Belite Bio, Inc (NASDAQ:BLTE) Q1 2023 Earnings Conference Call May 11, 2023 8:00 AM 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 - Cantor Fitzgerald & Co.

Timothy Lugo - William Blair & Company LLC

Yi Chen - H.C. Wainwright & Co, LLC

Bruce Jackson - The Benchmark Company

Yuan Zhi - B. Riley Securities

Operator

Good morning, and welcome to the Belite Bio Quarter One 2023 Financial Results Conference Call. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Belite Bio website following the conclusion of the event.

Before we begin, I'd like to reference you to the forward-looking statements and legal disclaimer slide on the screen. Joining us on today's call is Belite Bio’s Chairman and Chief Executive Officer, Dr. Tom Lin; Chief Scientific Officer, Dr. Nathan Mata; and Chief Financial Office, Hao-Yuan Chuang.

With that, I will now turn the call over to Tom.

Tom Lin

Thank you, Tara. Thank you, everyone, for joining our financial results for first quarter 2023. Joining me today is our CSO, Nathan Mata, who will be updating our recent clinical trial progress; and our CFO, Hao-Yuan, who will be updating our Q1 financial results.

For those that are new to Belite story, the company is developing a novel oral once-a-day treatment that potentially slows disease progression in Stargardt disease and Geographic Atrophy in dry AMD. There is 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 or no approved non-invasive treatments for Geographic Atrophy, which is predominantly in an elderly patient population.

We are currently in global Phase III for both indications. And so far, we have been granted fast track designation, rare pediatric disease designation, and orphan drug designations.

As mentioned, we are currently in Phase III development, and we have composition of matter patents until at least 2035. And with patent term extension and new patents to be filed, which will take us well into the 2040. So we still have a very long patent life on this drug.

So for the Stargardt indication, the Phase III is already two-thirds enrolled with estimated interim readouts by May 2024. We've also just recently presented a very promising 18-month treatment results from our Phase II, which our CSO will be presenting the results later on. We also expect to have the 24-month final data readouts for the Phase II study in Q4 this year. For the Geographic Atrophy in dry AMD indication, the Phase III is expected to start enrolling subjects in mid-2023.