Full Press Release Details
Belite Bio Reports Fourth Quarter and Full Year
2023 Financial Results and Provides Corporate Update
SAN DIEGO, March 11, 2024 - Belite Bio, Inc (NASDAQ:
BLTE) ("Belite Bio" 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 audited
financial results for full-year 2023 and the unaudited and unreviewed financial results for
the quarter ended December 31, 2023, and provided a business update.
was a productive year for Belite, from the initiation of our Phase III trial in GA, enrollment
completion of our Phase III Stargardt disease trial, to the exciting 24-month data from our Phase II Stargardt disease trial,"
said Dr. Tom Lin, Chairman and CEO of Belite Bio. "These milestones continue to underscore
the therapeutic potential of Tinlarebant, not only in Stargardt disease, for which there is still no approved treatment, but for patients
suffering from GA, for which an oral treatment would be game changing. As we enter 2024, we remain focused on our mission to develop oral
therapies for eye diseases with significant unmet medical needs and are well positioned to execute with our strong balance sheet. We expect
to share additional analysis from our Phase 2 Stargardt disease trial at the annual meeting of The Association for Research in Vision
and Ophthalmology (ARVO) in May, and to receive one-year interim data from our Phase 3 DRAGON trial later this year. We also look forward
to sharing additional enrollment updates on our Phase III PHOENIX trial in GA as the year progresses."
Full Year 2023 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 for
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
Audited Full Year 2023 and Unaudited
and Unreviewed Fourth Quarter 2023 Financial Results:
As of December 31, 2023, the Company had $88.2 million in cash, as compared with $42.1 million on December 31, 2022.
For the three months ended December 31, 2023, research and development
expenses were $4.9 million compared to $5.2 million for the same period in 2022. The decrease resulted primarily from higher R&D expenses
in the fourth quarter of 2022 as the DRAGON trial reached certain milestones in such quarter. For the year ended December 31, 2023,
research and development expenses were $24.8 million compared to $8.9 million for the same period in 2022. The increase in research and
development expenses was primarily attributable to increases in expenses related to conducting the DRAGON and PHOENIX trials.
For the three months ended December 31, 2023, general and administration
expenses were $2.1 million compared to $1.5 million for the same period in 2022. The increase resulted primarily from an increase in share-based
compensation granted in 2023. For the year ended December 31, 2023, general and administration expenses were $6.8 million compared
to $4.0 million for the same period in 2022. The increase resulted also primarily from an increase in share-based compensation granted
in 2023 and an increase in professional service fees.
For the three months ended December 31, 2023, the Company reported
a net loss of $7.0 million or ($0.25) per share compared to $6.8 million or ($0.27) per share for the same period in 2022. For the year
ended December 31, 2023, the Company reported a net loss of $31.6 million or ($1.19) per share, compared to a net loss of $12.6 million
or ($0.63) per share for the same period in 2022.
Belite Bio will host a webcast
on Tuesday, March 12, 2023, 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/blte2/1419894. 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.
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,
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, | ||||||||
| 2022 | 2023 | |||||||
| (Audited) | (Audited) | |||||||
| Expenses | ||||||||
| Research and development | 8,869 | 24,844 | ||||||
| General and administrative | 3,952 | 6,824 | ||||||
| Total operating expenses | 12,821 | 31,668 | ||||||
| Loss from operations | (12,821 | ) | (31,668 | ) | ||||
| Other income | ||||||||
| Total other income, net | 173 | 45 | ||||||
| Loss before income tax | (12,648 | ) | (31,623 | ) | ||||
| Income tax expense | - | 9 | ||||||
| Net loss | (12,648 | ) | (31,632 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | (196 | ) | 18 | |||||
| Total comprehensive loss | (12,844 | ) | (31,614 | ) | ||||
| Weighted average number of ordinary shares used in | ||||||||
| per share calculation: | ||||||||
| - Basic and Diluted | 19,976,596 | 26,593,673 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.63 | ) | $ | (1.19 | ) |
| For the Three Months | ||||||||
| Ended December 31, | ||||||||
| 2022 | 2023 | |||||||
| (Unaudited and Unreviewed) | (Unaudited and Unreviewed) | |||||||
| Expenses | ||||||||
| Research and development | 5,226 | 4,862 | ||||||
| General and administrative | 1,495 | 2,093 | ||||||
| Total operating expenses | 6,721 | 6,955 | ||||||
| Loss from operations | (6,721 | ) | (6,955 | ) | ||||
| Other expense | ||||||||
| Total other expense, net | (62 | ) | (36 | ) | ||||
| Loss before income tax | (6,783 | ) | (6,991 | ) | ||||
| Income tax expense | - | - | ||||||
| Net loss | (6,783 | ) | (6,991 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | 127 | 133 | ||||||
| Total comprehensive loss | (6,656 | ) | (6,858 | ) | ||||
| Weighted average number of ordinary shares used in | ||||||||
| per share calculation: | ||||||||
| - Basic and Diluted | 24,889,136 | 28,316,251 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.27 | ) | $ | (0.25 | ) |
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| December 31 | ||||||||
| 2022 | 2023 | |||||||
| (Audited) | (Audited) | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | 42,089 | $ | 88,157 | ||||
| Other receivables | - | 818 | ||||||
| Prepayments and other current assets | 716 | 947 | ||||||
| Other receivables due from related parties | 2 | 18 | ||||||
| Total current assets | 42,807 | 89,940 | ||||||
| Property and equipment, net | 541 | 490 | ||||||
| Prepayments and other non-current assets | 31 | 3,297 | ||||||
| Security deposits | 88 | 104 | ||||||
| Operating lease right-of-use asset, net | 806 | 811 | ||||||
| TOTAL ASSETS | $ | 44,273 | $ | 94,642 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accrued expenses and other liabilities | 1,906 | 3,325 | ||||||
| Operating lease liabilities - current | 198 | 308 | ||||||
| Total current liabilities | 2,104 | 3,633 | ||||||
| Non-current liabilities | ||||||||
| Operating lease liabilities -non - current | 668 | 578 | ||||||
| TOTAL LIABILITIES | 2,772 | 4,211 | ||||||
| Shareholders' equity | ||||||||
| Ordinary shares, par value of US$0.0001 per share; 400,000,000 shares authorized; 24,898,908 and 29,184,475 shares issued; 24,898,908 and 29,149,444 shares outstanding as of December 31, 2022 and 2023, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 81,761 | 162,305 | ||||||
| Accumulated other comprehensive loss | (392 | ) | (374 | ) | ||||
| Accumulated deficit | (39,871 | ) | (71,503 | ) | ||||
| Total shareholders' equity | 41,501 | 90,431 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 44,273 | $ | 94,642 |
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