60 Degrees Pharmaceuticals Earnings Call Transcripts
Fiscal Year 2026
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ARAKODA is being repositioned for babesiosis, with early expanded-access results showing clinical improvement in five patients and NAT-confirmed cure in 80%. January 2027 hospital-trial results will guide the FDA pathway, with a potential 2028 launch.
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The DSMB recommended completing the blinded hospital study, with no safety signal; follow-up of 30 patients is planned before unblinding in early 2027. The first three expanded access patients were reported cured, with two more outcomes expected in November.
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A clinical development campaign aims to expand ARAKODA's label from malaria to babesiosis, supported by promising early trial results and a strong safety profile. Key regulatory milestones are expected over the next 18 months, with a potential product launch in early 2028.
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ARAKODA's commercial growth is driven by both malaria prevention and emerging use in chronic babesiosis, with ongoing clinical trials aiming to expand its indications. Key milestones in 2024-2027 include diagnostic validation, interim clinical results, and a potential NDA submission.
Fiscal Year 2025
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ARAKODA's commercial pilot aims to boost awareness and sales, with a focus on malaria and chronic babesiosis. Three clinical trials are underway, and a breakthrough therapy designation for babesiosis is pending FDA feedback. Market potential exceeds $200M, with a cash runway through March 2026.
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ARAKODA's sales are rebounding post-pandemic, driven by both malaria prevention and off-label use for chronic babesiosis. Ongoing clinical trials and a commercial pilot program aim to expand indications and drive growth, with key data and regulatory milestones expected by 2026.