Belite Bio (BLTE) Q1 2025 earnings summary

Executive summary

• Advanced Tinlarebant clinical programs with ongoing global Phase III trials for Stargardt disease (STGD1) and geographic atrophy (GA), supported by strong regulatory designations in the U.S., Europe, and Japan.

• Interim analysis of the DRAGON Phase III trial in STGD1 showed Tinlarebant is safe, well tolerated, and stabilizes visual acuity, with DSMB recommending regulatory submission and no need for sample size increase.

• Enrollment in the PHOENIX Phase III trial for GA is progressing, with 464–465 of 500 subjects enrolled and completion expected in Q3 2025.

• Four-year cash runway secured, with $157.4M in cash and equivalents, supporting completion of all current clinical trials.

• Raised $15M in gross proceeds via a registered direct offering in February 2025.

Financial highlights

• Q1 2025 R&D expenses were $9.4M, up from $6.8M year-over-year, mainly due to share-based compensation and higher clinical trial costs.

• G&A expenses rose to $6.1M from $1.6M year-over-year, also driven by share-based compensation.

• Net loss for Q1 2025 was $14.3M, compared to $7.9M in Q1 2024.

• Cash, liquidity funds, and equivalents totaled $157.4M at quarter-end, bolstered by the $15M offering and stock option exercises.

• Other income grew to $1.2M from $0.5M year-over-year, driven by interest from deposits and treasury bills.

Outlook and guidance

• Sufficient cash to fund operations and complete all ongoing clinical trials over the next four years.

• DRAGON Phase III trial for STGD1 expected to complete in Q4 2025, with a three-month follow-up period; additional Phase III trials may be required for regulatory approval.

• PHOENIX Phase III trial in GA ongoing, with interim analysis planned and enrollment nearing target; additional Phase III study anticipated before NDA filing.

• Operating expenses expected to remain slightly higher in 2025 and 2026 due to clinical trial milestones, then decrease thereafter.

• No immediate impact expected from U.S. drug pricing policy changes; monitoring ongoing.