Company: SXTPW
Filing Date: 2025-01-30
Form Type: 424B5
Source: 0001213900-25-008098
Chunk: 21

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-01-30
Form: 424B5
Chunk 21
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.gov/study/NCT06478641. |

<div align='center'>S-8</div>

Trial 3 will be a Phase II open label study utilizing commercially available Arakoda. The Company, if approved by an IRB, plans to offer an approximately two-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. Ethics approval for this trial was received in January 2025, and we expect to begin enrolling patients in Q3 2025. In May 2024, we signed a research and collaboration agreement with North Carolina State University in which the College of Veterinary Medicine will screen 300 archived blood samples from patients exhibiting symptoms consistent with chronic fatigue symptoms by PCR for the presence of Babesia spp. In a second phase of the study, positive samples will be sequenced to determine which Babesiaspp are present. The data from this study will help define whether the incidence of Chronic Babesiosis may be more widespread than amongst PTLDS patients. 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. Should this potential collaboration be successful, we believe that the data from that study may provide supportive data for the clinical babesiosis development program, and could provide proof of concept for an expanded study to prove utility for veterinary indications. We believe, if the Company does not become capital-limited, that the results at least one of the above clinical 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. Parenteral Tafenoquine for Fungal Infections We plan to support a series of studies in animal models to determine whether single dose parenteral administration of Tafenoquine exhibits efficacy against Candidaspp including C. auris. These studies are being conducted under a sponsored research agreement with Monash University in Melbourne,