Belite Bio Q2 2026 Earnings Report

Belite Bio EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.73
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Belite Bio Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Belite Bio Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: After Market Closes
• Conference Call Date: Thursday, August 13, 2026
• Conference Call Time: 4:30PM ET

Belite Bio (NASDAQ:BLTE), Inc. (NASDAQ: BLTE) is a clinical-stage biotechnology company focused on discovering and developing small molecule therapeutics for metabolic and inflammatory diseases. Leveraging a proprietary drug-discovery platform, the company aims to address conditions such as nonalcoholic steatohepatitis (NASH) and obesity by targeting pathways involved in fibrosis, inflammation and metabolic regulation.

Belite Bio’s pipeline includes multiple candidates in preclinical and early clinical development stages. The company has established research collaborations with academic institutions and contract research organizations to advance its lead programs through regulatory milestones, emphasizing optimization of safety, efficacy and pharmacokinetic profiles to support future clinical trials.

Based in the United States, Belite Bio is led by a management team with extensive experience in biotechnology, drug development and regulatory affairs. The company’s strategic vision is to deliver innovative therapies for metabolic disorders with significant unmet medical needs and to pursue global clinical development to reach diverse patient populations.

Belite Bio Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: The FDA accepted tinlarebant’s NDA for Stargardt disease with priority review and set a PDUFA decision date of February 12, 2027, bringing the company closer to a potential U.S. approval.
• Positive Sentiment: Belite highlighted Phase III DRAGON data showing QAF values decreased approximately 2% from baseline after 25 months with tinlarebant, compared with an approximately 20% increase for placebo.
• Neutral Sentiment: The company is initiating a pediatric study in London for patients aged 3 to 11, while its DRAGON II study is currently expected to support Japan’s PMDA process rather than the U.S. NDA.
• Positive Sentiment: Belite ended the quarter with $780 million in cash, cash equivalents, and U.S. Treasury bills, which management said provides sufficient funding to commercialize tinlarebant after approval and advance its pipeline.
• Negative Sentiment: The geographic atrophy trial’s interim analysis is now expected in the first quarter of 2027, likely after the February FDA decision, while second-quarter R&D and SG&A expenses rose substantially year over year.

Presentation

[Operator]

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 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 at Belite Bio]

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 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. Now I'll turn the call over to Dr. Lin. Dr. Lin?

[Tom Lin, Chairman and CEO at Belite Bio]

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 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 disease.

[Tom Lin, Chairman and CEO at Belite Bio]

This quarter, we presented our phase III 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, 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 lipofuscin retinal 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.

[Tom Lin, Chairman and CEO at Belite Bio]

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?

[Hao-Yuan Chuang, CFO at Belite Bio]

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 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 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 2025 second quarter.

[Hao-Yuan Chuang, CFO at Belite Bio]

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 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'll now turn the call back to the operator for Q&A. Operator?

[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 star nine to raise your hand, 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]

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 II 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? Thank you.

[Tom Lin, Chairman and CEO at Belite Bio]

Thanks. Good questions. For the DRAGON II, I think at this stage it's still pretty much a Japan study for the PMDA. Right now, we don't believe that the DRAGON II 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 at Belite Bio]

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

[Judah Frommer, Analyst at Morgan Stanley]

Thanks.

[Operator]

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

[Marc Goodman, Analyst at Leerink]

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. Then third, have you done any claims database analysis to figure out exactly the number of patients that are in the U.S. that have actually under the claims database? Thanks.

[Tom Lin, Chairman and CEO at Belite Bio]

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

[Hao-Yuan Chuang, CFO at Belite Bio]

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

[Marc Goodman, Analyst at Leerink]

How much was the royalty payment?

[Hao-Yuan Chuang, CFO at Belite Bio]

No, we cannot disclose that. Columbia asked us to keep that as confidential. But it is related to the phase III completion.

[Marc Goodman, Analyst at Leerink]

Oh, okay. Just thoughts on European filing.

