BioVie Inc. reported a net loss of approximately $17.5 million for the fiscal year ending June 30, 2025, a significant decrease from the $32.1 million loss recorded in the previous year. This reduction of $14.6 million was primarily attributed to a decline in research and development expenses, which fell from $23.1 million to $9.3 million. The total operating expenses for the year were approximately $18.1 million, down from $32.2 million in the prior year, reflecting the completion of several clinical trials. The company has not generated any revenue to date and continues to rely on external financing to support its operations.

In terms of strategic developments, BioVie has been actively advancing its clinical programs. The company is focusing on its lead drug candidate, bezisterim (NE3107), which is being evaluated for the treatment of Alzheimer's disease, Parkinson's disease, and long COVID. A Phase 3 clinical trial for Alzheimer's disease faced challenges due to protocol deviations at several study sites, leading to the exclusion of patients from those sites. Despite this, preliminary data suggested a potential slowing of cognitive decline in the remaining participants. Additionally, BioVie has initiated a new Phase 2b study for bezisterim in patients with new-onset Parkinson's disease, which commenced in April 2025.

Operationally, BioVie has made notable progress in its clinical trials. The company received a $13.1 million grant from the U.S. Department of Defense to fund a clinical trial evaluating bezisterim for long COVID, which began in May 2025. As of June 30, 2025, BioVie had approximately $17.5 million in cash and cash equivalents, with total assets amounting to $21.6 million. The company’s stockholders' equity stood at approximately $19 million, reflecting a significant accumulated deficit of around $352.1 million.

Looking ahead, BioVie faces substantial challenges in securing additional financing to support its ongoing development efforts. The company has indicated that its future operations depend heavily on its ability to raise capital through equity sales or other strategic transactions. Management has expressed uncertainty regarding its ability to obtain sufficient funding on acceptable terms, which raises doubts about the company's ability to continue as a going concern. The financial statements for the year do not include any adjustments that might result from the outcome of this uncertainty.

In summary, while BioVie has made strides in its clinical programs and reduced its net losses, the company remains in a precarious financial position, heavily reliant on external funding to sustain its operations and continue its drug development initiatives.

About BIOVIE INC.

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