Belite Bio, Inc (NASDAQ:BLTE) Q4 2023 Results Conference Call March 12, 2024 4:30 PM ET

Company Participants

Tom Lin - Chiarman and Chief Executive Officer

Nathan Mata - Chief Scientific Officer

Hao-Yuan Chuang - Chief Financial Officer

Conference Call Participants

Jennifer Kim - Cantor

Yi Chen - H.C. Wainwright

Bruce Jackson - Benchmark

Operator

Hello, and thank you for joining us to discuss Belite Bio’s Fourth Quarter and Full-Year 2023 Financial Results. Joining the call are Dr. Tom Lin, Chairman and CEO of Belite Bio; Dr. Nathan Mata, Chief Scientific 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 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. [Operator Instructions]

Now I'll turn the call over to Dr. Lin.

Tom Lin

Thank you. Thank you, everyone, for joining our reporting for 2023 and for this quarter. I'm Tom Lin, CEO of Belite Bio. Joining me is our CFO, Dr. Nathan Mata and CFO, Hao-Yuan.

I'd like to start off by giving an overview. So Tinlarebant is a novel once-a-day oral tablet designed to bind to serum retinal binding protein or RBP4 as a means to specifically reduce retinol delivery to the eye. This approach is intended to slow or stop the formation of the toxic retinol derived by products, which are generated in the visual cycle and are implicated in progression of Stargardt disease and Geographic Atrophy.

Belite Bio believes that early intervention directed and emerging retinol pathology, which is not mediated by information, will be the best approach to potentially slow disease progression in Stargardt disease and in GA.

There's still a significant unmet need for both indications as currently, there is no approved treatment for Stargardt disease, and there are currently no approved oral treatments for GA, and we're already in global Phase 3 trials for both indications. So far, we have been granted fast track designation, rare pediatric disease designation and open drug designation in U.S., EU and now Japan. We have several patent families and with composition of meta-patents lasting until 2040, and with patent term extension and new patents to be filed, which will have patent protection way past the 2040s.

For Stargardt indication, the Phase 3 is already fully enrolled with estimated interim results by end of 2024 or early 2025. We will also be presenting further positive findings and treatment results from our annual Phase 2 results, which we'll be presenting at ARVO in May this year. For GA in Dry ND indication, we currently have more than 50 subjects enrolled in our global Phase 3 trial.