Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 122

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 122
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istamines (with the exception of one patient requiring
systemic steroids).

As
a result of the potential for skin rashes, following discussions with the FDA, Pelthos will conduct a slow dose escalation
study to further evaluate the incidence of rashes. By titrating the dose over several weeks, Pelthos anticipates that Pelthos
will reduce or eliminate this side effect. Pelthos expects that the slow dose escalation study will also help determine the need
for dose escalation in the final treatment regime. Even though the FDA has in the past approved drugs that listed rashes as a
potential side effect, Pelthos does not know if CC8464 will be approved by the FDA (or any foreign authority).

When
the dose escalation trial is funded, Pelthos will enroll approximately 20 healthy volunteers who will receive CC8464 over a period
of several weeks, with the dose escalation study expected to take approximately 9-12 months in total. Pelthos anticipates that
the slower dose escalation will decrease the likelihood of drug-related skin reactions. The primary endpoint of the dose escalation
trail will be safety and tolerability of the slower dose titration; however, Pelthos will also be measuring blood concentrations
of CC8464, which will allow it to better understand the pharmacokinetics of CC8464. Even if it is ultimately determined that Pelthos
will need an escalation period for chronic pain treatment therapy, which patients could well take for the remainder of their lives,
Pelthos does not believe the dose escalation approach will be consequential.

When
and if Pelthos decides to move forward with the CC8464, Pelthos expects to conduct the dose escalation trial in Australia to avail
itself of the streamlined regulatory structure and tax credit set forth above, utilizing its Australian subsidiary through which
the work will be conducted. The location of the POC has not been determined at this time, with availability of facilities
and patient population, costs, tax credits, and centers of excellence in the respective fields (EM or iSFN) all factors in the
ultimate determination of the location.

31 

In
parallel with the dose escalation study, Pelthos expects to run a pilot efficacy study on approximately ten EM patients. In this
study, Pelthos will induce EM flares, determine baseline pain, and then dose escalate CC8464, after which, Pelthos will attempt
to induce flares. The primary endpoint will be the