60 Degrees Pharmaceuticals, Inc. Common Stock

60 Degrees Pharmaceuticals has entered into an exclusive option agreement with the Florida State University Research Foundation covering intellectual property related to the development of Castanospermine for multiple tick-borne diseases. The agreement gives the company an exclusive option to negotiate an exclusive U.S. license for the patented technology and know-how, expanding collaboration with Florida State University to evaluate Castanospermine for Powassan virus disease, tick-borne encephalitis, alpha-gal syndrome, and post-treatment Lyme disease. Castanospermine is a naturally occurring iminosugar found in Australian chestnut that has demonstrated broad antiviral and immunomodulatory activity in preclinical studies, with human safety experience from clinical trials of the pro-drug Celgosivir. CEO Geoff Dow stated the agreement reflects the belief that Castanospermine may have its greatest long-term value as the basis for innovative prescription medicines addressing unmet needs in tick-borne diseases. The company is evaluating multiple regulatory pathways for Castanospermine while prioritizing prescription drug development, and recently engaged with the U.S. Food and Drug Administration regarding a new dietary ingredient notification for Australian Chestnut Extract.

60 Degrees Pharmaceuticals announced that an independent Data Safety Monitoring Board has recommended continuing its Phase 2 B-Free chronic Babesiosis study after reviewing safety data from the first six patients through Day 30. The open-label trial is evaluating recovery from fatigue following treatment with the ARAKODA regimen of tafenoquine in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp. The company plans to enroll up to 100 patients, with the primary endpoint being resolution of fatigue at Day 90 compared with baseline. Tafenoquine is already approved in the United States for malaria prophylaxis under the brand name ARAKODA. There is currently no FDA-approved treatment for babesiosis, a tick-borne disease with an annual incidence of at least 25,000 cases.