Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 32

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 32
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after, 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 and drug products be manufactured according to cGMP. Any failure by our third-party manufacturers to comply
with cGMP could lead to a shortage of BIV201 and NE3107. In addition, such failure could be the basis for action by the FDA to withdraw
approval, if granted to us, and for other regulatory enforcement action, including Warning Letters, product seizure, injunction or other
civil or criminal penalties.

BIV201 and bezisterim (NE3107) and any other product
candidates that we develop may have to compete with other products and product candidates for access to manufacturing facilities. There
are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing
to do so. If we need to find another source of drug substance