Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the BelitBio second quarter 2025 earnings call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. I will now hand the call over to Sophie Hunt. Please go ahead.

Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of BelitBio, Dr. Nathan Mata, Chief Scientific Officer, Dr. Hendrik Scholl, Chief Medical Officer, and Hao-Yuan Chuang, Chief Financial Officer. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I'll turn the call over to Dr. Lin.

Thank you for joining today's call to discuss our second quarter 2025 financial results. We have made excellent progress in the quarter towards advancing tenaraband in patients living with Stoggart's disease and geographic atrophy. For those who are new to our story, tenaraband is a first-in-class oral therapy intended to reduce the accumulation of toxic vitamin A byproducts, which is implicated in the progression of retinal lesions in patients with Stoggart's disease and geographic atrophy. We believe this approach will be effective in slowing or halting lesion growth, which would ultimately preserve vision. To give you some perspective on the importance of this potential therapy, Teneraband has been granted breakthrough therapy, rare pediatric disease, and fast-track designations in the US, and Pioneer designation in Japan. There's also been granted orphan drug designation in the U.S., Europe, and Japan. We believe this speaks to the significant unmet need for both indications as currently there is no approved treatment for Stuller's disease and no approved oral treatment for geographic atrophy. As importantly, we are uniquely positioned to address these unmet needs as we are already in global phase three trials for both indications. So with that, let me provide a high-level overview of the recent progress we have made. We have two studies underway with tenaraband in patients living with Stoddart's disease. These are the Phase III DRAGON trial and the Phase II-III DRAGON II trial. As part of the phase three DRAGON trial, we were pleased to announce earlier in the year that the Data Safety Monitoring Board had completed its interim analysis and recommended that the trial proceed without a sample size increase or modifications. They also recommended that we submit the data for further regulatory review for drug approval. As a result, the FDA granted Dandaraband breakthrough therapy designation, and we remain on track to complete the study in Q4 this year. The Dragon 2 trial also continues to be on track. We have enrolled 17 of our targeted enrollment of approximately 60 subjects, including about 10 Japanese subjects. The data from the Japanese subjects is intended to expedite a new drug application in Japan, where we have already been granted a pioneer drug designation. In geographic atrophy, I'm pleased to share that we recently completed enrollment of our Global Phase 3 study with 529 subjects enrolled. We recently also raised 15 million in gross proceeds in a registered direct offering on August the 8th. To summarize, we made excellent progress against our key milestones in the first half of the year. We are looking to carry this momentum into the second half of the year. Our balance sheet is also strong with four years of cash runway. We remain well positioned to advance Ternaryband as potentially the first oral treatment for people living with degenerative retinal disease. I'll now turn over the presentation to Haoyuan. Haoyuan.