BIOVIE INC.

BioVie Inc. is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease. The company's core business model revolves around the research, development, and eventual commercialization of its investigational drug candidates, primarily bezisterim (NE3107) for neurodegenerative diseases and BIV201 for advanced liver disease. Revenue generation is currently non-existent, and the company is in a pre-revenue stage, relying heavily on external financing to fund its operations and clinical trials. The primary customer segments, if products are approved, would be patients suffering from Alzheimer's disease (AD), Parkinson's disease (PD), Long COVID, and advanced liver cirrhosis with ascites.

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 Alzheimer's disease, Parkinson's disease, and Long COVID. For AD, a Phase 3 clinical trial (NCT04669028) was completed, but significant protocol deviations and cGCP violations at 15 study sites led to patient exclusions, rendering the trial underpowered for its primary endpoints. However, a descriptive slowing of cognitive decline and an advantage in age deceleration were observed in the remaining 81 patients in the Modified Intent to Treat population, with 57 in the Per-Protocol population. For PD, a Phase 2 study (NCT05083260) completed in December 2022 showed significant improvements in "morning on" symptoms and motor control in patients treated with bezisterim and levodopa, with no drug-related adverse events. A new Phase 2b study for new onset PD patients, not yet treated with carbidopa/levodopa, commenced in April 2025. In the Long COVID program, bezisterim is being evaluated for neurological symptoms, including fatigue and cognitive dysfunction, in a Phase 2 ADDRESS-LC study, which commenced in May 2025 and is fully funded by a $13.1 million ¹ grant from the U.S. Department of Defense (DOD).

The liver cirrhosis program focuses on BIV201 (continuous infusion terlipressin), which has received FDA Fast Track designation and Orphan Drug Status for ascites. BIV201 is being developed for patients with ascites and other life-threatening complications of advanced liver cirrhosis. A Phase 2 study (NCT04112199) for refractory ascites, which paused enrollment after 15 patients, showed a 30% ² reduction in ascites fluid during treatment compared to pre-treatment, with a 53% ³ reduction sustained for three months in patients who completed treatment. The company is finalizing the protocol design for a Phase 3 study of BIV201, targeting a broader ascites patient population, specifically those who have recently recovered from acute kidney injury (AKI), with a composite primary endpoint of complications and disease progression. The estimated total addressable ascites market size for BIV201 therapy exceeds $650 million ⁴ based on company estimates, with annual treatment costs for refractory ascites patients generating more than $5 billion ⁵.

For the fiscal year ended June 30, 2025, the company reported a net loss of approximately $17.5 million ⁶, a decrease from the net loss of $32.1 million ⁷ for the year ended June 30, 2024. Total operating expenses were approximately $18.1 million ⁸ for 2025, down from $32.2 million ⁹ in 2024. Research and development expenses significantly decreased to approximately $9.3 million ¹⁰ in 2025 from $23.1 million ¹¹ in 2024, primarily due to the completion of clinical studies in the prior fiscal year. Selling, general and administrative expenses were approximately $8.6 million ¹² in 2025, comparable to $8.8 million ¹³ in 2024. Other income, net, increased to approximately $524,000 ¹⁴ in 2025 from $59,000 ¹⁵ in 2024, driven by a decrease in the change in fair value of derivative liabilities of approximately $1.8 million ¹⁶ and a decline in interest expense of $2.6 million ¹⁷, partially offset by a decrease in interest income of approximately $284,000 ¹⁸.

Year-over-year, the net loss decreased by $14.6 million ¹⁹. This was primarily driven by a $13.8 million ²⁰ reduction in research and development expenses. Within R&D, direct study costs declined by approximately $7.4 million ²¹, clinical team payroll by approximately $1.4 million ²², and consultant expenses by approximately $3.0 million ²³. Other R&D decreases included $1.2 million ²⁴ in Chemistry, Manufacturing and Controls (CMC) and new drug discovery, $123,000 ²⁵ in travel & conferences, and $166,000 ²⁶ in publications. These decreases were partially offset by approximately $3.3 million ²⁷ in planning, development, and launch costs for the new Sunrise PD Phase 2 and Long COVID programs. The Long COVID Program incurred approximately $146,000 ²⁸ in expenses in 2025, net of $5.3 million ²⁹ reimbursement, compared to $106,000 ³⁰ in 2024. The Liver Program Phase 3 expenses increased to $173,000 ³¹ from $45,000 ³².

During the reported fiscal period, the company commenced a new Phase 2b study for bezisterim in new onset Parkinson's disease patients in April 2025. The Phase 2 ADDRESS-LC study for bezisterim in Long COVID also commenced in May 2025, fully funded by a $13.1 million ³³ DOD grant. The company also closed a best efforts public offering in September 2024, generating approximately $3.0 million ³⁴ in gross proceeds, and three registered direct offerings in October 2024, totaling approximately $15.9 million ³⁵ in gross proceeds. The Loan Agreement with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P. for growth capital loans was paid in full on its maturity date of December 1, 2024, including a final payment of $850,000 ³⁶.

BioVie's management expects future operations to be dependent on the successful completion of ongoing development and commercialization efforts for its product candidates, as well as its ability to secure additional financing. The company has not generated any revenues to date and does not anticipate any in the foreseeable future. Management expects future funding sources to include sales of equity, obtaining loans, or other strategic transactions. The company's financial statements have been prepared assuming it will continue as a going concern, but the recurring losses from operations and negative cash flows from operating activities raise substantial doubt about this ability.

