Belite Bio (NASDAQ:BLTE) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below.

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The full earnings call is available at https://events.q4inc.com/attendee/449343673

Summary

Belite Bio announced the FDA's acceptance of their new drug application for tinlarebant with a priority review, with a PDUFA date set for February 12, 2027.

The company's R&D expenses increased to $18.2 million in Q2 2026, up from $11 million in Q2 2025, due to royalty payments for milestone achievements.

Belite Bio reported a GAAP net loss of $28.4 million in Q2 2026, compared to a $16.3 million loss in Q2 2025, primarily due to increased R&D and SG&A expenses.

The company has a strong cash position with $780 million in cash, cash equivalents, and U.S. Treasury bills, providing a solid runway for commercialization and pipeline advancement.

Strategically, Belite Bio is focused on regulatory approval in the U.S. first, with European filings expected post-FDA approval, and has plans for pediatric studies in London.

The company expects to receive a priority review voucher if tinlarebant is approved, due to its rare pediatric disease designation.

CEO Dr. Lin highlighted the significance of their Phase 3 DRAGON study results and the potential impact of tinlarebant on Stargardt disease treatment.

Full Transcript

OPERATOR

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 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.

Julie Fallon, Investor Relations

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 Mata, Chief Scientific Officer, and Haoyuan Zhong, 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 details. 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.

Tom Lin, Chairman and CEO

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 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 disease. This quarter we presented our Phase 3 DRAGON study results at four medical conferences across four countries, including the recent American Society of Retina Specialists (ASRS) annual meeting.

At ASRS we presented new secondary endpoint data demonstrating subjects treated with tinlarebant showed a halt to slightly decreased QAF values; 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'll now turn the presentation over to Haoyuan to discuss the financials.

Haoyuan Zhong, Chief Financial Officer

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 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 increases in professional service fees, 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's 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 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'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. If you have dialed into today's call, again, please press star nine to raise your hand and star six 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.

Judah Frommer, Analyst at Morgan Stanley

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 tinlarebant. Do you have trial plans to move the label below 12 years old in the near term?

Tom Lin, Chairman and CEO

Thank you. Thanks. Good questions. For DRAGON-2, I think at this stage it's still pretty much a Japan study for the PMDA. Right now, we don't believe that 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.

Hendrik Scholl, Chief Medical Officer

Yeah, happy to. Thank you, Tom. So today 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.

OPERATOR

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

Mark Goodman, Analyst

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, you know, under the claims database? Thanks.

Tom Lin, Chairman and CEO

Haoyuan, do you want to take this, given that it's the royalty payment?

Haoyuan Zhong, Chief Financial Officer

Yes. Well, the first one 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 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, you know, surveyed about. About the question you just asked, how—

Mark Goodman, Analyst

How much was the royalty payment?

Haoyuan Zhong, Chief Financial Officer

No, we cannot disclose that. Columbia asked us to keep that as confidential. But, yeah, it's related to the Phase 3 completion.

Mark Goodman, Analyst

Okay. And then just thoughts on European filing.

Tom Lin, Chairman and CEO

Okay, so I can take that. So right now we are focused on the FDA with the PDUFA date on 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 consistent messaging and communications with the regulatory authorities outside of the U.S., given what we discuss with the FDA and approval.

And then that will be our strategy for ongoing regulatory filings.

OPERATOR

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

Tazeen Ahmad, Analyst at Bank of America

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 one?

Tom Lin, Chairman and CEO

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 U.S., but we're not at the privilege to reveal right now the names of the CDMOs. But these are all big names in the field, in the industry. So we have ex-U.S. and then a U.S.-based CDMO for that. So I hope that answers your question. What's the second and third question?

Tazeen Ahmad, Analyst at Bank of America

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?

Tom Lin, Chairman and CEO

So right now we don't believe there is an adcom being planned. But that doesn't mean that further down the line the FDA would want to use an adcom. So nothing on that right now. I would say that once we have more updates further down the line, then we'll probably reveal 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.

Tazeen Ahmad, Analyst at Bank of America

Okay, thanks.

OPERATOR

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

Steve Seedhouse, Analyst at Cantor

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 U.S. modeling cash runway.

Tom Lin, Chairman and CEO

Yep. You want to answer this?

Haoyuan Zhong, Chief Financial Officer

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.

Steve Seedhouse, Analyst at Cantor

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.

Tom Lin, Chairman and CEO

Sure. I can answer this question, but isn't that a question regarding the cash runway?

Steve Seedhouse, Analyst at Cantor

So I think I was just interested in the pediatric voucher for our own modeling purposes. But Haoyuan answered. Thank you.

Tom Lin, Chairman and CEO

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 the interim analysis for GA will probably be sometime first quarter next year, probably after February.

Steve Seedhouse, Analyst at Cantor

Great. Thank you for clarifying.

OPERATOR

And your next question comes from the line of Greg Sabenovich 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.

Yi Chen, Analyst at HC Wainwright

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?

Tom Lin, Chairman and CEO

So right now there haven't been any discussions 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 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.

Hendrik Scholl, Chief Medical Officer

Yeah, I'm happy to. And I think it's important to understand that lesion growth is not dramatically different across different age groups; that was shown in the ProgStar 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 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's important that we do not really want to comment on potential label while the NDA is under review.

Yi Chen, Analyst at HC Wainwright

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

Tom Lin, Chairman and CEO

Sure. Nathan, do you want to answer this question?

Nathan Mata, Chief Scientific Officer

I'm sorry, could you repeat the question?

Yi Chen, Analyst at HC Wainwright

Sorry. I think my audio—what percentage of patients have been compliant with the dosing regimen after 24 months in the GA study?

Nathan Mata, Chief Scientific Officer

In excess of 90%.

Yi Chen, Analyst at HC Wainwright

Okay, good. And my last question is, what's your estimated timeline for submission in Japan?

Tom Lin, Chairman and CEO

Japan will concurrently—it's happening at the same time. So given the Sakigake designation, it will probably be around three months after FDA approval they would want to approve the drug in Japan. So it's happening as we speak, with the FDA submission and the PMDA submission in parallel.

Yi Chen, Analyst at HC Wainwright

Got it. Thank you very much.

OPERATOR

And just a reminder, if you would like to ask a question, you can use the raise hand function or press star 9 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.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.