Belite Bio, Inc. (NASDAQ:BLTE) Q3 2023 Earnings Conference Call November 14, 2023 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

Jennifer Kim - Kento

Basma Radwan - Leerink Partners

Yi Chen - HC Wainwright

Bruce Jackson - The Benchmark Company

Operator

Hello and thank you for joining us to discuss Belite’s Third Quarter 2023 Financial Results. Joining the call is Dr. Tom Lin, Chairman and CEO, Dr. Nathan Mata, Chief Scientific Officer, and Hao-Wan Zhang, Chief Financial Officer of BeLite Bio. 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.

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

Tom Lin

Thank you. Thank you for joining our reporting for the third quarter. I'm Tom Lin, CEO of BeLite Bio. Joining me is our CSO, Nathan, and CFO, Hao. I'd like to start off by giving an overview. So, Tinlarebant is a normal once-a-day oral tablet designed to bind to serum retinal binding protein, or known as RBP4, as a means to specifically reduce retinal delivery to the eye. This approach is intended to slow or stop the formation of the toxic retinal derived by products which are generated in the visual cycle and are implicated in the progression of Stargardt’s disease and Geographic Atrophy secondary to dry AMD. We believe that early intervention directed at emerging retinal pathology, which is not mediated by inflammation, will be the best approach to potentially slow disease progression in Stargardt’s disease and Geographic Atrophy.

There still is significant unmet need for both indications, as currently there is no approved treatment for Stargardt’s disease and there are currently no approved oral treatments for GA, and we are already in Global Phase III trials for both indications. So far, we have been granted fast-track designation, rare pediatric disease designation, and orphan drug designation. 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 we will have patent protection way past the 2040s.

So we still have a very long patent life on this drug and we are already in late-stage development. For Stargardt’s indication, the Phase III is already fully enrolled. We've estimated interim readouts by second half of 2024. We've also just recently presented positive 24-month treatment results from our Phase II, which Nathan will be presenting the results later on.