Company: SXTPW
Filing Date: 2025-06-06
Form Type: DRS
Source: 0001213900-25-052232
Chunk: 18

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-06-06
Form: DRS
Chunk 18
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 for post-exposure prophylaxis of babesiosis in patients with tick bites, and (iii) Tafenoquine could become the leading treatment for Chronic Babesiosis. Clinical trial(s) to prove safety and efficacy, and approval by FDA and other regulators, would be required before Tafenoquine could be marketed for these indications.

| 24 | According to literature cited in Footnote 23. |

| 25 | According to literature cited in Footnote 23. |

| 26 | Dow and Smith, New Microbe and New Infect 2022; 45: 100964. |

| 27 | Queener et al Journal of Infectious Diseases 1992;165:764-8). |

| 28 | Liu et al. Antimicrobial Agents Chemo 2021;65:e00204-21, Marcos et al. IDCases 2022;27:e01460; Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:1015. |

| 29 | Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238. |

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Competitive Strengths Our main competitive strength has been our ability to achieve important clinical milestones inexpensively in therapeutic areas that other entities have found extremely challenging. With a small virtual management team, we have successfully built productive research partnerships with public and academic entities, and licensed products with well characterized safety profiles in prior clinical studies, thereby reducing the cost and risk of clinical development. This business and product model enabled Arakoda to be approved in 2018, with a total operating expense of < $10 million. We plan to focus in the future on generating proof of concept clinical data sets for the approved Arakoda regimen of Tafenoquine in other therapeutic areas, all of which is expected to foster and continue our existing tradition of inexpensive product development. Celgosivir Celgosivir is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C. 30The sponsors abandoned Celgosivir after completion of Phase II clinical trials involving 700+ patients, because other antivirals in development at the time had superior activity. The National University of Singapore initiated development of Celgosivir independently for Dengue fever. A clinical study, conducted in Singapore, the results of which were