Belite Bio reports Q2 loss, FDA accepts tinlarebant NDA

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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For comprehensive financial data and transcripts, visit The full earnings call is available at 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.