Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 1255

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 5
Chunk 1255
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 Currently, 60P’s pipeline under development covers development
programs for vector-borne, fungal, and viral diseases utilizing three of the Company’s future products: (i) new products that contain
the Arakoda regimen of Tafenoquine; (ii) new products that contain Tafenoquine; and (iii) Celgosivir.

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Following our initial public offering in July
2023, our initial strategic priority was to conduct a Phase IIB study that would have evaluated the potential of the Arakoda regimen
of Tafenoquine to accelerate disease recovery in COVID-19 patients with low risk of disease progression. In October 2023, we made a decision
to suspend this study. This was a consequence of advice previously received from the U.S. Food and Drug Administration (FDA), which we
interpreted to mean that the agency would not have granted clearance for the study to proceed unless we redesigned it to (i) enroll a
patient population in which receipt of Paxlovid or Lagevrio would be medically contraindicated, or (ii) 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.

2. Components of Results of Operations

Product Revenues - net of Discounts and Rebates

We receive the majority of our product revenues
from sales of our Arakoda product to resellers in the U.S. and abroad. Foreign sales to both Australia and Europe