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Belite Bio Reports Positive Interim Results for Tinlarebant in Stargardt Disease Trials
Belite Bio announced interim analysis results for Tinlarebant in STGD1, recommending trial continuation and regulatory submission.
Key Developments
Belite Bio, Inc. has unveiled promising updates regarding its leading drug candidate, Tinlarebant, aimed at treating Stargardt disease (STGD1) along with ongoing trials for geographic atrophy (GA). Following an interim analysis, an independent Data Safety Monitoring Board (DSMB) has endorsed the continuation of the pivotal Phase 3 DRAGON trial without modifications. The DSMB also recommended that interim data be submitted for regulatory review. The trial is on track to complete by Q4 2025, incorporating a three-month follow-up period. Additionally, Belite is advancing the Phase 3 PHOENIX trial for GA, with 464 participants currently enrolled out of a target of 500. The company raised $15 million in funding and reported a net loss of $14.3 million for Q1 2025. A conference call is set for May 14, 2025, to discuss these findings and future updates.
Optimistic Indicators
- The DSMB’s recommendation for the DRAGON trial to proceed without alterations suggests favorable safety and efficacy outcomes.
- The call for submitting interim data for regulatory review could expedite the drug approval timeline.
- The recent $15 million raised through a registered direct offering strengthens the company’s financial position for its clinical programs.
- Enrollment in the PHOENIX trial is progressing well, with 464 of the targeted 500 subjects now participating.
Challenges Ahead
- In Q1 2025, net losses rose to $14.3 million, a significant increase from $7.9 million in Q1 2024, signaling escalating financial hurdles.
- Research and development expenses surged from $6.8 million in Q1 2024 to $9.4 million in Q1 2025, indicating rising operational costs that may affect profitability.
- General and administrative costs escalated sharply from $1.6 million in Q1 2024 to $6.1 million in Q1 2025, prompting concerns about financial management and efficiency.
Frequently Asked Questions
What is the DRAGON trial for Tinlarebant?
The DRAGON trial is a pivotal Phase 3 study assessing Tinlarebant in adolescent patients with Stargardt disease, expected to conclude by Q4 2025.
What did the DSMB recommend regarding the trial?
The DSMB advised that the DRAGON trial continue without any modifications and encouraged the submission of interim data for regulatory assessment.
How much funding did Belite Bio raise recently?
Belite Bio secured $15 million in gross proceeds from a registered direct offering on February 5, 2025.
What is the primary endpoint of the PHOENIX trial?
The primary endpoint for the PHOENIX trial is the growth rate of atrophic lesions in patients suffering from geographic atrophy.
When is Belite Bio’s next webcast?
The next conference call will occur on May 14, 2025, at 4:30 p.m. ET to review financial results and company updates.
$BLTE Hedge Fund Activity
In the recent quarter, 10 institutional investors have added shares of $BLTE, whereas 15 reduced their holdings.
Recent Movements
- ARMISTICE CAPITAL, LLC added 167,930 shares (+inf%) in Q4 2024, estimated at $10,596,383.
- UBS GROUP AG reduced their position by 11,656 shares (-95.5%) in Q1 2025, valued at $771,860.
- MORGAN STANLEY increased their holdings by 9,956 shares (+1503.9%) in Q4 2024, estimated at $628,223.
- XTX TOPCO LTD divested 7,062 shares (-100.0%) in Q1 2025, for an estimated $467,645.
- JPMORGAN CHASE & CO sold 6,474 shares (-44.2%) in Q1 2025, amounting to $428,708.
- GOLDMAN SACHS GROUP INC eliminated 6,326 shares (-100.0%) in Q1 2025, valued at $418,907.
- GEODE CAPITAL MANAGEMENT, LLC acquired 6,053 shares (+90.3%) in Q1 2025, estimated at $400,829.
$BLTE Analyst Ratings
Recently, Wall Street analysts have provided updates on $BLTE, with 1 firm issuing a buy rating and none issuing sell ratings.
Analyst Insights
- Benchmark initiated a “Buy” rating for the stock on March 26, 2025.
Full Release Highlights
- The DSMB has supported the DRAGON trial’s continuation with no modifications and completion expected by Q4 2025.
- They also recommended submitting interim data for regulatory review.
- The PHOENIX trial is underway with 464 out of a targeted 500 participants enrolled.
- Belite Bio raised $15 million in gross proceeds during a registered direct offering on February 5, 2025.
