Belite Bio (BLTE) Q3 2025 earnings summary

Executive summary

• Completed enrollment of 530 subjects in the pivotal phase 3 PHOENIX trial for geographic atrophy (GA) and the pivotal phase 3 DRAGON trial for Stargardt disease (STGD1); final topline DRAGON data expected in Q4 2025.

• Regulatory agencies in China and the U.K. agreed to accept NDA and conditional marketing applications for Tinlarebant based on DRAGON interim results.

• Strengthened financial position with $15 million registered direct offering and $125 million private placement, with potential for up to $165 million more upon full warrant exercise.

• Tinlarebant granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; Sakigake Designation in Japan.

• Independent DSMB recommended continuation of DRAGON trial without modifications at interim analysis.

Financial highlights

• Cash, liquidity funds, time deposits, and U.S. Treasury bills totaled $275.6 million as of September 30, 2025.

• R&D expenses for Q3 2025 were $10.3 million, up from $6.8 million year-over-year, mainly due to PHOENIX and DRAGON trial costs and increased share-based compensation.

• G&A expenses rose to $12.7 million for Q3 2025 from $2.9 million year-over-year, primarily due to higher share-based compensation.

• Net loss for Q3 2025 was $21.7 million, compared to $8.7 million in Q3 2024; net loss for the nine months ended September 30, 2025 was $52.3 million, compared to $26.0 million in 2024.

• Operating cash outflow for Q3 2025 was $9.3 million, similar to $8.6 million in Q2.

Outlook and guidance

• Final topline data from the DRAGON trial in STGD1 expected in Q4 2025.

• NDA submissions in China, U.K., and other regions planned for the first half of 2026 to maintain a consistent data package.

• Interim analysis for the PHOENIX trial in GA planned for the second half of next year, with potential sample size re-estimation.

• Commercialization preparations underway, with U.S. and Japan prioritized for initial launches.

• Regulatory submissions for Tinlarebant in China and the UK are contingent on final DRAGON data and consistency with interim results.