Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 156

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 156
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 Accordingly, we express no such opinion.

Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a
matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit
committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on
the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which it relates.

Research and development expenses and related accruals

As described in Note 3 to the accompanying financial
statements, research and development expenses consist primarily of costs associated with the preclinical and/or clinical trials of drug
candidates, compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
and related contract research and third-party facility costs. The amounts recorded for clinical trial expenses represent the Company’s
estimates of clinical trial expenses based on facts and circumstances known to the Company at that time, and are dependent upon the timely
and accurate reporting of contract research organizations and other third-party vendors.

<div align='center'>F-2</div>

We identified the accounting for the research and
development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they are
complete, accurate and classified correctly, their significance, and the risk of material misstatement due to the nature and timing of
these costs and accruals. This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the procedures related
to their accounting.

Addressing the matter involved performing procedures
and evaluating audit evidence in connection with forming our overall opinion on the financial statements. These procedures included, obtaining
an understanding of management’s process and evaluating the design of controls