Belite Bio, Inc (NASDAQ:BLTE) Q2 2024 Earnings Conference Call August 12, 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

Basma Radwan - Leerink Partners
Jennifer Kim - Cantor
Yi Chen - H.C. Wainwright
Bruce Jackson - Benchmark

Operator

Hello, and thank you for joining us to discuss Belite Bio's Second 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 our 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. Please note that you can submit questions throughout the call by clicking on the Q&A box at the bottom of your screen, and we will respond to questions following our prepared remarks.

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

Tom Lin

Thanks, Julie. Thank you, everyone, for joining our second quarter 2024 earnings call. We had another strong quarter advancing our Tinlarebant trials, and I'm pleased with our progress in the year-to-date.

Let me start off with our accomplishments during the second quarter by the overview of our programs. We had a productive quarter marked by several advancements in our programs. We have initiated the Phase Ib and Phase 2/3 trial of Tinlarebant in adolescent stargardt patients, also known as a DRAGON II study. And we have already completed enrollment for Phase Ib portion with 6 subjects in Japan.

We've also received Sakigake designation in Japan, which means Pioneer Drug Designation in English. Such designation has only been granted to 27 drugs in its initiation in 2015, and Tinlarebant is the first ophthalmic drug to receive Sakigake designation, which is a testament to the groundbreaking potential of this drug and the unmet need it tends to address the people living with stargardt disease.

We've made progress in our pivotal global Phase 3 trial of Tinlarebant in geographic atrophy subject as well, now as the Phoenix study and have already enrolled nearly 200 subjects to upfront -- until now.

In addition, we've also raised $25 million from the registered direct offering in April here for strengthening our balance sheet. The Phase III DRAGON I study is fully enrolled with estimated interim readouts by Q4 2024 or early 2025 at the latest. As we enter the second half of the year, we are well positioned to execute on key milestones, and we look forward to sharing interim analysis from - initial interim analysis from our pivotal Phase III DRAGON study in the fourth quarter.