Belite Bio, Inc American Depositary Shares 2026 Q2 Earnings Call
Review the key takeaways and the transcript of this earnings call.
- Belite Bio Inc announced that the FDA has accepted their new drug application for their therapy for Stargardt's disease with priority review and set a decision date of February 12, 2027.
- In the second quarter of 2026, Belite Bio reported R&D expenses of $18.2 million, up from $11 million in Q2 2025, primarily due to a royalty payment related to milestone achievement.
- General and administrative expenses were $16.7 million in Q2 2026, compared to $6.5 million in Q2 2025, driven by increased professional service fees and team expansion.
- The net loss for Q2 2026 was $28.4 million, compared to $16.3 million in the same quarter of 2025.
- On a non-GAAP basis, excluding share-based compensation, R&D expenses were $17.2 million and G&A expenses were $10.9 million for Q2 2026.
- The company ended the quarter with $780 million in cash, cash equivalents, and US Treasury bills, providing a strong balance sheet and cash runway to commercialize their product and advance their pipeline.
- Belite Bio presented phase three Dragon study results at four medical conferences, showing secondary endpoint data where treated subjects had a 2% decrease in quantitative autofluorescence (qAF or SCF) at month 25, versus a 20% increase in placebo.
- SCF is a marker of toxic bisretinoid accumulation, a key driver of retinal degeneration in Stargardt's disease, supporting the drug's mechanism of action to halt or slow lesion growth.
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Transcript
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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 9 to raise your hand and star 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 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? 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.
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.
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 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.
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? 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.
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 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. 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.
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