Full Press Release Details
Bio Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
DIEGO, November 12, 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 third quarter ended September 30, 2024,
and provided a general business update.
"I am pleased with the continued progress we made across
our clinical programs. The pace of enrollment for the PHOENIX trial remains strong, and in the quarter, we completed the Phase 1b
DRAGON II trial of Tinlarebant in Stargardt disease in Japan and dosed the first patient in the Phase 2/3 portion of the trial. We
are well-positioned to achieve critical milestones and look forward to providing an update on the interim analysis from our pivotal
Phase 3 DRAGON trial toward the end of 2024 or early 2025," said Dr. Tom Lin, Chairman and CEO of
Belite. "In the quarter, we were also excited to welcome Dr. Scholl, a leading global expert in Stargardt disease and
age-related macular degeneration, as our Chief Medical Officer. Dr. Scholl's decision to join Belite following his
experience as Chair of the Data and Safety Monitoring Board for both our Phase 2 and Phase 3 Stargardt disease trials further
validates our belief in Tinlarebant's immense potential."
Quarter 2024 Business Highlights and Upcoming Milestones:
(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 age-related
macular degeneration (dry AMD) leading to retinal cell death and loss of vision.
Corporate Highlights
Hendrik P. N. Scholl, MD, MA, was appointed as the Company's
Chief Medical Officer. Dr. Scholl is the foremost globally recognized authority on Stargardt disease and age-related macular degeneration
and brings to Belite decades of expertise in treating retinal diseases, including the two key indications targeted by Tinlarebant.
Belite also recently announced the exercise of warrants by certain
holder of Belite's outstanding warrants, pursuant to which Belite received total gross proceeds of approximately $28.75 million,
which are expected to be used for general corporate purposes.
Quarter 2024 Financial Results:
2024, the Company had $109.0 million in cash, money market fund, time deposits and U.S treasury bills.
three months ended September 30, 2024, research and development expenses were $6.8 million compared to $8.7 million for the
same period in 2023. This decrease 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. For the nine months ended September 30,
2024, research and development expenses were $22.7 million compared to $20.0 million for the same period in 2023. The increase in
research and development expenses was primarily attributable to (i) a royalty payment for completion of a Phase 2 trial, and
(ii) share-based compensation granted in the third quarter of 2024.
For the three months ended September 30, 2024, general and administrative
expenses were $2.9 million compared to $2.2 million for the same period in 2023. For the nine months ended September 30, 2024, general
and administration expenses were $5.9 million compared to $4.7 million for the same period in 2023. The increase in G&A expenses
was primarily due to an increase in share-based compensation granted in the third quarter of 2024.
For the three months ended September 30, 2024, other income was
$1.1 million compared to $0.03 million for the same period in 2023. For the nine months ended September 30, 2024, other income was
$2.5 million compared to $0.08 million for the same period in 2023. The increase in other income was attributable to accrued interest
from time deposits and U.S. treasury bills.
For the three months ended September 30, 2024, the Company reported
a net loss of $8.7 million, compared to a net loss of $10.9 million for the same period in 2023. For the nine months ended September 30,
2024, the Company reported a net loss of $26.0 million, compared to a net loss of $24.6 million for the same period in 2023.
Belite Bio will host a webcast on Tuesday, November 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/blte5/1423080. A replay will be available 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 Stargardt disease type 1, or 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, and is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects
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 | For the Nine Months | |||||||||||||||
| Ended September 30, | Ended September 30, | |||||||||||||||
| 2023 | 2024 | 2023 | 2024 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | 8,743 | 6,842 | 19,982 | 22,685 | ||||||||||||
| General and administrative | 2,218 | 2,898 | 4,731 | 5,854 | ||||||||||||
| Total operating expenses | 10,961 | 9,740 | 24,713 | 28,539 | ||||||||||||
| Loss from operations | (10,961 | ) | (9,740 | ) | (24,713 | ) | (28,539 | ) | ||||||||
| Other income: | ||||||||||||||||
| Total other income, net | 27 | 1,061 | 81 | 2,501 | ||||||||||||
| Loss before income tax | (10,934 | ) | (8,679 | ) | (24,632 | ) | (26,038 | ) | ||||||||
| Income tax expense | 1 | - | 10 | 6 | ||||||||||||
| Net loss | (10,935 | ) | (8,679 | ) | (24,642 | ) | (26,044 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Foreign currency translation adjustments, net of nil tax | (55 | ) | 79 | (115 | ) | (27 | ) | |||||||||
| Total comprehensive loss | (10,990 | ) | (8,600 | ) | (24,757 | ) | (26,071 | ) | ||||||||
| Weighted average number of ordinary shares used in per share | ||||||||||||||||
| calculation: | ||||||||||||||||
| - Basic and Diluted | 27,315,550 | 30,687,305 | 26,013,012 | 30,231,207 | ||||||||||||
| Net loss per ordinary share | ||||||||||||||||
| - Basic and Diluted | $ | (0.40 | ) | $ | (0.28 | ) | $ | (0.95 | ) | $ | (0.86 | ) |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| December 31, | September 30, | |||||||
| 2023 | 2024 | |||||||
| Current assets | $ | 89,940 | $ | 111,268 | ||||
| Other assets | 4,702 | 4,553 | ||||||
| TOTAL ASSETS | $ | 94,642 | $ | 115,821 | ||||
| TOTAL LIABILITIES | $ | 4,211 | $ | 3,621 | ||||
| TOTAL SHAREHOLDERS' EQUITY | 90,431 | 112,200 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 94,642 | $ | 115,821 | ||||
| Ordinary shares authorized | 400,000,000 | 400,000,000 | ||||||
| Ordinary shares issued | 29,184,475 | 30,931,247 | ||||||
| Ordinary shares outstanding | 29,149,444 | 30,879,332 |
Media and Investor Relations Contact:
Wu /ir@belitebio.com