Belite Bio, Inc Q3 FY2025 earnings call

• Completed enrollment of Phase III PHOENIX trial with 530 subjects.
• Completed Phase III DRAGON trial for Stargardt's disease, final top line data expected end of current month.
• DRAGON II trial enrolled ~35 subjects out of targeted ~60, including 10 Japanese subjects, data to expedite Japan new drug application.
• Received positive regulatory feedback: China NMPA accepted NDA for priority review based on DRAGON trial interim analysis; U.K. MHRA accepted conditional marketing authorization application based on DRAGON interim analysis.
• Completed $50 million registered direct offering and upsized $125 million private placement, potential for additional $165 million upon full warrant exercise.

No detailed product segment financial performance breakdown provided. Key financials: Q3 2025 R&D expenses were $10.3 million vs $6.8 million same period last year. G&A expenses were $12.7 million vs $2.9 million same period last year. Net loss was $21.7 million vs $8.7 million same period last year. Cash position at end of Q3 was $275.6 million with liquidity from time deposits and U.S. treasury bills.

• Plan to submit NDA to China and U.K. in first half of 2026.
• Interim analysis for PHOENIX trial planned for second half of 2026.
• Estimate $200 million needed to commercialize Stargardt in the U.S.

• Uncertainties in timing of regulatory submissions and approvals.
• Dependence on successful clinical trial outcomes and regulatory feedback.
• Volatility in share-based compensation affecting expense figures.

Q: Whether submitted applications to regulatory agencies in China and U.K. and timeline for submission?

A: Not submitted, plan to submit in first half of 2026.

Q: Current amount of shares outstanding after recent announcement?

A: Approximately $35 million (as per S3 filing).

Q: Timeline for submitting application in Japan?

A: Still in discussion with Japan, expected first half, but need to prioritize based on data and country submission order.

Q: Structure of interim analysis for PHOENIX trial?

A: Likely a sample size reestimation similar to DRAGON, planned for second half of 2026.

Q: Baseline level for SG&A expenses going forward?

A: Hard to estimate as preparing for commercialization, expanding team, and ESOP involved which affects expenses.

Q: Steps for commercial preparation and region prioritization?

A: Focus on U.S., target first half 2026 submissions; U.S. sales force start with 20 people, potentially up to 40.

Q: Consistency of information for submissions to U.K. and China?

A: Same data set used for all, different presentation methods (in-person in Beijing for China, online for U.K.).