Belite Bio (BLTE) Q1 2025 earnings summary

Executive summary

• Advanced Tinlarebant clinical programs for Stargardt disease and geographic atrophy, with global phase III trials ongoing and strong regulatory designations in the U.S., Europe, and Japan.

• Interim analysis of the phase III Dragon trial in Stargardt disease showed no need for sample size increase, with DSMB recommending data submission for regulatory review.

• Enrollment in the Phoenix phase III trial for geographic atrophy is progressing well, with 464 of 500 subjects enrolled and completion expected in Q3 2025.

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

• Four-year cash runway secured, supporting completion of all current clinical trials.

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; $6.7M of the increase was non-cash share-based compensation.

• Cash, liquidity funds, and equivalents totaled $157.4M at quarter-end, bolstered by a $15M direct offering and $5.6M from 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.

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

• DRAGON trial completion expected by Q4 2025, including a three-month follow-up period.

• PHOENIX trial interim analysis planned; enrollment nearing target.

• Data from Japanese subjects in DRAGON II intended to support future new drug application in Japan.