Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 253

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 253
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6. [Reserved]

Not applicable.

Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations

Prospective investors should read the following
discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes
and other financial information included elsewhere in this annual report. Some of the information contained in this discussion and analysis
or set forth elsewhere in this annual report, including information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties. See “Cautionary Note Regarding Forward-Looking Statements.”
This discussion should be read in conjunction with our audited consolidated financial statements and the notes thereto included elsewhere
in this report. In this discussion, we may use certain non-generally accepted accounting principles (GAAP) financial measures. An explanation
of these non-GAAP financial measures and a reconciliation to the most directly comparable GAAP financial measures are included in this
“Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Investors should not consider
non-GAAP financial measures in isolation or as substitutes for financial information presented in compliance with GAAP.

1. Overview

We are a specialty pharmaceutical company with
a goal of using cutting-edge biological science and applied research to further develop and commercialize new therapies for the prevention
and treatment of infectious diseases. We have successfully achieved regulatory approval of Arakoda® (“Arakoda”), a malaria
preventative treatment that has been on the market since late 2019. 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