Company: SXTPW
Filing Date: 2025-01-30
Form Type: 424B5
Source: 0001213900-25-008098
Chunk: 20

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-01-30
Form: 424B5
Chunk 20
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. The study will enroll a minimum of 24 and up to 33 patients before an interim analysis is conducted, which will include both a test of significance and a sample size re-estimation in case this is required. The study design was reviewed by the FDA. We have signed clinical trial agreements with Tufts Medical Group, Yale, Rhode Island Hospital and Harvard Brigham & Women’s Hospital. The first patient was randomized on June 25, 2024. The earliest possible date that date would be available from the interim analysis would be January 31, 2026, assuming a minimum of 24 patients are enrolled prior to September 30, 2025. Further details are available on the clinicaltrials.gov website. 36 Trial 2 will be an expanded use study utilizing commercially available Arakoda. The Company, if approved by an Institutional Review Board (“IRB,” also known as an ethics committee), plans to offer up to one year of Arakoda at no cost to about 10 patients per year (i.e., immunocompromised patients who have previously failed standard of care treatment). Informed consent will be obtained from patients to collect a blood sample for PCR testing at the end of treatment, and patients will be asked to complete a babesiosis symptom questionnaire. The goal of the study is to generate additional prospective data to confirm the observation by Krause et al in a recent publication that an extended regimen of Tafenoquine cured 80% of immunocompromised patients with relapsing babesiosis. The first subject was enrolled in this study in January 2025. This study will commence utilizing proceeds from the current offering. More details about the study can be found on the clinicaltrials.gov website. 37

| 34 | Liu et al. Antimicrobial                                                                                    
 Agents Chemo 2021;65:e00204-21. Vydyam et al. J Infect Dis. 2024 Jan 3:jiad315. doi:10.1093/infdis/jiad315. |

| 35 | Marcos et al. IDCases 2022;27:e01460;                                                            
 Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:1015. |

| 36 | See: https://classic.clinicaltrials.gov/ct2/show/NCT06207370. |

| 37 | See: https://clinicaltrials