Company: SXTPW
Filing Date: 2025-06-06
Form Type: DRS
Source: 0001213900-25-052232
Chunk: 11

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-06-06
Form: DRS
Chunk 11
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 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                                                                                                         |

| 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.3 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). 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, 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 7,900.5 However,                  
 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 38,000 individuals.6,7 While this difference                    
 between the