• Belite Bio, Inc. announced its financial results for Q2 2024 and provided a general business update.
• The company is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs.
• Tinlarebant, a novel oral therapy, is intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA).
• General and administrative expenses were $1.4 million compared to $1.4 million for the same period in 2023.
• Belite Bio reported a net loss of $9.5 million for the three months ended June 30, 2024, compared to a net loss of $6.8 million for the same period in 2023.
SAN DIEGO, Aug. 09, 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 second quarter ended June 30, 2024, and provided a general business update.
“We continued to make meaningful strides in advancing Tinlarebant this quarter. We initiated our DRAGON II trial in adolescent STGD1 patients and have completed the enrollment for its phase 1b portion, and notably, we received Sakigake designation in Japan, a testament to the groundbreaking potential of this drug and the unmet need it stands to address for people living with STGD1. In GA, we are approaching 200 patients enrolled in our pivotal Phase 3 trial,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “In the quarter, we also bolstered our balance sheet, having raised $25 million in gross proceeds in a registered direct offering in April. As we enter the second half of the year, we are well positioned to execute on key milestones and look forward to sharing interim analysis from our pivotal Phase 3 DRAGON trial in the fourth quarter.”
Second Quarter 2024 Business Highlights and Upcoming Milestones:
Clinical Highlights
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 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
Second Quarter 2024 Financial Results:
Current Assets:
As of June 30, 2024, the Company had $112.3 million in cash, time deposits and U.S treasury bills.
R&D Expenses:
For the three months ended June 30, 2024, research and development expenses were $9.1 million compared to $5.5 million for the same period in 2023. For the six months ended June 30, 2024, research and development expenses were $15.8 million compared to $11.2 million for the same period in 2023. The increase in research and development expenses in both the quarter and year-to-date was primarily attributable to (i) a development milestone payment for completion of a phase 2 trial, and (ii) share-based compensation expense.
G&A Expenses:
For the three months ended June 30, 2024, general and administrative expenses were $1.4 million compared to $1.4 million for the same period in 2023. For the six months ended June 30, 2024, general and administration expenses were $3.0 million compared to $2.5 million for the same period in 2023. The increase year-to-date is primarily from an increase in share-based compensation expense.
Other Income:
For the three months ended June 30, 2024, other income was $1.0 million compared to $0.1 million for the same period in 2023. For the six months ended June 30, 2024, other income was $1.4 million compared to $0.1 million for the same period in 2023. The increase in both the quarter and year-to-date is attributed to accrued interest from time deposits and U.S. treasury bills.
Net Loss:
For the three months ended June 30, 2024, the Company reported a net loss of $9.5 million, compared to a net loss of $6.8 million for the same period in 2023. For the six months ended June 30, 2024, the Company reported a net loss of $17.4 million, compared to a net loss of $13.7 million for the same period in 2023.
Webcast Information
Belite Bio will host a webcast on Monday, August 12, 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/blte4/1422018. 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 that 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 Twitter, Instagram, 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 | For the Six Months | |||||||||||||||
Ended June 30, | Ended June 30, | |||||||||||||||
2023 | 2024 | 2023 | 2024 | |||||||||||||
Expenses | ||||||||||||||||
Research and development | 5,516 | 9,078 | 11,239 | 15,843 | ||||||||||||
General and administrative | 1,355 | 1,393 | 2,513 | 2,956 | ||||||||||||
Total operating expenses | 6,871 | 10,471 | 13,752 | 18,799 | ||||||||||||
Loss from operations | (6,871 | ) | (10,471 | ) | (13,752 | ) | (18,799 | ) | ||||||||
Other income: | ||||||||||||||||
Total other income, net | 62 | 977 | 54 | 1,440 | ||||||||||||
Loss before income tax | (6,809 | ) | (9,494 | ) | (13,698 | ) | (17,359 | ) | ||||||||
Income tax expense | 3 | - | 9 | 6 | ||||||||||||
Net loss | (6,812 | ) | (9,494 | ) | (13,707 | ) | (17,365 | ) | ||||||||
Other comprehensive income (loss) | ||||||||||||||||
Foreign currency translation adjustments, net of nil tax | (76 | ) | (10 | ) | (60 | ) | (106 | ) | ||||||||
Total comprehensive loss | (6,888 | ) | (9,504 | ) | (13,767 | ) | (17,471 | ) | ||||||||
Weighted average number of ordinary shares used in per share calculation: | ||||||||||||||||
- Basic and Diluted | 25,785,147 | 30,324,132 | 25,350,949 | 30,000,653 | ||||||||||||
Net loss per ordinary share | ||||||||||||||||
- Basic and Diluted | $ | (0.26 | ) | $ | (0.31 | ) | $ | (0.54 | ) | $ | (0.58 | ) | ||||
BELITE BIO, INC
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except share amounts)
December 31, | June 30, | |||||||
2023 | 2024 | |||||||
Current assets | $ | 89,940 | $ | 113,858 | ||||
Other assets | 4,702 | 4,572 | ||||||
TOTAL ASSETS | $ | 94,642 | $ | 118,430 | ||||
TOTAL LIABILITIES | $ | 4,211 | $ | 3,837 | ||||
TOTAL SHAREHOLDERS’ EQUITY | 90,431 | 114,593 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 94,642 | $ | 118,430 | ||||
Ordinary shares authorized | 400,000,000 | 400,000,000 | ||||||
Ordinary shares issued | 29,184,475 | 30,649,321 | ||||||
Ordinary shares outstanding | 29,149,444 | 30,612,359 | ||||||
Media and Investor Relations Contact:
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Last Trade: | US$50.99 |
Daily Change: | 0.09 0.18 |
Daily Volume: | 50,028 |
Market Cap: | US$1.560B |
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