Company: SXTPW
Filing Date: 2025-09-05
Form Type: 424B5
Source: 0001213900-25-085050
Chunk: 17

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-09-05
Form: 424B5
Chunk 17
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 chronic babesiosis utilizing commercially available Arakoda. The Company plans to offer an approximately three-month supply of Arakoda
at no cost to patients who have a clinical diagnosis, are willing to submit biological samples for testing, and answer babesiosis and
standardized fatigue inventories before and after treatment. The goal of this study will be to ascertain whether Arakoda treatment improves
patient-reported fatigue symptoms in individuals who symptoms of severe fatigue lasting more than six months and a diagnosis of chronic
babesiosis. Secondary objectives include assessing confirmable Babesia infection rates in these populations using validated
molecular assays, and assessing the safety and tolerability profile of Arakoda in this patient population.

In May 2024, we signed a research and collaboration
agreement with North Carolina State University in which the College of Veterinary Medicine will screen archived blood samples from 50
patients exhibiting symptoms consistent with chronic fatigue symptoms by PCR for the presence of Babesia spp by digital
PCR and DNA sequencing. This work is now complete. While the data cannot be disclosed at this time, the Company believes they are supportive
of the feasibility of executing Trial 3.

We believe, if the Company does not become capital-limited,
and no recruitment issues are encountered, that the results of one or more of the above studies will come to fruition in the first quarter
of 2026, potentially facilitating submission of a supplementary new drug application (or other appropriate regulatory filing) to FDA,
with the goal of obtaining marketing approval of Arakoda for treatment of Babesiosis. If successful, this will allow the Company to actively
market Arakoda for Babesiosis.

In March 2024, we initiated, in collaboration
with the North Carolina State University College of Veterinary Medicine, a pilot study of Tafenoquine for treatment of canine babesiosis
in the United States under a sponsored research program. That study is now complete. We believe there may be sufficient data to apply
to the FDA for a Minor Use/Minor Species (MUMS) designation and conditional marketing approval, and will now conduct a gap analysis to
determine whether additional work required prior to moving forward. This endeavor may provide important supporting information for submission
of an NDA for human babesiosis.

Parenteral Tafenoquine for Fungal Infections

We are nearing completion of a series of studies
in animal studies of single dose parenteral administration of Tafenoquine exhibits efficacy against Candida spp including C. auris. These studies have