Full Press Release Details
Belite Bio Reports Second Quarter 2024 Financial Results and Provides
August 9, 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:
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:
As of June 30, 2024, the Company had $112.3 million in cash, time deposits
and U.S treasury bills.
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.
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.
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.
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
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.
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
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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 | 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 | ) |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| 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:
Jennifer Wu /ir@belitebio.com
Julie Fallon /belite@argotpartners.com