Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 62

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 62
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 existing prescribing information, or prepare a new NDA as appropriate. The FDA could approve Tafenoquine (Arakoda or other regimen) or Celgosivir, but without including some or all of the prescribing information that we have requested. For instance, the FDA could approve Tafenoquine (Arakoda or other regimen) or Celgosivir in a more limited patient population or include additional warnings in the drug’s label. This, in turn, could substantially and detrimentally impact our ability to successfully commercialize Tafenoquine (Arakoda or other regimen) or Celgosivir and effectively protect our intellectual property rights in Tafenoquine (Arakoda or another regimen) or Celgosivir. We plan to proceed with a revised clinical trial of the Arakoda regimen of Tafenoquine for babesiosis (to include high-risk patients and a clinical primary endpoint as requested by FDA). At the time of this offering based on written and verbal feedback from FDA, we believe it is likely that our planned study, if it successfully meets its endpoint, would be pivotal, and therefore support regulatory approval of a supplementary NDA for the babesiosis treatment indication. However, the Company has not received the FDA’s formal minutes from the meeting and will not do so until 30 days following January 17 th, 2023. It is possible that our recollections of the FDA meeting are incorrect and that the official record of the meeting is different from our recollections. If this risk materializes, it might mean we have to do more than one clinical trial to reach regulatory approval which would harm our business. There is a risk that in switching to a clinical endpoint as FDA has requested that the sample size of the study required to reach statistical significance is more than planned, which would increase our costs and harm our business. It is possible that, due to the planned change to a clinical endpoint, there may be delays in obtaining necessary ethics or FDA approval, or that the number of patients required to reach an interim endpoint increases. If either of the risks in the prior sentence were realized it may delay the timeline to reach an interim analysis, thereby harming our business. If we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for Tafenoquine (Arakoda or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations. We currently have only a single product (Arak