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- **Clinical Milestones**: Completed Phase III enrollment for GA and Stargardt's disease, with DRAGON trial top-line data expected by end of November.
- **Regulatory Progress**: Secured priority review in China and conditional authorization in the UK, with global submissions planned for H1 2026.
- **Funding Strength**: $275.6 million cash post-Q3, supported by $175 million in recent financings and potential $165 million from warrant exercises.
- **Commercialization Plan**: Targeting U.S. launch with 20-40-person sales force, estimating $200 million in commercialization costs.
- **Financial Health**: Q3 net loss of $21.7 million driven by non-cash expenses, with stable operating cash outflow of $9.3 million.

**【CEO Summary Section】**
- Completed Phase III enrollment for GA (530 subjects) and Stargardt's disease (DRAGON trial). Final top-line data for DRAGON expected by end of November 2025.
- Received regulatory approvals for priority review in China (NMPA) and conditional marketing authorization in the UK (MHRA) based on interim DRAGON trial results.
- Secured $50 million registered direct offering and $125 million private placement, with potential additional $165 million from warrant exercises, providing $275.6 million in cash as of Q3 2025.
- Planning global submissions for Tinlarebant in first half of 2026, prioritizing U.S., Japan, and other key markets.

**【CFO Financial Commentary】**
- Q3 2025 net loss of $21.7 million (vs. $8.7 million YoY), driven by $12.9 million non-cash share-based compensation expenses.
- R&D expenses: $10.3 million (vs. $6.8 million YoY) due to DRAGON and PHOENIX trials.
- G&A expenses: $12.7 million (vs. $2.9 million YoY), primarily from equity incentive plan grants.
- Operating cash outflow: $9.3 million (similar to Q2 2025).
- Total cash: $275.6 million post-Q3, sufficient for clinical trials and commercialization.

**【Q&A Highlights】**
- **Regulatory Submissions**: Plan to submit applications in China, UK, and Japan in first half of 2026, using consistent DRAGON trial data package.
- **Share Outstanding**: Approximately 35 million shares (exact figure pending S-3 filing).
- **Japan Strategy**: Engaging PMDA for JNDA submission, targeting early market authorization.
- **PHOENIX Trial**: Interim analysis (H2 2026) will include sample size reestimation similar to DRAGON trial.
- **Commercialization Costs**: Estimate $200 million needed for U.S. launch, with initial sales force of 20-40 representatives.
- **Cash Sufficiency**: Current $275.6 million cash position, plus potential $165 million from warrants, deemed sufficient for commercial prep.


Belite Bio, Inc (BLTE) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

BLTE

BLTE fundamentals

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