60 Degrees Pharma Grants University of Kentucky Right to Refer to ARAKODA NDA in Support of SJ733 Phase IIb Study Page 1

• The University of Kentucky is initiating a Phase IIb clinical trial of candidate drug SJ733 for the treatment of vivax malaria.
• SJ733 will be combined with a single dose tafenoquine in the study.
• The right of referral gives the FDA the ability to review 60 Degrees Pharma’s regulatory file when the agency issues new study protocols for the SJ733tafenoquine Phase IIb program.

WASHINGTON, August 12, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or “60 Degrees Pharma”), a pharmaceutical company focused on developing novel drugs for infectious diseases, today announced that it has granted the University of Kentucky a referral right to the Company’s New Drug Application (“NDA”) for ARAKODA (tafenoquine).

ARAKODA is the company’s antimalarial drug approved by the U.S. Food and Drug Administration (“FDA”) in 2018 and is indicated for the prophylaxis of malaria in patients 18 years of age and older.

The reference permits the FDA to review clinical efficacy and safety data, nonclinical data, and chemistry, manufacturing and control information on ARAKODA as the agency reviews protocols and new Investigational New Drug (“IND”) applications related to the University of Kentucky’s investigational SJ733 Phase IIb program.

SJ733 is an oral ATP4 inhibitor of Plasmodiumwhich has been shown to have a favorable safety profile and rapid antiparasitic activity. The Phase IIb study being conducted by the University of Kentucky and Eisai Co. Ltd. (“Eisai”) will combine SJ733 with tafenoquine – the active ingredient in ARAKODA – to evaluate the safety, tolerability and pharmacokinetics of a single-dose combination of the two drugs. The trial is funded by the Global Health Innovative Technology Fund. The current state-of-the-art treatment for vivax malaria is a combination of tafenoquine and chloroquine administered for three days; however, resistance of P. vivax In some parts of the world, chloroquine is widely used.

“Innovations in treatment P. vivax “Malaria, which infects an estimated 14 million people each year, has been limited in recent decades,” said Dr. R. Kip Guy, principal investigator of the Phase IIb study and professor and dean of the University of Kentucky College of Pharmacy. “The upcoming study of SJ733 in combination with tafenoquine has the potential to pave the way for very meaningful improvements in malaria treatment worldwide.”