60 Degrees Pharmaceuticals (SCTP) Investor update summary

Business and portfolio

• Strategy centers on repositioning marketed ARAKODA (tafenoquine) for babesiosis using the existing chemistry, formulation and safety platform, with additional efficacy data needed for an expanded FDA label.

• ARAKODA was FDA-approved in 2018 for malaria prevention and launched in 2019; its weekly maintenance dosing and safety evidence from eight randomized studies involving ~1,100 patients underpin the repositioning plan.

• Pipeline also includes a veterinary tick-borne disease program, castanospermine research for alpha-gal with the University of Southern Mississippi, and licensing work on two other products.

• Common shares outstanding: 4.5 million; market capitalization: ~$2.5 million. A recent warrant inducement raised additional cash.

Babesiosis opportunity and evidence

• Severe babesiosis can cause anemia, organ dysfunction and prolonged recovery; cited mortality is 1%–2% in immunocompetent hospitalized patients and up to 20% in patients with risk factors.

• Relapsing disease in immunosuppressed or asplenic patients can persist for months to years; analysis of literature cases found each doubling of treatment duration associated with a 27% lower retreatment hazard.

• In a prospective expanded-access study, all first five patients had clinical improvement and negative conventional PCR after tafenoquine plus an atovaquone-containing regimen; 80% achieved definitive cure by NAT testing.

• Two additional subjects are enrolled; results are expected to update next year. Literature-case analysis estimated combination-treatment efficacy at 3.6x the expected level for atovaquone monotherapy.

Clinical program and regulatory path

• The randomized severe-babesiosis hospital study enrolled 30 patients; an October safety-board review found no safety signal. The trial compares tafenoquine plus standard care with placebo plus standard care.

• Hospital-study unblinding is planned for January 2027. A positive primary endpoint could support a regular sNDA focused on faster sustained clinical resolution; an alternate accelerated-approval pathway may use immunosuppressed-patient data and NAT negativity as a proposed surrogate.

• Planned steps include a pre-NDA meeting request after unblinding, a potential FDA meeting in March, and an sNDA meeting request in Q2; conditional on progress, a filing and potential priority-review decision are targeted for Q4 2027, with launch in 2028.

• Expanded-access and literature evidence are intended to support the regulatory case, particularly for immunosuppressed patients with substantial unmet need, alongside randomized hospital-study results.