Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 109

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 109
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 disease recovery in COVID-19 patients with low risk of disease progression. In October 2023, we made a decision to suspend this study. This was a consequence of advice previously received from the U.S. Food and Drug Administration (FDA), which we interpreted to mean that the Agency would not have granted clearance for the study to proceed unless we redesigned it to (i) enroll a patient population in which receipt of Paxlovid or Lagevrio would be medically contraindicated, or (ii) compare Tafenoquine to placebo in patients taking a “standard of care” regimen (defined by the FDA as Lagevrio or Paxlovid). The FDA’s position was somewhat surprising given that neither Paxlovid nor Lagevrio is indicated for treatment of COVID-19 in low-risk patients. We determined that conducting our study in an alternate population in the United States would be unfeasible, and that conducting an add-on-to standard of care study might not be Phase III enabling. Accordingly, we made a decision to pivot back to continue commercialization of Arakoda for malaria, and further evaluation of the Arakoda regimen of Tafenoquine for babesiosis and other diseases. We believe such an approach is both less risky and less expensive. Moving forward, our general strategy to achieve profitability and grow shareholder value has three facets: (i) increase sales of Arakoda; (ii) conduct clinical trials to expand the number of patients who can use Tafenoquine for new indications in the future; and (iii) reposition small molecule therapeutics with good clinical safety profiles for new indications. Business Developments The following highlights significant business developments in our business during the quarter ended September 30, 2024.

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| ● | On                                                                                                                                         
 July 22, 2024, we converted 1,291 shares of Series A Preferred Stock held by an investor into 40,000 shares of our common stock. On July   
 26, 2024, we converted an additional 1,032 shares of Series A Preferred Stock held by the investor into 33,334 shares of our common stock. |

| ● | In                                                                                                                                       
 August 2024, we granted the University of Kentucky a right of reference to our new drug application for ARAKODA®. The right of reference 
 will allow the FDA to review clinical efficacy and safety data, non-clinical data and chemistry, manufacturing and control information   
 on ARAKODA® as the FDA reviews protocols and