Full Press Release Details
Belite Bio Reports First-Quarter 2024 Financial Results and Provides
SAN DIEGO, May 13, 2024- 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:
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.
| Primary efficacy endpoint is slowing of atrophic lesion growth rate; safety and tolerability will also be assessed | ||
| Has enrolled 99 subjects |
Corporate Highlights
First Quarter 2024 Financial Results:
As of March 31, 2024, the Company had $95.5 million in cash and U.S
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
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.
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.
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.
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
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.
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 | ) |
UNAUDITED CONDENSED CONSOLIDATED BALANCE
(Amounts in thousands of US Dollars, except
| 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