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Sep 30
Belite Bio Q3 2025 Earnings Report
Belite Bio reported a higher net loss in Q3 2025 driven by increased R&D and G&A expenses, while cash reserves were significantly strengthened through new financings.
Key Takeaways
Belite Bio's Q3 2025 saw expanded R&D and administrative costs contribute to a wider net loss, while the company bolstered its cash position through strategic funding rounds to support ongoing clinical trials and regulatory initiatives.
Net loss widened to $21.7 million in Q3 2025, up from $8.7 million a year ago
Cash, liquidity funds, and U.S. treasury bills totaled $275.6 million as of quarter-end
R&D expenses rose to $10.3 million due to ongoing Phase 3 trials
Belite completed a $15M direct offering and $125M private placement, with potential for $165M more
Belite Bio
Belite Bio
Forward Guidance
Belite Bio is on track to report final Phase 3 DRAGON trial data in Q4 2025 and continues to advance regulatory submissions for Tinlarebant in multiple regions.
Positive Outlook
- 530 subjects enrolled in PHOENIX trial for geographic atrophy
- Final topline DRAGON trial data expected in Q4 2025
- NMPA accepted NDA with priority review for Stargardt treatment
- MHRA accepted CMA application for Stargardt treatment
- Strong cash position supports ongoing trials and regulatory plans
Challenges Ahead
- Net loss increased significantly year-over-year
- Operating expenses more than doubled versus Q3 2024
- No commercial revenue generated to date
- G&A expenses rose sharply due to share-based compensation
- Company remains pre-revenue and reliant on financing activities