Company: SXTPW
Filing Date: 2025-07-16
Form Type: 424B4
Source: 0001213900-25-064472
Chunk: 10

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-07-16
Form: 424B4
Chunk 10
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 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 |

| 1 | According to the Centers and Disease Control and Prevention |

| 2 | Conclusions from Company-commissioned market research. |

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Recent market data shows that Tafenoquine appears to be increasingly prescribed by Lyme physicians to manage Chronic Babesiosis. 3This trend may follow the recent publication of several case reports demonstrating activity in immunosuppressed patients with acute babesiosis, and animal data showing eradication of Babesiaparasites with Tafenoquine (primarily as Arakoda). 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 Babesiaparasites. Thus, we previously estimated the cumulative case load of Chronic Babesiosis may be as high as 1.01 million patients in the United States, but believe that, based on several new lines of evidence, the ceiling is 2-3 million. 4 We have recently completed market research involving interviews with 300 prescribing physicians, a survey of 6,000 U.S. adults, and an administrative claims dataset. Collectively this research suggests that the minimum number of persistent cases of babesiosis subject to insurance claims each year is approximately 7,900. 5However, prescribing intent and consumer survey data suggest that following a sustained diseases and product awareness campaign, assuming FDA labeling for babesiosis, and the commercial availability of sensitive molecular tests, the number of individuals diagnosed with persistent babesiosis with chronic fatigue treatable with Tafenoquine each year could be as high as 380,000 individuals, representing approximately $245 million in sales (based on the Arakoda wholesale acquisition cost ) and cumulatively 1.71 million patients treated with $1.1 billion in sales through patent expiry in 2035. 6,