BELITE BIO (BLTE) Company Report

Belite Bio, Inc. announced the pricing of an underwritten public offering of 2,272,727 American Depositary Shares (ADSs) at $154.00 per ADS.
The offering is expected to generate approximately $350.0 million in gross proceeds for the company.
The underwriters have a 30-day option to purchase up to 340,909 additional ADSs.
Net proceeds will be used for commercialization preparation, pipeline development and expansion, and working capital and general corporate purposes.
The offering is anticipated to close on or about December 3, 2025.

5 days ago

6-K

BELITE BIO, INC Reports Q3 2025 Balance Sheet

BLTE

Cash and cash equivalents for BELITE BIO, INC significantly increased from $31,677 thousand as of December 31, 2024, to $157,034 thousand as of September 30, 2025.
Total current assets rose from $147,073 thousand at December 31, 2024, to $277,213 thousand at September 30, 2025.
The company's total shareholders' equity increased from $145,821 thousand as of December 31, 2024, to $274,082 thousand as of September 30, 2025.
The accumulated deficit grew from $(107,647) thousand at December 31, 2024, to $(159,934) thousand at September 30, 2025.

6 days ago

6-K

Belite Bio Announces Proposed Underwritten Public Offering of ADSs

BLTE

New Projects/Investments

Belite Bio, Inc. announced on December 1, 2025, that it has commenced an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing one of its ordinary shares.
All of the securities in the offering are to be sold by Belite Bio, and the company intends to grant the underwriters a 30-day option to purchase additional ADSs.
The net proceeds from the offering are intended to be used for commercialization preparation, development and expansion of pipelines, and working capital and other general corporate purposes.
The offering is subject to market conditions, and there is no assurance as to whether or when it may be completed, or its actual size or terms.

6 days ago

6-K

Belite Bio Announces Positive Phase Three DRAGON Study Results for Tinlarebant

BLTE

Product Launch

New Projects/Investments

Belite Bio reported positive top-line results from its two-year phase three DRAGON study of Tinlarebant for Stargardt disease.
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the annualized rate of DDAF lesion growth compared to placebo.
Tinlarebant, an orally administered small molecule, maintained an excellent safety and tolerability profile over the two-year treatment period.
This represents the first-ever oral therapy in a retinal degenerative disease to demonstrate a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
Belite Bio plans to file the full data package with regulatory agencies in the first half of next year, anticipating a clear path toward potential approval.

6 days ago

Transcript

Belite Bio Announces Positive Phase III DRAGON Study Results for Tinlarebant

BLTE

New Projects/Investments

Belite Bio reported positive top-line results from its two-year phase III DRAGON trial of Tinlarebant for Stargardt disease, demonstrating statistically significant and clinically meaningful outcomes.
The study's primary endpoint showed a 36% reduction in the annualized rate of DDAF lesion growth compared to placebo, with a p-value of 0.0033.
Tinlarebant, an orally administered small molecule, was safe and well tolerated over the two-year treatment period, with a zero rate of serious treatment emergent adverse events.
This marks the first-ever oral therapy in a retinal degenerative disease to demonstrate a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
Belite Bio has received "green lights" for submission from regulatory authorities including the MHRA, China NMPA, and Japan, with discussions ongoing with the FDA.

6 days ago

Transcript

Belite Bio Reports Positive Phase Three DRAGON Topline Results for Tinlarebant

BLTE

Belite Bio announced positive topline results from its two-year phase three DRAGON study for Tinlarebant, an oral therapy for Stargardt disease.
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 36% slowing in DDAF lesion growth in patients treated with Tinlarebant compared to placebo.
Tinlarebant maintained an excellent safety and tolerability profile over the two-year treatment period, with no serious treatment-related adverse events reported.
This represents the first-ever oral therapy in a retinal degenerative disease to achieve a clinically meaningful slowdown of neurodegeneration, addressing a significant unmet medical need.
Belite Bio anticipates a clear path toward regulatory approval, believing the robust findings from this single study may be sufficient for market authorization.

6 days ago

Transcript

Belite Bio Announces Positive Phase 3 DRAGON Trial Results for Tinlarebant

BLTE

New Projects/Investments

Belite Bio announced positive topline results from its pivotal global Phase 3 DRAGON trial of Tinlarebant for adolescents with Stargardt disease, marking the first successful pivotal trial for this condition.
Tinlarebant met its primary efficacy endpoint, demonstrating a statistically significant 36% reduction in the growth rate of retinal lesions compared to placebo (p-value = 0.0033).
The drug was well tolerated throughout the 24-month trial, with a favorable safety profile and only four treatment-related discontinuations.
Belite Bio intends to file a New Drug Application (NDA) with the US FDA in the first half of 2026.

6 days ago

6-K

Belite Bio Announces Positive Phase 3 DRAGON Trial Results for Tinlarebant in Stargardt Disease

BLTE

Belite Bio announced positive topline results on December 1, 2025, from the global Phase 3 DRAGON trial for Tinlarebant in adolescents with Stargardt disease type 1 (STGD1).
Tinlarebant met its primary efficacy endpoint, demonstrating a statistically significant 36% reduction in the growth rate of retinal lesions compared to placebo (p-value = 0.0033).
This marks the first successful pivotal trial for STGD1, a condition that currently has no approved treatment worldwide.
The company plans to file a New Drug Application (NDA) with the US FDA in 1H 2026.
Tinlarebant was well tolerated throughout the trial, with only four treatment-related discontinuations.

6 days ago

Press Release

Belite Bio Reports Q3 2025 Financial Results and Clinical Milestones

BLTE

Earnings

New Projects/Investments

Debt Issuance

Belite Bio reported a net loss of $21.7 million for Q3 2025, compared to $8.7 million for the same period last year, with $12.9 million of the expense increase attributed to non-cash share-based compensation.
The company significantly strengthened its balance sheet by completing a $50 million registered direct offering and a $125 million private placement, resulting in $275.6 million in cash, liquidity from time deposits, and U.S. Treasury bills at the end of Q3 2025.
Key clinical progress includes completing enrollment for the Phase 3 Phoenix trial with 530 subjects and completing the Phase 3 DRAGON trial, with final top-line data anticipated by the end of November.
Regulatory agencies in China (NMPA) and the U.K. (MHRA) have agreed to accept New Drug Applications (NDAs) based on interim DRAGON trial results, with submissions planned for the first half of 2026. The company estimates approximately $200 million will be needed for U.S. commercialization, which current funding is expected to cover.

Nov 10, 2025, 9:30 PM

Transcript

Belite Bio Reports Q3 2025 Financial Results and Provides Pipeline Updates

BLTE

Earnings

New Projects/Investments

Belite Bio reported a net loss of $21,690 thousand for the third quarter of 2025, compared to a net loss of $8,679 thousand for the same period in 2024. Total operating expenses for Q3 2025 were $23,018 thousand, an increase from $9,740 thousand in Q3 2024.
The company's cash, liquidity fund, time deposits, and U.S. treasury bills amounted to $275.6 million. This follows the completion of a $15 million registered direct offering and a $125 million private placement, with potential for up to an additional $165 million upon full warrant exercise.
The pivotal Phase 3 DRAGON trial for Tinlarebant in Stargardt Disease (STGD1) has been completed, with topline data expected in Q4 2025.
Regulatory bodies, including China's NMPA and the United Kingdom's MHRA, have agreed to accept New Drug Application and Conditional Marketing Authorization applications, respectively, for Tinlarebant for Stargardt disease based on interim analysis results.
Enrollment has been completed for the Phase 3 PHOENIX trial of Tinlarebant in Geographic Atrophy (GA), with 530 subjects.