{"url_path":"/sec/sxtp/8-k/2026-07-09/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-07-09","source_url":"https://www.sec.gov/Archives/edgar/data/1946563/0001213900-26-076715-index.html","accession_number":"0001213900-26-076715","cik":"0001946563","ticker":"SXTP","issuer_name":"60 DEGREES PHARMACEUTICALS, INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1946563/0001213900-26-076715-index.html","primary_entity_key":"0001946563","primary_entity_name":"60 DEGREES PHARMACEUTICALS, INC."},"word_count":520,"has_tables":true,"body_markdown":"**Item 8.01 Other Events**\n\n** **\n\nOn July 7, 2026, the Company prepared, and\nas of the date of this notice was preparing for submission to the U.S. Food and Drug Administration (“FDA”), a statistical\nanalysis plan (the “SAP”) for the planned interim analysis of its randomized, placebo-controlled trial of tafenoquine in patients\nhospitalized with severe babesiosis (NCT0627370). The SAP states the following:\n\n \n\n“An interim analysis will be performed\nat the earlier of (i) 10/30/26 or (ii) after 24 of the 33 planned patients have been randomized and followed for at least 50 days. A conditional\npower (CP) analysis will be performed for time to sustained clinical resolution (TTSCR) and for time to molecular cure (TTMC), each independently.\nIf the CP is at least 80% then a log-rank test will be performed and a one-sided statistical significance of 0.02137 or less for time\nto TTSCR will result in early reporting of the study. If the conditional power is between 50% and 80% for either TTSCR or TTMC then a\nsample size reassessment will be performed. Sample size increase is capped at 33 additional patients (66 total). The results of the interim\nanalysis will be presented to the DSMB for recommendation to the sponsor. The Sponsor and investigators will be blind to the analysis\nand will not know the calculated clinical power of either endpoint if the study is continued.”\n\n \n\nAs of the date of this Current Report, the\nCompany had enrolled 23 patients in this study. The Company intends to submit an application for a Commissioner’s National Priority\nReview Voucher if the outcome of any interim and/or final analysis of the Company’s randomized, placebo-controlled trial of tafenoquine\nin patients hospitalized with severe babesiosis supports moving forward with a supplementary New Drug Application (sNDA) submission to\nthe FDA before the end of the first quarter of 2028. The Company is providing this disclosure to inform investors regarding its current\ndevelopment and regulatory plans. The Company’s expectations regarding the trial, any future sNDA submission, and any potential\nvoucher application are forward-looking statements and are subject to risks and uncertainties, including the outcome of clinical development,\ninteractions with regulatory authorities, and other factors that could cause actual results to differ materially from those anticipated. \n\n \n\n**Cautionary Statement Regarding Forward-Looking\nStatements**\n\n \n\nThis Current Report on Form 8-K includes forward-looking\nstatements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties\nthat could cause the Company’s actual results and financial position to differ materially. These risks and uncertainties include\nuncertainties associated with market conditions and other risks described under the heading “Risk Factors” in the Company’s\nSEC Filings on Form 10-K and Form 10-Q. The Company assumes no responsibility to update or revise any forward-looking statements to reflect\nevents, trends or circumstances after the date hereof.\n\n \n\n1\n\n \n\n**SIGNATURES**\n\n \n\nPursuant to the requirements\nof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto\nduly authorized.\n\n \n\n \n**60 DEGREES PHARMACEUTICALS, INC.**\n\n \n \n\nDate: July 9, 2026\nBy:\n*/s/ Geoffrey Dow*\n\n \nName:\nGeoffrey Dow\n\n \nTitle:\nChief Executive Officer and President\n\n \n\n2"}