Belite Bio, Inc

Ladies and gentlemen, thank you for joining us and welcome to the Be Light 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 into today's call, please press star nine to raise your hand and star six 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 Be Light Bio, 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'll 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 Biola Bio. as we rapidly approach a potential regulatory approval of Tendaraband for Stargardt's disease in the U.S. We are very pleased to announce that the FDA has accepted our new drug application for Tendaraband with priority review and establishing 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 pre-commercial 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's disease. This quarter, we presented our Phase III Dragon Study results at four medical conferences across four countries, including the recent American Society of Retinal Specialists, ASRS, annual meeting. At ASIS, we presented new secondary endpoint data demonstrating subjects treated with ternaraban showed a halt to 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 bus retinoid accumulation, a key driver of retinal degeneration in stardust disease. The prevention or reduction of QAF strongly aligns with TeneriBand'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 terapin for patients living with Stargardt's disease. We look forward to providing further updates as they become available. I'll now turn the presentation over to Hao-Yuan to discuss the financials. Hao?

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 additional milestones achieved under the license agreement. On a non-GAAP basis, excluding share-based compensation expenses, R&D expenses for the second quarter were $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 increasing 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 2025 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 remains very strong, and we are extremely well-funded into the future with a cash runway to commercialize Sennariband following a potential regulatory approval and to continue to advance our pipelines. With that, I'll 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 into today's call, again, please press star 9 to raise your hand, star 6 to unmute. Please stand by as we compile the Q&A roster. 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 U.S. filing and or regulatory process, any incremental interaction with FDA that would shed light on what that trial could be potentially utilized for in the U.S.? And then Latest thinking on going lower in age, going into peds for Tinlaraban. Do you have trial plans to move the label below 12 years old in the near term? Thank you.

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

Yeah, happy to. Thank you, Tom. So today we are initiating a PIP study, a pediatric study in London, where we will investigate chinlariband 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 Mark Goodman with Lyrinc. Your line is open. Please go ahead.

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

Hao, you want to take this given that it's the royalty payments?

Yep. Well, the first one is related to the completion of the phase three study. And I think I can also take the third question. We will, as we said on the press release, we do plan to host a commercial day event. It's going to be virtual in September. And we'll disclose about the numbers that we have surveyed about the question you just asked.

How much was the royalty payment?

No, we cannot disclose that. Columbia asked us to keep that as a confidential. But yeah, but it's related to the phase three 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 12th. So that's our top priority. We'll be highly focused in the next six months on getting the drug approved. So the European filing will probably be sometime... After the FDA approval, we want to 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 approval. And then there will be our strategy for ongoing regulatory filings. Thanks.

And your next question comes from Tazin 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. 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 one? Thanks.

There's a few questions there. So I'll answer the first one. And then I probably have to get you to repeat the last two, three questions. So the first one, we do have a CDMO in the US. These are all the... We're not at the... I'm privileged 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's 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 don't believe there is an air comm being planned, but that doesn't mean that further down the line, the FDA would want to use an air comm. So nothing on that right now. So I would say that once we have more updates further down the line, then we'll probably update that at a more appropriate time. But at this stage, we just received the acceptance, so we don't have any further details on that.

Okay, thanks.

And your next question comes from the line of Steve 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 so, if you'd look to auction that just for the purposes of us modeling cash runway. How?

You want to have cash runway? So you want to answer this?

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 whether we're going to sell it or we're going to use it. So we will confirm that later while we continue to monitor the market and our own pipeline, etc.,

Okay, thanks for that. And then I also was hoping you could just provide an update on the geographic atrophy trial, whether you're 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 isn't that a question regarding the cash runway? I was just interested in the pediatric voucher for our own modeling purposes, but Hao-Yuan answered. Thank you.

All right, thanks. So the GA interim analysis falls during the busiest time with interacting with the FDA. So 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 with the interim analysis for the GA will probably be sometime first quarter next year, probably after February.

Great, thank you for clarifying. And your next question comes from the line of Greg Savinovich with Mizuho. Your line is open, please go ahead. A reminder that you may need to unmute locally. And we'll move on to the next question for now. Your next question comes from Yi Chen with HC Wainwright. Your line is open, please go ahead.

Thank you for taking my questions. Just to clarify, has the FDA clearly indicated that the label will include patients over the age of 20 years old? Is that correct?

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

Yeah, I'm happy too. And I think it's important to understand that lesion growth is not dramatically different across different age groups. That was shown in the Proxstar study. We have essentially the same progression rate of patients Any age underneath 18 and 18 to 50 and patients 50 plus showed a slightly larger but still similar progression rate when we look at DDAF progression. Given that the underlying cause of the disease, namely ABCO4 dysfunction, is exactly the same, I would see no reason why the label would not include patients older than 20. But I think it's important that we do not really want to comment on potential label while the NDA is under review.

Got it. Do you currently have data regarding how many, what percentage of patients are compliant with the dosing regimen after 24 months?

Nathan, do you want to answer this question?

I'm sorry, could you repeat the question? Four percent of your patients have been compliant with the dosing regimen after 24 months. In the GA study? In excess of 90%. Okay, good. And my last question is, what's your estimate timeline for submission in Japan?

Japan concurrently is happening at the same time. So given the Sakigake destination, it will probably be around three months after FDA approval. They will want to approve the drug in Japan. So it's happening as we speak with the FDA submission and the PMD submission is in parallel. Thank you very much.

And just a reminder, if you would like to ask a question, you can use the raise hand function or press star nine if you've dialed in. And I see no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.