Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the Be Light Bio fourth quarter and full year 2024 earnings conference 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 conference over to Julie Fallon. Please go ahead.

Hello, and thank you for joining us to discuss BeLiveBio's fourth quarter and full year 2024 financial results. Joining the call today are Dr. Tom Lin, Chairman and CEO of BeLiveBio, Dr. Hendrik Scholl, Chief Medical Officer, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Wan 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. Lin.

Thank you for joining today's call to discuss our fourth quarter and full year 2024 financial results. 2024 was an exciting year for Be Light, as we continue to make strong progress towards advancing Teneraband in patients living with Staggers disease and geographic atrophy. For those who are new to our story, Teneraband is a first-in-class oral therapy intended to reduce the accumulation of toxic vitamin A byproducts, which have been implicated in the progression of retinal lesions in patients with Staggers disease and geographic atrophy. We believe this approach will be effective in slowing or halting lesion growth, which would ultimately preserve vision. It is important to note that our approach focuses on early intervention of emerging retinal pathology that is not mediated by inflammation. We believe that this may be the best approach to potentially slow the progression of STAVA and GA. To give you some perspective on the importance of this potential therapy, Tenerbent has been granted rare pediatric disease and fast-track designations in the U.S., and pioneer drug designation, 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 Starr's disease and no approved oral treatment for GA. And more importantly, we are uniquely positioned 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 the lab in patients living with Stargardt's disease. These are the Phase 3 Dragon trial and the Phase 2-3 Dragon 2 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 maintaining the sample size at 104 subjects. In addition, they recommend we submit the data for further regulatory review for drug approval. With the DSMB's review done, completion of the trial is on track for end of this year. The Dragon 2 trial continues to progress rapidly. We have enrolled 11 of our targeted enrollment of approximately 60 subjects including about 10 Japanese subjects. Data from the Japanese subjects 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 progress in our clinical global phase three Phoenix trial, which has already enrolled over 400 subjects to date. We expect to increase the number of subjects to be enrolled in Phoenix trial from approximately 430 subjects to 500 subjects, as we have been making good progress on our subject enrollment. To summarize, with the excellent progress in our phase three trials and the promising interim results from phase three study and a four-year cash runway, we remain well positioned in advancing TenderaBand as potentially the first oral treatment for people living with degenerative retinal diseases. I'll now turn over the presentation to Nathan. Nathan, please.