Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the Be Light Bio first 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 in to today's call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.

Hello, and thank you for joining us to discuss Be Light Bio's first quarter 2025 financial results. Joining the call today are Dr. Tom Lin, Chairman and CEO of Be Light Bio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Haoyang Zhang, 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 Lynn.

Thank you for joining today's call to discuss our first quarter 2025 financial results. We continue to make good progress in this quarter towards advancing Teneraband in patients living with Starler's disease and geographic atrophy. For those who are new to our story, tenarumab 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 Stargardt'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, tenaraband has been granted rare pediatric disease and fast-track designations in the U.S. and pioneer drug designations in Japan. It has 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 Stargardt's disease and no approved oral treatment for geographic atrophy. And more importantly, we are uniquely positioned as we are already in global phase 3 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 Tenerbent in patients living with Stargardt's disease. These are the phase 3 DRAGON trial and the phase 2-3 DRAGON2 trial. As part of the Phase 3 Dragon trial, we recently announced that the Data Safety Monitoring Board has completed its interim analysis, which is based on all subjects having completed the one-year assessment period. The DSMB recommended that the trial proceed without sample size increase or modifications, so essentially maintain the sample size at 104 subjects. In addition, they recommended that we submit the data for further regulatory review for drug approval. With the DSMB's review done, completion of a trial is on track for end of this year. The Dragon 2 trial continues to progress rapidly. We have enrolled 16 of our targeted enrollment of approximately 60 subjects, including about 10 Japanese subjects. Data from a Japanese subject is intended to expedite a new drug application in Japan, to which we have already been granted a pioneer drug designation. In GA, we also continue to make progress in our clinical global phase three Phoenix trial, which has already enrolled 464 subjects to date. We expect Phoenix trial to be fully enrolled for 500 subjects in Q3 this year. To summarize, with the excellent progress in our phase three trials and promising interim results from phase three Stargardt study, 2025 is off to a great start from a clinical perspective, and our balance sheet is also strong with a four-year cash runway. We remain well-positioned in advancing to a net band as potentially the first oral treatment for people living with degenerative retinal disease. I'd like to now turn over the presentation to Nathan.