Company: SXTPW
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001213900-25-043779
Chunk: 156

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-05-15
Form: 10-Q
Item: Part I, Item 2
Chunk 156
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) compare Tafenoquine to placebo
in patients taking a “standard of care” regimen (defined by the FDA as Lagevrio or Paxlovid). The FDA’s position was
somewhat surprising given that neither Paxlovid nor Lagevrio is indicated for treatment of COVID-19 in low-risk patients. We determined
that conducting our study in an alternate population in the United States would be unfeasible, and that conducting an add-on-to standard
of care study might not be Phase III enabling. Accordingly, we made a decision to pivot back to continue commercialization of Arakoda
for malaria, and further evaluation of the Arakoda regimen of Tafenoquine for babesiosis and other diseases. We believe such an approach
is both less risky and less expensive.

Moving forward, our general strategy to achieve
profitability and grow shareholder value has three facets: (i) increase sales of Arakoda; (ii) conduct clinical trials to expand the number
of patients who can use Tafenoquine for new indications in the future; and (iii) reposition small molecule therapeutics with good clinical
safety profiles for new indications.

Business Developments

The following highlights significant business
developments in our business during the quarter ended March 31, 2025.

●On January 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.

●On January 20, 2025, we issued a total of 15,809 shares of common stock and paid $60,000 in cash to our
executives in settlement of 2024 performance bonuses, as approved by our Board in December 2024.

23

●On January 28, 2025, we announced the approval by an Investigational Review Board (IRB) of a new Phase
II clinical study. The study (NCT06656351) will evaluate the efficacy and safety of the ARAKODA® regimen (tafenoquine) over 90 days
for treating patients with a presumptive diagnosis of chronic babesiosis who have experienced severe fatigue with significant functional
impairment for at least six months upon enrollment. Patient enrollment is expected to begin in Q3 2025.

●In February 2025,