Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 22

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 22
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 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, the Company 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.

    30
    Sorbera et al, Drugs of
    the Future 2005; 30:545-552.
  
    31
    Low et. al., Lancet ID
    2014; 14:706-715.
  
    32
    Watanabe et al, Antiviral
    Research 2016; 10:e19.

10

Expansion of U.S. Arakoda Sales

Hiring
of Chief Commercial Officer. In February 2024, we hired Kristen Landon to lead our commercial efforts to reintroduce Arakoda for
malaria prevention and conduct new product planning initiatives in tick-borne disease for babesiosis. We spent the first quarter of 2024
analyzing the current landscape in the malaria prevention market, conducting primary market research among providers and consumers, and
assessing agency partners for a virtual/digital marketing pilot program. Additionally, we kicked off a market assessment on the babesiosis
space including desk top research and qualitative interviews with Key Opinion Leaders in the Infectious Disease and Lyme Community.