Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 7

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 7
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8, 2025, we announced that the first patient has been enrolled in NCT06478641, an expanded access clinical study intended to
confirm the activity of tafenoquine in treating patients with persistent babesiosis who have failed standard of care treatment and are
at high risk of experiencing a relapse.

Patent
License Agreement

On
December 23, 2024, we and Tufts Medical Center announced signing of a Patent License Agreement to jointly advance the development and
commercialization of tafenoquine for the treatment and prevention of babesiosis. Tafenoquine is not currently approved by the U.S. Food
and Drug Administration (“FDA”) for the treatment and prevention of babesiosis. The agreement follows initiation of collaboration
between researchers from both organizations to study the activity of tafenoquine against babesiosis, a serious tick-borne disease caused
by microscopic parasites that infect red blood cells. The study formed the basis of U.S. Provisional Patent Application No. 63/461,060,
and related U.S. utility and PCT applications, granting the parties shared intellectual property rights to tafenoquine’s potential
future use for babesiosis.

Expansion
of Tafenoquine Clinical Trial for Babesiosis to Brigham and Women’s Hospital

On
December 11, 2024, we entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) in Boston to conduct a double-blind,
placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized
babesiosis patients. The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical
unmet medical need. The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis,
a tick-borne illness often found as a co-infection of Lyme disease.

4

ARAKODA®
Promotional Pilot in Advance of Expanded U.S. Launch

On October 3, 2024, we announced that we have
commenced a nine-month promotional pilot to bring greater awareness of ARAKODA® (tafenoquine) and its benefits to patients and healthcare
providers who prescribe it. The pilot program includes inside, or virtual, sales representatives who will conduct outreach to prospective
and current ARAKODA customers to promote the co-pay program and increase sales. The status of this program is outlined in the “Strategy”
section