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Mar 31, 2025
Belite Bio Q1 2025 Earnings Report
Belite Bio reported its financial results for the first quarter ended March 31, 2025, showing an increase in net loss and operating expenses compared to the previous year.
Key Takeaways
Belite Bio experienced a significant increase in net loss and operating expenses in Q1 2025 compared to Q1 2024, primarily due to higher research and development and general and administrative expenses. Despite the financial results, the company made progress in its clinical trials, with the DRAGON trial proceeding without modification and the PHOENIX trial continuing enrollment.
Net loss for Q1 2025 was $14.3 million, an increase from $7.9 million in Q1 2024.
Research and development expenses rose to $9.4 million in Q1 2025 from $6.8 million in Q1 2024.
General and administrative expenses increased to $6.1 million in Q1 2025 from $1.6 million in Q1 2024.
The DRAGON Phase 3 trial for adolescent Stargardt disease was recommended to proceed without modification, with trial completion expected by Q4 2025.
Forward Guidance
Belite Bio is focused on advancing its clinical programs for Tinlarebant, with key milestones expected in 2025, including the completion of the DRAGON trial and continued enrollment in the PHOENIX trial.
Positive Outlook
- Independent DSMB recommended the pivotal Phase 3 DRAGON trial proceed without modification.
- DSMB recommended submitting interim data for DRAGON for further regulatory review for drug approval.
- PHOENIX trial for geographic atrophy is ongoing with 464 of targeted 500 subjects enrolled.
- Trial completion for DRAGON expected by Q4 2025.
- Raised $15 million in gross proceeds from a registered direct offering in February 2025.
Challenges Ahead
- No specific negative forward guidance was provided in the report.
- The company did not provide specific revenue or profit guidance.
- The report did not mention any potential delays in clinical trials.
Historical Earnings Impact
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