Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 79

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 79
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 organizations and additional
legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures
and other treatments, has become intense. As a result, increasingly high barriers are being erected to the entry of new products
such as ours.

Risks
Related to Our Business Operations

We
may not be successful in our efforts to identify or discover additional compounds and may fail to capitalize on programs or compounds
that may be a greater commercial opportunity or for which there is a greater likelihood of success.

Beyond
the development and commercialization of CC8464, CT2000 and CT3000, the future success of our business depends upon our ability
to identify, develop and commercialize compounds based on the platform technology. CC8464, along with CT2000 and CT3000, which
were derived from CC8464, was discovered in our labs using our technologies. Research programs to identify new compounds will
require to invest substantial technical, financial and human resources. We may fail to identify other potential compounds for
clinical development for several reasons. For example, our research may be unsuccessful in identifying potential compounds or
our potential compounds may be shown to have harmful side effects, may be commercially impracticable to manufacture or may have
other characteristics that may make the products unmarketable or unlikely to receive marketing approval.

Additionally,
because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or compounds or for indications
that later prove to have greater commercial potential. Our spending on current and future research and development programs may
not yield any commercially viable products. If we do not accurately evaluate the commercial potential for a particular compound,
we may relinquish valuable rights to that compound through strategic collaboration, licensing or other arrangements in cases in
which it would have been more advantageous for us to retain sole development and commercialization rights to such compound. Alternatively,
we may allocate internal resources to a compound in a therapeutic area in which it would have been more advantageous to enter
into a partnering arrangement.

46 

If
any of these events occur, we may be forced to abandon our development efforts with respect to a particular compound or fail to
develop a potentially successful compound, which could have a material adverse effect on our business, financial condition, results
of operations and prospects.

If
we are unable to manage expected growth in the scale and complexity of our operations, our performance may suffer.

If
we are successful in executing our business strategy, we will need to expand our managerial,