Belite Bio, Inc American Depositary Shares Status update
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Ladies and gentlemen, thank you for joining us and welcome to the Belite Bio 2026 Commercial Day. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star 9 to raise your hand and star 6 to unmute. I will now hand the conference over to Julie Fallon.
Please go ahead. Good morning, everyone, and welcome to the Belite Bio Commercial Day.
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. Our goals for today are to provide you with an overview of the current diagnosis path and treatment paradigm for Stargardt disease type 1, how Stargardt impacts people's day-to-day lives, the significant unmet need for treatment, and Belite Bio's commercial preparedness strategy. We have a full agenda, so with that, let me turn the call over to Dr. Lin, Belite Bio's chairman and CEO, for opening remarks.
Dr. Lin? Good morning, everyone, and thank you for joining us for Belite Bio's Commercial Day.
We are pleased to have the opportunity to share how we are preparing for what we believe could be a transformational next chapter for our company and for patients living with Stargardt disease type 1. At Belite Bio, our mission is to preserve vision and pioneer degenerative retinal disease treatments where few or none exist today. We are approaching one of the most significant milestones in Belite Bio's history. As we recently announced, FDA has accepted our NDA for tinlarebant in Stargardt disease type 1. The FDA also granted priority review and assigned a PDUFA date of February 12, 2027. We are very encouraged by this milestone and believe the FDA's NDA acceptance with priority review reflects the immediate need for an approved treatment for Stargardt disease.
Furthermore, we believe this reinforces the quality and depth of the data that we have generated throughout this drug development program. If approved, tinlarebant will be the first and only approved treatment for Stargardt disease type 1. Approval would also mark Belite's evolution into a commercial-stage biotech company and allow us to begin delivering on the vision that has guided this organization since its founding. While the NDA is under review, our focus remains on ensuring we are ready to deliver for patients, physicians, and the broader retinal community. We have been building the capabilities needed to support a successful U.S. launch. From commercial infrastructure and market preparation to physician education and patient support planning, all the goal of being ready to serve patients quickly. We have assembled a highly experienced team with deep expertise in rare disease, ophthalmology, and commercialization.
Joining us today are Belite Bio's Chief Medical Officer, Dr. Hendrik Scholl, Chief Commercial Officer, Kelly Kilpatrick, and Chief Financial Officer, Hao-Yuan Chuang. Our objective is to give you an opportunity to hear from experts and get a clear view of the work we have done to support commercial readiness and why we believe the Belite team is well-positioned to execute successfully. Also with us today, you'll hear from Dr. Michel Michaelides, who will provide an overview of tinlarebant and the unmet medical need in Stargardt disease. Dr. Paul Bernstein, who will discuss the current treatment landscape and the opportunity to define the standard of care. From the Belite team, Dr. Hendrik Scholl will provide an overview of the global Stargardt opportunity, and Kelly Kilpatrick will discuss our U.S. commercial launch strategy. We'll also have time at the end for Q&A.
First, we are honored to welcome Tracy and Hava, who are both living with Stargardt disease type 1, to share their personal journey. Hearing their story reminds us why this work matters and reinforces our commitment to bringing meaningful innovation to patients. Thank you again for joining us, and I will now turn it over to Tracy and Hava.
I began to not be able to have enough light in an already lit room. I was beginning to make a lot of typographical errors at my workplace, and my assignments took a lot longer. But for me, the most impacting realization was when I began to get into car accidents. It did not dawn on me that it was my vision. I always assumed it to be the other driver. But my last car accident really woke me up, and that's when I decided to go get my eyes checked.
When I was reading the chart, all I could see was the letter E, the biggest letter on the chart. The doctor was saying how I only was doing that to get a pair of glasses since my little brother got a pair. I was 8 years old. I didn't understand what full vision meant and being able to see that meant. So he cut my prescription in half. From there, I wore the glasses, and one of my teachers went up to my mom and was concerned that I had a learning disability because I was falling behind in reading, and that I was still looking very close to my computer. So that is what really made my mom was like, "Okay, something's wrong here. She's not- She's not reading well, she's not playing basketball well. They think she has a learning disability.
Just all these little things started to add up, even though I had a pair of glasses. That really was a huge point where I was diagnosed.
To be honest, when I was explained what Stargardt disease was and what to expect, honestly, I wasn't listening. I still had vision. I couldn't believe that this was happening, and I went on with my day-to-day. But I had to learn from myself and my own experiences as to what was happening with my eyes, and that brought up so many unwanted feelings for me. I did not want to believe what had been shared with me. I still had vision enough to still drive. I could still use my phone without a problem. But within a year's time, or even longer than that, 2 years, I'll even say, I began to notice that the vision was getting worse, because I couldn't see faces clear anymore, and reading my phone was more challenging.
That's pretty much, I think, the time span that it took for me to accept what has happened to me.
I was sitting there, 9 years old, and I remember this so clearly. I was dancing in the doctor's office, singing a random song, and the doctor came in, and they looked at us, and they were like, "You're going to have to pull Hava out of private school, and she will never be able to drive a car." And that is the only memory I have from being diagnosed at 9 years old with Stargardt disease, is being told some of the worst news of my life. I went to school with my two cousins, and just not being able to drive, knowing when I turned 16, I wouldn't be behind a car. And that's all I thought about with my eye disease. I didn't understand what it was. No one explained to me what Stargardt was, just the things that I couldn't do. I love reading. I can't read a paperback book, and that's really hit me hard, I think, this past year.
I've always been a huge reader. I have a Kindle, I listen to audiobooks, but there's nothing like turning a page of a book. Driving is a huge one, and it probably will always be. I don't know what my future is going to look like, especially with wanting to be a mother, with taking my kids to school or taking my kids to practice. Just having those little things I know I won't be able to do with my kiddos. I would definitely say a huge one is traveling. I love traveling, but I can't travel by myself yet. Airports scare me, and they are very visually overstimulating, and I have a hard time navigating them.
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