- A conference call is scheduled for May 14, 2025, at 4:30 p.m. ET.
SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) —
Belite Bio, Inc
(NASDAQ: BLTE) is focused on clinical advancements in therapeutics for degenerative retinal diseases, announcing Q1 2025 results and company updates.
“The interim analysis of our Phase 3 DRAGON trial marks a significant milestone for us,” stated Dr. Tom Lin, Chairman and CEO of Belite Bio. “Feedback from the DSMB on safety and efficacy is encouraging as we approach trial completion by the end of 2025. We remain committed to delivering innovative treatment options for patients dealing with significant unmet medical needs.”
“`# Progress on Stargardt Disease and Geographic Atrophy Treatments
Vitamin A plays a vital role in vision but can also contribute to retinal diseases. In conditions such as Stargardt disease (STGD1) and Geographic Atrophy (GA), the accumulation of toxic byproducts from Vitamin A, known as bisretinoids, can lead to retinal cell death and vision loss.
## Stargardt Disease (STGD1)
Accumulating bisretinoids are a significant factor in the development and progression of STGD1. Currently, no approved treatments exist for this condition. Notably, Tinlarebant has received Fast Track and Rare Pediatric Disease Designations in the U.S., alongside Orphan Drug Designation in several regions including Europe and Japan. Additionally, it has been recognized as a Sakigake (Pioneer Drug) in Japan.
### Clinical Trials
#### DRAGON Trial
This ongoing, 24-month, pivotal Phase 3 trial involves a global, randomized (2:1, active: placebo), double-masked, placebo-controlled design focused on adolescent STGD1 patients.
– An independent Data Safety Monitoring Board (DSMB) recommended continuing the trial after a pre-specified interim analysis, confirming the sample size of 104 subjects.
– The DSMB also advised submitting data for regulatory approval.
– The primary efficacy endpoint is the rate of growth of atrophic lesions, with safety and tolerability also assessed.
– Completion is anticipated by Q4 2025, including a three-month follow-up.
#### DRAGON II Trial
This trial combines a Phase 1b open-label study with a Phase 2/3, 24-month randomized (1:1, active: placebo) design, also targeting adolescent STGD1 patients.
– Currently, 16 subjects have been enrolled, with an overall target of approximately 60 subjects aged 12 to 20, including around 10 Japanese participants.
– The aim for Japanese data is to support a future new drug application in Japan.
– As with the DRAGON trial, the primary efficacy endpoint centers on the growth of atrophic lesions with safety and tolerability assessments.
## Geographic Atrophy (GA)
GA is a degenerative disease of the retina that can result in blindness, particularly in the elderly. The progression of GA is also linked to the accumulation of bisretinoids. Presently, there are no FDA-approved oral treatments for GA.
### Ongoing Trials
#### PHOENIX Trial
This ongoing 24-month study employs a randomized (2:1, active: placebo), double-masked, placebo-controlled design for evaluating GA patients.
– To date, 464 of the target 500 subjects have been enrolled.
– The primary efficacy endpoint focuses on the growth rate of atrophic lesions, complemented by assessments of safety and tolerability.
– The company plans to conduct an interim analysis soon.
## Corporate Highlights
In February 2025, Belite completed a registered direct offering at market price, generating gross proceeds of $15 million. This includes potential proceeds of an additional $15 million from the exercise of five-year warrants associated with the offering.
## First Quarter 2025 Financial Results
### Current Assets
As of March 31, 2025, Belite reported $157.4 million in cash, liquidity funds, time deposits, and U.S. Treasury bills.
### Research and Development Expenses
For the first quarter ended March 31, 2025, R&D expenses reached $9.4 million, up from $6.8 million in the same quarter of 2024. This increase is driven by higher share-based compensation and slightly elevated clinical trial costs related to the PHOENIX trial.
### General and Administrative Expenses
G&A expenses surged to $6.1 million for the same quarter, rising from $1.6 million in 2024. This increase was largely due to greater share-based compensation granted recently.
### Other Income
Other income for the first quarter totaled $1.2 million, compared to $0.5 million for the same period in the previous year, driven by accrued interest from time deposits and U.S. treasury bills.
### Net Loss
Belite reported a net loss of $14.3 million for the first quarter ended March 31, 2025, a significant increase from a net loss of $7.9 million in the corresponding quarter in 2024.
