60 DEGREES PHARMACEUTICALS, INC.

60 Degrees Pharmaceuticals announced an update regarding its clinical trial for tafenoquine in patients hospitalized with severe babesiosis. The company will conclude enrollment at 30 patients, with results expected in January 2027. The DSMB recommended completing the study as planned, and no safety issues were identified. The company plans to request a pre-sNDA meeting with the FDA in January 2027 to discuss regulatory pathways, and additional data from a separate expanded access study will be released in November 2026.

60 Degrees Pharmaceuticals, Inc. announced it has entered into definitive agreements for a private placement to issue and sell an aggregate of 574,713 shares of its common stock (or pre-funded warrants) along with Series A and short-term Series B warrants. The purchase price is $1.74 per share and accompanying warrants, with an exercise price of $1.49 per share for the warrants. The offering is expected to generate approximately $1.0 million in gross proceeds, which the company intends to use for working capital and general corporate purposes.

60 Degrees Pharmaceuticals, Inc. has enrolled the minimum 24 patients required to trigger an interim analysis in its clinical study (NCT06207370) evaluating tafenoquine for severe babesiosis. The outcome of this analysis, which assesses the drug's efficacy and safety, is expected to be disclosed by October 6, 2026. Following the interim readout, the company intends to meet with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for a New Drug Application (NDA) for tafenoquine in babesiosis, an indication for which there is currently no FDA-approved treatment.

60 Degrees Pharmaceuticals has prepared a statistical analysis plan (SAP) for the interim analysis of its randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis (NCT0627370). The interim analysis will occur by October 30, 2026, or after 24 of the 33 planned patients have been randomized and followed for at least 50 days. The company has currently enrolled 23 patients and aims to apply for a Commissioner’s National Priority Review Voucher if the trial results support a supplementary New Drug Application (sNDA) submission to the FDA before the end of the first quarter of 2028.

60 Degrees Pharmaceuticals, Inc. announced an exclusive option agreement with the Florida State University Research Foundation (FSURF) for intellectual property related to castanospermine. This agreement grants the company an exclusive option to negotiate a U.S. license for castanospermine's use in treating Powassan virus disease, tick-borne encephalitis, alpha-gal syndrome, and post-treatment Lyme disease. The company will use an evaluation period to develop a commercialization strategy, prioritizing prescription drug development over its dietary supplement strategy for castanospermine.

60 Degrees Pharmaceuticals, Inc. announced its 2026 Annual Meeting of Stockholders to be held virtually on August 5, 2026. Key proposals include the election of five directors, an amendment to increase the shares available under the 2022 Equity Incentive Plan by 800,000, and an amendment to effect a reverse stock split at a ratio of 1:5 to 1:10. Stockholders will also vote on ratifying the independent auditor and approving a management success fee of 5-6% of deal proceeds for certain strategic transactions or the sale of Arakoda.

60 Degrees Pharmaceuticals announced that the independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its B-Free chronic babesiosis study (NCT06656351). This recommendation follows a review of safety data from the first six patients through Day 30. The B-Free study is evaluating the ARAKODA® regimen of tafenoquine for recovery from severe persistent fatigue in patients with babesiosis, a condition for which no FDA-approved treatment currently exists.

60 Degrees Pharmaceuticals announced a patent licensing agreement with Florida State University, enabling large-scale extraction of castanospermine from Australian Chestnut seeds for non-prescription uses. Concurrently, the company will meet with the FDA on July 1, 2026, to discuss a Non-Notification Letter concerning its New Dietary Ingredient Notification (NDIN) for Australian Chestnut Extract, aiming to clarify safety information and submit a revised NDIN.

60 Degrees Pharmaceuticals, Inc. announced its intention to submit an application for a Commissioner’s National Priority Review Voucher. This application is contingent on the positive outcome of interim or final analysis from its randomized, placebo-controlled trial of tafenoquine for severe babesiosis. The company aims to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) before the end of the first quarter of 2028, based on supportive trial results.

60 Degrees Pharmaceuticals announced that the first patient for the 2026 tick season has been enrolled in its clinical trial (NCT06207370) evaluating tafenoquine for treating babesiosis. This enrollment puts the company approximately one month ahead of schedule, suggesting that minimum enrollment for an interim analysis could be achieved as soon as early July 2026. The randomized, double-blind, placebo-controlled trial, conducted at five sites in the Northeastern U.S., will enroll at least 24 patients before separate interim analyses on clinical symptom resolution and parasite clearance are conducted.