Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 34

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 34
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At any time and for any reason, we may determine
that one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to
warrant the allocation of resources toward such program or drug candidate. Accordingly, we may choose not to develop a potential drug
candidate or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates
or programs. For example, BIV201 has received Orphan Drug designation for HRS. On June 23, 2021, we announced that FDA has provided guidance
on our planned Phase 3 clinical trial of BIV201 in (HRS-AKI) and have since reached agreement on the key elements of the trial design.
Thereafter, we deprioritized HRS-AKI program to focus on bezisterim (NE3107). When we suspend, deprioritize or terminate a program or
drug candidate in which we have invested significant resources, we will have expended resources on a program that will not provide a full
return on our investment and may have missed the opportunity to have allocated those resources to potentially more productive uses, including
existing or future programs or drug candidates.

We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.

We have never manufactured products in the highly
regulated environment of pharmaceutical manufacturing, and our team has limited experience in the manufacture of drug therapies. There
are numerous regulations and requirements that must be maintained to obtain licensure and permitting required prior to the commencement
of manufacturing, as well as additional requirements to continue manufacturing pharmaceutical products. We currently do not own or lease
facilities that could be used to manufacture any products that might be developed by us, and have contracted with an experienced Contract
Manufacturing Organization (“CMO”) to perform the manufacturing of our new product candidates BIV201 and bezisterim (NE3107).
In addition, we do not have the resources at this time to acquire or lease suitable facilities. If we or our CMO fail to comply with regulations,
to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable regulations and
to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations, which would cause
you to lose all of your investment.

In addition, the FDA and other regulatory authorities
require that product candidates