A major growth area for the company is the continued development of bezisterim for Parkinson's disease. A new Phase 2b study of bezisterim as a potential first-line therapy for patients with new onset PD commenced in April 2025. This multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design is expected to last 20 weeks from initial screening to safety follow-up. The FDA permitted the company to proceed with this study in July 2024. This trial aims to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in PD patients who have not yet been treated with carbidopa/levodopa, building on positive Phase 2 data that showed significant improvements in "morning on" symptoms and clinically meaningful improvement in motor control.

Another significant growth area is the Long COVID program, where bezisterim is being evaluated for neurological symptoms, including fatigue and cognitive dysfunction. The Phase 2 ADDRESS-LC study, a randomized (1:1), placebo-controlled, multicenter trial, commenced in May 2025. This study is fully funded by a clinical trial grant of $13.1 million ³⁷ from the U.S. Department of Defense (DOD), awarded in April 2024. The FDA approved the associated Investigational New Drug Application (IND) in August 2024, allowing the company to proceed with this novel anti-inflammatory approach. The company believes bezisterim has the potential to reduce neurological symptoms in the estimated 20 million ³⁸ individuals in the U.S. currently or previously affected by Long COVID.

For the Alzheimer's disease program, following the identification of significant protocol deviations and cGCP violations at 15 study sites in the Phase 3 clinical trial of bezisterim, the company is considering two paths forward: either employing the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance, or designing a new Phase 3 study that leverages recent scientific literature and the company's understanding of bezisterim's effects in mild-to-moderate AD patients. Additional DNA methylation data continues to be collected and analyzed from the completed trial.

In the liver cirrhosis program, the company is finalizing the protocol design for a Phase 3 study of BIV201 (continuous infusion terlipressin). This study will 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). This represents a broader patient population than the initial target of refractory ascites. The company received guidance from the FDA regarding the design and endpoints for definitive Phase 3 clinical testing in June 2023 and December 2024. BIV201 has FDA Fast Track designation and Orphan Drug Status for ascites and is administered as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile, and India. The company believes BIV201 could potentially provide a superior terlipressin drug delivery system globally, with room temperature stability for 2 years, a key product differentiation. The total potentially addressable ascites market size for BIV201 therapy is estimated to exceed $650 million ³⁹.

The company's capital allocation plans include continued investment in research and development. R&D expenses for the year ended June 30, 2025, were approximately $9.3 million ⁴⁰, a significant reduction from $23.1 million ⁴¹ in the prior year due to clinical trial completions. However, approximately $3.3 million ⁴² was allocated to the planning, development, and launch of the new Sunrise PD Phase 2 and Long COVID programs. The company also raised approximately $3.0 million ⁴³ in gross proceeds from a public offering in September 2024 and approximately $15.9 million ⁴⁴ in gross proceeds from three registered direct offerings in October 2024. The company does not intend to pay any cash dividends on its Common Stock in the foreseeable future, preferring to retain future earnings to finance business development and expansion.

The company faces substantial risks, including the inherent uncertainty of biopharmaceutical development, where product candidates may fail in clinical trials due to lack of efficacy or harmful side effects, or fail to receive regulatory approvals, as exemplified by the underpowered Phase 3 AD trial due to cGCP violations at 15 study sites. The company has no approved products or generated revenues to date, raising substantial doubt about its ability to continue as a going concern without significant additional capital, which may not be available on acceptable terms. Reliance on third-party contractors for clinical trials and manufacturing exposes the company to risks of non-compliance with regulatory requirements like cGCPs and cGMP, potentially causing delays or preventing commercialization. Competition from larger, better-resourced biopharmaceutical companies, including those developing therapies for advanced liver cirrhosis (e.g., Ocelot Bio) and AD/PD (e.g., Biogen, Eli Lilly), poses a significant threat. Intellectual property protection is uncertain, with patents potentially being challenged, invalidated, or circumvented, and the limited lifespan of patents may not provide sufficient competitive advantage. The company is also subject to ongoing securities class action litigation and shareholder derivative lawsuits, alleging material misrepresentations related to the bezisterim AD trial, which will require significant management time and attention, incur substantial legal expenses, and are subject to a $2 million ⁴⁵ deductible on insurance coverage. Furthermore, the company's stock price is volatile, and future equity offerings could lead to significant dilution for existing stockholders, especially given the downward adjustment features in certain warrants.

Management's message to shareholders emphasizes the company's commitment to developing innovative drug therapies for neurological and neurodegenerative disorders and advanced liver disease, despite being in a pre-revenue, clinical-stage phase. They acknowledge the significant challenges and uncertainties inherent in drug development, including the need for substantial additional capital to fund ongoing operations and clinical trials. Management explicitly states that the company's future viability is largely dependent on its ability to raise this capital through equity sales, loans, or strategic transactions. They are actively pursuing the development of bezisterim for Parkinson's disease and Long COVID, with new Phase 2 studies commencing in April 2025 and May 2025, respectively, and are finalizing the protocol for a Phase 3 study of BIV201 for liver cirrhosis. The company also highlights its efforts to protect intellectual property through patents and confidentiality agreements. Despite the ongoing securities class action and shareholder derivative lawsuits, management believes these claims are without merit and intends to defend vigorously. The strategic priorities appear to be focused on advancing the clinical development of their lead drug candidates, securing necessary financing, and managing legal and regulatory compliance.