Belite Bio, Inc (NASDAQ:BLTE) Q4 2022 Earnings Conference Call April 3, 2023 4:30 PM ET

Company Participants

Tom Lin - Chief Executive Officer

Nathan Mata - Chief Scientific Officer

Hao-Yuan Chuang - Chief Financial Officer

Conference Call Participants

Jennifer Kim - Cantor Fitzgerald

Lachlan Hanbury-Brown - William Blair

Yi Chen - H.C. Wainwright

Bruce Jackson - The Benchmark Company

Yuan Zhi - B. Riley Securities

Operator

Good afternoon and welcome to the Belite Bio 2022 Full Year 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. [Operator Instructions] As a reminder, this call is being recorded and a replay will be made available on the Belite website following the event.

I'd now like to turn call over to Tom Lin, Chairman and Chief Executive Officer of Belite Bio. Please go ahead, Tom.

Tom Lin

Thank you, Tara. Thank you, everyone, for participating in this earnings call. I'd like to take this opportunity to give you an update on our current overview and milestones. So, we're currently 18th month into a 24-month open label Phase 2 study, which we will be presenting that data at ARVO by the end of the month. At the same time, we are also halfway, we recruited 41 subjects out of the 90 subjects into our global Phase 3 Stargardt study and we are expected expecting interim readouts by mid-2024 next year. We recently met with the FDA to request that we increased the sample size from 60 to 90. The reason being that after analyzing very promising top line treatment data from our Phase 2, we ran some simulations and we worked out that if we increase the sample size to 90, we would have more data going to the interim. And that will give us a very good chance of meeting that growth rate we can for efficacy. We've also initiated our global Phase 3 trial in geographic atrophy secondary to dry AMD, which is expected to start enrolling subjects by midyear this year.

So with the interim analysis, coming up for the Phase 2 18-month data, we feel that this will probably give a very good reference to what does data study will look out for our Phase 3.

Okay. Next slide, please.

So, the market opportunity is that, today there's still no treatment for Stargardt disease and currently there's about 30,000 subjects in -- 30 subset of patients in the U.S. with Stargardt and currently there’s no treatment. In terms of AMD, it is still a very large population globally and this is still arising given the aging population worldwide. As you can see on the graph on the right, the graph shows that with more advance age, the more advance the AMD gets. And at the stage of AMD, we know about the wet AMD, the market about $10 billion a year. But geographic atrophy, we expect this to surpass the wet AMD market. Even though there is the entire complements that are getting approved or patents that's approved, we still think that there's still a very good -- there's still an unmet need given there is still a noninvasive form of treatment such as oral therapies which we think would surpass the market for AMD.