60 Degrees Pharmaceuticals (SCTP) Investor presentation summary

Program overview

• Tafenoquine development spans chronic, relapsing and severe acute babesiosis; the programs are intended to contribute to a shared regulatory evidence package.

• Sponsored studies use a four-day loading regimen followed by weekly dosing; the approved malaria-prophylaxis label uses a three-day loading regimen.

• Tafenoquine is FDA-approved for malaria prevention and P. vivax radical cure, but is not approved for babesiosis; efficacy for babesiosis has not been established.

Safety platform

• ARAKODA has been marketed since 2019, with 52 weeks of controlled weekly-dose safety data and more than 1,100 clinical-study participants cited.

• G6PD testing is central to safe use; tafenoquine is contraindicated with G6PD deficiency or unknown status, and monitoring for hemolysis is recommended.

• The cited safety profile includes reversible cornea verticillata; long half-life can delay hemolytic, psychiatric, hypersensitivity and methemoglobin effects.

• The blinded hospital DSMB reported no safety signal preventing continued use of tafenoquine as intended.

Chronic babesiosis study

• B-FREE is an open-label Phase II outpatient study screening up to 100 people with disabling fatigue and recent laboratory evidence of exposure; primary per-protocol analysis requires baseline Babesia NAT positivity and 16 completers.

• Treatment is 200 mg on Days 1–4, then 200 mg weekly through Day 89; the primary endpoint is change in MFI-General Fatigue through Day 90.

• Screening found genus-level dPCR positivity in 2/9 participants, with 0/9 positive on B. microti NAT and 0/9 on Mayo species-specific PCR; no participant yet qualified for primary per-protocol analysis.

• Diagnostic challenge includes low or intermittent parasite density, possible atypical species and the lack of an accepted chronic-babesiosis case definition; B-FREE embeds diagnostic discovery in the treatment study.