Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 27

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 27
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 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. 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.

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 Candida spp including
C. auris. These studies are being 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 ATP4 inhibitor
in combination with Tafenoquine as the combination partner drug. It was recently announced that the SJ733 development program would be
partially supported by a grant from the Global Health Innovative Technology Fund (“GHIT”). As part of its shares for services
agreement with KTI, the Company recently received a detailed feasibility assessment and business plan for the project, including an assessment
of potential PRV eligibility. The Company has provided KTI with a right of reference to its Arakoda IND, in order to assist with regulatory
approvals of forthcoming clinical trials.

Celgosivir for Antiviral Diseases

Reviewing prior studies of Celgosivir for Zika, Dengue and RSV, it
is evident that the drug protects against the pathological