60 Degrees Pharmaceuticals (SCTP) H.C. Wainwright 27th Annual Global Investment Conference summary

Strategic Overview and Market Opportunity

• Focus on expanding sales and market cap through commercialization of ARAKODA, an FDA-approved malaria prevention drug, and leveraging its platform for babesiosis, a tick-borne disease with significant unmet need.

• Market research indicates potential for over $200 million in sales by 2035, with chronic babesiosis as the largest contributor.

• Expanding the current product label could triple the asset's value by addressing both malaria and babesiosis markets.

• Patent life for ARAKODA extends to 2035, supporting long-term growth.

• Babesiosis, post-treatment Lyme disease, and alpha-gal syndrome represent large, underserved markets with limited or no FDA-approved treatments.

Commercial Initiatives and Financial Highlights

• Launched a commercial pilot program for malaria prevention, partnering with IQVIA for outreach, sales, and copay assistance.

• Q2 2026 product revenue reached $208k, up 106% YoY, with a gross margin of 27%.

• Gross margin stabilized at about 50% as volume increased, with profitability expected at scale.

• Recent financing in July 2026 provided additional liquidity, extending the runway into early October 2026.

• Commercial product sales now contribute measurable revenue, while babesiosis development remains the primary capital driver.

Clinical Research and Regulatory Strategy

• Multiple clinical studies are underway for babesiosis, including randomized, open-label, and expanded use trials, with interim analysis expected by October 2026.

• Three targeted clinical trials underway: severe babesiosis, immunosuppressed patients, and chronic babesiosis.

• The regulatory strategy aims for an accelerated approval pathway, using surrogate relapse markers and leveraging totality-of-evidence precedents.

• A regular SNDA pathway is also being pursued, supported by efficacy data from hospital studies and expanded access programs.

• Data from these trials could support label expansion for ARAKODA, with earliest regulatory discussions possible by late 2025.