Company: SXTPW
Filing Date: 2025-06-06
Form Type: DRS
Source: 0001213900-25-052232
Chunk: 16

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-06-06
Form: DRS
Chunk 16
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); absence of any black-box safety warnings; good tolerability, including in women and individuals with prior psychiatric medical history; and a comparable adverse event rate to placebo with up to 12 months continuous dosing. 23Tafenoquine entered the commercial supply chains in the U.S. and Australia in the third quarter of 2019.

| 19 | According to the European Centre for Disease Prevention and Control |

| 20 | According to the Centers for Disease Control and Prevention. |

| 21 | In 2014, we signed a cooperative research and development agreement with the United States Army Medical and Materiel Development Activity (Agreement W81XWH-14-0313). Under this agreement, we agreed to submit an NDA for Tafenoquine to the FDA (as Arakoda), while the US Army agreed to finance the bulk of the necessary development activities in support of that goal. |

| 22 | Zottig et al Military Medicine 2020; 185 (S1): 687. |

| 23 | Tan and                                                                                                                                  
 Hwang Journal of Travel Medicine, 2018, 1–2; Baird Journal of Travel Medicine 2018:, 1–13; Schlagenhauf et al Travel Medicine            
 and Infectious Disease 2022; 46:102268; McCarthy et al CID 2019:69:480-486; Dow et al. Malar J (2015) 14:473; Dow et al. Malaria Journal 
 2014, 13:49; Novitt-Moreno et al Travel Med Infect Dis 2022 Jan-Feb;45:102211.                                                           |

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The only major limitation of Arakoda is the requirement for a G6PD test prior to administration. 24The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic anemia in individuals with G6PD deficiency. 25G6PD is one of the most common enzyme deficiencies and is implicated in hemolysis following administration/ingestion of a variety of oxidant drugs/food. G6PD must also be ruled out as a possible cause when diagnosing neonatal jaundice. As a consequence, G6PD testing is widely available in the United States through commercial pathology service providers (e.g., Labcorp, Quest Diagnostics, etc.). Although these tests have a turn-around