Company: SXTPW
Filing Date: 2025-06-06
Form Type: DRS
Source: 0001213900-25-052232
Chunk: 24

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-06-06
Form: DRS
Chunk 24
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 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, and a manuscript for publication is now in preparation. 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 will now conduct a gap analysis to determine whether additional work required
prior to moving forward with submission of NADA for Tafenoquine for canine babesiosis. A successful NADA would be important supporting
information for a 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 been conducted under a sponsored research agreement with Monash University in Melbourne, Australia, and
should be completed by Q2 2025.

Combination Partner for Tafenoquine for Malaria

Most new antimalarial treatment products are developed
as drug combinations to proactively combat drug resistance. We believe that Tafenoquine, due to its long half-life and activity against
all parasite species and strains, would be an ideal partner in a drug combination. Recently, Kentucky Technology Inc. (“KTI”),
completed Phase IIA studies in P. vivax malaria, in which they evaluated the safety and efficacy of SJ733, their