The earnings call highlights significant regulatory and clinical progress for Tinlarebant, indicating a strong position in advancing treatments for Stargardt disease and geographic atrophy. However, financial losses and the potential for extended regulatory timelines pose challenges.

Company Guidance

In the Belite Bio Second Quarter 2025 Earnings Call, the company provided detailed guidance on its progress and financial standings. The focus was on the advancement of Tinlarebant, a potential first oral treatment for Stargardt disease and geographic atrophy, both of which are currently without approved therapies. Tinlarebant has received multiple designations, including Breakthrough Therapy and Fast Track in the U.S., and orphan drug status in the U.S., Europe, and Japan. The company is conducting two studies on Stargardt disease, the Phase III DRAGON trial and the Phase II/III DRAGON II trial. The DRAGON trial has progressed well, with the FDA recommending further regulatory review after an interim analysis. Additionally, the global Phase III study for geographic atrophy completed enrollment with 529 subjects. Financially, Belite reported R&D expenses of $11 million and G&A expenses of $6.5 million, resulting in a net loss of $16.3 million for Q2 2025. The company has $149.2 million in cash and expects a four-year cash runway, excluding commercialization costs, supported by a recent $15 million capital raise.

Tinlarebant's Regulatory Advancements

Tinlarebant has been granted breakthrough therapy, rare pediatric disease, and Fast Track designations in the U.S., as well as Pioneer designation in Japan. It has also received orphan drug designation in the U.S., Europe, and Japan.

Progress in Clinical Trials

The Phase III DRAGON trial for Stargardt disease has proceeded without modifications, and Tinlarebant remains on track to complete the study in Q4 2025. The geographic atrophy study has completed enrollment with 529 subjects.

Strong Financial Position

The company raised $15 million in a registered direct offering, maintaining a cash runway of 4 years, which supports the completion of all three Phase III trials.

Belite Bio, Inc. ADR (BLTE) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

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BLTE Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 18, 2025	2025 (Q3)	-0.50 / -	-0.28	―	―	―
Aug 11, 2025	2025 (Q2)	-0.41 / -0.50	-0.31	-61.29% (-0.19)
May 14, 2025	2025 (Q1)	-0.35 / -0.45	-0.27	-66.67% (-0.18)	―
Mar 17, 2025	2024 (Q4)	-0.31 / -0.32	-0.25	-28.00% (-0.07)
Nov 12, 2024	2024 (Q3)	-0.29 / -0.28	-0.4	30.00% (+0.12)
Aug 09, 2024	2024 (Q2)	-0.26 / -0.31	-0.26	-19.23% (-0.05)
May 14, 2024	2024 (Q1)	-0.28 / -0.27	-0.33	18.18% (+0.06)
Mar 12, 2024	2023 (Q4)	-0.30 / -0.25	-0.37	32.43% (+0.12)
Nov 14, 2023	2023 (Q3)	-0.32 / -0.40	-0.11	-263.64% (-0.29)
Aug 09, 2023	2023 (Q2)	-0.30 / -0.26	-0.08	-225.00% (-0.18)

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat

Missed

BLTE Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Aug 11, 2025	$69.88	$69.50	-0.54%
May 14, 2025	$60.89	$61.60	+1.17%
Mar 17, 2025	$67.44	$67.81	+0.55%
Nov 12, 2024	$78.64	$81.15	+3.19%

Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.

FAQ

When does Belite Bio, Inc. ADR (BLTE) report earnings?

Belite Bio, Inc. ADR (BLTE) is schdueled to report earning on Nov 18, 2025, Before Open (Confirmed).

What is Belite Bio, Inc. ADR (BLTE) earnings time?

Belite Bio, Inc. ADR (BLTE) earnings time is at Nov 18, 2025, Before Open (Confirmed).

Where can I see when companies are reporting earnings?

You can see which companies are reporting today on our designated earnings calendar.

What companies are reporting earnings today?

You can see a list of the companies which are reporting today on TipRanks earnings calendar.

What is BLTE EPS forecast?

BLTE EPS forecast for the fiscal quarter 2025 (Q3) is -0.5.

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