60P is addressing the unmet medical need associated with infectious diseases through the development and commercialization of new small molecule therapeutics. By focusing on synthetic drugs (made by chemists in labs, excluding biologics) with good safety profiles based on prior clinical studies, 60P believes it has a cost-effective path to new indications that capitalizes on existing research to reduce costs and risk. 60P is expanding its commercialization efforts related to ARAKODA (tafenoquine), an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by the FDA in 2018. In Q2 2023, sales of ARAKODA increased by 150% relative to the same period in 2022, at an accelerating growth rate.

60P is implementing clinical research programs to evaluate the utility of the ARAKODA regimen of tafenoquine for non-malaria disease indications, with an upcoming planned Phase 2a study of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the end of 2023. According to Company estimates, 47,000 cases of babesiosis (infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the United States each year, and the incidence rate is increasing. Estimates are that 10% of Lyme disease patients are co-infected with babesiosis. 60P is also testing the viability of another product (Celgosivir) to determine whether to advance it into further clinical development and may seek to develop and license other molecules in the future.

• ARAKODA® (tafenoquine) – Overview
  • Safe, long-acting, mechanistically differentiated anti-malarial approved by FDA
  • Discovered by and co-developed with U.S. Army
  • 1,100+ patient exposures in 8+ published trials, weekly dosing for up to one year
  • Commercially available in U.S. via network of major national distributors
  • Existing commercial/regulatory infrastructure expected to facilitate cost-effective pathway to new/expanded indications following targeted clinical trials and label changes
• ARAKODA Regimen of Tafenoquine - Research & Development Agenda
  • Company has strong IP for malaria and other indications
  • Preparing to launch a Phase 2a study of tafenoquine in hospitalized babesiosis patients before the end of 2023
  • 47,000 cases of babesiosis (infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the US each year, and the incidence rate is increasing
• 60 Degrees Pharmaceuticals – Overview
  • Seasoned Management Team and Board
  • Profound clinical expertise in tafenoquine and related therapeutics
  • Team has together led/managed four clinical trials
  • Collectively led multiple pharmaceutical product approvals/ international pharmaceutical product launches
  • Collectively led/provided guidance to multiple public & private entities
  • Participated in/led multiple public listings