[Tom Lin, Chairman and CEO at Belite Bio]

Okay. I can take that. Right now we are focused on the FDA with the PDUFA date in February 12th. That is our top priority. We will be highly focused in the next six months on getting the drug approved. 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 a consistent message and communications with the regulatory authorities outside of the U.S. given what we discuss with the FDA and the approval, and then there will be our strategy for ongoing regulatory filings.

[Marc Goodman, Analyst at Leerink]

Thanks.

[Operator]

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]

Thanks for taking 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? 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.

[Tom Lin, Chairman and CEO at Belite Bio]

There is a few questions there. I will answer the first one, and then I probably have to get you to repeat the last two, three of your questions. The first one, we do have a CDMO in the U.S. We are not 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-U.S. and then a U.S.-based CDMO for that. I hope that answers your question. What is the second and third question?

[Tazeen Ahmad, Analyst at Bank of America]

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

[Tom Lin, Chairman and CEO at Belite Bio]

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. 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 update that at a more appropriate time. 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]

Thanks.

[Operator]

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

[Steven 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 us modeling cash runway.

[Tom Lin, Chairman and CEO at Belite Bio]

Hao, you want to cash runway, you want to answer this?

[Hao-Yuan Chuang, CFO at Belite Bio]

Yep. 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 are going to sell it or we are going to use it. We will confirm that later, while we continue to monitor the market and our own pipeline, et cetera.

[Steven Seedhouse, Analyst at Cantor]

Okay. Thanks for that. 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.

[Tom Lin, Chairman and CEO at Belite Bio]

Sure. I can answer this question. Isn't that question regarding the cash runway?

[Steven Seedhouse, Analyst at Cantor]

I was just interested in the pediatric voucher for our own modeling purposes. Hao, you want to answer it. Thank you.

[Tom Lin, Chairman and CEO at Belite Bio]

All right, thanks. 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. With that timeline, our top priority is with the FDA approval. I suspect that with the interim analysis for the GA will probably be sometime first quarter next year, probably after February.

[Steven Seedhouse, Analyst at Cantor]

Great. Thank you for clarifying.

[Operator]

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. We'll move on to the next question for now. Your next question comes from Yi Chen with H.C. Wainwright. Your line is open. Please go ahead.

[Yi Chen, Analyst at H.C. 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 at Belite Bio]

Right now, there haven'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?

[Hendrik Scholl, Chief Medical Officer at Belite Bio]

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 PHOENIX study. We have essentially the same progression rate of patients any age underneath 18 and 18 to 50, and patients 50+ 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 is important that we do not really want to comment on potential label while the NDA is under review.

[Yi Chen, Analyst at H.C. Wainwright]

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

[Tom Lin, Chairman and CEO at Belite Bio]

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

[Nathan Mata, Chief Scientific Officer at Belite Bio]

I am sorry, could you repeat the question? Sorry, I think my audio.

[Yi Chen, Analyst at H.C. Wainwright]

What percent or percentage of patients have been compliant with the dosing regimen after 24 months?

[Nathan Mata, Chief Scientific Officer at Belite Bio]

In the GA study or the DRAGON II study?

[Tom Lin, Chairman and CEO at Belite Bio]

No, in the DRAGON II study.

[Nathan Mata, Chief Scientific Officer at Belite Bio]

In excess of 90%.

[Yi Chen, Analyst at H.C. Wainwright]

Okay, got it. My last question is, what's your estimate timeline for submission in Japan?

[Tom Lin, Chairman and CEO at Belite Bio]

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

[Yi Chen, Analyst at H.C. 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 nine if you have dialed in. I see no further questions at this time. This concludes today's call. Thank you for attending. You may now disconnect.

Participants

Executives

• Julie Fallon, Investor Relations
• Tom Lin, Chairman and CEO
• Hao-Yuan Chuang, CFO
• Hendrik Scholl, Chief Medical Officer
• Nathan Mata, Chief Scientific Officer

Analysts

• Judah Frommer, Analyst at Morgan Stanley
• Marc Goodman, Analyst at Leerink
• Tazeen Ahmad, Analyst at Bank of America
• Steven Seedhouse, Analyst at Cantor
• Yi Chen, Analyst at H.C. Wainwright