Belite Bio, Inc. (NASDAQ:BLTE) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET
Company Participants
Tom Lin - Chairman and Chief Executive Officer
Nathan Mata - Chief Scientific Officer
Hao-Yuan Chuang - Chief Financial Officer
Conference Call Participants
Yi Chen - H. C. Wainwright
Basma Radwan - Leerink Partners
Operator
Hello, and thank you for joining us to discuss Belite Bio’s First Quarter 2024 Financial Results. Joining the call today 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, Judy. Thank you, everyone, for joining our reporting for the fourth quarter. I'm Tom Lin, CEO of Belite Bio. Joining me is our CSO, Nathan Mata and CFO, Hao-Yuan.
I'd like to start off with an overview. Tinlarebant is a novel once-a-day oral tablet designed to bind to serum retinol binding protein known as 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 at emerging retinol pathology, which is not mediated by information, will be the best approach to potentially slow disease progression in Stargardt disease and 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 2040s, and with patent term extension and new patents to be filed, we will have patent protection past the 2040s.
For Stargardt indication, at ARVO last week we presented further positive findings and treatments results from our end of Phase 2 results which our CSO will be presenting. The Phase 3 is fully enrolled and estimated interim results by end of 2024 or early 2025. We've also initiated a Phase 2 study in Stargardt’s, which will recruit Japanese patients that is required for NDA in Japan. For GA, Dry AMD indication, we currently have about 100 subjects enrolled in our Phase 3 in GA.