Belite Bio Inc (FRA:D01)

Q2 2026 Belite Bio, Inc Earnings Call Transcript

Aug 13, 2026 / 08:30 PM GMT

Release Date Price: €143 (-7.74%)

Transcript

Key Points

Positve

Belite Bio Inc (BLTE) received FDA acceptance of its New Drug Application (NDA) for Tinlarabant with Priority Review, establishing a PDUFA date of February 12, 2027.
New secondary endpoint data from the Phase 3 DRAGON study presented at ASRS showed that Tinlarabant halted or slightly decreased QAF values (by ~2%) at month 25, compared to a ~20% increase in the placebo group.
The company is initiating a pediatric study (PIP) in London to investigate Tinlarabant in patients aged 3 to 11, potentially expanding the label to younger patients.
Belite Bio Inc (BLTE) ended the quarter with a strong cash position of $780 million, providing a runway to commercialize Tinlarabant and advance its pipeline.
The company expects to receive a Priority Review Voucher (PRV) upon approval due to its Rare Pediatric Disease designation, which could be monetized.
The company is progressing with a parallel regulatory submission in Japan, leveraging the Sakigake designation, with a potential approval timeline roughly three months after the FDA decision.

Negative

R&D expenses increased significantly to $18.2 million in Q2 2026, up from $11 million in Q2 2025, partly due to a confidential royalty payment for a Phase 3 milestone.
SG&A expenses more than doubled to $16.7 million in Q2 2026 from $6.5 million in the prior year, driven by team expansion and professional fees.
The company's GAAP net loss widened to $28.4 million in Q2 2026, compared to a $16.3 million loss in the same quarter of 2025.
The interim analysis for the Geographic Atrophy (GA) trial has been delayed to Q1 2027, likely after the FDA PDUFA date, due to the company's focus on the regulatory review process.
The company remains uncertain about the final FDA label, as discussions have not yet occurred, and it cannot confirm whether the label will include patients over 20 years old.
The company is unable to disclose the amount of the royalty payment, which may raise questions about transparency regarding its R&D cost structure.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

BLTE.OQ - Belite Bio, Inc
Q2 2026 Belite Bio, Inc Earnings Call
Aug 13, 2026 / 08:30PM GMT

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Presentation
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Unidentified_1 [1]
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Ladies and gentlemen, thank you for joining us and welcome to the BeLight 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.

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Unidentified_2 [2]
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Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of BeLight Bio.

Dr. Hendrik Scholl,

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