Belite Bio Reports Second Quarter 2025 Financial Results and Provides

Belite Bio Reports Second Quarter 2025 Financial Results and Provides

SAN DIEGO, August 11, 2025- Belite Bio, Inc (NASDAQ:

BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that

have significant unmet medical needs, today announced its financial results for the second quarter ended June 30, 2025, and provided

a general business update.

"This quarter, we remained on track with the strategic objectives

we outlined at the start of the year, including the completion of enrollment in our pivotal Phase 3 PHOENIX trial - an important

milestone in our development efforts for people living with geographic atrophy," said Dr. Tom Lin, Chairman and CEO of Belite

Bio. "We also received Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease from the FDA, underscoring

its potential as the first-ever treatment for this patient population and acknowledging the significant unmet need for people living

with this debilitating disease. With the DRAGON trial on track to complete by the end of this year, we remain focused on advancing Tinlarebant

toward key clinical and regulatory milestones."

Second Quarter 2025 Business Highlights and Upcoming Milestones:

Tinlarebant (LBS-008) is an oral, potent, once-daily, retinol

binding protein 4 (RBP4) antagonist that decreases RBP4 levels in the blood and reduces vitamin A (retinol) delivery to the eye without

disrupting systemic retinol delivery to other tissues. Vitamin A is critical for normal vision but can accumulate as toxic byproducts

in individuals affected with STGD1 and GA, the advanced form of dry age-related macular degeneration (AMD), leading to retinal cell death

Corporate Highlights

Second Quarter 2025 Financial Results:

As of June 30, 2025, the Company had $149.2 million in cash,

liquidity funds, time deposits, and U.S treasury bills.

For the three months ended June 30, 2025, research and development

expenses were $11.0 million compared to $9.1 million for the same period in 2024. For the six months ended June 30, 2025, research

and development expenses were $20.4 million compared to $15.8 million for the same period in 2024. The increase in research and development

expenses in both the quarter and year-to-date was primarily attributable to (i) higher pass-through expenses related to the PHOENIX

trial and manufacturing expenses payments, partially offset by lower DRAGON trial expenses and a development milestone payment for the

completion of a phase 2 trial in 2024; (ii) an increase in share-based compensation expenses.

For the three months ended June 30, 2025, general and administrative

expenses were $6.5 million compared to $1.4 million for the same period in 2024. For the six months ended June 30, 2025, general

and administration expenses were $12.7 million compared to $3.0 million for the same period in 2024. The increase in general and administrative

expenses in both the quarter and year-to-date was primarily due to an increase in share-based compensation expenses.

For the three months ended June 30, 2025, other income was $1.3

million compared to $1.0 million for the same period in 2024. For the six months ended June 30, 2025, other income was $2.5 million

compared to $1.4 million for the same period in 2024. The increase in both the quarter and year-to-date was attributed to interest from

time deposits and U.S. treasury bills.

For the three months ended June 30, 2025, the Company reported

a net loss of $16.3 million, compared to a net loss of $9.5 million for the same period in 2024. For the six months ended June 30,

2025, the Company reported a net loss of $30.6 million, compared to a net loss of $17.4 million for the same period in 2024.

Belite Bio will host a webcast on Monday, August 11, 2025, at

4:30 p.m. Eastern Time to discuss the Company's financial results and provide a business update. To join the webcast, please

visit https://events.q4inc.com/attendee/127464226. A replay will be available for approximately 90 days following the event.

Belite Bio is a clinical-stage drug development company focused on

advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease

type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic

diseases. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently

being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX)

us at www.belitebio.com.

Important Cautions Regarding Forward Looking Statements

This press release contains forward-looking statements about future

expectations and plans, as well as other statements regarding matters that are not historical facts. These statements include but are

not limited to statements regarding the potential implications of clinical data for patients, and Belite Bio's advancement of,

and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates,

and any other statements containing the words "expect", "hope" and similar expressions. Actual results may differ

materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited

to Belite Bio's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates,

which may not support further development or regulatory approval; the timing to complete relevant clinical trials and/or to receive the

interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval; the content

and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio's drug candidates;

the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the "Risk Factors" section in Belite

Bio's filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently

available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether

as a result of new information, future events or otherwise, except as may be required by law.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS

OF OPERATIONS AND COMPREHENSIVE LOSS

(Amounts in thousands of US Dollars, except

share and per share amounts)

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands of US Dollars, except

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