Full Press Release Details
Belite Bio Reports Full-Year 2022 Operational
Highlights and Financial Results
SAN DIEGO, March 31, 2023- Belite Bio,
Inc (NASDAQ: BLTE) ("Belite" or the "Company"), a San Diego based clinical stage biopharmaceutical
drug development company targeting eye diseases with significant unmet medical needs, today announced its financial results for the full-year
ended December 31, 2022 and provided a general business update.
"2022 was a transformative year for Belite, with achievements
across key clinical and corporate milestones including the closing of our successful initial public offering, enrollment in over 11 countries
for our pivotal Phase 3 DRAGON trial, and Phase 2 efficacy data reinforcing the potential for tinlarebant to slow down disease progression
in Stargardt disease," said Dr. Tom Lin, Belite's Chairman and CEO. "As we look towards 2023, we remain focused on late-stage
advancement of tinlarebant with continued enrollment in the DRAGON trial and the first patient of the Phase 3 PHOENIX trial in GA is expected
to be enrolled during mid-year. We also expect to present the 18-month efficacy and safety data from our two-year Phase 2 trial in Stargardt
disease during ARVO this year. With our balance sheet strengthened, we are well-positioned to execute across our near-term catalysts and
work towards our mission of developing oral therapies for eye diseases with significant unmet medical needs."
Full Year 2022 Business Highlights and Upcoming Milestones:
Tinlarebant (LBS-008) is an oral, once daily, retinol binding
protein 4 (RBP4) antagonist that decreases RBP4 levels in the blood and selectively lowers vitamin A (retinol) delivery to the eye as
a means to potentially reduce the accumulation of toxic vitamin A byproducts within the eye leading to preservation of the retina. Vitamin
A is critical for normal vision but it can be converted to toxic byproducts (bisretinoids) in degenerative retinal diseases such as STGD1
and GA leading to photoreceptor cell death and vision loss.
Corporate Highlights
Full Year 2022 Financial Results:
Cash and Cash Equivalents: As of December 31, 2022, the Company
had $42.1 million in cash.
For the year ended December 31, 2022, research and development expenses
were $8.9 million compared to $7.4 million for the same period in 2021. Research and development expense increase was primarily attributable
to an increase in wages and salaries due to our R&D team expansion and increased share-based compensation expenses.
For the year ended December 31, 2022, general and administration expenses
were $4.0 million compared to $2.4 million for the same period in 2021. General and Administration expenses increased by approximately
$1.6 million from the year ended December 31, 2021, to the year ended December 31, 2022, which was primarily due to an increase in professional
service fees incurred, an increase of D&O insurance expense, and increase of wages and salaries.
For the year ended December 31, 2022, the Company reported a net loss
of $12.6 million, compared to a net loss of $9.7 million for the same period in 2021.
Belite Bio will host a webcast to discuss the Company's financial
results and provide a business update. The call is scheduled for Monday, April 3, 2023, at 4:30 p.m. Eastern Time. To join the live webcast
please click here. A replay will be available approximately two hours after the event for 90
Belite Bio is a San Diego based clinical stage biopharmaceutical drug
development company targeting eye diseases with significant unmet medical needs, such as advanced dry age-related macular degeneration
(commonly known as Geographic Atrophy, or advanced Dry AMD), Stargardt disease, and 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, plans and prospects, as well as any 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, clinical development, regulatory
milestones, and commercialization of its product candidates, and any other statements containing the words "expect", "will",
"believe", "target", and other 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 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 LOSS
(Amounts in thousand US Dollars,
except share and per share amounts)
| For the Years Ended | ||||||||||||
| December 31, | ||||||||||||
| 2020 | 2021 | 2022 | ||||||||||
| Expenses | ||||||||||||
| Research and development | 3,688 | 7,419 | 8,869 | |||||||||
| General and administrative | 2,055 | 2,378 | 3,952 | |||||||||
| Total operating expenses | 5,743 | 9,797 | 12,821 | |||||||||
| Loss from operations | (5,743 | ) | (9,797 | ) | (12,821 | ) | ||||||
| Other income (expense): | ||||||||||||
| Total other (expense) income, net | (9 | ) | 131 | 173 | ||||||||
| Loss before income tax | (5,752 | ) | (9,666 | ) | (12,648 | ) | ||||||
| Income tax expense | (1 | ) | - | - | ||||||||
| Net loss | (5,753 | ) | (9,666 | ) | (12,648 | ) | ||||||
| Other comprehensive income (loss) | ||||||||||||
| Foreign currency translation adjustments, net of nil tax | 6 | (152 | ) | (196 | ) | |||||||
| Total comprehensive loss | $ | (5,747 | ) | $ | (9,818 | ) | (12,844 | ) | ||||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||||||
| - Basic and Diluted | 8,790,397 | 9,569,932 | 19,976,596 | |||||||||
| Net loss per ordinary share | ||||||||||||
| - Basic and Diluted | $ | (0.65 | ) | $ | (1.01 | ) | $ | (0.63 | ) |
SELECTED CONSOLIDATED BALANCE
in thousand US Dollars)
| December 31 | ||||||||
| 2021 | 2022 | |||||||
| Current assets | $ | 17,431 | $ | 42,807 | ||||
| Other assets | 917 | 1,466 | ||||||
| TOTAL ASSETS | $ | 18,348 | $ | 44,273 | ||||
| TOTAL LIABILITIES | $ | 1,635 | $ | 2,772 | ||||
| Total convertible preferred shares | 31,806 | - | ||||||
| Total shareholders' (deficit) equity | (15,093 | ) | 41,501 | |||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' (DEFICIT) EQUITY | $ | 18,348 | $ | 44,273 | ||||
| SUPPLEMENTAL DISCLOSURE | ||||||||
| Ordinary shares authorized | 492,179,086 | 492,179,086 | ||||||
| Ordinary shares issued and outstanding | 10,274,403 | 24,898,908 |
Media and Investor Relations Contact:
Jennifer Wu /ir@belitebio.com
Tim McCarthy /tim@lifesciadvisors.com