Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 30

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 30
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), and the commercial viability of bezisterim (NE3107) if it were to be approved and marketed.

Any delay or further delay in the development,
introduction or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance
characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term
nature of our projects and other risk factors described elsewhere in this document, we may not be able to successfully complete the development
or marketing of any drugs, which could cause us to cease operations.

From time to time, the FDA may have feedback on
our clinical trial designs, including for example certain of our endpoints and outcome measures. As a result, we may consider revisions
to our protocols which may delay progress in implementing our trials. We may fail to successfully develop and commercialize our product
candidate(s) if it is found to be unsafe or ineffective in clinical trials; does not receive necessary approval from the FDA or foreign
regulatory agencies; fails to conform to a changing standard of care for the disease it seeks to treat; or is less effective or more expensive
than current or alternative treatment methods.

Drug development failure can occur at any stage
of clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated
clinical targets. Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses,
and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials
could be required before we submit our product candidates for approval. We cannot guarantee that the FDA or comparable foreign regulatory
authorities will view our product candidates as having efficacy even if positive results are observed in clinical trials. In some instances,
there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due
to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations,
changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants. If the results of
our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical
endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates,
we may be delayed in obtaining marketing approval, if at all. Additionally, any safety concerns observed