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Belite Bio, Inc
8/13/2026
Ladies and gentlemen, thank you for joining us and welcome to the Be Light Bio second quarter 2026 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 conference over to Julie Fallon. Please go ahead.
Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Be Light Bio, 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. Additionally, today we will be discussing certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. And now I'll turn the call over to Dr. Lin. Dr. Lin?
Thank you, Julie. Good afternoon, everyone. Thank you for joining our second quarter 2026 financial results and corporate update call. The first half of this year has been both exciting and deeply productive for Biola Bio. as we rapidly approach a potential regulatory approval of Tendaraband for Stargardt's disease in the U.S. We are very pleased to announce that the FDA has accepted our new drug application for Tendaraband with priority review and establishing a PDUFA date of February 12, 2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program. In parallel, With our pre-commercial preparations, we remain highly engaged with the medical and patient communities. The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stargardt's disease. This quarter, we presented our Phase III Dragon Study results at four medical conferences across four countries, including the recent American Society of Retinal Specialists, ASRS, annual meeting. At ASIS, we presented new secondary endpoint data demonstrating subjects treated with ternaraban showed a halt to slightly decreased QAF values, decreased by approximately 2% at month 25 compared to baseline. In contrast, subjects in the placebo group exhibited an approximately 20% increase in QAF values over the same period. Quantitative autofluorescence, or QAF, is a marker of toxic bus retinoid accumulation, a key driver of retinal degeneration in stardust disease. The prevention or reduction of QAF strongly aligns with TeneriBand's mechanism of action, reinforcing its potential to halt or slow lesion growth. Looking ahead, we remain confident in our data, our science, and the transformative potential of terapin for patients living with Stargardt's disease. We look forward to providing further updates as they become available. I'll now turn the presentation over to Hao-Yuan to discuss the financials. Hao?
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