Prepared remarks
Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio Second Quarter 2026 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 2026 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 U.S. We are very pleased to announce that the FDA has accepted our New Drug Application for tinlarebant with priority review and established a PDUFA date of February 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 four medical conferences across four countries, including the recent American Society of Retinal Specialists (ASRS) annual meeting. At ASRS, we presented new secondary endpoint data demonstrating that subjects treated with tinlarebant showed a halt to a slight decrease in 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, and the transformative potential of tinlarebant for patients living with Stargardt 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 2026, our R&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 an additional milestone achieved under the license agreement. On a non-GAAP basis, excluding share-based compensation expenses, R&D expense for the second quarter was $17.2 million compared to $8.6 million in the second quarter of 2025. SG&A expenses in Q2 were $16.7 million compared to $6.5 million for the same period in 2025. The increase was primarily due to increases in professional service fees, wages, and salaries resulting from our team expansion. On a non-GAAP basis, SG&A expenses for the second quarter were $10.9 million compared to $1.3 million in the second quarter of 2025. 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 reported a net loss of $21.6 million for the second quarter compared to $8.7 million in the same quarter of 2025. We ended the quarter with $780 million in cash, cash equivalents, and U.S. Treasury bills. Overall, our balance sheet remains 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 pipeline. With that, I will now turn the call back to the operator for Q&A. Operator?
Questions and answers
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 and 6 to unmute. First question comes from the line of Judah Frommer with Morgan Stanley. Your line is open. Please go ahead.
Hi, guys. Congrats on the progress, and thanks for taking the questions. A couple from us. With the NDA accepted now, what are your thoughts on the role that Dragon 2 can play for the U.S. filing and/or regulatory process? Any incremental interaction with FDA that would shed light on what that trial could potentially be utilized for in the U.S.? And then, latest thinking on going lower in age, moving into pediatrics 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 Dragon 2, at this stage it is still primarily a Japan study for the PMDA. Right now, we do not believe that Dragon 2 will contribute to the NDA process in the U.S. As for the pediatric study, we do have plans, and I will let Hendrik shed more light on the details of that study.
Happy to. Thank you, Tom. We are initiating a pediatric investigation plan (PIP) study in London where we will investigate tinlarebant in patients aged 3 to 11. This will be the basis to inform regulatory processes for patients that are younger than 12 years old.
And your next question comes from the line of Marc Goodman with Leerink. Your line is open. Please go ahead.
Hi. Could you tell us how much the royalty payment was, the one-timer that is within R&D? Second question, tell us what you are thinking with respect to European filing. And then third, have you done any claims database analysis to figure out the number of patients in the United States under claims databases?
Hao-Yuan, would you like to take this, given that it is a one-time royalty payment?
Yes. The first one is related to the completion of the Phase 3 study. I can also address the third question. As we noted in the press release, we do plan to host a commercial day event; it will be virtual in September, and we would disclose the numbers and the survey data that speak to your question then.
How much was the royalty payment?
We cannot disclose that. Our partner has asked us to keep that confidential, but it is related to the Phase 3 completion.
And then just thoughts on European filing?
I can take that. Right now, we are focused on the FDA with the PDUFA date of February 12. That is our top priority. We will be highly focused in the next six months on getting the drug approved. The European filing will likely occur sometime after FDA approval. We want to align our strategy with the FDA approval, and there will be consistent messaging and communications with regulatory authorities outside the U.S. based on our discussions with the FDA and the outcome of the approval process. We will share our strategy for ongoing regulatory filings in due course.
And your next question comes from Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.
My questions are: in terms of manufacturing, have you stated where your manufacturing site is and whether that facility has completed an FDA inspection recently, or will that be part of the requirement to get approval? And secondly, what are your latest thoughts on the possibility of an advisory committee given the consolidated review timeline? When do you think is the latest realistically that you would be told if the agency decided to hold one?
There are a few questions there. I will answer the first one and then ask you to repeat the last two or three questions. For the first one, we do have a CDMO in the U.S. and another ex-U.S. CDMO. We are not at liberty to reveal the names right now, but these are well-established companies in the industry. I hope that answers your manufacturing question. Could you repeat the second and third questions?
It was more about the FDA and, given the consolidated timeline for review, what are your thoughts about having an advisory committee? Has the agency talked about that, and realistically, when is the latest they could tell you if they were going to hold one?
Right now, we do not believe an advisory committee is being planned, but that does not mean that later the FDA might request one. We have no indication of an advisory committee at this stage. Once we have more updates later in the review process, we will disclose them at an appropriate time. At this stage we have only received acceptance of the NDA, so we do not have further details about advisory committee planning.
And your next question comes from the line of Steven Seedhouse with Cantor. Your line is open. Please go ahead.
Thanks so much. Congrats on the NDA filing acceptance in the U.S. I was hoping you could confirm or clarify that you expect a Priority Review Voucher if you receive approval, and if so, would you consider auctioning it for modeling cash runway? And I was also hoping for an update on the geographic atrophy trial: whether you are still planning an interim readout later this year and the precise timing of an update from that interim analysis.
Hao-Yuan, do you want to address the voucher and cash runway question?
Yes. We do expect that if we receive approval, we should receive a Priority Review Voucher because we have a rare pediatric disease designation. We have not yet decided whether we would sell it or use it; we will confirm our approach later as we monitor the market and our pipeline. Regarding the geographic atrophy interim analysis, that analysis falls during our busiest time interacting with the FDA around the PDUFA date in mid-February. I would expect the busiest interaction period to be in December and January 2027. Given that timeline and our priority on FDA approval, I suspect the interim analysis for the GA trial will probably be sometime in Q1 next year, likely after February.
And your next question comes from the line of Graig Suvannavejh with Mizuho. Your line is open. A reminder that you may need to unmute locally. 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?
At this stage there have not been any discussions on the label yet. Label discussions typically occur later in the review process. Given the data we have, we believe it is possible to obtain a broader label, but I will ask Hendrik to provide more expert input on this.
I am happy to comment. It is important to understand that lesion growth is not dramatically different across different age groups; that was shown in the under-18, 18-to-50, and over-50 analyses. Patients over 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 the same across ages, I see no reason why the label would not include patients older than 12. However, we do not want to comment on potential label details while the NDA is under review.
Do you currently have data regarding what percentage of patients are compliant with the dosing regimen after 24 months in the Stargardt study?
Nathan, would you like to answer that question?
Sorry, could you repeat the question? I think my audio cut out.
What percentage of patients have been compliant with the dosing regimen after 24 months in your Stargardt study?
In excess of 90%.
My last question is: what is your estimated timeline for submission in Japan?
Japan will be handled concurrently. Given our Sakigake designation, it will probably be around three months after FDA approval. The Japan submission strategy is progressing alongside the FDA submission.
I see no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.