Belite Bio (BLTE) Q4 2024 earnings summary

Executive summary

• Advanced Tinlarebant as a first-in-class oral therapy for Stargardt disease (STGD1) and geographic atrophy (GA), with global phase III trials ongoing for both indications.

• Tinlarebant received rare pediatric disease, fast-track, and orphan drug designations in the U.S., Europe, and Japan, highlighting significant unmet need.

• No FDA-approved treatments exist for STGD1 or oral treatments for GA, representing significant unmet needs.

• Interim analysis of the phase III Dragon trial in Stargardt disease led to DSMB recommending continuation without changes and submission for regulatory review.

• Enrollment in the phase III Phoenix trial for GA increased to 500 subjects due to strong recruitment progress.

Financial highlights

• R&D expenses were $29.9M in 2024, up from $24.8M in 2023, mainly due to increased royalty payments and share-based compensation.

• G&A expenses rose to $10.1M in 2024 from $6.8M in 2023, driven by higher share-based compensation.

• Net loss was $36.1M in 2024, compared to $31.6M in 2023.

• Cash and investments totaled $145.2M at year-end 2024, up from $88.2M at year-end 2023.

• Raised $15M in a registered direct offering in February 2025, with potential for an additional $15M from warrant exercises.

Outlook and guidance

• Four-year cash runway projected, not including costs for a potential second GA phase III study.

• Completion of the Dragon trial expected by year-end or Q4 2025; Phoenix trial enrollment to close by end of Q2 2025, with study completion targeted for Q3.

• Regulatory submissions for Tinlarebant in Stargardt disease to proceed following DSMB recommendation.