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Belite Bio Reports First-Quarter 2024 Financial Results and Provides Corporate Update

SAN DIEGO, May 13, 2024 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), 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, 2024 and provided a general business update.

“It has been a strong start to 2024 with the initiation of the DRAGON II trial and the recent closing of our $25 million registered direct offering in April 2024,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “At the annual meeting of The Association for Research in Vision and Ophthalmology (ARVO), we announced additional analysis from our completed Phase 2 trial of Tinlarebant in adolescent STGD1 supporting its potential to slow or even halt disease progression. We are encouraged by these findings and look forward to building on this momentum as we continue to evaluate the potentially life-changing impact of this therapy in our ongoing STGD1 trials, DRAGON & DRAGON II, as well as in GA through our PHOENIX trial.”

First Quarter 2024 Business Highlights and Upcoming Milestones:

Clinical Highlights

Tinlarebant (LBS-008) is designed to be 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 to normal vision but can accumulate as toxic byproducts in individuals affected with STGD1 and GA (the advanced form of Dry AMD) leading to retinal cell death and loss of vision.

Corporate Highlights

First Quarter 2024 Financial Results:

Current Assets:

As of March 31, 2024, the Company had $95.5 million in cash and U.S treasury bills.

R&D Expenses:

For the three months ended March 31, 2024, research and development expenses were $6.8 million compared to $5.7 million for the same period in 2023. The increase in research and development expenses was primarily attributable to (i) conducting the DRAGON trial, (ii) initiating the DRAGON II trial, and (iii) increased wages and salaries due to our R&D team expansion and share-based compensation granted in the third quarter of 2023.

G&A Expenses:

For the three months ended March 31, 2024, general and administrative expenses were $1.6 million compared to $1.2 million for the same period in 2023. The increase resulted primarily from an increase in share-based compensation granted in the third quarter of 2023.

Net Loss:

For the three months ended March 31, 2024, the Company reported a net loss of $7.9 million, compared to a net loss of $6.9 million for the same period in 2023. 

Webcast Information

Belite Bio will host a webcast on Tuesday, May14, 2024, 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://wsw.com/webcast/cc/blte3/1420956. A replay will be available for approximately 90 days following the event.

About Belite Bio

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs such as (i) atrophic age-related macular degeneration (AMD), commonly known as Geographic Atrophy (GA) in advanced dry AMD, and (ii) autosomal recessive Stargardt disease type 1, or STGD1, in addition to specific metabolic diseases. For more information, follow us on TwitterInstagram, LinkedIn, Facebook, 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.

 
BELITE BIO, INC
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,  
    2023     2024  
Expenses                
Research and development     5,723       6,765  
General and administrative     1,158       1,563  
Total operating expenses     6,881       8,328  
Loss from operations     (6,881 )     (8,328 )
Other income (expense):                
Total other (expense) income, net     (8 )     463  
Loss before income tax     (6,889 )     (7,865 )
Income tax expense     6       6  
Net loss     (6,895 )     (7,871 )
Other comprehensive income (loss)                
Foreign currency translation adjustments, net of nil tax     16       (96 )
Total comprehensive loss   $ (6,879 )     (7,967 )
Weighted average number of ordinary shares used in per share calculation:                
– Basic and Diluted     20,950,240       29,677,173  
Net loss per ordinary share                
– Basic and Diluted   $ (0.33 )     (0.27 )
 
BELITE BIO, INC
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except share amounts)
 
    December 31,     March 31,  
    2023     2024  
Current assets   $ 89,940     $ 96,468  
Other assets     4,702       4,679  
TOTAL ASSETS   $ 94,642     $ 101,147  
                 
TOTAL LIABILITIES   $ 4,211     $ 4,677  
                 
TOTAL SHAREHOLDERS’ EQUITY     90,431       96,470  
                 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 94,642     $ 101,147  
                 
Ordinary shares authorized     400,000,000       400,000,000  
Ordinary shares issued     29,184,475       29,802,332  
Ordinary shares outstanding     29,149,444       29,794,433  

Media and Investor Relations Contact:
Jennifer Wu /ir@belitebio.com
Julie Fallon /belite@argotpartners.com


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