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Jun 30
Belite Bio Q2 2025 Earnings Report
Belite Bio reported its second quarter 2025 financial results and provided a corporate update.
Key Takeaways
Belite Bio reported a net loss of $16.3 million for Q2 2025, an increase from $9.5 million in Q2 2024, primarily due to higher research and development and general and administrative expenses. The company also announced the completion of enrollment in its pivotal Phase 3 PHOENIX trial and received Breakthrough Therapy Designation for Tinlarebant for Stargardt disease.
Net loss for Q2 2025 was $16.3 million, compared to $9.5 million for the same period in 2024.
Research and development expenses increased to $11.0 million in Q2 2025 from $9.1 million in Q2 2024.
General and administrative expenses significantly rose to $6.5 million in Q2 2025 from $1.4 million in Q2 2024.
The company completed enrollment with 529 subjects in the pivotal Phase 3 PHOENIX trial for geographic atrophy.
Belite Bio
Belite Bio
Forward Guidance
Belite Bio expects to complete the DRAGON trial by Q4 2025 and plans to submit the data for drug approval. The company also anticipates conducting an interim analysis for the PHOENIX trial.
Positive Outlook
- DRAGON trial completion expected by Q4 2025 (including a three-month follow-up period).
- Plans to submit DRAGON trial data for drug approval.
- Expects to conduct an interim analysis for the PHOENIX trial.
- Tinlarebant granted Breakthrough Therapy Designation for Stargardt disease by the U.S. FDA.
- Raised approximately $15 million in gross proceeds in a registered direct offering on August 8, 2025.
Challenges Ahead
- No specific negative forward guidance was provided in the report.
- The company did not provide specific revenue or profitability guidance.
- Future clinical trial results may not support further development or regulatory approval.
- The timing to complete relevant clinical trials and/or receive interim/final data is subject to change.
- The content and timing of decisions made by regulatory authorities regarding drug approval are uncertain.