60 Degrees Pharmaceuticals, Inc. filed a Current Report on Form 8-K with the Securities and Exchange Commission on October 23, 2026, to furnish an updated investor presentation. The filing indicates the company intends to use the updated materials in meetings with investors, analysts, and other members of the investment community.
The presentation, dated October 23, 2026, focuses on the company's tafenoquine program for babesiosis. The document outlines a strategy to develop the drug across three distinct clinical settings: chronic disease, severe acute disease, and relapsing disease. The company states that a marketed antimalarial platform now has converging evidence across these settings.
Regarding the severe acute program, the presentation details a randomized hospital study involving 30 subjects. The study employs a four-day loading regimen of 200 mg daily followed by weekly maintenance dosing. The blinded follow-up for this study is scheduled to complete in early January 2027, with unblinding to follow.
In the relapsing disease category, the company reports that the first three patients treated via expanded access were confirmed NAT-negative after treatment. The presentation notes that cases four and five are approaching disclosure. Additionally, the company submitted a Statement of Interest (SOI) to the FDA in September 2026 requesting a National Priority Review for a potential supplemental New Drug Application (sNDA) in 2027.
The presentation emphasizes that the safety profile of tafenoquine is based on data from its use as an antimalarial prophylaxis. It notes that the long terminal half-life of the drug supports weekly dosing and requires specific pre-treatment screening, including G6PD testing, due to contraindications in G6PD deficiency. The document also highlights that a common adverse event observed in the prophylaxis data was cornea verticillata, which was described as reversible after treatment cessation.
