Full Press Release Details
Belite Bio Reports Fourth Quarter and Full Year
2024 Financial Results and Provides Corporate Update
March 17, 2025 (GLOBE NEWSWIRE) - 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 fourth quarter and full-year ended December 31, 2024, and provided a business update.
made exciting progress in our clinical development efforts over the past year, and the recent completion of the interim analysis of
the Phase 3 DRAGON trial was an important milestone that brought us one step closer to realizing Tinlarebant's potential to
slow progression of STGD1," said Dr. Tom Lin, Chairman and CEO of Belite. "We are very excited with the DSMB's
recommendation and the safety profile of Tinlarebant, and we remain on track to complete the trial by the fourth quarter of 2025.
With the continued execution in our Phase 3 trials and the close of our recent $15 million registered direct offering on
February 5, 2025, we remain well positioned through key milestones as we advance Tinlarebant as a novel therapeutic for people
living with degenerative retinal diseases."
Full Year 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 for normal vision
but can accumulate as toxic byproducts in individuals affected with STGD1 and GA, the advanced form of dry age-related macular degeneration
(AMD), leading to retinal cell death and loss of vision.
| Following a pre-specified interim analysis, an independent DSMB recommended trial continuation without modifications, maintaining a sample size of 104 subjects | ||
| In addition, the DSMB recommended to submit the data for further regulatory review for drug approval | ||
| Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed |
Corporate Highlights
Full Year 2024 and Reviewed Fourth Quarter 2024 Financial Results:
of December 31, 2024, the Company had $31.7 million in cash, as compared with $88.2 million on December 31, 2023.
As of December 31, 2024, the Company had $113.5 million in liquidity fund, time deposits and U.S treasury bills, as compared with
nil on December 31, 2023.
the three months ended December 31, 2024, research and development expenses were $7.3 million compared to $4.9 million for
the same period in 2023. The increase resulted primarily from share-based compensation granted in the third quarter of 2024 and higher
R&D expenses in the fourth quarter of 2024 as the PHOENIX trial reached certain milestones.
the year ended December 31, 2024, research and development expenses were $29.9 million compared to $24.8 million for the same period
in 2023. The increase in research and development expenses was primarily attributable to (i) an increase in royalty payments
for the completion of a Phase 2 trial, (ii) an increase in share-based compensation granted in the third quarter of 2024 and (iii) a
decrease in clinical trial expenses, which was mainly attributed to fewer contract research organization milestone payments related to
the DRAGON trial, partially offset by the increase in the DRAGON II trial expenses and the Australian research and development tax incentive,
which is recognized as a reduction to research and development expenses.
the three months ended December 31, 2024, general and administration expenses were $4.2 million compared to $2.1 million for
the same period in 2023. For the year ended December 31, 2024, general and administration expenses were $10.1 million compared to
$6.8 million for the same period in 2023. The increase for both the quarter and full year was primarily driven by an increase in share-based
compensation granted in the third quarter of 2024.
months ended December 31, 2024, other income was $1.4 million compared to other expense $0.04 million for the same period in 2023.
For the year ended December 31, 2024, other income was $3.9 million compared to $0.05 million for the same period in 2024. The increase
in other income was interest derived from cash in banks, our investments in liquidity funds, U.S. treasury bills, and time deposits from
financial institutions.
months ended December 31, 2024, the Company reported a net loss of $10.1 million or ($0.32) per share compared to $7.0 million
or ($0.25) per share for the same period in 2023. For the year ended December 31, 2024, the Company reported a net loss of $36.1
million or ($1.18) per share, compared to a net loss of $31.6 million or ($1.19) per share for the same period in 2023.
Bio will host a webcast on Monday, March 17, 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/481614529.
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.
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 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us
on Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking
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.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(Amounts in thousands of US Dollars, except
share and per share amounts)
| For the Year | ||||||||
| Ended December 31, | ||||||||
| 2023 | 2024 | |||||||
| Expenses | ||||||||
| Research and development | 24,844 | 29,939 | ||||||
| General and administrative | 6,824 | 10,057 | ||||||
| Total operating expenses | 31,668 | 39,996 | ||||||
| Loss from operations | (31,668 | ) | (39,996 | ) | ||||
| Other income | ||||||||
| Total other income, net | 45 | 3,858 | ||||||
| Loss before income tax | (31,623 | ) | (36,138 | ) | ||||
| Income tax expense | 9 | 6 | ||||||
| Net loss | (31,632 | ) | (36,144 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | 18 | (286 | ) | |||||
| Total comprehensive loss | (31,614 | ) | (36,430 | ) | ||||
| Weighted average number of ordinary shares used in | ||||||||
| per share calculation: | ||||||||
| - Basic and Diluted | 26,593,673 | 30,538,378 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (1.19 | ) | $ | (1.18 | ) |
| For the Three Months | ||||||||
| Ended December 31, | ||||||||
| 2023 | 2024 | |||||||
| (Unaudited and Unreviewed) | (Unaudited) | |||||||
| Expenses | ||||||||
| Research and development | 4,862 | 7,254 | ||||||
| General and administrative | 2,093 | 4,203 | ||||||
| Total operating expenses | 6,955 | 11,457 | ||||||
| Loss from operations | (6,955 | ) | (11,457 | ) | ||||
| Other expense | ||||||||
| Total other income (expense), net | (36 | ) | 1,357 | |||||
| Loss before income tax | (6,991 | ) | (10,100 | ) | ||||
| Income tax expense | - | - | ||||||
| Net loss | (6,991 | ) | (10,100 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | 133 | (259 | ) | |||||
| Total comprehensive loss | (6,858 | ) | (10,359 | ) | ||||
| Weighted average number of ordinary shares used in | ||||||||
| per share calculation: | ||||||||
| - Basic and Diluted | 28,316,251 | 31,453,211 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.25 | ) | $ | (0.32 | ) |
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| December 31 | ||||||||
| 2023 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | 88,157 | $ | 31,677 | ||||
| Investments | - | 113,472 | ||||||
| Other receivables | 818 | 575 | ||||||
| Prepayments and other current assets | 947 | 1,349 | ||||||
| Other receivables due from related parties | 18 | - | ||||||
| Total current assets | 89,940 | 147,073 | ||||||
| Property and equipment, net | 490 | 444 | ||||||
| Intangible assets | - | 31 | ||||||
| Prepayments and other non-current assets | 3,297 | 3,960 | ||||||
| Security deposits | 104 | 103 | ||||||
| Operating lease right-of-use asset, net | 811 | 521 | ||||||
| TOTAL ASSETS | $ | 94,642 | $ | 152,132 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accrued expenses and other liabilities | 3,325 | 5,761 | ||||||
| Other payables to related parties | - | 13 | ||||||
| Operating lease liabilities - current | 308 | 276 | ||||||
| Total current liabilities | 3,633 | 6,050 | ||||||
| Non-current liabilities | ||||||||
| Operating lease liabilities -non - current | 578 | 261 | ||||||
| TOTAL LIABILITIES | 4,211 | 6,311 | ||||||
| Shareholders' equity | ||||||||
| Ordinary shares, par value of US$0.0001 per share; 400,000,000 shares authorized; 29,184,475 and 31,857,802 shares issued; 29,149,444 and 31,826,549 shares outstanding as of December 31, 2023 and 2024, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 162,305 | 254,125 | ||||||
| Accumulated other comprehensive loss | (374 | ) | (660 | ) | ||||
| Accumulated deficit | (71,503 | ) | (107,647 | ) | ||||
| Total shareholders' equity | 90,431 | 145,821 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 94,642 | $ | 152,132 |
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