Boris Peaker • Titan Partners

Question 1

Boris Peaker's questions to Belite Bio Inc (BLTE) leadership • Q2 2025

Aug 11, 2025

Question

Boris Peaker of Titan Partners asked about the status of FDA discussions regarding the DRAGON trial's interim data, its potential to trigger an NDA filing, and the data requirements from the DRAGON-2 study. He also inquired about plans for an interim analysis for the PHOENIX trial in geographic atrophy.

Answer

Chairman & CEO Tom Lin explained that the FDA recommended completing the 24-month DRAGON study for a potential single-study approval based on robust data, rather than pursuing an accelerated approval. He confirmed a single-study filing on DRAGON-1 is possible. He also stated that the PHOENIX trial will have an interim analysis around the halfway point, with the timeline yet to be finalized.

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Question 2

Boris Peaker's questions to Ocugen Inc (OCGN) leadership • Q2 2025

Aug 1, 2025

Question

Boris Peaker from Titan Partners asked if the recent DSMB review for OCU400 in Retinitis Pigmentosa included a futility analysis or was purely for safety. He also requested the timing and expected content of the next interim update for OCU410 in Geographic Atrophy, the timeline for regulatory feedback from the EMA, and clarity on when the revenue from the Korean partnership would be recognized.

Answer

Chief Medical Officer Dr. Huma Qamar clarified that the DSMB review for OCU400 was purely for safety with no futility analysis. She and CEO Shankar Musunuri confirmed that an interim data update for the OCU410 ARMOR trial, including structural and functional outcomes at later time points, is planned for Q4. Mr. Musunuri added that feedback from the EMA on the Stargardt trial is expected by Q4 2025. Chief Accounting Officer Ramesh Ramachandran explained that the revenue from the Korean partnership will be recognized over a period extending into 2027, not at a single point in time.