comply with regulatory requirements could delay or prevent regulatory approval ⁵⁸. The unplanned exclusion of patients from 15 study sites in the AD Phase 3 trial due to protocol deviations and cGCP violations highlights this risk, leaving the trial underpowered for its primary endpoints ⁵⁹. The company also has no manufacturing experience and relies on a Contract Manufacturing Organization (CMO), and any failure by the CMO to comply with cGMP could lead to product shortages or regulatory action ⁶⁰. Furthermore, the company has limited experience in drug development and may not be able to successfully develop any drugs, which could cause it to cease operations ⁶¹.

The company faces material risks including the inherent uncertainty of biopharmaceutical development, with product candidates potentially failing in clinical trials due to lack of efficacy, safety concerns, or failure to meet primary endpoints, as exemplified by the underpowered Phase 3 AD trial after excluding 15 sites due to cGCP violations ⁶². There is a significant reliance on third-party contractors for clinical trials and manufacturing, and their failure to comply with contractual duties or regulatory requirements (cGCP, cGMP) could lead to delays, regulatory disapproval, or product shortages ⁶³. The company has no products approved for commercial sale and has never generated revenue, raising substantial doubt about its ability to continue as a going concern without securing substantial additional capital through equity sales, loans, or strategic transactions ⁶⁴. Legal proceedings, including a shareholder class action complaint and two shareholder derivative lawsuits alleging material misrepresentations and breaches of fiduciary duty related to the AD Phase 3 study, pose a significant risk, requiring substantial management time and attention, incurring legal expenses, and potentially resulting in unfavorable outcomes or substantial damages exceeding the $2 million deductible on insurance coverage ⁶⁵. Intellectual property risks are also material, as the company's ability to compete depends on obtaining and protecting patent rights for its drug candidates, which are uncertain and can be challenged, invalidated, or circumvented, potentially leading to loss of exclusivity or inability to commercialize products without infringing third-party rights ⁶⁶.

Management's message to shareholders conveys a tone of cautious optimism regarding its clinical pipeline, despite acknowledging significant challenges and the company's pre-revenue stage. They emphasize the ongoing development of innovative drug therapies for neurological and neurodegenerative disorders and advanced liver disease, highlighting the potential of bezisterim for Parkinson's disease and Long COVID, and BIV201 for liver cirrhosis ⁶⁷. A key strategic priority is the advancement of new clinical studies, specifically the new Phase 2b study of bezisterim for new-onset PD, which commenced in April 2025, and the Phase 2 ADDRESS-LC study for Long COVID, which commenced in May 2025 and is fully funded by a $13.1 million grant from the U.S. Department of Defense ⁶⁸. Another strategic priority is the finalization of the protocol design for the Phase 3 study of BIV201, targeting a broader ascites patient population with a composite primary endpoint of complications and disease progression in patients recovering from AKI ⁶⁹. Management explicitly states that the company's future viability is largely dependent upon its ability to raise additional capital, expecting future funding to come from sales of equity, loans, or other strategic transactions, and acknowledges that there is no assurance of obtaining sufficient financing on acceptable terms ⁷⁰.