## Webcast Information
Belite Bio will host a webcast on Wednesday, May 14, 2025, at 4:30 p.m. Eastern Time to discuss financial results and provide a business update. Interested parties can join the webcast through [this link](https://events.q4inc.com/attendee/137642555). A replay will be available for approximately 90 days on the Company’s investor relations website.
## About Belite Bio
Belite Bio is committed to developing novel therapeutics for degenerative retinal diseases with unmet medical needs, such as STGD1 and GA in advanced dry age-related macular degeneration (AMD). Their lead candidate, Tinlarebant, targets the reduction of toxic accumulation in the eye and is undergoing extensive clinical evaluation across multiple trials.
## Important Cautions Regarding Forward-Looking Statements
This release contains forward-looking statements about expectations and plans. Actual results may differ due to various factors, including the company’s ability to demonstrate safety and efficacy, clinical results, trial timing, and regulatory authority decisions.# Belite Bio Reports Financial Results with Key Insights on Operations
## Overview of Financial Impact
Belite Bio’s recent filings with the U.S. Securities and Exchange Commission provide critical insights into the regulatory approval of its drug candidates, particularly Tinlarebant. Investors should be aware of the potential efficacy of these products as well as the associated risks extensively outlined in the “Risk Factors” section. While the company has made projections based on current data, it does not commit to updating these forecasts unless necessitated by legal obligations.
## Condensed Financial Statements
### Unaudited Statements of Operations and Comprehensive Loss
The following table summarizes significant financial metrics from Belite Bio’s recent performance. All amounts are in thousands of US dollars, except for share and per-share figures.
|
BELITE BIO, INC
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,
2024 |
||||||||
| 2025 | ||||||||
| Expenses | 6,765 | 9,396 | ||||||
| Research and development | 1,563 | 6,121 | ||||||
| Total operating expenses | 8,328 | 15,517 | ||||||
| Loss from operations | (8,328) | (15,517) | ||||||
## Conclusion
Belite Bio’s financial outlook remains contingent on various factors, including regulatory developments and operational efficiency. Stakeholders are encouraged to focus on the company’s advancements in drug candidates and their associated risks as detailed in official reports.
Financial Overview: Income, Losses, and Comprehensive Income Analysis
| Other income: | ||||||||
| Total other income, net | 463 | 1,240 | ||||||
| Loss before income tax | (7,865 | ) | (14,277 | ) | ||||
| Income tax expense | 6 | – | ||||||
| Net loss | (7,871 | ) | (14,277 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | (96 | ) | 18 | |||||
| Total comprehensive loss | (7,967 | ) | (14,259 | ) | ||||
| Weighted average number of ordinary shares used in per share calculation: |
# Belite Bio, Inc. Reports Recent Financial Data
|
BELITE BIO, INC
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands of US Dollars, except share amounts) |
||||||||
| December 31, | March 31, | |||||||
| 2024 | 2025 | |||||||
| Current assets | $ | 147,073 | $ | 159,287 | ||||
| Other assets | ||||||||
| – Basic and Diluted | 29,677,173 | 32,084,106 | ||||||
| Net loss per ordinary share | ||||||||
| – Basic and Diluted | $ | (0.27) | $ | (0.45) | ||||
# Financial Summary: Total Assets and Shareholders’ Equity
| 5,059 | 4,914 | |||||||
| TOTAL ASSETS | $ | 152,132 | $ | 164,201 | ||||
| TOTAL LIABILITIES | $ | 6,311 | $ | 6,131 | ||||
| TOTAL SHAREHOLDERS’ EQUITY | 145,821 | 158,070 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 152,132 | $ | 164,201 |
# Key Shareholder Information Revealed: Current Ordinary Shares Breakdown
## Ordinary Shares Authorized
– **Total Authorized:** 400,000,000 shares
## Ordinary Shares Issued
– **Total Issued:** 31,857,802 shares
– **Latest Issued Total:** 32,595,001 shares
## Ordinary Shares Outstanding
– **Current Outstanding Shares:** 31,826,549 shares
– **Latest Outstanding Total:** 32,544,784 shares
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### Contact Information
**Media and Investor Relations:**
– **Jennifer Wu**
[[email protected]](mailto:[email protected])
– **Julie Fallon**
[[email protected]](mailto:[email protected])
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**Disclaimer:**
The opinions expressed in this article are solely those of the author and do not necessarily align with the views of Nasdaq, Inc.
