Belite Bio, Inc (BLTE) Q2 2026 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio second Quarter 26 Earnings Call. 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 in to today's call, please press 9 to raise your hand. And 6 to unmute. I will now hand the conference over to Julie Fallon. Please go ahead.

Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Belite Bio, Dr. Hendrik Scholl, Chief Medical Officer; Dr. Nathan L. 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. Additionally, today we will be discussing certain non GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the press release we issued today. And now I will turn the call over to Dr. Lin. Dr. Lin?

Thank you, Julie. Good afternoon, everyone. Thank you for joining our second quarter 26 financial results and corporate update call. The first half of this year has been both exciting and deeply productive for Belite Bio. As we rapidly approach a potential regulatory approval of tinlarebant for Stargardt disease in the US. We are very pleased to announce that the FDA has accepted our new drug application for tinlarebant with priority review. And establishing a PDUFA date of 02/12/2027. We believe this reflects the strength, consistency, and depth of clinical data generated across our development program. In parallel with our precommercial preparations, we remain highly engaged with the medical and patient communities. The enthusiasm we are seeing underscores the profound need for a new treatment paradigm in Stargardt disease. This quarter, we presented our Phase 3 Dragon study results at 4 medical conferences across 4 countries. Including the recent American Society of Retinal Specialists, ASRS, annual. At ASRS, we presented new secondary endpoint data demonstrating subjects treated with tinlarebant showed a halt to a slightly decreased QAF values, decreased by approximately 2%. At month 25 compared to baseline. In contrast, subjects in the placebo group exhibited an approximately 20% increase in QAF values over the same period. Quantitative autofluorescence or QAF is a marker of toxic bisretinoid accumulation. A key driver of retinal degeneration in Stargardt disease. The prevention or reduction of QAF strongly aligns with tinlarebant's mechanism of action. Reinforcing its potential to halt or slow lesion growth. Looking ahead, we remain confident in our data. Our science, the transformative potential of tinlarebant for patients living with Stargardt's disease. We look forward to providing further updates as they become available. I will now turn the presentation over to Hao-Yuan to discuss the financials. Hao-Yuan?

Thank you, Tom. We have had a strong first half of the year and continue to execute well against our plan. Let me recap our financial statements. For the second quarter of 26, our R and D expenses were $18.2 million compared to $11 million for the same period in 2025. The increase was primarily due to a royalty payment for additional milestone achieved under the license agreement. On a non GAAP basis, excluding share based compensation expenses, R and D expense for the second quarter were $17.2 million compared to $8.6 million in the second quarter 25. SG&A expenses in Q2 was $16.7 million compared to $6.5 million for the same period in 2025. The increase was primarily due to increase in professional service fee wages, and salary resulting from our team expansions. On a non GAAP basis, SG&A expenses for the second quarter were $10.9 million compared to $1.3 million in 25 second quarter. The GAAP net loss in the second quarter was $28.4 million compared to $16.3 million in the same quarter. In 2025. On a non GAAP basis, we report a net loss of $21.6 million for the second quarter compared to $8.7 million in 2025 same quarter. We ended the quarter with $780 million in cash, cash equivalents and U. S. Treasury bills. Overall, our balance sheet remained very strong. And we are extremely well funded into the future with a cash runway to commercialize tinlarebant following a potential regulatory approval and to continue to advance our pipelines. With that, I will now turn the call back to the operator for Q&A. Operator?

We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. If you have dialed in to today's call, again, please press 9 to raise your hand. 6 to unmute. First question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.

Yeah. Hi, guys. Congrats on the progress, and thanks for taking the questions. A couple from us. I guess with the NDA accepted now, what are your thoughts on the role that Dragon 2 can play for The US filing or and or regulatory process? Any incremental interaction with FDA that would shed light on what that trial could be potentially utilized for in The US? And then, latest thinking on going lower in age, going into peds, for tinlarebant? Do you have trial plans to move the label below 12 years old in the near term? Thank you.

Thanks. Good questions. As for the Dragon 2, I think at this stage, it is still pretty much, a Japan study for the PMDA. Right now, we do not think we do not believe that you know, the Dragon 2 will contribute to the NDA process. As for the pediatric study, we do have plans, and I will let Hendrik shed more light on the details of that study.

Yeah. Happy to. Thank you, Tom. So, True, we are initiating a PIP study, a pediatric study in London where we will investigate tinlarebant in patients of the age 3 to 11. And this will be the basis to inform regulatory processes for patients that are younger than 12 years old. Thanks.

And your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead.

Yeah. Hi. Could you tell us how much the royalty payment was, the 1-timer that is within R&D? Second question, just tell us what you are thinking with respect to European filing. And then third, have you done any claims database analysis to figure out, like, exactly the number of patients that are in The United States that have actually you know, under the claims database. Thanks.

Hao-Yuan, you want to take this given that it is zero royalty payments?

Yep. Well, the first 1 is related to the, completion of the Phase 3 study. And I think I can also take the third question. We will you know, as we noted on the press release, we do plan to host a commercial day event. it is going to be virtual. In September, and we would disclose about, the numbers that we have, you know, survey about the question you just asked.

How much was the royalty payment?

