60 DEGREES PHARMACEUTICALS, INC.

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.

60 Degrees Pharmaceuticals, Inc. announced the appointment of Eric Francois to its Board of Directors, effective May 13, 2026. Mr. Francois is a strategic financial executive with over 20 years of leadership experience in the healthcare and life sciences sectors. His extensive background includes roles as a Managing Director in healthcare investment banking at Raymond James and Credit Suisse, and as Chief Financial Officer of SCYNEXIS, Inc., where he raised over $300 million in capital. He also serves as an independent director for other life sciences companies.

60 Degrees Pharmaceuticals, Inc. reported its financial results for the first quarter of fiscal year 2026, ending March 31, 2026. The company experienced a 1% decrease in net product revenues, falling to $162 thousand from $164 thousand in the prior year's quarter. Gross profit also declined to $76 thousand from $90 thousand, while operating expenses rose to $2.17 million. Consequently, the net loss attributable to common shareholders increased to $2.21 million, or $1.28 per share, compared to a net loss of $2.00 million, or $6.25 per share, in the first quarter of 2025.

60 Degrees Pharmaceuticals reported an increased net loss of $(2.09) million for the first quarter of 2026, compared to $(1.88) million in the prior year, with net revenue significantly declining to $76,377. The company's management raised substantial doubt about its ability to continue as a going concern due to accumulated losses and insufficient revenues. Despite this, cash and cash equivalents improved to $3.34 million, largely due to $3.37 million in net proceeds from an At-The-Market (ATM) offering during the quarter.