Belite Bio's Q2 2025 Earnings Call: Unpacking Key Contradictions in Strategy and Financial Outlook

Regulatory Strategy and Filing Timeline, Operating Expenses and Cash Burn, Timeline for Enrollment and Study Completion, Accelerated Approval Path, and Interim Analysis Timeline for DRAGON Trial are the key contradictions discussed in Belite Bio's latest 2025Q2 earnings call.



Tinlarebant Clinical Trial Progress:
- Belite Bio's Tinlarebant Phase III DRAGON trial was recommended to proceed without a sample size increase by the Data Safety Monitoring Board.
- The trial is on track to complete in Q4 2025, with the potential for regulatory review and approval based on the interim data.
- This progress was driven by the positive interim analysis results and the breakthrough therapy designation granted by the FDA.

Funding and Financial Position:
- Belite Bio raised $15 million in gross proceeds through a registered direct offering on August 8, 2025.
- The company reported a net loss of $16.3 million for Q2 2025, primarily due to higher expenses in R&D and G&A, especially share-based compensation.
- The additional funds and strong financial position with 4 years of cash runway are expected to support the completion of all three Phase III trials without considering commercialization costs.

Geographic Atrophy Study Enrollment and Interim Analysis:
- Enrollment for the global Phase III study in geographic atrophy was completed with 529 subjects enrolled.
- An interim analysis (IA) is planned for the study, which is expected to be conducted at a timepoint similar to the DRAGON trial.
- The successful enrollment was due to the significant unmet need for treatments in geographic atrophy and the potential for Tinlarebant to become the first oral treatment for this condition.

DRAGON II Trial Enrollment and Timing:
- The DRAGON II trial has enrolled 17 out of a targeted 60 subjects, including about 10 Japanese subjects.
- The enrollment is expected to be completed by the end of 2025, with the potential for regulatory approval based on the study's data.
- The enrollment progress is influenced by strategic timing to not compete with the DRAGON I trial and the potential for regulatory approval based on the study's data.