No. We cannot disclose that. Columbia has asked us to keep that as confidential. But, yeah, but it is related to the phase 3 completion. Okay.

And then just thoughts on European filing?

Okay. So I can take that. So right now, we are focused on, the FDA with the PDUFA date in February 12. So that is our top priority. We will probably we will be highly focused in the next 6 months. On getting the drug approved. So the European filing will probably be sometime after the FDA approval. We wanna align everything with the FDA, the approval and all that, and there will be the consistent, message and communications with the regulatory authorities outside of the US. Given what we discussed with the FDA and the approval. And then there will be our strategy for ongoing regulatory filings. Thanks.

And your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.

My questions. In terms of manufacturing, have you stated where your manufacturing site is and whether or not that facility has completed an FDA inspection. Recently, or is that going to be part of the requirement to get approval? And then secondly, just wanted to get your latest thoughts on the possibility of an AdCom, you know, just given the consolidated time that the FDA would have to review. When do you think is the latest realistically that you would be told if the agency decided to hold 1? Thanks.

There are a few questions there. So I will answer the first 1, and then I and I will have to get you to repeat the last 2 or 3 questions. So for the first 1, we do have a, CDMO, in the US. These are all the we are not at liberty to reveal right now the names of the CDMOs, but these are all big names in the field, in the industry. So we have an ex-US and then a US-based CDMO for that. So I hope that answers your question. what is the second and third question?

It was more about the FDA. And given the consolidated timeline for review, what is your thought about having an AdCom? Has the agency talked about that? And realistically, when is the latest they could tell you if they were going to give you an AdCom?

So right now, we do not believe there is a AdCom being planned, but that does not mean that, you know, further down the line, the FDA would want to use an AdCom. So nothing on that right now. So I would say that once we have more updates further down the line, then we will probably reveal that and update that at a more appropriate time. But at this stage, we just received the acceptance, so we do not have any further details on that. Okay. Thanks.

And your next question comes from the line of Steven Seedhouse with Cantor. Your line is open. Please go ahead.

Great. Thanks so much. Congrats on the NDA filing acceptance in the U.S. I was hoping you could just confirm or clarify that you expect a priority review voucher if you receive approval and if you if so, if you would look to auction that just for the purposes of us modeling cash runway.

Hao-Yuan, you want to re cash runway? So Yep. You want to answer this?

Yep. Well, yeah, we do expect that if we receive approval, we should get the priority review voucher just because we do have, the rare pediatric disease designation. We have not decided, you know, whether we are going to sell it or we are going to use it. So we will, you know, confirm that later. But we continue to monitor the market and, you know, our own pipeline, etcetera.

Okay. Thanks for that. And then I also was hoping you could just provide an update on the geographic atrophy trial, whether you are still planning an interim readout later this year and what the precise timing of an update from that interim analysis might be. Thank you.

Sure. I can answer this question. But is not that a question regarding the cash runway? No. So I think He was just interested in the PRV. Oh, okay. voucher for our own modeling purposes. But Hao-Yuan, you want to answer it. Thank you. Alright. Thanks.

So the GA interim analysis falls during the busiest time with interacting with the FDA. With the PDUFA date, in mid February, I would expect the busiest time to be in December and January 2027. So with that, timeline, our top priority is with the FDA approval. So I suspect that, you know, with the interim analysis for the GA will probably be sometime in Q1 next year. Probably after February. Great. Thank you for clarifying.

And your next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open. Please go ahead. A reminder that you may need to unmute locally. And we will move on to the next question for now. The next question comes from Yi Chen with H. C. Wainwright. Your line is open. Please go ahead.

Thank you for taking my questions. Just to clarify, has the FDA stated clearly that the label will include patients over the age of 12 years old. Is that correct?

So right now, there have not been any discussion on the label yet. I believe they will come sometime later in the process, in the review process. But at this stage, given the data and all that, we believe that we would be able to get the full label or the more broader label. I will ask Hendrik to give more expert advice on this. Hendrik?

I am happy to. And I think it is important to understand that lesion growth is not dramatically different across different age groups. That was shown in the under 18 and 18 to 50 and patients 50 showed a slightly larger but still a similar progression rate when we look at DDAF progression. Given that the underlying cause of the disease namely ABCA4 dysfunction, is exactly the same, I would see no reason why the label would not include patients older than 20. But I think it is it is important that we do not really wanna comment on potential label while the NDA is under review. Got it.

Do you currently have data regarding how many or percentage of patients are compliant with the dosing regimen? After 24 months.

Sure. Nathan, you want to answer this question?

I am sorry. Could you repeat the question? Sorry. I think my audio cut out.

What percentage of patients have been compliant with the dosing regimen? After 24 months. In the GA study? Well, the In your Stargardt study. that is right. Study. Yeah.

In excess of 90%. Okay. Got it.

And my last question is, what is your estimated timeline for submission in Japan?

Japan will be concurrently happening at the same time. Mhmm. So given the Sakigake Designation, it will probably be around 3 months after FDA approval. They want to approve the drug in Japan. So it is happening as we speak. With the FDA submission and the 9 if you dialed in. And 6 to unmute.

And I see no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.