Company: SXTPW
Filing Date: 2025-07-07
Form Type: S-1
Source: 0001213900-25-061842
Chunk: 25

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-07-07
Form: S-1
Chunk 25
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 will include both a test of significance and a sample size re-estimation in case this is required. We have signed clinical trial agreements with Tufts Medical Group, Yale, Rhode Island Hospital, and Brigham & Women’s Hospital. The first patient was randomized on June 25, 2024, and six patients completed the study prior to implementation of the protocol modifications disclosed above. 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. 35 Trial 2 is an expanded use study utilizing commercially available Arakoda. Patients will be offered up to one year of Arakoda at no cost to up to a total of 15 patients (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 molecular 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. As of the date of this filing, we had enrolled one patient in this study. More details about the study can be found on the clinicaltrials.gov website. 36

| 33 | 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. |
| 34 | Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238.                                                                          |
| 35 | See entry for NCT06207370 on the clinicaltrials.gov website                                                                          |
| 36 | See entry for NCT06478641 on the clinicaltrials.gov website                                                                          |

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Trial 3 will be a Phase II open label study patients
with chronic babesiosis utilizing commercially available Arakoda. The Company plans to offer an approximately three-month supply of Arakoda
at no cost to patients who have a clinical diagnosis, are willing to submit biological samples for testing, and answer babes