Full Press Release Details
Belite Bio Reports First Quarter 2025
Financial Results and Provides Corporate Update
SAN DIEGO, May 13, 2025-
Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical 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 first
quarter ended March 31, 2025, and provided a business update.
"We continue to advance the clinical development of
Tinlarebant, reaching a major milestone with the favorable interim analysis of our Phase 3 DRAGON trial earlier this year," said
Dr. Tom Lin, Chairman and CEO of Belite Bio. "We are excited by the encouraging feedback from the DSMB on the safety and efficacy
outcomes in DRAGON as we work toward trial completion by the end of 2025. We are focused on maintaining strong execution across our late-stage
clinical programs as we aim to deliver new treatment options for people living with degenerative retinal diseases, where there is significant
First Quarter 2025 Business Highlights and Upcoming Milestones:
Tinlarebant is an oral, once-daily, potent 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 (bisretinoids)
in individuals affected with STGD1 and GA, the advanced form of dry age-related macular degeneration (AMD), leading to retinal cell death
Corporate Highlights
First Quarter 2025 Financial Results:
As of March 31, 2025, the Company had $157.4 million in cash, liquidity
funds, time deposits, and U.S treasury bills.
For the three months ended March 31, 2025, research and development
expenses were $9.4 million compared to $6.8 million for the same period in 2024. The increase in research and development expenses was
primarily attributable to (i) share-based compensation granted in the third quarter of 2024 and first quarter of 2025, (ii) slightly higher
clinical trial expenses related to the PHOENIX trial.
For the three months ended March 31, 2025, general and
administrative expenses were $6.1 million compared to $1.6 million for the same period in 2024. The increase resulted primarily from
an increase in share-based compensation granted in the third quarter of 2024 and first quarter of 2025.
For the three months ended March 31, 2025, other income was $1.2 million
compared to $0.5 million for the same period in 2024. The increase in other income was attributable to accrued interest from time deposits
and U.S. treasury bills.
For the three months ended March 31, 2025, the Company reported
a net loss of $14.3 million, compared to a net loss of $7.9 million for the same period in 2024.
Belite Bio will host a webcast on Wednesday, May 14, 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/137642555. A replay will be available for approximately 90 days following the event at
the Company's Investor Relations website at https://investors.belitebio.com/presentations-events/events.
Belite Bio is a clinical-stage biopharmaceutical 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 patients and
or visit 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 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)
| For the Three Months Ended March 31, | ||||||||
| 2024 | 2025 | |||||||
| Expenses | ||||||||
| Research and development | 6,765 | 9,396 | ||||||
| General and administrative | 1,563 | 6,121 | ||||||
| Total operating expenses | 8,328 | 15,517 | ||||||
| Loss from operations | (8,328 | ) | (15,517 | ) | ||||
| Other income: | ||||||||
| Total other income, net | 463 | 1,240 | ||||||
| Loss before income tax | (7,865 | ) | (14,277 | ) | ||||
| Income tax expense | 6 | - | ||||||
| Net loss | (7,871 | ) | (14,277 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | (96 | ) | 18 | |||||
| Total comprehensive loss | (7,967 | ) | (14,259 | ) | ||||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||
| - Basic and Diluted | 29,677,173 | 32,084,106 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.27 | ) | $ | (0.45 | ) |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| December 31, | March 31, | |||||||
| 2024 | 2025 | |||||||
| Current assets | $ | 147,073 | $ | 159,287 | ||||
| Other assets | 5,059 | 4,914 | ||||||
| TOTAL ASSETS | $ | 152,132 | $ | 164,201 | ||||
| TOTAL LIABILITIES | $ | 6,311 | $ | 6,131 | ||||
| TOTAL SHAREHOLDERS' EQUITY | 145,821 | 158,070 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 152,132 | $ | 164,201 | ||||
| Ordinary shares authorized | 400,000,000 | 400,000,000 | ||||||
| Ordinary shares issued | 31,857,802 | 32,595,001 | ||||||
| Ordinary shares outstanding | 31,826,549 | 32,544,784 |
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