Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 28

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 28
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 effects of viruses through a combination of anti-inflammatory and antiviral
effects. These properties suggest it might have a beneficial effect in several viral diseases. Celgosivir is synthesized from Castanospermine,
which is obtained from botanical sources in low yield, making its inherent cost of goods potentially high. Castanospermine is also quite
water soluble, making it amenable to intravenous formulation. As of the date of this report, Florida State University Research Foundation
(“FSURF”) had sold their remaining SXTP shares, and funds raised therefrom were insufficient to cover the cost of the proof
of concept studies in a hamster model of COVID-19 that we had originally planned. We instead intend to investigate the potential activity
of celgosivir in other respiratory viruses in different non-clinical models.

Post-Marketing Requirements

We have an FDA post-marketing requirement to
conduct a malaria prophylaxis study of Arakoda in pediatric and adolescent subjects. We proposed to the FDA, in late 2021, that this
might not be safe to execute given that malaria prevention is administered to asymptomatic individuals and that methemoglobinemia (damage
to the hemoglobin in blood that carries oxygen) occurred in 5% of patients, and exceeded a level of 10% in 3% of individuals in a study
conducted by another sponsor in pediatric subjects with symptomatic vivax malaria.37 The FDA has asked us to propose an alternate
design, for which we submitted a concept protocol in the fourth quarter of 2022, and submitted a full protocol in July, 2024. We estimate
the cost of conducting the study proposed by the FDA, if conducted in the manner suggested by the FDA, would be $2 million, and, due
to the time periods required to secure protocol approvals from the FDA and Ethics Committees, could not be initiated any earlier than
the Second quarter of 2026.

36See: https://clinicaltrials.gov/study/NCT06478641.

37Velez
                                            et al 2021 - Lancet Child Adolesc Health 2022; 6: 86–95.

12

Intellectual
Property

We
are co-owners, with the U.S. Army, of patents in the United States and certain foreign jurisdictions directed toward use of Tafenoquine
for malaria and have obtained an exclusive worldwide license from the U.S. Army to practice these inventions. We also have an exclusive