Company: PTHS
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001753926-25-001326
Chunk: 161

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 161
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 animal models). The results showed that CT2000 significantly reduced the number of paw wipes within 15 minutes
of administration of capsaicin and that CT2000 continued to show efficacy over a 60-minute period following administration. This
eye pain model was only validated for a short duration, with the results summarized in the following graph: 

Trial
Two 

In
the second trial, benzalkonium chloride (“BAC”) was instilled in mice eyes over a multiday period to create a model
of dry eye disease (the study was repeated twice). BAC is a detergent that irritates the eyes and simulates dry eye disease. As
with the capsaicin model summarized above, increased paw wipes over 60 seconds are a surrogate to measure ocular pain. Following
the induction of dry eye using BAC, the mice were dosed with CT2000 four times per day for 7 days. CT2000 reduced the frequency
of paw wipes within a single day of administration and showed cumulative efficacy over time (the analgesic effect appeared to
further improve when dosed over several days). The results after 1 day of dosing CT2000 are summarized in the following graph: 

Following
the animal studies, if successful, Pelthos intends to move into proof-of-concept (“POC”) studies in humans. Pelthos
plans to conduct the POC study in Australia to avail itself of the streamlined regulatory structure and a 43.5% tax credit for
clinical expenses incurred in Australia and, on January 9, 2023, established an Australian subsidiary through which the work will
be conducted. Pelthos is planning to conduct the POC in a clinic in Brisbane, Australia and is in the process of contracting
the services to perform a trial in patients suffering from pain associated with dry-eye disease.

29 

Depot
Program: Based on several novel formulations of CC8464, Pelthos’s most recently launched program, titled CT3000, is
for the potential treatment of post operative pain with the use of nerve blocks.  Examples would include knee surgery or
shoulder surgery. Existing therapies for nerve blocks lead to neuromuscular blockade which prevents movement following surgery.
Doctors often want patients to move soon after surgery to avoid complications such as blood clots. A NaV1.7 inhibitor used for
nerve blocks may provide good analgesia but will not lead to neuromuscular blockade