Company: SXTPW
Filing Date: 2025-09-05
Form Type: 424B5
Source: 0001213900-25-085050
Chunk: 19

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-09-05
Form: 424B5
Chunk 19
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). These properties suggest it might provide support to patients suffering numerous conditions. Botanical extracts
require only a 75-day notification to the FDA, and do not require clinical trials or pre-marketing approval. The Company currently has
at least 8.8 kgs of castanospermine in inventory as a consequence of its prior agreements with Trevally, LLC and other entities. The Company
will utilize this stockpile to assess the technical and commercial feasibility of developing botanical extracts of Australian Chestnut
trees as a complementary approach to ongoing non-clinical assessments of celgosivir for viral diseases.

<div align='center'>S-10</div>

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. 37The 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 third quarter of 2026. 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 in the field of all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria. We also have an exclusive worldwide license to use manufacturing information and non-clinical and clinical data that the U.S. Army possesses relating to use of Tafenoquine for all therapeutic applications and uses excluding radical cure of symptomatic vivax malaria. We are co-owners, with Singapore Health Sciences Pte Ltd. and National University of Singapore, of patents in the United States and certain foreign jurisdictions directed toward the use of Cel