Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 33

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 33
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phthalmic toxicology studies. Channel expects to announce the
toxicology results in May 2025. The efficacy studies are as follows:

Trial One 

In the first trial, rabbits were treated
with capsaicin (i.e., Pepper spray) to mimic an acute ocular insult in a common, validated model for acute eye pain studies. Following
the capsaicin treatment, the rabbits were treated with CT2000, which was dosed four times over a 24-hour period. Pain was measured
by the number of paw wipes over 60 seconds (paw wipes are a recognized surrogate of eye pain in 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, Channel intends to move into proof-of-concept (“POC”) studies in humans. Channel
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. Channel is planning to conduct the POC in a clinic in Brisbane, Australia and are is in the process of contracting
the services to perform a trial in patients suffering from pain associated with dry-eye disease.

Dep