Full Press Release Details
Belite Bio Reports First-Quarter 2023 Operational Highlights and
SAN DIEGO, May 10, 2023- Belite Bio, Inc (NASDAQ: BLTE) ("Belite"
or the "Company"), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting
retinal degenerative eye diseases which have significant unmet medical needs, today announced its financial results for the first quarter
ended March 31, 2023 and provided a general business update.
"The promising interim data after 18 months of treatment in our
Phase 2 trial further reinforces the potential of Tinlarebant, an oral, once daily retinol binding protein antagonist, to slow disease
progression in STGD1." said Dr. Tom Lin, Belite's Chairman and CEO. "We remain focused on advancing late-stage
development of Tinlarebant and are pleased with the 60% enrollment seen to date in our pivotal Phase 3 DRAGON trial. We remain on track
to enroll the first patient in our Phase 3 PHOENIX trial in GA in mid-2023."
Dr. Nathan L. Mata, Chief Scientific Officer of Belite Bio added,
"The 18-month data from our Phase 2 trial presented at ARVO are encouraging and highlight the ability of Tinlarebant to slow expansion
of autofluorescence and the majority of the subjects showed no transition to atrophic (DDAF) lesions. Among the minority subjects who
did transition to DDAF lesions, Tinlarebant slowed the rate of progression compared to those reported in a natural history study. We believe
these 18-month Phase 2 data continue to reinforce the potential of Tinlarebant to be a transformative oral treatment for patients with
First Quarter 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 selectively lowers vitamin A (retinol) delivery
to the eye without disrupting systemic lipoprotein delivery to other tissues. Vitamin A is critical to normal vision but can accumulate
as toxic byproducts and lead to retinal cell death and vision loss in certain eye diseases like STGD1 and GA, the advanced form of dry
Age-Related Macular Degeneration (dry AMD).
Corporate Highlights
First Quarter 2023 Financial Results:
Cash and Cash Equivalents: As of March 31, 2023, the Company
had $37.8 million in cash.
For the three months ended March 31, 2023, research and development
expenses were $5.7 million compared to $0.9 million for the same period in 2022. The increase in research and development expenses was
primarily attributable to an increase in (i) research for and activities related to conducting DRAGON and PHOENIX trials, and (ii) wages
and salaries due to our R&D team expansion.
For the three months ended March 31, 2023, general and administration
expenses were $1.2 million compared to $0.2 million for the same period in 2022. The increase in general and administration expenses was
primarily due to increases in professional service fees, insurance premium for directors' and officers' liability insurance,
and wages and salaries.
For the three months ended March 31, 2023, the Company reported
a net loss of $6.9 million, compared to a net loss of $1.1 million for the same period in 2022.
Belite Bio will host a webcast to discuss the Company's financial
results and provide a business update. The call is scheduled for Thursday, May 11, 2023, at 8:00 a.m. Eastern Time. To join
the live webcast please click here. A replay will be available approximately two hours after the event for 90 days.
Belite Bio is a clinical stage biopharmaceutical drug development company
focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs, such as STGD1
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; expectations for the timing of initiation,
enrollment and completion of, and data relating to, its clinical trials; the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approval of Belite Bio's drug candidates; whether additional clinical trials may
be required for DRAGON or PHOENIX studies based on their respective data; 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, | ||||||||
| 2022 | 2023 | |||||||
| Expenses | ||||||||
| Research and development | 878 | 5,723 | ||||||
| General and administrative | 175 | 1,158 | ||||||
| Total operating expenses | 1,053 | 6,881 | ||||||
| Loss from operations | (1,053 | ) | (6,881 | ) | ||||
| Other income (expense): | ||||||||
| Total other (expense) income, net | (17 | ) | (8 | ) | ||||
| Loss before income tax | (1,070 | ) | (6,889 | ) | ||||
| Income tax expense | - | 6 | ||||||
| Net loss | (1,070 | ) | (6,895 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | 25 | 16 | ||||||
| Total comprehensive loss | $ | (1,045 | ) | (6,879 | ) | |||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||
| - Basic and Diluted | 10,274,403 | 20,950,240 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.10 | ) | $ | (0.33 | ) |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
| December 31, | March 31, | |||||||
| 2022 | 2023 | |||||||
| Current assets | $ | 42,807 | $ | 38,423 | ||||
| Other assets | 1,466 | 1,395 | ||||||
| TOTAL ASSETS | $ | 44,273 | $ | 39,818 | ||||
| TOTAL LIABILITIES | $ | 2,772 | $ | 4,649 | ||||
| TOTAL SHAREHOLDERS' EQUITY | 41,501 | 35,169 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 44,273 | $ | 39,818 | ||||
| Ordinary shares authorized | 492,179,086 | 400,000,000 | ||||||
| Ordinary shares issued and outstanding | 24,898,908 | 24,914,741 |
Media and Investor Relations Contact:
Jennifer Wu /ir@belitebio.com
Tim McCarthy /tim@lifesciadvisors.com
Note: (1) Although we have compared
the published data for the above studies to our interim data in the LBS-008-CT02 trial, the value of such comparisons is limited because
they are derived from studies conducted under different protocols, at different sites, with different patient populations, and results
were analyzed using non-standardized methods. We note our future trials may not confirm the comparisons or analyses we have made to date.
(2) For each subject, the mean lesion size between
eyes was determined and the average value for the lesion sizes within each study group was calculated. The data show mean lesion sizes
within each group standard error of the mean at each timepoint.