Belite Bio, Inc Q2 FY2025 earnings call

• Progress in Tinlarebant development: 2 studies underway for Stargardt disease (Phase III DRAGON and Phase II/III DRAGON II trials); Phase III geographic atrophy study completed enrollment with 529 subjects. - Tinlarebant has breakthrough, rare pediatric disease, Fast Track, Pioneer, and orphan drug designations. - Q2 2025 financials: R&D and G&A expenses increased, net loss widened, but cash runway remains strong with $149.2 million in cash and $15 million raised.

For Q2 2025, R&D expenses were $11 million compared to $9.1 million in the same period last year, driven by higher pass-through expenses and manufacturing costs offset by lower DRAGON trial expenses. G&A expenses were $6.5 million vs $1.4 million last year, mainly due to increased share-based compensation. Net loss was $16.3 million vs $9.5 million prior year. Cash position at end of Q2 was $149.2 million, with $15 million raised via registered direct offering on August 8, and 4 years of cash runway expected without commercialization costs.

• Expect 4 years of cash runway without considering commercialization costs. - Expect to complete all 3 Phase III trials with current cash. - Anticipate cash outflow of around $40-45 million over the next 2 years, then dial down.

Forward-looking statements are subject to risks and uncertainties, actual results may differ materially.需参考SEC filings for additional risk details.

Q: What is the status of the FDA discussion regarding the interim data from the DRAGON trial?

A: Filed breakthrough based on IA data, met with FDA, recommended completing 24-month study and submitting final data for possible single study approval with robust statistical significance.

Q: What is the status of the PHOENIX trial's interim analysis for geographic atrophy?

A: There will be an IA for GA, but timeline details not specified, will be at a halfway mark similar to Stargardt.

Q: What is the current estimate timeline for reaching the target enrollment of 60 patients in the DRAGON II trial?

A: Initially launched in Japan, expanding into additional countries to accelerate enrollment, expect to complete enrollment end of this year.

Q: What about the scale of commercial force needed to bring the drug to market?

A: Current cash burn forecast for 4 years runway doesn't include full commercialization costs, will build budget once approval confirmed.

Q: How soon after data release can filing occur, considering CMC and long-term safety data?

A: Long-term safety data will have 300 subjects by first quarter of next year from both studies. Ongoing discussion with FDA on CMC, on track but will have further discussion before submission.