Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 11

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 11
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s,
as further described below:

    ●
    Treatment
    of Chronic Tick-Borne Disease (Babesiosis). Babesia parasites are co-transmitted by the same ticks that transmit Borrelia,
    the Lyme disease bacterium. Although Lyme in the acute phase is generally viewed by the medical community as being treatable with
    antibiotics, individuals who are not treated, or fail treatment, may go on to develop long term, and potentially debilitating, chronic
    symptoms such as fatigue, body aches, and cognitive problems.1 This condition is defined by the Centers for Disease Control
    and Prevention (“CDC”) as Post-Treatment Lyme Disease Syndrome (“PTLDS”) or simply as Lyme in the patient
    community.1 Although there are no published estimates, key opinion leaders have stated that as many as 50% of Lyme/PTLDS
    patients are believed to be co-infected with Babesia parasites, a diagnosis referred to in the Lyme community as “Chronic
    Babesiosis.” Prescribers in the Lyme disease community utilize a number of therapeutic modalities to manage the symptoms of
    Chronic Babesiosis, including FDA-approved pharmaceuticals such as atovaquone and azithromycin (these are assumed to suppress the
    growth of Babesia parasites).2

Recent market data shows that Tafenoquine
appears to be increasingly prescribed by Lyme physicians to manage Chronic Babesiosis. This trend may follow the recent publication of
several case reports demonstrating activity in immunosuppressed patients with acute babesiosis, and animal data showing eradication of
Babesia parasites with Tafenoquine (primarily as Arakoda).3 The Company believes the recent increases in sales of Arakoda
have been driven by organic growth of these activities. There are no formal epidemiological publications articulating the incidence or
prevalence of Chronic Babesiosis, so these metrics must be inferred based on data for PTLDS and the rate of coinfection with Babesia
parasites. Thus, the cumulative case load of Chronic Babesiosis may be as high as1.01 million patients in the United States.4
We believe, based on our market research that at least 37% of this market, or 375,000 cases, may be addressable with Tafenoquine
during the remainder of its market exclusivity window for malaria. We are undertaking additional research to determine how much additional
market